# Commission Implementing Regulation (EU) No 667/2013Show full title

Commission Implementing Regulation (EU) No 667/2013 of 12 July 2013 concerning the authorisation of diclazuril as a feed additive            for chickens reared for laying (holder of authorisation Elanco GmbH) and repealing Regulation (EC) No 162/2003 (Text with            EEA relevance)         

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U.K.

# Commission Implementing Regulation (EU) No 667/2013                     

# of 12 July 2013

# concerning the authorisation of diclazuril as a feed additive for chickens reared for laying (holder of authorisation [F1Elanco GmbH]) and repealing Regulation (EC) No 162/2003                     

# (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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives                           for use in animal nutrition(1), and in particular Article 9(2) thereof,                        

Whereas:

(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and                              procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised                              pursuant to Council Directive 70/524/EEC(2).

(2)Diclazuril, CAS number 101831-37-2, was authorised for 10 years in accordance with Directive 70/524/EEC as a feed additive                              for use on chickens reared for laying by Commission Regulation (EC) No 162/2003(3). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article                              10(1) of Regulation (EC) No 1831/2003.

(3)In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was                              submitted for the re-evaluation of diclazuril, as a feed additive for chickens reared for laying, requesting that additive                              to be classified in the additive category ‘coccidiostats and histomonostats’. That application was accompanied by the particulars                              and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 31 January 2013(4) that, under the proposed conditions of use in feed, diclazuril does not have an adverse effect on animal, human health or                              the environment and it is effective in controlling coccidiosis in chickens reared for laying. It also verified the report                              on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No                              1831/2003.

(5)The assessment of diclazuril, CAS number 101831-37-2, shows that the conditions for authorisation, as provided for in Article                              5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified                              in the Annex to this Regulation.

(6)As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulation (EC) No 162/2003 should                              be repealed.

(7)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it                              is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting                              from the authorisation.

(8)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:

Textual Amendments

F1Substituted by Commission Implementing Regulation (EU) 2019/138 of 29 January 2019 amending Regulations (EC) No 1356/2004, (EC) No 1464/2004,                                 (EC) No 786/2007, (EC) No 971/2008, (EU) No 1118/2010, (EU) No 169/2011 and Implementing Regulations (EU) No 888/2011 and                                 (EU) No 667/2013 as regards the name of the holder of the authorisation for feed additives (Text with EEA relevance).

# Article 1U.K.

The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’ is authorised                     as an additive in animal nutrition subject to the conditions laid down in that Annex.                  

# Article 2U.K.

Regulation (EC) No 162/2003 is repealed.

# Article 3U.K.

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 2 February                     2014 in accordance with the rules applicable before 2 August 2013 may continue to be placed on the market and used until the                     existing stocks are exhausted.                  

# Article 4U.K.

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

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

## ANNEXU.K.

1

OJ L 268, 18.10.2003, p. 29.                           

2

OJ L 270, 14.12.1970, p. 1.                           

3

OJ L 26, 31.1.2003, p. 3.                           

4

*EFSA Journal* 2013; 11(3):3106.