Criticism of EFSA's scientific opinion on combinatorial effects of 'stacked' GM plants.

Science.gov (United States)

Bøhn, Thomas

2018-01-01

Recent genetically modified plants tend to include both insect resistance and herbicide tolerance traits. Some of these 'stacked' GM plants have multiple Cry-toxins expressed as well as tolerance to several herbicides. This means that non-target organisms in the environment (biodiversity) will be co-exposed to multiple stressors simultaneously. A similar co-exposure may happen to consumers through chemical residues in the food chain. EFSA, the responsible unit for minimizing risk of harm in European food chains, has expressed its scientific interest in combinatorial effects. However, when new data showed how two Cry-toxins acted in combination (added toxicity), and that the same Cry-toxins showed combinatorial effects when co-exposed with Roundup (Bøhn et al., 2016), EFSA dismissed these new peer-reviewed results. In effect, EFSA claimed that combinatorial effects are not relevant for itself. EFSA was justifying this by referring to a policy question, and by making invalid assumptions, which could have been checked directly with the lead-author. With such approach, EFSA may miss the opportunity to improve its environmental and health risk assessment of toxins and pesticides in the food chain. Failure to follow its own published requests for combinatorial effects research, may also risk jeopardizing EFSA's scientific and public reputation. Copyright © 2017. Published by Elsevier Ltd.

EFSA Panel on Food Contact Materials , Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 224 (FGE.224): Consideration of genotoxic potential for two α,β - unsaturated thiophenes from subgroup 5.2 of FGE.19 by EFSA

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Lund, Pia

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of two flavouring substances from subgroup 5.2 of FGE.19 in the Flavouring Group Evaluation 224 (FGE.224). The Flavour Industry has...... provided additional genotoxicity studies for one of the two substances in FGE.224, namely 5-methyl-2-thiophenecarbaldehyde [FL-no: 15.004]. The data requested by EFSA for the other substance, 3-acetyl-2,5-dimethylthiophene [FL-no: 15.024] of FGE.224 will be provided subsequently according to the Flavour...... are still pending and no conclusion could be drawn in the present FGE. © European Food Safety Authority, 2013...

Update on the state of play of Animal Health and Welfare and Environmental Impact of Animals derived from SCNT Cloning and their Offspring, and Food Safety of Products Obtained from those Animals

OpenAIRE

European Food Safety Authority

2012-01-01

The European Food Safety Authority (EFSA) received in December 2011, a request from the European Commission for an update on the possible scientific developments for cloning of farmed animals for food production purposes. The present Statement follows the EFSA 2009 and 2010 Statements and the EFSA 2008 Scientific Opinion, and is based on peer reviewed scientific literature published since the EFSA 2010 Statement, information made available to EFSA following a call for data, and discu...

Opinion of the Scientific Panel on Genetically Modified Organisms on a question from the Commission related to the Austrian notification of national legislation governing GMOs under article 95(5) of the Treaty

DEFF Research Database (Denmark)

Andersson, H. C.; Bartsch, D.; Buhk, H.-J.

2003-01-01

Opinion adopted on 4 July 2003 (Question No EFSA-Q-2003-001); EFSA=European Food Safety Authority......Opinion adopted on 4 July 2003 (Question No EFSA-Q-2003-001); EFSA=European Food Safety Authority...

Assessment of recent developmental immunotoxicity studies with bisphenol A in the context of the 2015 EFSA t-TDI

Science.gov (United States)

Hessel, Ellen V.S.; Ezendam, Janine; van Broekhuizen, Fleur A.; Hakkert, Betty; DeWitt, Jamie; Granum, Berit; Guzylack, Laurence; Lawrence, B. Paige; Penninks, Andre; Rooney, Andrew A.; Piersma, Aldert H.; van Loveren, Henk

2017-01-01

Summary Humans are exposed to bisphenol A (BPA) mainly through the diet, air, dust, skin contact and water. There are concerns about adverse health effects in humans due to exposure to bisphenol A (BPA). The European Food Safety Authority (EFSA) has extensively reviewed the available literature to establish a temporary Tolerable Daily Intake (t-TDI). This exposure level was based on all available literature published before the end of 2012. Since then, new experimental animal studies have emerged, including those that identified effects of BPA on the immune system after developmental exposure. These studies indicate that developmental immunotoxicity might occur at lower dose levels than previously observed and on which the current EFSA t-TDI is based. The Dutch National Institute for Public Health and the Environment (RIVM) organized an expert workshop in September 2015 to consider recently published studies on the developmental immunotoxicity of bisphenol A (BPA). Key studies were discussed in the context of other experimental studies. The workshop concluded that these new experimental studies provide credible evidence for adverse immune effects after developmental exposure to BPA at 5 μg/kg BW/day from gestation day 15 to postnatal day 21. Supportive evidence for adverse immune effects in similar dose ranges was obtained from other publications that were discussed during the workshop. The dose level associated with adverse immune effects is considerably lower than the dose used by EFSA for deriving the t-TDI. The workshop unanimously concluded that the current EFSA t-TDI warrants reconsideration in the context of all currently available data. PMID:27352639

Recovery in environmental risk assessment at EFSA

NARCIS (Netherlands)

Brock, T.C.M.

2016-01-01

EFSA performs environmental risk assessments (ERAs) for single potential stressors such as plant protection products, genetically modified organisms and feed additives and for invasive alien species that are harmful for plant health. In this risk assessment domain, the EFSA Scientific Committee

EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2015. Scientific Opinion on the risks to public health related to the presence of nickel in food and drinking water

OpenAIRE

Petersen, Annette

2015-01-01

EFSA received a request from the Hellenic Food Authority (EFET) for a scientific opinion on the risk to human health from the presence of nickel (Ni) in food, particularly in vegetables. The EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) decided to extend the risk assessment also to drinking water. The reproductive and developmental toxicity in experimental animals was selected as the critical effect for the assessment of chronic effects of Ni. A tolerable daily intake of 2.8 µg ...

EFSA's scientific activities and achievements on the risk assessment of genetically modified organisms (GMOs) during its first decade of existence: looking back and ahead.

Science.gov (United States)

Devos, Yann; Aguilera, Jaime; Diveki, Zoltán; Gomes, Ana; Liu, Yi; Paoletti, Claudia; du Jardin, Patrick; Herman, Lieve; Perry, Joe N; Waigmann, Elisabeth

2014-02-01

Genetically modified organisms (GMOs) and derived food and feed products are subject to a risk analysis and regulatory approval before they can enter the market in the European Union (EU). In this risk analysis process, the role of the European Food Safety Authority (EFSA), which was created in 2002 in response to multiple food crises, is to independently assess and provide scientific advice to risk managers on any possible risks that the use of GMOs may pose to human and animal health and the environment. EFSA's scientific advice is elaborated by its GMO Panel with the scientific support of several working groups and EFSA's GMO Unit. This review presents EFSA's scientific activities and highlights its achievements on the risk assessment of GMOs for the first 10 years of its existence. Since 2002, EFSA has issued 69 scientific opinions on genetically modified (GM) plant market registration applications, of which 62 for import and processing for food and feed uses, six for cultivation and one for the use of pollen (as or in food), and 19 scientific opinions on applications for marketing products made with GM microorganisms. Several guidelines for the risk assessment of GM plants, GM microorganisms and GM animals, as well as on specific issues such as post-market environmental monitoring (PMEM) were elaborated. EFSA also provided scientific advice upon request of the European Commission on safeguard clause and emergency measures invoked by EU Member States, annual PMEM reports, the potential risks of new biotechnology-based plant breeding techniques, evaluations of previously assessed GMOs in the light of new scientific publications, and the use of antibiotic resistance marker genes in GM plants. Future challenges relevant to the risk assessment of GMOs are discussed. EFSA's risk assessments of GMO applications ensure that data are analysed and presented in a way that facilitates scientifically sound decisions that protect human and animal health and the environment.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on Dihydrocapsiate

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of a synthetic dihydrocapsiate (DHC) as a food ingredient in the context of Regulation (EC) No 258/97 taking into account...

EFSA Panel on Biological Hazards (BIOHAZ); Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2011 update)

DEFF Research Database (Denmark)

Hald, Tine

) assessment was developed by EFSA for its own use to provide a generic risk assessment approach applicable across EFSA’s scientific Panels, for biological agents notified for intentional use in the whole food chain. The safety of unambiguously defined biological agents at the highest taxonomic unit......EFSA is requested to assess the safety of a broad range of biological agents (including microorganisms and viruses) in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS...

European Food Safety Authority; Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to beta-palmitate and increased calcium absorption pursuant to Article 14 of Regulation (EC

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, EFSA was asked to review the scientific comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to beta-palmitate and increased...... calcium absorption pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments submitted to EFSA via the European Commission Services originated from the applicant (IDACE). EFSA has reviewed the comments and shared them with the chair of the NDA Panel, Prof. Albert Flynn, and the chair of the NDA...

[Safety assessment of foods derived from genetically modified plants].

Science.gov (United States)

Pöting, A; Schauzu, M

2010-06-01

The placing of genetically modified plants and derived food on the market falls under Regulation (EC) No. 1829/2003. According to this regulation, applicants need to perform a safety assessment according to the Guidance Document of the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA), which is based on internationally agreed recommendations. This article gives an overview of the underlying legislation as well as the strategy and scientific criteria for the safety assessment, which should generally be based on the concept of substantial equivalence and carried out in relation to an unmodified conventional counterpart. Besides the intended genetic modification, potential unintended changes also have to be assessed with regard to potential adverse effects for the consumer. All genetically modified plants and derived food products, which have been evaluated by EFSA so far, were considered to be as safe as products derived from the respective conventional plants.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the safety of astaxanthin-rich ingredients (AstaREAL A1010 and AstaREAL L10) as novel food ingredients

DEFF Research Database (Denmark)

Tetens, Inge; Poulsen, Morten

2014-01-01

/day. Mean and high-level (95th percentile) daily intakes of 0.106 mg/kg bw and 0.256 mg/kg bw astaxanthin from the NFIs were estimated, based on European consumption data of the proposed food categories. The consumption of the NFIs is not considered to be nutritionally disadvantageous. There are no safety....... The Panel notes that the maximum recommended intake of 4 mg astaxanthin per day (0.06 mg/kg bw) and the estimated mean intake based on the use levels in the proposed food categories (0.106 mg/kg bw per day) exceed the ADI by approximately two- and three-fold, respectively. The Panel therefore concludes......Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of astaxanthin-rich ingredients AstaREAL A1010 and AstaREAL L10 as novel food ingredients (NFIs) in the context of Regulation...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Guidance on the scientific requirements for health claims related to physical performance

DEFF Research Database (Denmark)

Tetens, Inge

The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) to draft guidance on scientific requirements for health claims related to physical performance. This guidance has been drawn from scientific opinions of the NDA Panel on such health...... claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in this area. It is not intended that the document should include an exhaustive list of beneficial effects and studies/outcome measures which...

EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), 2013. Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2013 update)

DEFF Research Database (Denmark)

Licht, Tine Rask; Baggesen, Dorte Lau

EFSA is requested to assess the safety of a broad range of biological agents in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide...... a harmonised generic pre-assessment to support safety risk assessments performed by EFSA’s scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended), and the completeness of the body of knowledge...... is the one in the most recently published scientific opinion. The 2013 update reviews previously assessed microorganisms including bacteria, yeasts, filamentous fungi, oomycetes and viruses used for plant protection purposes. All taxonomic units previously recommended for the QPS list had their status...

The European Food Safety Authority scientific opinion on a risk profile related to production and consumption of insects as food and feed

DEFF Research Database (Denmark)

Finke, Mark D; Rojo, S; Roos, Nanna

2015-01-01

Authority (EFSA) to conduct a review of the current knowledge about biological, chemical and environmental risks associated with production and consumption of insects. National authorities in some EU member states (Belgium, the Netherlands and France) have conducted national assessments (ANSES, 2015; FASFC...

Risk identification in food safety: Strategy and outcomes of the EFSA emerging risks exchange network (EREN), 2010-2014

DEFF Research Database (Denmark)

Costa, M. C.; Goumperis, T.; Andersson, W.

2017-01-01

should be considered emerging or not, and if it merited further consideration, such as generating data on the issue, starting a full risk assessment and/or consultation of other bodies. According to the emerging risks identification process set in place at EFSA, the issues discussed and found...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014 . Scientific Opinion on the substantiation of a health claim related to zinc and normal growth pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...

EFSA Panel on Dietetic Products, Nutrition and Allerg ies (NDA) ; Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations

DEFF Research Database (Denmark)

Tetens, Inge

The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to draft guidance on scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. This guidance has been drawn from scientific...... and studies/outcome measures which are acceptable. Rather, it presents examples drawn from evaluations already carried out in order to illustrate the approach of the Panel, as well as some examples which are currently under consideration within ongoing evaluations. A draft of this guidance document, endorsed...

Reply to the EFSA (2016) on the relevance of recent publications (Hofmann et al. 2014, 2016) on environmental risk assessment and management of Bt-maize events (MON810, Bt11 and 1507).

Science.gov (United States)

Kruse-Plass, Maren; Hofmann, Frieder; Kuhn, Ulrike; Otto, Mathias; Schlechtriemen, Ulrich; Schröder, Boris; Vögel, Rudolf; Wosniok, Werner

2017-01-01

In this commentary, we respond to a report of the EFSA GMO Panel (EFSA EFSA Supp Publ, 1) that criticises the outcomes of two studies published in this journal (Hofmann et al. Environ Sci Eur 26: 24, 2; Environ Sci Eur 28: 14, 3). Both publications relate to the environmental risk assessment and management of Bt-maize, including maize events MON810, Bt11 and maize 1507. The results of Hofmann et al. (Environ Sci Eur 26: 24, 2), using standardised pollen mass filter deposition measurements, indicated that the EFSA Panel model had underestimated pollen deposition and, hence, exposure of non-target organisms to Bt-maize pollen. The results implied a need for safety buffer distances in the kilometre range for protected nature reserve areas instead of the 20-30 m range recommended by the EFSA Panel. As a result, the EFSA Panel revised their model (EFSA EFSA J 13: 4127, 4), adopting the slope of the empirical data from Hofmann et al. The intercept, however, was substantially reduced to less than 1% at one point by introducing further assumptions based on the estimates of mainly panel members, citing possible 'uncertainty'. Hofmann et al. (Environ Sci Eur 28: 14, 3) published extensive empirical data regarding pollen deposition on leaves. These results were part of a larger 3-year study involving detailed measurements of pollen release, dispersal and deposition over the maize flowering period. The data collected in situ confirmed the previous predictions of Hofmann et al. (Environ Sci Eur 26: 24, 2). Mean levels and observed variability of pollen deposition on maize and four lepidopteran host plants exceeded the assumptions and disagreed with the conclusions of the EFSA Panel. The EFSA Panel reacted in a report (EFSA EFSA Supp Publ, 1) criticising the methods and outcomes of the two published studies of Hofmann et al. while reaffirming their original recommendations. We respond here point-by-point, showing that the critique is not justified. Based on our results on

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific opinion on niacin and contribution to normal energy-yielding metabolism: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific opinion on biotin and contribution to normal energy-yielding metabolism: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 12, Revision 2 (FGE.12Rev2): Primary saturated or unsaturated alicyclic alcohol, aldehyde, acid, and esters from chemical group 7

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs....... However, this does not preclude evaluation of the flavouring substances in the present group using the Procedure (SCF, 1999a). It is considered that on the basis of the default MSDI approach these nine flavouring substances would not give rise to safety concerns at the estimated levels of intake arising...

Health safety issues of synthetic food colorants.

Science.gov (United States)

Amchova, Petra; Kotolova, Hana; Ruda-Kucerova, Jana

2015-12-01

Increasing attention has been recently paid to the toxicity of additives used in food. The European Parliament and the Council published the REGULATION (EC) No. 1333/2008 on food additives establishing that the toxicity of food additives evaluated before 20th January 2009 must be re-evaluated by European Food Safety Authority (EFSA). The aim of this review is to survey current knowledge specifically on the toxicity issues of synthetic food colorants using official reports published by the EFSA and other available studies published since the respective report. Synthetic colorants described are Tartrazine, Quinoline Yellow, Sunset Yellow, Azorubine, Ponceau 4R, Erythrosine, Allura Red, Patent Blue, Indigo Carmine, Brilliant Blue FCF, Green S, Brilliant Black and Brown HT. Moreover, a summary of evidence on possible detrimental effects of colorant mixes on children's behaviour is provided and future research directions are outlined. Copyright © 2015 Elsevier Inc. All rights reserved.

Calculation of dietary exposure to acrylamide in the Norwegian population

OpenAIRE

Norwegian Scientific Committee for Food Safety

2015-01-01

The Norwegian Scientific Committee for Food Safety (VKM) is requested by the Norwegian Food Safety Authority (NFSA) to calculate the dietary exposure to acrylamide in the Norwegian population. NFSA refers to the recent scientific opinion on acrylamide in food by the European Food Safety Authority (EFSA). EFSA concludes that acrylamide in food potentially increases the risk of developing cancer for consumers in all age groups.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to caffeine and increased alertness pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from SmithKline Beecham Limited, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to choline and “development of brain” pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 310 (FGE.310): Rebaudioside A from chemical group 30

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate rebaudioside A [FL-no: 16.113], a steviol glycoside. The substance was not considered to have genotoxic potential. Since a comprehensive and adequate...... toxicological database, including human studies, is available for steviol glycosides, the Panel based its evaluation of rebaudioside A on a comparison of the ADI of 4 mg/kg bw, expressed as steviol, established by EFSA, with the estimated dietary exposure figures based on the MSDI and mTAMDI approaches....... The Panel concluded that rebaudioside A [FL-no: 16.113] would not give rise to safety concerns at the estimated level of intake arising from its use as flavouring substance....

EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2015. Scientific Opinion on the risks to public health related to the presence of nickel in food and drinking water

DEFF Research Database (Denmark)

Petersen, Annette

EFSA received a request from the Hellenic Food Authority (EFET) for a scientific opinion on the risk to human health from the presence of nickel (Ni) in food, particularly in vegetables. The EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) decided to extend the risk assessment also...... to drinking water. The reproductive and developmental toxicity in experimental animals was selected as the critical effect for the assessment of chronic effects of Ni. A tolerable daily intake of 2.8 µg Ni/kg body weight (b.w.) per day was derived from a lower 95 % confidence limit for a benchmark dose at 10...... after oral exposure to Ni was selected as the critical effect suitable for the assessment of acute effects of Ni. A lowest BMDL10 of 1.1 µg Ni/kg b.w. was derived for the incidence of SCD following oral exposure to Ni of human volunteers. The CONTAM Panel applied a margin of exposure (MOE) approach...

Pilot project on the Danish implementation of FoodEx2 as part of the Standard Sample Description for the electronic transmission of harmonised chemical occurrence data to EFSA (NP/EFSA/DCM/2012/01)

DEFF Research Database (Denmark)

Andersen, Jens Hinge; Christensen, Tue

The National Food Institute at the Technical University of Denmark has been recoding and transmitting data for chemical contaminants and pesticide residues to EFSA in the SSD format on behalf of the Danish Veterinary and Food Authority using FoodEx1 and MATRIX food classification. To prepare...... for the updated data format for food description and classification, FoodEx2, this terminology has been fully translated into the Danish language. The translation tables (based on FoodEx1 as food classification) prepared while performing the data transmission grant project (Electronic Transmission of Chemical...... Occurrence Data (CFP/EFSA/DATEX/2009/01)) have been supplemented with the FoodEx2 code, comprising of base term and additional (non-implicit) facets. Approximately 1000 distinct food descriptions from the LIMS have been associated with the equivalent FoodEx2 codes. The performance of FoodEx2 in classifying...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to iodine and contribution to normal cognitive development pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to iodine and contribution to normal thyroid function pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to “complex carbohydrates” and “contribute to satiety” pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to prunes and contribution to normal bowel function pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to DHA and contribution to normal brain development pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from DSM Nutritional Products, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver...

EFSA Panel on Genetically Modified Organisms (GMO); Scientific Opinion on an application (EFSAGMO-NL-2012-107) for the placing on the market of maize MON 810 pollen under Regulation (EC) No 1829/2003 from Monsanto

DEFF Research Database (Denmark)

Sørensen, Ilona Kryspin

In this opinion, the EFSA GMO Panel addresses the safety of maize MON 810 pollen to complete the scope of an application (RX-MON 810) for the marketing of genetically modified maize MON 810 with the use of MON 810 pollen as or in food. Data on molecular characterisation of maize MON 810 did...... apply to the Cry1Ab protein expressed in MON 810 pollen. While the EFSA GMO Panel is not in a position to conclude on the safety of maize pollen in or as food in general, it concludes that the genetic modification in maize MON 810 does not constitute an additional health risk if maize MON 810 pollen...

EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2016. Scientific opinion on malachite green in food

DEFF Research Database (Denmark)

Petersen, Annette

Malachite green (MG) has been used globally in aquaculture but is not registered for use infood-producing animals in the European Union. The European Commission requested EFSA to evaluatewhether a reference point for action (RPA) of 2 lg/kg for the sum of MG and its major metaboliteleucomalachite...

The importance of data collection for timely and accurate risk assessment

Science.gov (United States)

Gilsenan, MB

2017-09-01

The European Food Safety Authority (EFSA) is responsible for food safety risk assessments at EU level. It provides independent scientific advice on risks associated with the food chain to support EU risk management decisions. Since its establishment, EFSA has amassed a wealth of data to underpin its risk assessments, such as food consumption data, monitoring data and experimental data. Increasing transparency of its risk assessments is a core objective of EFSA. EFSA aims to enhance the quality and transparency of its outputs by giving insofar as possible access to data and methods underpinning its scientific outputs. This paper provides an overview of the role of EFSA, its core data collections and their regulatory framework, as well as data quality and standardisation aspects. Finally, the paper elaborates on EFSA’s 2020 strategy in relation to data, and describes EFSA scientific data warehouse and Knowledge Junction in this regard.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) , 2013. Scientific Opinion on the substantiation of a health claim related to Transitech ® and improvement of bowel function which is maintained after cessation of consumption of the food pursuant to Article 13

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Vivatech, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientif...... of the food. A cause and effect relationship has not been established between the consumption of Transitech® and improvement of bowel function which is maintained after cessation of consumption of the food. © European Food Safety Authority, 2013...... substantiation of a health claim related to Transitech® and improvement of bowel function which is maintained after cessation of consumption of the food. The food, Transitech®, that is the subject of the health claim is sufficiently characterised. The claimed effect, improvement of bowel function which...... is maintained after cessation of consumption of the food, is a beneficial physiological effect. In weighing the evidence, the Panel considered that the one study that investigated the claimed effect did not show an effect of Transitech® on bowel function which is maintained after cessation of consumption...

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2016 Scientific Opinion on Flavouring Group Evaluation 75, Revision 1 (FGE.75Rev1): Consideration of tetrahydrofuran derivatives evaluated by JECFA (63rd meeting) structurally related to tetrahydrofuran

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Nørby, Karin Kristiane

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of the EFSA was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is neces......The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of the EFSA was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation...... for anhydrolinalool oxide (5) [FL-no: 13.097]. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The JECFA concluded all the 11...... with the JECFA conclusion ‘No safety concern at estimated level of intake as flavouring substances’ based on the maximised survey-derived daily intake (MSDI) approach. The specifications for the materials of commerce have also been considered and for all 11 substances, the information is adequate....

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2016. Scientific opinion on Flavouring Group Evaluation 400 (FGE.400): 3-(1- ((3,5-dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2,4-dione

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Nørby, Karin Kristiane

modifier in specific categories of food. There is no safety concern with respect to genotoxicity. A 90-day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed...... for various foods in different food categories.......The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 3-(1-((3,5-dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to citrulline-malate and faster recovery from muscle fatigue after exercise pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Biocodex, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scienti......Following an application from Biocodex, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...... on the scientific substantiation of a health claim related to citrulline-malate and faster recovery from muscle fatigue after exercise. The Panel considers that citrulline-malate is sufficiently characterised. The claimed effect proposed by the applicant is “improved recovery from muscle fatigue”. Faster recovery...... function. The evidence provided by the applicant did not establish that a faster reduction of blood lactate concentrations through a dietary intervention leads to faster recovery from muscle fatigue by contributing to the restoration of muscle function after exercise. No conclusions could be drawn from...

The role of the safety authority

International Nuclear Information System (INIS)

Gelder, P. de

2004-01-01

The original programme of the Belgium Workshop did not include a scheduled talk by a representative of the safety authority. However, because of the interest expressed by FSC delegates in this player, a speaker stepped forward. Pieter De Gelder, division head of AVN spoke of the role of the safety authority in the local dialogue. He recalled that in Belgium a safety authority in the modern sense of the word was founded only in the mid 1990's. The safety authority is a federal agency (FANC), while AVN is a private company, a contractor to FANC. Mr. De Gelder highlighted that the regulators are not formal members of the partnerships and do not attend each meeting. However, from time to time, partnerships invite experts from FANC and AVN to give presentations on specific topics. In particular, these experts have provided information on their roles and activities in the process, on legal and authorization procedures, and on the evaluation of ONDRAF/NIRAS dossiers. Mr. De Gelder observed that they found a very motivated local audience and they have committed themselves to continued interaction with the partnerships. Finally, he stressed that this type of public interaction around the repository issue is new to the regulator. (author)

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the modification of the authorisation of a health claim related to cocoa flavanols and maintenance of normal endotheliumdependent vasodilation pursuant to Article 13(5) of Regulation (EC) No 1924

DEFF Research Database (Denmark)

Tetens, Inge

2014-01-01

Following an application from Barry Callebaut Belgium NV, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the modification of the authoris......Following an application from Barry Callebaut Belgium NV, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the modification...... of the authorisation of a health claim related to “cocoa flavanols help maintain the elasticity of blood vessels, which contributes to normal blood flow”, pursuant to Article 13(5) of Regulation (EC) No 1924/2006. The modification concerns an extension of the authorised conditions of use of the claim to a high......-flavanols (HF) cocoa extract to be consumed in capsules, tablets or added to “other foods, including beverages”. Cocoa flavanols, which are the subject of the health claim, have been sufficiently characterised. Maintenance of normal endothelium-dependent vasodilation is a beneficial physiological effect...

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2016. Scientific opinion on Flavouring Group Evaluation 313, (FGE.313): α,β-unsaturated 3(2H)-furanone derivatives from chemical group 13

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Nørby, Karin Kristiane

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of EFSA was requested to evaluate three flavouring substances, 2,5-dimethyl-4-ethoxyfuran-3(2H)-one [FL-no: 13.117], 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] and 4-Acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13......–activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that the two flavouring substances [FL-no: 13.117, 13.119] do not give rise to safety concerns at their level of dietary intake, estimated on the basis of the Maximised...... Survey-derived Daily Intake (MSDI) approach. For the flavouring substance [FL-no: 13.175], toxicity data are required. Besides the safety assessment of the flavouring substance, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity...

The French Nuclear Safety Authority (ASN)

International Nuclear Information System (INIS)

Alloso, Ph.

2011-01-01

This article presents the statutes, the organization and the missions of the Nuclear Safety Authority (ASN) whose scope includes radiation protection since 2002. Globally ASN is in charge of: -) participating to the making of laws and regulations, -) delivering administrative authorizations, -) controlling the conformity of nuclear installations and activities with the laws and regulations, -) informing the public, and -) reporting on the state of nuclear safety and radiation protection each year. (A.C.)

Coverage of endangered species in environmental risk assessments at EFSA

NARCIS (Netherlands)

Brock, T.C.M.

2016-01-01

The EFSA performs environmental risk assessment (ERA) for single potential stressors such as plant protection products, genetically modified organisms and feed additives, and for invasive alien species that are harmful to plant health. This ERA focusses primarily on the use or spread of such

Statistical modelling of usual intake. Scientific report submitted to EFSA

NARCIS (Netherlands)

Voet, van der H.; Klaveren, van J.D.; Arcella, D.; Bakker, M.; Boeing, H.; Boon, P.E.; Crépét, A.; Dekkers, A.; Boer, de W.; Dodd, K.W.; Ferrari, P.; Goedhart, P.W.; Hart, A.; Heijden, van der G.W.A.M.; Kennedy, M.; Kipnis, V.; Knüppel, S.; Merten, C.; Ocké, M.; Slob, W.

2010-01-01

Within the EFSA Article 36 project “European Tool Usual Intake” (ETUI) a workshop was organised in May 2010 where the different available models to calculate usual intake were presented and discussed. This report integrates the workshop background document, the presentations given by experts, and

Safety culture competition - expectations of a regulatory authority

International Nuclear Information System (INIS)

Keil, D.; Gloeckle, W.

2000-01-01

The accident at the Chernobyl nuclear power station on April 26, 1986 influenced the development of reactor safety and promulgated two basic concepts especially in Germany. On the one hand, extensive measures of in-plant accident management have greatly reduced the so-called residual risk. On the other hand, a comprehensive safety approach has been initiated which comprises the nuclear power plant as a system together with people, technology, and organization and also includes safety culture. In a modern regulatory concept based on the dynamic development of safety, the authority's classical regulatory function of controlling is supplemented by the objective of promoting safety. While preserving the division of responsibilities between the regulatory authority and plant operators, the authority uses 'constructive critical dialog' as a tool to enhance safety. Besides the regulatory assessment of safety culture on the basis of indications or indicators, also the continuous promotion of safety culture in a dialog with plant operators is seen as one of the duties of a regulatory authority. Continued efforts are necessary to maintain the high level of safety culture in German nuclear power plants. Operators are expected to establish a safety management which assigns top priority to safety issues, and which pursues the goal of supervising and promoting safety culture. Developments on the deregulated electricity markets must not lead to safety aspects ranking second to economic aspects. Moreover, also under changed boundary conditions, only the safe operation of nuclear power plants ensures economic viability. (orig.) [de

Consejo de Seguridad Nuclear: the Spanish safety authority

International Nuclear Information System (INIS)

Gonzalez, E.

1993-01-01

The Spanish Authority in Nuclear Safety and Radiological Protection was created by special law in 1981. The Consejo de Seguridad Nuclear (CNS) was established independent of the Government and reporting direct to Congress. This five-member commission is responsible for assisting the Government and other institutions in safety matters, with the the authority to impose safety conditions on all activities related to radioactive materials, and particularly on the nuclear power plants. (author) 1 fig

TSO support to safety authorities in new reactor licensing

Energy Technology Data Exchange (ETDEWEB)

Numark, N.J.; Bowling, M.L. [Numark Associates, Inc., Washington, DC (United States)

2013-07-01

Technical Support Organizations (TSOs) can provide review assistance to a safety authority in a cost-effective and timely manner. TSO scope tailored to safety authority needs. TSOs must understand and adhere to safety authority priorities and culture. TSOs must be flexible in regulatory approaches, work locations, time zones, and languages. Safety authorities have varying technical support needs. For instance, authorities may have substantial staff and expertise on various types of commercial Nuclear Power Plants (NPP), substantial staff and expertise on a single type of commercial NPP, limited staff but with expertise on commercial NPPs or limited staff and no expertise on commercial NPPs.

Hydration and chemical ingredients in sport drinks: food safety in the European context.

Science.gov (United States)

Urdampilleta, Aritz; Gómez-Zorita, Saioa; Soriano, José M; Martínez-Sanz, José M; Medina, Sonia; Gil-Izquierdo, Angel

2015-05-01

Before, during and after physical activity, hydration is a limiting factor in athletic performance. Therefore, adequate hydration provides benefits for health and performance of athletes. Besides, hydration is associated to the intake of carbohydrates, protein, sodium, caffeine and other substances by different dietary aids, during the training and/or competition by athletes. These requirements have led to the development of different products by the food industry, to cover the nutritional needs of athletes. Currently in the European context, the legal framework for the development of products, substances and health claims concerning to sport products is incomplete and scarce. Under these conditions, there are many products with different ingredients out of European Food Safety Authority (EFSA) control where claims are wrong due to no robust scientific evidence and it can be dangerous for the health. Further scientific evidence should be constructed by new clinical trials in order to assist to the Experts Commitees at EFSA for obtaining robust scientific opinions concerning to the functional foods and the individual ingredients for sport population. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Comprehensive European dietary exposure model (CEDEM) for food additives.

Science.gov (United States)

Tennant, David R

2016-05-01

European methods for assessing dietary exposures to nutrients, additives and other substances in food are limited by the availability of detailed food consumption data for all member states. A proposed comprehensive European dietary exposure model (CEDEM) applies summary data published by the European Food Safety Authority (EFSA) in a deterministic model based on an algorithm from the EFSA intake method for food additives. The proposed approach can predict estimates of food additive exposure provided in previous EFSA scientific opinions that were based on the full European food consumption database.

M&R 2016, 154, (ClientEarth and Pesticide Action Network v EFSA)

NARCIS (Netherlands)

Peeters, M.G.W.M.

2015-01-01

Belangenafweging bij het bekendmaken van persoonsgegevens in het kader van een verzoek om milieu informatie die specifieke deskundigenadvisering betreft. In hoger beroep wordt het besluit van EFSA tot geheimhouden van de namen van externe deskundigen die geadviseerd hebben over de totstandkoming van

to Aliphatic and Alicyclic Mono-, Di-, Tri-, and Polysulphides with or without Additional Oxygenated Functional Groups from Chemical Group 20 evaluated by EFSA in FGE.08Rev1 (2009)

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs...... provided by the Industry. For the remaining 17 substances use levels must be provided. These are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation. In order to determine whether the conclusion......, and/or information on specifications). For two substances [FL-no: 12.169 and 12.241] the Procedure should not be applied until adequate genotoxicity data become available and for eight substances [FL-no: 12.009, 12.013, 12.020, 12.023, 12.045, 12.074, 12.155 and 12.280] additional toxicity data...

EFSA (European Food Safety Authority) and ECDC (European Centre for Disease Prevention and Control), 2015. EU Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2013

DEFF Research Database (Denmark)

Korsgaard, Helle Bisgaard

The antimicrobial resistance data on zoonotic and indicator bacteria in 2013, submitted by 28 EU MSs, were jointly analysed by EFSA and ECDC. Resistance in zoonotic Salmonella and Campylobacter species from humans, animals and food, and resistance in indicator Escherichia coli and enterococci...... from broilers and/or pigs in several MSs. Multi-resistance and co-resistance to critically important antimicrobials in both human and animal isolates were uncommon. A minority of isolates from animals belonging to a few Salmonella serovars (notably Kentucky and Infantis) had a high level of resistance......,as well as data on meticillin-resistant Staphylococcus aureus, in animals and food were addressed. ‘Microbiological’ resistance was assessed using epidemiological cut-off (ECOFF) values in animal and food isolates and, where possible, in human isolates. For human isolates interpreted based on clinical...

Statement on the safety of glucosamine for patients receiving coumarin anticoagulants

DEFF Research Database (Denmark)

Tetens, Inge

2011-01-01

The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies to provide a scientific statement on the safety of glucosamine for patients receiving coumarin anticoagulants. More than 40 case reports have been collected by drug-monitoring agencies...... cases haemorrhage occurred in a variety of organs, and in one case this resulted in a persistent vegetative state. The evidence for an interaction between glucosamine and coumarin anticoagulants is strengthened by the observation that in the majority of cases the INR began to fall to normal values when...... glucosamine intake was discontinued. There is insufficient information to conclude on a mechanism for an interaction between glucosamine and coumarin anticoagulants. There are also insufficient data in the case reports to derive a dose-response relationship for glucosamine and to assess the level of risk...

Nuclear Safety Authority independence, progresses to be considered

International Nuclear Information System (INIS)

Delzangles, Hubert

2013-01-01

The Nuclear Safety Authority is an independent administrative body. Nevertheless, functional and organic independence from operators and government can have different degrees. Having a look on the actual context, where government holds a large part of the main nuclear French operators, independence has to be maximal in order to avoid any conflict of interest that could attempt to nuclear safety. In a global point of view, it is possible to think about the risks or the benefits of the institutionalized cooperation between national regulators on the necessary independence of the Nuclear Safety Authority

EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2015. Scientific Opinion on acrylamide in food

DEFF Research Database (Denmark)

Petersen, Annette

EFSA was asked to deliver a scientific opinion on acrylamide (AA) in food. AA has widespread uses as an industrial chemical. It is also formed when certain foods are prepared at temperatures above 120 °C and low moisture, especially in foods containing asparagine and reducing sugars. The CONTAM...... Panel evaluated 43 419 analytical results from food commodities. AA was found at the highest levels in solid coffee substitutes and coffee, and in potato fried products. Mean and 95th percentile dietary AA exposures across surveys and age groups were estimated at 0.4 to 1.9 µg/kg body weight (b.w.) per...

Safety performance indicators used by the Russian Safety Regulatory Authority in its practical activities on nuclear power plant safety regulation

International Nuclear Information System (INIS)

Khazanov, A.L.

2005-01-01

The Sixth Department of the Nuclear, Industrial and Environmental Regulatory Authority of Russia, Scientific and Engineering Centre for Nuclear and Radiation Safety process, analyse and use the information on nuclear power plants (NPPs) operational experience or NPPs safety improvement. Safety performance indicators (SPIs), derived from processing of information on operational violations and analysis of annual NPP Safety Reports, are used as tools to determination of trends towards changing of characteristics of operational safety, to assess the effectiveness of corrective measures, to monitor and evaluate the current operational safety level of NPPs, to regulate NPP safety. This report includes a list of the basic SPIs, those used by the Russian safety regulatory authority in regulatory activity. Some of them are absent in list of IAEA-TECDOC-1141 ('Operational safety performance indicators for nuclear power plants'). (author)

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) , 2013. Scientific Opinion on the safety of “ coriander seed oil ” as a Novel Food ingredient

DEFF Research Database (Denmark)

Tetens, Inge; Poulsen, Morten

were observed when feeding other vegetable oils, although not as severe as that seen for CSO. The dose level of CSO was more than a thousand fold higher than the proposed use level. In a subchronic study using 150, 450 or 1 000 mg/kg bw per day of CSO, a treatment-related effect was observed on blood......Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on “coriander seed oil (CSO)” as a novel food ingredient (NFI) in the context of Regulation (EC) No 258/97. Petroselinic acid (PA......) is the major fatty acid in CSO. Conventional edible oil technologies are used to manufacture the NFI. The NFI is intended to be marketed as a food supplement for healthy adults, at a maximum level of 600 mg per day (i.e. 8.6 mg/kg bw per day for a 70 kg person), which would lead to significantly higher intakes...

The French Nuclear Safety Authority - ASN

International Nuclear Information System (INIS)

2013-01-01

The ASN (Nuclear Safety Authority) was created by the act of 13 June 2006 concerning the transparency and safety of nuclear activities. The ASN is an independent administrative body that is in charge of controlling nuclear activities in France. The ASN has a workforce of 471 people and a budget of about 76 millions euros. This article details its missions and how it is organized to cover all the French territory. (A.C.)

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific Opinion on Dietary Reference Values for cobalamin (vitamin B12)

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for cobalamin (vitamin B12). The Panel considers that the approach based on a combination of biomarkers of cobalamin status, i.e. serum....... For pregnancy and lactation, additional cobalamin intakes related to the accumulation of cobalamin in fetal tissues and transfer of cobalamin into breast milk are considered and AIs of 4.5 and 5 μg/day, respectively, are proposed....

Implementation of Electronic Transmission of Chemical Occurrence Data (CFP/EFSA/DATEX/2009/01) in Denmark

DEFF Research Database (Denmark)

Andersen, Jens Hinge

EFSA has prepared a standard data model for the transmission of chemical occurrence data and pesticide residues. This model is referred to as the “Standard Model” (SM) or the “Standard Sample Description” (SSD). The aim of the present project was to collect and transform data from the Danish...... national data repositories for chemical contaminants and pesticides and in coding these according to the SM and to facilitate the continued use of the SM in answering future EFSA data calls in these areas. Restructuring was performed using existing equipment and programming tools. SAS procedures and Excel...... mapping tables were developed to handle the data transformation. The main challenges were mapping existing data to the SM, synthesising necessary information missing in the national repository, and dealing with the complexity of pesticide substance reporting....

