COMMISSION IMPLEMENTING REGULATION (EU) 2022/1457

of 2 September 2022

amending Implementing Regulation (EU) 2017/2330 as regards the terms of authorisation of iron (II) chelate of amino acids hydrate 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 13(3) 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 an authorisation.

(2) The use of iron (II) chelate of amino acids hydrate as a feed additive was authorised for all animal species by Commission Implementing Regulation (EU) 2017/2330 (2).

(3) In accordance with Article 13(1) of Regulation (EC) No 1831/2003, the Commission requested the European Food Safety Authority (‘the Authority’) to issue an opinion on whether the authorisation of iron (II) chelate of amino acids hydrate as a feed additive would still meet the conditions laid down in Article 5 of Regulation (EC) No 1831/2003, if modified as proposed by the applicant. That modification consists in the extension of the protein sources for the amino acids and in the introduction of a minimum specification for free amino acids and of a tighter specification of the iron content. The request was accompanied by the relevant supporting data.

(4) The Authority concluded in its opinion of 29 September 2021 (3) that the modifications of the terms of authorisation applied for do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the feed additive. The Authority concluded that the additive should be considered a skin and eye irritant and a skin sensitizer, and stated a potential risk due to exposure by 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 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 proposed modifications to the authorisation shows that the conditions for authorisation as provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.

(6) For reasons of clarity, the composition of the additive should be modified to include the indication that the additive consists of a preparation.

(7) Implementing Regulation (EU) 2017/2330 should therefore be amended accordingly.

(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 In the Annex to Implementing Regulation (EU) 2017/2330, the entry for iron (II) chelate of amino acids hydrate is amended in accordance with the Annex to this Regulation.

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, 2 September 2022. For the Commission The President Ursula VON DER LEYEN

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

(2) Commission Implementing Regulation (EU) 2017/2330 of 14 December 2017 concerning the authorisation of Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate as feed additives for all animal species and of Iron dextran as feed additive for piglets and amending Regulations (EC) No 1334/2003 and (EC) No 479/2006 (OJ L 333, 15.12.2017, p. 41).

(3) EFSA Journal 2021;19(10):6894.