18.6.2016   

EN

Official Journal of the European Union

L 161/21

(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,