Commission Implementing Regulation (EU) 2015/724 of 5 May 2015 concerning the authorisation of retinyl acetate, retinyl palmitate and retinyl propionate as feed additives for all animal species (Text with EEA relevance)

COMMISSION IMPLEMENTING REGULATION (EU) 2015/724

of 5 May 2015

concerning the authorisation of retinyl acetate, retinyl palmitate and retinyl propionate 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 ([^E0001]), 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 ([^E0002]).

• (2) Vitamin A was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was subsequently entered in the Register of feed additives as 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 vitamin A in the form of retinyl acetate, retinyl palmitate and retinyl propionate as feed additives and their preparations for all animal species and, in accordance with Article 7 of that Regulation, for a new use in water for drinking. The applicant requested these additives 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 12 December 2012 ([^E0003]) that, under the proposed conditions of use in feed, retinyl acetate, retinyl palmitate and retinyl propionate do not have an adverse effects on animal health, human health or the environment.

• (5) The Authority further concluded that retinyl acetate, retinyl palmitate and retinyl propionate are effective sources of vitamin A and that no safety concerns would arise for users. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

• (6) The assessment of retinyl acetate, retinyl palmitate and retinyl propionate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied except for water for drinking. Accordingly, the use of these substances should be authorised in feed as specified in the Annex to this Regulation. Maximum contents should be set for vitamin A irrespective of its form. Vitamin A should not be administered directly via water for drinking because an additional route of administration would increase the risk for consumers. Therefore, the authorisation of retinyl acetate, retinyl palmitate and retinyl propionate as nutritional additives belonging to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’ should be denied as regards their use in water. This prohibition does not apply to those additives within a compound feed subsequently administered via water.

• (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 Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

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 additives in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Authorisation of retinyl acetate, retinyl palmitate and retinyl propionate, as additives belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is denied for use in water.

Article 3

The substances specified in the Annex and premixtures containing these substances, which are produced and  labelled before 26 November 2015 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted.

Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 26 May 2016 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 26 May 2017 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 4

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.

ANNEX