Scientific Opinion on Review of the European Union Summary Report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks—Terms of reference 2 to 7

OpenAIRE

EFSA Panel on Animal Health and Welfare (AHAW)

2013-01-01

The Animal Health and Welfare (AHAW) Panel of the European Food Safety Authority (EFSA) has evaluated the European Union Summary Report on Trends and Sources of Zoonoses, Zoonotic Agents and Food-borne Outbreaks by EFSA and ECDC (the report) with regard to data needs and subsequent analyses that will minimise the impact of existing data gaps and inconsistencies. Specific assessments performed for bovine tuberculosis, echinococcosis, Q fever, brucellosis, rabies, cysticercosis and tularaemia s...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the extension of use for DHA and EPA-rich algal oil from Schizochytrium sp. as a Novel Food ingredient

DEFF Research Database (Denmark)

Tetens, Inge; Poulsen, Morten

2014-01-01

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on an extension of use for docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)-rich algal oil from Schizochytrium sp. as a novel food...... population, excluding pregnant and lactating women. In a previous opinion on the Tolerable Upper Intake Level of EPA, DHA and docosapentaenoic acid (DPA), the Panel concluded that supplemental intake of EPA and DHA combined at doses up to 5 g/day, does not give rise to safety concerns for adults. Based...... ingredient (NFI) in the context of Regulation (EC) No 258/97. The NFI is already authorised for use in a range of foodstuffs at specified maximum levels. The applicant requests an extension of use of the NFI in food supplements up to a maximum DHA and EPA content of 3 g per daily dose for the adult...

[Assessment of allergenicity of genetically modified food crops].

Science.gov (United States)

Schauzu, M; Pöting, A; Rubin, D; Lampen, A

2012-03-01

The placing on the European Union's market of genetically modified crops requires authorization by the European Commission which is based on the proof that the derived foods are as safe as their conventional counterparts. The assessment of potential allergenicity is part of the necessary investigations recommended in the updated Guidance Document of the Scientific Panel on Genetically Modified Organisms (GMO) of the European Food Safety Authority (EFSA), which is based on internationally agreed recommendations. All genetically modified crops which so far have been authorized in the European Union were evaluated by the EFSA GMO Panel which considered it unlikely that their overall allergenicity has been altered.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific Opinion on the substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

Following an application from Han-Asiabiotech GmbH, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...... in blood pressure when Symbiosal® was consumed instead of table salt for eight weeks in the context of a salt-restricted diet, but that no other human studies in which these results have been replicated were provided, that the animal studies did not support the results of the human study...

Technical Report, Outcome of the public consultation on the draft Scientific Opinion of the EFSA Panel on Contaminants on the Food Chain (CONTAM) on acrylamide in food

DEFF Research Database (Denmark)

Petersen, Annette

The EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) has endorsed its draft Scientific Opinion on the risks to public health related to the presence of acrylamide (AA) in food. The opinion has undergone a public consultation from 1 July 2014 to 15 September 2014. Overall, EFSA has...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on bovine lactoferrin

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment for ‘lactoferrin’ as a food ingredient in the context of Regulation (EC) No 258/97 taking into account the comments and objections...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on bovine lactoferrin

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment of ‘lactoferrin’ as a food ingredient in the context of Regulation (EC) No 258/97 taking into account the comments and objections...

Nuclear safety authority. Strategical planning 2005- 2007

International Nuclear Information System (INIS)

Anon.

2006-01-01

The Nuclear safety Authority (A.S.N.) provides, in the name of the state, the monitoring of nuclear safety and radiation protection to protect workers, patients, public and environment from the risks in relation with nuclear activities and more broadly with ionizing radiations, it contributes to citizens information in these areas. The ambition of A.S.N. is to carry out a successful, legitimate, credible nuclear monitoring, recognized by citizens and that constitutes an international reference. (N.C.)

Relations between the safety authority and the nuclear power plant operators

International Nuclear Information System (INIS)

Laverie, M.; Flandrin, R.

1991-01-01

The French experience has led the safety authority to pay particular attention to the competence of a nuclear operator and to the exercise of his responsibility. In this context, safety does not seem to be improved by the imposition of too many regulations and control activities. On the contrary, an excessive regulatory framework may blunt the operator's awareness of his responsibility. It is the duty of the safety authority to fix the safety objectives. It is the operator's duty to establish the practical conditions for attaining these objectives and to justify these conditions to the safety authority. It is also his duty to implement them correctly. The authority must then verify the quality of this implementation by random inspection methods. Each of the two partners, each conforming to his role and exercise of his particular responsibilities, must remain vigilant. These different actions necessitate a permanent technical dialogue which is not in contradiction with the exercise of strict regulatory control. (orig.)

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to Preservation ® and “ rapid recovery of cellular activity post stress ” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from ICP Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Malta, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...... substantiation of a health claim related to Preservation® and “rapid recovery of cellular activity post stress”. The Panel considers that Preservation®, which contains an extract of prickly pear cactus Opuntia ficus-indica, is sufficiently characterised. The claimed effect is “rapid recovery of cellular activity...

Creating a safety culture in the regulatory authority: The Cuban experience

International Nuclear Information System (INIS)

Ferro Fernandez, R.; Guillen Campos, A.

2002-01-01

The Cuban regulatory authority has been working during several years for the fostering and development of a high Safety Culture level in nuclear activities in the country. As starting point to achieve this objective the assessment of the Safety Culture level in the regulatory authority performance was considered an important issue. For this purpose a preliminary diagnosis was carried out by means of a national survey that allowed identifying some areas of the regulatory activity that required improvements in order to achieve a higher Safety Culture and to immediately implement appropriate actions. Two of the most important actions undertaken were: the statement of the regulatory authority Safety Policy which governs and determines the performance of this organization and its staff and also the implementation of a new interaction practice at top level between the regulatory authority and the utilities of the nuclear sector through the Annual Regulatory Conference. The present paper summarizes these two introduced practices into the Cuban regulatory activity. (author)

The French nuclear safety authority, an independent administrative body

International Nuclear Information System (INIS)

Lacoste, A.C.

2007-01-01

The Nuclear Safety Authority (ASN) is officially responsible for controlling safety and radioactivity in France so as to protect wage-earners, patients, the public and the environment from nuclear-related risks. It draws on the work done by the Institute of Radioprotection and Nuclear Safety (IRSN), and provides information to the public on these questions. The Authority's goal is to ensure an effective, legitimate, impartial and creditable control recognized by the public and serving as an international reference mark. ASN is led by a board of 5 commissaries, has a staff of 420 employees most of them civil servants, has an annual budget of 50 million euros and relies on 11 regional departments

Exchange of information between nuclear safety authorities: Policy of the French regulator

International Nuclear Information System (INIS)

Asty, Michel

2000-01-01

Full text: The decree setting up the Nuclear Safety Authority in 1973 entrusted it with international assignments whose objectives are still valid: - develop exchanges of information with foreign counterparts on regulatory systems and practices, on problems encountered in the nuclear safety field and on provisions made, with a view to enhancing its approach, and - becoming better acquainted with the actual operating practice of these Safety Authorities from which lessons could be learned for its own working procedures; - improving its position in the technical discussions with the French operators, since its arguments would be strengthened by practical knowledge of conditions abroad; - make known and explain the French approach and practices in the nuclear safety field and provide information on measures taken to deal with the problems encountered. This approach has several objectives: - promote the circulation of information on French positions on certain issues, such as very low level waste, for instance; - assist some countries wishing to create or modify their Nuclear Safety Authority, such as countries of the former USSR, the Central and Eastern European countries, and emerging countries on other continents; - help, when requested, foreign Safety Authorities required to issue permits for nuclear equipment of French origin; - provide the countries concerned with all relevant information on French nuclear installations located near their frontiers. Examples are given on the way the French Nuclear Safety Authority implements these objectives. (author)

Barley genotypic β-glucan variation combined with enzymatic modifications direct its potential as a natural ingredient in a high fiber extract

DEFF Research Database (Denmark)

Mikkelsen, Mette S.; Meier, Sebastian; Jensen, Morten G.

2017-01-01

-glucan/l, providing European Food Safety Authority (EFSA) and U.S. Food and Drug Administration (FDA) recommended amounts (3 g β-glucan/day) from three portions. TAF extracts of Lys5f and KVL408 grains reached extraordinary high concentrations of 8- 9 g β-glucan/l. The β-glucan molecular mass decreased with enzyme...... robustness in Lys5f  and KVL408 raw materials favor these in a β-glucan rich extract with potential for EFSA and FDA health and Nutrition claims....

EFSA ; Scientific Opinion on Flavouring Group Evaluation 98 (FGE.98): Consideration of three ring-unsaturated delta-lactones)

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of three unsaturated delta-lactones [FL-no: 10.031, 10.037 and 10.044] previously evaluated by the JECFA at their 49th meeting in 1997. The JECFA considered that further information...... on the metabolism of these three substances was required and that they should be evaluated together with other substances containing alpha,beta-unsaturation and that, therefore, their evaluation should be deferred. However, the EFSA Panel has considered that these three JECFA evaluated aliphatic lactones can...... be hydrolysed and metabolised to innocuous products in line with the aliphatic lactones evaluated by EFSA in FGE.10Rev2. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern...

Scientific Opinion on a Qualified Presumption of Safety (QPS) approach for the safety assessment of botanicals and botanical preparations

DEFF Research Database (Denmark)

Pilegaard, Kirsten

preparation for QPS status, it has been possible to develop a structured assessment scheme that provides a practical method for assessing botanicals and botanical preparations for which an adequate body of knowledge exists and therefore without the need for further testing. Reiterative applications...... in the development of a comprehensive, systematic and transparent methodology. The Scientific Committee recommends its use as an extension of the 2009 EFSA guidance for the safety assessment of botanicals and botanical preparations intended to be used in food supplements....

Technical nuclear safety in France. Control by the governmental authority

International Nuclear Information System (INIS)

1991-12-01

In publishing this latest edition, we have endeavoured to provide the reader with the information necessary to obtain a full understanding of the regulatory system applied to ensure technical nuclear safety in France. As the reader will discover in the following pages, technical nuclear safety is a matter which must be settled in advance of the actual operation of civil nuclear installations; the primary requirement is to mobilize those involved to anticipate and prevent. The fundamental options on which the French system is based, the relationship between the operator and the safety authority must be clearly stated: independence of judgement and decision, complementarity of responsibilities. It is for the governmental authorities to determine the technical nuclear safety objectives, which are becoming more and more consistent if not unified throughout the world. It is for the operator to propose technical provisions in order to achieve these objectives. It is for the governmental authorities to verify, by technical safety analyses, the adequacy of the provisions in terms of the defined objectives. It is for the operator to properly implement these approved provisions. And, finally, it is for the governmental authorities to verify, by sampling, the quality of their implementation and to make from them the necessary regulatory inferences. This sequence of events requires permanent frank in-depth dialogue. The effectiveness of the regulatory action must therefore reside not in close technical restraint but in the interactions between responsible partners

Technical nuclear safety in France. Control by the governmental authority

Energy Technology Data Exchange (ETDEWEB)

NONE

1991-12-15

In publishing this latest edition, we have endeavoured to provide the reader with the information necessary to obtain a full understanding of the regulatory system applied to ensure technical nuclear safety in France. As the reader will discover in the following pages, technical nuclear safety is a matter which must be settled in advance of the actual operation of civil nuclear installations; the primary requirement is to mobilize those involved to anticipate and prevent. The fundamental options on which the French system is based, the relationship between the operator and the safety authority must be clearly stated: independence of judgement and decision, complementarity of responsibilities. It is for the governmental authorities to determine the technical nuclear safety objectives, which are becoming more and more consistent if not unified throughout the world. It is for the operator to propose technical provisions in order to achieve these objectives. It is for the governmental authorities to verify, by technical safety analyses, the adequacy of the provisions in terms of the defined objectives. It is for the operator to properly implement these approved provisions. And, finally, it is for the governmental authorities to verify, by sampling, the quality of their implementation and to make from them the necessary regulatory inferences. This sequence of events requires permanent frank in-depth dialogue. The effectiveness of the regulatory action must therefore reside not in close technical restraint but in the interactions between responsible partners.

EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on Dietary reference values for water

DEFF Research Database (Denmark)

Tetens, Inge

This Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) deals with the setting of dietary reference values for water for specific age groups. Adequate Intakes (AI) have been defined derived from a combination of observed intakes in population groups with desirable...

French safety authority projects in the field of research and test reactors

International Nuclear Information System (INIS)

Saint Raymond, P.; Duthe, M.; Abou Yehia, H.

2001-01-01

This paper gives an outline of some actions initiated by the French safety authority in the field of research and test reactors. An important action concerns the definition of the authorisation criteria for the implementation of experiments in these reactors. In particular, it is necessary to define clearly in which conditions an experiment may be authorised internally by the operating organisation or needs a formal approval by the safety authority. The practice related to the systematic safety reassessment of old facilities and the regulatory provisions associated with the decommissioning are presented after a discussion on the ageing issues. (author)

Radiation protection databases of nuclear safety regulatory authority

International Nuclear Information System (INIS)

Janzekovic, H.; Vokal, B.; Krizman, M.

2003-01-01

Radiation protection and nuclear safety of nuclear installations have a common objective, protection against ionising radiation. The operational safety of a nuclear power plant is evaluated using performance indicators as for instance collective radiation exposure, unit capability factor, unplanned capability loss factor, etc. As stated by WANO (World Association of Nuclear Operators) the performance indicators are 'a management tool so each operator can monitor its own performance and progress, set challenging goals for improvement and consistently compare performance with that of other plants or industry'. In order to make the analysis of the performance indicators feasible to an operator as well as to regulatory authorities a suitable database should be created based on the data related to a facility or facilities. Moreover, the international bodies found out that the comparison of radiation protection in nuclear facilities in different countries could be feasible only if the databases with well defined parameters are established. The article will briefly describe the development of international databases regarding radiation protection related to nuclear facilities. The issues related to the possible development of the efficient radiation protection control of a nuclear facility based on experience of the Slovenian Nuclear Safety Administration will be presented. (author)

Assessing and monitoring impacts of genetically modified plants on agro-ecosystems

DEFF Research Database (Denmark)

Arpaia, S.; Messéan, A.; Birch, N.A.

2014-01-01

The environmental impacts of genetically modified crops is still a controversial issue in Europe. The overall risk assessment framework has recently been reinforced by the European Food Safety Authority(EFSA) and its implementation requires harmonized and efficient methodologies. The EU-funded re...

EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on establishing Food-Based Dietary Guidelines

DEFF Research Database (Denmark)

Tetens, Inge

This Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) provides guidance on the translation of nutrient based dietary advice into guidance, intended for the European population as a whole, on the contribution of different foods or food groups to an overall diet...

EFSA Panel on Plant Protection Products and their Residues (PPR); EFSA Scientific Opinion on the science behind the revision of the guidance document on dermal absorption

DEFF Research Database (Denmark)

Petersen, Annette

will be finalised and published only after adoption and publication of this opinion. This opinion has been developed after a public consultation of EFSA on the current guidance document and an outsourced project carried out by the UK Chemicals Regulation Directorate (CRD, 2010). It is not intended...... that have an impact on absorption, a description of important elements in the design of experimental studies and an analysis of available data on dermal absorption of PPPs. The PPR Panel concludes that assessment of dermal absorption in the absence of specific studies can be performed based on default...

Complementary safety assessments - Report by the French Nuclear Safety Authority

International Nuclear Information System (INIS)

2011-12-01

As an immediate consequence of the Fukushima accident, the French Authority of Nuclear Safety (ASN) launched a campaign of on-site inspections and asked operators (mainly EDF, AREVA and CEA) to make complementary assessments of the safety of the nuclear facilities they manage. The approach defined by ASN for the complementary safety assessments (CSA) is to study the behaviour of nuclear facilities in severe accidents situations caused by an off-site natural hazard according to accident scenarios exceeding the current baseline safety requirements. This approach can be broken into 2 phases: first conformity to current design and secondly an approach to the beyond design-basis scenarios built around the principle of defence in depth. 38 inspections were performed on issues linked to the causes of the Fukushima crisis. It appears that some sites have to reinforce the robustness of the heat sink. The CSA confirmed that the processes put into place at EDF to detect non-conformities were satisfactory. The complementary safety assessments demonstrated that the current seismic margins on the EDF nuclear reactors are satisfactory. With regard to flooding, the complementary safety assessments show that the complete reassessment carried out following the flooding of the Le Blayais nuclear power plant in 1999 offers the installations a high level of protection against the risk of flooding. Concerning the loss of electrical power supplies and the loss of cooling systems, the analysis of EDF's CSA reports showed that certain heat sink and electrical power supply loss scenarios can, if nothing is done, lead to core melt in just a few hours in the most unfavourable circumstances. As for nuclear facilities that are not power or experimental reactors, some difficulties have appeared to implement the CSA approach that was initially devised for reactors. Generally speaking, ASN considers that the safety of nuclear facilities must be made more robust to improbable risks which are not

Pump performance and reliability follow-up by the French Safety Authorities

International Nuclear Information System (INIS)

Clausner, J.P.; De La Ronciere, X.; Scott de Martinville, E.; Courbiere, P.

1990-12-01

This paper will present, through actual examples, the methodology of the performance and reliability safety-related pumps evaluation applied by the French Safety Authorities and the lessons drawn from this evaluation

ILK statement about the regulatory authorities' perception of operators' self-assessment of safety culture

International Nuclear Information System (INIS)

2005-01-01

Over the past few years, German licensing and supervisory authorities have devoted increasing attention to safety management and safety culture issues. At present, German plant operators are introducing systems for self-assessment of the safety culture in their plants, such as the Safety Culture Assessment System developed by VGB Power Tech (VGB-SBS). In its statement, the International Committee on Nuclear Technology (ILK) addresses an effective approach of the authorities in evaluating the self-assessment of safety culture conducted by operators. ILK proposes a total of ten recommendations for evaluating the self-assessment system of the operators by the authority. The regulatory authorities should see to it that the operators establish a self-assessment system for aspects of organization and personnel, and use it continuously. The measures derived from this self-assessment by the operators, and the reasons underlying them, should be discussed with the authorities. In addition to the operators, also the regulatory authorities and the technical expert organizations commissioned by them should carry out self-assessments of their respective supervisory activities, taking into account also special events, such as changes in government, and develop appropriate programs of measures to be taken. In evaluating safety culture, the regulatory authorities should strive to support the activities of operators in improving their safety culture. A spirit of mutual confidence and cooperation should exist between operators and authorities. The recommendations expressed in the statement deliberately leave room for detailed implementation by the parties concerned. (orig.)

Efficacy of antibiotic treatment and test-based culling strategies for eradicating brucellosis in commercial swine herds

NARCIS (Netherlands)

Dieste-Pérez, L.; Frankena, K.; Blasco, J.M.; Muñoz, P.M.; Jong, de M.C.M.

2016-01-01

Swine brucellosis caused by Brucella suis biovar 2 is an emerging disease in continental Europe. Without effective vaccines being available, the European Food Safety Authority (EFSA) recommends the full depopulation of infected herds as the only strategy to eradicate B. suis outbreaks. Using data

Efficacy of antibiotic treatment and test-based culling strategies for eradicating brucellosis in commercial swine herds

NARCIS (Netherlands)

Dieste-Pérez, L.; Frankena, K.; Blasco, J. M.; Muñoz, P. M.; De Jong, M. C M

2016-01-01

Swine brucellosis caused by Brucella suis biovar 2 is an emerging disease in continental Europe. Without effective vaccines being available, the European Food Safety Authority (EFSA) recommends the full depopulation of infected herds as the only strategy to eradicate B. suis outbreaks. Using data

Safety assessment plans for authorization and inspection of radiation sources

International Nuclear Information System (INIS)

2002-05-01

The objective of this TECDOC is to enhance the efficacy, quality and efficiency of the whole regulatory process. It provides advice on good practice administrative procedures for the regulatory process for preparation of applications, granting of authorizations, inspection, and enforcement. It also provides information on the development and use of standard safety assessment plans for authorization and inspection. The plans are intended to be used in conjunction with more detailed advice related to specific practices. In this sense, this TECDOC provides advice on a systematic approach to evaluations of protection and safety while other IAEA Safety Guides assist the user to distinguish between the acceptable and the unacceptable. This TECDOC covers administrative advice to facilitate the regulatory process governing authorization and inspection. It also covers the use of standard assessment and inspection plans and provides simplified plans for the more common, well established uses of radiation sources in medicine and industry, i.e. sources for irradiation facilities, industrial radiography, well logging, industrial gauging, unsealed sources in industry, X ray diagnosis, nuclear medicine, teletherapy and brachytherapy

Safety assessment plans for authorization and inspection of radiation sources

International Nuclear Information System (INIS)

1999-09-01

The objective of this TECDOC is to enhance the efficacy, quality and efficiency of the whole regulatory process. It provides advice on good practice administrative procedures for the regulatory process for preparation of applications, granting of authorizations, inspection, and enforcement. It also provides information on the development and use of standard safety assessment plans for authorization and inspection. The plans are intended to be used in conjunction with more detailed advice related to specific practices. In this sense, this TECDOC provides advice on a systematic approach to evaluations of protection and safety while other IAEA Safety Guides assist the user to distinguish between the acceptable and the unacceptable. This TECDOC covers administrative advice to facilitate the regulatory process governing authorization and inspection. It also covers the use of standard assessment and inspection plans and provides simplified plans for the more common, well established uses of radiation sources in medicine and industry, i.e. sources for irradiation facilities, industrial radiography, well logging, industrial gauging, unsealed sources in industry, X ray diagnosis, nuclear medicine, teletherapy and brachytherapy

[Recommendations for inspections of the French nuclear safety authority].

Science.gov (United States)

Rousse, C; Chauvet, B

2015-10-01

The French nuclear safety authority is responsible for the control of radiation protection in radiotherapy since 2002. Controls are based on the public health and the labour codes and on the procedures defined by the controlled health care facility for its quality and safety management system according to ASN decision No. 2008-DC-0103. Inspectors verify the adequacy of the quality and safety management procedures and their implementation, and select process steps on the basis of feedback from events notified to ASN. Topics of the inspection are communicated to the facility at the launch of a campaign, which enables them to anticipate the inspectors' expectations. In cases where they are not physicians, inspectors are not allowed to access information covered by medical confidentiality. The consulted documents must therefore be expunged of any patient-identifying information. Exchanges before the inspection are intended to facilitate the provision of documents that may be consulted. Finally, exchange slots between inspectors and the local professionals must be organized. Based on improvements achieved by the health care centres and on recommendations from a joint working group of radiotherapy professionals and the nuclear safety authority, changes will be made in the control procedure that will be implemented when developing the inspection program for 2016-2019. Copyright © 2015. Published by Elsevier SAS.

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 06, Revision 2 (FGE.06Rev2): Straight- and branched-chain aliphatic unsaturated primary alcohols, aldehydes, carboxylic acids, and esters from chemical groups 1

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs...... in the commercial flavouring material. Forty-six candidate substances are classified into structural class I. The remaining two substances [FL-no: 05.143 and 09.884] are classified into structural class II. Thirty-eight of the flavouring substances in the present group have been reported to occur naturally...... in a wide range of food items. According to the default MSDI approach, the 48 flavouring substances in this group have intakes in Europe from 0.001 to 120 microgram/capita/day, which are below the thresholds of concern value for both structural class I (1800 microgram/person/day) and structural class II...

EFSA Panel on food contact materials, enzymes, flavourings and processing aids (CEF); Scientific Opinion on Flavouring Group Evaluation 23, Revision 2 (FGE.23Rev2): Aliphatic, alicyclic and aromatic ethers including anisole derivatives from chemical groups 15, 16, 22, 26 and 30

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs...... in the Member States. In particular, the Panel was requested to evaluate 19 flavouring substances in the Flavouring Group Evaluation 23, Revision 2 (FGE.23Rev2), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 19 flavouring substances belong to chemical groups 15, 16, 22......-no: 03.022] Industry has informed that it occurs as a mixture of E- & Z-isomers, however, the composition of the mixture has to be specified. Two of the flavouring substances are classified into structural class I, seven are classified into structural class II and 10 are classified into structural class...

Nuclear risk and communication: the essential role of safety authorities

International Nuclear Information System (INIS)

Hautin, N.

1998-01-01

Full text of publication follows: whether concerning mad cow disease, asbestos, nuclear, OGM or now, dioxin in French meat, public health risks have been making the headlines of newspapers for a while. And, firms whose activity is associated with these risks are in effect in the defendants box. Therefore, communicating becomes difficult: their word is suspect and, debates quite rapidly exceed the firm competencies to become a socio-cultural conflict. This paper explores in nuclear fields the essential role of safety authorities in such communication cases. Our surveys and the comparative case study between the pipe at La Hague and 'contaminated' nuclear transports in France are eloquent: the messages of nuclear firms is perceived through their image of a State within the State built from the past and reinforced by the negative prism of the news. Regular and technical arguments (the respect of norms) entertain the debate rather than hush it. That is why we could infer an objective, and independent opinion is required, one different from the firm, the public and ministries: its role of referee could allow a constructive dialog between the public and the firm. Risk communication nature and efficiency depend on that (cf. the diagram). As a solution, we think about a legitimate authority organization identified by the public first, but by other actors as well. From the public point of view, if we see the place of pressure groups (e.g. Greenpeace) in the debate as a measure of the lack of trust in the independence of safety authorities, we can infer that it is a reaffirmation of democracy which is demanded by the French public, which could be satisfied with powerful safety authorities. That is why safety authorities have an essential role to play, beyond this of control, in nuclear risk communication towards the public. Diagram: communication path between a nuclear firm and the public during conflict. (author)

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to beta-palmitate and contribution to softening of stools pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

2014-01-01

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...... to deliver an opinion on the scientific substantiation of a health claim related to beta-palmitate and contribution to softening of stools. The food constituent, beta-palmitate, that is the subject of the health claim, is sufficiently characterised. Contribution to softening of stools is a beneficial...... physiological effect for infants. In weighing the evidence the Panel took into account that, out of two human intervention studies with important methodological limitations, one suggested a stool-softening effect of beta-palmitate whereas the second did not, that one animal study did not support a stool...

Cooperation between the French and German safety authorities: a process of progress

International Nuclear Information System (INIS)

Lacoste, A.C.; Hennenhoefer, G.

1996-01-01

Considerable efforts are devoted in several countries worldwide for the designing of a new generation of electro-nuclear reactors with noticeable safety improvements with respect to the existing units. The EPR (European Pressurized water Reactor) project is the first example of a joint survey and collaboration effort between two countries, France and Germany, both characterized by a strong nuclear industry and competence. Franco-German relations have considerably expanded in recent years, enabling the French and German electricians, manufacturers (EDF, Siemens, Framatome..), and safety authorities (DSIN, IPSN, BMU, GRS..) to adopt common positions and decisions on fundamental topics about technical aspects of safety. This kind of collaboration and alignment was obviously only possible because two conditions were fulfilled: the discussion concerned future reactors and not those already built for which safety rules and provisions are not easily modified; and a common industrial project existed and had consequently to comply with jointly defined safety objectives. These two conditions are still fulfilled, so it should be possible for the work between French and German safety authorities to continue successfully, even in the next more delicate stage, involving definition of common positions on more detailed technical provisions. Finally, it is unthinkable that this important work undertaken by France and Germany could be carried out without frequent consultation of the safety authorities of other nuclear countries, notably in Europe. (J.S.). 1 fig

Monitoring of polycyclic aromatic hydrocarbons (PAH) in food supplements containing botanicals and other ingredients on the Dutch market

NARCIS (Netherlands)

Martena, M.J.; Grutters, M.; Groot, de H.N.; Konings, E.J.M.; Rietjens, I.

2011-01-01

Food supplements can contain polycyclic aromatic hydrocarbons (PAH). The European Food Safety Authority (EFSA) has defined 16 priority PAH that are both genotoxic and carcinogenic and identified eight priority PAH (PAH8) or four of these (PAH4) as good indicators of the toxicity and occurrence of

Scientific Opinion on the assessment of potential impacts of genetically modified plants on non-target organisms

DEFF Research Database (Denmark)

Arpaia, Salvatore; Bartsch, Detlef; Delos, Marc

The European Food Safety Authority (EFSA) asked the Panel on Genetically Modified Organisms to establish a self-tasking Working Group with the aim of (1) producing a scientific review of the current guidance of the GMO Panel for Environmental Risk Assessment (ERA), focusing on the potential impacts...... of GM plants on Non-Target Organisms (NTOs), (2) proposing criteria for NTOs selection, and (3) providing advise on standardized testing methodology. This initiative was undertaken in response to a need and request from a wide range of stakeholders, including the European Commission and Member States....... In first instance, the self-tasking Working Group on Non-Target Organisms (EFSA NTO WG) mainly considered impacts of GM plants on invertebrate species, but also took account of ecosystem functions that could be altered. The EFSA NTO WG considered the necessity for clear and objective protection goals...

Expectations of the Swiss safety authorities

International Nuclear Information System (INIS)

Naegelin, R.

1994-01-01

On the one hand, nuclear energy can contribute significantly to our energy supply without much environmental consequences. On the other hand, there is a potential for large environmental consequences. The nuclear power plants are vastly different from conventional industrial activities where much has been learned through trial and error processes leading to slow improvements in their safety performance. Hence one cannot afford to learn from mistakes as an approach to safety improvement. It is more important to think ahead and precautions must be taken through proper design and operation before accidents can occur. The precondition for such an approach is what one now refers to as 'safety culture'. This requires a prerequisite frame of mind to 'desire' safety. In addition, the necessary technical 'ability' is also required, without which any culture cannot be realized. Culture is a human reaction to its environment so that it can live in harmony with the real or imaginary world. In the course of human history, different cultures, e.g. hunters and farmers, have evolved to adopt with the prevailing habitats. The term culture is also associated with a humane form of pre-industrial and industrial society. These cultures were, at least partially, the result of pressure to perform suitable actions. However, in the present modern times, things function quite well with less apparent pressure. Thereby positive values in the working culture become questionable. The traits that are endangered include thoroughness, carefulness and sense of duty in ones daily work habits. Also the removal of work from its central position in human life is involved, threatening care by pressure or time and costs. (author)

GlyEFSA NDA Panel (EFSA Panel on Dietetic Product s, Nutrition and Allergies), 20 13 . Scientific Opinion on the substantiation of a health claim related to glycaemic carbohydrates and recovery of normal muscle function (contraction) after stren uous exercise pursuant to Article 13(5) of Regulation

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Aptonia, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...... substantiation of a health claim related to glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise. The food constituent, glycaemic carbohydrates, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect. Recovery...... to the recovery of normal skeletal muscle function (contraction), the Panel concludes that a cause and effect relationship has been established between the consumption of glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise....

Safety and Availability Checking for User Authorization Queries in RBAC

Directory of Open Access Journals (Sweden)

Jian-feng Lu

2012-09-01

Full Text Available This paper introduces the notion of safety and availability checking for user authorization query processing, and develop a recursive algorithm use the ideas from backtracking-based search techniques to search for the optimal solution. For the availability checking, we introduce the notion of max activatable set (MAS, and show formally how MAS can be determined in a hybrid role hierarchy. For the safety checking, we give a formal definition of dynamic separation-of-duty (DSoD policies, and show how to reduce the safety checking for DSoD to a SAT instance.

EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on Dietary Reference Values for carbohydrates and dietary fibre

DEFF Research Database (Denmark)

Tetens, Inge

This Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) deals with the establishment of Dietary Reference Values for carbohydrates and dietary fibre. Nutritionally, two broad categories of carbohydrates can be differentiated: “glycaemic carbohydrates”, i.e. carbohydrates...

EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on principles for deriving and applying Dietary Reference Values

DEFF Research Database (Denmark)

Tetens, Inge

This Opinion of the EFSA Panel on Dietetic products, Nutrition, and Allergies (NDA) deals with the general principles for development and application of Dietary Reference Values (DRVs). These quantitative reference values for nutrient intakes for healthy individuals and populations are based...

75 FR 60113 - Pesticide Science Policy; Notice of Withdrawal

Science.gov (United States)

2010-09-29

... anticipates working collaboratively with the European Union, through the European Food Safety Authority (EFSA... Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of... resulting from single-units (i.e., decomposited results). III. International Interest in Working Together on...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to carbohydrate solutions and maintenance of physical performance during endurance exercise pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from the British Specialist Nutrition Association Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies...... (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to carbohydrate solutions and maintenance of physical performance during endurance exercise. The food, which is proposed by the applicant to be the subject of the health claim, is “carbohydrate solutions...... of physical performance during endurance exercise as compared to “water–electrolyte solutions” cannot be established on the basis of the information provided. Maintenance of physical performance during endurance exercise is a beneficial physiological effect. Three meta-analyses of human intervention studies...

French nuclear safety authorities: for a harmonization of nuclear safety at the European level

International Nuclear Information System (INIS)

Anon.

2004-01-01

The European Commission is working on 2 directives concerning nuclear energy: the first one is dedicated to nuclear safety and the second to the management of radioactive wastes and spent fuels. In the context of the widening of the European Union and of the inter-connection of the different electric power grids throughout Europe, the harmonization of the rules in the nuclear safety field is seen by manufacturers as a mean to achieve a fair competition between nuclear equipment supplying companies and by the French nuclear safety authorities (FNSA) as a mean to keep on improving nuclear safety and to be sure that competitiveness does not drive safety standards down. According to FNSA the 2 European directives could give a legal framework to the harmonization and should contain principles that reinforce the responsibility of each state. FNSA considers that the EPR (European pressurized water reactor) may be an efficient tool for the harmonization because of existing industrial cooperation programs between France and Germany and between France and Finland. (A.C.)

Design of a Risk based Control System for Toxoplasma gondii in a pork supply chain

NARCIS (Netherlands)

Heres, L.; Swanenburg, M.; Koeijer, de A.A.; Boender, G.J.; Oorburg, D.; Urlings, B.; Wisselink, H.J.

2015-01-01

Toxoplasma gondii is recognized as one of the major foodborne pathogens. The European Food Safety Authority (EFSA) concluded that T. gondii is one of the public health hazards in pigs to be covered within a modern meat inspection and advised to include serological testing of pigs and audits of pig

EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2015. Scientific Opinion on the risks to animal and public health and the environment related to the presence of nickel in feed

OpenAIRE

Petersen, Annette

2015-01-01

Following a request from the European Commission, the risks to animal and human health and the environment related to the presence of nickel (Ni) in feed were assessed by the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel). The presence of Ni in feed can arise from both natural and anthropogenic sources. Additionally, certain feed materials contain metallic Ni, since it is used as a catalyst in their production. Based on the differences observed between the Ni exposure levels esti...

EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2015. Scientific Opinion on nitrofurans and their metabolites in food

DEFF Research Database (Denmark)

Petersen, Annette

and carcinogenic and, also, have non-neoplastic effects in animals. Margins of exposure (MOEs) were calculated at 2.0 × 105 or greater for carcinogenicity and at 2.5 × 103 or greater for non-neoplastic effects. The CONTAM Panel concluded that it is unlikely that exposure to food contaminated with nitrofuran marker...... metabolites at or below 1.0 µg/kg is a health concern. A scenario in which foods are considered to be contaminated with semicarbazide, from use of carrageenan as a food additive, at 1 µg/kg was used to assess whether it is appropriate to apply the RPA to foods of non-animal origin; MOEs of greater than 104......Nitrofurans are antimicrobial agents not authorised for use in food-producing animals in the European Union. Nitrofurans are rapidly metabolised, occurring in animal tissues as protein-bound metabolites. The European Commission requested EFSA to provide a scientific opinion on the risks to human...

Safety culture as an element of contact and cooperation between utilities, research and safety authorities

International Nuclear Information System (INIS)

Hoegberg, L.

1994-01-01

The safety culture approach may simply be seen as a recognition of the close interdependence between safety and organisational processes: achievement of technical safety objectives will largely depend on the quality of the implementation processes in the organisations concerned. With a slight modification of the original INSAG formulation, SKI defines safety culture as 'a consciously formulated and implemented set of values in an organisation, which establishes that, as an overriding priority, safety issues receive the attention warranted by their significance'. In practice, a high level of safety culture means the systematic organisation and implementation of a number of activities aimed at creating a high quality defence in depth against both technical and human failures that may cause accidents. An enquiring and learning attitude is a key element of such a safety culture. For example, to prevent accidents, the organisation always needs to be reactive to incidents, by performing proper root cause analysis of both technical and organisational factors, and taking appropriate corrective actions. The long term organisational objective should be to be proactive and identify deficiencies in technology and organisation that may lead to serious incidents or, at worst, accidents and take corrective action even before actual occurrence of incidents of substantial safety significance. (author) 13 refs

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to non-digestible carbohydrates and reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Beneo-Orafti SA, Sensus BV and Cosucra-Groupe Warcoing SA, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA...... not contribute to post-prandial glycaemia. This opinion applies to non-digestible carbohydrates (e.g. non-starch polysaccharides, resistant oligosaccharides and resistant starch) which should replace sugars in foods or beverages in order to obtain the claimed effect. The Panel considers that the food constituent......-prandial glycaemic responses might be a beneficial physiological effect. In weighing the evidence, the Panel took into account that consumption of non-digestible carbohydrates results in reduced post-prandial blood glucose (and insulinaemic) responses compared with the consumption of sugars on a weight...

DARHT: INTEGRATION OF AUTHORIZATION BASIS REQUIREMENTS AND WORKER SAFETY

International Nuclear Information System (INIS)

MC CLURE, D. A.; NELSON, C. A.; BOUDRIE, R. L.

2001-01-01

This document describes the results of consensus agreements reached by the DARHT Safety Planning Team during the development of the update of the DARHT Safety Analysis Document (SAD). The SAD is one of the Authorization Basis (AB) Documents required by the Department prior to granting approval to operate the DARHT Facility. The DARHT Safety Planning Team is lead by Mr. Joel A. Baca of the Department of Energy Albuquerque Operations Office (DOE/AL). Team membership is drawn from the Department of Energy Albuquerque Operations Office, the Department of Energy Los Alamos Area Office (DOE/LAAO), and several divisions of the Los Alamos National Laboratory. Revision 1 of the DARHT SAD had been written as part of the process for gaining approval to operate the Phase 1 (First Axis) Accelerator. Early in the planning stage for the required update of the SAD for the approval to operate both Phase 1 and Phase 2 (First Axis and Second Axis) DARHT Accelerator, it was discovered that a conflict existed between the Laboratory approach to describing the management of facility and worker safety

TSO Role in Supporting the Regulatory Authority in View of Safety Culture

International Nuclear Information System (INIS)

Khamaza, A.; Vasilishin, A.

2016-01-01

Human and organizational factors are always of paramount importance at nuclear and radiation safety as well as in the safety regulation provision. Major NPP accidents occurred merely reaffirm this fact. The role of an authority that regulates nuclear safety increases each time in the aftermath of accidents perceived as a shock together with the importance of scientific and technical support. SEC NRS was established in 1987, the next year after the Chernobyl NPP accident aiming to strengthen supervision over works carried out at the nuclear industry enterprises. Currently SEC NRS provides comprehensive scientific and technical support to Rostechnadzor including safety review and regulatory legal documents development to regulate safety along with safety culture.

Approaches in the risk assessment of genetically modified foods by the Hellenic Food Safety Authority.

Science.gov (United States)

Varzakas, Theodoros H; Chryssochoidis, G; Argyropoulos, D

2007-04-01

Risk analysis has become important to assess conditions and take decisions on control procedures. In this context it is considered a prerequisite in the evaluation of GM food. Many consumers worldwide worry that food derived from genetically modified organisms (GMOs) may be unhealthy and hence regulations on GMO authorisations and labelling have become more stringent. Nowadays there is a higher demand for non-GM products and these products could be differentiated from GM products using the identity preservation system (IP) that could apply throughout the grain processing system. IP is the creation of a transparent communication system that encompasses HACCP, traceability and related systems in the supply chain. This process guarantees that certain characteristics of the lots of food (non-GM origin) are maintained "from farm to fork". This article examines the steps taken by the Hellenic Food Safety Authority to examine the presence of GMOs in foods. The whole integrated European legislation framework currently in place still needs to be implemented in Greece. Penalties should be enforced to those who import, process GMOs without special licence and do not label those products. Similar penalties should be enforced to those companies that issue false certificates beyond the liabilities taken by the food enterprises for farmers' compensation. We argue that Greece has no serious reasons to choose the use of GMOs due to the fact that the structural and pedologic characteristics of the Greek agriculture favour the biological and integrated cultivation more. Greece is not in favour of the politics behind coexistence of conventional and GM plants and objects to the use of GMOs in the food and the environment because the processor has a big burden in terms of money, time and will suffer a great deal in order to prove that their products are GMO free or that any contamination is adventitious or technically unavoidable. Moreover, Greece owns a large variety of genetic

Quality and safety of nuclear plants: the role of the administrative authorities

International Nuclear Information System (INIS)

Queniart, D.

