Information update; European Union regulation 781 of 2013

The active substance fipronil was included in Annex I to council Directive 91/414/EEC of 15 July 1991 and with respect to the placing of plant protection products on the market by European Commission(EC) Directive 2007/52/EC requiring further risk assessment be done. Since fipronil was included in Annex I to Directive 91/414/EEC are deemed to be approved under regulation (EU) No 540/2011 of May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances.

Based on new information received from Italy concerning risks to honeybees caused by coated maize seeds treated with plants protection products containing fiprolin, the EC decide to review the approval of that active substance. The EC, in accordance with article 21(2) of Regulation (EC) No. 1107/2009, asked the European Food Safety Authority (EFSA) for scientific and technical assistance to assess this new information and to review the risk assessment of fipronil as regards its impact on bees. The Authority presented its conclusion on the risk assessment of fipronil as regards bees on 27May 2013.

For the use as seed treatment in Maize, EFSA identified high risks for bees from plant protection products containing the active substance fipronil, in particular resulting from use of dust. In addition, unacceptable risks due to acute or chronic effects on colony survival and development could not be excluded for several crops. Furthermore, EFSA identified some missing information for each of the evaluated uses, in particular as regards long term risks to honeybees from dust exposure, from potential exposure to residues in pollen and nectar, from potential exposure to guttation fluid and from exposure to residues in succeeding crops, weeds and soil.

In the light of the new scientific and technical knowledge, the EC considered that there are indications that some approved uses of fipronil do not satisfy the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 with respect to the impact on beesa and that the high risk for bees could not be excluded expect by imposing further restriction. Seeds of crops which have been treated with plant protection products containing fipronilshall not be used or placed on the market with the exception of seeds intended to be sown in greenhouses and seed of leek, onions, shallots and the group of Brassica vegetables intended to be sown in fields and harvested before flowering.

The EuropeanUnionmembers’ states have been upto 31st December 2013 to withdraw or amend existing authorizations for pesticides containing fipronil as active substance. The grace period shall expire on 28th February 2014 and the Regulation will enter into force from 1 March 2014.

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