Fipronil was included in Annex I to Directive 91/414/EEC on 1 October 2007 by Commission Directive 2007/52/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 specific provisions of the approval were amended by Commission Directive 2010/21/EU, to permit only use as a seed treatment and only where the seed coating is performed in professional seed treatment facilities, which must apply the best available techniques to ensure that the release of dust during application to the seed, storage and transport can be minimised, and where adequate drilling equipment is used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission.
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 August 2012 the European Commission requested the EFSA to perform an evaluation of the active substance fipronil and deliver its conclusions on the risk assessment for bees, in particular 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 fipronil at Member State level, taking into account the available EFSA Conclusion (EFSA Scientific Report (2006) 65, 1-110), and the EFSA Scientific Opinion on the science behind the development of a risk assessment of plant protection products on bees (EFSA Journal 2012;10(5):2668). In addition, the recent EFSA statement ‘Assessment of the scientific information from the Italian project “APENET” investigating effects on honeybees of coated maize seeds with some neonicotinoids and fipronil’ (EFSA Journal 2012;10(6):2792), and related scientific publications, as well as any further data from studies, research and monitoring activities considered relevant were also taken into account in the current evaluation.
Several data gaps were identified with regard to the risk to honey bees from exposure via dust, from consumption of contaminated nectar and pollen, and from exposure via guttation fluid for the authorised uses of fipronil as a seed treatment. Furthermore, the risk assessment following exposure to residues in insect honeydew, the risk assessment from plant and soil metabolites (except soil photolysis metabolites), the risk assessment from exposure to residues in succeeding crops or weeds and the risk assessment for pollinators other than honey bees could not be finalised on the basis of the available information. A high risk was indicated or could not be excluded in relation to certain aspects of the risk assessment for honey bees for some of the authorised uses. For some exposure routes it was possible to identify a low risk for some of the authorised uses.