1977-10-01

After specifying the notions of 'safety' and 'quality', the terms and conditions governing the intervention of the public authorities in the matter of safety of nuclear plants are described: individual permits, the establishing and application of technical rules of a general character, surveillance of the plants. The criteria and regulations guiding the evaluation of safety and quality and, in conclusion, insisting on the necessity for permanent discussions among the various organizations concerned are presented

Guidance on a harmonised framework for pest risk assessment and the identification and evaluation of pest risk management options by EFSA

DEFF Research Database (Denmark)

Baker, R.; Candresse, T.; Dormannsné Simon, E.

2010-01-01

The Scientific Panel on Plant Health was requested by EFSA to develop a guidance document on a harmonised framework for risk assessment of organisms harmful to plants and plant products and the identification and evaluation of risk management options. The document provides guiding principles on a...

Authorization Basis Safety Classification of Transfer Bay Bridge Crane at the 105-K Basins

International Nuclear Information System (INIS)

CHAFFEE, G.A.

2000-01-01

This supporting document provides the bases for the safety classification for the K Basin transfer bay bridge crane and the bases for the Structures, Systems, and Components (SSC) safety classification. A table is presented that delineates the safety significant components. This safety classification is based on a review of the Authorization Basis (AB). This Authorization Basis review was performed regarding AB and design baseline issues. The primary issues are: (1) What is the AB for the safety classification of the transfer bay bridge crane? (2) What does the SSC safety classification ''Safety Significant'' or ''Safety Significant for Design Only'' mean for design requirements and quality requirements for procurement, installation and maintenance (including replacement of parts) activities for the crane during its expected life time? The AB information on the crane was identified based on review of Department of Energy--Richland Office (RL) and Spent Nuclear Fuel (SNF) Project correspondence, K Basin Safety Analysis Report (SAR) and RL Safety Evaluation Reports (SERs) of SNF Project SAR submittals. The relevant correspondence, actions and activities taken and substantive directions or conclusions of these documents are provided in Appendix A

The French nuclear safety authority's experience with radioactive transport inspection

International Nuclear Information System (INIS)

Jacob, E.; Aguilar, J.

2004-01-01

About 300,000 radioactive material packages are transported annually in France. Most consist of radioisotopes for medical, pharmaceutical or industrial use. On the other hand, the nuclear industry deals with the transport of fuel cycle materials (uranium, fuel assemblies, etc.) and waste from power plants, reprocessing plants and research centers. France is also a transit country for shipments such as spent fuel packages from Switzerland or Germany, which are bound for Sellafield in Great Britain. The French nuclear safety authority (DGSNR: Directorate General for Nuclear Safety and Radioprotection) has been responsible since 1997 for the safety of radioactive material transport. This paper presents DGNSR's experience with transport inspection: a feedback of key points based on 300 inspections achieved during the past five years is given

Role of young child formulae and supplements to ensure nutritional adequacy in U.K. young children

DEFF Research Database (Denmark)

Vieux, Florent; Brouzes, Chloé M C; Maillot, Matthieu

2016-01-01

The European Food Safety Authority (EFSA) states that young child formulae (YCFs) “cannot be considered as a necessity to satisfy the nutritional requirements” of children aged 12–36 months. This study quantifies the dietary changes needed to ensure nutritional adequacy in U.K. young children who...... consume YCFs and/or supplements and in those who do not. Dietary data from 1147 young children (aged 12–18 months) were used to identify, using linear programming models, the minimum changes needed to ensure nutritional adequacy: (i) by changing the quantities of foods initially consumed by each child....../day, respectively). Increasing YCF and supplement consumption was the shortest way to cover the EFSA nutrient requirements of U.K. children....

FSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Guidance on the scientific requirements for health claims related to functions of the ne rvous system, including psycholog ical functions

DEFF Research Database (Denmark)

Tetens, Inge

The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies to draft guidance on scientific requirements for health claims related to functions of the nervous system, including psychological functions. This guidance has been drawn from scientific opinions......, and was released for public consultation from 17 October 2011 to 16 December 2011....

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the essential composition of infant and follow-on formulae

DEFF Research Database (Denmark)

Tetens, Inge

2014-01-01

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the essential composition of infant and follow-on formula. This opinion reviews the opinion provided by the Scientific Committee on Food...... in 2003 on the essential requirements of infant and follow-on formulae in light of more recent evidence and by considering the Panel’s opinion of October 2013 on nutrient requirements and dietary intakes of infants and young children in the European Union. The minimum content of a nutrient in formula...... proposed in this opinion is derived from the intake levels the Panel had considered adequate for the majority of infants in the first six months of life in its previous opinion and an average amount of formula consumed during this period. From a nutritional point of view, the minimum contents of nutrients...

Scientific Opinion on the safety and efficacy of Lactobacillus plantarum (NCIMB 40027) as a silage additive for all animal species

OpenAIRE

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

2013-01-01

The strain of Lactobacillus plantarum is intended to improve the ensiling process at proposed doses ranging from 1 x 108 to 1 x 109 CFU/kg fresh material. This speciesis considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been established and as no antibiotic resistance of concern was detected, the use of the strain in the production of silage is presumed safe for livestock species, for consumers of product...

EFSA (European Food Safety Authority) and ECDC (European Centre for Disease Prevention and Control), 2015. The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2014

OpenAIRE

Helwigh, Birgitte; Porsbo, Lone Jannok; Boysen, Louise; Bager, Flemming

2015-01-01

This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of the zoonoses monitoring activities carried out in 2014 in 32 European countries (28 Member States (MS) and four non-MS). Campylobacteriosis was the most commonly reported zoonosis with an increase in confirmed human cases in the European Union (EU) since 2008. In food the occurrence of Campylobacter remained high in broiler meat. The decreasing EU trend for conf...

Intervention of French safety authorities during the design and construction phases of the Creys-Malville plant

International Nuclear Information System (INIS)

Orzoni, G.

1985-01-01

The intervention of French safety authorities during the design and construction phases of the Creys-Malville plant has been made by the different means of technical regulation, of several successive authorizations bound to different steps, and of numerous surveillance visits. Some safety-related problems have been met. Some of them are detailed, relating to the basis accident for containment design, decay heat removal, polar crane of reactor building, seismic resistance of main vessel internals, core cover plug, design and fabrication of steam generators. The main problems met during the design reviews and the construction phase of the plant have been solved in time; the safety level reached is provisionally judged acceptable by the French safety authorities

EFSA and ECDC (European Food Safety Authority and European Centre for Disease Prevention and Control), 2015. The European Union Summary Report on Trends and Sources of Zoonoses, Zoonotic Agents and Food-borne Outbreaks in 2013

DEFF Research Database (Denmark)

Helwigh, Birgitte

This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of the zoonoses monitoring activities carried out in 2013 in 32 European countries (28 Member States and four non-Member States). Campylobacter iosis was the most comm...... chain of tuberculosis due to Mycobacterium bovis, Brucella, Trichinella, Echinococcus, Toxoplasma , rabies, Coxiella burnetii (Q fever), West Nile Virus and tularaemia....

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids) , 2016. Scientific Opinion on Flavouring Group Evaluation 90, Revision 1 (FGE.90Rev1): consideration of six substances evaluated by JECFA (68th meeting) structurally related to aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols, aromatic tertiary alcohols and their esters evaluated by EFSA in FGE.18Rev1 and FGE.75Rev1

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Nørby, Karin Kristiane

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of EFSA was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary...... refined exposure estimation and to judge whether a re-evaluation according to the Procedure is needed....

Mancozeb is an optimum example of diversity of toxicological classification of pesticides in Portugal

OpenAIRE

Amaro, Pedro

2012-01-01

The Portuguese Pesticide Regulation Authority (AFN) classifies the fungicide MANCOZEB as Harmful (Xn) or Irritant (Xi), ignoring that: in UE, the European Food Safety Authority (EFSA) classify, beyond Xi, as R63 – Possible risk of harm to the unborn child; and, in the USA, the Environmental Protection Agence (EPA) classify as Carcinogenic (Probable human carcinogen). These reality justify that mancozeb is a optimum example, in Portugal, of the strange and frequen...

Developments related to the National Nuclear Safety Authority of Romania

International Nuclear Information System (INIS)

Baciu, Florin

1998-01-01

The contribution presents the status of the National Commission for Nuclear Activity Control (CNCAN) as indicated by the provisions of a Romanian Government Decision of May 1998. As specified in the art.3 the main tasks of the Commission are the following: to issue authorization and exercise permits of activities in nuclear field; to supervise the applications of the provisions stipulated by the law concerning development in safety conditions of nuclear activities; to develop instructions as well as nuclear safety regulations to ensure the quality assurance and functioning in safety conditions of the nuclear facilities and plants, the protection against nuclear radiation of the professionally exposed personnel, of the population, of the environment and of the material goods, the physical protection, the records, preservation and transport of radioactive material and of fissionable materials as well as the management of radioactive waste; organizes expert and is responsible for the state control concerning the integrated application of the law provisions in the field of quality constructions in which nuclear installations of national interest are located, during all the phases and for all the components of the quality system in this field; issues specialty and information documentation specific to its own activity, provides the information of the public through official publication, official statements to the press and other specific form of information; carries out any other tasks provided by law in the field of regulations and control of nuclear activity. Author presents also the CNCAN staff number evolution, the new structure, the staff distribution at headquarters, local agencies and national radiation monitoring network. Finally, the author discusses the legal provisions related to management manual procedures

EFSA (European Food Safety Authority) and ECDC (European Centre for Disease Prevention and Control), 2015. The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2014

DEFF Research Database (Denmark)

Helwigh, Birgitte; Porsbo, Lone Jannok; Boysen, Louise

This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of the zoonoses monitoring activities carried out in 2014 in 32 European countries (28 Member States (MS) and four non-MS). Campylobacteriosis was the most commonly re......, molluscs and products thereof’. The report further summarises trends and sources along the food chain of tuberculosis due to Mycobacterium bovis, Brucella, Trichinella, Echinococcus, Toxoplasma, rabies, Coxiella burnetii (Q fever), West Nile virus and tularaemia....

Mining and mining authorities in Saarland 2016. Mining economy, mining technology, occupational safety, environmental protection, statistics, mining authority activities. Annual report

International Nuclear Information System (INIS)

2016-01-01

The annual report of the Saarland Upper Mining Authority provides an insight into the activities of mining authorities. Especially, the development of the black coal mining, safety and technology of mining as well as the correlation between mining and environment are stressed.

THE NATIONAL AUTHORITY FOR ANIMAL HEALTH AND FOOD SAFETY, THE MAIN BODY INVOLVED IN FOOD SAFETY IN ROMANIA

Directory of Open Access Journals (Sweden)

PETRUTA-ELENA ISPAS

2012-05-01

Full Text Available This paper is intended to present the role, functions and responsibilities of the National Authority for Animal Health and Food Safety as the main body involved in food safety in Romania. It will be also exposed the Regulation 178/2002 of the European Parliament and the Council, the general food ”law” in Europe, and Law 150/2004, which transposed into Romanian legislation Regulation 178/2002.

EFSA and ECDC (European Food Safety Authority and European Centre for Disease Prevention and Control), 2015. The European Union Summary Report on Trends and Sources of Zoonoses, Zoonotic Agents and Food-borne Outbreaks in 2013

OpenAIRE

Helwigh, Birgitte

2015-01-01

This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of the zoonoses monitoring activities carried out in 2013 in 32 European countries (28 Member States and four non-Member States). Campylobacter iosis was the most commonly reported zoonosis. After several years of an increasing European Union (EU) trend, the human Campylobacter iosis notification rate has stabilised. In food and animals no EU trends were observed a...

Barriers to Safety Event Reporting in an Academic Radiology Department: Authority Gradients and Other Human Factors.

Science.gov (United States)

Siewert, Bettina; Swedeen, Suzanne; Brook, Olga R; Eisenberg, Ronald L; Hochman, Mary

2018-05-15

Purpose To investigate barriers to reporting safety concerns in an academic radiology department and to evaluate the role of human factors, including authority gradients, as potential barriers to safety concern reporting. Materials and Methods In this institutional review board-approved, HIPAA-compliant retrospective study, an online questionnaire link was emailed four times to all radiology department staff members (n = 648) at a tertiary care institution. Survey questions included frequency of speaking up about safety concerns, perceived barriers to speaking up, and the annual number of safety concerns that respondents were unsuccessful in reporting. Respondents' sex, role in the department, and length of employment were recorded. Statistical analysis was performed with the Fisher exact test. Results The survey was completed by 363 of the 648 employees (56%). Of those 363 employees, 182 (50%) reported always speaking up about safety concerns, 134 (37%) reported speaking up most of the time, 36 (10%) reported speaking up sometimes, seven (2%) reported rarely speaking up, and four (1%) reported never speaking up. Thus, 50% of employees spoke up about safety concerns less than 100% of the time. The most frequently reported barriers to speaking up included high reporting threshold (69%), reluctance to challenge someone in authority (67%), fear of disrespect (53%), and lack of listening (52%). Conclusion Of employees in a large academic radiology department, 50% do not attain 100% reporting of safety events. The most common human barriers to speaking up are high reporting threshold, reluctance to challenge authority, fear of disrespect, and lack of listening, which suggests that existing authority gradients interfere with full reporting of safety concerns. © RSNA, 2018.

EFSA Panel on Biological Hazards (BIOHAZ); Scientific Opinion on the risk of transmission of classical scrapie via in vivo derived embryo transfer in ovine animals

DEFF Research Database (Denmark)

Hald, Tine; Baggesen, Dorte Lau

. Under natural exposure conditions, animals that are heterozygous or homozygous A136R154R171 display respectively a low or negligible risk of being infected. The genetic control of the susceptibility to classical scrapie is also likely to impact on the risk of transmitting the disease via embryo transfer......The risk of transmission of classical scrapie via the transfer of in vivo derived embryo in ovines was assessed, taking into account the scientific information made available since the last EFSA opinion on this topic (2010) (see http://www.efsa.europa.eu/en/efsajournal/pub/1429.htm). The potential...... impact of PrP genotype of the embryo and/or of the ram and donor ewe on this risk was also assessed. The new data made available over the last three years further reinforce the view that classical scrapie could be vertically transmitted in sheep. Since the possibility of such vertical transmission...

The quality and safety of nuclear plants: the part played by the administrative authorities

International Nuclear Information System (INIS)

Queniart, Daniel

1976-01-01

After specifying the notions of 'safety' and 'quality', the terms and conditions governing the intervention of the public authorities in the matter of safety of nuclear plants are described: individual permits, the establishing and application of technical rules of a general character, surveillance of the plants. The criteria and regulations guiding the evaluation of safety and quality and, in conclusion, insisting on the necessity for permanent discussions among the various organizations concerned are presented [fr

EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on Dietary Reference Values for carbohydrates and dietary fibre

OpenAIRE

Tetens, Inge

2011-01-01

This Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) deals with the establishment of Dietary Reference Values for carbohydrates and dietary fibre. Nutritionally, two broad categories of carbohydrates can be differentiated: “glycaemic carbohydrates”, i.e. carbohydrates digested and absorbed in the human small intestine, and „dietary fibre‟, non-digestible carbohydrates passing to the large intestine. In this Opinion, dietary fibre is defined as non-digestible car...

Safety and environmental protection - realization efforts regarding the authorization of power engineering plants

International Nuclear Information System (INIS)

Dreyhaupt, F.J.

1982-01-01

As to power plants the author calls special attention to three statements concerning questions on safety and environmental protection which play a decisive part in authorizing conventional and nuclear facilities. After investigating the most important legal fundamental principles for the authorization of power engineering plants, the Atomic Act and the Federal Immission Protection Act, the author discusses the problems that arise with the application of the authorization procedures. The reasons which can be made responsible for the long running periods of the authorization procedures and therewith of the realization of the site installation work are given. Finally, the author describes and judges the outlines of regulations for large scale furnaces and for the TA-air supplementary clause. (orig.) [de

EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2015. Scientific Opinion on risks for public health related to the presence of chlorate in food

DEFF Research Database (Denmark)

Petersen, Annette

Following a request from the European Commission, the risks to human health related to the presence of chlorate in food were assessed by the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel). The presence of chlorate in food can arise from the use of chlorinated water for food processing...... and the disinfection of food-processing equipment. Inhibition of iodine uptake in humans was identified as the critical effect for chronic exposure to chlorate. A tolerable daily intake (TDI) of 3 µg chlorate/kg body weight (b.w.) was set by read-across from a TDI of 0.3 µg/kg b.w. derived for this effect...... with mild or moderate iodine deficiency. Mean and 95th percentile acute exposures were below the ARfD for all age groups indicating no concern. Based on the current practices in food industry, application of a hypothetical maximum residue limit (MRL) of 0.7 mg/kg for all foodstuffs and drinking water would...

European Food Safety Authority; Outcome of the Public consultation on the Draft Opinion of the Scientific Panel on Dietetic Products, Nutrition, and Allergies (NDA) on principles for deriving and applying Dietary Reference Values

DEFF Research Database (Denmark)

Tetens, Inge

consultation and outlines how these were taken into account in the final opinion. EFSA had received 38 contributions from 12 interested parties (individuals, non-governmental organisations, industry organisations, academia and national assessment bodies). After a meeting with national experts on Dietary...

European Food Safety Authority; Outcome of the Public consultation on the Draft Opinion of the Scientific Panel on Dietetic products, Nutrition, and Allergies (NDA) on Dietary Reference Values for carbohydrates and dietary fibre

DEFF Research Database (Denmark)

Tetens, Inge

consultation and outlines how these were taken into account in the final opinion. EFSA had received 100 contributions from 24 interested parties (individuals, non-governmental organisations, industry organisations, academia, national assessment bodies and Member States). The main comments which were received...

Report from the nuclear safety authority about the preparation of nuclear facilities to the year 2000 transition

International Nuclear Information System (INIS)

Lacoste, A.C.

1999-01-01

The French nuclear safety authority with the technical help of the Institute of Nuclear Protection and Safety (IPSN) started in 1998 an evaluation and control work of the measures taken by the different nuclear facility operators in anticipation of the year 2000 transition. This report makes a status of the state of preparation of nuclear facilities prior to the transition: 1 - The nuclear safety and the year 2000 transition (defense-in-depth approach, preventive actions); 2 - The action of the safety authority (demands addressed to the operators of nuclear facilities, technical evaluation and control of the methodology adopted by each operator, preparation of the safety authority to the transition, follow up of the international actions); 3 - Status of the preparation of the different operators: Electricite de France (EdF) (corrective actions, inventory and investigation of computer systems, results, corrections, preventive actions, defensive actions, synthesis), research centres, storage sites and shutdown reactors, waste storage centres of the ANDRA, CEA facilities, decommissioned or partially dismantled reactors, fuel cycle centres.. (J.S.)

Statement on the safety of taxifolin-rich extract fromDahurian Larch (Larix gmelinii)

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

.e. infants, young children and children up to 9 years) for the food categories set out in the application, and by taking into the extension of use of taxifolin from yogurt to a wider range of dairy products. In 2016, the EFSA NDA Panel adopted the Scientific Opinion on the safety of taxifolin-rich extract...... from Dahurian Larch (Larix gmelinii) as a novel food ingredient in non-alcoholic beverages, yogurts, chocolate confectionery and food supplements pursuant to Regulation (EC) No 258/97. In order to address the present mandate, an intake assessment was carried out by taking into account all...

Safety and authorizations relating to the use of new fuel in research reactors

International Nuclear Information System (INIS)

Niel, J.-C.; Abou Yehia, H.

1999-01-01

After giving a brief reminder of the procedure applied in France for granting licences to modify research reactors, we outline in this paper the main safety aspects associated with using new fuel in these reactors. Finally, by way of an example, we focus on the procedure followed for converting the cores of the OSIRIS (70 MW) and ISIS (700 kW) reactors to U 3 Si 2 Al fuel and the conclusions of the corresponding safety assessments. (author)

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on Dietary Reference Values for protein

DEFF Research Database (Denmark)

Tetens, Inge

This opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) deals with the setting of Dietary Reference Values (DRVs) for protein. The Panel concludes that a Population Reference Intake (PRI) can be derived from nitrogen balance studies. Several health outcomes possibly...... for growth and maintenance. For pregnancy, an intake of 1, 9 and 28 g/d in the first, second and third trimesters, respectively, is proposed in addition to the PRI for non-pregnant women. For lactation, a protein intake of 19 g/d during the first six months, and of 13 g/d after six months, is proposed...

Legal and Illegal Colours

DEFF Research Database (Denmark)

Larsen, John Christian

2008-01-01

opinions on food additives, including colours, and on the bioavailability and safety of nutrient sources. The WG ADD consists of several members from the AFC Panel together with selected external experts. The draft opinions go forward to the AFC Panel for discussion and final adoption. The adopted opinions......://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620761956.htm. Accessed 12.05.08.] this paper only deals with some of the major issues that the Panel has faced in relation to the use of food colours. The three topics to be dealt with are (1) evaluation of illegal colours in food in the EU (EFSA, 2005), (2) re-evaluation of the authorised...... food colours in the EU (ongoing, but one opinion on Red 2G has been published; EFSA, 2007), and (3) evaluation of 'the Southampton study' on hyperactivity in children after intake of food colours (and sodium benzoate) (ongoing at the time of this presentation, but an opinion has now been published...

NPA applications development in the nuclear safety authority framework

International Nuclear Information System (INIS)

Maselj, A.; Vojnovic, D.; Gregonc, M.

1999-01-01

Due to the present tasks of the SNSA (Slovenian Nuclear Safety Administration) there was a need to gain a tool for analysing the transients of the Krsko Nuclear Power Plant at the SNSA. Combining the RELAP5 code with graphical interface NPA (Nuclear Plant Analyzer), the SNSA management saw an opportunity to have a powerful instrument for analyses and assessments on a user friendly basis and without high costs. The Krsko NPP Analyzer is a joint project of the SNSA and the operator, the Krsko NPP. The RELAP5/Mod2.5 input deck was constructed by the Krsko NPP's experts and their subcontractors. In 1996 the work started with translation of input model from RELAP5/Mod2.5 version to Mod3.2. This was done by Tractebel which combined NPA masks with translated input deck and constructed new dynamic function and interactive commands between graphical MMI (Man Machine Interface) and simulation code. Since Tractebel performed similar activities for the Belgian plants, their experience was used through a transfer of knowledge to the SNSA. After this phase of the project, a user of the NPP Analyzer can run accidents as SBLOCA, Main Steam Line Break, Feed Water Break, SGTR, and many other transients activating and combining interactive commands, starting from a full power operation. This project has not been finished yet. Improvements of the input deck should be done. The Critical Safety Function window will be created. The analyzer will be a helpful tool during the training program for Accident Assessment Group, which will give to the experts basic knowledge of plant operation, its systems, and physical phenomena during a steady state and transients or accidents. Also a new dimension is added to the existing safety evaluations at the SNSA to confirm the requested level of nuclear safety at the Krsko NPP. (author)

Guidance on the environmental risk assessment of plant pests

DEFF Research Database (Denmark)

Baker, R.; Candresse, T.; Dormannsne Simon, E.

2011-01-01

The European Food Safety Authority (EFSA) requested the Panel on Plant Health to develop a methodology for assessing the environmental risks posed by harmful organisms that may enter, establish and spread in the European Union. To do so, the Panel first reviewed the methods for assessing...... the environmental risks of plant pests that have previously been used in pest risk assessment. The limitations identified by the review led the Panel to define the new methodology for environmental risk assessment which is described in this guidance document. The guidance is primarily addressed to the EFSA PLH...... (biodiversity) and the functional (ecosystem services) aspects of the environment, this new approach includes methods for assessing both aspects for the first time in a pest risk assessment scheme. A list of questions has been developed for the assessor to evaluate the consequences for structural biodiversity...

International conference on strengthening of nuclear safety in Eastern Europe. Armenian Nuclear Regulatory Authority

International Nuclear Information System (INIS)

Nersesyan, V.

1999-01-01

The status of the Armenian Nuclear Regulatory Authority (ANRA) are described in detail with its main task and responsibilities concerning regulations and surveillance of nuclear and radiation safety. The following issues are presented: nuclear legislation; inspection activities; licensing of significant safety related modifications and modernization of NPPs; incidents at NPPs; personnel training; emergency planning; surveillance of nuclear materials; radioactive waste management; and plan of the ANRA perspective development

Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: testing an European Food Safety Authority-tiered approach.

Science.gov (United States)

Speijers, Gerrit; Bottex, Bernard; Dusemund, Birgit; Lugasi, Andrea; Tóth, Jaroslav; Amberg-Müller, Judith; Galli, Corrado L; Silano, Vittorio; Rietjens, Ivonne M C M

2010-02-01

This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (ii) Adequate characterization and description of the botanical parts and preparation methodology used is needed. Safety of a botanical ingredient cannot be assumed only relying on the long-term safe use of other preparations of the same botanical. (iii) Because of possible adulterations, misclassifications, replacements or falsifications, and restorations, establishment of adequate quality control is necessary. (iv) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (v) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (vi) Adequate data and methods for appropriate exposure assessment are often missing. (vii) Safety regulations concerning toxic contaminants have to be complied with. The application of the guidance approach can result in the conclusion that safety can be presumed, that the botanical ingredient is of safety concern, or that further data are needed to assess safety.

The nuclear safety authority (ASN) presents its report on the status of nuclear safety and radiation protection in France in 2010

International Nuclear Information System (INIS)

2011-01-01

After a presentation of the French nuclear safety authority (ASN) and of some events which occurred in 2010, this report present the actions performed by the ASN in different fields: nuclear activities (ionizing radiations and risks for health and for the environment), principles and actors of control of nuclear safety, radiation protection and environment protection, regulation, control of nuclear activities and of exposures to ionizing radiations, emergency situations, public information and transparency, international relationship. It proposes a regional overview of nuclear safety and radiation protection in France. It addresses the activities controlled by the ASN: medical and non medical usages of ionizing radiations, transportation of radioactive materials, electronuclear power stations, installations involved in the nuclear fuel cycle, research nuclear installations and other nuclear installations, safety in basic nuclear installation dismantling, radioactive wastes and polluted sites

Safety evaluation report on Tennessee Valley Authority: Browns Ferry nuclear performance plan

International Nuclear Information System (INIS)

1989-10-01

This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Plant and in supporting documents has been prepared by the US Nuclear Regulatory commission staff. The Browns Ferry Nuclear Plant consists of three boiling-water reactors at a site in Limestone County, Alabama. The plan addresses the plant-specific concerns requiring resolution before the startup of Unit 2. The staff will inspect implementation of those TVA programs that address these concerns. Where systems are common to Units 1 and 2 or to Units 2 and 3, the staff safety evaluations of those systems are included herein. 85 refs

Safety evaluation report on Tennessee Valley Authority: Watts Bar Nuclear Performance Plan

International Nuclear Information System (INIS)

1990-01-01

This safety evaluation report on the information submitted by the Tennessee Valley Authority in its Nuclear Performance Plan for the Watts Bar Nuclear Plant and in supporting documents has been prepared by the US Nuclear Regulatory Commission staff. The plan addresses the plant-specific corrective actions as part of the recovery program for licensing of Unit 1. The staff will be monitoring and inspecting the implementation of the programs. The plan does not address all licensing matters that will be required for fuel load and operation of Unit 1. Those remaining licensing matters have been addressed in previous safety evaluations or will be addressed in accordance with routing NRC licensing practices. 97 refs

Taxonomy of Probiotic Microorganisms

Science.gov (United States)

Felis, Giovanna E.; Dellaglio, Franco; Torriani, Sandra

When referring to probiotics, one refers to probiotic strains, i.e., the microbial individuals, sub-cultures of billion of almost identical cells ideally derived from the same mother cell. Therefore, beneficial effects attributed to probiotics are ascribed in fact to specific strains. However, these strains have to be, by law, clearly identified at the species level (Pineiro and Stanton, 2007). In fact, probiotics have to be safe for consumption, and the evaluation of QPS - qualified presumption of safety - status by the European Food Safety Authority (EFSA) (Opinion, 2007) is discussed for species, not for single strains.

76 FR 63988 - Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits

Science.gov (United States)

2011-10-14

...-0097] Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits AGENCY: Federal Motor... motor carriers that applied to participate in the Agency's long-haul pilot program to test and... intent to proceed with the initiation of a United States- Mexico cross-border long-haul trucking pilot...

Public safety around dams : Grand River Conservation Authority

Energy Technology Data Exchange (ETDEWEB)

Moore, N [Grand River Conservation Authority, Cambridge, ON (Canada)

2009-07-01

Ontario's Grand River Conservation Authority (GRCA) is a corporate body, through which municipalities, landowners and other organizations work cooperatively to manage the watershed and outdoor recreation. This involves reducing flood damage; improving water quality; providing adequate water supply; protecting natural areas; watershed planning; and environmental education. This presentation discussed public safety issues regarding a dam in the GRCA that is 5 minutes to downtown Brantford; 5 minutes to several elementary and secondary schools; and a popular area for anglers. The city of Brantford owns the east embankment and the Brant conservation area is located on the west embankment. The safeguards included measures to involve the municipality and local police; install better signage; install better fencing; and public education. Increasing public awareness of the dangers surrounding dams was an important point of the presentation. Results included reduced trespassing and greater community awareness. figs.

Criteria adopted by the Argentine Nuclear Regulatory Authority for assessing digital systems related to safety

International Nuclear Information System (INIS)

Terrado, Carlos A.; Chiossi, Carlos E.; Felizia, Eduardo R.; Roca, Jose L.; Sajaroff, Pedro M.

2004-01-01

Following the technological evolution in Instrumentation and Control (I and C) design, analog components are replaced by digital in almost every industry. Due to growing challenges of obsolescence and increasing maintenance costs, licensees of nuclear and radioactive installations are increasingly upgrading or replacing their existing I and C analog systems and components. In existing installations, this involves analog to digital replacements. In new installations design, the use of digital I and C systems is being considered from the very beginning, becoming a good alternative, even in safety applications. Up to now, in Argentina, there is no specific rules for safety-related digital systems, every safety system, analog or digital, must comply with the same generic regulations. The Nuclear Regulatory Authority is now developing criteria to assess digital systems related to safety in nuclear and radioactive installations. In this paper some of those criteria, based on local research and the recognized state of the art, are explained. From a regulatory point of view, the use of digital technology often raises new technical and licensing issues, particularly for safety-related applications. Examples include new failure modes, the potential for common-cause failure of redundant components, electromagnetic interference (EMI), software verification and validation, configuration management and a more exhaustive quality assurance system. The mentioned criteria comprehend the design, operation, maintenance and acquisition of digital systems and components important to safety. The main topics covered are: requirements specifications for digital systems, planning and documentation for digital system development, effectiveness of a digital system, commercial off the shelf (COTS) treatment and considerations involving tools for software development. (author)

Water and beverage consumption among children aged 4?13 years in France: analyses of INCA 2 (?tude Individuelle Nationale des Consommations Alimentaires 2006?2007) data

OpenAIRE

Vieux, Florent; Maillot, Matthieu; Constant, Florence; Drewnowski, Adam

2016-01-01

Objective To examine the consumption of plain water among children in France and compare total water intakes with guidelines issued by the European Food Safety Authority (EFSA). Design Nationally representative data were used to assess food, beverage and water consumption by sex, age group (4?8 years, 9?13 years), income-to-poverty ratio, eating occasion and location. Beverages were classified into nine groups: water (tap or bottled), milk, 100 % fruit juice, sodas, fruit drinks, hot beverage...

RNAi-based GM plants: food for thought for risk assessors.

Science.gov (United States)

Ramon, Matthew; Devos, Yann; Lanzoni, Anna; Liu, Yi; Gomes, Ana; Gennaro, Andrea; Waigmann, Elisabeth

2014-12-01

RNA interference (RNAi) is an emerging technology that offers new opportunities for the generation of new traits in genetically modified (GM) plants. Potential risks associated with RNAi-based GM plants and issues specific to their risk assessment were discussed during an international scientific workshop (June 2014) organized by the European Food Safety Authority (EFSA). Selected key outcomes of the workshop are reported here. © 2014 Society for Experimental Biology, Association of Applied Biologists and John Wiley & Sons Ltd.

Guidance on the scientific requirements for health claims related to gut and immune function

DEFF Research Database (Denmark)

Tetens, Inge

2011-01-01

The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products Nutrition and Allergies (NDA) to draft guidance on scientific requirements for health claims related to gut and immune function. This guidance has been drawn from scientific opinions of the NDA Panel on such health......, was subjected to public consultation (28 September 2010 to 22 October 2010), and was also discussed at a technical meeting with experts in the field on 2 December 2010 in Amsterdam....

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on health benefits of seafood (fish and shellfish) consumption in relation to health risks associated with exposure to methylmercury

DEFF Research Database (Denmark)

Tetens, Inge

2014-01-01

Following a request from the European Commission to address the risks and benefits as regards fish/seafood consumption related to relevant beneficial substances (e.g. nutrients such as n-3 long-chain polyunsaturated fatty acids) and the contaminant methylmercury, the Panel on Dietetic Products...... effects of seafood consumption in relation to health outcomes and population subgroups that have been identified by the FAO/WHO Joint Expert Consultation on the Risks and Benefits of Fish Consumption and/or the EFSA Panel on Contaminants in the context of a risk assessment related to the presence...... of mercury and methylmercury in food as relevant for the assessment. These included the effects of seafood consumption during pregnancy on functional outcomes of children’s neurodevelopment and the effects of seafood consumption on cardiovascular disease risk in adults. The Panel concluded that consumption...

Claimed effects, outcome variables and methods of measurement for health claims on foods proposed under European Community Regulation 1924/2006 in the area of appetite ratings and weight management.

Science.gov (United States)

Martini, Daniela; Biasini, Beatrice; Rossi, Stefano; Zavaroni, Ivana; Bedogni, Giorgio; Musci, Marilena; Pruneti, Carlo; Passeri, Giovanni; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Dei Cas, Alessandra; Bonadonna, Riccardo C; Del Rio, Daniele

2018-06-01

All the requests for authorisation to bear health claims under Articles 13(5) and 14 in the context of appetite ratings and weight management have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of the insufficient substantiation of the claimed effects (CEs). This manuscript results from an investigation aimed to collect, collate and critically analyse the information related to outcome variables (OVs) and methods of measurement (MMs) in the context of appetite ratings and weight management compliant with Regulation 1924/2006. Based on the literature review, the appropriateness of OVs and MMs was evaluated for specific CEs. This work might help EFSA in the development of updated guidance addressed to stakeholders interested in bearing health claims in the area of weight management. Moreover, it could drive the applicants during the design of randomised controlled trials aimed to substantiate such claims.

Notification and authorization for the use of radiation sources (supplement to IAEA Safety Standards Series No. GS-G-1.5)

International Nuclear Information System (INIS)

2007-04-01

The achievement and maintenance of a high level of safety in the use of radiation sources depend on there being a sound legal and governmental infrastructure, including a national regulatory body with well-defined responsibilities and functions. These responsibilities and functions include establishing and implementing a system for notification and authorization for control over radiation sources, including a system for review and assessment of applications for authorization. The Safety Requirements publication entitled Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety establishes the requirements for legal and governmental infrastructure. The term 'infrastructure' refers to the underlying structure of systems and organizations. This includes requirements concerning the establishment of a regulatory body for radiation sources and the responsibilities and functions assigned to it. The International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (the Basic Safety Standards or the BSS) establish basic requirements for protection against risks associated with exposure to ionizing radiation and for the safety of radiation sources. The application of the BSS is based on the presumption that national infrastructures are in place to enable governments to discharge their responsibilities to for radiation protection and safety. This TECDOC provides practical guidance on the process for dealing with applications for authorization and accepting notifications to regulatory bodies. Examples of guidelines that may be used by persons required to notify or apply for authorization and of the regulatory body's review and assessment procedures are provided in the Appendices. The TECDOC is oriented towards national regulatory infrastructures concerned with protection and safety for radiation sources used in medicine, industry, agriculture, research and education

Notification and authorization for the use of radiation sources (supplement to IAEA Safety Standards Series No. GS-G-1.5)

International Nuclear Information System (INIS)

2010-10-01

The achievement and maintenance of a high level of safety in the use of radiation sources depend on there being a sound legal and governmental infrastructure, including a national regulatory body with well-defined responsibilities and functions. These responsibilities and functions include establishing and implementing a system for notification and authorization for control over radiation sources, including a system for review and assessment of applications for authorization. The Safety Requirements publication entitled Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety establishes the requirements for legal and governmental infrastructure. The term 'infrastructure' refers to the underlying structure of systems and organizations. This includes requirements concerning the establishment of a regulatory body for radiation sources and the responsibilities and functions assigned to it. The International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (the Basic Safety Standards or the BSS) establish basic requirements for protection against risks associated with exposure to ionizing radiation and for the safety of radiation sources. The application of the BSS is based on the presumption that national infrastructures are in place to enable governments to discharge their responsibilities to for radiation protection and safety. This TECDOC provides practical guidance on the process for dealing with applications for authorization and accepting notifications to regulatory bodies. Examples of guidelines that may be used by persons required to notify or apply for authorization and of the regulatory body's review and assessment procedures are provided in the Appendices. The TECDOC is oriented towards national regulatory infrastructures concerned with protection and safety for radiation sources used in medicine, industry, agriculture, research and education

Notification and authorization for the use of radiation sources (Supplement to IAEA Safety Standards Series No. GS-G-1.5)

International Nuclear Information System (INIS)

2011-10-01

The achievement and maintenance of a high level of safety in the use of radiation sources depend on there being a sound legal and governmental infrastructure, including a national regulatory body with well-defined responsibilities and functions. These responsibilities and functions include establishing and implementing a system for notification and authorization for control over radiation sources, including a system for review and assessment of applications for authorization. The Safety Requirements publication entitled Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety establishes the requirements for legal and governmental infrastructure. The term 'infrastructure' refers to the underlying structure of systems and organizations. This includes requirements concerning the establishment of a regulatory body for radiation sources and the responsibilities and functions assigned to it. The International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (the Basic Safety Standards or the BSS) establish basic requirements for protection against risks associated with exposure to ionizing radiation and for the safety of radiation sources. The application of the BSS is based on the presumption that national infrastructures are in place to enable governments to discharge their responsibilities to for radiation protection and safety. This TECDOC provides practical guidance on the process for dealing with applications for authorization and accepting notifications to regulatory bodies. Examples of guidelines that may be used by persons required to notify or apply for authorization and of the regulatory body's review and assessment procedures are provided in the Appendices. The TECDOC is oriented towards national regulatory infrastructures concerned with protection and safety for radiation sources used in medicine, industry, agriculture, research and education. The IAEA

Zoonoses in Europe: distribution and trends - the EFSA-ECDC Community Summary Report 2008

DEFF Research Database (Denmark)

Lahuerta, Angela; Helwigh, Birgitte; Mäkelä, Pia

2010-01-01

,554) in the EU. Foodstuffs that are considered the main source for human listeriosis in the EU include ready-to-eat (RTE) products (fish and meat), soft cheeses, salads and sandwiches. An EFSA-ECDC collaborative survey on Listeria in RTE products and in clinical cases of human listeriosis started in January 2010......, the results of which will contribute to a better understanding about listeriosis in the EU. Q-fever increased by 172% in 2008 (1,594) compared with 2007 (585). This was mainly due to several outbreaks in people entering areas with infected sheep and goats mainly in the Netherlands. In-depth investigations...... from 2007 (2,905 cases). In animals VTEC was mainly isolated from cattle and, in lower proportion from small ruminants such as sheep and goats. In food, VTEC was detected in a considerable proportion of cow milk samples. The 2008 annual Community Summary Report describes the five-year trends...

Lack of genotoxicity in vivo for food color additive Tartrazine.

