Independent Scientific Advice: Comparing Policies on Conflicts of Interest in the EU and the US

Independent Scientific Advice: Comparing Policies on Conflicts of Interest in the EU and the US

Advancing food safety: strategic recommendations from the 'ONE - Health, Environment & Society - Conference 2022'.

EFSA's assistance for the 2015 Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF) in relation to rBST

Modification of the current MRLs for acetamiprid in flowering brassica and figs.

Modification of the existing MRLs for dimethomorph in various commodities.

The European Commission's Scientific Committee on Health, Environmental and Emerging Risks and the World Health Organization recently published reports which concluded that a large proportion of melanoma and non-melanoma skin cancer is attributable to sunbed use, and that there is no need to use sunbeds as there are no health benefits and they are not needed to achieve an optimal vitamin D level. The overall conclusion from both bodies was that there is no safe limit for UV irradiance from sunbeds. We are, however, deeply concerned that these assessments appear to be based on an incomplete, unbalanced and non-critical evaluation of the literature. Therefore, we rebut these conclusions by addressing the incomplete analysis of the adverse health effects of UV and sunbed exposure (what is 'safe'?) and the censored representation of beneficial effects, not only but especially from vitamin D production. The stance taken by both agencies is not sufficiently supported by the data and in particular, current scientific knowledge does not support the conclusion sunbed use increases melanoma risk.

Identification of emerging risks: an appraisal of the procedure trialled by EFSA and the way forward

Offline: Difficult truths about a post-truth world

In 2012, the European Food Safety Authority (EFSA) suggested a tolerable upper intake level (UL) for vitamin D at 100 µg/day for adults based on the risk of hypercalcaemia. EFSA concluded that consumption of up to 50 µg/day does not lead to hypercalcaemia in children and adolescents (10-17 years). Furthermore, EFSA stated that there is no reason to assume that children and adolescents in the phase of rapid bone formation and growth have a lower tolerance for vitamin D compared to adults, and a UL of 100 µg/day for adolescents aged 11-17 years and 50 µg/day in children 1-10 years, taking the smaller body size into account, was proposed.
 The Norwegian Food Safety Authority (NFSA) is currently revising the national regulation of maximum limits in food supplements (not yet harmonised in the European Economic Area (EEA)), including maximum limits for vitamin D. NFSA has therefore requested the Norwegian Scientific Committee for Food Safety (VKM) to evaluate the assumption in the EFSA opinion that children and adolescents can tolerate the same amount of vitamin D as adults due to rapid bone formation and growth. In children and adolescents with lower weight than adults, this assumption actually implies that adolescents can tolerate more vitamin D per kg body weight than adults. VKM is therefore requested to evaluate if there is scientific evidence that a UL at 50 µg/day for children (1-10 years) and 100 µg/day for adolescents (11-17 years) is safe.
 The present statement is prepared by members of the Panel on Nutrition, Dietetic Products and Novel Food and Allergy in VKM.
 Three literature searches were performed to find new relevant studies investigating high intakes of vitamin D in children and adolescents and the role of vitamin D in bone formation and growth.
 No studies supporting a higher tolerance to vitamin D in children and adolescents due to rapid bone formation and growth were retrieved in the literature search. Moreover, there is apparently no firm association between bone formation and vitamin D levels in children during their growth period into adolescence and adulthood. 
 No studies investigating high intakes of vitamin D in children 1-10 years were found. Furthermore, no studies that have examined safety issues and/or adverse effects of vitamin D supplementation in doses above 50 µg/day in adolescents were identified. It can therefore not be concluded that the UL at 50 µg/day in children (1-10 years) and 100 µg/day in adolescents (11-17 years) is safe.
 In the 2002 report from European Scientific Committee on Food (SCF), a UL was set at 25 µg/day for children aged 2-10 years, and 50 µg/day for adolescents aged 11-17 years (corresponding to the UL for adults at that time). To the best of knowledge no serious, harmful effects have been reported for these doses of vitamin D.

