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amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acibenzolar-S-methyl, ethoxyquin, flusilazole, isoxaflutole, molinate, propoxycarbazone, pyraflufen-ethyl, quinoclamine and warfarin 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), Article 18(1)(b) and Article 49(2) thereof,
Whereas:
(1)
For acibenzolar-S-methyl, isoxaflutole, molinate, propoxycarbazone and pyraflufen-ethyl, maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For ethoxyquin and flusilazole, MRLs were set in Part A of Annex III to that Regulation. For quinoclamine and warfarin no MRLs are set in Regulation (EC) No 396/2005, and as those active substances are not included in Annex IV to that Regulation, the default value of 0,01 mg/kg laid down in Article 18(1)(b) of that Regulation applies.
(2)
For acibenzolar-S-methyl, the European Food Safety Authority, hereinafter the Authority, submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (2). The Authority proposed to change the residue definition. It recommended lowering the MRLs for bananas and tomatoes. For other products it recommended keeping the existing MRLs. It concluded that concerning the MRLs for apples, pears and mangoes some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. Those MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.
(3)
The non-inclusion of ethoxyquin in Annex I to Council Directive 91/414/EEC (3) is provided for in Commission Decision 2011/143/EU (4). All existing authorisations for plant protection products containing the active substance ethoxyquin have been revoked. In accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1)(a) thereof the MRLs set out for that active substance in Annex III should therefore be deleted. This should not apply to those MRLs corresponding to CXLs based on uses in third countries provided that they are acceptable with regard to consumer safety. Nor should it apply in cases where MRLs have been specifically set as import tolerances.
(4)
For ethoxyquin, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (5). It concluded that concerning the CXL for pears, some information was not available and that further consideration by risk managers was required. For pears a risk for consumers was identified. It is therefore appropriate to set the MRL at the specific limit of determination. The Authority identified some uncertainties concerning the toxicological reference values for ethoxyquin. Because a risk to consumers cannot be excluded at residue levels below the current MRL, for pears the value of 0,05 mg/kg should apply from the date of application of this Regulation.
(5)
The period of inclusion of flusilazole in Annex I to Directive 91/414/EEC provided for in Commission Directive 2006/133/EC (6) expired on 30 June 2008. Since flusilazole is no longer approved as an active substance and all existing authorisations for plant protection products containing that active substance have been revoked, MRLs set out for that active substance in Annex III should be deleted in accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1)(a) thereof.
(6)
For flusilazole, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (7). It identified concerning the CXLs for apples, pears, table grapes, peaches, bovine liver, kidney, meat and fat, sheep meat and fat and swine meat and fat a risk for consumers. For peaches this risk for consumers is identified at residue levels below the current MRL. Therefore, for peaches the value of 0,01 mg/kg should apply from the date of application of this Regulation.
(7)
For isoxaflutole, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (8). It proposed to change the residue definition. It recommended lowering the MRLs for sweet corn, maize grain and sugar cane. It concluded that concerning the MRL for poppy seed no information was available and that further consideration by risk managers was required. The MRL for poppy seed should be set at the specific limit of determination or at the default MRL as set out in Article 18(1)(b) of Regulation (EC) No 396/2005.
(8)
For molinate, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (9). It concluded that concerning the MRL for rice some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRL for that product should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. This MRL will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.
(9)
For propoxycarbazone, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (10). It proposed to change the residue definition. It recommended keeping the existing MRLs for certain products.
(10)
For pyraflufen-ethyl, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (11). It proposed to change the residue definition. It concluded that concerning the MRLs for citrus fruit, tree nuts, pome fruit, stone fruit, table and wine grapes, currants (red, black and white), gooseberries, elderberries, table olives, potatoes, rape seed, olives for oil production, barley grain, oats grain, rye grain, wheat grain and hops some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for these products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. The Authority concluded that concerning the MRL for cotton seed no information was available and that further consideration by risk managers was required. The MRL for cotton seed should be set at the specific limit of determination or at the default MRL as set out in Article 18(1)(b) of Regulation (EC) No 396/2005.
(11)
For quinoclamine, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (12). All existing authorisations for plant protection products containing quinoclamine are restricted to non-edible crops. It is therefore appropriate to set the MRLs at the specific limit of determination.
(12)
For warfarin, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (13). All existing authorisations for plant protection products containing warfarin are restricted to the use as rodenticide only and are not intended for direct application on edible crops. It is therefore appropriate to set the MRLs at the default limit of determination.
(13)
As regards products of plant and animal origin for which neither relevant authorisations or import tolerances were reported at Union level nor Codex MRLs were available, the Authority concluded that further consideration by risk managers was required. Taking into account the current scientific and technical knowledge, MRLs for those products should be set at the specific limit of determination or at the default MRL in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005.
(14)
The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain limits of determination. As regards several substances, those laboratories concluded that for certain commodities technical development requires the setting of specific limits of determination.
(15)
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.
(16)
Regulation (EC) No 396/2005 should therefore be amended accordingly.
(17)
In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been lawfully produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained.
(18)
A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs.
(19)
Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account.
(20)
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
Annexes II, III and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were lawfully produced before 16 January 2015:
(1)
as regards the active substances acibenzolar-S-methyl, isoxaflutole, molinate, propoxycarbazone, pyraflufen-ethyl, quinoclamine and warfarin in and on all products;
(2)
as regards the active substance ethoxyquin in and on all products except pears;
(3)
as regards the active substance flusilazole in and on all products except peaches.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 16 January 2015.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 June 2014.附件及原文下载：
(EU) No 703_2014.pdf
For the Commission
The President
Jos Manuel BARROSO
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