Science.gov (United States)

Bastaki, Maria; Farrell, Thomas; Bhusari, Sachin; Pant, Kamala; Kulkarni, Rohan

2017-07-01

Tartrazine is approved as a food color additive internationally with INS number 102, in the United States as food color subject to batch certification "Food, Drug, and Cosmetic" (FD&C) Yellow No. 5, and in Europe as food color additive with E number 102. In their evaluation of the color (2013), the European Food Safety Authority (EFSA) expressed concerns of potential genotoxicity, based primarily on one genotoxicity study that was not conducted according to Guidelines. The present in vivo genotoxicity study was conducted according to OECD Guidelines in response to EFSA's request for additional data. The animal species and strain, and the tissues examined were selected specifically to address the previously reported findings. The results of this study show clear absence of genotoxic activity for Tartrazine, in the bone marrow micronucleus assay and the Comet assay in the liver, stomach, and colon. These data addressed EFSA's concerns for genotoxicity. The Joint WHO/FAO Committee on Food Additives (JECFA) (2016) also reviewed these data and concluded that there is no genotoxicity concern for Tartrazine. Negative findings in parallel genotoxicity studies on Allura Red AC and Ponceau 4R (published separately) are consistent with lack of genotoxicity for azo dyes used as food colors. Copyright © 2017 Elsevier Ltd. All rights reserved.

NRPA develops regulatory cooperation with Central Asian authorities for nuclear safety and radiation protection

International Nuclear Information System (INIS)

2009-01-01

With the support of the Norwegian Ministry of Foreign Affairs, the NRPA has initiated a regional regulatory cooperation project with Kazakhstan, Kyrgyzstan and Tajikistan to improve regulations on nuclear safety, radiation protection and environmental issues, and assist the countries in re mediating radioactively contaminated sites. There is a critical lack in the regulatory basis for carrying out such remediation work, including a lack of relevant radiation and environmental safety norms and standards, licensing procedures and requirements for monitoring, as well as expertise to transform such a basis into practice. (Author)

Procedure for getting safety classed concrete structures approved by Finnish Radiation and Nuclear Safety Authority

International Nuclear Information System (INIS)

Halme, Ville-Juhani

2015-01-01

Posiva is preparing geological final disposal in the Finnish bedrock in Olkiluoto, Eurajoki. The final disposal facility includes encapsulation plant and underground repository. Most of the main civil structures are concrete structures. STUK is the supervising authority in civil structures. The National Building Code of Finland and STUK's Regulatory Guide on nuclear safety (YVL) are the most important instructions when constructing concrete structures into nuclear installation. Posiva has classified concrete structures in two classes according STUK's YVL-guidance: EYT (non-nuclear) and Safety Class 3 (SC 3, nuclear safety significance). When building SC 3 concrete structures, specific protocol must be followed. Protocol includes planned routines for design, construction, supervision, quality control (QC) and quality assurance (QA) activities. Documents relating concrete structures must be approved by Posiva and STUK before construction work. After structures have been designed and actual building is ongoing, there are two main steps. Before concreting, readiness inspection for concreting must be arranged. Readiness inspection will be arranged according to a specific plan and the date must be informed to STUK. After establishing readiness for concreting, casting work can begin. Once concrete structures are done, inspected and approved, final documentation according to a quality control plan will be reviewed by Posiva. After Posiva's approval, final documentation will be sent for STUK's approval. In the end STUK will give the permission for commissioning of the concrete structures after approved commissioning inspection. The document is made up of an abstract and a poster

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013 . Scientific opinion on Dietary Reference Values for fluoride

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for fluoride, which are provided as Adequate Intake (AI) from all sources, including non-dietary sources. Fluoride is not an essential nutrient...... and adults, including pregnant and lactating women. For pregnant and lactating women, the AI is based on the body weight before pregnancy and lactation. Reliable and representative data on the total fluoride intake of the European population are not available. © European Food Safety Authority, 2013...

European Food Safety Authority; Outcome of the Public consultation on the Draft Opinion of the Scientific Panel on Dietetic products, Nutrition, and Allergies (NDA) on Dietary Reference Values for fats, including saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, trans

DEFF Research Database (Denmark)

Tetens, Inge

these were taken into account in the final opinion. EFSA had received contributions from 40 interested parties (individuals, non-governmental organisations, industry organisations, academia and national assessment bodies). The main comments which were received during the public consultation related to...

Assessing and monitoring impacts of genetically modified plants on agro-ecosystems: the approach of AMIGA project

Directory of Open Access Journals (Sweden)

S. Arpaia

2014-06-01

Full Text Available The environmental impacts of genetically modified crops is still a controversial issue in Europe. The overall risk assessment framework has recently been reinforced by the European Food Safety Authority(EFSA and its implementation requires harmonized and efficient methodologies. The EU-funded research project AMIGA − Assessing and monitoring Impacts of Genetically modified plants on Agro-ecosystems − aims to address this issue, by providing a framework that establishes protection goals and baselines for European agro-ecosystems, improves knowledge on the potential long term environmental effects of genetically modified (GM plants, tests the efficacy of the EFSA Guidance Document for the Environmental Risk Assessment, explores new strategies for post market monitoring, and provides a systematic analysis of economic aspects of Genetically Modified crops cultivation in the EU. Research focuses on ecological studies in different EU regions, the sustainability of GM crops is estimated by analysing the functional components of the agro-ecosystems and specific experimental protocols are being developed for this scope.

Artificial sweeteners

DEFF Research Database (Denmark)

Larsen, John Christian

2012-01-01

Low-calorie sweeteners are authorised food additives in the European Union (EU). The safety of these sweeteners has been evaluated in accordance with internationally agreed principles for the safety evaluation of food additives. In the EU, the European Commission’s Scientific Committee for Food...... (SCF) was the scientific guarantor for the safety of food additives until March 2003. Since then this has been taken over by the European Food Safety Authority (EFSA), notably its Scientific Panel on Food Additives and Nutrient Sources Added to Food (ANS Panel). Based on the large number...... of toxicological studies that are requested for the safety evaluation of food additives, a no observed adverse effect level (NOAEL) is identified for the most sensitive effect in the most sensitive animal species. A safety factor of 100 is normally applied to the NOAEL in order to establish an acceptable daily...

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 24, Revision 2 (FGE.24Rev2)

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Frandsen, Henrik Lauritz

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 24 flavouring substances in the Flavouring Group Evaluation 24, Revision 2, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision...... the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all 24 candidate substances....

EFSA (European Food Safety Authority), 2016. Dietary exposure assessment to pyrrolizidine alkaloids in the European population

DEFF Research Database (Denmark)

Petersen, Annette

Chronic and acute dietary exposure to pyrrolizidine alkaloids (PAs) was estimated in the European population via the consumption of plant-derived foods. This resulted in highest estimates of mean chronic dietary exposure of 34.5–48.4 ng/kg body weight (bw) per day in ‘Toddlers’ (LB–UB) and 154...

EFSA EFSA ; Scientific Opinion on Flavouring Group Evaluation 99 (FGE.99): Consideration of furanone derivatives evaluated by the JECFA (63rd, 65th and 69th meetings)

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further...

Improving Research Reactor Accident Response Capability at the Hungarian Nuclear Safety Authority

International Nuclear Information System (INIS)

Vegh, J.; Gajdos, F.; Horvath, Cs.; Matisz, A.; Nyisztor, D.

2013-06-01

The paper describes the design and implementation of an on-line operation monitoring and accident response support system to be used at the CERTA emergency response centre of Hungarian Atomic Energy Authority (HAEA). The monitored facility is the Budapest Research Reactor (BRR), which is a tank-type thermal reactor having 10 MW thermal power. The basic reason for the development of the on-line safety information system is to extend the emergency response capability of the CERTA crisis centre to include emergencies related to BRR, as well. CERTA is operated by HAEA at its Budapest headquarters and the centre already has an on-line system for monitoring the state of the four units of Paks NPP, Hungary. The system is called CERTA VITA and it is able to monitor the four VVER-440/V213 units during their normal operation, and during emergencies (including severe accidents). Ensuring appropriate emergency response capabilities, as well as improving the presently available systems and tools was one of the important recommendations resulting from the analyses following the severe accident at Fukushima. This task is valid not only for the operators of the nuclear facilities but also for the nuclear safety authorities, therefore HAEA decided to launch a project - together with the Centre for Energy Research, the operator of BRR - to establish an on-line information system similar to the CERTA VITA used for monitoring the four units of the Paks NPP. It is believed that by the introduction of this new on-line system the accident response capabilities of HAEA will be further enhanced and the BRR emergencies will be handled at the same professional level as potential emergencies at Paks NPP. (authors)

EFSA EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 304 (FGE.304): Five carboxamides from chemical group 30

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate five flavouring substances in the Flavouring Group Evaluation 304, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances...... data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Specifications including complete purity criteria and identity for the materials of commerce have been provided for all five candidate substances....

Re-evaluation of azo dyes as food additives

DEFF Research Database (Denmark)

Pratt, Iona; Larsen, John Christian; Mortensen, Alicja

2013-01-01

additives to be assessed by the Scientific Committee on Food, many years ago, (ii) because of concern regarding possible health effects of artificial colours arising since the original evaluations.Concerns includedbehavioural effects in children, allergic reactions, genotoxicity and possible carcinogenicity......Aryl azo compounds are widely used as colorants (azo dyes) in a wide range of products including textiles, leather, paper, cosmetics, pharmaceuticals and food.As part of its systematic re-evaluation of food additives, the European Food Safety Authority (EFSA) has carried out new risk assessments...

Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) and “energy and vitality” (ID 18, 26, 62, 105, 122, 145, 165, 3962, 4054, 4440), “invigoration of the body” (ID 2383, 2386, 2391, 2393, 2409, 2441, 2463, 2488, 3834, 3883), “general health” (ID, 1313, 3348, 4182, 4613), “rejuvenation” (ID 3981, 4023), “tonic” (ID 1703, 3462, 3581, 4418), “stimulant” (ID 3190, 3506) and “metabolic benefits” (ID 4438) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

EFSA-Q-2008-3196,EFSA-Q-2008-3221,EFSA-Q-2008-3922,EFSA-Q-2008-4079,EFSA-Q-2008-4191,EFSA-Q-2008-4233,EFSA-Q-2008-4307,EFSA-Q-2008-4550,EFSA-Q-2008-4599,EFSA-Q-2008-4678,EFSA-Q-2008-4696,EFSA-Q-2008-4735,EFSA-Q-2008-4766,EFSA-Q-2008-4893,EFSA-Q-2010-00371 , EFSA-Q-2008-805,EFSA-Q-2008-813,EFSA-Q-...

Nuclear safety culture and nuclear safety supervision

International Nuclear Information System (INIS)

Chai Jianshe

2013-01-01

In this paper, the author reviews systematically and summarizes up the development process and stage characteristics of nuclear safety culture, analysis the connotation and characteristics of nuclear safety culture, sums up the achievements of our country's nuclear safety supervision, dissects the challenges and problems of nuclear safety supervision. This thesis focused on the relationship between nuclear safety culture and nuclear safety supervision, they are essential differences, but there is a close relationship. Nuclear safety supervision needs to introduce some concepts of nuclear safety culture, lays emphasis on humanistic care and improves its level and efficiency. Nuclear safety supervision authorities must strengthen nuclear safety culture training, conduct the development of nuclear safety culture, make sure that nuclear safety culture can play significant roles. (author)

Index to Nuclear Safety: a technical progress review by chronology, permuted title, and author. Vol. 11(1)--Vol. 18(6)

Energy Technology Data Exchange (ETDEWEB)

Cottrell, W.B.; Klein, A.

1978-04-11

This index to Nuclear Safety covers articles published in Nuclear Safety, Vol. 11, No. 1 (January-February 1970), through Vol. 18, No. 6 (November-December 1977). It is divided into three sections: a chronological list of articles (including abstracts) followed by a permuted-title (KWIC) index and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center (NSIC), covers all safety aspects of nuclear power reactors and associated facilities. Over 450 technical articles published in Nuclear Safety in the last eight years are listed in this index.

Index to Nuclear Safety: a technical progress review by chronology, permuted title, and author. Vol. 11(1)--Vol. 18(6)

International Nuclear Information System (INIS)

Cottrell, W.B.; Klein, A.

1978-01-01

This index to Nuclear Safety covers articles published in Nuclear Safety, Vol. 11, No. 1 (January-February 1970), through Vol. 18, No. 6 (November-December 1977). It is divided into three sections: a chronological list of articles (including abstracts) followed by a permuted-title (KWIC) index and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center (NSIC), covers all safety aspects of nuclear power reactors and associated facilities. Over 450 technical articles published in Nuclear Safety in the last eight years are listed in this index

Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) claiming biotransformation of xenobiotic substances (ID 1378, 2388, 2401, 3900, 3942, 4039, 4510, 4513, 4544, 4628, 4639), “elimination”, “cleansing” and “purification” (ID 1347, 4024, 4442

DEFF Research Database (Denmark)

Tetens, Inge

EFSA-Q-2008-2084 , EFSA-Q-2008-2115 , EFSA-Q-2008-2620 , EFSA-Q-2008-3121 , EFSA-Q-2008-3134 , EFSA-Q-2008-3888 , EFSA-Q-2008-4616 , EFSA-Q-2008-4658 , EFSA-Q-2008-4736 , EFSA-Q-2008-4751 , EFSA-Q-2010-00395 , EFSA-Q-2010-00410 , EFSA-Q-2010-00463 , EFSA-Q-2010-00466 , EFSA-Q-2010-00497 , EFSA-Q-...

Scientific Opinion on the substantiation of health claims related to eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA) and maintenance of normal cardiac function (ID 504, 506, 516, 527, 538, 703, 1128, 1317, 1324, 1325), maintenance of normal blood glucose, -cholesterol concentrations (ID 527, 538, 1317, 1325, 4689), protection of the skin from photo-oxidative (UV-induced) damage (ID 530), improved absorption of EPA and DHA (ID 522, 523)

DEFF Research Database (Denmark)

Tetens, Inge

EFSA-Q-2008-1291 , EFSA-Q-2008-1293 , EFSA-Q-2008-1303 , EFSA-Q-2008-1307 , EFSA-Q-2008-1309 , EFSA-Q-2008-1310 , EFSA-Q-2008-1314 , EFSA-Q-2008-1317 , EFSA-Q-2008-1325 , EFSA-Q-2008-1353 , EFSA-Q-2008-1490 , EFSA-Q-2008-1867 , EFSA-Q-2008-2054 , EFSA-Q-2008-2061 , EFSA-Q-2008-2062 , EFSA-Q-2008-...

Scientific Opinion on the substantiation of health claims related to non characterised bacteria and yeasts pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

EFSA-Q-2008-3668 , EFSA-Q-2008-3669 , EFSA-Q-2008-3670 , EFSA-Q-2008-3671 , EFSA-Q-2008-3672 , EFSA-Q-2008-3673 , EFSA-Q-2008-3674 , EFSA-Q-2008-3675 , EFSA-Q-2008-3676 , EFSA-Q-2008-3677 , EFSA-Q-2008-3692 , EFSA-Q-2008-3693 , EFSA-Q-2008-3697 , EFSA-Q-2008-3700 , EFSA-Q-2008-3701 , EFSA-Q-2008-...

Safety evaluation report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan

International Nuclear Information System (INIS)

1991-01-01

This safety evaluation report (SER) was prepared by the US Nuclear Regulatory Commission (NRC) staff and represents the second and last supplement (SSER 2) to the staff's original SER published as Volume 3 of NUREG-1232 in April 1989. Supplement 1 of Volume 3 of NUREG-1232 (SSER 1) was published in October 1989. Like its predecessors, SSER 2 is composed of numerous safety evaluations by the staff regarding specific elements contained in the Browns Ferry Nuclear Performance Plan (BFNPP), Volume 3 (up to and including Revision 2), submitted by the Tennessee Valley Authority (TVA) for the Browns Ferry Nuclear Plant (BFN). The Browns Ferry Nuclear Plant consists of three boiling-water reactors (BWRs) at a site in Limestone County, Alabama. The BFNPP describes the corrective action plans and commitments made by TVA to resolve deficiencies with its nuclear programs before the startup of Unit 2. The staff has inspected and will continue to inspect TVA's implementation of these BFNPP corrective action plans that address staff concerns about TVA's nuclear program. SSER 2 documents the NRC staff's safety evaluations and conclusions for those elements of the BFNPP that were not previously addressed by the staff or that remained open as a result of unresolved issues identified by the staff in previous SERs and inspections

Safety of Ecklonia cava phlorotannins as a novel food pursuant to Regulation (EC) No 258/97

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

/97. The novel food is a phlorotannin-rich alcohol extract of Ecklonia cava, which is an edible marine brown alga species. The information provided on the composition, the specifications, the production process and the batch-to-batch variability of the novel food is sufficient and does not raise safety concerns......Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of Ecklonia cava phlorotannins (marketed as SeaPolynolTM) as a novel food submitted pursuant to Regulation (EC) No 258....... The intention is to market the novel food as a food supplement for healthy individuals over the age of 12 years. A subchronic repeated dose oral toxicity study in rodents tested the novel food at daily doses of 0, 375, 750 and 1,500 mg/kg body weight (bw). The Panel considers the middose as the no...

A new food frequency questionnaire to assess chocolate and cocoa consumption.

Science.gov (United States)

Vicente, Filipa; Saldaña-Ruíz, Sandra; Rabanal, Manel; Rodríguez-Lagunas, María J; Pereira, Paula; Pérez-Cano, Francisco J; Castell, Margarida

2016-01-01

Cocoa has been highlighted as a food with potential benefits to human health because of its polyphenol content. However, few studies show the contribution of cocoa and chocolate products in polyphenol intake. The aim of this work was to develop a food frequency questionnaire (FFQ) for evaluating the intake of food products containing cocoa (C-FFQ). A sample of 50 university students was recruited to complete the 90-item questionnaire, a validated questionnaire (called here European Food Safety Authority [EFSA]-Q) as well as a 24-hour dietary recall (24 HDR). Spearman correlation test, Bland-Altman plots, and quintile classification analysis were conducted together with the Wilcoxon test and descriptive statistics. Significant correlations between the C-FFQ and the EFSA-Q for the most common cocoa/chocolate products were observed (P cocoa/chocolate products frequently consumed by the participants were detected by the C-FFQ and 24 HDR which were not included in the EFSA-Q. According to the C-FFQ, chocolate bars were the main source of cocoa in university students, but dairy products also provided an important amount of cocoa. The developed C-FFQ questionnaire can be considered as a valid option for assessing the consumption frequency of cocoa/chocolate-derived products, thereby allowing the evaluation of cocoa polyphenol intake in further studies. Copyright © 2016 Elsevier Inc. All rights reserved.

Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) and improved bioavailability of nutrients (ID 384, 1728, 1752, 1755), energy and nutrient supply (ID 403, 413, 457, 487, 667, 1675, 1710, 2901, 4496) and presence of a nutrient in the human body

DEFF Research Database (Denmark)

Tetens, Inge

EFSA-Q-2008-1171 , EFSA-Q-2008-1190 , EFSA-Q-2008-1200 , EFSA-Q-2008-1244 , EFSA-Q-2008-1274 , EFSA-Q-2008-1454 , EFSA-Q-2008-1507 , EFSA-Q-2008-2411 , EFSA-Q-2008-2446 , EFSA-Q-2008-2464 , EFSA-Q-2008-2485 , EFSA-Q-2008-2488 , EFSA-Q-2008-3634 , EFSA-Q-2010-00449...

Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

Science.gov (United States)

Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

2015-09-01

Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

EFSA ND A Panel ( EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to eicosapentanoic acid (EPA) and “ reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the d evelopment of attention, difficulties in children with ADHD - like symptoms ” pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following an application from Minami Nutrition Health BVBA, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation...... of a health claim related to eicosapentaenoic acid (EPA) and “reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with attention deficit hyperactivity disorder (ADHD)-like symptoms”. The food constituent, EPA, which is the subject...... of the health claim, is sufficiently characterised. The claimed effect proposed by the applicant is “reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with ADHD-like symptoms. These children are also characterised by less...

European Food Safety Authority; Outcome of the Public Consultation on the Draft Opinion of the Scientific Panel on Dietetic Products, Nutrition, and Allergies (NDA) on establishing Food-Based Dietary Guidelines

DEFF Research Database (Denmark)

Tetens, Inge

taken into account in the final opinion. EFSA had received 60 contributions from 19 interested parties (individuals, non-governmental organisations, industry organisations, academia and national assessment bodies). After a meeting with national experts on Dietary Reference Values which was held...... of diet-health relationships, possible adverse health effects of excessive consumption of sugar(s), sugar-sweetened beverages, the performance of risk-benefit analysis, the contribution of food supplements and fortified food as nutrient sources in the diet, and to the section on implementation...

Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health

DEFF Research Database (Denmark)

Tetens, Inge

2011-01-01

The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) t to draft guidance on scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. This guidance has been drawn from scientific...... opinions of the NDA Panel on such health claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in these areas. It is not intended that the document should include an exhaustive list of beneficial effects...

Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2016-01-01

The European Food Safety Authority (EFSA) has asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to gut and immune function published in 2011. Since then, the NDA Panel has completed the evaluation...... the shortcomings that prevented the substantiation of these claims. The general document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims, and it may be further updated, as appropriate, in the light of experiences gained from the evaluation...

Guidance on methodology for evaluation of the effectiveness of options for reducing the risk of introduction and spread of organisms harmful to plant health in the EU territory

DEFF Research Database (Denmark)

Baker, R.; Candresse, T.; Dormannsné Simon, E.

2012-01-01

The European Food Safety Authority (EFSA) requested the Panel on Plant Health (PLH Panel) to provide guidance for the evaluation of the effectiveness of the options for plants and plant products for reducing the risk of introduction and spread of harmful organisms in the European Union territory...... and guidance documents for assessing a proposed RRO. In addition, the current document provides recommendations for assessing RROs, specifically: on experimental design; on the use of statistical methods including approaches for studying uncertainty; on the use of quantitative pathway analysis and spread...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to “non-digestible oligo- and polysaccharides including galactooligosaccharides, oligofructose, polyfructose and inulin” and “increase in calcium

DEFF Research Database (Denmark)

Tetens, Inge

to deliver an opinion on the scientific substantiation of a health claim related to “non-digestible oligo- and polysaccharides including galacto-oligosaccharides, oligofructose, polyfructose and inulin” and “increase in calcium absorption”. The scope of the application was proposed to fall under a health...... claim referring to children’s development and health. The food constituents that are proposed by the applicant to be the subject of the health claim are “non-digestible oligo- and polysaccharides including galacto-oligosaccharides, oligofructose, polyfructose and inulin”. Upon requests by EFSA...... for clarification on the food constituent, the applicant did not clarify the food constituent that is the subject of the health claim. The Panel considers that the food constituents, “non-digestible oligo- and polysaccharides including galacto-oligosaccharides, oligofructose, polyfructose and inulin”, which...

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 93, Revision 1 (FGE.93Rev1)

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Frandsen, Henrik Lauritz

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further...... through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The two substances 5-ethyl-4-methyl-2-(2-methylpropyl)-thiazoline [FL-no: 15.130] and 5-ethyl-4-methyl-2...... and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all five substances...

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013 . S tatement on the safety of ' Cetyl Myristoleate Complex ' as an ingredient in food supplements

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinion on the safety of „Cetyl Myristoleate Complex‟ (CMC) as a novel food ingredient in the light of a new repeated dose 90-day oral toxicity study in mice. In its p...

Safety assessment of Olkiluoto NPP units 1 and 2. Decision of the Radiation and Nuclear Safety Authority regarding the periodic safety review of the Olkiluoto NPP

International Nuclear Information System (INIS)

2010-02-01

In this safety assessment the Radiation and Nuclear Safety Authority (STUK) has evaluated the safety of the Olkiluoto Nuclear Power Plant units 1 and 2 in connection with the periodic safety review. This safety assessment provides a summary of the reviews, inspections and continuous oversight carried out by STUK. The issues addressed in the assessment and the related evaluation criteria are set forth in the nuclear energy and radiation safety legislation and the regulations issued thereunder. The provisions of the Nuclear Energy Act concerning the safe use of nuclear energy, security and emergency preparedness arrangements, and waste management are specified in more detail in the Government Decrees and Regulatory Guides issued by STUK. Based on the assessment, STUK consideres that the Olkiluoto Nuclear Power Plant units 1 and 2 meet the set safety requirements for operational nuclear power plants, the emergency preparedness arrangements are sufficient and the necessary control to prevent the proliferation of nuclear weapons has been appropriately arranged. The physical protection of the Olkiluoto nuclear power plant is not yet completely in compliance with the requirements of Government Decree 734/2008, which came into force in December 2008. Further requirements concerning this issue based also on the principle of continuous improvement were included in the decision relating to the periodic safety review. The safety of the Olkiluoto nuclear power plant was assessed in compliance with the Government Decree on the Safety of Nuclear Power Plants (733/2008), which came into force in 2008. The decree notes that existing nuclear power plants need not meet all the requirements set out for new plants. Most of the design bases pertaining to the Olkiluoto 1 and 2 nuclear power plant units were set in the 1970s. Substantial modernisations have been carried out at the Olkiluoto 1 and 2 nuclear power plant units since their commissioning to improve safety. This is in line with

Index to Nuclear Safety: a technical progress review by chronology, permuted title, and author, Volume 18 (1) through Volume 22 (6)

International Nuclear Information System (INIS)

Cottrell, W.B.; Passiakos, M.

1982-06-01

This index to Nuclear Safety covers articles published in Nuclear Safety, Volume 18, Number 1 (January-February 1977) through Volume 22, Number 6 (November-December 1981). The index is divided into three section: a chronological list of articles (including abstracts), a permuted-title (KWIC) index, and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. Over 300 technical articles published in Nuclear Safety in the last 5 years are listed in this index

Index to Nuclear Safety: a technical progress review by chronology, permuted title, and author, Volume 18 (1) through Volume 22 (6)

Energy Technology Data Exchange (ETDEWEB)

Cottrell, W.B.; Passiakos, M.

1982-06-01

This index to Nuclear Safety covers articles published in Nuclear Safety, Volume 18, Number 1 (January-February 1977) through Volume 22, Number 6 (November-December 1981). The index is divided into three section: a chronological list of articles (including abstracts), a permuted-title (KWIC) index, and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. Over 300 technical articles published in Nuclear Safety in the last 5 years are listed in this index.

Principles for the risk assessment of genetically modified microorganisms and their food products in the European Union.

Science.gov (United States)

Aguilera, Jaime; Gomes, Ana R; Olaru, Irina

2013-10-01

Genetically modified microorganisms (GMMs) are involved in the production of a variety of food and feed. The release and consumption of these products can raise questions about health and environmental safety. Therefore, the European Union has different legislative instruments in place in order to ensure the safety of such products. A key requirement is to conduct a scientific risk assessment as a prerequisite for the product to be placed on the market. This risk assessment is performed by the European Food Safety Authority (EFSA), through its Scientific Panels. The EFSA Panel on Genetically Modified Organisms has published complete and comprehensive guidance for the risk assessment of GMMs and their products for food and/or feed use, in which the strategy and the criteria to conduct the assessment are explained, as well as the scientific data to be provided in applications for regulated products. This Guidance follows the main risk assessment principles developed by various international organisations (Codex Alimentarius, 2003; OECD, 2010). The assessment considers two aspects: the characterisation of the GMM and the possible effects of its modification with respect to safety, and the safety of the product itself. Due to the existing diversity of GMMs and their products, a categorisation is recommended to optimise the assessment and to determine the extent of the required data. The assessment starts with a comprehensive characterisation of the GMM, covering the recipient/parental organism, the donor(s) of the genetic material, the genetic modification, and the final GMM and its phenotype. Evaluation of the composition, potential toxicity and/or allergenicity, nutritional value and environmental impact of the product constitute further cornerstones of the process. The outcome of the assessment is reflected in a scientific opinion which indicates whether the product raises any safety issues. This opinion is taken into account by the different European regulatory

Additional safety assessments, follow-up of stress tests of the French nuclear power stations. Action plan of the nuclear safety authority

International Nuclear Information System (INIS)

2012-01-01

This document presents the French national action plan defined by the Nuclear Safety Authority (ASN) in compliance with the recommendations made by the ENSREG (European nuclear safety regulators group). It refers to decisions taken at the national level after the Fukushima accident, recommendations after European stress tests, and recommendations after the extraordinary meeting of contracting parties at the Convention on Nuclear Safety of August 2012. For different topics, this document recalls the recommendations made by the peer review, indicates the ASN's opinion and progress or ASN's requirements for different power stations. The first part addresses the recommendations made by peers and based on the European review. Topics concern natural hazards (effects, detection, inspections and controls related to earthquakes, margin assessment with respect to flooding and natural hazards), the loss of safety systems (cooling systems, electricity supplies, actions, instruments, training, and so on), the management of a severe accident (reference levels, measures, guides, exercises, training, management of contaminated water, radiation protection, premises). The second part deals with topics addressed within the frame of the Convention: national organisations, organisations in an emergency and post-accidental situation, international cooperation. A third part addresses the follow-up of additional measures issued by the ASN

Needs, requirements and challenges for technical support to nuclear safety authority

International Nuclear Information System (INIS)

Madonna, A.; Orsini, G.

2010-01-01

To face the very broad range of technical matters on which the regulatory and licensing activity are based, and related research and development activity, the Nuclear Safety Authorities (NSA) may need to rely upon external technical and scientific support. In providing technical support to NSA, the experience shows, from one side, the importance to have technical support organizations (TSO) with recognized competence, independence and appropriate regulatory view, and from the other side, the importance to have within the NSAs well developed management and technical capability to address, coordinate and use the results of the external technical support. Retaining the NSA the full responsibility for the final decision. Under which conditions and modus operandi the external support shall be provided in order to comply with requirements of being independent, competent and timely provided, fulfilling the administrative procedures, is the subject of attention and consideration of TSO function today. The Italian regulatory body is currently going to be institutionally re-established according to new law approved in 2009 /1/ and it needs to be resourced and fully organized with necessary capacities in the nearest future. The perspective of a new nuclear program, recently launched by the government, with significant incoming tasks for regulation and licensing, against the existing limited resources, let foresee a substantial potential need for technical support and advice. ITER-Consult (Ltd), created in 2003 in Italy, has well developed capabilities to provide independent technical evaluation and support to NSAs, to maintain safety culture and updated knowledge, to transfer know how and to establish international cooperation and networking. This mission is guided assuming as values the independence, the professional competence, the transparency, the credibility and the establishment of respectful relationship with the partners. Challenges exist for funding and operational

Role of supervising authorities in NPP operation safety ensuring

International Nuclear Information System (INIS)

Elagin, Yu.P.

2001-01-01

The main working spheres and results gained during 40 years of activity of the Great Britain Nuclear Installation Inspectorate (NII) are considered. The new approach to safety analysis developed with NII participation is described in details. The important role of the safety analysis realization, utilization of modern methods for risk estimation and safety culture principles introduction at NPPs is shown [ru

Index to Nuclear Safety: a technical progress review by chrology, permuted title, and author, Volume 11(1) through Volume 20(6)

Energy Technology Data Exchange (ETDEWEB)

Cottrell, W B; Passiakos, M

1980-06-01

This index to Nuclear Safety, a bimonthly technical progress review, covers articles published in Nuclear Safety, Volume II, No. 1 (January-February 1970), through Volume 20, No. 6 (November-December 1979). It is divided into three sections: a chronological list of articles (including abstracts) followed by a permuted-title (KWIC) index and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center (NSIC), covers all safety aspects of nuclear power reactors and associated facilities. Over 600 technical articles published in Nuclear Safety in the last ten years are listed in this index.

Scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow-on formula manufactured from protein hydrolysates

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance for the preparation and presentation of applications for authorisation of infant and/or follow-on formula manufactured from...... protein hydrolysates. This guidance document addresses the information and data to be submitted to EFSA on infant and follow-on formulae manufactured from protein hydrolysates with respect to the safety and suitability of the specific formula and/or the formula’s efficacy in reducing the risk...

Quality systems for radiotherapy: Impact by a central authority for improved accuracy, safety and accident prevention

International Nuclear Information System (INIS)

Jaervinen, H.; Sipilae, P.; Parkkinen, R.; Kosunen, A.; Jokelainen, I.

2001-01-01

High accuracy in radiotherapy is required for the good outcome of the treatments, which in turn implies the need to develop comprehensive Quality Systems for the operation of the clinic. The legal requirements as well as the recommendation by professional societies support this modern approach for improved accuracy, safety and accident prevention. The actions of a national radiation protection authority can play an important role in this development. In this paper, the actions of the authority in Finland (STUK) for the control of the implementation of the new requirements are reviewed. It is concluded that the role of the authorities should not be limited to simple control actions, but comprehensive practical support for the development of the Quality Systems should be provided. (author)

Monitoring of polycyclic aromatic hydrocarbons (PAH) in food supplements containing botanicals and other ingredients on the Dutch market.

Science.gov (United States)

Martena, M J; Grutters, M M P; De Groot, H N; Konings, E J M; Rietjens, I M C M

2011-01-01

Food supplements can contain polycyclic aromatic hydrocarbons (PAH). The European Food Safety Authority (EFSA) has defined 16 priority PAH that are both genotoxic and carcinogenic and identified eight priority PAH (PAH8) or four of these (PAH4) as good indicators of the toxicity and occurrence of PAH in food. The current study aimed to determine benzo[a]pyrene and other EFSA priority PAH in different categories of food supplements containing botanicals and other ingredients. From 2003 to 2008, benzo[a]pyrene exceeded the limit of quantification (LOQ) in 553 (44%) of 1258 supplements with a lower-bound mean of 3.37 µg kg(-1). In 2008 and 2009, benzo[a]pyrene and 12 other EFSA priority PAH were determined in 333 food supplements. Benzo[a]pyrene exceeded the LOQ in 210 (63%) food supplements with a lower-bound mean of 5.26 µg kg(-1). Lower-bound mean levels for PAH4 and PAH8(-indeno[1,2,3-cd]pyrene) were 33.5 and 40.5 µg kg(-1), respectively. Supplements containing resveratrol, Ginkgo biloba, St. John's wort and propolis showed relatively high PAH4 levels in 2008 and 2009. Before 2008, supplements with these ingredients and also dong quai, green tea or valerian contained relatively high benzo[a]pyrene levels. On average, PAH4 intake resulting from food supplement use will be at the lower end of the range of contributions of main food groups to PAH4 exposure, although individual food supplements can contribute significantly to PAH4 exposure. Regular control of EFSA indicator PAH levels in food supplements may prove a way forward to reduce further the intake of PAH from food.

Mycotoxins in horse feed: Incidence of deoxynivalenol in oat samples from stud farms

Directory of Open Access Journals (Sweden)

Urošević Miroslav I.

2011-01-01

Full Text Available Reports concerning mycotoxins in horse feed are very rare and are typically restricted to fumonisins. As a non-ruminant monogastric species, horses may be more sensitive to adverse effects of mycotoxins, but the most severe effect of fumonisin B1 (FB1 in equines is that it causes fatal leucoencephalomalacia. In recent years, the European Food Safety Authority (EFSA has evaluated several mycotoxins as “undesirable substances in animal feed” with the aim of establishing guidance values for the feed industry. In its evaluation of deoxynivalenol (DON, EFSA concluded that this toxin exhibited toxic effects in all species, but that horses were more tolerant towards this toxin than pigs. According to the available data, a systematic survey on mycotoxins in horse feed in Serbia has not been published. Therefore, the aim of this study was to investigate the incidence of mycotoxins in horse feed in Vojvodina. Samples of oats for horse consumption, collected in 2010, were analyzed by enzyme immunoassays (ELISA for deoxynivalenol contamination. Twelve samples of oats were taken from twelve horse studs, with sport, school and hobby horses.

Glyphosate: useful, dangerous? To license or to phase out?

Directory of Open Access Journals (Sweden)

Karl Ernst v. Mühlendahl, Matthias Otto

2016-12-01

Full Text Available Glyphosate, a herbicide blocking an enzyme essential for all plants, but not for animals and humans, has certain advantages as compared to other plant protection products. It is not persistent. Due to the production and application of more than 700.000 tons per year, large portions of mankind are exposed. The International Agency on Research on Cancer (IARC of the World Health Organisation (WHO has looked more closely on glyphosate and has classified it as “probably carcinogenic for humans (2A” The German Bundesamt für Risikobewertung (BfR and the European Food Safety Authority (EFSA have analysed the data and contradict the IARC classification. In this paper, the process of decision finding and essential arguments for the contradictory classification are commented. In the ensuing public discussions, conflicts could have been rationalized if the BfR and the EFSA had offered more transparency regarding their evaluation and had restricted their opinions and their proposals to their genuine task: to propose regulations concerning the risks (which follow from possible hazards.

Additional safety assessments. Report by the Nuclear Safety Authority - December 2011

International Nuclear Information System (INIS)

2011-12-01

The first part of this voluminous report proposes an assessment of targeted audits performed in French nuclear installations (water pressurized reactors on the one hand, laboratories, factories and waste and dismantling installations on the other hand) on issues related to the Fukushima accident. The examined issues were the protection against flooding and against earthquake, and the loss of electricity supplies and of cooling sources. The second part addresses the additional safety assessments of the reactors and the European resistance tests: presentation of the French electronuclear stock, earthquake, flooding and natural hazards (installation sizing, safety margin assessment), loss of electricity supplies and cooling systems, management of severe accidents, subcontracting conditions. The third part addresses the same issues for nuclear installations other than nuclear power reactors

Index to Nuclear Safety. A technical progress review by chronology, permuted title, and author. Vol. 11, No. 1--Vol. 17, No. 6

International Nuclear Information System (INIS)

Cottrell, W.B.; Klein, A.

1977-01-01

This index to Nuclear Safety covers articles in Nuclear Safety Vol. 11, No. 1 (Jan.-Feb. 1970), through Vol. 17, No. 6 (Nov.-Dec. 1976). The index includes a chronological list of articles (including abstract) followed by KWIC and Author Indexes. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. The index lists over 350 technical articles in the last six years of publication

Index to Nuclear Safety. A technical progress review by chronology, permuted title, and author. Vol. 11, No. 1--Vol. 17, No. 6

Energy Technology Data Exchange (ETDEWEB)

Cottrell, W.B.; Klein, A.

1977-02-23

This index to Nuclear Safety covers articles in Nuclear Safety Vol. 11, No. 1 (Jan.-Feb. 1970), through Vol. 17, No. 6 (Nov.-Dec. 1976). The index includes a chronological list of articles (including abstract) followed by KWIC and Author Indexes. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. The index lists over 350 technical articles in the last six years of publication.

Radiation Authority and Nuclear Safety in Finland (STUK); La autoridad de Radiacion y Seguridad Nuclear de Finlandia (STUK)

Energy Technology Data Exchange (ETDEWEB)

NONE

2006-07-01

Created in 1958 as an institute in charge of inspecting radioactive equipment used in hospitals, STUK is nowadays a specialised organisation whose functions cover all fields for applying radiation and nuclear safety. (Author)

Handling of thermal paper: Implications for dermal exposure to bisphenol A and its alternatives.

Directory of Open Access Journals (Sweden)

Meghan R Bernier

Full Text Available Bisphenol A (BPA is an endocrine disrupting chemical used in a wide range of consumer products including photoactive dyes used in thermal paper. Recent studies have shown that dermal absorption of BPA can occur when handling these papers. Yet, regulatory agencies have largely dismissed thermal paper as a major source of BPA exposure. Exposure estimates provided by agencies such as the European Food Safety Authority (EFSA are based on assumptions about how humans interact with this material, stating that 'typical' exposures for adults involve only one handling per day for short periods of time (30% of individuals hold thermal paper with more than three fingertips, and >60% allow the paper to touch their palm. Only 11% of the participants we observed were consistent with the EFSA model for time of contact and dermal surface area. Mathematical modeling based on handling times we measured and previously published transfer coefficients, concentrations of BPA in paper, and absorption factors indicate the most conservative estimated intake from handling thermal paper in this population is 51.1 ng/kg/day, similar to EFSA's estimates of 59 ng/kg/day from dermal exposures. Less conservative estimates, using published data on concentrations in thermal paper and transfer rates to skin, indicate that exposures are likely significantly higher. Based on our observational data, we propose that the current models for estimating dermal BPA exposures are not consistent with normal human behavior and should be reevaluated.

Action taken by the french safety authorities for fire protection and fire fighting in basic nuclear plants

International Nuclear Information System (INIS)

Savornin, J.; Gibault, M.; Berger, R.; Kaluzny, Y.; Wallard, H.E.; Winter, D.

