# Commission Regulation (EU) No 1146/2014Show full title

Commission Regulation (EU) No 1146/2014 of 23 October 2014 amending Annexes II, III, IV and V to Regulation (EC) No 396/2005            of the European Parliament and of the Council as regards maximum residue levels for anthraquinone, benfluralin, bentazone,            bromoxynil, chlorothalonil, famoxadone, imazamox, methyl bromide, propanil and sulphuric acid in or on certain products (Text            with EEA relevance)         

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U.K.

# Commission Regulation (EU) No 1146/2014                     

# of 23 October 2014

# amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards                        maximum residue levels for anthraquinone, benfluralin, bentazone, bromoxynil, chlorothalonil, famoxadone, imazamox, methyl                        bromide, propanil and sulphuric acid 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 5(1), Article 14(1)(a), Article 18(1)(b) and Article 49(2) thereof,                        

Whereas:

(1)For bentazone, bromoxynil, chlorothalonil, famoxadone and imazamox, maximum residue levels (MRLs) were set in Annex II and                              Part B of Annex III to Regulation (EC) No 396/2005. For benfluralin and propanil, MRLs were set in Part A of Annex III to                              that Regulation. For anthraquinone, methyl bromide and sulphuric acid 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 anthraquinone, the European Food Safety Authority, hereinafter ‘the Authority’, submitted a reasoned opinion on the existing                              MRLs in accordance with Article 12(1) thereof(2).The non-inclusion of anthraquinone in Annex I to Council Directive 91/414/EEC(3) is provided for in Commission Decision 2008/986/EC(4). Considering that the use of anthraquinone is no longer authorised within the Union and no authorised uses in third countries                              have been notified, it is appropriate to set the MRLs at the specific limit of determination or at the default MRL in accordance                              with Article 18(1)(b) of Regulation (EC) No 396/2005.

(3)For benfluralin, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation                              (EC) No 396/2005(5). It recommended lowering the MRLs for lettuce, scarole, rocket, witloof, beans (fresh, with pods), beans (fresh, without                              pods), peas (fresh, with pods), peas (fresh, without pods), lentils, beans (dry), peas (dry), sunflower seeds, rape seeds,                              barley grain, wheat grain and chicory roots. It recommended keeping the existing MRLs for certain products. It concluded that                              concerning the MRLs for garlic, tomatoes, cucumbers, melons and peanuts no information was available and that further consideration                              by risk managers was required. The MRLs for these commodities 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.

(4)For bentazone, 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 lowering the MRLs for garlic, shallots, herbs, beans (fresh,                              without pods), peas (fresh, with pods), peas (fresh, without pods), peanuts, millet, poultry (meat, fat and liver) and birds'                              eggs. It recommended keeping the existing MRLs for certain products. It concluded that concerning the MRLs for potatoes, leek,                              herbal infusions (dried, leaves), swine (meat, fat, liver and kidney), bovine (meat, fat, liver and kidney), sheep (meat,                              fat, liver and kidney), goat (meat, fat, liver and kidney) and milk (from cattle, sheep and goat), 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. It also concluded that concerning the MRLs for spring onions, cucumbers, poppy seeds and soya beans no                              information was available and that further consideration by risk managers was required. The MRLs for these commodities 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.

(5)For bromoxynil, 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 proposed to change the residue definition. It recommended lowering the MRLs for garlic, onions, shallots, sweetcorn,                              asparagus, leek and linseeds. It recommended keeping the existing MRLs for certain products. It concluded that concerning                              the MRL for hops 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.

