LegalizeCommission Regulation (EU) No 473/2012 of 4 June 2012 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for spinetoram (XDE-175) in or on certain products Text with EEA relevance
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 18(4) thereof,
Whereas:
(1) For spinetoram (XDE-175) MRLs are set in Part A of Annex III to Regulation (EC) No 396/2005.
(2) In accordance with Article 53 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (2), France notified on 11 May 2012 to the Commission the temporary authorisation of plant protection products containing the active substance spinetoram (XDE-175), due to an unexpected outbreak of Drosophila suzukii, a danger that was unforeseeable and could not be contained by any other reasonable means. Consequently, France has also notified to the other Member States, the Commission and the Authority in accordance with Article 18(4) of Regulation (EC) No 396/2005 that it has authorised the placing on the market in its territory of cherries, raspberries and blueberries containing pesticide residues higher than the MRLs. Currently, those MRLs are established at the limit of determination in Annex III to Regulation (EC) No 396/2005.
(3) France submitted to the Commission an appropriate consumer risk assesment and proposed temporary MRLs on that basis.
(4) The European Food Safety Authority, hereinafter "the Authority", assessed the data provided and issued a statement (3) on the safety of the proposed temporary MRLs.
(5) The Authority concluded that the emergency use of spinetoram (XDE-175) on cherries, raspberries and blueberries is not likely to result in a consumer exposure exceeding the toxicological reference value and therefore is not expected to pose a public health concern.
(6) France did not report details of supervised field trials, nor complete a quality assessment of such trials. The Authority had to base its statement on the assumption that the supervised field trials are valid and confirm the proposed temporary MRLs. In order to verify the correctness of the assumption, France should update the evaluation report as soon as possible.
(7) Based on the statement of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 18(4) of Regulation (EC) No 396/2005.
(8) Regulation (EC) No 396/2005 should therefore be amended accordingly.
(9) Given that the emergency uses of plant protection products concerning spinetoram are already authorized by France and the resulting urgent need to ensure a high level of consumer protection, it is appropriate to provide for the MRLs by applying the procedure referred to in Article 45(5) of Regulation (EC) No 396/2005.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
Annex III to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the next day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 June 2012.
For the Commission The President José Manuel BARROSO
(2) OJ L 309, 24.11.2009, p. 1.
(3) European Food Safety Authority; Statement on the modification of the existing MRLs for spinetoram in cherries, raspberries and blueberries. EFSA Journal 2012;10(5):2708. [24 pp.] doi:10.2903/j.efsa.2012.2708. Available online: http://www.efsa.europa.eu/efsajournal.htm