1989-03-01

The safety goal for nuclear installations is to prevent the dispersal of radioactive substances, both in the work area and outside the buildings into the environment. It is therefore at the design stage, then during construction and subsequent operation that it is necessary to take preventive measures against the outbreak of fire, and to take precautions to ensure that the consequences will always be limited. The paper describes the arrangements made by the French safety authorities to provide protection against fire in both nuclear plants and nuclear fuel cycle installations at all these stages

Safety Evaluation Report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan: Browns Ferry Unit 2 restart

International Nuclear Information System (INIS)

1989-04-01

This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Power Station and in supporting documents has been prepared by the US Nuclear Regulatory Commission staff. The plan addresses the plant-specific concerns requiring resolution before startup of Unit 2. The staff will inspect implementation of those programs. Where systems are common to Units 1 and 2 or to Units 2 and 3, the staff safety evaluations of those systems are included herein. 3 refs

EFSA CEF Panel (EFSA Panel on Fo od Contact Materials, Enzymes, Flavourings and Proce ssing Aids), 2015. Scientific Opinion on Flavouring Group Evalua tion 35, Revision 1 (FGE.35Rev1)

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Nørby, Karin Kristiane

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate three flavouring substances in the Flavouring Group Evaluation 35, Revision 1, using the Procedure in Commission Regulation (EC) No 1565/2000. The present ...

Condensyl® and decreases sperm DNA damage which is a risk factor for male infertility: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

Following an application from Laboratoire Nurilia submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the s......Following an application from Laboratoire Nurilia submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

Following an application from Biosearch Life, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scien......Following an application from Biosearch Life, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

L-carnitine and contribution to normal lipid metabolism: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2018-01-01

Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scien......Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

Nuclear safety

International Nuclear Information System (INIS)

Tarride, Bruno

2015-10-01

The author proposes an overview of methods and concepts used in the nuclear industry, at the design level as well as at the exploitation level, to ensure an acceptable safety level, notably in the case of nuclear reactors. He first addresses the general objectives of nuclear safety and the notion of acceptable risk: definition and organisation of nuclear safety (relationships between safety authorities and operators), notion of acceptable risk, deterministic safety approach and main safety principles (safety functions and confinement barriers, concept of defence in depth). Then, the author addresses the safety approach at the design level: studies of operational situations, studies of internal and external aggressions, safety report, design principles for important-for-safety systems (failure criterion, redundancy, failure prevention, safety classification). The next part addresses safety during exploitation and general exploitation rules: definition of the operation domain and of its limits, periodic controls and tests, management in case of incidents, accidents or aggressions

Organization of public authorities in France for the event of an incident or accident involving nuclear safety: Simulation of a nuclear crisis

International Nuclear Information System (INIS)

Cartigny, J.; Majorel, Y.

1986-01-01

The French nuclear safety regulations lay down the action to be taken in the event of an incident or accident involving the types of radiological hazard that could arise in a nuclear installation or during the transport of radioactive material. The organization established for this purpose is designed to ensure that the technical measures taken by the authorities responsible for nuclear safety, radiation protection, public order and public safety are fully effective. The Interministerial Nuclear Safety Committee (Comite interministeriel de la securite nucleaire), which reports to the Prime Minister, co-ordinates the measures taken by the public authorities. The public authorities and the operators together organize exercises designed to verify the whole complex of measures foreseen in the event of an incident or accident. These exercises, which have been carried out in a systematic manner in France for some years, are based on scenarios which are as realistic as possible and enable the following objectives to be achieved: (1) analysis of the crisis apparatus (ORSECRAD plans, individual intervention plans, information conventions); (2) uncovering gaps or inadequacies; (3) arrangements for interchange of information between the various participants whose responsibilities involve them in the emergency; and (4) allowance for the information requirements of the media and the population. The information drawn from these exercises enables the various procedures to be improved step by step. (author)

Efficacy and safety testing of mycotoxin-detoxifying agents in broilers following the European Food Safety Authority guidelines.

Science.gov (United States)

Osselaere, A; Devreese, M; Watteyn, A; Vandenbroucke, V; Goossens, J; Hautekiet, V; Eeckhout, M; De Saeger, S; De Baere, S; De Backer, P; Croubels, S

2012-08-01

Contamination of feeds with mycotoxins is a worldwide problem and mycotoxin-detoxifying agents are used to decrease their negative effect. The European Food Safety Authority recently stated guidelines and end-points for the efficacy testing of detoxifiers. Our study revealed that plasma concentrations of deoxynivalenol and deepoxy-deoxynivalenol were too low to assess efficacy of 2 commercially available mycotoxin-detoxifying agents against deoxynivalenol after 3 wk of continuous feeding of this mycotoxin at concentrations of 2.44±0.70 mg/kg of feed and 7.54±2.20 mg/kg of feed in broilers. This correlates with the poor absorption of deoxynivalenol in poultry. A safety study with 2 commercially available detoxifying agents and veterinary drugs showed innovative results with regard to the pharmacokinetics of 2 antibiotics after oral dosing in the drinking water. The plasma and kidney tissue concentrations of oxytetracycline were significantly higher in broilers receiving a biotransforming agent in the feed compared with control birds. For amoxicillin, the plasma concentrations were significantly higher for broilers receiving an adsorbing agent in comparison to birds receiving the biotransforming agent, but not to the control group. Mycotoxin-detoxifying agents can thus interact with the oral bioavailability of antibiotics depending on the antibiotic and detoxifying agent, with possible adverse effects on the health of animals and humans.

chemical subgroup 1.2.2 of FGE.19 by EFSA

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider in the Flavouring Group Evaluation 205, the additional data on genotoxicity submitted by the Industry on two representative substances, oct-1-en-3-one [FL...... with a steep toxicity curve, and with a very narrow concentration range resulting in mutagenicity. Both substances were also tested in mammalian cells for gene mutations at the hprt locus and for structural and numerical chromosomal aberrations in the micronucleus assay. Also in mammalian cells the test...

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2015. Scientific Opinion on Flavouring Group Evaluation 303, Revision 1 (FGE.303Rev1): Spilanthol from chemical group 30

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Nørby, Karin Kristiane

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the flavouring substance spilanthol [FL-no: 16.121] in Flavouring Group Evaluation 303, Revision 1, using the Procedure according to Commission Regulation...... (MSDI) approach. Besides the safety assessment of the flavouring substance, the specifications for the material of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the material of commerce have been provided for the candidate substance....

Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2007. Annual report

International Nuclear Information System (INIS)

2007-04-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2007 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials; (8) Emergency planning and preparedness; (9) International activities; (10) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) Abbreviations

Is an ecosystem services-based approach developed for setting specific protection goals for plant protection products applicable to other chemicals?

Science.gov (United States)

Maltby, Lorraine; Jackson, Mathew; Whale, Graham; Brown, A Ross; Hamer, Mick; Solga, Andreas; Kabouw, Patrick; Woods, Richard; Marshall, Stuart

2017-02-15

Clearly defined protection goals specifying what to protect, where and when, are required for designing scientifically sound risk assessments and effective risk management of chemicals. Environmental protection goals specified in EU legislation are defined in general terms, resulting in uncertainty in how to achieve them. In 2010, the European Food Safety Authority (EFSA) published a framework to identify more specific protection goals based on ecosystem services potentially affected by plant protection products. But how applicable is this framework to chemicals with different emission scenarios and receptor ecosystems? Four case studies used to address this question were: (i) oil refinery waste water exposure in estuarine environments; (ii) oil dispersant exposure in aquatic environments; (iii) down the drain chemicals exposure in a wide range of ecosystems (terrestrial and aquatic); (iv) persistent organic pollutant exposure in remote (pristine) Arctic environments. A four-step process was followed to identify ecosystems and services potentially impacted by chemical emissions and to define specific protection goals. Case studies demonstrated that, in principle, the ecosystem services concept and the EFSA framework can be applied to derive specific protection goals for a broad range of chemical exposure scenarios. By identifying key habitats and ecosystem services of concern, the approach offers the potential for greater spatial and temporal resolution, together with increased environmental relevance, in chemical risk assessments. With modifications including improved clarity on terminology/definitions and further development/refinement of the key concepts, we believe the principles of the EFSA framework could provide a methodical approach to the identification and prioritization of ecosystems, ecosystem services and the service providing units that are most at risk from chemical exposure. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights

Complementary Safety Assessments for Research Reactors for the French Nuclear Safety Authority

International Nuclear Information System (INIS)

Kassiotis, Christophe; Rigaud, Antoine; Evrard, Lydie

2013-01-01

The 'Autorite de surete nucleaire' (ASN) requested licensees to undertake stress tests, called complementary safety assessments (CSA), of their installations on May 5th 2011, following the accident that occurred in Japan on March 11th 2011. Their mission consisted in providing feedback on the consequences of potential extreme events. In this process, all the French facilities were divided into three categories of decreasing priority, depending on two main factors: on the one hand, their vulnerability to the various phenomena that led to the Fukushima accident, and on the other hand, the amount of radioactive elements that would be dispersed in the event of a failure of the safety functions. On the 79 high-priority facilities, only five of them are research or experimental reactors (including two currently shutdown or in decommissioning) and their operators (the 'Comissariat a l'energie atomique et aux energies alternatives' (CEA) and the 'Institut Laue Langevin') submitted their reports to the ASN on September 15 th 2011. Concerning the lower-priority facilities, including three other facilities (two research reactors operated by the CEA and a facility operated by ITER Organization) the deadline was September 15 th 2012. Finally, the remaining facilities were not asked to submit a report yet, but they will have to do it later, mainly on the occasion of their next periodic safety review. The analyses of the cliff-edge effects, that may occur in extreme situations (exceptional scale event, combination of several disasters...), led to the definition of a hardened safety core concept by the 'Institut de radioprotection et de surete nucleaire' (IRSN). This hardened safety core of structures, equipment and organizational measures must ensure the ultimate protection of the concerned facilities in extreme situations : it is designed to prevent severe accidents (or curb their progression), limit large scale releases for extreme accidents, and enables the operating teams to

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 76, Revision 1 (FGE.76Rev1)

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Frandsen, Henrik Lauritz

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further...... by Industry for use as a flavouring substance in Europe and will therefore not be considered any further. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data...... as flavouring substances, as these substances could not be evaluated because of concern with respect to genotoxicity. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 26 substances, the information is adequate....

Drug packaging in 2014: authorities should direct more efforts towards medication safety.

Science.gov (United States)

2015-05-01

In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety. Although pharmaceutical companies and drug regulatory agencies seem to be taking more account of the risk of accidental poisoning in children, the level of protection remains low overall in the absence of stringent measures on the part of the authorities. New drugs too often have poor-quality or even dangerous packaging at the time of their market introduction. And the packaging quality of older drugs is disturbing. Pharmaceutical companies no longer invest in the packaging of these products, and agencies often fail to take advantage of the opportunities provided by their reassessment to improve the situation. The inappropriate labelling of certain injectable drugs remains a source of medication errors, sometimes resulting in very serious consequences. In 2014, signs of progress in the packaging of several drugs show that its role in medication safety is better appreciated. But the persistence of dangers in the pharmaceuticals market, created by "unfinished", overly complex or poor-quality packaging, raises the question of the responsibility of pharmaceutical companies and agencies for past and present accidents.

Safety Evaluation report on Tennessee Valley Authority: Sequoyah nuclear performance plan

International Nuclear Information System (INIS)

1988-05-01

This Safety Evaluation Report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Sequoyah Nuclear Performance Plan, through Revision 2, and supporting documents has been prepared by the US Nuclear Regulatory Commission staff. The plan addresses the plant-specific concerns requiring resolution before startup of either of the Sequoyah units. In particular, the SER addresses required actions for Unit 2 restart. In many cases, the programmatic aspects for Unit 1 are identical to those for Unit 2; the staff will conduct inspections of implementation of those programs. Where the Unit 1 program is different, the staff evaluation will be provided in a supplement to this SER. On the basis of its review, the staff concludes that Sequoyah-specific issues have been resolved to the extent that would support restart of Sequoyah Unit 2

State Regulatory Authority (SRA) Coordination of Safety, Security, and Safeguards of Nuclear Facilities: A Framework for Analysis

International Nuclear Information System (INIS)

Mladineo, S.; Frazar, S.; Kurzrok, A.; Martikka, E.; Hack, T.; Wiander, T.

2013-01-01

In November 2012 the International Atomic Energy Agency (IAEA) sponsored a Technical Meeting on the Interfaces and Synergies in Safety, Security, and Safeguards for the Development of a Nuclear Power Program. The goal of the meeting was to explore whether and how safeguards, safety, and security systems could be coordinated or integrated to support more effective and efficient nonproliferation infrastructures. While no clear consensus emerged, participants identified practical challenges to and opportunities for integrating the three disciplines’ regulations and implementation activities. Simultaneously, participants also recognized that independent implementation of safeguards, safety, and security systems may be more effective or efficient at times. This paper will explore the development of a framework for conducting an assessment of safety-security-safeguards integration within a State. The goal is to examine State regulatory structures to identify conflicts and gaps that hinder management of the three disciplines at nuclear facilities. Such an analysis could be performed by a State Regulatory Authority (SRA) to provide a self-assessment or as part of technical cooperation either with a newcomer State, or to a State with a fully developed SRA.

Index to Nuclear Safety. A technical progress review by chronology, permuted title, and author. Vol 11, No. 1 through Vol. 16, No. 6

International Nuclear Information System (INIS)

Cottrell, W.B.; Klein, A.

1976-04-01

This index to Nuclear Safety covers articles in Nuclear Safety Vol. 11, No. 1 (Jan.-Feb. 1970) through Vol. 16, No. 6 (Nov.-Dec. 1975). Included in the index is a chronological list of articles (including abstract) followed by both a KWIC index and an Author Index. Nuclear Safety is a bimonthly technical progress review prepared by the Nuclear Safety Information Center and covers all safety aspects of nuclear power reactors and associated facilities. The index lists over 300 technical articles in the last six years of publication

Index to Nuclear Safety. A technical progress review by chronology, permuted title, and author. Vol 11, No. 1 through Vol. 16, No. 6

Energy Technology Data Exchange (ETDEWEB)

Cottrell, W.B.; Klein, A.

1976-04-01

This index to Nuclear Safety covers articles in Nuclear Safety Vol. 11, No. 1 (Jan.-Feb. 1970) through Vol. 16, No. 6 (Nov.-Dec. 1975). Included in the index is a chronological list of articles (including abstract) followed by both a KWIC index and an Author Index. Nuclear Safety is a bimonthly technical progress review prepared by the Nuclear Safety Information Center and covers all safety aspects of nuclear power reactors and associated facilities. The index lists over 300 technical articles in the last six years of publication.

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Statement on the safety of ‘Cetyl Myristoleate Complex’ as an ingredient in food supplements

DEFF Research Database (Denmark)

Tetens, Inge; Poulsen, Morten

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinion on the safety of ‘Cetyl Myristoleate Complex’ (CMC) as a novel food ingredient in the light of additional information submitted by the applicant. In its previous...... 90-day study cannot serve as a reliable source of information supporting the absence of adverse effects of CMC. The dossier of this new mandate contains three new references which were not submitted and hence not considered in the previous assessments. The Panel notes that two references do...

Xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2018-01-01

Following an application from TA‐XAN AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scient......Following an application from TA‐XAN AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

Building competence in radiation and nuclear safety through education and training - the approach of a national regulatory authority

International Nuclear Information System (INIS)

Karfopoulos, K.L.; Carinou, E.; Kamenopoulou, V.; Dimitriou, P.; Housiadas, Ch.

2015-01-01

The Greek Atomic Energy Commission (EEAE) is the national competent authority for radiation and nuclear safety and security as well as for the radiation protection of ionizing and artificially produced non-ionizing radiation. The legal framework determines, inter alia, the responsibilities in education and training issues. The EEAE has a range of activities, in providing postgraduate and continuous education and training on radiation protection, and nuclear safety and security, at the national and international levels. At the national level, and particularly in the medical field, the EEAE is a participant in and a major contributor to the Inter-University Postgraduate Program on Medical Radiation Physics. Since 2003, the EEAE has been the Regional Training Center (RTC) for radiation, transport and waste safety of the International Atomic Energy Agency (IAEA) for the European Region in the English language. Moreover, the EEAE has also been recognized as the IAEA's Regional Training Center (RTC) in nuclear security in the English language since 2013. The EEAE recently proceeded to two significant initiatives: the design of a national program for education and training, and the certification of the Department of Education according to ISO 29990:2010. In this paper, the initiatives taken to enhance the radiation protection system in the country through education and training are presented. (authors)

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2015. Scientific Opinion on Flavouring Group Evaluation 25, Revision 3 (FGE.25Rev3): Aliphatic hydrocarbons from chemical group 31

DEFF Research Database (Denmark)

Nørby, Karin Kristiane; Beltoft, Vibe Meister

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 14 flavouring substances in the Flavouring Group Evaluation 25, Revision 3, using the Procedure in Commission Regulation (EC) No 1565/2000. None...... on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity and identity criteria for the materials of commerce have been provided for all 14...

Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2009. Annual report

International Nuclear Information System (INIS)

2010-04-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2009 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials and physical protection of nuclear materials; (8) Emergency planning and preparedness; (9) International activities; (10) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) UJD SR organization chart; (13) Abbreviations.

Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2008. Annual report

International Nuclear Information System (INIS)

Zemanova, D.; Pirozekova, M.

2009-04-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2008 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials and physical protection of nuclear materials; (8) Activity of Building Office; (9) Emergency planning and preparedness; (10) International activities; (11) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) UJD SR organization chart; (13) Abbreviations

The need for strategic development of safety sciences.

Science.gov (United States)

Busquet, Francois; Hartung, Thomas

2017-01-01

The practice of risk assessment and regulation of substances has largely developed as a patchwork of circumstantial additions to a nowadays more or less shared international toolbox. The dominant drivers from the US and Europe have pursued remarkably different approaches in the use of these tools for regulation, i.e., a more risk-based approach in the US and a more precautionary approach in Europe. We argue that there is need for scientific developments not only for the tools but also for their application, i.e., a need for Regulatory Science or, perhaps better, Safety Science. While some of this is emerging on the US side as strategic reports, e.g., from the National Academies, the NIH and the regulatory agencies, especially the EPA and the FDA, such strategic developments beyond technological developments are largely lacking in Europe or have started only recently at EFSA, ECHA or within the flagship project EU-ToxRisk. This article provides a rationale for the creation of a European Safety Sciences Institute (ESSI) based on regulatory and scientific needs, political context and current EU missions. Moreover, the possible modus operandi of ESSI will be described along with possible working formats as well as anticipated main tasks and duties. This mirrors the triple alliance on the American side (US EPA, NIH and FDA) in revamping regulatory sciences. Moreover, this could fit the political agenda of the European Commission for better implementation of existing EU legislation rather than creating new laws.

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 76, Revision 1 (FGE.76Rev1)

OpenAIRE

Beltoft, Vibe Meister; Binderup, Mona-Lise; Frandsen, Henrik Lauritz; Lund, Pia; Nørby, Karin Kristiane

2013-01-01

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present opinion concerns a group of 26 sulphur-containing heterocyclic compounds evaluated by the JECFA at the 59th m...

Safety of nuclear installations in the Slovak Republic and activities of the Nuclear Regulatory Authority of the Slovak Republic in 2007

International Nuclear Information System (INIS)

Zemanova, D.

2008-01-01

Prepared pursuant to the provisions of the Atomic Act, the report provides information on the safety of nuclear installation in the Slovak Republic and activities of the Nuclear Regulatory Authority of the Slovak Republic ( UJD SR). UJD SR executes its activities in the area of legislation, issuance of authorizations and permissions for the siting, construction, operation and decommissioning of nuclear installations, in the area of reviews, assessments and control of nuclear safety of nuclear installations and emergency planning, in the area of records and accountability of nuclear materials, independent public information and in the area of international co-operation focused on peaceful uses of nuclear power. Based on the results of inspection activities and evaluation of safety indicators, UJD SR assessed the operation of nuclear installations in the Slovak Republic as safe and reliable. No significant event that could have a negative impact on the personnel, population or environment occurred in 2007. (orig.)

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 21, Revision 4 (FGE.21Rev4)

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Frandsen, Henrik Lauritz

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 59 flavouring substances in the Flavouring Group Evaluation 21, Revision 4, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision...... of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all 41 candidate substances...

Technical organization of safety authorities for the event of an accident at a nuclear installation

International Nuclear Information System (INIS)

Scherrer, J.; Evrard, J.M.; Ney, J.

1986-01-01

Within the general context of nuclear safety, the Central Nuclear Installation Safety Service of the French Ministry for Industry and its technical backup, the Institute for Radiation Protection and Nuclear Safety of the CEA (Atomic Energy Commission), have established a special organization designed to provide real-time forecasts of the evolution of a nuclear accident situation with sufficient forewarning for the local representative of the Government (the Commissaire de la Republique in the Departement affected) to implement, as required, effective countermeasures to protect the population - for example, confinement indoors or evacuation. Descriptions are given of the principles of this organization and the particular precautions taken to confront the problems of mobilizing experts and of dealing with the saturation of normal telecommunications channels to be expected in the event of a nuclear accident. The organization set up for the installations belonging to Electricite de France is given as a detailed example. Particular stress is placed on the organizational arrangements of the Institute for Radiation Protection and Nuclear Safety designed to provide the emergency teams with the evaluation and forecasting tools they require to carry out their tasks. The procedures are on the whole well developed for atmospheric radioactivity transport, for which operational models already exist. Computer-backed methods with improved performance are at present being developed. A method of forecasting the behaviour of the releases resulting from nuclear accidents is set out for pressurized water reactors, based on evaluating the physical state of the installation, confinement integrity, availability of safety and backup systems, support systems and feed sources and on forecasting how this state will develop on the basis of measured and inferred physical values transmitted from the affected power station through a national network. The experience acquired during accident

Index to Nuclear Safety. A technical progress review by chronology, permuted title, and author. Vol. 11, No. 1 through Vol. 15, No. 6

International Nuclear Information System (INIS)

Cottrell, W.B.; Klein, A.

1975-04-01

This issue of the Index to Nuclear Safety covers only articles included in Nuclear Safety, Vol. 11, No. 1, through Vol. 15, No. 6. This index is presented in three sections as follows: Chronological List of Articles by Volume; Permuted Title (KWIC) Index; and Author Index. (U.S.)

Re-evaluation of natural food colours—State of the art

DEFF Research Database (Denmark)

Dusemund, B.; Parent-Massin, D.; Mortensen, Alicja

2011-01-01

regarding the re-evaluation of natural food colours, including: (1) the extracts are often made from different natural sources, (2) the extracts can be made using a range of extraction solvents/methods, (3) chemical characterisation of different extracts is usually missing, (4) detailed specifications......Having started the re-evaluation of food additives in accordance with the Commission Regulation (EU) No 257/2010 of 25 March 2010 the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) of the European Food Safety Authority (EFSA) identified several complicating issues...... levels as food additive to exposure resulting from the regular diet can be applied....

Meat Juice Serology and Improved Food Chain Information as Control Tools for Pork-Related Public Health Hazards.

Science.gov (United States)

Felin, E; Jukola, E; Raulo, S; Fredriksson-Ahomaa, M

2015-09-01

The seroprevalence of Salmonella spp., pathogenic Yersinia spp., Toxoplasma gondii and Trichinella spp. was studied in 1353 finishing pigs from 259 farms that were allocated according to farm types: large fattening farms (≥ 1000 pig places), small fattening farms (Food Safety Authority (EFSA) considers Salmonella spp., Yersinia enterocolitica, T. gondii and Trichinella spp. as the most relevant biological hazards in the context of meat inspection of pigs. The seroprevalence of these important zoonotic pathogens was low in Finland, except that of Yersinia. The seroprevalence of Toxoplasma was significantly higher in pigs originating from small-scale fattening farms (P food chain information (FCI). © 2014 Blackwell Verlag GmbH.

Mining and mining authorities in Saarland 2016. Mining economy, mining technology, occupational safety, environmental protection, statistics, mining authority activities. Annual report; Bergbau und Bergbehoerden im Saarland 2016. Bergwirtschaft, Bergtechnik, Arbeitsschutz, Umweltschutz, Statistiken, Taetigkeiten der Bergbehoerden. Jahresbericht

Energy Technology Data Exchange (ETDEWEB)

NONE

2016-07-01

The annual report of the Saarland Upper Mining Authority provides an insight into the activities of mining authorities. Especially, the development of the black coal mining, safety and technology of mining as well as the correlation between mining and environment are stressed.

Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on betaine as a novel food (NF) pursuant to Regulation (EC) No 258/97. The information provided on the composition, the specifications, the batch......-to-batch variability, stability and production process of the NF is sufficient and does not raise concerns about the safety of the NF. The NF is proposed to be used in foods intended to meet additional requirements for intense muscular effort with a maximum intake of 2.5 g/day of betaine for sports people above 10...... as not sufficient. However, the total exposure to betaine from the diet (about 830 mg/day) is not known to be associated with adverse effects. Moreover, no adverse effects on platelet counts were noted in human intervention studies with exposure levels of 4 g/day of betaine for up to 6 months. A significant...

Challenges in developing TSO to provide technical support in nuclear safety and security to Pakistan Nuclear Regulatory Authority

International Nuclear Information System (INIS)

Mallick, Shahid A.; Sherwani, Uzman Habib; Mehdi, M. Ammar

2010-01-01

This paper highlights the needs for the establishment of a technical support organization (TSO) in Pakistan Nuclear Regulatory Authority (PNRA), challenges faced during its development, application of training need assessment required for the competency development of its technical manpower and difficulties encountered after its evolution. Key issues addressed include recruitment of technical manpower and enhancing their competencies, acquisition of proper tools required for safety review and assessment, development of a sustainable education and training program consistent with the best international practices and taking the measures to get confidence of the regulatory body. (author)

Safety evaluation report related to operation of Sequoyah Nuclear Plant, Units 1 and 2, Docket nos. 50-327 and 50-328, Tennessee Valley Authority

Energy Technology Data Exchange (ETDEWEB)

NONE

1979-03-01

A safety evaluation of the Tennessee Valley Authority's application for a license to operate its Sequoyah Nuclear Plant, Units 1 and 2, located in Hamilton County, Tennessee, has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. It consists of a technical review and staff evaluation of applicant information on: (1) population density, land use, and physical characteristics of the site area; (2) design, fabrication, construction, testing criteria, and performance characteristics of plant structures, systems, and components important to safety; (3) expected response of the facility to anticipated operating transients, and to postulated design basis accidents; (4) applicant engineering and construction organization, and plans for the conduct of plant operations; and (5) design criteria for a system to control the plant's radiological effluents. The staff has concluded that the plant can be operated by the Tennessee Valley Authority without endangering the health and safety of the public provided that the outstanding matters discussed in the report are favorably resolved. (author)

Management of safety, safety culture and self assessment

International Nuclear Information System (INIS)

Carnino, A.

2000-01-01

Safety management is the term used for the measures required to ensure that an acceptable level of safety is maintained throughout the life of an installation, including decommissioning. The safety culture concept and its implementation are described in part one of the paper. The principles of safety are now quite well known and are implemented worldwide. It leads to a situation where harmonization is being achieved as indicated by the entry into force of the Convention on Nuclear Safety. To go beyond the present nuclear safety levels, management of safety and safety culture will be the means for achieving progress. Recent events which took place in major nuclear power countries have shown the importance of the management and the consequences on safety. At the same time, electricity deregulation is coming and will impact on safety through reductions in staffing and in operation and maintenance cost at nuclear installations. Management of safety as well as its control and monitoring by the safety authorities become a key to the future of nuclear energy.(author)

For optimum safety technologies: understanding relations between the different national authorities and the technical support organizations

International Nuclear Information System (INIS)

Mahmoud, N.S.; Mostafa Aziz, Mostafa

2010-01-01

TSOs describe expert independent organizations, which provide supports for government, regulatory authorities, utilities and industry. The TSO must dispose different competences and objectives in order to deliver to the four independent authorities the technical and scientific knowledge. This comprehensive knowledge, from TSO, should perform through the research and development activities (R and D). Concerning the government, TSOs consider the R and D on the management procedures to characterize the links, to differentiate roles to prevent the overlapping efforts, and finally to build a central data bank in nuclear technologies for the other three authorities. For regulatory organizations, R and D are involved in the regulatory requirements and surveillance processes. On the other side R and D, in case of utilities, activities should focus on the improvement of safety operations for nuclear power and its new generations, and for other nuclear/radiological facilities. Finally, the forth TSOs has R and D targets that should concentrate mainly on material, efficiency, and durability of different equipment and parts involved in the nuclear activities during manufacturing. (author)

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 21, Revision 4 (FGE.21Rev4)

OpenAIRE

Beltoft, Vibe Meister; Binderup, Mona-Lise; Frandsen, Henrik Lauritz; Lund, Pia; Nørby, Karin Kristiane

2013-01-01

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 59 flavouring substances in the Flavouring Group Evaluation 21, Revision 4, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to the inclusion of the assessment of new toxicity data on one supporting substance 5,6-dihydro-2,4,6-tris(2-methylpropyl)-4H-1,3,5-dithiazine [FL-no: 15.113], which is considered to be str...

SNS vil høre om det supplerende materiale giver anledning til yderligere kommentarer eller ændrer risikovurderingen. Zea mays (1507). EFSAs udtalelse og vurdering af 1507 majsen. Modtaget 14-03-2005, deadline 29-03-2005, svar 23-03-2005

DEFF Research Database (Denmark)

Kjellsson, Gøsta; Damgaard, Christian; Strandberg, Morten Tune

2005-01-01

"DMU har via EFSAs GMOnet indhentet de nye oplysninger (mail fra SNS d. 14-03-2005) til ansøgningen om godkendelse til markedsføring til import og videreforarbejdning af den genmodificerede majs (1507). DMU har først gennemgået materialet for at undersøge om det ændrer den risikovurdering vi tidl...

Scientific Opinion on the safety and suitability for use by infants of follow-on formulae with a protein content of at least 1.6 g/100 kcal

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety and suitability for use by infants of follow-on formulae (FOF) based on cow’s milk intact protein with a protein content...... of at least 1.6 g/100 kcal (rounded value) that meet otherwise the requirements of relevant EU legislation. If the formula under evaluation is considered to be safe and suitable for use by infants, the NDA Panel is also asked to advise on whether FOF based on goat’s milk intact protein, soy protein isolates...... legislation is safe and suitable for healthy infants living in Europe with an intake of complementary foods of a sufficient quality. This conclusion does not apply to infant formula (IF). The Panel also concludes that the safety and suitability of FOF with a protein content of at least 1.6 g/100 kcal...

Highway Safety Program Manual: Volume 3: Motorcycle Safety.

Science.gov (United States)

National Highway Traffic Safety Administration (DOT), Washington, DC.

Volume 3 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on aspects of motorcycle safety. The purpose and specific objectives of a State motorcycle safety program are outlined. Federal authority in the highway safety area and general policies…

Development of French technical safety regulations: safety fundamental rules

International Nuclear Information System (INIS)

Lebouleux, P.

1982-09-01

The technical regulation related to nuclear safety in France is made of a set of regulation texts, of a different nature, that define the requirements for the construction, commissioning and operations of nuclear facilities. Simultaneously, the safety authorities (Service Central de Surete des Installations Nucleaires: SCSIN) issue recommendations or guides which are not strictly speaking regulations in the juridical sense; they are called ''Regles Fondamentales de Surete'' (RFS). The RFS set up and detail the conditions, the respect of which is deemed to be complying with the French regulation pratice, for the subject to which they relate. Their purpose is to make known rules judged acceptable by safety authorities, thus making the safety review easier. The RFS program is described. A RFS -or a letter- can also give the result of the examination of the constructor and operator code (RCC) by safety authorities

Development of French technical safety regulations: safety fundamental rules

International Nuclear Information System (INIS)

Lebouleux, P.

1983-01-01

The technical regulation related to nuclear safety in France is made of a set of regulation texts, of a different nature, that define the requirements for the construction, commissioning and operating of nuclear facilities. Simultaneously, the safety authorities (Service Central de Surete des Installations Nucleaires: SCSIN) issue recommendations or guides which are not strictly speaking regulations in the juridicial sense; they are called Regles Fondamentales de Surete (RFS). The RFS set up and detail the conditions, the respect of which is deemed to be complying with the French regulation practice, for the subject to which they relate. Their purpose is to make known rules judged acceptable by safety authorities, thus making the safety review easier. The RFS program is described. A RFS - or a letter - can also give the result of the examination of the constructor and operator codes (RCC) by safety authorities

Safety of pyrroloquinoline quinone disodium salt as a novel food pursuant to Regulation (EC) No 258/97

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on pyrroloquinoline quinone disodium salt (PQQ), trade name BioPQQTM, as a novel food pursuant to Regulation (EC) No 258/97. PQQ is produced...... by fermentation using Hyphomicrobium denitrificans CK-275 and purification process. PQQ has a minimum purity of 99.0%. The information provided on the composition, specifications, batch-to-batch variability, stability and production process of PQQ is sufficient and does not raise safety concerns. The applicant...... intends to market PQQ for use in food supplements for healthy adults, except pregnant and lactating women, at a maximum proposed level of consumption of 20 mg/day (corresponding to 0.29 mg/kg bw per day for a 70-kg person). The proposed level of consumption is at least 250 times higher than the estimated...

Use of probabilistic safety assessment in supporting regulatory authority`s work; Todennaekoeisyyspohjaisen turvallisuusanalyysin kaeyttoe viranomaistyoen tukena

Energy Technology Data Exchange (ETDEWEB)

Julin, A

1995-11-01

The aim of the study was to examine possibilities to use probabilistic safety assessment (PSA) more effectively in regulatory control of nuclear power plants. The structure, results and evaluation methods of PSA along with the necessary equations and principles, which could be used in utilising level 1 PSA results in decision making, have been introduced. The presented examples describe the ways PSA has been utilised abroad and particularly in Finnish Centre for Radiation and Nuclear Safety (STUK). The examples calculated in the study are based on the SPSA code and the PSA model of Olkiluoto nuclear power plant (TVO). The examples compare component safety classes versus safety importance and the risk of continued operation versus shutdown alternative in residual heat removal system failures. In addition to this allowed outage times, as calculated by PSA, were compared to allowed outage times according to technical specifications. The last 9 years operating experiences of TVO II was also examined by analysing the risk importance of significant component failures and operational disturbances. The analysis showed that the contribution of component failures and operational disturbances to the overall core damage risk during the studied time period was only 5 per cent. It appeared that the rare, significant initiating events provide the main contribution to the total cumulative risk. (57 refs., 22 figs., 17 tabs.).

EFSA Panel on Dietetic Products, Nutrition and Allergi es (NDA) ; Scientific Opinion - Statement on the safety of the “conjugated linoleic acid (CLA) - rich oils” Clarinol ® and Tonalin TG 80 as Novel Food ingredients

DEFF Research Database (Denmark)

Tetens, Inge

that the additional information provided does not contain evidence thath would modify its previous conclusions regarding the effects of CLA on insulin sensitivity/glucose metabolism, blood lipids, lipid peroxidation, or subclinical inflammation. The Panel also considers that the new studies provided do not address......Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinions on the safety of the conjugated linoleic acid (CLA)-rich oils Clarinol® and Tonalin® TG 80 as Novel Food ingredients in the light of additional information...... uses and daily doses for up to six months. The safety of CLA consumption for periods longer than six months has not been established under the proposed conditions of use. The safety of CLA consumption by type-2 diabetic subjects has not been established. © European Food Safety Authority, 2012...

Human factors in safety assessment. Safety culture assessment

International Nuclear Information System (INIS)

Zhang Li; Deng Zhiliang; Wang Yiqun; Huang Weigang

1996-01-01

This paper analyses the present conditions and problems in enterprises safety assessment, and introduces the characteristics and effects of safety culture. The authors think that safety culture must be used as a 'soul' to form the pattern of modern safety management. Furthermore, they propose that the human safety and synthetic safety management assessment in a system should be changed into safety culture assessment. Finally, the assessment indicators are discussed

Scientific Opinion on the safety of Arracacia xanthorrhiza as a novel food

DEFF Research Database (Denmark)

Tetens, Inge

2015-01-01

countries. According to the applicant, arracacha is consumed in the same way as other crops such as potato, cassava, yam or carrot. The NF is intended for human consumption in dishes such as “sudados”, soups and stews. EFSA requested the applicant to provide information on potential “other formats...

The formal notices of the French authority of nuclear safety; Les mises en demeure de l'autorite de surete nucleaire

Energy Technology Data Exchange (ETDEWEB)

NONE

2002-07-01

The French authority of nuclear safety (ASN) publishes on its web site (http://www.asn.gouv.fr) the formal notices and official statements addressed by the ASN to the concerned responsible persons (operators of nuclear facilities, directors of companies etc..) when anomalies requiring a corrective action have been noticed during on-site or off-site safety inspections. This document brings together the formal notices addressed by the ASN since June 2000 and up to April 2002. (J.S.)

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 300, Revision 1 (FGE.300Rev1): One cyclo-aliphatic amide from chemical group 33

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Frandsen, Henrik Lauritz; Nørby, Karin Kristiane

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate a flavouring substance,cyclopropanecarboxylic acid (2-isopropyl-5-methyl-cyclohexyl)-amide [FL-no: 16.115] in the Flavouring Group Evaluation 300, Revision 1....... The substance was not considered to have genotoxic potential. The substance was evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity....... The Panel concluded that the substance [FL-no: 16.115] does not give rise to safety concern at its levels of dietary intake estimated on the basis of the Maximised Survey-derived Daily Intake MSDI approach. Besides the safety assessment of this flavouring substance, the specifications for the material...

Risk assessment of flavouring substances used in foods

DEFF Research Database (Denmark)

Norby, Karin; Beltoft, Vibe Meister; Greve, Krestine

2006-01-01

not to present a safety concern, have been specified. In the project a very comprehensive database (the FLAVIS database) has been developed for the evaluation. It compiles information on the about 2800 flavouring substances used in Europe: specifications, structural class, food categories used in, intake data......The aim of the present project, the FLAVIS project, is to perform risk assessment of chemically defined flavouring substances. The evaluations are then presented to the European Food Safety Authority (EFSA) for final adoption in its Scientific Panel on food additives, flavourings, processing aids...... and materials in contact with food. The regulatory background for the work is found in the European Parliament and Council Regulation No. 2232/96 laying down a procedure for the establishment of a list of flavouring substances the use of which will be authorised to the exclusion of all others in the EU...

Organisational culture at the Radiation and Nuclear Safety Authority of Finland's department of Nuclear Reactor Regulation

International Nuclear Information System (INIS)

Reiman, T.; Norros, L.

2001-03-01

A case study to investigate the organisational culture of the regulatory authority was conducted at the Radiation and Nuclear Safety Authority of Finland's (STUK) Nuclear Reactor Regulation (YTO) - department. Organisational culture is defined as a pattern of shared basic assumptions, which are basically unconscious. Objectives of the study were to conceptualise and describe the main characteristics of YTO's organisational culture and to carry out a tentative core task analysis of the inspectors' work. A combination of quantitative and qualitative methods was used in the research. YTO's culture was identified as a hierarchy-focused culture with less emphasis on innovation or social support. However, the ideal values of the personnel emphasised also social support and goal setting. Ambiguous goals were felt by some personnel as increased uncertainty about the meaningfulness of one's job. Also a lack of feedback was mentioned. The core task analysis identified the critical functions of the regulatory practice. These functions specify the three roles of the regulatory authority, the expert role, the public role and the authority role. The culture must support the fulfilment of the requirements of all the three roles. Development needs in YTO's culture were identified and recommendations were made. (au)

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to fruits and/or vegetables (ID 1212, 1213, 1214, 1217, 1218, 1219, 1301, 1425, 1426, 1427, 1428, 1429, 1430) and to the “Mediterranean diet” (ID 1423) pursuant

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to fruits and/or vegetables and to the “Mediterranean diet”. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from...

Lessons learned on the design and the conduct of Post-Authorization Safety Studies

DEFF Research Database (Denmark)

Engel, Pierre; Almas, Mariana Ferreira; De Bruin, Marieke Louise

2017-01-01

Aims: To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. Methods: A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted...... the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. Conclusions: To the best of our...... knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review...

Nuclear safety in Slovak Republic. Regulatory aspects of NPP nuclear safety

International Nuclear Information System (INIS)

Lipar, M.

1999-01-01

Regulatory Authority (UJD) is appointed by the Slovak Republic National Council as an Executive Authority for nuclear safety supervision. Nuclear safety legislation, organisation and resources of UJD, its role and responsibilities are described together with its inspection and licensing functions and International cooperation concerning improvements of safety effectiveness. Achievements of UJD are listed in detail

Water and beverage consumption among children aged 4-13 years in France: analyses of INCA 2 (Étude Individuelle Nationale des Consommations Alimentaires 2006-2007) data.

