(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 4 July 2019 (2) and 25 May 2020 (3) that, under the proposed conditions of use, iron chelate of lysine and glutamic acid does not have an adverse effect on animal health and consumer safety. It also concluded that the additive is an eye irritant, skin and respiratory sensitizer, and stated a risk for the users of the additive upon inhalation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that that the additive does not pose an additional risk for the environment compared to other authorised compounds of iron and that it is an efficacious source of iron for all animal species. 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.
(5) The assessment of the additive shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are, subject to the relevant protective measures for the users of the additive, satisfied. Accordingly, the use of the additive should be authorised.
(6) 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, 30 November 2020.
For the Commission
The President
Ursula VON DER LEYEN
(1)
OJ L 268, 18.10.2003, p. 29
.
(2)
EFSA Journal
2019;17(7):5792.
(3)
EFSA Journal
18(6):6164.
ANNEX
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