# Commission Implementing Regulation (EU) No 642/2013Show full title

Commission Implementing Regulation (EU) No 642/2013 of 4 July 2013 concerning the authorisation of niacin and niacinamide            as feed additives for all animal species (Text with EEA relevance)         

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U.K.

# Commission Implementing Regulation (EU) No 642/2013                     

# of 4 July 2013

# concerning the authorisation of niacin and niacinamide as feed additives 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)Niacin (nicotinic acid) and niacinamide (nicotinamide) were authorised without a time limit in accordance with Directive 70/524/EEC                              as feed additives for use on all animal species as part of the group ‘Vitamins, pro-vitamins and chemically well-defined substances                              having similar effect’. Those feed additives were subsequently entered in the Community Register of feed additives as existing                              products, 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, five applications                              were submitted for the re-evaluation of niacin and niacinamide, as a feed additive for all animal species, requesting those                              additives to be classified in the additive category ‘nutritional additives’. Those applications were 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 opinions of 22 May 2012(3), 14 June 2012(4) (5) (6), and 12 September 2012(7) that, under the proposed conditions of use in feed, niacin and niacinamide do not have an adverse effect on animal and consumer                              health, and are not expected to pose additional risk for the environment. The Authority does not consider that there is a                              need for specific requirements of post-market monitoring. The Authority also concluded that no safety concerns would arise                              for users provided that appropriate protective measures are taken. 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 niacin and niacinamide shows that the conditions for authorisation, as provided for in Article 5 of Regulation                              (EC) No 1831/2003, are satisfied. Accordingly, the use of those additives 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, pre-mixtures 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 substances 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’, are authorised as an additive in animal                     nutrition subject to the conditions laid down in that Annex.                  

# Article 2U.K.

The substances specified in the Annex and feed containing those substances, which are produced and labelled before 25 January                     2014 in accordance with the rules applicable before 25 July 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, 4 July 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* 2012; 10(6):2731.                           

4

*EFSA Journal* 2012; 10(7):2781.                           

5

*EFSA Journal* 2012; 10(7):2788.                           

6

*EFSA Journal* 2012; 10(7):2789.                           

7

*EFSA Journal* 2012; 10(10):2885.