Commission Implementing Regulation (EU) 2024/3162 of 18 December 2024 concerning the authorisation of ferric tyrosine chelate as a feed additive for all poultry species for fattening, all poultry species reared for laying, and turkeys and minor poultry species reared for breeding (holder of authorisation: Akeso Biomedical, Inc. USA, represented in the Union by Pen & Tec Consulting SLU)

Official Journal EN of the European Union L series 2024/3162 19.12.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/3162 of 18 December 2024 concerning the authorisation of ferric tyrosine chelate as a feed additive for all poultry species for fattening, all poultry species reared for laying, and turkeys and minor poultry species reared for breeding (holder of authorisation: Akeso Biomedical, Inc. USA, represented in the Union by Pen & Tec Consulting SLU) (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 2003on 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 ferric tyrosine chelate. 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 ferric tyrosine chelate as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening, minor poultry species to point of lay, turkeys for fattening and rearing to point of lay, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional groups ‘gut flora stabilisers’ and ‘other zootechnical additives’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 23 January 2019(2)and 14 March 2024(3) that, under the proposed conditions of use, ferric tyrosine chelate is safe for the target species, the consumers and the environment. It also concluded that the additive poses a risk to users by inhalation, and should also be considered as an irritant to skin, eyes and mucous membranes. Due to the presence of nickel, ferric tyrosine chelate should also be considered as a dermal and respiratory sensitiser. The Authority further concluded that, under the proposed conditions of use, ferric tyrosine chelate has the potential to improve zootechnical parameters of birds and to reduce the caecal load of Campylobacter spp. by at least 1 log10-units in the target species, thus with a potential impact to reduce the risk of human campylobacteriosis. The Authority recommended including a specification for maximum lithium content in a potential authorisation of the additive, while it did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed and water submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) On 24 July 2024, the applicant informed the Commission that the maximum nickel content in the additive is now set at 20 mg nickel/kg of feed additive instead of 50 mg/kg, and the maximum lithium content in the additive is now set at 50 mg lithium/kg of feed additive instead of 1 200mg/kg. In addition, on 10 July 2024, the applicant withdrew the application as regards the authorisation of ferric tyrosine chelate in the functional group ‘gut flora stabilisers’.

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) EFSA Journal 2019; 17(2):5608.

(3) EFSA Journal 2024; 22:e8734.

ELI: http://data.europa.eu/eli/reg_impl/2024/3162/oj 1/4EN OJ L, 19.12.2024

(6) In view of the above, the Commission considers that ferric tyrosine chelate satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of ferric tyrosine chelate should be authorised. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(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 Authorisation The substance specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an 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, 18 December 2024.

For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2024/3162/ojANNEX Minimum Maximum Identifica- Name of the Species or content content tion number Composition, chemical formula, End of period of holder of Additive category of Maximum age Other provisions of the feed description, analytical method authorisation authorisation animal mg/kg of complete feedingstuff additive with a moisture content of 12 %

Category: zootechnical additives. Functional group: other zootechnical additives (reduction of the caecal load of Campylobacter spp.) 4d28 Akeso Ferric Additive composition All poultry – 20 200 1. In the directions for 8 January 2035 Biomedical, tyrosine Ferric tyrosine chelate having a species for use of the additive Inc. USA, chelate minimum content of 820 g/kg fattening and premixtures, represented in total tyrosine, 80 g/kg iron the storage the Union by and 60 g/kg total nitrogen. All poultry conditions and Pen & Tec 50–100 g/kg of a graphite species stability to heat Consulting SLU coloured microtracer. reared for treatment shall be

Impurities: laying indicated. — Nickel ≤ 20 mg/kg 2. For users of the Turkeys — Lithium ≤ 50 mg/kg additive and and minor Solid form. premixtures, feed poultry business operators Characterisation of the active species shall establish substance reared for operational

Ferric tyrosine chelate: breeding procedures and — C 27H 30FeN 3O 9 organisational — CAS number: 202406-43-7 measures to Produced by chemical synthesis. address potential risks resulting from Analytical method(1) their use. Where For the quantification of total those risks cannot

iron in the feed additive: be eliminated by — inductively coupled plasma- such procedures atomic emission and measures, the spectrometry, ICP-AES (EN additive and

15510); or premixtures shall be used with personal skin, eye and breathing protective equipment.

ELI:

http://data.europa.eu/eli/reg_impl/2024/3162/oj 3/4 OJ L,

19.12.2024 ENMinimum Maximum Identifica- Name of the Species or content content tion number Composition, chemical formula, End of period of holder of Additive category of Maximum age Other provisions of the feed description, analytical method authorisation authorisation animal mg/kg of complete feedingstuff additive with a moisture content of 12 %

Category: zootechnical additives. Functional group: other zootechnical additives (reduction of the caecal load of Campylobacter spp.) — inductively coupled plasma- atomic emission spectrometry, ICP-AES (EN

15621) with pressure digestion; or — atomic absorption spectrometry, AAS (EN ISO

6869).

For the determination of tyrosine

in the feed additive: ion exchange chromatography method with post-column derivatisation and photometric detection (Commission Regulation (EC) No 152/2009).

For the determination of the added content of ferric tyrosine chelate in premixtures and

compound feed: enumeration of colour coated particles of the graphite coloured microtracer present at fixed mass ratio in the feed additive.

(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evalua tion-reports_en.

4/4

ELI:

http://data.europa.eu/eli/reg_impl/2024/3162/oj EN OJ L,

19.12.2024