LegalizeCommission Implementing Regulation (EU) No 684/2014 of 20 June 2014 concerning the authorisation of canthaxanthin as a feed additive for breeder hens (holder of the authorisation DSM Nutritional products Ltd) Text with EEA relevance
Article 1
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.
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.
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 | 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; — maximum 4,4 % of butylated hydroxytoluene. Impurities: — dichloromethane: ≤ 80 mg/kg additive. Solid form. Characterisation of the active substance Canthaxanthin produced by chemical synthesis or with Yarrowia lipolytica CBS 146148. Chemical formula: C40H52O2 CAS Number: 514-78-3 Purity: minimum 96 % of total colouring matters (expressed as canthaxanthin) Carotenoids other than canthaxanthin: not more than 5 % of total colouring matters. 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 treatment. 2. The mixture of different sources of the active substance canthaxanthin shall not exceed 6 mg canthaxanthin/kg of complete feedingstuff. 3. The mixture of this additive with other additives containing canthaxanthin and/or other carotenoids is allowed provided that the total concentration of the mixture does not exceed 80 mg total carotenoids/kg of complete feedingstuff. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the 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 breathing, eye and skin protective equipment. | 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 |
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.