Commission 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

• CELEX: Implementing Regulation (EU) No 684/2014
• Articles: 3

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 .

Schedules & Appendices

ANNEX

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