Science.gov (United States)

Vieux, Florent; Maillot, Matthieu; Constant, Florence; Drewnowski, Adam

2016-09-01

To examine the consumption of plain water among children in France and compare total water intakes with guidelines issued by the European Food Safety Authority (EFSA). Nationally representative data were used to assess food, beverage and water consumption by sex, age group (4-8 years, 9-13 years), income-to-poverty ratio, eating occasion and location. Beverages were classified into nine groups: water (tap or bottled), milk, 100 % fruit juice, sodas, fruit drinks, hot beverages, sports drinks and flavoured waters. Total water volume in relation to energy intake (litres/kcal) was also examined. INCA 2 study (Étude Individuelle Nationale des Consommations Alimentaires 2006-2007). French children (n 835) aged 4-13 years. Total water intakes were accounted for by plain water (34 %), beverages (26 %) and food moisture (40 %). Plain water could be tap (18 %) or bottled (16 %). Older children drank more plain water than did younger children and boys drank more plain water than did girls. No socio-economic gradient for plain water consumption was observed. About 90 % of children did not meet the EFSA water intake recommendations. The daily water shortfall ranged from 367 to 594 ml/d. Water-to-energy ratio was 0·75-0·77 litres/1000 kcal (4184 kJ). Children drank milk at breakfast and plain water during lunch and dinner. Caloric beverages provided 10 % of dietary energy; consumption patterns varied by eating location. Total water intakes among young children in France were below EFSA-recommended levels. Analyses of beverage consumption patterns by eating occasion and location can help identify ways to increase water consumption among children.

Activities of Nuclear Regulatory Authority and safety of nuclear facilities in the Slovak Republic in 1993

International Nuclear Information System (INIS)

1994-04-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (NRA SR) in 1993 is presented. These activities are reported under the headings: (1) Introduction; (2) Regulatory activities at nuclear power plants units in operation; (2.1) Nuclear power plant SEP-EBO V-1; (4) Selected operation events and safety assessment in NPP SEP-EBO V-1; (2.2) Safety assessment of NPP SEP-EBO V-2; (3) Results of regulatory activities at the decommissioning of NPP A-1; (4) Regulatory activities at units under construction SEP-EMO - NPP Mochovce; (5) Further regulatory activities. (5.1) Preparation of designated personnel; (5.2) Inspection and accountancy of nuclear material; (5.3) Security provisions; (5.4) Accounted items and double use items; (5.5) Problem of radioactive wastes; (6.1) International co-operation activities of NRA; (6.2) Emergency planning; (6.3) International activities for quality enhancement of national supervision; (7) Conclusion [sk

Scientific Opinion of the Panel on Genetically Modified Organisms on an application (Reference EFSA-GMO-CZ-2006-33) for the placing on the market of the insect-resistant and glyphosate-tolerant genetically modified maize MON 88017 x MON 810, for food and feed uses, import and processing under

DEFF Research Database (Denmark)

Sørensen, Ilona Kryspin

. Further information from applications for placing the single insert lines MON 88017 and MON 810 on the market under EU regulatory procedures was taken into account where appropriate. The scope of application EFSA-GMO-CZ-2006-33 is for food and feed uses, import and processing of genetically modified maize...... MON 88017 x MON 810 and all derived products, but excluding cultivation in the EU. The EFSA GMO Panel assessed maize MON 88017 x MON 810 with reference to the intended uses and the appropriate principles described in the Guidance Document of the Scientific Panel on Genetically Modified Organisms...... or survival of feral maize plants in case of accidental release into the environment of maize MON 88017 x MON 810 viable grains during transportation and processing. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of maize MON 88017 x MON...

16 CFR 1500.2 - Authority.

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Authority. 1500.2 Section 1500.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND ENFORCEMENT REGULATIONS § 1500.2 Authority. Authority under the...

Safety of hydroxytyrosol as a novel food pursuant to Regulation (EC) No 258/97

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on hydroxytyrosol, which is chemically synthesised, as a novel food (NF) pursuant to Regulation (EC) No 258/97. The information provided on the comp......Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on hydroxytyrosol, which is chemically synthesised, as a novel food (NF) pursuant to Regulation (EC) No 258/97. The information provided...... of hydroxytyrosol from the consumption of olive oils and olives, which has not been associated with adverse effects, and considering the similar kinetics of hydroxytyrosol in rats and humans, the Panel considers that the MoE for the NF at the intended uses and use levels is sufficient for the target population....... The Panel concludes that the novel food, hydroxytyrosol, is safe under the proposed uses and use levels....

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 304, Revision 1 (FGE.304Rev1): Four carboxamides from Chemical Groups 30

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Frandsen, Henrik Lauritz

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate four flavouring substances in the Flavouring Group Evaluation 304, Revision 1 (FGE.304Rev1) using the Procedure in Commission Regulation (EC) No 1565...... criteria and identity for the materials of commerce have been provided for all four candidate substances....

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 215 (FGE.215): Seven α,β-Unsaturated Cinnamyl Ketones from subgroup 3.2 of FGE.19

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Lund, Pia

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 3.2 of FGE.19 in the Flavouring Group Evaluation 215 (FGE.215). The Flavour Industry has...

Technical University of Denmark Microbiological contaminants in food in the European Union in 2004-2009

DEFF Research Database (Denmark)

Helwigh, Birgitte; Korsgaard, Helle; Grønlund, Anne Christine Jørgensen

(Salmonella, Campylobacter, Listeria, Yersinia, verotoxigenic Escherichia coli (VTEC), Brucella)and non-zoonotic microbiological contaminants (histamine, Enterobacter sakazakii and staphylococcal enterotoxins) in food to the zoonoses database at the European Food Safety Authority (EFSA). Norway...... also been excluded from the detailed analyses of the microbiological contaminants in Chapter 3. Initially, 86% of the reported samples were assumed to be representative of the occurrence of microbiological contaminants in domestically produced food. However, when samples without specific sampling unit...... and figures alone. For some foodstuffs, the occurrence of microbiological contaminants increased along the food production chain, which indicates either cross-contamination during production or microbiological growth during shelf-life. For other foodstuffs, the occurrence of microbiological contaminants...

16 CFR 1700.2 - Authority.

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

Safety culture

International Nuclear Information System (INIS)

Keen, L.J.

2003-01-01

Safety culture has become a topic of increasing interest for industry and regulators as issues are raised on safety problems around the world. The keys to safety culture are organizational effectiveness, effective communications, organizational learning, and a culture that encourages the identification and resolution of safety issues. The necessity of a strong safety culture places an onus on all of us to continually question whether the safety measures already in place are sufficient, and are being applied. (author)

Safety of synthetic trans-resveratrol as a novel food pursuant to Regulation (EC) No 258/97

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2016-01-01

food is not nutritionally disadvantageous. In accordance with the EFSA Scientific opinion on genotoxicity testing strategies, the Panel considers that the negative in vivo genotoxicity assay is sufficient to rule out the concern based on the positive in vitro chromosomal aberration tests. Reduced body......Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked for an opinion on the safety of synthetic trans-resveratrol as a novel food with a purity of ≥99% (w/w). The Panel considers that the information provided on the composition...... and specifications of the novel food is sufficient. The applicant intends to market the novel food as a food supplement in capsule or tablet form at daily doses up to 150 mg/day. The Panel considers that resveratrol does not have a nutritionally relevant role in the human diet and that the consumption of the novel...

EFSA Panel on Dietetic Products, Nutrition and Allergies; Scientific Opinion on the substantiation of health claims related to creatine and increased attention (ID 1524) and improvement of memory (ID 1528) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to creatine and increased attention and improvement of memory. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from...... stakeholders. The food constituent that is the subject of the health claims is creatine. The Panel considers that creatine is sufficiently characterised....

Cumulative risk assessment of phthalate exposure of Danish children and adolescents using the hazard index approach

DEFF Research Database (Denmark)

Søeborg, T; Frederiksen, H; Andersson, Anna-Maria

2012-01-01

Human risk assessment of chemicals is traditionally presented as the ratio between the actual level of exposure and an acceptable level of exposure, with the acceptable level of exposure most often being estimated by appropriate authorities. This approach is generally sound when assessing the risk...... of individual chemicals. However, several chemicals may concurrently target the same receptor, work through the same mechanism or in other ways induce the same effect(s) in the body. In these cases, cumulative risk assessment should be applied. The present study uses biomonitoring data from 129 Danish children...... and adolescents and resulting estimated daily intakes of four different phthalates. These daily intake estimates are used for a cumulative risk assessment with anti-androgenic effects as the endpoint using Tolerable Daily Intake (TDI) values determined by the European Food Safety Authorities (EFSA) or Reference...

[Genetically modified food and allergies - an update].

Science.gov (United States)

Niemann, Birgit; Pöting, Annette; Braeuning, Albert; Lampen, Alfonso

2016-07-01

Approval by the European Commission is mandatory for placing genetically modified plants as food or feed on the market in member states of the European Union (EU). The approval is preceded by a safety assessment based on the guidance of the European Food Safety Authority EFSA. The assessment of allergenicity of genetically modified plants and their newly expressed proteins is an integral part of this assessment process. Guidance documents for the assessment of allergenicity are currently under revision. For this purpose, an expert workshop was conducted in Brussels on June 17, 2015. There, methodological improvements for the assessment of coeliac disease-causing properties of proteins, as well as the use of complex models for in vitro digestion of proteins were discussed. Using such techniques a refinement of the current, proven system of allergenicity assessment of genetically modified plants can be achieved.

Assessment of the effectiveness of the Hungarian nuclear safety regulatory authority by international expert teams

International Nuclear Information System (INIS)

Voeroess, L.; Lorand, F.

2001-01-01

On the basis of the role nuclear regulatory authorities (NRA) have to fulfil and the new challenges affecting them, in the paper an overview is made on how the Hungarian NRA has evaluated and utilised the results of different international efforts in the enhancement of its effectiveness and efficiency. The reviews have been conducted by different groups of experts organised by highly recognised international organisations (e.g. IAEA, EC) and highly competent foreign regulatory bodies. The different reviews of activities and working conditions of the HAEA NSD have resulted in a generally positive picture, however, it also revealed weaknesses as well. They recognised the developments made in recent years and also appreciated the overall favourable level of nuclear safety in Hungary, identified 'good practices' and made recommendations and suggestions for the most important and most efficient ways for future improvements. These are cited or referenced in the paper. At the end, some recommendations have been formed based on the experiences gained from the review missions and from our self-assessment. (author)

Nuclear law - Nuclear safety

International Nuclear Information System (INIS)

Pontier, Jean-Marie; Roux, Emmanuel; Leger, Marc; Deguergue, Maryse; Vallar, Christian; Pissaloux, Jean-Luc; Bernie-Boissard, Catherine; Thireau, Veronique; Takahashi, Nobuyuki; Spencer, Mary; Zhang, Li; Park, Kyun Sung; Artus, J.C.

2012-01-01

This book contains the contributions presented during a one-day seminar. The authors propose a framework for a legal approach to nuclear safety, a discussion of the 2009/71/EURATOM directive which establishes a European framework for nuclear safety in nuclear installations, a comment on nuclear safety and environmental governance, a discussion of the relationship between citizenship and nuclear, some thoughts about the Nuclear Safety Authority, an overview of the situation regarding the safety in nuclear waste burying, a comment on the Nome law with respect to electricity price and nuclear safety, a comment on the legal consequences of the Fukushima accident on nuclear safety in the Japanese law, a presentation of the USA nuclear regulation, an overview of nuclear safety in China, and a discussion of nuclear safety in the medical sector

77 FR 25179 - Patient Safety Organizations: Voluntary Relinquishment From Surgical Safety Institute

Science.gov (United States)

2012-04-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety... voluntary relinquishment from the Surgical Safety Institute of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the...

Safety of UV-treated milk as a novel food pursuant to Regulation (EC) No 258/97

DEFF Research Database (Denmark)

Poulsen, Morten

2016-01-01

nature raised by Member States. The novel food is cow’s milk (whole, semi-skimmed or skimmed) to which a treatment with ultraviolet (UV) radiation is applied after pasteurisation in order to extend the shelf life of the milk. This treatment results in an increase in the vitamin D3 concentrations......Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on UV-treated milk as a novel food submitted pursuant to Regulation (EC) No 258/97, taking into account the comments and objections of a scientific...... of infants (up to 1 year of age). The Panel considers that it is unlikely that tolerable upper intake levels established by EFSA for children aged 1–10 years, adolescents and adults will be exceeded. The Panel considers that the novel food is not nutritionally disadvantageous. The data provided do not give...

Safety balance: Analysis of safety systems

International Nuclear Information System (INIS)

Delage, M.; Giroux, C.

1990-12-01

Safety analysis, and particularly analysis of exploitation of NPPs is constantly affected by EDF and by the safety authorities and their methodologies. Periodic safety reports ensure that important issues are not missed on daily basis, that incidents are identified and that relevant actions are undertaken. French safety analysis method consists of three principal steps. First type of safety balance is analyzed at the normal start-up phase for each unit including the final safety report. This enables analysis of behaviour of units ten years after their licensing. Second type is periodic operational safety analysis performed during a few years. Finally, the third step consists of safety analysis of the oldest units with the aim to improve the safety standards. The three steps of safety analysis are described in this presentation in detail with the aim to present the objectives and principles. Examples of most recent exercises are included in order to illustrate the importance of such analyses

Safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No 258/97

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

provided on the composition, the specifications, the production process, the batch-to-batch variability and the stability of the NF is sufficient and does not raise safety concerns. The applicant intends to use the NF in a number of energy-reduced/sugar-free/no-added-sugar foods in quantities of up to 15......Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the dried aerial parts of Hoodia parviflora as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The information...... mg per serving. The applicant also proposes to provide the NF as a food supplement. The target population proposed by the applicant is adults. The highest intake estimates were found in the group of elderly (≥ 65 years) individuals, with a high intake of 1.0 mg/kg body weight (bw) per day. One 90-day...

Water and beverage consumption patterns among 4 to 13-year-old children in the United Kingdom

Directory of Open Access Journals (Sweden)

Florent Vieux

2017-05-01

Full Text Available Abstract Background The UK government has announced a tax on sugar-sweetened beverages. The aim of this study was to assess consumption patterns for plain drinking water relative to sugary beverages among UK children. Methods Dietary intake data for 845 children aged 4–13 years came from the nationally representative cross-sectional National Diet and Nutrition Survey, 2008–2011. Beverage categories were drinking water (tap or bottled, milk, 100% fruit juices, soda, fruit drinks, tea, coffee, sports drinks, flavored waters, and liquid supplements. Consumption patterns were examined by age group, gender, household incomes, time and location of consumption, region and seasonality. Total water consumption from drinking water, beverages, and foods, and the water-to-calorie ratios (L/kcal were compared to the EFSA (European Food Safety Authority adequate intake standards. Results Total water intake (1338 ml/d came from plain water (19%, beverages (48%, and food moisture (33%. Plain drinking water provided 258 g/d (241 g/d for children aged 4–8 years; 274 g/d for 9–13 years, mostly (83.8% from tap. Water and beverages supplied 901 g /d of water. Tap water consumption increased with income and was highest in the South of England. The consumption of bottled water, soda, tea and coffee increased with age, whereas milk consumption declined. About 88.7% of children did not meet EFSA adequate intake standards. The daily water shortfall ranged from 322 ml/d to 659 ml/d. Water-to-calorie ratio was 0.845 L/1000 kcal short of desirable levels of 1.0–1.5 L/1000 kcal. Conclusion Total water intake were at 74.8% of EFSA reference values. Drinking water consumption among children in the UK was well below US and French estimates.

Water and beverage consumption patterns among 4 to 13-year-old children in the United Kingdom.

Science.gov (United States)

Vieux, Florent; Maillot, Matthieu; Constant, Florence; Drewnowski, Adam

2017-05-19

The UK government has announced a tax on sugar-sweetened beverages. The aim of this study was to assess consumption patterns for plain drinking water relative to sugary beverages among UK children. Dietary intake data for 845 children aged 4-13 years came from the nationally representative cross-sectional National Diet and Nutrition Survey, 2008-2011. Beverage categories were drinking water (tap or bottled), milk, 100% fruit juices, soda, fruit drinks, tea, coffee, sports drinks, flavored waters, and liquid supplements. Consumption patterns were examined by age group, gender, household incomes, time and location of consumption, region and seasonality. Total water consumption from drinking water, beverages, and foods, and the water-to-calorie ratios (L/kcal) were compared to the EFSA (European Food Safety Authority) adequate intake standards. Total water intake (1338 ml/d) came from plain water (19%), beverages (48%), and food moisture (33%). Plain drinking water provided 258 g/d (241 g/d for children aged 4-8 years; 274 g/d for 9-13 years), mostly (83.8%) from tap. Water and beverages supplied 901 g /d of water. Tap water consumption increased with income and was highest in the South of England. The consumption of bottled water, soda, tea and coffee increased with age, whereas milk consumption declined. About 88.7% of children did not meet EFSA adequate intake standards. The daily water shortfall ranged from 322 ml/d to 659 ml/d. Water-to-calorie ratio was 0.845 L/1000 kcal short of desirable levels of 1.0-1.5 L/1000 kcal. Total water intake were at 74.8% of EFSA reference values. Drinking water consumption among children in the UK was well below US and French estimates.

Recent advances in the risk assessment of melamine and cyanuric acid in animal feed

Energy Technology Data Exchange (ETDEWEB)

Dorne, Jean Lou, E-mail: jean-lou.dorne@efsa.europa.eu [Unit on Contaminants, European Food Safety Authority, Largo N. Palli 5/A, 43121 Parma (Italy); Doerge, Daniel R. [NCTR, Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079 (United States); Vandenbroeck, Marc [Unit on Contaminants, European Food Safety Authority, Largo N. Palli 5/A, 43121 Parma (Italy); Fink-Gremmels, Johanna [University of Utrecht (Netherlands); Mennes, Wim [RIVM, Bilthoven (Netherlands); Knutsen, Helle K. [Norwegian Institute of Public Health, Oslo (Norway); Vernazza, Francesco [Dietary and Chemical Monitoring, European Food Safety Authority, Largo N. Palli 5/A, 43121 Parma (Italy); Castle, Laurence [FERA, York (United Kingdom); Edler, Lutz [German Cancer Research Center, Heidelberg (Germany); Benford, Diane [Food Standard Agency, London (United Kingdom)

2013-08-01

Melamine can be present at low levels in food and feed mostly from its legal use as a food contact material in laminates and plastics, as a trace contaminant in nitrogen supplements used in animal feeds, and as a metabolite of the pesticide cyromazine. The mechanism of toxicity of melamine involves dose-dependent formation of crystals with either endogenous uric acid or a structural analogue of melamine, cyanuric acid, in renal tubules resulting in potential acute kidney failure. Co-exposure to melamine and cyanuric acid in livestock, fish, pets and laboratory animals shows higher toxicity compared with melamine or cyanuric acid alone. Evidence for crystal formation between melamine and other structural analogs i.e. ammelide and ammeline is limited. Illegal pet food adulterations with melamine and cyanuric acid and adulteration of milk with melamine resulted in melamine–cyanuric acid crystals, kidney damage and deaths of cats and dogs and melamine–uric acid stones, hospitalisation and deaths of children in China respectively. Following these incidents, the tolerable daily intake for melamine was re-evaluated by the U.S. Food and Drug Administration, the World Health Organisation, and the Scientific Panel on Contaminants in the Food Chain of the European Food Safety Authority (EFSA). This review provides an overview of toxicology, the adulteration incidents and risk assessments for melamine and its structural analogues. Particular focus is given to the recent EFSA risk assessment addressing impacts on animal and human health of background levels of melamine and structural analogues in animal feed. Recent research and future directions are discussed. - Highlights: ► Melamine in food and feed. ► Forms crystals in kidney with uric acid or cyanuric acid. ► Toxicity higher with cyanuric acid. ► Recent EFSA risk assessment. ► Animal and human health.

Recent advances in the risk assessment of melamine and cyanuric acid in animal feed

International Nuclear Information System (INIS)

Dorne, Jean Lou; Doerge, Daniel R.; Vandenbroeck, Marc; Fink-Gremmels, Johanna; Mennes, Wim; Knutsen, Helle K.; Vernazza, Francesco; Castle, Laurence; Edler, Lutz; Benford, Diane

2013-01-01

Melamine can be present at low levels in food and feed mostly from its legal use as a food contact material in laminates and plastics, as a trace contaminant in nitrogen supplements used in animal feeds, and as a metabolite of the pesticide cyromazine. The mechanism of toxicity of melamine involves dose-dependent formation of crystals with either endogenous uric acid or a structural analogue of melamine, cyanuric acid, in renal tubules resulting in potential acute kidney failure. Co-exposure to melamine and cyanuric acid in livestock, fish, pets and laboratory animals shows higher toxicity compared with melamine or cyanuric acid alone. Evidence for crystal formation between melamine and other structural analogs i.e. ammelide and ammeline is limited. Illegal pet food adulterations with melamine and cyanuric acid and adulteration of milk with melamine resulted in melamine–cyanuric acid crystals, kidney damage and deaths of cats and dogs and melamine–uric acid stones, hospitalisation and deaths of children in China respectively. Following these incidents, the tolerable daily intake for melamine was re-evaluated by the U.S. Food and Drug Administration, the World Health Organisation, and the Scientific Panel on Contaminants in the Food Chain of the European Food Safety Authority (EFSA). This review provides an overview of toxicology, the adulteration incidents and risk assessments for melamine and its structural analogues. Particular focus is given to the recent EFSA risk assessment addressing impacts on animal and human health of background levels of melamine and structural analogues in animal feed. Recent research and future directions are discussed. - Highlights: ► Melamine in food and feed. ► Forms crystals in kidney with uric acid or cyanuric acid. ► Toxicity higher with cyanuric acid. ► Recent EFSA risk assessment. ► Animal and human health

Author Details

African Journals Online (AJOL)

Ghirxi, KT. Vol 1 (2011) - Articles Human errors and system variability in safety investigations of maritime casualties: an expression of systemic concerns. Abstract. ISSN: 2026-6324. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners ...

Author Details

African Journals Online (AJOL)

Oloyede, AR. Vol 29, No 1 (2011) - Articles Microbiological Safety of Corn-Based Snack Product, Aadun, Sold in Abeokuta, South-Western Nigeria Abstract. ISSN: 0189-7241. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners ...

49 CFR 374.503 - Authority.

Science.gov (United States)

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Authority. 374.503 Section 374.503 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION... Incidental Charter Rights § 374.503 Authority. Motor carriers transporting passengers, in interstate or...

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 96 (FGE.96): Consideration of 88 flavouring substances considered by EFSA for which EU production volumes / anticipated production volumes have been submitted

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further...

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 9, Revision 5 (FGE.09Rev5): Secondary alicyclic saturated and unsaturated alcohols, ketones and esters containing secondary alicyclic alcohols

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Frandsen, Henrik Lauritz; Nørby, Karin Kristiane

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 21 flavouring substances in the Flavouring Group Evaluation 9, Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. The present revi...

Discussion on the safety classification of nuclear safety mechanical equipment

International Nuclear Information System (INIS)

Shen Wei

2010-01-01

The purpose and definition of the equipment safety classification in nuclear plant are introduced. The differences of several safety classification criterions are compared, and the object of safety classification is determined. According to the regulation, the definition and category of the safety functions are represented. The safety classification method, safety classification process, safety class interface, and the requirement for the safety class mechanical equipment are explored. At last, the relation of the safety classification between the mechanical and electrical equipment is presented, and the relation of the safety classification between mechanical equipment and system is also presented. (author)

Author Details

African Journals Online (AJOL)

Oloo, JEO. Vol 10, No 11 (2010) - Articles Food safety and quality management in Kenya: An overview of the roles played by various stakeholders. Abstract PDF. ISSN: 1684-5374. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners ...

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African Journals Online (AJOL)

Nketsia-Tabiri, J. Vol 39, No 1 (2006) - Articles Irradiation of ready meals for microbiological safety and shelf-life extension. 1. Microbiological quality of waakye and other ready-to-eat meals. Abstract. ISSN: 0855-0042. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's ...

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African Journals Online (AJOL)

Abey, KA. Vol 17, No 1 (2017) - Articles Knowledge and practices of food hygiene and safety among camel milk handlers in the pastoral camel value chain in Kenya Abstract PDF. ISSN: 1684-5374. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL ...

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African Journals Online (AJOL)

Perry, EC. Vol 18 (2012): Supplement 1 - Articles Securing South Africa during the 2010 FIFA World Cup: Legacy implications for post-event safety and security. Abstract. ISSN: 1117-4315. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's ...

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African Journals Online (AJOL)

Ogo, IN. Vol 15, No 1 (2004) - Articles Listeria monocytogenes and other Listeria species in poul try faeces applied as manure on farm lands: Environmental health and food safety. Abstract PDF. ISSN: 01891731. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More ...

The Peroxidation of Leukocytes Index Ratio Reveals the Prooxidant Effect of Green Tea Extract

Directory of Open Access Journals (Sweden)

Ilaria Peluso

2016-01-01

Full Text Available Despite tea increased plasma nonenzymatic antioxidant capacity, the European Food Safety Administration (EFSA denied claims related to tea and its protection from oxidative damage. Furthermore, the Supplement Information Expert Committee (DSI EC expressed some doubts on the safety of green tea extract (GTE. We performed a pilot study in order to evaluate the effect of a single dose of two capsules of a GTE supplement (200 mg × 2 on the peroxidation of leukocytes index ratio (PLIR in relation to uric acid (UA and ferric reducing antioxidant potential (FRAP, as well as the sample size to reach statistical significance. GTE induced a prooxidant effect on leukocytes, whereas FRAP did not change, in agreement with the EFSA and the DSI EC conclusions. Besides, our results confirm the primary role of UA in the antioxidant defences. The ratio based calculation of the PLIR reduced the sample size to reach statistical significance, compared to the resistance to an exogenous oxidative stress and to the functional capacity of oxidative burst. Therefore, PLIR could be a sensitive marker of redox status.

Discussion on building safety culture inside a nuclear safety regulatory body

International Nuclear Information System (INIS)

Fan Yumao

2013-01-01

A strong internal safety culture plays a key role in improving the performance of a nuclear regulatory body. This paper discusses the definition of internal safety culture of nuclear regulatory bodies, and explains the functions that the safety culture to facilitate the nuclear safety regulation and finally puts forward some thoughts about building internal safety culture inside regulatory bodies. (author)

Author Details

African Journals Online (AJOL)

Alfadul, S.M. Vol 10, No 6 (2010) - Articles Use of nanotechnology in food processing, packaging and safety – review. Abstract PDF. ISSN: 1684-5374. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners · Terms and Conditions of Use ...

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African Journals Online (AJOL)

de Reuck, S. Vol 26, No 1 (2014) - Articles Factors Associated with Safety Events in Air Traffic Control Abstract. ISSN: 1010-2728. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners · Terms and Conditions of Use · Contact AJOL ...

9 CFR 592.10 - Authority.

Science.gov (United States)

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall...

General scientific guidance for stakeholders on health claim applications

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2016-01-01

of Article 13.1 claims except for claims put on hold by the European Commission, and has evaluated additional health claim applications submitted pursuant to Articles 13.5, 14 and also 19. In addition, comments received from stakeholders indicate that general issues that are common to all health claims need...... based on the experience gained to date with the evaluation of health claims, and it may be further updated, as appropriate, when additional issues are addressed.......The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products Nutrition and Allergies (NDA) to update the General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims published in March 2011. Since then, the NDA Panel has completed the evaluation...

Regulatory review of safety cases and safety assessments - associated challenges

International Nuclear Information System (INIS)

Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

2006-01-01

Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

9 CFR 590.10 - Authority.

Science.gov (United States)

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... Authority. The Administrator shall perform, for and under the supervision of the Secretary, such duties as...

48 CFR 50.101-1 - Authority.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Authority. 50.101-1... EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT Extraordinary Contractual Actions 50.101-1 Authority. (a... following agencies to exercise the authority conferred by Pub. L. 85-804 and to delegate it to other...

[Do residents and nurses communicate safety relevant concerns? : simulation study on the influence of the authority gradient].

Science.gov (United States)

St Pierre, M; Scholler, A; Strembski, D; Breuer, G

2012-10-01

Due to the negative impact on decision-making too steep authority gradients in teams represent a risk factor for patient safety. As residents and nursing staff may fear sanctions they may be reluctant to forward critical information to or challenge planned actions of attending physicians. In the setting of a simulation course it was investigated whether and to what extent team members would challenge decisions of familiar attending physicians. In each case where participants did not voice an opinion the underlying motives for the behavior were investigated. A total of 59 physicians and 18 nursing staff participated in the scenario. During a rapid sequence induction they were confronted with 7 critical situations created by the attending physician who had been instructed by the simulation team. Recommendations of the German Society of Anaesthesiology were ignored as well as clinical standard operating procedures (SOPs) and two potentially fatal drug administrations were ordered. An attempt was made to determine whether team members were aware of the safety threat at all and if so how they would solve the resulting conflicts. The level of verbal challenge was scored. During debriefing participants were asked to verbalize the motives which they thought might account for their silence or level of challenge. In situations where non-verbal conflict resolution was possible 65% of the participants pursued that strategy whereas 35% voiced an opinion. Situations necessitating verbal intervention were identified in 66% but 72% of the participants chose to remain silent. Team members decided to challenge the attending physician in only 28% of the situations. In 35% their statement was oblique, in 25% the problem was addressed but not further pursued and only in 40% did participants show crisp advocacy and assertiveness and initiated discussion. Asked why they had refrained from challenging the attending physician 37% had no answer, in 35% of situations participants observed a

Selecting of key safety parameters in reactor nuclear safety supervision

International Nuclear Information System (INIS)

He Fan; Yu Hong

2014-01-01

The safety parameters indicate the operational states and safety of research reactor are the basis of nuclear safety supervision institution to carry out effective supervision to nuclear facilities. In this paper, the selecting of key safety parameters presented by the research reactor operating unit to National Nuclear Safety Administration that can express the research reactor operational states and safety when operational occurrence or nuclear accident happens, and the interrelationship between them are discussed. Analysis shows that, the key parameters to nuclear safety supervision of research reactor including design limits, operational limits and conditions, safety system settings, safety limits, acceptable limits and emergency action level etc. (authors)

Scientific Opinion on the safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97

DEFF Research Database (Denmark)

Poulsen, Morten

2017-01-01

concentrate through an ethanolic extraction using an adsorptive resin column to retain the phenolic components. The Panel considers that the production process is sufficiently described and does not raise concerns about the safety of the novel food. The NF is intended to be added to beverages and yogurts...... to provide 80 mg PACs per serving. The target population is the adult general population. The mean and 95th percentile estimates for the all-user intakes from all proposed food-uses are 68 and 192 mg/day, respectively, for female adults, and 74 mg/day and 219 mg/day, respectively, for male adults. Taking......Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on ‘cranberry extract powder’ as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council...

SAFETY

CERN Multimedia

Niels Dupont

2013-01-01

CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

Post-authorization safety surveillance of a liquid pentavalent vaccine in Guatemalan children.

Science.gov (United States)

Asturias, Edwin J; Contreras-Roldan, Ingrid L; Ram, Malathi; Garcia-Melgar, Ana J; Morales-Oquendo, Vilma; Hartman, Katharina; Rauscher, Martina; Moulton, Lawrence H; Halsey, Neal A

2013-12-02

Combination vaccines have improved the efficiency of delivery of new vaccines in low and middle-income countries. Post-authorization monitoring of adverse events (AEs) after vaccination with a liquid pentavalent DTwP-HepB-Hib combination vaccine was conducted in Guatemalan infants. A prospective observational safety study of the incidence of medical attended events (MAEs) and serious adverse events (SAEs) in children who received pentavalent and oral polio vaccines at 2, 4 and 6 months of age was conducted in two clinics at the Institute of Guatemala. Parents were contacted by telephone after each dose. All outpatient, emergency department visits, and hospitalizations were monitored. A self-controlled analysis was conducted to determine if there was evidence of increased risk of MAEs or SAEs following vaccines as compared to control time windows. Of 3000 recruited infants, 2812 (93.7%) completed the third dose and 2805 (93.5%) completed follow-up. Ten AEs in eight infants, of which four SAEs in four infants, were classified as related to the vaccine. Thirteen deaths were reported due to common illnesses of infancy, and none were judged to be related to the vaccine. The mortality rate (4.4 per 1000) was lower than expected for the population. The incidence-rate-ratio for healthcare visits was lower in post-vaccination time windows than for control windows; after the first vaccine dose, the rate ratios for the risk periods of 0-1, 2-6, and 7-30 days post-vaccination were 0.3, 0.5, and 0.7, respectively (all statistically significantly different from the reference value of 1.0 for the 31-60 day control period). The liquid pentavalent vaccine was associated with lower rates of health care visits and not associated with increases in SAEs or hospitalizations. Systems can be set up in low to middle income countries to capture all health care visits to monitor the safety of new vaccines. Copyright © 2013 Elsevier Ltd. All rights reserved.

Safety analysis SFR 1. Long-term safety

Energy Technology Data Exchange (ETDEWEB)

2008-12-15

An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the regulatory

Safety analysis SFR 1. Long-term safety

International Nuclear Information System (INIS)

2008-12-01

An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the regulatory

Safety analysis SFR 1. Long-term safety

Energy Technology Data Exchange (ETDEWEB)

2008-12-15

An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the

Vitamin B12 determination in milk, whey and different by-products of ricotta cheese production by ultra performance liquid chromatography coupled with tandem mass spectrometry

Directory of Open Access Journals (Sweden)

Adele Repossi

2017-10-01

Full Text Available Vitamin B12 (cobalamin is a metal complex composed of a central cobalt ion bonded to six ligands. It is essential for major biological functions such as protein, fat and carbohydrate metabolism, the maintenance of the central nervous system, and the formation of red blood cells. Since mammals cannot synthesize cobalamin, dietary intake represents the only natural source for humans. Dairy products can provide significant levels of cobalamin; moreover, the European Food Safety Authority (EFSA panel has set the recommended intake at 4 μg/day for adults. Vitamin B12 content was determined in milk and several matrices related to the process of transformation of the residual whey from Parmigiano Reggiano cheese-making to obtain ricotta cheese. In addition, vitamin B12 degradation during ricotta cheese shelf-life was studied. The analyses were performed using an ultra performance liquid chromatography-tandem mass spectrometry method. Results show that vitamin B12 amount in ricotta from dairy and experimental cheese-making brings respectively 1/8 to 1/4 of the adequate intake in adults established by EFSA. In addition, shelf-life experiment shows that cobalamine is fairly rapidly degraded in ricotta: light effect seems to be significant, even if the light exposure is short. The use of photoprotective packaging material increases B12 shelf-life in the early stage of storage.

Vitamin B12 determination in milk, whey and different by-products of ricotta cheese production by ultra performance liquid chromatography coupled with tandem mass spectrometry

Science.gov (United States)

Repossi, Adele; Zironi, Elisa; Gazzotti, Teresa; Serraino, Andrea; Pagliuca, Giampiero

2017-01-01

Vitamin B12 (cobalamin) is a metal complex composed of a central cobalt ion bonded to six ligands. It is essential for major biological functions such as protein, fat and carbohydrate metabolism, the maintenance of the central nervous system, and the formation of red blood cells. Since mammals cannot synthesize cobalamin, dietary intake represents the only natural source for humans. Dairy products can provide significant levels of cobalamin; moreover, the European Food Safety Authority (EFSA) panel has set the recommended intake at 4 μg/day for adults. Vitamin B12 content was determined in milk and several matrices related to the process of transformation of the residual whey from Parmigiano Reggiano cheese-making to obtain ricotta cheese. In addition, vitamin B12 degradation during ricotta cheese shelf-life was studied. The analyses were performed using an ultra performance liquid chromatography-tandem mass spectrometry method. Results show that vitamin B12 amount in ricotta from dairy and experimental cheese-making brings respectively 1/8 to 1/4 of the adequate intake in adults established by EFSA. In addition, shelf-life experiment shows that cobalamine is fairly rapidly degraded in ricotta: light effect seems to be significant, even if the light exposure is short. The use of photoprotective packaging material increases B12 shelf-life in the early stage of storage. PMID:29564230

Highway Safety Program Manual: Volume 8: Alcohol in Relation to Highway Safety.

Science.gov (United States)

National Highway Traffic Safety Administration (DOT), Washington, DC.

Volume 8 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on alcohol in relation to highway safety. The purpose and objectives of the alcohol program are outlined. Federal authority in the area of highway safety and general policies regarding…

75 FR 63774 - Pipeline Safety: Safety of On-Shore Hazardous Liquid Pipelines

Science.gov (United States)

2010-10-18

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Pipelines AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of... Gas Pipeline Safety Act of 1968, Public Law 90-481, delegated to DOT the authority to develop...

State safety oversight program : audit of the tri-state oversight committee and the Washington metropolitan area transit authority, final audit report, March 4, 2010.

Science.gov (United States)

2010-03-04

The Federal Transit Administration (FTA) conducted an on-site audit of the safety program implemented by the Washington Metropolitan Area Transit Authority (WMATA) and overseen by the Tri-State Oversight Committee (TOC) between December 14 and 17, 20...

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 72, Revision 1 (FGE.72Rev1): Consideration of aliphatic, branched-chain saturated and unsaturated alcohols, aldehydes, acids, and related esters

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Frandsen, Henrik Lauritz

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further...... threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for all 23 substances considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances......” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 23 substances, the information is adequate...

MICROBIOLOGICAL SAFETY BIBLIOGRAPHY

Science.gov (United States)

More than a thousand articles on biological safety in infectious disease laboratories are listed for the use of supervisors responsible for the safety of laboratory personnel. An author index is included.

Pathways and factors for food safety and food security at PFOS contaminated sites within a problem based learning approach.

Science.gov (United States)

Brambilla, Gianfranco; D'Hollander, Wendy; Oliaei, Fardin; Stahl, Thorsten; Weber, Roland

2015-06-01

Perfluorooctanesulfonic acid (PFOS) and related substances have been listed in Annex B of the Stockholm Convention. The implementation requires inventories of use, stockpiles, and environmental contamination including contaminated sites and measures for (risk) reduction and phase out. In most countries monitoring capacity is not available and therefore other approaches for assessment of contaminated sites are needed. Available informations about PFOS contamination in hot spot areas and its bio-accumulation in the food webs have been merged to build up a worst-case scenario We model PFOS transfer from 1 to 100ngL(-1) range in water to extensive and free-range food producing animals, also via the spread of contaminated sludges on agriculture soils. The modeling indicates that forages represented 78% of the exposure in ruminants, while soil accounted for >80% in outdoor poultry/eggs and pigs. From the carry-over rates derived from literature, in pork liver, egg, and feral fish computed concentration falls at 101, 28 and 2.7ngg(-1), respectively, under the 1ngL(-1) PFOS scenario. Assuming a major consumption of food produced from a contaminated area, advisories on egg and fish, supported by good agriculture/farming practices could abate 75% of the human food intake. Such advisories would allow people to become resilient in a PFOS contaminated area through an empowerment of the food choices, bringing the alimentary exposure toward the current Tolerable Daily Intake (TDI) of 150ngkg(-1)bodyweightd(-1) proposed by the European Food Safety Authority (EFSA). Copyright © 2014 Elsevier Ltd. All rights reserved.

Beyond safety accountability

CERN Document Server

Geller, E Scott

2001-01-01

Written in an easy-to-read conversational tone, Beyond Safety Accountability explains how to develop an organizational culture that encourages people to be accountable for their work practices and to embrace a higher sense of personal responsibility. The author begins by thoroughly explaining the difference between safety accountability and safety responsibility. He then examines the need of organizations to improve safety performance, discusses why such performance improvement can be achieved through a continuous safety process, as distinguished from a safety program, and provides the practic

EFSA CEF Penal (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 212, Revision 2 (FGE.212Rev2): α,β-Unsaturated alicyclic ketones and precursors from chemical subgroup 2.6 of FGE.19

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Lund, Pia

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 24 flavouring substances from subgroup 2.6 of FGE.19 in the Flavouring Group Evaluation 212, Revision 2. The Panel concluded in ...

Industrial safety: its structuring and content

International Nuclear Information System (INIS)

Munoz, A.; Rodriguez, J.; Martinez-Val, J.M.

