Holistic environmental risk assessment for bees.

Outcome of a public consultation on the draft Guidance to develop specific protection goals options for environmental risk assessment at EFSA, in relation to biodiversity and ecosystem services

Outcome of the First Round of Public Consultation on the draft Guidance Document on the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp. and Solitary Bees)

EFSA Supporting PublicationsVolume 11, Issue 4 583E Event reportOpen Access EFSA's 19th Scientific Colloquium on Biodiversity as protection goal in environmental risk assessment for EU agro-ecosystems 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: 14 April 2014 https://doi.org/10.2903/sp.efsa.2014.EN-583 Published date: 14 April 2014 Question number: EFSA-Q-2013-00912 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 VII. References AMIGA http://www.amigaproject.eu/project/objectives/. EFSA, 2010. Report on the PPR stakeholder workshop Protection goals for environmental risk assessment of pesticide: What and where to protect? EFSA Journal 2010; 8(7):1672, 46 pp. doi:10.2903/j.efsa.2010.1672. EFSA, 2011; Review of current practices of environmental risk assessment within EFSA. Supporting Publication: 2011:116. 39 p. EFSA GMO Panel (EFSA Panel on Genetically Modifed Organisms), 2010. Guidance on the environmental risk assessment of genetically modifed plants. EFSA Journal 2010; 8(11):1879. 111 pp. doi:10.2903/j.efsa.2010.1879. EFSA GMO Panel (EFSA Panel on Genetically Modifed Organisms), 2013. Guidance on the environmental risk assessment of genetically modifed animals. EFSA Journal 2013; 11(5):3200, 190 pp. doi:10.2903/j.efsa.2013.3200. EFSA PLH Panel (EFSA Panel on Plant Health), 2010. Guidance on a harmonised framework for pest risk assessment and the identifcation and evaluation of pest risk management options by EFSA. EFSA Journal 2010; 8(2):1495, 66 pp. doi:10.2093/j.efsa.2010.1495. EFSA PLH Panel (EFSA Panel on Plant Health), 2011. Guidance on the environmental risk assessment of plant pests. EFSA Journal 2011; 9(12):2460, 121 pp. doi:10.2093/j. efsa.2011.2460. EFSA PPR Panel (EFSA Panel on Plant Protection Products and their Residues), 2009. Guidance Document on Risk Assessment for Birds & Mammals on request from EFSA. EFSA Journal 2009; 7(12): 1438. doi:10.2903/j.efsa.2009.1438. EFSA PPR Panel (EFSA Panel on Plant Protection Products and their Residues), 2010. Scientifc Opinion on the development of specifc protection goal options for environmental risk assessment of pesticides, in particular in relation to the revision of the Guidance Documents on Aquatic and Terrestrial Ecotoxicology (SANCO/3268/2001 and SANCO/10329/2002). EFSA Journal 2010; 8(10):1821. 55 pp. doi:10.2903/j.efsa.2010.1821. EFSA PPR Panel (EFSA Panel on Plant Protection Products and their Residues), 2013. Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-feld surface waters. EFSA Journal 2013; 11(7):3290, 268 pp. doi:10.2903/j. efsa.2013.3290. Hommen U, Baveco JMH, Galic N and van den Brink PJ, 2010. Potential application of ecological models in the European environmental risk assessment of chemicals. I. Review of protection goals in EU directives and regulations. Integrated Environmental Assessment and Management, 6, 325– 337. Nienstedt KM, Brock TCM, van Wensem J, Montforts M, Hart A, Aagaard A, Alix A, Boesten J, Bopp SK, Brown C, Capri E, Forbes V, Koepp H, Liess M, Luttik R, Maltby L, Sousa J P, Streissl F and Hardy AR, 2012. Development of a framework based on an ecosystem services approach for deriving specifc protection goals for environmental risk assessment of pesticides. Sci Total Environ, 415, 31– 38. Rabinowitz D, 1981. Seven forms of rarity. Pages 205– 217 in H. Synge, editor. The biological aspects of rare plant conservation. Wiley, New York. Topping CJ, Kjær LJ, Hommen U, Høye TT, Preuss TG, Sibly RM and van Vliet P. 2014 in press. Recovery based on plot experiments is a poor predictor of landscape-level population impacts of agricultural pesticides. Environmental Toxicology and Chemistry. Accepted manuscript online: 5 Sep 2013, DOI: 10.1002/etc.2388. Volume11, Issue4April 2014583E This article also appears in:Scientific colloquia ReferencesRelatedInformation

