Imidacloprid was included in Annex I to Directive 91/414/EEC on 1 August 2009 by Commission Directive 2008/116/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. The peer review leading to the approval of this active substance was finalised on 29 May 2008 as set out in the EFSA Scientific Report (2008) 148. 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 or granules (EFSA Journal 2013;11(1):3068).
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in recital 7 of Commission Implementing Regulation (EU) No 485/2013 (i.e. including the uses that may have been withdrawn due to restrictions of Regulation (EU) No 485/2013).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 imidacloprid 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 high risks could not be excluded or the risk assessment could not be finalised. 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. The risk assessment for honeybees from residues in surface water could not be finalised with the available information. However, it is noted that pertinent risk assessments were available for two open field spray uses (the EU representative uses in tomato and apple) that indicated a low risk to honeybees.