1999-01-01

Industrial development has led to an on-going increase in productivity, but the concept of safety has also become highly relevant. In this article, the authors address the structuring and content of industrial safety which involves laying down essential safety requirements, both in manufacturing and processes and in products. (Author)

Reactor safety; Description and evaluation of safety activities in Nordic countries

International Nuclear Information System (INIS)

Wahlstroem, B.; Gunsell, L.

1998-03-01

The report gives a description of safety activities in the nuclear power industry. The study has been carried out as a part of the four year programme in Nordic Safety Research (NKS) which was completed in 1997. The objective of the NKS/RAK-1.1 project 'A survey and an evaluation of safety activities in nuclear power' was to make a broad description of various activities important for safety and to make an assessment of their efficiency. A special consideration was placed on a comparison of practices in Finland and Sweden, and between their nuclear utilities. The study has been divided into two parts, one theoretical part in which a model of the relationships between various activities important for safety has been constructed and one practical part where a total of 62 persons have been interviewed at the authorities, the nuclear utilities and one reactor vendor. To restrict the amount of work two activities, safety analysis and experience feedback, were selected. A few cases connected to incidents at nuclear power plants were discussed in more detail. The report has been structured around a simple model of nuclear safety consisting of the concepts of goals, means and outcomes. This model illustrates the importance of goal formulation, systematic planning and feedback of operational experience as major components in nuclear safety. In assessing organisation and management at authorities and the power utilities there is a clear trend of decentralisation and delegation of authority. The general impression from the study is that the safety activities in Finland and Sweden are efficient and well targeted. The experience from the methodology is favourable and the comparison of practices gives a good ground for a discussion of contents and targeting of safety activities. (EG) activities. (EG)

Safety margins in deterministic safety analysis

International Nuclear Information System (INIS)

Viktorov, A.

2011-01-01

The concept of safety margins has acquired certain prominence in the attempts to demonstrate quantitatively the level of the nuclear power plant safety by means of deterministic analysis, especially when considering impacts from plant ageing and discovery issues. A number of international or industry publications exist that discuss various applications and interpretations of safety margins. The objective of this presentation is to bring together and examine in some detail, from the regulatory point of view, the safety margins that relate to deterministic safety analysis. In this paper, definitions of various safety margins are presented and discussed along with the regulatory expectations for them. Interrelationships of analysis input and output parameters with corresponding limits are explored. It is shown that the overall safety margin is composed of several components each having different origins and potential uses; in particular, margins associated with analysis output parameters are contrasted with margins linked to the analysis input. While these are separate, it is possible to influence output margins through the analysis input, and analysis method. Preserving safety margins is tantamount to maintaining safety. At the same time, efficiency of operation requires optimization of safety margins taking into account various technical and regulatory considerations. For this, basic definitions and rules for safety margins must be first established. (author)

Assessment of Safety Culture within the Pakistan Nuclear Regulatory Authority (PNRA)

Energy Technology Data Exchange (ETDEWEB)

Afzal, Muhammad [Pakistan Nuclear Regulatory Authority, Islamabad (Pakistan); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2015-10-15

The objective of this study is to assess the SC of the Pakistan Nuclear Regulatory Authority (PNRA) by developing a performance indicator-based questionnaire. Aspects that potentially play important roles in developing perceptions of SC, including age, type of job, gender and duty hours of regulatory staff, are given due importance in this study. The study also identifies the strengths and weaknesses in the SC of the PNRA and can be used as a model study to assess the SC of other RBs. The questionnaire, developed to assess the SC of the PNRA, was in line with the PNRA's own defined attributes for SC. In the past, significant efforts have been made to ensure the safe operation of NPPs by improving designs and operating procedures; however, the nuclear accident at the Fukushima NPP in Japan in March 2011 revealed that the currently allotted hardware safety margins are not sufficient, and much work is needed to improve safety management in terms of SC. Initially, the concept of SC was introduced for operating organizations to ensure safe operation of NPPs; nonetheless, more recent investigations of nuclear events and accidents, especially Fukushima, and at Davis-Besse, in the US, have revealed that a strong focus is required to address and improve the SC of Regulatory Bodies (RBs). Strong SC is considered a vital tool for RBs to achieve their objectives and discharge their responsibilities in an effective and efficient manner. Though the relationship between the SC of RBs and that of operating organizations is not straight forward, it is believed that the former has a strong influence over the latter. The questionnaire was consistent in terms of the credible nature of its questions, and the response group covered different levels of PNRA staff, from managers to lower level staff. The results show that the PNRA staff have a very good understanding of the nature and significance of attributes of SC and are doing their best to exercise the same within the

Assessment of Safety Culture within the Pakistan Nuclear Regulatory Authority (PNRA)

International Nuclear Information System (INIS)

Afzal, Muhammad; Choi, Kwang Sik

2015-01-01

The objective of this study is to assess the SC of the Pakistan Nuclear Regulatory Authority (PNRA) by developing a performance indicator-based questionnaire. Aspects that potentially play important roles in developing perceptions of SC, including age, type of job, gender and duty hours of regulatory staff, are given due importance in this study. The study also identifies the strengths and weaknesses in the SC of the PNRA and can be used as a model study to assess the SC of other RBs. The questionnaire, developed to assess the SC of the PNRA, was in line with the PNRA's own defined attributes for SC. In the past, significant efforts have been made to ensure the safe operation of NPPs by improving designs and operating procedures; however, the nuclear accident at the Fukushima NPP in Japan in March 2011 revealed that the currently allotted hardware safety margins are not sufficient, and much work is needed to improve safety management in terms of SC. Initially, the concept of SC was introduced for operating organizations to ensure safe operation of NPPs; nonetheless, more recent investigations of nuclear events and accidents, especially Fukushima, and at Davis-Besse, in the US, have revealed that a strong focus is required to address and improve the SC of Regulatory Bodies (RBs). Strong SC is considered a vital tool for RBs to achieve their objectives and discharge their responsibilities in an effective and efficient manner. Though the relationship between the SC of RBs and that of operating organizations is not straight forward, it is believed that the former has a strong influence over the latter. The questionnaire was consistent in terms of the credible nature of its questions, and the response group covered different levels of PNRA staff, from managers to lower level staff. The results show that the PNRA staff have a very good understanding of the nature and significance of attributes of SC and are doing their best to exercise the same within the

33 CFR 147.5 - Delegation of authority.

Science.gov (United States)

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Delegation of authority. 147.5 Section 147.5 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OUTER CONTINENTAL SHELF ACTIVITIES SAFETY ZONES § 147.5 Delegation of authority. The authority to...

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 226 (FGE.226): Consideration of genotoxicity data on one α,β-unsaturated aldehyde from chemical subgroup 1.1.1(b) of FGE.19 by EFSA

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of one flavouring substance from subgroup 1.1.1(b) of FGE.19 in the Flavouring Group Evaluation 226. The Flavour Industry has provi...

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 213, Revision 1 (FGE.213Rev1): Consideration of genotoxic potential for α , β -Unsaturated Alicyclic ketones and precursors from chemical subgroup

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Lund, Pia

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 26 flavouring substances from subgroup 2.7 of FGE.19 in the Flavouring Group Evaluation 213. In the first version of FGE.213 the...

Nutrition issues in Codex: health claims, nutrient reference values and WTO agreements: a conference report.

Science.gov (United States)

Aggett, Peter J; Hathcock, John; Jukes, David; Richardson, David P; Calder, Philip C; Bischoff-Ferrari, Heike; Nicklas, Theresa; Mühlebach, Stefan; Kwon, Oran; Lewis, Janine; Lugard, Maurits J F; Prock, Peter

2012-03-01

Codex documents may be used as educational and consensus materials for member governments. Also, the WTO SPS Agreement recognizes Codex as the presumptive international authority on food issues. Nutrient bioavailability is a critical factor in determining the ability of nutrients to provide beneficial effects. Bioavailability also influences the quantitative dietary requirements that are the basis of nutrient intake recommendations and NRVs. Codex, EFSA and some national regulatory authorities have established guidelines or regulations that will permit several types of health claims. The scientific basis for claims has been established by the US FDA and EFSA, but not yet by Codex. Evidence-based nutrition differs from evidence-based medicine, but the differences are only recently gaining recognition. Health claims on foods may provide useful information to consumers, but many will interpret the information to mean that they can rely upon the food or nutrient to eliminate a disease risk. NRVs are designed to provide a quantitative basis for comparing the nutritive values of foods, helping to illustrate how specific foods fit into the overall diet. The INL-98 and the mean of adult male and female values provide NRVs that are sufficient when used as targets for individual intakes by most adults. WTO recognizes Codex as the primary international authority on food issues. Current regulatory schemes based on recommended dietary allowances are trade restrictive. A substantial number of decisions by the EFSA could lead to violation of WTO agreements.

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) ; Scientific Opinion on Flavouring Group Evaluation 305 (FGE.305): L - Methionylglycine of chemical group 34

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Frandsen, Henrik Lauritz

use in foods that are not heated or intended to be heated. Besides the safety assessment of the flavouring substance, the specifications for the material of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the material of commerce have......The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate one flavouring substance, the dipeptide L-methionylglycine [FL-no: 17.037], in the Flavouring Group Evaluation 305, using the Procedure in Commission...... been provided for the candidate substance. © European Food Safety Authority, 2013...

Scientific Opinion on the safety of synthetic N-acetyl-D-neuraminic acid as a novel food pursuant to Regulation (EC) No 258/97

DEFF Research Database (Denmark)

Poulsen, Morten

2017-01-01

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on synthetic N-acetyl-d-neuraminic acid (NANA) as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The information...... on the composition, the specifications, the batch-to-batch variability, stability and production process of the NF is sufficient and does not raise concerns about the safety of the NF. The NF is intended to be marketed as an ingredient in formulae and foods for infants and young children as well as an ingredient...... in a variety of foods and in food supplements for the general population. NANA is naturally present in human milk, in a bound and free form. The Margin of Exposure, which was based on the no-observed-adverse effect level (NOAEL) of 493 mg/kg body weight (bw) per day from a subchronic study and the anticipated...

International conference on the strengthening of nuclear safety in Eastern Europe. Keynote papers. Regulatory aspects of NPP safety, status of safety improvements, status of safety analysis report

International Nuclear Information System (INIS)

1999-06-01

The Objective of the Conference was to assess the past decade of nuclear safety efforts in countries operating WWER and RBMK nuclear reactors and to address remaining safety issues which require further work. A particular focus of the Conference was on international co-operation and assistance and where such efforts should be focused in the future. All Eastern European countries that operate RBMK or WWER reactors participated in the Conference, and presented papers on three key areas of nuclear safety: Regulatory Aspects of Nuclear Power Plant Safety; Status of Safety Improvements; and Status of Safety Analysis Reports. In addition, representatives from 18 additional countries that provide financial and/or technical assistance and co-operation in the area of WWER and RBMK safety offered the most extensive commentary. Key international (IAEA, World Association of Nuclear Operators, the Nuclear Energy Agency, the G-24 NUSAC, the European Commission, and the EBRD) organizations that provide nuclear safety assistance for WWER and RBMK reactors also made presentations. There is no question that considerable progress on nuclear safety has been made in Eastern Europe. Special mention should be made of successful efforts to strengthen the independence and technical competence of the nuclear regulatory authorities. Efforts should now concentrate on improving the depth and scope of the technical abilities of the regulatory authorities. More attention by governments is needed to ensure that the regulatory authorities have the financial resources and enforcement authority to fully execute their missions. In respect to the operators of the nuclear power plants, they have demonstrated clear progress in operational safety improvements. Significant additional efforts are required to maintain and enhance an effective safety culture. Design safety improvement programmes are in place in all countries. Implementation of these programmes has varied and is particularly affected by

Independent safety organization

International Nuclear Information System (INIS)

Kato, W.Y.; Weinstock, E.V.; Carew, J.F.; Cerbone, R.J.; Guppy, J.G.; Hall, R.E.; Taylor, J.H.

1985-01-01

Brookhaven National Laboratory has conducted a study on the need and feasibility of an independent organization to investigate significant safety events for the Office for Analysis and Evaluation of Operational Data, USNRC. The study consists of three parts: the need for an independent organization to investigate significant safety events, alternative organizations to conduct investigations, and legislative requirements. The determination of need was investigated by reviewing current NRC investigation practices, comparing aviation and nuclear industry practices, and interviewing a spectrum of representatives from the nuclear industry, the regulatory agency, and the public sector. The advantages and disadvantages of alternative independent organizations were studied, namely, an Office of Nuclear Safety headed by a director reporting to the Executive Director for Operations (EDO) of NRC; an Office of Nuclear Safety headed by a director reporting to the NRC Commissioners; a multi-member NTSB-type Nuclear Safety Board independent of the NRC. The costs associated with operating a Nuclear Safety Board were also included in the study. The legislative requirements, both new authority and changes to the existing NRC legislative authority, were studied. 134 references

EFSA NDA Panel (EFSA Panel on Dietetic Product s, Nutrition and Allergies), 2013 . Scientific Opinion on the substantiation of a health claim related to magnesium and contributio n to normal development of bone pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

and effect relationship has been established between dietary intake of magnesium and contribution to normal development of bone. The following wording reflects the scientific evidence: “Magnesium contributes to normal development of bone”. The target population is infants and children up to three years....... © European Food Safety Authority, 2013...

Periodic safety review of the HTR-10 safety analysis

International Nuclear Information System (INIS)

Chen Fubing; Zheng Yanhua; Shi Lei; Li Fu

2015-01-01

Designed by the Institute of Nuclear and New Energy Technology (INET) of Tsinghua University, the 10 MW High Temperature Gas-cooled Reactor-Test Module (HTR-10) is the first modular High Temperature Gas-cooled Reactor (HTGR) in China. According to the nuclear safety regulations of China, the periodic safety review (PSR) of the HTR-10 was initiated by INET after approved by the National Nuclear Safety Administration (NNSA) of China. Safety analysis of the HTR-10 is one of the key safety factors of the PSR. In this paper, the main contents in the review of safety analysis are summarized; meanwhile, the internal evaluation on the review results is presented by INET. (authors)

EFSA ; Scientific Opinion on Flavouring Group Evaluation 59, Revision 1 (FGE.59Rev1): Consideration of aliphatic and aromatic ethers evaluated by JECFA (61st meeting and 63rd meeting) structurally related to aliphatic, alicyclic and aromatic ethers including anisole derivatives evaluated by EFSA in FGE.23 Rev2 (2010)

DEFF Research Database (Denmark)

Larsen, John Christian; Nørby, Karin Kristiane; Beltoft, Vibe Meister

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further......, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for two substances, are information on the composition...

Scientific Opinion on the safety of ‘heat-treated milk products fermented with Bacteroides xylanisolvens DSM 23964’ as a novel food

DEFF Research Database (Denmark)

Tetens, Inge; Poulsen, Morten

2015-01-01

Following a request from the European Commission, the EFSA NDA Panel was asked to carry out the additional assessment for ‘pasteurised milk products fermented with Bacteroides xylanisolvens DSM 23964’ as a novel food (NF) in the context of Regulation (EC) No 258/97. Pasteurised or ultra-high-temp......Following a request from the European Commission, the EFSA NDA Panel was asked to carry out the additional assessment for ‘pasteurised milk products fermented with Bacteroides xylanisolvens DSM 23964’ as a novel food (NF) in the context of Regulation (EC) No 258/97. Pasteurised or ultra......-high-temperature-treated milk is used for the fermentation process with B. xylanisolvens DSM 23964. After fermentation the product is heat treated for one hour at 75 °C to ensure the absence of viable B. xylanisolvens DSM 23964. The Panel considers the information provided on the identity and characterisation of B...

Safety evaluations required in the safety regulations for Monju and the validity confirmation of safety evaluation methods

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-08-15

The purposes of this study are to perform the safety evaluations of the fast breeder reactor 'Monju' and to confirm the validity of the safety evaluation methods. In JFY 2012, the following results were obtained. As for the development of safety evaluation methods needed in the safety examination achieved for the reactor establishment permission, development of the analysis codes, such as a core damage analysis code, were carried out according to the plan. As for the development of the safety evaluation method needed for the risk informed safety regulation, the quantification technique of the event tree using the Continuous Markov chain Monte Carlo method (CMMC method) were studied. (author)

OECD/NEA International Conference on Global Nuclear Safety Enhancement Organised in co-operation with the Nuclear Regulation Authority (NRA) of Japan On the Occasion of the 50. Anniversary of Japan Joining the OECD

International Nuclear Information System (INIS)

Tanaka, Shunichi; Oshima, Kenzo; Fuketa, Toyoshi; Echavarri, Luis E.; ); Ostendorff, William C.; Viktorovich Ferapontov, Alexey; Lachaume, Jean-Luc; Yoo, Guk Hee; Lyons, James E.; ); Weightman, Mike; ); Gurria, Angel; ); Ishihara, Hirotaka

2014-04-01

On 8 April 2014 in Tokyo, Japan, an international conference on enhancing global nuclear safety was held by the Nuclear Energy Agency (NEA) of the Organisation for Economic Co-operation and Development(OECD), in co-operation with the Nuclear Regulation Authority (NRA) of Japan. This document brings together the 12 presentations (slides) given at this conference organized in 3 sessions: 1 - Opening Session: Opening Remarks (S. Tanaka); Statement by L.E. Echavarri; Session 1 - Global Safety Enhancements: USNRC Actions in Response to the Fukushima Nuclear Accident (W.C. Ostendorff); Synergy of National and International Regulatory Efforts to Enhance Global Nuclear Safety (A. Viktorovich Ferapontov); Global Safety Enhancements, The French Nuclear Safety Authority (ASN)'s position (J.L. Lachaume); Nuclear Safety and Security Commission builds up safety and security (G.H. Yoo); Session 2 - Learning from Experience to Improve Safety: Lessons Learned from the Fukushima Dai-ichi Accident and Responses in New Regulatory Requirements (T. Fuketa); NEA Activities to Enhance the Nuclear Regulatory Framework (L.E. Echavarri); Learning from Experience to Improve Safety - its importance, its mechanisms and its challenges (J.E. Lyons); Learning from Experience to Improve Nuclear Safety - A Perspective from the UK (M. Weightman); Conclusions and Closing Remarks (A. Gurria, H. Ishihara)

Accelerator production of tritium authorization basis strategy

International Nuclear Information System (INIS)

Miller, L.A.; Edwards, J.; Rose, S.

1996-01-01

The Accelerator Production of Tritium (APT) project has proposed a strategy to develop the APT authorization basis and safety case based on DOE orders and fundamental requirements for safe operation. The strategy is viable regardless of whether the APT is regulated by DOE or by an external regulatory body. Currently the operation of Department of Energy (DOE) facilities is authorized by DOE and regulated by DOE orders and regulations while meeting the environmental protection requirements of the Environmental Protection Agency (EPA) and the states. In the spring of 1994, Congress proposed legislation and held hearings related to requiring all DOE operations to be subject to external regulation. On January 25, 1995, DOE, with the support of the White House Council on Environmental Quality, created the Advisory Committee on External Regulation of Department of Energy Nuclear Safety. This committee divided its recommendations into three areas: (1) facility safety, (2) worker safety, and (3) environmental protection. In the area of facility safety the committee recommended external regulation of DOE nuclear facilities by either the Nuclear Regulatory Commission (NRC) or a restructured Defense Nuclear Facilities Safety Board (DNFSB). In the area of worker safety, the committee recommended that the Occupational Safety and Health Administration (OSHA) regulate DOE nuclear facilities. In the environmental protection area, the committee did not recommend a change in the regulation by the EPA and the states of DOE nuclear facilities. If these recommendations are accepted, all DOE nuclear facilities will be impacted to some extent

Regulatory role and approach of BARC Safety Council in safety and occupational health in BARC facilities

International Nuclear Information System (INIS)

Rajdeep; Jayarajan, K.; Taly, Y.K.

2016-01-01

Bhabha Atomic Research Centre is involved in multidisciplinary research and developmental activities, related to peaceful use of nuclear energy and its societal benefits. In order to achieve high level of performance of these facilities, the best efforts are made to maintain good health of the plant personnel and good working conditions. BARC Safety Council (BSC), which is the regulatory body for BARC facilities, regulates radiation safety, industrial safety and surveillance of occupational health, by implementing various rules and guidelines in BARC facilities. BARC Safety framework consists of various committees in a 3-tier system. The first tier is BSC, which is the apex body authorized for issuing directives, permissions, consents and authorizations. It is having responsibility of ensuring protection and safety of public, environment, personnel and facilities of BARC through enforcement of radiation protection and industrial safety programmes. Besides the 18 committees in 2"n"d tier, there are 6 other expert committees which assist in functioning of BSC. (author)

Safety performance indicators program

International Nuclear Information System (INIS)

Vidal, Patricia G.

2004-01-01

In 1997 the Nuclear Regulatory Authority (ARN) initiated a program to define and implement a Safety Performance Indicators System for the two operating nuclear power plants, Atucha I and Embalse. The objective of the program was to incorporate a set of safety performance indicators to be used as a new regulatory tool providing an additional view of the operational performance of the nuclear power plants, improving the ability to detect degradation on safety related areas. A set of twenty-four safety performance indicators was developed and improved throughout pilot implementation initiated in July 1998. This paper summarises the program development, the main criteria applied in each stage and the results obtained. (author)

EUROSAFE Forum for nuclear safety. Towards Convergence of Technical Nuclear Safety Practices in Europe. Safety Improvements - Reasons, Strategies, Implementation

Energy Technology Data Exchange (ETDEWEB)

Erven, Ulrich (ed.) [Gesellschaft fuer Anlagen- und Reaktorsicherheit, GRS mbH, Schwertnergasse 1, 50667 Koeln (Germany); Cherie, Jean-Bernard (ed.) [Institut de Radioprotection et de Surete Nucleaire, IRSN, BP 17, 92262 Fontenay-aux-Roses Cedex (France); Boeck, Benoit De (ed.) [Association Vincotte Nuclear, AVN, Rue Walcourt 148, 1070 Bruxelles (Belgium)

2005-07-01

The EUROSAFE Forum for Nuclear Safety is part of the EUROSAFE approach, which consists of two further elements: the EUROSAFE Tribune and the EUROSAFE Web site. The general aim of EUROSAFE is to contribute to fostering the convergence of technical nuclear safety practices in a broad European context. This is done by providing technical safety and research organisations, safety authorities, power utilities, the rest of the industry and non-governmental organisations mainly from the European Union and East-European countries, and international organisations with a platform for the presentation of recent analyses and R and D in the field of nuclear safety. The goal is to share experiences, to exchange technical and scientific opinions, and to conduct debates on key issues in the fields of nuclear safety and radiation protection. The EUROSAFE Forum on 2005 focused on Safety Improvements, Reasons - Strategies - Implementation, from the point of view of the authorities, TSOs and industry. Latest work in nuclear installation safety and research, waste management, radiation safety as well as nuclear material and nuclear facilities security carried out by GRS, IRSN, AVN and their partners in the European Union, Switzerland and Eastern Europe are presented. A high level of nuclear safety is a priority for the countries of Europe. The technical safety organisations play an important role in contributing to that objective through appropriate approaches to major safety issues as part of their assessments and research activities. The challenges to nuclear safety are international. Changes in underlying technologies such as instrumentation and control, the impact of electricity market deregulation, demands for improved safety and safety management, the ageing of nuclear facilities, waste management, maintaining and improving scientific and technical knowledge, and the need for greater transparency - these are all issues where the value of an international approach is gaining

EUROSAFE Forum for nuclear safety. Towards Convergence of Technical Nuclear Safety Practices in Europe. Safety Improvements - Reasons, Strategies, Implementation

Energy Technology Data Exchange (ETDEWEB)

Erven, Ulrich [Gesellschaft fuer Anlagen- und Reaktorsicherheit, GRS mbH, Schwertnergasse 1, 50667 Koeln (Germany); Cherie, Jean-Bernard [Institut de Radioprotection et de Surete Nucleaire, IRSN, BP 17, 92262 Fontenay-aux-Roses Cedex (France); Boeck, Benoit De [Association Vincotte Nuclear, AVN, Rue Walcourt 148, 1070 Bruxelles (Belgium)

2005-07-01

The EUROSAFE Forum for Nuclear Safety is part of the EUROSAFE approach, which consists of two further elements: the EUROSAFE Tribune and the EUROSAFE Web site. The general aim of EUROSAFE is to contribute to fostering the convergence of technical nuclear safety practices in a broad European context. This is done by providing technical safety and research organisations, safety authorities, power utilities, the rest of the industry and non-governmental organisations mainly from the European Union and East-European countries, and international organisations with a platform for the presentation of recent analyses and R and D in the field of nuclear safety. The goal is to share experiences, to exchange technical and scientific opinions, and to conduct debates on key issues in the fields of nuclear safety and radiation protection. The EUROSAFE Forum on 2005 focused on Safety Improvements, Reasons - Strategies - Implementation, from the point of view of the authorities, TSOs and industry. Latest work in nuclear installation safety and research, waste management, radiation safety as well as nuclear material and nuclear facilities security carried out by GRS, IRSN, AVN and their partners in the European Union, Switzerland and Eastern Europe are presented. A high level of nuclear safety is a priority for the countries of Europe. The technical safety organisations play an important role in contributing to that objective through appropriate approaches to major safety issues as part of their assessments and research activities. The challenges to nuclear safety are international. Changes in underlying technologies such as instrumentation and control, the impact of electricity market deregulation, demands for improved safety and safety management, the ageing of nuclear facilities, waste management, maintaining and improving scientific and technical knowledge, and the need for greater transparency - these are all issues where the value of an international approach is gaining

Safety design guide for safety related systems for CANDU 9

International Nuclear Information System (INIS)

Lee, Duk Su; Chang, Woo Hyun; Lee, Nam Young; A. C. D. Wright

1996-03-01

In general, two types of safety related systems and structures exist in the nuclear plant; The one is a systems and structures which perform safety functions during the normal operation of the plant, and the other is a systems and structures which perform safety functions to mitigate events caused by failure of the normally operating systems or by naturally occurring phenomena. In this safety design guide, these systems are identified in detail, and the major events for which the safety functions are required and the major safety requirements are identified in the list. As the probabilistic safety assessments are completed during the course of the project, additions or deletions to the list may be justified. 3 tabs. (Author) .new

Safety design guide for safety related systems for CANDU 9

Energy Technology Data Exchange (ETDEWEB)

Lee, Duk Su; Chang, Woo Hyun; Lee, Nam Young [Korea Atomic Energy Research Institute, Daeduk (Korea, Republic of); Wright, A.C.D. [Atomic Energy of Canada Ltd., Toronto (Canada)

1996-03-01

In general, two types of safety related systems and structures exist in the nuclear plant; The one is a systems and structures which perform safety functions during the normal operation of the plant, and the other is a systems and structures which perform safety functions to mitigate events caused by failure of the normally operating systems or by naturally occurring phenomena. In this safety design guide, these systems are identified in detail, and the major events for which the safety functions are required and the major safety requirements are identified in the list. As the probabilistic safety assessments are completed during the course of the project, additions or deletions to the list may be justified. 3 tabs. (Author) .new.

New Safety rules

CERN Multimedia

Safety Commission

2008-01-01

The revision of CERN Safety rules is in progress and the following new Safety rules have been issued on 15-04-2008: Safety Procedure SP-R1 Establishing, Updating and Publishing CERN Safety rules: http://cern.ch/safety-rules/SP-R1.htm; Safety Regulation SR-S Smoking at CERN: http://cern.ch/safety-rules/SR-S.htm; Safety Regulation SR-M Mechanical Equipment: http://cern.ch/safety-rules/SR-M.htm; General Safety Instruction GSI-M1 Standard Lifting Equipment: http://cern.ch/safety-rules/GSI-M1.htm; General Safety Instruction GSI-M2 Standard Pressure Equipment: http://cern.ch/safety-rules/GSI-M2.htm; General Safety Instruction GSI-M3 Special Mechanical Equipment: http://cern.ch/safety-rules/GSI-M3.htm. These documents apply to all persons under the Director General’s authority. All Safety rules are available at the web page: http://www.cern.ch/safety-rules The Safety Commission

Improvements related with the safety required by the Argentine Regulatory Authority to the Atucha I Nuclear Central

International Nuclear Information System (INIS)

Calvo, J.; Michelin, C.; Navarro, R.; Waldman, R.

2006-01-01

The Argentinean Nuclear Regulation Authority (ARN) verified the existence of changes in the state of some internal components of the reactor of the Atucha I Nuclear Power station that, of continuing in the time, it could take to an inconvenient degradation for the safety operation of the installation. In consequence, to the effects of preventing that reach this situation, at the end of 1999, the ARN required to the Responsible Entity for the operation of this power station the implementation of an important improvements program in the internal components of the reactor. Additionally, and based on the results of the Probabilistic Safety analysis, it was added the one mentioned improvements program the implementation of an alternative cooling system of the reactor core denominated Second Drain of Heat, due to it was determined that, for some accidental sequences, their performance would reduce considerably the probability of damage to the core. The concretion of the improvements program implied to the Responsible Entity the realization of an important quantity of engineering studies, tests and specific inspections that allowed to carry out changes on the control bars of the reactor and its guide tubes; the coolant channels; the sensors of neutron flow; and diverse components of the primary and moderator systems. On the other hand also it was implemented the system Second Drain of Heat, what represents a considerable effort to make compatible the instrumentation and control of last generation, with the instrumentation and existent control systems in the power station. Also, it was requested to be carried out an integrity of the pressure recipient for to demonstrate the existence of an acceptable margin for the difference among the acceptable limit temperatures and of ductile/fragile transition of the material for all the possible accidental scenarios during the useful life of the reactor. (Author)

IAEA safety standards and approach to safety of advanced reactors

International Nuclear Information System (INIS)

Gasparini, M.

2004-01-01

The paper presents an overview of the IAEA safety standards including their overall structure and purpose. A detailed presentation is devoted to the general approach to safety that is embodied in the current safety requirements for the design of nuclear power plants. A safety approach is proposed for the future. This approach can be used as reference for a safe design, for safety assessment and for the preparation of the safety requirements. The method proposes an integration of deterministic and risk informed concepts in the general frame of a generalized concept of safety goals and defence in depth. This methodology may provide a useful tool for the preparation of safety requirements for the design and operation of any kind of reactor including small and medium sized reactors with innovative safety features.(author)

Leadership and Safety Culture: Leadership for Safety

International Nuclear Information System (INIS)

Fischer, E.

2016-01-01

Following the challenge to operate Nuclear Power Plants towards operational excellence, a highly skilled and motivated organization is needed. Therefore, leadership is a valuable success factor. On the other hand a well-engineered safety orientated design of NPP’s is necessary. Once built, an NPP constantly requires maintenance, ageing management and lifetime modifications. E.ON tries to keep the nuclear units as close as possible to the state of the art of science and technology. Not at least a requirement followed by our German regulation. As a consequence of this we are continuously challenged to improve our units and the working processes using national and international operational experiences too. A lot of modifications are driven by our self and by regulators. That why these institutions — authorities and independent examiners—contribute significantly to the safety success. Not that it is easy all the day. The relationship between the regulatory body, examiners and the utilities should be challenging but also cooperative and trustful within a permanent dialog. To reach the common goal of highest standards regarding nuclear safety all parties have to secure a living safety culture. Without this attitude there is a higher risk that safety relevant aspects may stay undetected and room for improvement is not used. Nuclear operators should always be sensitized and follow each single deviation. Leaders in an NPP-organization are challenged to create a safety-, working-, and performance culture based on clear common values and behaviours, repeated and lived along all of our days to create a least a strong identity in the staffs mind to the value of safety, common culture and overall performance. (author)

16 CFR 1101.71 - Delegation of authority.

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Delegation of authority. 1101.71 Section... INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Delegation of Authority to Information Group § 1101.71 Delegation of authority. (a) Delegation. Pursuant to section 27(b)(9) of the CPSA...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to Lactobacillus rhamnosus ATCC 53103 (LGG) and “gastro-intestinal health” (ID 906) and maintenance of tooth mineralisation (ID 3018) pursuant to Article 13

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to Lactobacillus rhamnosus ATCC 53103 (LGG) and “gastrointestinal health” and maintenance of tooth mineralisation. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has...... received from Member States or directly from stakeholders. The food constituent that is the subject of the health claims is L. rhamnosus ATCC 53103 (LGG). The Panel considers that L. rhamnosus ATCC 53103 (LGG) is sufficiently characterised....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to chitosan and reduction in body weight (ID 679, 1499), maintenance of normal blood LDL-cholesterol concentrations (ID 4663), reduction of intestinal transit time (ID

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to chitosan and reduction in body weight, maintenance of normal blood LDL-cholesterol concentrations, reduction of intestinal transit time and reduction of inflammation. The scientific substantiation is based on the information provided by the Member States in the consolidated list...... of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claim is chitosan. The Panel considers that chitosan is sufficiently characterised....

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to folate and maintenance of normal blood pressure (ID 176) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... claims in relation to folate and maintenance of normal blood pressure. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to xanthan gum and changes in bowel function (ID 837) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... claims in relation to xanthan gum and changes in bowel function. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food...

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to spermidine and contribution to normal hair growth (ID 1705) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health...... claims in relation to spermidine and contribution to normal hair growth. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders...

Recommendations for successful substantiation of new health claims in the European Union

DEFF Research Database (Denmark)

Pravst, Igor; Kušar, Anita; Žmitek, Katja

2018-01-01

Background While functional foods offer promise for public health and innovation in the food industry, the efficiency of such foods should be assured to protect consumers from misleading claims. Globally, many countries regulate the communication of the health effects of such foods to final...... consumers. Scope and approach In the European Union (EU), the use of health claims was harmonized in 2006. All claims need to be scientifically assessed by the European Food Safety Authority (EFSA) and pre-approved. Implementing the regulation has involved a steep learning curve for stakeholders, resulting...... recommendations should be seen as a starting point for researchers in the area of nutrition and food technology, and for those dealing with functional foods, including the food industry. Keywords Functional foods; Health claims; Food labelling; Substantiation; Regulation; European Union...

Heavy metal concentrations in cocoa beans (Theobroma cacao L.) originating from East Luwu, South Sulawesi, Indonesia

Science.gov (United States)

Assa, A.; Noor, A.; Yunus, M. R.; Misnawi; Djide, M. N.

2018-03-01

Concentrations of some heavy metals (Pb, Cu, Cd, As and Hg) were assessed for cocoa beans (Theobroma cacao L) originating from East Luwu, South Sulawesi, Indonesia after five-day fermentation. Consisting of PB 123, BR 25, and MCC 02 cocoa clones, the spectrophotometric analysis showed that concentrations of Pb, Cd, As and Hg in the cocoa beans over the three clones was below the detection limits of 0.100; 0.050, 0.010 and 0.005 mg/kg. For Cu, they were 19.343; 10.391, and 18.594 mg/kg respectively, but still below the maximum critical levels, established by the European Food Safety Authority (EFSA). Concentrations of those five heavy metals in the bean shells were found to be parallel to those in the cocoa beans, except for Pb.

The ascent of the blessed: regulatory issues on health effects and health claims for probiotics in Europe and the rest of the world.

Science.gov (United States)

Dronkers, T M G; Krist, L; Van Overveld, F J; Rijkers, G T

2018-05-25

The outcome of the first series of health claim applications for probiotics in Europe as evaluated by the European Food Safety Authority (EFSA) has, up to 2013 almost completely yielded negative results. All recent applications also have been rejected, including the latest on prevention of mastitis in breastfeeding mothers. In other developed countries, such as Switzerland, Japan and Canada, the health effects of probiotics, for which scientific evidence has been provided, can be communicated to potential consumers. The number of clinical trials with probiotics over recent years shows a trend to level off or even decline. At the same time, clinical research into the role of (gut) microbiota in a wide variety of diseases and conditions is booming. Ultimately, this may offer new indications for gut microbiota management by probiotics, prebiotics or other food supplements.

EuroFIR eBASIS: application for health claims submissions and evaluations

DEFF Research Database (Denmark)

Kiely, M.; Black, L.J.; Plumb, J.

2010-01-01

Background: The European Food Information Resource (EuroFIR) network has established the eBASIS (Bioactive Substances in Food Information System) online food composition and biological effects database for plant-derived bioactive compounds (phytochemicals). On the basis of submitted evidence......, the European Food Safety Authority (EFSA) expert panel on Dietetic Products, Nutrition and Allergies assesses whether claims made under articles 13.1, 13.5 or 14 of the Regulation (EC) 1924/2006, which governs the use of nutrition and health claims on foods, are scientifically justified. This report evaluates...... the eBASIS biological effects database in the preparation and evaluation of health claims dossiers. Methods: The eBASIS biological effects database is a compilation of expert-evaluated data extracted from the literature, prioritising human intervention studies to investigate health effects...

200 Area Deactivation Project Facilities Authorization Envelope Document

International Nuclear Information System (INIS)

DODD, E.N.

2000-01-01

Project facilities as required by HNF-PRO-2701, Authorization Envelope and Authorization Agreement. The Authorization Agreements (AA's) do not identify the specific set of environmental safety and health requirements that are applicable to the facility. Therefore, the facility Authorization Envelopes are defined here to identify the applicable requirements. This document identifies the authorization envelopes for the 200 Area Deactivation

Status of the IAEA safety standards programme

International Nuclear Information System (INIS)

2002-01-01

This presentation describes the status of the IAEA safety standards program to May 2002. The safety standards program overcome whole main nuclear implementations as General safety, Nuclear safety, Radiation safety, Radioactive waste safety, and Transport safety. Throughout this report the first column provides the list of published IAEA Safety Standards. The second gives the working identification number (DS) of standards being developed or revised. The bold type indicates standard issued under the authority the Board of Governors, others are issued under authority of the Director General. The last column provides the list of Committees, the first Committee listed has the lead in the preparation and review of the particular standard

EFSA CEF Panel (EFSA Panel on Fo od Contact Materials, Enzymes, Flavourings and Proce ssing Aids), 2015. Scientific Opinion on Flavouring Group Evalua tion 09, Revision 6 (FGE.09Rev6): Secondary alicyclic saturated and unsaturated alcohols, ketones and esters containing secondary alicyclic alcohols

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Nørby, Karin Kristiane

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 22 flavouring substances in the Flavouring Group Evaluation 9, Revision 6, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the subs...

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 210, Revision 1 (FGE.210Rev1): Consideration of genotoxic potential for α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Lund, Pia

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 13 flavouring substances in Flavouring Group Evaluation 210 (FGE.210) and one additional substance [FL-no: 07.225] in this revis...

Renovation of the exploitation authorization

International Nuclear Information System (INIS)

Garcia Delgado, L.

2009-01-01

With the current administrative framework, nuclear power plant licenses are granted for the-year periods. The Cofrentes NPP Operating License is valid until March 2011 and its renewal has to be requested before March 2010. Cofrentes NPP is working on an application for renewal until 2021. This work requires assessments of the facility's nuclear Safety-related performance between 1999 and 2008, as well as evaluations and subsequent implementation of new legislation that, when applied, will benefit safety. (Author)

The 2002 Drigg post-closure safety case: implementation of a multiple factor safety case

International Nuclear Information System (INIS)

Lean, C.B.; Grimwood, P.D.; Watts, L.; Fowler, L.; Thomson, G.; Kelly, E.; Hodgkinson, D.

