Conclusion on the peer review of the pesticide risk assessment for bees for the active substance thiamethoxam considering all uses other than seed treatments and granules

Tabs

Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(8):4212 [70 pp.].
doi
10.2903/j.efsa.2015.4212
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2013-00638
Approved
31 July 2015
Published
26 August 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (831.09 KB) Download Appendix A (3.16 MB) Download Appendix B (180.94 KB)
Abstract

The European Food Safety Authority (EFSA) was asked by the European Commission to perform a risk assessment of neonicotinoids, including thiamethoxam, as regards the risk to bees, as a follow up of previous mandates received from the European Commission on neonicotinoids. In this context the conclusions of EFSA concerning the risk assessment for bees for the active substance thiamethoxam are reported. The context of the evaluation was that required by the European Commission in accordance with Article 21 of Regulation (EC) No 1107/2009 to review the approval of active substances in light of new scientific and technical knowledge and monitoring data. The conclusions were reached on the basis of the evaluation of all authorised uses of thiamethoxam other than seed treatments and granules in Europe (including the foliar spray uses as referred to in recital 7 of Commission Implementing Regulation (EU) No 485/2013). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the submitted studies and literature data as well as any other relevant data available at national level and made available to EFSA, are presented. Missing information identified as being required to allow for a complete risk assessment is listed. Concerns are identified.

Summary

Thiamethoxam was included in Annex I to Directive 91/414/EEC on 1 February 2007 by Commission Directive 2007/6/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. A specific conclusion was issued by EFSA on 19 December 2012 on the risk assessment for bees as regards the authorised uses applied as seed treatments and granules (EFSA Journal 2013;11(1):3067). In addition, EFSA finalised a specific conclusion following the submission of post-approval data concerning the risk assessment for honeybees (EFSA Journal 2012;10(3):2601).

The specific provisions of the approval were amended by Commission Implementing Regulation (EU) No 485/2013, to restrict the uses of clothianidin, thiamethoxam and imidacloprid, to provide for specific risk mitigation measures for the protection of bees and to limit the use of the plant protection products containing these active substances to professional users. In particular, the uses as seed treatment and soil treatment of plant protection products containing clothianidin, thiamethoxam or imidacloprid have been prohibited for crops attractive to bees and for cereals except for uses in greenhouses and for winter cereals. Foliar treatments with plant protection products containing these active substances have been prohibited for crops attractive to bees and for cereals with the exception of uses in greenhouses and uses after flowering.

With reference to Article 31 of Regulation (EC) No 178/2002 and in accordance with Article 21 of Regulation (EC) No 1107/2009 to review the approval of active substances in light of new scientific and technical knowledge and monitoring data, in June 2013 the European Commission requested EFSA to provide conclusions concerning an updated risk assessment for bees for the three neonicotinoids (namely clothianidin, imidacloprid and thiamethoxam), taking into account all uses other than seed treatments and granules, including foliar spray uses as mentioned in recital 7 of Commission Implementing Regulation (EU) No 485/2013 (i.e. including the uses that may have been withdrawn due to the restrictions of Regulation (EU) No 485/2013). This mandate is a follow up of previous mandates received from the European Commission on neonicotinoids to perform an evaluation with regard to the acute and chronic effects on colony survival and development, taking into account effects on bee larvae and bee behaviour, and the effects of sublethal doses on bee survival and behaviour.

The conclusions laid down in this report were reached on the basis of the evaluation of the existing data submitted for the approval of the active substance at EU level and for the authorisation of plant protection products containing thiamethoxam at Member State level, taking into account the uses other than seed treatments and granules. In addition, any other relevant data available at national level and made available to EFSA were taken into account and, where relevant, the results of a systematic literature review awarded by EFSA and conducted by the Food and Environmental Research Agency (FERA) on clothianidin, thiamethoxam and imidacloprid and the risk to bees (EFSA supporting publication 2015:EN-756). The EFSA guidance document on the risk assessment of plant protection products on bees (EFSA Journal 2013;11(7):3295) was used for the current evaluation.

For all the authorised uses, high risks were identified or could not be excluded, or the risk assessment could not be finalised. It is noted, however, that for the authorised uses in permanent greenhouse structures, a low risk to honeybees, bumble bees and solitary bees was concluded for all exposure routes, except the risk assessment for honeybees from residues in surface water which could not be finalised.

Keywords
thiamethoxam, peer review, risk assessment, pesticide, insecticide
Print on demand
Number of Pages
70