# Commission Implementing Regulation (EU) No 795/2013Show full title

Commission Implementing Regulation (EU) No 795/2013 of 21 August 2013 concerning the authorisation of choline chloride as            a feed additive for all animal species (Text with EEA relevance)         

        - Previous
        - Next

U.K.

# Commission Implementing Regulation (EU) No 795/2013                     

# of 21 August 2013

# concerning the authorisation of choline chloride as a feed additive for all animal species

# (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)Choline chloride was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on                              all animal species as part of the group ‘Vitamins, pro-vitamins and chemically well-defined substances having similar effect’.                              That product was subsequently entered in the European Union 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 choline chloride, as a feed additive for all animal species, requesting that additive to                              be classified in the additive category ‘nutritional additives’. 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 6 September 2011(3) that, under the proposed conditions of use in feed, choline chloride does not have an adverse effect on animal and consumer                              health, and it is not expected to pose additional risk for the environment. The Authority also concluded that no safety concerns                              would arise for users provided that appropriate protective measures are taken. The Authority does not consider that there                              is a need for specific requirements of post-market monitoring. 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 choline chloride 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 substance should be authorised as specified in the Annex to                              this Regulation.

(6)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 the disposal of existing stocks of the additive, premixtures and compound                              feed containing it, as authorised by Directive 70/524/EEC.

(7)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.

The preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group                     ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is authorised as an additive in animal                     nutrition subject to the conditions laid down in that Annex.                  

# Article 2U.K.

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 11 March                     2014 in accordance with the rules applicable before 11 September 2013, may continue to be placed on the market and used until                     the existing stocks are exhausted.                  

# 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.*                   

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

Done at Brussels, 21 August 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

1

OJ L 268, 18.10.2003, p. 29.                           

2

OJ L 270, 14.12.1970, p. 1.                           

3

*EFSA Journal 2011*; 9(9):2353.