# Commission Regulation (EU) No 289/2014Show full title

Commission Regulation (EU) No 289/2014 of 21 March 2014 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 foramsulfuron, azimsulfuron, iodosulfuron, oxasulfuron,            mesosulfuron, flazasulfuron, imazosulfuron, propamocarb, bifenazate, chlorpropham and thiobencarb in or on certain products            (Text with EEA relevance)         

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U.K.

# Commission Regulation (EU) No 289/2014                     

# of 21 March 2014

# 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 foramsulfuron, azimsulfuron, iodosulfuron, oxasulfuron, mesosulfuron, flazasulfuron, imazosulfuron, propamocarb,                        bifenazate, chlorpropham and thiobencarb 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 foramsulfuron, azimsulfuron, iodosulfuron, oxasulfuron, mesosulfuron, flazasulfuron and imazosulfuron maximum residue                              levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For propamocarb MRLs were set in                              Part A of Annex III to that Regulation.

(2)For foramsulfuron, 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 recommended, for certain products, raising or keeping the existing MRLs or setting MRLs at the level identified                              by the Authority. It concluded that concerning the MRL for maize grain some information was not available and that further                              consideration by risk managers was required. As there is no risk for consumers, MRL for this 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 2 years from the publication of this Regulation.

(3)For azimsulfuron, 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). It recommended lowering the MRL for rice.

(4)For iodosulfuron, 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(4). It proposed to change the residue definition. It recommended lowering the MRLs for barley grain, maize grain, rye grain                              and wheat grain. For linseed it recommended keeping the existing MRL. It concluded that concerning the MRLs for linseed and                              maize forage 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 2 years from the publication of this Regulation.

(5)For oxasulfuron, 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(5). It recommended lowering the MRLs for soya bean.

(6)For mesosulfuron, 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). It proposed to change the residue definition. It recommended, for certain products, raising or keeping the existing MRLs                              or setting MRLs at the level identified by the Authority.

(7)For flazasulfuron, 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 recommended lowering the MRLs for citrus fruit and table and wine grapes. It concluded that concerning the MRLs for table                              olives and olives for oil production 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 2 years from the publication of this Regulation.

(8)For imazosulfuron, 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 concluded that concerning the MRLs for barley grain, rice grain, rye grain and wheat grain 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 2 years from the publication of this                              Regulation.

(9)For propamocarb, 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 proposed to change the residue definition. As regards rocket (rucola) and leek, after submitting the opinion referred                              to in the first sentence, the Authority submitted a further opinion concerning the MRLs(10). It is appropriate to take that opinion into account.

(10)The Authority indicated that the evaluated use for propamocarb in leek as well as the existing MRL for lettuce may raise concerns                              of consumer protection. The Authority therefore recommended lowering the existing MRLs for lettuce. The MRL for leek should                              be set at the specific limit of determination or at the default MRL as laid down in Article 18(1)(b) of Regulation (EC) No                              396/2005.

(11)The Authority recommended lowering the existing MRLs for potatoes, radishes, onions, tomatoes, peppers, aubergines (egg plants),                              cucumbers, gherkins, courgettes, pumpkins, broccoli, Brussels sprouts, head cabbage, Chinese cabbage, kohlrabi, lettuce. It                              recommended, for certain products, raising or keeping the existing MRLs or setting MRLs at the level identified by the Authority.                              It concluded that concerning the MRLs for cauliflower, lamb’s lettuce, scarole, cress, land cress, rocket (rucola), red mustard,                              *Brassica* spp. (leaves and sprouts), fresh herbs, swine (muscle, fat, kidney), bovine (muscle, fat, kidney), sheep (muscle, fat, kidney),                              goat (muscle, fat, kidney), milk (cattle, sheep, goat), poultry (muscle, fat, 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; the review will take into account the information available within 2 years from the publication                              of this Regulation. For other products the Authority recommended raising or keeping the existing MRLs.

(12)As regards products of plant and animal origin for which neither relevant authorisations nor 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 as laid down in Article 18(1)(b) of Regulation (EC) No 396/2005.

(13)As regards thiobencarb the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of                              Regulation (EC) No 396/2005(11). As regards bifenazate and chlorpropham 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(12) (13). It proposed to change the residue definitions. The European Union reference laboratories identified reference standards                              as commercially not available for the residue definitions proposed by the Authority. Residue definitions for bifenazate and                              chlorpropham should be set in Annex II to Regulation (EC) No 396/2005 and the residue definition for thiobencarb should be                              set in Annex V to Regulation (EC) No 396/2005. Those residue definitions will be reviewed; the review will take into account                              the information available within 2 years from the publication of this Regulation.

(14)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.

(15)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.

(16)Regulation (EC) No 396/2005 should therefore be amended accordingly.

(17)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.

(18)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.

(19)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 1U.K.

Annexes II, III and V 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 11 April 2014:                  

as regards the active substances foramsulfuron, azimsulfuron, iodosulfuron, oxasulfuron, mesosulfuron, flazasulfuron, imazosulfuron,                              bifenazate, chlorpropham and thiobencarb in and on all products;                           

as regards the active substance propamocarb in and on all products except lettuce.

