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.
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.
ANNEXSupplementary provisions
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 .