EN Official Journal of the European Union L 161/21

COMMISSION IMPLEMENTING REGULATION (EU) 2016/973

of 17 June 2016

concerning the authorisation of zinc bislysinate 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.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of Zinc chelate of L-Lysinate HCl accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) That application concerns the authorisation of Zinc chelate of L-Lysinate HCl 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 October 2015 (2) that, under the proposed conditions of use, Zinc chelate of L-Lysinate HCl does not have an adverse effect on animal or consumer health and that no safety concerns for users would arise provided that appropriate protective measures are taken.

(5) With respect to the impacts on the environment, in particular the drainage and run-off of zinc to surface water, the Authority recommended in its opinion of 8 April 2014 (3) to decrease significantly the maximum contents of zinc in complete feed for several target species. However, in order not to risk not meeting the physiological needs of animals also in special life periods or any other negative impacts on animal health, the decrease of zinc contents recommended by the Authority should not be introduced in one step. With the objective of further reductions, feed business operators and research institutes should be encouraged to collect new scientific data about the physiological needs of the different animal species.

(6) The Authority concluded furthermore that Zinc chelate of L-Lysinate HCl may be considered as an efficacious source of zinc for all animal species and recommended to name that substance zinc bislysinate. 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 Article 21 of Regulation (EC) No 1831/2003. The assessment of zinc bislysinate 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.

(7) 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 substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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, 17 June 2016. For the Commission The President Jean-Claude JUNCKER

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

(2) EFSA Journal 2015;13(11):4267.

(3) EFSA Journal 2014;12(5):3668.