# 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 11 October 2014.

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

Done at Brussels, 21 March 2014.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

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

Annex II is amended as follows:

the columns for foramsulfuron, azimsulfuron, iodosulfuron, oxasulfuron, mesosulfuron, flazasulfuron and imazosulfuron are                                       replaced by the following:                                    

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

the following column for propamocarb is added:

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

the heading of the column for bifenazate in the table is replaced by the following:

‘Bifenazate (sum of bifenazate plus bifenazate-diazene expressed as bifenazate) (F) (A)’;                                    

the entry for the footnote for bifenazate below the table is amended as follows:
                      -  after the substance name and the letter (F), the letter ‘(A)’ is added to read ‘Bifenazate (sum of bifenazate plus bifenazate-diazene                                             expressed as bifenazate) (F) (A)’ as title for the footnotes on bifenazate;                                           
                      -  after the text of footnote (F) the following is added:    ‘(A)The European Union reference laboratories identified the reference standard for bifenazate-diazene as commercially not available.                                                   When re-viewing the MRL, the Commission will take into account the commercial availability of the reference standard referred                                                   to in the first sentence by 22 March 2015, or, if that reference standard is not commercially available by that date, the                                                   unavailability of it.’; 

the heading of the column for chlorpropham in the table is replaced by the following:

‘Chlorpropham (F)(R)(A)’;                                    

the entry for the footnote for chlorpropham below the table is amended as follows:
                      -  after the substance name and the letters (F) and (R) the letter ‘(A)’ is added to read ‘Chlorpropham (F) (R) (A)’ as title                                             for the footnotes on chlorpropham;                                           
                      -  after the text of the existing footnotes (F) and (R)the following is added:    ‘(A)The European Union reference laboratories identified the reference standard for 4'-hydroxychlorpropham-O-sulphonic acid (4-HSA)                                                   as commercially not available. When re-viewing the MRL, the Commission will take into account the commercial availability                                                   of the reference standard referred to in the first sentence by 22 March 2015, or, if that reference standard is not commercially                                                   available by that date, the unavailability of it.’; 

Annex III is amended as follows:

in Part B, the columns for foramsulfuron, azimsulfuron, iodosulfuron, oxasulfuron, mesosulfuron, flazasulfuron and imazosulfuron                                       are deleted;                                    

in Part A, the column for propamocarb is deleted;

Annex V is amended as follows:

the heading of the column for thiobencarb in the table is replaced by the following:

‘Thiobencarb (4-chlorobenzyl methyl sulfone) (A)’;                                    

the entry for the footnote for thiobencarb below the table is amended as follows:

after the substance name the letter ‘(A)’ is added to read ‘Thiobencarb (4-chlorobenzyl methyl sulfone) (A)’ as title for                                       the footnotes on thiobencarb;                                    

the following is added:

### ‘(A)The European Union reference laboratories identified the reference standard for 4-chlorobenzyl methyl sulfone as commercially                                             not available. When re-viewing the MRL, the Commission will take into account the commercial availability of the reference                                             standard referred to in the first sentence by 22 March 2015, or, if that reference standard is not commercially available                                             by that date, the unavailability of it.’

1

OJ L 70, 16.3.2005, p. 1.                           

2

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for foramsulfuron according to Article                              12 of Regulation (EC) No 396/2005. *EFSA Journal* 2012; 10(1):2962. [28 pp.].                           

3

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for azimsulfuron according to Article                              12 of Regulation (EC) No 396/2005. *EFSA Journal* 2012; 10(10):2941. [24 pp.].                           

4

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for iodosulfuron according to Article                              12 of Regulation (EC) No 396/2005. *EFSA Journal* 2012; 10(11):2974. [28 pp.].                           

5

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for oxasulfuron according to Article                              12 of Regulation (EC) No 396/2005. *EFSA Journal* 2012; 10(10):2942. [28 pp.].                           

6

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for mesosulfuron according to Article                              12 of Regulation (EC) No 396/2005. *EFSA Journal* 2012; 10(11):2976. [27 pp.].                           

7

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for flazasulfuron according to Article                              12 of Regulation (EC) No 396/2005. *EFSA Journal* 2012; 10(11):2958. [25 pp.].                           

8

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for imazosulfuron according to Article                              12 of Regulation (EC) No 396/2005. *EFSA Journal* 2012;10(12):3010 [26 pp.].                           

9

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for propamocarb according to Article                              12 of Regulation (EC) No 396/2005. *EFSA Journal* 2013; 11(4):2903. [72 pp.].                           

10

European Food Safety Authority; Modification of the existing MRLs for propamocarb in rocket and leek. *EFSA Journal* 2013; 11(6):3255. [32 pp.].                           

11

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for thiobencarb according to Article                              12 of Regulation (EC) No 396/2005. *EFSA Journal* 2011; 9(8):2341. [17 pp.].                           

12

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for bifenazate according to Article 12                              of Regulation (EC) No 396/2005. *EFSA Journal* 2011; 9(10):2484. [35 pp.].                           

13

European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for chlorpropham according to Article                              12 of Regulation (EC) No 396/2005. *EFSA Journal* 2012; 10(2):2584. [53 pp.].