# Commission Regulation (EU) No 668/2013Show full title

Commission Regulation (EU) No 668/2013 of 12 July 2013 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 2,4-DB, dimethomorph, indoxacarb, and pyraclostrobin in            or on certain products (Text with EEA relevance)         

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U.K.

# Commission Regulation (EU) No 668/2013                     

# of 12 July 2013

# 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 2,4-DB, dimethomorph, indoxacarb, and pyraclostrobin 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) and Article 49(2) thereof,                        

Whereas:

(1)For 2,4-DB, indoxacarb and pyraclostrobin, maximum residue levels (MRLs) are set in Annex II and Part B of Annex III to Regulation                              (EC) No 396/2005. For dimethomorph, MRLs are set in Part A of Annex III to Regulation (EC) No 396/2005.

(2)Certain technical adaptations should be made, in particular the name of the active substance ‘2,4 DB’ should be replaced by                              ‘2,4-DB’. Annex II and Part B of Annex III to Regulation (EC) No 396/2005 should therefore be amended accordingly.

(3)For 2,4-DB, 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. The Authority concluded that concerning the MRLs for barley grain,                              oats grain, rye grain and wheat grain, for meat, fat, liver and kidney of swine, bovine animals, sheep and goat, as well as                              for cattle milk, sheep milk and goat milk 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 taking into account the information                              available within two years from the publication of this Regulation.

(4)For dimethomorph, 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(3). The Authority proposed to change the residue definition. The Authority recommended lowering the MRLs for pineapples, potatoes,                              spring onions, cucumbers, gherkins, courgettes, melons, kohlrabi, scarole, witloof, beans (fresh, without pods), poppy seed                              and rape seed, for meat, fat, liver and kidney of swine, bovine animals, sheep and goat, as well as for poultry meat, poultry                              fat, poultry liver, cattle milk, sheep milk, goat milk and birds’ eggs. For other products it recommended raising or keeping                              the existing MRLs. The Authority concluded that concerning the MRLs for blackberries, raspberries and spinach 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 taking into account the information available within two years from the publication                              of this Regulation. As regards bulb vegetables — others, the MRL should be set at a different level than identified by the                              Authority, given that there is no risk for consumers and based on additional information on the good agricultural practices                              provided by Germany. As regards garlic, onions, shallots, broccoli, head cabbage, leafy brassica, lettuce, scarole, spinach,                              beet leaves and celery, after submitting the opinion referred to in the first sentence, the Authority submitted further opinions                              concerning the MRLs(4) (5). It is appropriate to take those opinions into account.

(5)For indoxacarb, 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(6). The Authority proposed to change the residue definition. The Authority recommended lowering the MRLs for blueberries, currants,                              gooseberries, rose hips, mulberries, azarole, elderberries, Brussels sprouts, head cabbage, scarole, peanuts, rape seed and                              maize grain. For other products it recommended raising or keeping the existing MRLs. The Authority concluded that concerning                              the MRLs for apples, broccoli, cauliflower, lamb’s lettuce, rocket, rucola, leaves and sprouts of brassica, poultry meat,                              poultry fat, poultry liver and birds’ eggs 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 taking into account the information                              available within two years from the publication of this Regulation. As regards strawberries, raspberries, Chinese cabbage,                              lamb’s lettuce, beans (fresh, with pods), cardoons, fennel and rhubarb, after submitting the opinion referred to in the first                              sentence, the Authority submitted a further opinion concerning the MRLs(7). It is appropriate to take that opinion into account.

