COMMISSION REGULATION (EU) No 322/2012
of 16 April 2012
amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for clopyralid, dimethomorph, fenpyrazamine, folpet and pendimethalin 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 14(1)(a) thereof,
Whereas:
(1)
For folpet and pendimethalin maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For clopyralid and dimethomorph MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For fenpyrazamine, no MRLs were set before in any of the Annexes to Regulation (EC) No 396/2005, so the default value of 0,01 mg/kg applied.
(2)
In the context of a procedure, for the authorisation of the use of a plant protection product containing the active substance dimethomorph on spinach and beet leaves an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.
(3)
As regards clopyralid, such an application was made for cauliflower, broccoli, head cabbage, linseed, swedes, turnips and animal products, taking into account uses on animal feed crops fed to domestic food producing animals. As regards fenpyrazamine, such an application was made for grapes, tomatoes, peppers, aubergines, and cucurbits with edible peel. As regards folpet, such an application was made for wine grapes, garlic and tomatoes. As regards pendimethalin, such an application was made for leafy brassica, kohlrabi and herbs.
(4)
In accordance with Article 8 of Regulation (EC) No 396/2005, these applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission.
(5)
The European Food Safety Authority, hereinafter "the Authority", assessed the applications and the evaluation reports, examining in particular the risks to the consumer and where relevant to animals and gave reasoned opinions on the proposed MRLs (2). It forwarded these opinions to the Commission and the Member States and made them available to the public.
(6)
The Authority concluded in its reasoned opinions that, as regards use of folpet on wine grapes, a potential risk to consumer health could not be excluded, if the MRL was raised, as requested by the applicant. Therefore, the MRL should not be raised. As regards clopyralid on milk, the Authority proposed a lower MRL provided that the analytical method was validated. As there is no evidence provided for this, the MRL should be kept unmodified.
(7)
As regards all other applications, the Authority concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short term exposure due to extreme consumption of the relevant crops and products showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded.
(8)
Based on the reasoned opinions 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 14(2) of Regulation (EC) No 396/2005.
(9)
Regulation (EC) No 396/2005 should therefore be amended accordingly.
(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 and neither the European Parliament nor the Council has opposed them,
HAS ADOPTED THIS REGULATION:
Article 1
Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth 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, 16 April 2012.