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EFSA Supporting PublicationsVolume 14, Issue 4 1208E Technical reportOpen Access Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2016 European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this authorIrina Olaru, Irina OlaruSearch for more papers by this authorElisabeth Waigmann, Elisabeth WaigmannSearch for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this authorIrina Olaru, Irina OlaruSearch for more papers by this authorElisabeth Waigmann, Elisabeth WaigmannSearch for more papers by this author First published: 28 April 2017 https://doi.org/10.2903/sp.efsa.2017.EN-1208 Requestor: EFSA Question number: EFSA-Q-2017-00264 This guidance document is applicable for applications submitted until 26 March 2021. 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 EFSA (European Food Safety Authority), 2015. Clarifications on EFSA GMO Panel recommendations on the Insect Resistance Management plan for genetically modified maize MON 810. EFSA Supporting Publication 2015; 12(7):EN-842, 14 pp. doi:10.2903/sp.efsa.2015.EN-842 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2011. Guidance for risk assessment of food and feed from genetically modified plants. EFSA Journal 2011a; 9(5):2150, 37 pp. doi:10.2903/j.efsa.2011.2150 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2012. Scientific Opinion supplementing the conclusions of the environmental risk assessment and risk management recommendations for the cultivation of the genetically modified insect resistant maize Bt11 and MON 810. EFSA Journal 2012; 10(12):3016, 32 pp. doi:10.2903/j.efsa.2012.3016 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2015. Scientific Opinion updating risk management recommendations to limit exposure of non-target Lepidoptera of conservation concern in protected habitats to Bt-maize pollen. EFSA Journal 2015; 13(7):4127, 31 pp. doi:10.2903/j.efsa.2015.4127 EFSA Scientific Committee, 2016a. Scientific opinion on coverage of endangered species in environmental risk assessments at EFSA. EFSA Journal 2016; 14(2):4312, 124 pp. doi: 10.2903/j.efsa.2016.4312 EFSA Scientific Committee, 2016b. Scientific opinion on recovery in environmental risk assessments at EFSA. EFSA Journal 2016; 14(2):4313. 85 pp. doi: 10.2903/j.efsa.2016.4313 EFSA Scientific Committee, 2016c. Guidance to develop specific protection goals options for environmental risk assessment at EFSA, in relation to biodiversity and ecosystem services. EFSA Journal 2016; 14(6):4499, 50 pp. doi:10.2903/j.efsa.2016.4499 Hofmann F, Otto M and Wosniok W, 2014. Maize pollen deposition in relation to the distance from the nearest pollen source under common cultivation – Results of 10 years of monitoring (2001–2010). Environmental Sciences Europe, 26, 24, doi:10.1186/s12302-014-0024-3 Hofmann F, Kruse‑Plass M, Kuhn U, Otto M, Schlechtriemen U, derSchrö B, Vögel R and Wosniok W, 2016. Accumulation and variability of maize pollen deposition on leaves of European Lepidoptera host plants and relation to release rates and deposition determined by standardised technical sampling. Environmental Sciences Europe, 28, 14, doi:10.1186/s12302-016-0082-9 Lang A, Oehen B, Ross J-H, Bieri K and Steinbrich A, 2015. Potential exposure of butterflies in protected habitats by Bt maize cultivation: A case study in Switzerland. Biological Conservation, 192, 369– 377 Volume14, Issue4April 20171208E ReferencesRelatedInformation

Assessment of new scientific elements supporting the prolongation of prohibition of the placing on the market of genetically modified oilseed rape GT73 for food and feed purposes in Austria

The European Food Safety Authority (EFSA) carried out an online public consultation to receive input from interested parties/persons on the draftscientific opinion on the adequacy and sufficiencyevaluation of existing guidelines for the molecular characterisation (MC), environmental risk assessment (ERA) and post-market environmental monitoring (PMEM) of genetically modified insects containing engineered gene drives. This draft scientific opinion was endorsed by the EFSA Panel on Genetically Modified Organisms (GMOs) for public consultation on 29 January 2020, and prepared by EFSA'sGene Drive expert Working Group and scientific officers. The public consultation was open from 17 February 2020 until 24 April 2020. EFSA received comments from 36 different interested parties/persons. Overall, comments raised reveal different, often contrasting, opinions and perspectives toward the deliberate release into the environment of gene drive modified insects for insect disease vector/pest control, and on the adequacy and sufficiency of current risk assessment frameworks for the MC, ERA and PMEM of such insects.The public consultation comments were analysed and taken into consideration by the GMO Panel, the Gene Drive expert Working Group and EFSA's scientific officers during the revision and finalisation of the scientific opinion.EFSA,the Gene Drive expert Working Group and the GMO Panel wish to sincerely thank all contributors to the public consultation for their invaluableinput. This technical report contains the comments received and clarifies how they have been considered for the revision and finalisation of the scientific opinion. The final scientific opinion was adopted by the GMO Panel on 14 October 2020, and published in the EFSA Journal.

