Authorisation
The preparation 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.
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 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
Maximum residues limits in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: other zootechnical additives (stabilisation of reproductive performance)
4d161g
DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o.
Canthaxanthin
Additive composition
Preparation containing minimum:
10 % of canthaxanthin;
≤ 2,2 % ethoxyquin;
dichloromethane: ≤ 10 mg/kg additive.
Characterisation of the active substance
canthaxanthin
C 40 H 52 O 2
CAS No: 514-78-3
Assay: Minimum 96 %
Produced by chemical synthesis
Analytical method
( 1 )
—
For the determination of canthaxanthin in the feed additive: spectrophotometry (426 nm)
—
For the determination of canthaxanthin in premixtures and feedingtuffs: Normal Phase High Performance Liquid Chromatography coupled to VIS detection (NP-HPLC-VIS, 466 nm)
Breeder hens
—
6
6
1.
In the directions for use of the additive and premixture, indicate the storage conditions and stability to heat processing.
2.
The mixture of different sources of canthaxanthin shall not exceeded 6 mg canthaxanthin/kg of complete feedingstuff.
3.
The mixture of this preparation with canthaxanthin and other carotenoids is allowed provided that the total concentration of the mixture does not exceed 80 mg/kg of complete feedingstuff.
4.
For user safety: breathing protection, safety glasses and gloves should be worn during handling.
10 July 2024
15 mg canthaxanthin/kg liver (wet tissue) and 2,5 mg canthaxanthin/kg skin/fat (wet tissue)
( 1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/eurl-feed-additives