# Commission Regulation (EU) No 834/2013Show full title

Commission Regulation (EU) No 834/2013 of 30 August 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 acequinocyl, bixafen, diazinon, difenoconazole,            etoxazole, fenhexamid, fludioxonil, isopyrazam, lambda-cyhalothrin, profenofos and prothioconazole in or on certain products            (Text with EEA relevance)         

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U.K.

# Commission Regulation (EU) No 834/2013                     

# of 30 August 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 acequinocyl, bixafen, diazinon, difenoconazole, etoxazole, fenhexamid, fludioxonil, isopyrazam, lambda-cyhalothrin,                        profenofos and prothioconazole 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 diazinon, etoxazole, fenhexamid, lambda-cyhalothrin and profenofos maximum residue levels (MRLs) were set in Annex II                              and Part B of Annex III to Regulation (EC) No 396/2005. For acequinocyl, bixafen, difenoconazole, fludioxonil, isopyrazam,                              prosulfocarb and prothioconazole MRLs were set in Part A of Annex III 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                              acequinocyl on cucumbers, melons and pumpkins, an application was made in accordance with Article 6(1) of Regulation (EC)                              No 396/2005 for modification of the existing MRLs.

(3)As regards bixafen, such an application was made for rape seed, linseed, poppy seed and mustard seed. As regards difenoconazole,                              such an application was made for quinces, beetroot, carrots, horseradish, Jerusalem artichokes, parsnips, parsley root, radishes,                              salsify, bulb vegetables, cucurbits (inedible peel), witloof, globe artichokes, rice and chicory roots. As regards etoxazole,                              such an application was made for cherries, plums and bananas. As regards fenhexamid, such an application was made for currants                              and beans with pods. As regards fludioxonil, such an application was made for cucurbits (inedible peel) and radishes. As regards                              isopyrazam, such an application was made for pome fruits, apricots, peaches, linseed, poppy seed, rape seed and mustard seed.                              As regards lambda-cyhalothrin, such an application was made for azarole and persimmon. As regards prosulfocarb, such an application                              was made for fennel. As regards prothioconazole, such an application was made for rape seed, linseed, poppy seed and mustard                              seed.

(4)In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was made for difenoconazole on papaya.                              The applicant claims that the authorised use of difenoconazole on such crop in Brazil leads to residues exceeding the MRL                              in Regulation (EC) No 396/2005 and that a higher MRL is necessary to avoid trade barriers for the importation of that crop.

(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 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.

(7)The Authority concluded in its reasoned opinions that, as regards the use of acequinocyl on melons and pumpkins, the use of                              isopyrazam on apricots and the use of prosulfocarb on fennel, the submitted data are not sufficient to set new MRLs. As regards                              the use of acequinocyl on cucumbers, the Authority concluded that the submitted data are not sufficient to set a new MRL for                              the northern EU outdoor use.

(8)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.

(9)On 7 July 2012 the Codex Alimentarius Commission (CAC)(3) adopted a Codex maximum residue limit (CXL) for profenofos on chilli peppers. This CXL is safe for consumers in the Union                              and should therefore be included in Regulation (EC) No 396/2005 as MRL(4).

(10)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 relevant requirements of Article 14(2) of Regulation (EC) No 396/2005.

(11)As regards diazinon, in Regulation (EC) No 396/2005, an MRL of 0,3 mg/kg was set for pineapples and lowered to 0,1 mg/kg in                              the Annex to Commission Regulation (EU) No 899/2012 of 21 September 2012(5). The Commission was informed that the MRL of 0,3 mg/kg for diazinon on pineapples, as it stood before being amended, had                              been set as an import tolerance. As a high level of consumer protection is maintained, it is appropriate to set that MRL to                              0,3 mg/kg in order to avoid trade barriers. As Regulation (EU) No 899/2012 applies as of 26 April 2013, it is appropriate                              for the MRL for diazinon on pineapples, provided by this Regulation, to apply from the same date on.

(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 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.

This Regulation shall enter into force on the day following that of its publication in the *Official Journal of the European Union*.                  

It shall, however, apply from 26 April 2013 for diazinon on pineapples of code number 0163080.

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

Done at Brussels, 30 August 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:

In Annex II, the columns for diazinon, etoxazole, fenhexamid, lambda-cyhalothrin and profenofos are replaced by the following:

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

Annex III is amended as follows:

In Part A, the columns for acequinocyl, bixafen, difenoconazole, fludioxonil isopyrazam and prothioconazole are replaced by                                       the following:                                    

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

In Part B, the column for lambda-cyhalothrin is replaced by the following:

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

1

OJ L 70, 16.3.2005, p. 1.                           

2

EFSA scientific reports available online: http://www.efsa.europa.eu:

Reasoned opinion on the modification of the existing MRLs for acequinocyl in cucumbers, melons and pumpkins. EFSA Journal                              2013; 11(3):3134 [23 pp.]. doi:10.2903/j.efsa.2013.3134.                           

Reasoned opinion on the modification of the existing MRLs for bixafen in rape seed, linseed, poppy seed and mustard seed.                              EFSA Journal 2013; 11(2):3127 [28 pp.]. doi:10.2903/j.efsa.2013.3127.                           

Reasoned opinion on the modification of the existing MRLs for difenoconazole in various crops. EFSA Journal 2013; 11(3):3149                              [37 pp.]. doi:10.2903/j.efsa.2013.3149.                           

Reasoned opinion on the modification of MRLs for etoxazole in cherry, plum and banana. EFSA Journal 2012; 10(12):3006 [23                              pp.]. doi:10.2903/j.efsa.2012.3006.                           

Reasoned opinion on the modification of the existing MRLs for fenhexamid in currants and beans with pods. EFSA Journal 2013;                              11(2):3110 [25 pp.]. doi:10.2903/j.efsa.2013.3110.                           

Reasoned opinion on the modification of the existing MRLs for fludioxonil in cucurbits inedible peel and radishes. EFSA Journal                              2013; 11(2):3113 [25 pp.]. doi:10.2903/j.efsa.2013.3113.                           

Reasoned opinion on the modification of the existing MRLs for isopyrazam in pome fruits, various stone fruits and oilseeds.                              EFSA Journal 2013; 11(4):3165 [34 pp.]. doi:10.2903/j.efsa.2013.3165.                           

Reasoned opinion on the modification of the existing MRLs for lambda-cyhalothrin in azarole and persimmon. EFSA Journal 2013;                              11(2):3117 [27 pp.]. doi:10.2903/j.efsa.2013.3117.                           

Reasoned opinion on the modification of the existing MRL(s) for prosulfocarb in fennel. EFSA Journal 2013;11(3):3133 [27 pp.].                              doi:10.2903/j.efsa.2013.3133.                           

Reasoned opinion on the modification of the existing MRLs for prothioconazole in rape seed, linseed, poppy seed and mustard                              seed. EFSA Journal 2012; 10(11):2952 [35 pp.]. doi:10.2903/j.efsa.2012.2952.                           

3

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.                           

4

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.]. doi:10.2903/j.efsa.2012.2859.                           

5

OJ L 273, 6.10.2012, p. 1.