Outcome of the pesticides peer review meeting on general recurring issues in ecotoxicology

The European Food Safety Authority (EFSA) carried out a public consultation to receive input from interested parties on the draft scientific opinion on a systems-based approach to the environmental risk assessment of multiple stressors in honey bees. This draft scientific opinion was prepared by the EFSA Scientific Committee, supported by a Working Group on the development of a holistic and integrated approach to the environmental risk assessment of multiple stressors in bees. The draft opinion was endorsed by the EFSA Scientific Committee for public consultation on 11 November 2020. The written public consultation was open from 07 January 2021 until 04 March 2021. EFSA received comments from 17 different interested parties. EFSA and its Scientific Committee wish to thank all stakeholders for their contributions to this work. The present report contains the comments received and details how they have been considered for the finalisation of the opinion. The final opinion was adopted at the Scientific Committee Plenary meeting on 14 April 2021 and will be published in the EFSA Journal.

Assessment of new scientific elements supporting the prolongation of prohibition of the placing on the market of genetically modified oilseed rape Ms8, Rf3 and Ms8×Rf3 for food and feed purposes in Austria

Outcome of a public consultation on the draft guidance of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms

EFSA Supporting PublicationsVolume 13, Issue 6 1038E Technical reportOpen Access Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for imidacloprid 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: 10 June 2016 https://doi.org/10.2903/sp.efsa.2016.EN-1038Citations: 2 Published date: 10 June 2016 Question number: EFSA-Q-2016-00347 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 References EFSA (European Food Safety Authority), 2008. Conclusion regarding the peer review of the pesticide risk assessment of the active substance imidacloprid. EFSA Journal 2008; 6(5):148, 120 pp. doi:10.2903/j.efsa.2008.148r EFSA (European Food Safety Authority), 2013a. Conclusion on the peer review of the pesticide risk assessment for bees for the active substance imidacloprid. EFSA Journal 2013; 11(1):3068, 55 pp. doi:10.2903/j.efsa.2013.3068 EFSA (European Food Safety Authority), 2013b. EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees). EFSA Journal 2013; 11(7):3295, 268 pp. doi:10.2903/j.efsa.2013.3295 EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk assessment for bees for the active substance imidacloprid considering all uses other than seed treatments and granules. EFSA Journal 2015; 13(8):4211, 82 pp. doi:10.2903/j.efsa.2015.4211 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 Germany, 2005. Draft assessment report on the active substance imidacloprid prepared by the rapporteur Member State Germany in the framework of Directive 91/414/EEC, December 2005. Kamler and Jaš, 2003. Nectar production of selected winter rape cultivars. Journal of Apicultural Science 47/2 Maynard et al., 2014. Weeds in the treated field - a realistic scenario for pollinator risk assessment? Julius-Kühn-Archiv, 450, 2015, p. 56ff, Hazards of pesticides to bees-12th International Symposium of the ICP-PR Bee Protection Group, Ghent (Belgium), September 15–17, 2014 Mesquida et al., 1988. A study of rape seed (Brassica napus L. var. Oleifera Metzger) flower nectar secretions. Apidology 19/3. Citing Literature Volume13, Issue6June 20161038E ReferencesRelatedInformation

Bees provide essential ecosystem services and help maintain floral biodiversity. However, there is an ongoing decline of wild and domesticated bee species. Since agricultural pesticide use is a key driver of this process, there is a need for a protective risk assessment. To achieve a more protective registration process, two bee species, Osmia bicornis/Osmia cornuta and Bombus terrestris, were proposed by the European Food Safety Authority as additional test surrogates to the honey bee Apis mellifera. We investigated the acute toxicity (median lethal dose, LD50) of multiple commercial insecticide formulations towards the red mason bee (O. bicornis) and compared these values to honey bee regulatory endpoints. In two thirds of all cases, O. bicornis was less sensitive than the honey bee. By applying an assessment factor of 10 on the honey bee endpoint, a protective level was achieved for 87% (13 out 15) of all evaluated products. Our results show that O. bicornis is rarely an adequate additional surrogate species for lower tier risk assessment since it is less sensitive than the honey bee for the majority of investigated products. Given the currently limited database on bee species sensitivity, the honey bee seems sufficiently protective in acute scenarios as long as a reasonable assessment factor is applied. However, additional surrogate species can still be relevant for ecologically meaningful higher tier studies.

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

Outcome of a public consultation of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the draft general scientific guidance for stakeholders on health claim applications