(6)For pyraclostrobin, 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). The Authority recommended lowering the MRLs for scarole and lupins (dry). For other products it recommended raising or keeping                              the existing MRLs. The Authority concluded that concerning the MRLs for table grapes, celery, cotton seed and coffee beans                              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 taking into account the information available within two years from the publication                              of this Regulation. As regards oranges, leafy brassica, linseed, peanuts, poppy seed, sesame seed, rape seed, mustard seed,                              cotton seed, safflower, borage, gold of pleasure and castor bean, after submitting the opinion referred to in the first sentence,                              the Authority submitted further opinions concerning the MRLs(9) (10). It is appropriate to take those opinions into account. As regards cherries, peaches, plums, strawberries, blackberries,                              raspberries, blueberries, papaya, onions, cucurbits – edible peel, barley, oats, rye, sorghum and wheat, after the Authority                              submitted the opinion referred to in the first sentence, the Codex Alimentarius Commission (CAC)(11) adopted Codex MRLs (CXLs) for pyraclostrobin. It is appropriate to take these CXLs into account, with the exception of those                              CXLs which are not safe for a European consumer group and for which the Union presented a reservation to the CAC(12).

(7)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.

(8)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.

(9)A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States                              and interested parties to prepare themselves to meet the new requirements which will result from the modification of the MRLs.

(10)Annex II to Regulation (EC) No 396/2005 and Part A and B of Annex III to that Regulation should therefore be amended accordingly.

(11)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.

(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 1U.K.

Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

# Article 2U.K.

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 2 February 2014:                  

as regards the active substances 2,4-DB and dimethomorph in and on all products;

as regards the active substance indoxacarb in and on all products except head cabbage and scarole (broad-leaf endive);

as regards the active substance pyraclostrobin in and on all products except scarole (broad-leaf endive).

# Article 3U.K.

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 2 February 2014.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 12 July 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:

Annex II is amended as follows:

the columns for 2,4-DB, indoxacarb and pyraclostrobin are replaced by the following:

### **‘Pesticide residues and maximum residue levels (mg/kg)**

the following column for dimethomorph is added:

### **‘Pesticide residues and maximum residue levels (mg/kg)**

in Annex III, the columns for 2,4-DB, dimethomorph, indoxacarb, and pyraclostrobin are deleted.

1

OJ L 70, 16.3.2005, p. 1.                           

2

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for 2,4-DB according to Article 12 of                              Regulation (EC) No 396/2005. EFSA Journal 2011; 9(10):2420. [35 pp.].                           

3

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for dimethomorph according to Article                              12 of Regulation (EC) No 396/2005. EFSA Journal 2011; 9(8):2348. [64 pp.].                           

4

European Food Safety Authority; Modification of the existing MRLs for dimethomorph in spinach and beet leaves (chard). EFSA                              Journal 2011; 9(11):2437. [24 pp.].                           

5

European Food Safety Authority; Modification of the existing MRLs for dimethomorph in several vegetable crops. EFSA Journal                              2012; 10(7):2845. [35 pp.].                           

6

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for indoxacarb according to Article 12                              of Regulation (EC) No 396/2005. EFSA Journal 2011;9(8):2343. [83 pp.], as published on 3 September 2012.                           

7

European Food Safety Authority; Modification of the existing MRLs for indoxacarb in various crops. EFSA Journal 2012; 10(7):2833.                              [33 pp.], as published on 5 September 2012.                           

8

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for pyraclostrobin according to Article                              12 of Regulation (EC) No 396/2005. EFSA Journal 2011; 9(8):2344. [92 pp.].                           

9

European Food Safety Authority; Modification of the existing MRLs for pyraclostrobin in various crops. EFSA Journal 2011;                              9(3):2120. [41 pp.].                           

10

European Food Safety Authority; Modification of the existing MRLs for pyraclostrobin in leafy brassica and various cereals.                              EFSA Journal 2012; 10(3):2606 [36 pp.].                           

11

Codex Committee on Pesticide Residues reports available on:

http://www.codexalimentarius.org/download/report/777/REP12_PRe.pdf

Joint FAO/WHO food standards programme Codex Alimentarius Commission. Appendix II and III. Thirty-Fifth Session. Rome, Italy,                              2 - 7 July 2012.                           

12

Scientific support for preparing an EU position in the 44th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA                              Journal 2012; 10(7):2859 [155 pp.].