EFSA Supporting PublicationsVolume 13, Issue 1 988E Technical reportOpen Access Report on the public consultation on the EFSA draft Scientific Opinion on Recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 28 January 2016 https://doi.org/10.2903/sp.efsa.2016.EN-988 Published date: 28 January 2016 Question number: EFSA-Q-2015-00293 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat References Cramer GM, Ford RA, Hall RL, 1978. Estimation of toxic hazard - a decision tree approach. Food and Cosmetic Toxicology 16: 255– 276. EC (European Commission), 2001. Guidance of the Scientific Committee on Food (SCF) for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation. SCF/CS/PLEN/GEN/100 Final. 19 December 2001. EFSA (European Food Safety Authority), 2015. Public consultation on draft scientific opinion on "recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials" (closed on 7 October 2015). Available online. EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2016. Scientific opinion on recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials. EFSA Journal 2016; 14(1):4357, 28 pp. doi:10.2903/j.efsa.2016.4357. EFSA Scientific Committee, 2012a. Scientific Opinion on exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC). EFSA Journal 2012; 10(7):2750, 103 pp. EFSA Scientific Committee, 2012b. Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data. EFSA Journal 2012; 10(3):2579. [ 32 pp.] doi:10.2903/j.efsa.2012.2579. Available online. International Life Sciences Institute (ILSI), 2015. Guidance on best practices on the risk assessment of non-intentional added substances (NIAS) in food contact materials and articles. ILSI Europe Report Series 2015, ISBN: 9789078637424. DOI: D/2015/10.996/39. Koster S, Rennen M, Leeman W, Houben G, Muilwijk B, van Acker F and Krul L (2014). A novel safety assessment strategy for non-intentionally added substances (NIAS) in carton food contact materials. Food Addit. Contam. 2014, Part A 31(3), 422– 443. Munro IC, Ford RA, Kennepohl E, Sprenger JG, 1996. Correlation of structural class with no observed effect levels: a proposal for establishing a threshold of concern. Food and Chemical Toxicology, 34, 829– 867. Rennen M, Koster S, Krul C, Houben G. Application of the threshold of toxicological concern (TTC) concept to the safety assessment of chemically complex food matrices. Food and Chemical Toxicology 2011, 49: 933– 940. Volume13, Issue1January 2016988E ReferencesRelatedInformation

EFSA Supporting PublicationsVolume 13, Issue 7 1054E Technical reportOpen Access Outcome of the consultation with Member States and EFSA on the basic substance application for Origanum vulgare L. essential oil for use in plant protection as a fungicide, bactericide and insecticide European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 08 July 2016 https://doi.org/10.2903/sp.efsa.2016.EN-1054Citations: 1 Published date: 08 July 2016 Question number: EFSA-Q-2016-00234 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Documentation provided to EFSA ITAB, 2015. Basic substance application on Origanum vulgare L. essential oil submitted in the context of Article 23 of Regulation (EC) No 1107/2009. October 2015. Documentation made available to EFSA by the European Commission. ITAB, 2016. Basic substance application update on Origanum vulgare L. essential oil submitted in the context of Article 23 of Regulation (EC) No 1107/2009. May 2016. Documentation made available to EFSA by the applicant. References EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2016a. Diarr-Stop S Plus® for pigs for fattening. EFSA Journal 2016; 14(5):4472, 15 pp. doi:10.2903/j.efsa.2016.4472 EFSA (European Food Safety Authority), 2016b. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for Satureja montana L. for use in plant protection as fungicide and bactericide on various crops. EFSA supporting publication 2016:EN-1051, 65 pp. EFSA (European Food Safety Authority), 2012a. Compendium of botanicals reported to contain naturally occurring substances of possible concern for human health when used in food and food supplements. EFSA Journal 2012; 10(5):2663, 60 pp. doi:10.2903/j.efsa.2012.2663. EFSA (European Food Safety Authority), 2012b. Conclusion on the peer review of the pesticide risk assessment of the active substance thymol. EFSA Journal 2012; 10(11):2916, 43 pp. doi:10.2903/j.efsa.2012.2916 EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2012c. Scientific Opinion on the safety and efficacy of phenol derivatives containing ring-alkyl, ring-alkoxy and side-chains with an oxygenated functional group (chemical group 25) when used as flavourings for all species. EFSA Journal 2012; 10(2):2573, 19 pp. doi:10.2903/j.efsa.2012.2573 EFSA ANS (Food Additives and Nutrient Sources added to Food), 2010. Scientific Opinion on the use of oregano and lemon balm extracts as a food additive. EFSA Journal 2010; 8(2):1514, 19 pp. doi:10.2903/j.efsa.2010.1514 European Commission, 2014. Guidance Document on botanical active substances used in plant protection products. SANCO/11470/2012-rev. 8, 20 March 2014 IARC (International Agency for Research on Cancer), 2004. Methyleugenol. IARC Monographs on some Chemicals Present in Industrial and Consumer Products, Food and Drinking-water, vol. 10. Lyon, France ISO (International Organization for Standardization), under development. No 1371: Essential oil of oregano [Origanum vulgare L. subs. Hirtum (Link) Ietsw] United Kingdom, 2011. Draft Assessment Report (DAR) on the active substance thymol prepared by the rapporteur Member State the United Kingdom in the framework of Directive 91/414/EEC, June 2011. WHO (World Health Organization), 2010. Monographs on medicinal plants commonly used in the Newly Independent States (NIS), Geneva, Switzerland, 450 pp. Citing Literature Volume13, Issue7July 20161054E ReferencesRelatedInformation