2004-01-01

British Nuclear Fuels plc (BNFL) owns and operates the Drigg disposal site, which is the UK's principal facility for the disposal of low level radioactive waste (LLW). Disposals are carried out under the terms of an authorization granted by the UK Environment Agency (the Agency). The Agency periodically reviews the authorization to take account of new information and any revisions to regulatory requirements. In September 2002 new Operational Environmental and Post-Closure Safety Cases (OESC and PCSC respectively) were submitted to the Agency to support the next authorization review. The OESC assesses radiological safety aspects up until closure of the site, including a post-operational management phase, whilst the PCSC considers the longer-term radiological safety. The Drigg disposal facility has been operational since 1959. For the first 3 decades of operations, disposals were solely by tumble tipping wastes into excavated trenches. This was phased out in favour of vault disposal and disposals to the trenches were completed in 1995. The first vault (Vault 8) commenced operations in 1988 and construction of future vaults is planned up to the estimated end of disposal operations in about 50 years time. This paper describes the main components of the 2002 Drigg PCSC and how they relate to each other. Central to the safety case is a systematic comprehensive post-closure radiological safety assessment (PCRSA). However, the importance of the more qualitative aspects of the safety case, including a demonstration of optimisation, is also highlighted. In addition, other confidence-building activities which are key to developing and presenting the safety case are discussed. (author)

International conference on the strengthening of nuclear safety in Eastern Europe. Keynote papers. Regulatory aspects of NPP safety, status of safety improvements, status of safety analysis report

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-06-01

The Objective of the Conference was to assess the past decade of nuclear safety efforts in countries operating WWER and RBMK nuclear reactors and to address remaining safety issues which require further work. A particular focus of the Conference was on international co-operation and assistance and where such efforts should be focused in the future. All Eastern European countries that operate RBMK or WWER reactors participated in the Conference, and presented papers on three key areas of nuclear safety: Regulatory Aspects of Nuclear Power Plant Safety; Status of Safety Improvements; and Status of Safety Analysis Reports. In addition, representatives from 18 additional countries that provide financial and/or technical assistance and co-operation in the area of WWER and RBMK safety offered the most extensive commentary. Key international (IAEA, World Association of Nuclear Operators, the Nuclear Energy Agency, the G-24 NUSAC, the European Commission, and the EBRD) organizations that provide nuclear safety assistance for WWER and RBMK reactors also made presentations. There is no question that considerable progress on nuclear safety has been made in Eastern Europe. Special mention should be made of successful efforts to strengthen the independence and technical competence of the nuclear regulatory authorities. Efforts should now concentrate on improving the depth and scope of the technical abilities of the regulatory authorities. More attention by governments is needed to ensure that the regulatory authorities have the financial resources and enforcement authority to fully execute their missions. In respect to the operators of the nuclear power plants, they have demonstrated clear progress in operational safety improvements. Significant additional efforts are required to maintain and enhance an effective safety culture. Design safety improvement programmes are in place in all countries. Implementation of these programmes has varied and is particularly affected by

Implementation of the safety culture for HANARO Safety Management

International Nuclear Information System (INIS)

Wu, Jongsup; Han, Geeyang; Kim, Iksoo

2008-01-01

Safety is the fundamental principal upon which the management system is based. The IAEA INSAG(International Nuclear Safety Group) states the general aims of the safety management system. One of which is to foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behavior in individuals and teams so as to allow them to carry out their tasks safety. The safety culture activities have been implemented and the importance of safety management in nuclear activities for a reactor application and utilization has also been emphasized more than 10 years in HANARO which is a 30 MW multi-purpose research reactor and achieved its first criticality in February 1995. The safety culture activities and implementations have been conducted continuously to enhance its safe operation like the seminars and lectures related to safety matters, participation in international workshops, the development of safety culture indicators, the survey on the attitude of safety culture, the development of operational safety performance indicators (SPIs), the preparation of a safety text book and the development of an e-Learning program for safety education. (author)

Nuclear safety. Seguranca nuclear

Energy Technology Data Exchange (ETDEWEB)

Aveline, A [Rio Grande do Sul Univ., Porto Alegre, RS (Brazil). Inst. de Fisica

1981-01-01

What is nuclear safety Is there any technical way to reduce risks Is it possible to put them at reasonable levels Are there competitiveness and economic reliability to employ the nuclear energy by means of safety technics Looking for answers to these questions the author describes the sources of potential risks to nuclear reactors and tries to apply the answers to the Brazilian Nuclear Programme. (author).

Decision no. 2011-DC-0215 of the French nuclear safety authority from May 5, 2011, ordering ITER Organization to proceed to a complementary safety evaluation of its basic nuclear facility in the eyes of the Fukushima Daiichi nuclear power plant accident

International Nuclear Information System (INIS)

2011-01-01

As a consequence of the accident of the Fukushima Daiichi nuclear power plant (Japan), the French Prime Minister entrusted the French nuclear safety authority (ASN) with the mission to carry out a safety analysis re-evaluation of the French nuclear facilities, and in particular the nuclear power plants. A decision has been addressed by the ASN to each nuclear operator with the specifications of this safety re-evaluation analysis and the list of facilities in concern. This document is the decision addressed to the ITER Organization, operator of the ITER tokamak facility of Cadarache (France). (J.S.)

The role of the public sector's research programme in support of the authorities and in building confidence on the safety of spent fuel disposal

International Nuclear Information System (INIS)

Vuori, S.; Rasilainen, K.

2002-01-01

A multiphase research programme was launched in 1989 to support the Finnish authorities in their activities concerning spent fuel management. The Finnish programme for spent fuel management has so far managed to keep its original time schedule at least partly due to clearly defined responsibilities between the nuclear energy producing industry and the authorities. It appears that the public sector's research programme has been successful in its supporting role by providing research results both on technical/ natural science and social science issues. In addition, the research programme has contributed directly and indirectly in building confidence on the post-closure and operational safety of a spent fuel disposal facility. (authors)

78 FR 12065 - Patient Safety Organizations: Delisting for Cause for Independent Data Safety Monitoring, Inc.

Science.gov (United States)

2013-02-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety... Safety Monitoring, Inc. due to its failure to correct a deficiency. The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the listing of PSOs, which are entities or component...

Assessment of safety culture: Changing regulatory approach in Hungary

International Nuclear Information System (INIS)

Ronaky, Jozsef; Toth, Andras

2002-01-01

Hungarian Atomic Energy Authority (HAEA) is changing its inspection practice and assessment methods of safety performance and safety culture in operating nuclear facilities. The new approach emphasises integrated team inspection of safety cornerstones and systematic assessment of safety performance of operators. (author)

Safety and security profiles of industry networks used in safety- critical applications

Directory of Open Access Journals (Sweden)

Mária FRANEKOVÁ

2008-01-01

Full Text Available The author describes the mechanisms of safety and security profiles of industry and communication networks used within safety – related applications in technological and information levels of process control recommended according to standards IEC 61784-3,4. Nowadays the number of vendors of the safety – related communication technologies who guarantees besides the standard communication, the communication amongst the safety – related equipment according to IEC 61508 is increasing. Also the number of safety – related products is increasing, e. g. safety Fieldbus, safety PLC, safety curtains, safety laser scanners, safety buttons, safety relays and other. According to world survey the safety Fieldbus denoted the highest growth from all manufactured safety products.The main part of this paper is the description of the safety-related Fieldbus communication system, which has to guaranty Safety Integrity Level.

Challenges in promoting radiation safety culture

International Nuclear Information System (INIS)

Mod Ali, Noriah

2008-01-01

Safety has quickly become an industry performance measure, and the emphasis on its reliability has always been part of a strategic commitment. This paper presents an approach taken by Malaysian Nuclear Agency (Nuclear Malaysia) and authority to develop and implement safety culture for industries that uses radioactive material and radiation sources. Maintaining and improving safety culture is a continuous process. There is a need to establish a program to measure, review and audit health and safety performance against predetermined standards. Proper safety audit will help to identify the non-compliance of safety culture as well as the deviation of management, individual and policy level commitment; review of radiation protection program and activities should be preceded. (author)

ITER-FEAT safety

International Nuclear Information System (INIS)

Gordon, C.W.; Bartels, H.-W.; Honda, T.; Raeder, J.; Topilski, L.; Iseli, M.; Moshonas, K.; Taylor, N.; Gulden, W.; Kolbasov, B.; Inabe, T.; Tada, E.

2001-01-01

Safety has been an integral part of the design process for ITER since the Conceptual Design Activities of the project. The safety approach adopted in the ITER-FEAT design and the complementary assessments underway, to be documented in the Generic Site Safety Report (GSSR), are expected to help demonstrate the attractiveness of fusion and thereby set a good precedent for future fusion power reactors. The assessments address ITER's radiological hazards taking into account fusion's favourable safety characteristics. The expectation that ITER will need regulatory approval has influenced the entire safety design and assessment approach. This paper summarises the ITER-FEAT safety approach and assessments underway. (author)

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to glycaemic carbohydrates and maintenance of normal brain function (ID 603, 653) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Tetens, Inge

; attention; memory”. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal brain function. The Panel considers that maintenance of normal brain function is a beneficial...... claims in relation to glycaemic carbohydrates and maintenance of normal brain function. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from...

The Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2010

International Nuclear Information System (INIS)

2010-05-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2010 is presented. These activities are reported under the headings: Address of the Chairperson; (1) Legislative activities; (2) Issuance of authorizations, assessment, supervisory activities and enforcement; (3) Nuclear safety of nuclear power plants; (4) Nuclear materials and physical protection of nuclear materials; (5) Powers of the office building; (6) Emergency planning and preparedness; (7) International activities; (8) Public communication; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Appendix: UJD SR organization chart; The International Nuclear Event Scale (INES); Abbreviations.

Safety, risk and Harrisburg

International Nuclear Information System (INIS)

Titterton, E.

1979-06-01

The author discusses public attitudes to safety, industrial accidents and reactor accidents, in particular the accident at Three-Mile Island. Arguments in favour of nuclear power, including its relative safety, are presented

Low atmospheric pressure system for stunning broiler chickens

DEFF Research Database (Denmark)

EFSA Panel on Animal Health and Welfare (AHAW); More, Simon; Bicout, Dominique

2017-01-01

on broiler chickens. The ad hoc Working Group (WG) set up by EFSA performed the assessment in three main steps, i.e. checking the data provided against the criteria laid down in the EFSA Guidance (EFSA AHAW Panel, 2013); running an extensive literature search, followed by data extraction and performing......, be suitable for depopulation, respecting the technical conditions defined in the present conclusions. The WG considers that a revision of the present version of the EFSA Guidance could be beneficial....

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 12, Revision 4 (FGE.12Rev4): primary saturated or unsaturated alicyclic alcohols, aldehydes, acids and esters from chemical groups 1 and 7

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Binderup, Mona-Lise; Frandsen, Henrik Lauritz

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 12 flavouring substances in Flavouring Group Evaluation 12, Revision 4 (FGE.12Rev4), including two additional substances, using the Procedure in Commission...... (the Procedure) that integrates information on structure–activity relationships, intake from current uses and the toxicological threshold of concern and available data on metabolism and toxicity. The Panel concluded that none of the 12 substances [FL-nos: 02.134, 02.186, 02.216, 02.217, 05.157, 05.......182, 05.183, 05.198, 08.135, 09.342, 09.670 and 09.829] gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the maximised survey-derived daily intake approach. Besides the safety assessment of these flavouring substances, the specifications for the materials...

Experiment to evaluate software safety

International Nuclear Information System (INIS)

Soubies, B.; Henry, J.Y.

1994-01-01

The process of licensing nuclear power plants for operation consists of mandatory steps featuring detailed examination of the instrumentation and control system by the safety authorities, including softwares. The criticality of these softwares obliges the manufacturer to develop in accordance with the IEC 880 standard 'Computer software in nuclear power plant safety systems' issued by the International Electronic Commission. The evaluation approach, a two-stage assessment is described in detail. In this context, the IPSN (Institute of Protection and Nuclear Safety), the technical support body of the safety authority uses the MALPAS tool to analyse the quality of the programs. (R.P.). 4 refs

IAEA Safety Standards

International Nuclear Information System (INIS)

2016-09-01

The IAEA Safety Standards Series comprises publications of a regulatory nature covering nuclear safety, radiation protection, radioactive waste management, the transport of radioactive material, the safety of nuclear fuel cycle facilities and management systems. These publications are issued under the terms of Article III of the IAEA’s Statute, which authorizes the IAEA to establish “standards of safety for protection of health and minimization of danger to life and property”. Safety standards are categorized into: • Safety Fundamentals, stating the basic objective, concepts and principles of safety; • Safety Requirements, establishing the requirements that must be fulfilled to ensure safety; and • Safety Guides, recommending measures for complying with these requirements for safety. For numbering purposes, the IAEA Safety Standards Series is subdivided into General Safety Requirements and General Safety Guides (GSR and GSG), which are applicable to all types of facilities and activities, and Specific Safety Requirements and Specific Safety Guides (SSR and SSG), which are for application in particular thematic areas. This booklet lists all current IAEA Safety Standards, including those forthcoming

[Weighing use and safety of therapeutic agents and feed additives (author's transl)].

Science.gov (United States)

van der Wal, P

1982-02-01

(1) The pros and cons of using feed additives and therapeutic agents may be successfully weighed in the light of carefully considered consumer requirements. (2) The socio-economic interests of the producer and the welfare of the animal will also determine the response of the production apparatus to consumer requirements. (3) Consumption of the current amounts of products of animal origin and maintenance of price and quality will only be feasible in the event of rational large-scale production in which constituents used in nutrition, prophylaxis and therapeutics are highly important factors. (4) Using these ingredients should be preceded by accurate evaluation of their use and safety. Testing facilities, conduct of studies and reporting should be such as to make the results nationally and internationally acceptable to all those concerned. (5) In deciding whether feed constituents are acceptable in view of the established use and safety, compliance will have to be sought with those standards which are accepted in other fields of society. Measures which result in raising the price of food without actually helping to reduce the risks to the safety of man, animals and environment, are likely to be rejected by any well-informed consumer who is aware of the facts. (6) For accurate weighing of use and safety at a national level, possibilities are hardly adequate in Europe. Decisions reached within the framework of the European Community, also tuned to U.S.A.- conditions are rightly encouraged. A centrally managed professionally staffed and equipped test system in the European Community would appear to be indispensable.

Activities of the Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear facilities in the Slovak Republic in 1994

International Nuclear Information System (INIS)

1995-01-01

The report summarizes activities of the Nuclear Regulatory Authority of the Slovak Republic (NRA SR) in 1994 and briefly presents results of the national expert supervision over nuclear safety facilities in the SR in 1994. In 1994, the NRA SR have performed a national supervision of following organizations: SE, a.s. - Jaslovske Bohunice Nuclear Power Plant (V-1 Nuclear Power Plant (V-1 NPP), V-2 Nuclear Power Plant (V-2 NPP), A-1 Nuclear Power Plant (A-1 NPP)); Mochovce Nuclear Power Plant; Radioactive waste repository, Mochovce); Organizations providing a specialized training of NPP personnel; Organizations providing specific deliveries and activities for the nuclear power industry; Organizations having an owner of nuclear materials; Organizations providing activities related to import of radioactive sources; Organizations using radioactive sources. Organization structure of the NRA SR is explained. In the presented Chapter 1 - Safety of nuclear power plants in the Slovak Republic - safety aspects of the Slovak NPPs are reported. The next activities are reported: nuclear materials and safeguards; radioactive waste; emergency planning and NRA SR's control and crisis centre; international activities to improve the national surveillance quality; other activities

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Statement on the safety of lacto-N-neotetraose and 2'-O-fucosyllactose as novel food ingredients in food supplements for children

DEFF Research Database (Denmark)

Poulsen, Morten

2015-01-01

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on the safety of lacto-N-neotetraose and 2'‑O-fucosyllactose as novel food ingredients in food supplements for children (excluding infants...... of 1.5 g for LNnT and 3 g for 2’-FL for children (4–18 years of age). In this scientific assessment, maximum daily intakes from food supplements for toddlers, children and teenagers are presented and two scenarios are calculated in which the maximum daily intakes from food supplements are added...... in intake levels which were reported to cause mild gastrointestinal symptoms in adults....

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 11, Revision 3 (FGE.11Rev3): Aliphatic dialcohols, diketones, and hydroxyketones from chemical groups 8 and 10

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Frandsen, Henrik Lauritz; Nørby, Karin Kristiane

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 11 flavouring substances in the Flavouring Group Evaluation 11, Revision 3, using the Procedure in Commission Regulation (EC) No 1565/2000. The substances......, the specifications for the materials of commerce have also been considered. Specifications including complete purity criteria and identity for the materials of commerce have been provided for all candidate substances....

Safety indicators: an efficient tool for a better safety

International Nuclear Information System (INIS)

Aufort, P.; Lars, R.

1993-01-01

Safety indicators based on the examination of the Operating Technical Specifications have been defined with the aim of following the in-operation safety level of French nuclear power plants. These safety indicators are operation feedback tools which permit the a posteriori justification and the adjustment of actual procedures. They would allow detection of an abnormal unavailability occurrence rate or a situation revealing a potential safety problem. So, data acquisition, processing, analysis and display software allowing trend analysis of these indicators has been developed so far as: a reflexion tool for the power plant operators about the safety instructions and the adjustment of preventive maintenance, and a help for decision making at a national level for the examination and the improvement of Operating Technical Specifications. This paper presents the objectives of these safety indicators, the processing tool associated, the preliminary results obtained and more elaborate processing of these indicators. These safety indicators may be very useful in framing probabilistic safety assessments. (author)

Safety culture: modern slogan or effective contribution to safety?

International Nuclear Information System (INIS)

Salm, M.

1994-01-01

Safety culture is defined and its impact on nuclear power plants is documented using the words of the INSAG of IAEA. Two examples from the field of aviation and space flight testify, that the upper management, by its sheer image, may considerably influence actions of the lower levels of the hierarchy. Management therefore can do a lot more for safety than is commonly assumed. Two examples, although separated by 57 years, show that the mentioned influence remains unchanged inspire of progress in management- and organisation-methods as well as in safety-engineering. Safety culture is an overriding element of safety, acting at all levels of a hierarchy. Its action is most important on those levels, for which precise reglementation is hardly possible. The chain of technical and organisational measures guarantees safety only under the condition, that it is embedded in 'safety culture'. Safety culture therefore merits our full attention. (author) 1 fig

Nuclear safety in France

International Nuclear Information System (INIS)

Laverie, M.

1981-02-01

The principles and rules governing the safety of nuclear installations are defined as from three fundamental principles and three practical rules as follows: First principle: the operator is responsible and of the highest order. Second principle: the public authorities exercise their control responsibility with respect to the design, construction and running of the installations. Third principle: nuclear safety, this is to accept that man and his technique are not infallible and that one must be prepared to control the unpredictable. First rule: the installations must include several 'lines of defence' in succession and to the extent where this is possible these must be independent of each other. Second rule: procedures are required and supervised by the Government Departments. Third rule: nuclear safety requires that any incident or anomaly must undergo an analysis in depth and is also based on a standing 'clinical' examination of the installations. The definition is given as to how the public authorities exercise their intervention: terms and conditions of the intervention by the safety authorities, authorization procedures, surveillance of the installations, general technical regulations. Two specific subjects are presented in the addendum, (a) the choice of nuclear power station sites in France and (b) the storage of radioactive wastes [fr

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2015. Scientific Opinion on Flavouring Group Evaluation 21, Revision 5 (FGE.21Rev5): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

DEFF Research Database (Denmark)

Nørby, Karin Kristiane; Beltoft, Vibe Meister

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 41 flavouring substances in Flavouring Group Evaluation 21, Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision...... have also been considered. Adequate specifications, including complete purity criteria and identity for the materials of commerce, have been provided for all 41 candidate substances....

Radiation safety audit

International Nuclear Information System (INIS)

Kadadunna, K.P.I.K.; Mod Ali, Noriah

2008-01-01

Audit has been seen as one of the effective methods to ensure harmonization in radiation protection. A radiation safety audit is a formal safety performance examination of existing or future work activities by an independent team. Regular audit will assist the management in its mission to maintain the facilities environment that is inherently safe for its employees. The audits review the adequacy of facilities for the type of use, training, and competency of workers, supervision by authorized users, availability of survey instruments, security of radioactive materials, minimization of personnel exposure to radiation, safety equipment, and the required record keeping. All approved areas of use are included in these periodic audits. Any deficiency found in the audit shall be corrected as soon as possible after they are reported. Radiation safety audit is a proactive approach to improve radiation safety practices and identify and prevent any potential radiation accident. It is an excellent tool to identify potential problem to radiation users and to assure that safety measures to eliminate or reduce the problems are fully considered. Radiation safety audit will help to develop safety culture of the facility. It is intended to be the cornerstone of a safety program designed to aid the facility, staff and management in maintaining a safe environment in which activities are carried out. The initiative of this work is to evaluate the need of having a proper audit as one of the mechanism to manage the safety using ionizing radiation. This study is focused on the need of having a proper radiation safety audit to identify deviations and deficiencies of radiation protection programmes. It will be based on studies conducted on several institutes/radiation facilities in Malaysia in 2006. Steps will then be formulated towards strengthening radiation safety through proper audit. This will result in a better working situation and confidence in the radiation protection community

47 CFR 0.332 - Actions taken under delegated authority.

Science.gov (United States)

2010-10-01

... Delegations of Authority Wireless Telecommunications Bureau § 0.332 Actions taken under delegated authority. In discharging the authority conferred by § 0.331, the Chief, Wireless Telecommunications Bureau... safety, homeland security, national security, emergency management and preparedness, and disaster...

Nuclear safety in France

International Nuclear Information System (INIS)

Servant, J.

1979-12-01

The main areas of nuclear safety are considered in this paper, recalling the laws and resolutions in force and also the appropriate authority in each case. The following topics are reviewed: radiological protection, protection of workers, measures to be taken in case of an accident, radioactive effluents, impact on the environment of non-nuclear pollution, nuclear plant safety, protection against malicious acts, control and safeguard of nuclear materials, radioisotopes, transport of radioactive substances, naval propulsion, waste management, nuclear plant decommissioning and export of nuclear equipment and materials. Finally, the author describes the role of the general Secretariat of the Interdepartmental Committee on Nuclear Safety

Framework of nuclear safety and safety assessment

International Nuclear Information System (INIS)

Furuta, Kazuo

2007-01-01

Since enormous energy is released by nuclear chain reaction mainly as a form of radiation, a great potential risk accompanies utilization of nuclear energy. Safety has been continuously a critical issue therefore from the very beginning of its development. Though the framework of nuclear safety that has been established at an early developmental stage of nuclear engineering is still valid, more comprehensive approaches are required having experienced several events such as Three Mile Island, Chernobyl, and JCO. This article gives a brief view of the most basic principles how nuclear safety is achieved, which were introduced and sophisticated in nuclear engineering but applicable also to other engineering domains in general. (author)

Safety for all: bringing together patient and employee safety.

Science.gov (United States)

Stevenson, R Lynn; Moss, Lesley; Newlands, Tracey; Archer, Jana

2013-01-01

The safety of patients and of employees in healthcare have historically been separately managed and regulated. Despite efforts to reduce injury rates for employees and adverse events for patients, healthcare organizations continue to see less-than-optimal outcomes in both domains. This article challenges readers to consider how the traditional siloed approach to patient and employee safety can lead to duplication of effort, confusion, missed opportunities and unintended consequences. The authors propose that only through integrating patient and employee safety activities and challenging the paradigms that juxtapose the two will healthcare organizations experience sustained and improved safety practice and outcomes. Copyright © 2013 Longwoods Publishing.

Discussion about risk-informed regulations on the nuclear safety

International Nuclear Information System (INIS)

Gu Yeyi

2008-01-01

The article introduces the background and status quo of regulations on the nuclear safety in China, and points out the inadequacies existing with the current regulations. The author explains the risk-informed safety management concerning its development, status quo, and achievements made, in an attempt to make out the trend of improving regulations on the nuclear safety through risk-informed methods. Combining the U.S. development program of establishing risk-informed regulations on the nuclear safety, the author narrates principles and features of the new regulations system, and provides suggestions for the promotion of risk-informed safety management and establishment of risk-informed regulations on the nuclear safety. (author)

Safety assessment, safety performance indicators at the Paks Nuclear Power Plant

International Nuclear Information System (INIS)

Baji, C.; Vamos, G.; Toth, J.

2001-01-01

The Paks Nuclear Power Plant has been using different methods of safety assessment (event analysis, self-assessment, probabilistic safety analysis), including performance indicators characterizing both operational and safety performance since the early years of operation of the plant. Regarding the safety performance, the indicators include safety system performance, number of scrams, release of radioactive materials, number of safety significant events, industrial safety indicator, etc. The Paks NPP also reports a set of ten indicators to WANO Performance Indicator Programme which, among others, include safety related indicators as well. However, a more systematic approach to structuring and trending safety indicators is needed so that they can contribute to the enhancement of the operational safety. A more comprehensive set of indicators and a systematic evaluation process was introduced in 1996. The performance indicators framework proposed by the IAEA was adapted to Paks in this year to further improve the process. Safety culture assessment and characterizing safety culture is part of the assessment process. (author)

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 73, Revision 3 (FGE.73Rev3): Consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th and 63rd meeting

DEFF Research Database (Denmark)

Beltoft, Vibe Meister; Frandsen, Henrik Lauritz; Nørby, Karin Kristiane

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further...... of one additional substance, beta-ionyl acetate [FL-no: 09.305] cleared for genotoxicity concern in FGE.213Rev1. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern.......712] considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered...

Safety goals and safety culture opening plenary. 2. Safety Regulation Implemented by Gosatomnadzor of Russia

International Nuclear Information System (INIS)

Gutsalov, A.T.; Bukrinsky, A.M.

2001-01-01

This paper describes principles and approaches used by Gosatomnadzor of Russia in establishing safety goals. The link between safety goals and safety culture is demonstrated. The paper also contains information on nuclear regulatory activities in Russia. Regulatory documents of Gosatomnadzor of Russia do not provide precise definitions of safety goals as IAEA documents INSAG-3 or INSAG-12 do. However, overall activities of Gosatomnadzor of Russia are directed to the achievement of these safety goals, as Gosatomnadzor of Russia is a federal executive authority responsible for the regulation of nuclear and radiation safety in accordance with the Russian Federal Law 'On the Use of Nuclear Energy'. Thus, in the Statement of the Policy of the Russian Regulatory Authority, enacted in 1992, it was established that the overall activities of Gosatomnadzor of Russia are directed to the achievement of the main goal. This goal is to establish conditions that ensure that personnel, the public, and the environment are protected from unacceptable radiation and nonproliferation of nuclear materials. The practical application of such a method as given by the publication of Statements of Policy of Gosatomnadzor of Russia may be considered as a safety culture element. 'General Provisions of NPP Safety Ensuring' (OPB-88/ 97) is a regulatory document of the highest level in the hierarchy of regulatory documents of Gosatomnadzor of Russia. It establishes quantitative values of safety goals as do the foregoing IAEA documents. Thus, this regulatory document sets up the following: 1. The estimated total probability of severe accidents should not exceed 10 5 /reactor.yr. 2. The estimated probability of the worst possible radioactive release to the environment specified in the standards should not exceed 10 -7 /reactor.yr in the case of severe beyond-design-basis accidents. 3. The probability of a reactor vessel failure should not exceed 10 -7 /reactor.yr. The foregoing values are somehow

Beverage Consumption Habits in Italian Population: Association with Total Water Intake and Energy Intake

Directory of Open Access Journals (Sweden)

Lorenza Mistura

2016-10-01

Full Text Available Background: The aim of this study was to investigate total water intake (TWI from water, beverages and foods among Italian adults and the elderly. Methods: Data of 2607 adults and the elderly, aged 18–75 years from the last national food consumption survey, INRAN-SCAI 2005-06, were used to evaluate the TWI. The INRAN-SCAI 2005-06 survey was conducted on a representative sample of 3323 individuals aged 0.1 to 97.7 years. A 3-day semi-structured diary was used for participants to record the consumption of all foods, beverages and nutritional supplements. Results: On average, TWI was 1.8 L for men and 1.7 L for women. More than 75% of women and 90% of men did not comply with the European Food Safety Authority (EFSA Adequate Intake. The contribution of beverages to the total energy intake (EI was 6% for the total sample. Water was the most consumed beverage, followed by alcoholic beverages for men and hot beverages for women. Conclusion: According to the present results, adults and elderly Italians do not reach the adequate intake for water as suggested by the EFSA and by the national reference level of nutrient and energy intake. Data on water consumption should also be analyzed in single socio-demographic groups in order to identify sub-groups of the population that need more attention and to plan more targeted interventions.

Glyceria maxima as new test species for the EU risk assessment for herbicides: a microcosm study.

Science.gov (United States)

Mohr, S; Schott, J; Hoenemann, L; Feibicke, M

2015-03-01

In its recent guidance document on tiered risk assessment for plant protection products for aquatic organisms, the European Food Safety Authority (EFSA) proposed to use Glyceria maxima as monocotyledonous grass species for the testing of special herbicide groups. However, published toxicity data for this species is very limited and there is no test guideline for Glyceria sp. For this reason a microcosm study was conducted in order to gain experience on the degree of sensitivity of G. maxima to the herbicidal substances clodinafop-propargyl (grass herbicide) and fluroxypyr (auxin) in comparison to the already established test organism water milfoil Myriophyllum spicatum and the duckweed species Landoltia punctata. Five concentrations without replicates were tested for each test substance using 10 microcosms and three microcosms served as controls. The experiment was run for 8 weeks. Morphological endpoints were used to determine growth and EC50 values. The results show that M. spicatum was most sensitive to fluroxypyr (37 days EC50 for roots: 62 µg/L) and G. maxima most sensitive to clodinafop-propargyl (22 days EC50 for total shoot length: 48 µg/L) whereas the duckweed species was considerable less sensitive. Hence, G. maxima turns out to be a good candidate for testing grass specific herbicides, supporting its inclusion as an additional macrophyte test for the risk assessment of herbicides as proposed by the EFSA.

Cholesterol lowering effect of a commercial margarine in hypercholesterolemic adults: a review of the scientific literature.

Directory of Open Access Journals (Sweden)

Raquel Bernácer

2013-03-01

Full Text Available Introduction: the hypercholesterolemia is a growing problem, responsible of one fifth of coronary events in Spain. It is considered that plant sterols (PS could play an important role in their treatment.Objective: we review the role of a range of functional foods with added PS (including specific studies using Flora pro•activ in adults with hypercholesterolemia.Methods: we performed a review of the literature in the PubMed database to locate human studies that have evaluated the role of Flora pro•activ or PS fortified foods with a similar composition. We also have been consulted the European Food Safety Authority (EFSA database.Results: Flora pro•activ demonstrated in rigorous scientific studies to lower cholesterol in adults with hypercholesterolemia. Two servings of Flora pro•activ (1.5 g PS are needed to observe this effect. Lowering cholesterol with Flora pro•activ (2 servings / day oscillate as EFSA notes, between 7 and 10%. This effect is observed after 2-3 weeks. Its composition allows to make health claims about lowering cholesterol as is described for the European Union. The cholesterol-lowering efficacy of PS enriched foods that are not margarine, mayonnaise, salad dressings or dairy products is under-researched. With few exceptions, the use of fortified foods with PS is safe.Conclusions: the current scientific evidence justify the promotion of the use of PS to lower LDL cholesterol in adults with hypercholesterolemia.

Safety Evaluations of Bifidobacterium bifidum BGN4 and Bifidobacterium longum BORI

Directory of Open Access Journals (Sweden)

Min Jeong Kim

2018-05-01

amount of putrescine, commonly found in living cells, at levels similar to or lower than that found in other foods (e.g., spinach, ketchup, green pea, sauerkraut, and sausage. B. bifidum BGN4 showed higher resistance to gentamicin than the European Food Safety Authority (EFSA cut-off. However, this paper shows the gentamicin resistance of B. bifidum BGN4 was not transferred via conjugation with L. acidophilus ATCC 4356, the latter of which is highly susceptible to gentamicin. The entire genomic sequence of B. bifidum BGN4 has been published in GenBank (accession no.: CP001361.1, documenting the lack of retention of plasmids capable of transferring an antibiotic-resistant gene. Moreover, there was little genetic mutation between the first and 25th generations of B. bifidum BGN4. Tetracycline-resistant genes are prevalent among B. longum strains; B. longum BORI has a tet(W gene on its chromosome DNA and has also shown resistance to tetracycline. However, this research shows that its tetracycline resistance was not transferred via conjugation with L. fermentum AGBG1, the latter of which is highly sensitive to tetracycline. These findings support the continuous use of B. bifidum BGN4 and B. longum BORI as probiotics, both of which have been reported as safe by several clinical studies, and have been used in food supplements for many years.

Iron and contribution to the normal function of the immune system: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2016-01-01

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

Vitamin C and protection of DNA, proteins and lipids from oxidative damage: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

Vitamin C and contribution to the normal function of the immune system: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2015-01-01

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

Stablor® and reduction of visceral fat while maintaining lean mass: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2017-01-01

Following an application from Laboratoires Nutrition et Cardiometabolisme, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

Vitamin E and protection of DNA, proteins and lipids from oxidative damage: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2016-01-01

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

Calcium and contribution to the normal development of bones: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

DEFF Research Database (Denmark)

Sjödin, Anders Mikael

2016-01-01

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

Interaction of national and foreign safety guidelines

International Nuclear Information System (INIS)

Domaratzki, Z.

1991-01-01

A commercial contract for a nuclear power plant includes an agreement on the appropriate safety requirements with which the plant must conform. This may involve adopting the safety requirements of the exporting country, the importing country or a combination of the two sets of safety requirements. To ensure that a high level of safety is achieved it is appropriate that the regulatory authorities in the two countries should establish a co-operative arrangement which will extend for the life of the plant. The regulatory authority in the importing country will need to develop a good understanding of the design, safety analysis and operating history of the reactor type which is being purchased. The regulator in the exporting country can be of great assistance in this regard. The co-operative arrangement should extend into the commissioning and operating stage at which point there will be a two way flow of information. During the operating stage information exchange should include significant operating events, operating problems, new safety related research information, necessary design changes and the results of periodic updating of the safety analysis. In some cases the co-operation should extend to training of regulatory staff. The choice of national versus foreign safety requirements may be important. However, if the two regulatory authorities are to discharge their legal and moral safety responsibilities it is at least equally important to maintain a co-operative arrangement for the life of the plant. (author)

Calculation and definition of safety indicators

International Nuclear Information System (INIS)

Cristian, I.; Branzeu, N.; Vidican, D.; Vladescu, G.

1997-01-01

This paper presents, based on Cernavoda safety indicators proposal, the purpose definition and calculation formulas for each of the selected safety indicators. Five categories of safety indicators for Cernavoda Unit 1 were identified, namely: overall plant safety performance; initiating events; safety system availability, physical barrier integrity; indirect indicators. Definition, calculation and use of some safety indicators are shown in a tabular form. (authors)

Complementary safety assessments of the French nuclear power plants (European 'stress tests'). Report by the French nuclear safety authority - December 2011

International Nuclear Information System (INIS)

2011-12-01

After having recalled the organisation of nuclear safety and radiation protection regulation in France, presented the French nuclear safety regulations (acts, decrees, orders, ASN decisions, rules and guides), described the nuclear safety approach in France (the 'defense in depth' concept), and ASN's sanctions powers, this report presents the French approach to complementary safety assessments (CSAs) with their different types of specifications (those consistent with European specification, those broader than the European specifications, and those which take into account some situations resulting from a malevolent act), and with the different categories of facilities concerned by these CSAs. It presents the organisation of the targeted inspections and outlines the transparency of this action and public information. Then, after an overview of the French nuclear power plant fleet, it discusses how earthquakes, flooding, and other extreme natural phenomena related to flooding are taken into account in the design of facilities and in terms of evaluation of safety margins. It describes the consequences of some critical situations (loss of electrical power supplies and cooling systems) and how they could be dealt with. It also addresses the different aspects of a severe accident management (organisation, measures, and actions to be performed) and the conditions related to the use of outside contractors

42 CFR 81.1 - Purpose and Authority.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Purpose and Authority. 81.1 Section 81.1 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH... EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000 Introduction § 81.1 Purpose and Authority...

Safety and environment

International Nuclear Information System (INIS)

Cogne, F.

1975-01-01

The author analyses the papers presented by C. Starr and M. Muntzing at the Paris Conference on the maturity of nuclear energy. The main problems raised in the matter of safety (safety of the plants, plutonium toxicity, the possibilities of theft or sabotage, treatment and storage of the waste) are analyzed and it is pointed out that the hazards arising from the use of nuclear power are contained within reasonable limits. The experts should take the initiative of informing the general public on these matters as the mass media circulate too much inaccurate information in this field. As concerns the environment, it is the choice of sites and the harmonizing of the rules and procedures which appear to be the most important problems for the authorities charged with safety measures [fr

Divergent effects of transformational and passive leadership on employee safety.

Science.gov (United States)

Kelloway, E Kevin; Mullen, Jane; Francis, Lori

2006-01-01

The authors concurrently examined the impact of safety-specific transformational leadership and safety-specific passive leadership on safety outcomes. First, the authors demonstrated via confirmatory factor analysis that safety-specific transformational leadership and safety-specific passive leadership are empirically distinct constructs. Second, using hierarchical regression, the authors illustrated, contrary to a stated corollary of transformational leadership theory (B. M. Bass, 1997), that passive leadership contributes incrementally to the prediction of organizationally relevant outcomes, in this case safety-related variables, beyond transformational leadership alone. Third, further analyses via structural equation modeling showed that both transformational and passive leadership have opposite effects on safety climate and safety consciousness, and these variables, in turn, predict safety events and injuries. Implications for research and application are discussed. Copyright 2006 APA.

EPR safety. Consideration of the internal and external hazards in the safety studies

International Nuclear Information System (INIS)

Gueguin, H.

2008-04-01

The author presents the main points of the Preliminary Safety Report of EDF on the EPR reactor safety. It concerns the considerations of the internal (fire, flood, explosions, pipes failures) and external (earthquakes, airplane falls, explosions, exceptional natural disasters, extreme meteorological conditions) damages. It presents how the safety report takes into account the aggression. (A.L.B.)

Quality and safety of nuclear installations: the role of administration, and, nuclear safety and regulatory procedures

International Nuclear Information System (INIS)

Queniart, D.

1979-12-01

In the first paper the author defines the concepts of safety and quality and describes the means of intervention by the Public Authorities in safety matters of nuclear installations. These include individual authorisations, definition and application of technical rules and surveillance of installations. In the second paper he defines the distinction between radiation protection and safety and presents the legislative and regulatory plan for nuclear safety in France. A central safety service for nuclear installations was created in March 1973 within the Ministry of Industrial and Scientific Development, where, amongst other tasks, it draws up regulatory procedures and organizes inspections of the installations. The main American regulations for light water reactors are outlined and the French regulatory system for different types of reactors discussed

Comparison of beverage consumption in adult populations from three different countries: do the international reference values allow establishing the adequacy of water and beverage intakes?

Science.gov (United States)

Nissensohn, Mariela; Fuentes Lugo, Daniel; Serra-Majem, Lluis

2016-07-13

Recommendations of adequate total water intake (aTWI) have been proposed by the European Food Safety Agency (EFSA) and the Institute of Medicine (IOM)of the United States of America. However, there are differences in the approach used to support them: IOM recommendation is based on average intakes observed in NHANES III (Third National Health and Nutrition Examination Survey) and EFSA recommendation on a combination of observed intakes from 13 different European countries. Despite these recommendations of aTWI, the currently available scientifi c evidence is not sufficient to establish a cut-off value that would prevent disease, reduce the risk for chronic diseases or improve health status. To compare the average daily consumption of fluids (water and other beverages) in selective samples of population from Mexico, US and Spain, evaluating the quantity of fluid intake and understanding the contribution of each fluid type to the total fl uid intake. We also aim to determine if they reached adequate intake (AI) values, as defi ned by three different criteria: IOM, EFSA and water density. Three studies were compared: from Mexico, the National Health and Nutrition Survey conducted in 2012 (NHNS 2012); from US, the NHANES III 2005-2010 and from Spain the ANIBES study leaded in 2013. Different categories of beverages were used to establish the pattern of energy intake for each country. Only adult population was selected. TWI of each study was compared with EFSA and IOM AI recommendations, as well as applying the criterion of water density (mL/kcal). The American study obtained the higher value of total kcal/day from food and beverages (2,437 ± 13). Furthermore, the percentage of daily energy intake coming from beverages was, for American adults, 21%. Mexico was slightly behind with 19% and Spain ANIBES study registered only 12%. ANIBES showed signifi cantly low AI values for the overall population, but even more alarming in the case of males. Only 12% of men, in

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to sugar-free chewing gum sweetened with xylitol and plaque acid neutralisation (ID 485), maintenance of tooth mineralisation (ID 486, 562, 1181), reduction of dental

DEFF Research Database (Denmark)

Tetens, Inge

claims in relation to sugar-free chewing gum sweetened with xylitol and plaque acid neutralisation, maintenance of tooth mineralisation, reduction of dental plaque, and defence against pathogens in the middle ear. The scientific substantiation is based on the information provided by the Member States...... in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food that is the subject of the health claims is sugar-free chewing gum sweetened with xylitol. The Panel considers that sugar-free chewing gum sweetened with xylitol...

Decision no. 2011-DC-0214 of the French nuclear safety authority from May 5, 2011, ordering CIS bio international company to proceed to a complementary safety evaluation of its basic nuclear facility in the eyes of the Fukushima Daiichi nuclear power plant accident

International Nuclear Information System (INIS)