COMMISSION IMPLEMENTING REGULATION (EU) 2019/8

of 3 January 2019

concerning the authorisation of hydroxy analogue of methionine and its calcium salt 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.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of hydroxy analogue of methionine and its calcium salt as a feed additive for use in feed for all animal species. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of hydroxy analogue of methionine and its calcium salt as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 February 2018 (2) that, under the proposed conditions of use, hydroxy analogue of methionine and its calcium salt does not have an adverse effect on animal health, human health or the environment.

(5) The Authority also concluded that the additive is an effective source of methionine for all animal species and that, even though the ruminal degradation of the additive in ruminants is lower than that of DL-methionine, the additive should be protected against degradation in the rumen.

(6) 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.

(7) The assessment of this additive shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

(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 Authorisation The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’ is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2 Entry into force 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, 3 January 2019. For the Commission The President Jean-Claude JUNCKER

(1) OJ L 268, 18.10.2003, p. 29.

(2) EFSA Journal 2018;16(3):5198.