(6)For chlorothalonil, 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 apples, pears, quinces, medlars, loquat, apricots, peaches, table and wine grapes,                              strawberries, gooseberries, bananas, papayas, potatoes, carrots, celeriac, horseradish, parsnips, parsley root, salsify, turnips,                              garlic, onions, shallots, spring onions, tomatoes, aubergines, cucumbers, gherkins, courgettes, melons, pumpkins, watermelons,                              cauliflowers, Brussels sprouts, head cabbages, celery leaves, parsley, beans (fresh, with pods), beans (fresh, without pods),                              peas (fresh, with pods), peas (fresh, without pods), lentils (fresh), asparagus, celery, leek, cultivated fungi, beans (dry),                              lentils (dry), peas (dry), lupins (dry), peanuts, barley grain, oat grain, wheat grain, rye grain, hops, swine (meat, fat,                              liver and kidney), bovine (meat, fat, liver and kidney), sheep (meat, fat, liver and kidney), goat (meat, fat, liver and kidney),                              poultry (meat, fat and liver), milk (from cattle, sheep and goat) and birds' eggs, 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.

(7)For famoxadone, 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 recommended lowering the MRL for oat grain. It recommended keeping the existing MRLs for certain products. It concluded                              that concerning the MRLs for rape seeds, swine (meat, fat, liver and kidney), bovine (meat, fat, liver and kidney), sheep                              (meat, fat, liver and kidney), goat (meat, fat, liver and kidney), poultry (meat, fat and liver), milk (from cattle, sheep                              and goat) and birds' eggs, 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.

(8)For imazamox, 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 concluded that concerning the MRLs for beans (fresh, with pods), peas (fresh, without pods), beans (dry), lentils (dry),                              peas (dry), sunflower seeds, rape seeds, soya beans, maize, rice swine (meat, fat, liver and kidney), bovine (meat, fat, liver                              and kidney), sheep (meat, fat, liver and kidney), goat (meat, fat, liver and kidney) and milk (from cattle, sheep and goat),                              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.

(9)For methyl bromide, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) thereof(11). The non-inclusion of methyl bromide in Annex I to Directive 91/414/EEC is provided for in Commission Decision 2008/753/EC(12) and confirmed in Commission Decision 2011/120/EU(13). No authorised uses in third countries have been notified. For methyl bromide the default MRLs cannot be quantified by control                              laboratories and it is therefore not appropriate to set any MRLs for this substance. However, methyl bromide is naturally                              transformed into bromide ion, for which MRLs quantifiable by control laboratories are already established.

(10)For propanil, 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(14). The non-inclusion of propanil in Annex I to Directive 91/414/EEC is provided for in Commission Decision 2008/769/EC(15) and confirmed in Commission Implementing Regulation (EU) No 1078/2011(16). Considering that the use of propanil is no longer authorised within the Union and no authorised uses in third countries                              have been notified, it is appropriate to set the MRLs at the limit of determination or at the default MRL in accordance with                              Article 18(1)(b) of Regulation (EC) No 396/2005. The MRLs set out for propanil in Annex III should therefore be deleted in                              accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1)(a) thereof.

(11)For sulphuric acid, the Authority submitted a reasoned opinion in accordance with Article 12(1) thereof(17). The non-inclusion of sulphuric acid in Annex I to Directive 91/414/EEC is provided for in Commission Decision 2008/937/EC(18). Considering the low toxicity of sulphuric acid the Authority recommended not setting any MRLs. It is therefore appropriate                              to include sulphuric acid in Annex IV to Regulation (EC) No 396/2005.

(12)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.

(13)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.

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

(15)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.

(16)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.

(17)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.

(18)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, IV 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 18 May 2015.                  

# 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, however, apply from 18 May 2015.

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

Done at Brussels, 23 October 2014.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

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

Annex II is amended as follows:

The columns for bentazone, bromoxynil, chlorothalonil, famoxadone and imazamox are replaced by the following:

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

The following column for benfluralin is added:

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

In Annex III, the columns for benfluralin, bentazone, bromoxynil, chlorothalonil, famoxadone, imazamox and propanil are deleted.

In Annex IV the entry ‘Sulphuric acid’ is added, in alphabetical order.

In Annex V, the following columns for anthraquinone and propanil are added:

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

1

OJ L 70, 16.3.2005, p. 1.                           