EFSA Supporting PublicationsVolume 14, Issue 9 1298E Technical reportOpen Access Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for pyridalyl in light of confirmatory data European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 28 September 2017 https://doi.org/10.2903/sp.efsa.2017.EN-1298 Requestor: European Commission Question number: EFSA-Q-2017-00624 AboutReferencesRelatedInformationPDFPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessClose modalShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL References EFSA (European Food Safety Authority), 2013. Conclusion on the peer review of the pesticide risk assessment of the active substance pyridalyl. EFSA Journal 2013; 11(8):3240, 87pp. oi:10.2903/j.efsa.2013.3240. EFSA (European Food Safety Authority), 2015. Technical report on the outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for pyridalyl in light of confirmatory data. EFSA Supporting Publication 2015; 12(8):EN-865, 11 pp. doi:10.2903/sp.efsa.2015.EN-865 European Commission, 2003. Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under council directive 91/414/EEC. Sanco/221/2000 –rev.10- final. 25 February 2003 European Commission, 2013. Guidance document on the procedures for submission and assessment of confirmatory information following approval of an active substance in accordance with Regulation (EC) No 1107/2009. SANCO 5634/2009-rev. 6.1 Volume14, Issue9September 20171298E ReferencesRelatedInformation RecommendedOutcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for oxathiapiprolin in light of confirmatory dataEuropean Food Safety Authority (EFSA), EFSA Supporting PublicationsOutcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for isopyrazam in light of confirmatory dataEuropean Food Safety Authority (EFSA), EFSA Supporting PublicationsOutcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for iodosulfuron and prosulfuron in light of confirmatory dataEuropean Food Safety Authority (EFSA), EFSA Supporting PublicationsConclusion on the peer review of the pesticide risk assessment of the active substance pyridalylEuropean Food Safety Authority, EFSA JournalPeer review of the pesticide risk assessment of the active substance rape seed oilEuropean Food Safety Authority (EFSA), Fernando Alvarez, Maria Arena, Domenica Auteri, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Mark Egsmose, Gabriella Fait, Franco Ferilli, Varvara Gouliarmou, Laia Herrero Nogareda, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Alberto Linguadoca, Christopher Lythgo, Oriol Magrans, Iris Mangas, Ileana Miron, Tunde Molnar, Laura Padovani, Juan Manuel Parra Morte, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Laura Villamar-Bouza, EFSA Journal

Establishing a NexGen, mechanism-based environmental risk assessment paradigm shift: Are we ready yet?

BackgroundIn the European Union (EU), genetically modified (GM) crops are permitted for cultivation only after a thorough risk assessment and a decision by the European Commission (EC). The central scientific body assessing food-related risks is the European Food Safety Authority (EFSA). It aims to provide high-quality scientific advice for EU decision-makers. However, both the way EFSA performs risk assessment and the independence of its panel members have been subjected to consistent criticism. In this paper, I examine part of the environmental risk assessment in the Scientific Opinion issued by the EFSA GMO Panel, specifically, the impacts of GM maize MON810 on honeybees and earthworms. The evaluated EFSA document forms the scientific basis of the pending EC Draft implementing decision to renew the authorisation for the lawful cultivation of MON810. I assess the reliability of scientific information cited in the Opinion, the use of this information by EFSA, and the safety conclusions drawn in a form of an extended peer review.ResultsMy research indicates that the scientific studies cited in the EFSA Opinion in the sections concerning the possible impacts of GM maize on honeybees and earthworms stem predominantly from reliable sources in terms of authorship, financial support, and status of the study. However, the reliability of the studies varies significantly concerning the ecological relevance of the experiments. Moreover, the body of referenced evidence is insufficient to draw conclusions on risk. Relevantly, several types of shortcomings in the use of scientific information in the risk assessment were identified as prevalent, namely: EFSA omits relevant available studies, selectively cites information, misquotes studies, fails to acknowledge uncertainties, fails to call for further research where needed, and fails to critically interpret studies and their findings.ConclusionsOverall, the findings indicate that the reliability of scientific information and particularly its use by the EFSA GMO Panel produces low-quality scientific advice, which is inconsistent with the Authority Mission Statement. My research would support the call by the European Parliament and NGOs on the EC to withdraw its Draft implementing decision intended to renew the authorisation of MON810 cultivation.

EMBO Reports (2019) e48036 The cultivation of genetically modified (GM) crops in the EU remains a highly polemic issue. The only GM crop event that is currently authorised is the insect‐resistant maize “MON810”. The GM potato variety “Amflora” with improved tuber starch composition was approved for cultivation in 2010, but later withdrawn. One of the main reasons that not more GM crops are authorised for cultivation is a regulatory gridlock with a recurring inability to reach a qualified majority in the designated committee for either approval or rejection [1]. Several EU member states experience domestic pressure against adoption of GM crops [2], [3], [4]. The European Commission (EC) therefore developed legislation—the Directive EU 2015/412, adopted by the European Parliament (EP) in 2015—to give member states the possibility to restrict or prohibit cultivation of authorised GM crops in their territory (opt‐out mechanism). The request to exclude a particular GM event from cultivation may be communicated to the EC after risk assessment, or after authorisation provided that the restriction is in conformity with the EU law, reasoned, proportional, non‐discriminatory and based on compelling grounds (Article 26b(3) of Directive 2015/412). To date, 17 member states and two autonomous regions have used this possibility. In parallel, the EC also proposed an analogous mechanism for the import of GM food and …