Regulation (EC) No 1107/2009 on Plant Protection Products
Already in Directive 91/414/EEC, it was laid down that active substances contained in plant protection products could only be approved if it they could be used safely regarding human health (operators, bystanders, consumers) and the environment (in particular groundwater and non target organisms, such as bees).
Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market is applicable from 14 June 2011. This Regulation repealed Directive 91/414/EEC, and provides for clear criteria for the approval of active substances including criteria in relation to honey bees in Annex II point 3.8.3: "An active substance, safener or synergist shall be approved only if it is established following an appropriate risk assessment on the basis of Community or internationally agreed test guidelines, that the use under the proposed conditions of use of plant protection products containing this active substance, safener or synergist:
- will result in a negligible exposure of honeybees, or
- has no unacceptable acute or chronic effects on colony survival and development, taking into account effects on honeybee larvae and honeybee behaviour.
The dossiers for active substances and plant protection products referred to in Article 8(1) of Regulation (EC) 1107/2009 have to comply with the minimum data requirements set under Commission Regulation (EU) 544/2011 and Commission Regulation (EU) 545/2011. Those requirements also include extensive testing on ecotoxicology, including bees.
New data requirements which are at the moment in the final stage of adoption will be applicable as from January 2014 and should be applied to all new dossiers and renewals of old ones to be submitted as from 2014 onwards.
Insecticides are, by their nature, toxic to bees. However, their use should still be possible if exposure does not occur or is minimised to levels which do not generate harmful effects. Nevertheless, in 2008 and 2009 several Member States reported accidental releases of clothianidin, thiamethoxam, fipronil and imidacloprid, resulting in substantial losses of honey bee colonies. The Commission therefore took measures by reinforcing in Commission Directive 2010/21/EU the conditions for the placing on the market and use of those active substances. Furthermore, this Directive requires Member States to initiate specific monitoring programmes to verify the real exposure of honeybees to those active substances.
Risk Assessment of Plant Protection Products on bees
In March 2011, the Commission asked European Food Safety Authority (EFSA) to revise the Risk Assessment scheme of Plant Protection Products on bees. The Commission asked EFSA to follow a two steps approach:
- to deliver an opinion on the science behind the development of a risk assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp and solitary bees). The EFSA opinion was published on 18 April 2012 ;
- to develop a guidance document on the risk assessment of plant protection products on bees. The Guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees was published 4 July 2013.
Ongoing review of active substances
In March 2012, following new scientific findings in the open literature as regards the sublethal effects of some insecticides belonging the chemical class of neonicotinoids, the Commission asked EFSA to assess the new studies. EFSA published a statement on 30 May 2012.
In April 2012, according the provisions laid down in Article 21 of Regulation 1107/2009, the Commission requested EFSA to review the risk assessment of neonicotinoids as regards their impact on bee health. Efsa conclusions on imidacloprid, clothianidin and thiametoxam have been published on 16 January 2013.
A restriction of use of 3 pesticides (nenicotinoids (NNI) - clothianidin, imidacloprid and thiametoxam) has been adopted by the Commission (Regulation (EU) No 485/2013 ). The move followed votes on 15 March 2013 to Member States' experts meeting at a Standing Committee on the Food Chain and Animal Health and on 29 April 2013 at an Appeal Committee where EU Member States did not reach a qualified majority – either in favour or against the Commission's proposal.
In August 2012, following the EFSA statement on the assessment of the scientific information from the Italian project "APENET ", the Commission, according the provisions laid down in Article 21 of Regulation 1107/2009, requested EFSA to review the risk assessment of fipronil as regards its impact on bee health. The EFSA conclusions were published on 27 May 2013.
The Commission Regulation (EU) No 781/2013 was adopted on 14 August 2013. This regulation limits the use of fipronil to treatment of seeds intended to be sown in greenhouses and seeds of some vegetables intended to be sown in fields and harvested before flowering.