2

European Food Safety Authority; ‘Reasoned opinion on the review of the existing maximum residue levels (MRLs) for anthraquinone                              according to Article 12 of Regulation (EC) No 396/2005’. *EFSA Journal* 2012;10(6):2761. (6 pp.).                           

3

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).                           

4

Commission Decision 2008/986/EC of 15 December 2008 concerning the non-inclusion of anthraquinone in Annex I to Council Directive                              91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ L 352, 31.12.2008, p. 48).                           

5

European Food Safety Authority, 2013, ‘Reasoned opinion on the review of the existing maximum residue levels (MRLs) for benfluralin                              according to Article 12 of Regulation (EC) No 396/2005’. *EFSA Journal* 2013;11(6):3278. (33 pp.).                           

6

European Food Safety Authority; ‘Reasoned opinion on the review of the existing maximum residue levels (MRLs) for bentazone                              according to Article 12 of Regulation (EC) No 396/2005’. *EFSA Journal* 2012;10(7):2822. (65 pp.).                           

7

European Food Safety Authority; ‘Reasoned opinion on the review of the existing maximum residue levels (MRLs) for bromoxynil                              according to Article 12 of Regulation (EC) No 396/2005’. *EFSA Journal* 2012;10(8):2861. (41 pp.).                           

8

European Food Safety Authority; ‘Reasoned opinion on the review of the existing maximum residue levels (MRLs) for cholorothalonil                              according to Article 12 of Regulation (EC) No 396/2005’. *EFSA Journal* 2012;10(10):2940. (87 pp.).                           

9

European Food Safety Authority; ‘Reasoned opinion on the review of the existing maximum residue levels (MRLs) for famoxadone                              according to Article 12 of Regulation (EC) No 396/2005. *EFSA Journal* 2012;10(7):2835’. (53 pp.)].                           

10

European Food Safety Authority, 2013, ‘Reasoned opinion on the review of the existing maximum residue levels (MRLs) for imazamox                              according to Article 12 of Regulation (EC) No 396/2005’. *EFSA Journal* 2013;11(6):3282. (34 pp.).                           

11

European Food Safety Authority, 2013, ‘Reasoned opinion on the review of the existing maximum residue levels (MRLs) for methyl                              bromide according to Article 12 of Regulation (EC) No 396/2005’. *EFSA Journal* 2013;11(7):3339. (29 pp.).                           

12

Commission Decision 2008/753/EC of 18 September 2008 concerning the non-inclusion of methyl bromide in Annex I to Council                              Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ L 258, 26.9.2008, p. 68).                           

13

Commission Decision 2011/120/EU of 21 February 2011 concerning the non-inclusion of methyl bromide in Annex I to Council Directive                              91/414/EEC (OJ L 47, 22.2.2011, p. 19).                           

14

European Food Safety Authority, 2013, ‘Reasoned opinion on the review of the existing maximum residue levels (MRLs) for propanil                              according to Article 12 of Regulation (EC) No 396/2005’. *EFSA Journal* 2013;11(6):3280. (22 pp.).                           

15

Commission Decision 2008/769/EC of 30 September 2008 concerning the non-inclusion of propanil in Annex I to Council Directive                              91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ L 263, 2.10.2008, p. 14).                           

16

Commission Implementing Regulation (EU) No 1078/2011 of 25 October 2011 concerning the non-approval of the active substance                              propanil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing                              of plant protection products on the market (OJ L 279, 26.10.2011, p. 1).                           

17

European Food Safety Authority, ‘Review of the existing maximum residue levels (MRLs) for sulphuric acid according to Article                              12 of Regulation (EC) No 396/2005’. *EFSA Journal* 2012;10(1):2556. (9 pp.).                           

18

Commission Decision 2008/937/EC of 5 December 2008 concerning the non-inclusion of sulphuric acid in Annex I to Council Directive                              91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ L 334, 12.12.2008, p. 88).