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)

• CELEX: Implementing Regulation (EU) 2024/3162
• Articles: 3

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.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the feed additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg/kg of complete feedingstuff with a moisture content of 12 %

Category: zootechnical additives. Functional group: other zootechnical additives (reduction of the caecal load of Campylobacter spp.)

4d28

Akeso Biomedical, Inc. USA, represented in the Union by Pen & Tec Consulting SLU

Ferric tyrosine chelate

Additive composition

Ferric tyrosine chelate having a minimum content of 820 g/kg total tyrosine, 80 g/kg iron and 60 g/kg total nitrogen.

50–100 g/kg of a graphite coloured microtracer.

Impurities:

—

Nickel ≤ 20 mg/kg

—

Lithium ≤ 50 mg/kg

Solid form.

Characterisation of the active substance

Ferric tyrosine chelate:

—

C 27 H 30 FeN 3 O 9

—

CAS number: 202406-43-7

Produced by chemical synthesis.

Analytical method

( 1 )

For the quantification of total iron in the feed additive:

—

inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15510); or

—

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.

All poultry species for fattening

All poultry species reared for laying

Turkeys and minor poultry species reared for breeding

–

20

200

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.

8 January 2035

( 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-evaluation-reports_en .