COMMISSION REGULATION (EU) No 592/2012
of 4 July 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 bifenazate, captan, cyprodinil, fluopicolide, hexythiazox, isoprothiolane, metaldehyde, oxadixyl and phosmet 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 bifenazate and captan maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For cyprodinil, fluopicolide, hexythiazox, metaldehyde, oxadixyl and phosmet MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For isoprothiolane no MRLs were set before in any of the Annexes to Regulation (EC) No 396/2005.
(2)
In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance bifenazate on currants (red, black and white), raspberries and blackberries an application was made under Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.
(3)
As regards captan, such an application was made on blackberries, raspberries, blueberries, currants (red, black and white) and gooseberries. As regards cyprodinil, such an application was made in fresh herbs, spinach and beet leaves, lettuce, lamb's lettuce, cress, scarole, rocket/rucola and leaves and sprouts of Brassica spp. As regards fluopicolide, such an application was made for in radishes, onions, potatoes and kale. As regards hexythiazox, such an application was made for tea. As regards metaldehyde such an application was made for strawberries, potatoes, kohlrabi, lettuce and other salad plants, the whole group of spinach and similar, the whole group of herbs and rape seed. As regards phosmet, such an application was made for potatoes, apricots, peaches, table olives, olives for oil production and rape seed.
(4)
In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was made for isoprothiolane on rice. The authorised use of isoprothiolane on rice in Japan leads to a higher residue than the MRL in Regulation (EC) No 396/2005. To avoid trade barriers for the importation of this crop, a higher MRL are necessary.
(5)
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.
(6)
The Commission received information from Belgium about residues of oxadixyl on parsley, celery and leeks which exceed the current MRLs. According to the Belgium authorities, the unexpected presence of oxadixyl in these crops is due to the persistence of the active substance in soil. Belgium submitted an application in accordance with Article 6(3) of Regulation (EC) No 396/2005 for modifications to those MRLs.
(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 fluopicolide in onion, the submitted data are not sufficient to derive a new MRL. As regards use of metaldehyde in strawberries and kohlrabi, the submitted data are not sufficient to derive a new MRL. As regards phosmet in apricots, the submitted data is not sufficient to derive a new MRL.
(9)
As regards use of bifenazate on raspberries and blackberries, no modification of the MRLs is necessary, since the MRLs set out in Annex II to Regulation (EC) No 396/2005 are identical with those requested.
(10)
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.
(11)
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.
(12)
Regulation (EC) No 396/2005 should therefore be amended accordingly.
(13)
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, 4 July 2012.