# Commission Regulation (EU) No 1138/2013Show full title

Commission Regulation (EU) No 1138/2013 of 8 November 2013 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 bitertanol, chlorfenvinphos, dodine and vinclozolin            in or on certain products (Text with EEA relevance)         

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U.K.

# Commission Regulation (EU) No 1138/2013                     

# of 8 November 2013

# 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 bitertanol, chlorfenvinphos, dodine and vinclozolin 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 Articles 14(1)(a) and 18(1)(b) and Article 49(2) thereof,                        

Whereas:

(1)For bitertanol, chlorfenvinphos and vinclozolin maximum residue levels (MRLs) were set in Annex II and Part B of Annex III                              to Regulation (EC) No 396/2005. For dodine 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                              dodine on pome fruits, peaches, apricots, cherries, table olives and olives for oil production an application was made in                              accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.

(3)In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was made for dodine on bananas. The                              applicant claims that the authorised use of dodine on such crops in Northern, Central and South America leads to residues                              exceeding the MRL authorised under Regulation (EC) No 396/2005 and that a higher MRL is necessary to avoid trade barriers                              for the importation of bananas.

(4)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.

(5)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.

(6)The United Kingdom submitted a request to the Authority under Article 43 of Regulation (EC) No 396/2005 to assess the risks                              the current MRL for bitertanol on bananas may pose, in the light of the acute reference dose (ARfD) for bitertanol, established                              in October 2010(3).

(7)For dodine, the Authority concluded that all requirements with respect to data were met and that the modifications to the                              MRLs requested by the applicant 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 substance. Neither the lifetime exposure to that substance via consumption of all food products that may contain that                              substance, nor the short-term exposure due to high 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.

(8)For bitertanol, the Authority, in its opinion of 21 February 2012, identified an acute health concern for consumers and recommended                              lowering the MRL for bitertanol on bananas(4). Having identified an acute health concern for consumers as regards bitertanol on bananas, the Authority assessed the safety                              of the existing MRLs for bitertanol on other crops for which MRLs were set above the limit of determination (LOD). The Authority                              recommended lowering the MRLs for pome fruit, stone fruit, cucurbits (edible peel) and tomatoes. MRLs for those products should                              be set at the LOD appropriate for the specific substance/product combination.

(9)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.

(10)All existing authorisations for plant protection products containing the active substances chlorfenvinphos and vinclozolin                              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 those active substances in Annexes II and III should therefore be deleted.

(11)The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt                              the existing LODs for bitertanol, chlorfenvinphos and dodine. Those laboratories concluded that technical development permits                              the setting of lower LODs for the three substances. In the light of the conclusions of those laboratories, it is appropriate                              to set lower MRLs.

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

(13)For vinclozolin, the model established by the Authority to assess acute and chronic risk(5) shows that a high level of consumer protection is maintained. This Regulation should therefore provide for a transitional                              arrangement, in order to allow normal marketing, processing and consumption of products which have been lawfully produced                              before the application of this Regulation.

(14)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.

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

# Article 2U.K.

As regards bitertanol in sugar beet (root) of code number 0900010, dodine in cherries of code number 0140020 and vinclozolin                     in all products, 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 6 June 2014.                  

# 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 6 June 2014. However, for dodine in table olives of code number 0161030, bananas of code number 0163020                     and olives for oil production of code number 0402010, it shall apply from its date of entry into force.                  

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

Done at Brussels, 8 November 2013.

*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 column for bitertanol is replaced by the following:

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

the columns for chlorfenvinphos and vinclozolin are deleted;

Annex III is amended as follows:

in Part A, the column for dodine is replaced by the following:

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

in Part B, the column for bitertanol is replaced by the following:

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

in Part B, the columns for chlorfenvinphos and vinclozolin are deleted;

in Annex V, the following columns for chlorfenvinphos and vinclozolin are added:

### **‘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 dodine in various fruit crops. EFSA Journal 2013;11(1):3077                              [31 pp.]. doi:10.2903/j.efsa.2013.3077.                           

Reasoned opinion on the modification of the existing MRL for dodine in pome fruit, apricots and olives. EFSA Journal 2013;11(2):3112                              [25 pp.]. doi:10.2903/j.efsa.2013.3112.                           

3

Conclusion on the peer review of the pesticide risk assessment of the active substance bitertanol. EFSA Journal 2010;8(10):1850                              [63 pp.]. doi:10.2903/j.efsa.2010.1850.                           

4

Reasoned Opinion on the Assessment of the consumer safety of the existing MRL for bitertanol in bananas. EFSA Journal 2012;10(2):2599                              [34 pp.]. doi:10.2903/j.efsa.2012.2599.                           

5

http://www.efsa.europa.eu/en/mrls/docs/calculationacutechronic_2.xls