COMMISSION REGULATION (EU) No 270/2012
of 26 March 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 amidosulfuron, azoxystrobin, bentazone, bixafen, cyproconazole, fluopyram, imazapic, malathion, propiconazole and spinosad 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 azoxystrobin, bentazone, bixafen, malathion and propiconazole, maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For amidosulfuron, cyproconazole, flusilazole, malathion and spinosad, MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For fluopyram and imazapic, 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 azoxystrobin on seeds of mustard, poppy and gold of pleasure an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.
(3)
As regards bentazone, such an application was made for legume vegetables and fresh herbs. As regards bixafen, such an application was made for rape seed, linseed, mustard seed and poppy seed. As regards amidosulfuron, such an application was made for bovine fat, kidney, liver and milk, taking into account existing uses on cereals and grass fed to ruminants. As regards cyprococonazole, such an application was made for rape seed. As regards fluopyram, such an application was made for pome fruit, strawberry, grapes, carrots, onion bulb, spring onions, tomatoes, sweet corn, cucurbits, flowering brassica, Brussels sprouts, head cabbage, Chinese cabbage, lamb's lettuce, lettuce, cress, land cress, rucola, red mustard, leaves and sprouts of brassica, globe artichokes, leek, peaches, peppers, peas and peas with and without pods, rape seed, wheat and animal products, taking into account uses on animal feed crops fed to domestic food producing animals. On root and tuber vegetables, bulb, brassica, fruiting vegetables, leafy vegetables and herbs that substance may also be present due to treatment of previous crops. Therefore, an application was made to raise the MRLs also for these crops. As regards propiconazole, such an application was made for rice. As regards spinosad, such an application was made for blackberries, raspberries, bananas, radishes and parsley.
(4)
In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was made for flusilazole for tea. The applicant claims that authorised use of flusilazole on tea in Indonesia leads to residues exceeding the MRL in Regulation (EC) No 396/2005 and that a higher MRL is necessaryto avoid trade barriers for the importation of tea.
(5)
As regards imazapic, such an application was made to raise the current MRLs for sugar cane from Central and South America (Costa Rica, Brazil, Guatemala). As regards fluopyram, such an application was made to raise the current MRLs for citrus, tree nuts, apple, stone fruits, strawberries, cane fruit, blueberries, bananas, potato, radish, garlic, onions, shallots, peppers, aubergines, okra, sweet corn, scarole, herbs, legume vegetables, pulses, oilseeds, cereals, hops, spices, and sugar beet from the United States. As regards malathion, such an application was made to raise the current MRL for camomille from Egypt.
(6)
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.
(7)
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.
(8)
The Authority concluded in its reasoned opinions that, as regards use of bentazone on peas with and without pods, the MRLs were already fixed at the levels corresponding to the intended authorised uses. As regards beans and lentils, the Authority proposed lower MRLs based on the assumption, that the current MRLs were no longer needed. In the absence of information confirming that assumption the MRLs should be kept unmodified. As regards fluopyram, with the exception of tree nuts, pome fruit, cherries, strawberries, potato, onions, pulses, peanuts, rape seed, soya bean, maize, rye, sorghum, wheat and sugar beet, no evidence was submitted about the authorisation in the United States for the crops for which import tolerance were requested. Therefore the requirements set out in Article 14 (2) of Regulation (EC) No 396/2005 were not fulfilled. As regards flusilazole the Authority concluded that, as regards use on tea the data were not adequate to support the MRL requested. As regards malathion on camomille, the Authority proposed two MRLs, one based on the data concerning residues since 2007 and a second one taking into account a possible change of the agricultural practice after 2007 in Egypt. Since there is no evidence of such a change it is appropriate to take the first proposal of the Authority. As regards spinosad the Authority concluded that, as regards use on blackberries and raspberries the data were not adequate to support the MRLs requested.
(9)
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.
(10)
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.
(11)
Regulation (EC) No 396/2005 should therefore be amended accordingly.
(12)
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 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, 26 March 2012.