Commission Implementing Regulation (EU) 2025/1423 of 17 July 2025 amending Implementing Regulation (EU) No 684/2014 as regards the terms of the authorisation of a preparation of canthaxanthin as a feed additive for breeder hens (holder of authorisation: DSM Nutritional Products Ltd.)

• CELEX: Implementing Regulation (EU) 2025/1423
• Articles: 4

Article 1 Amendment to Implementing Regulation (EU) No 684/2014

The Annex to Implementing Regulation (EU) No 684/2014 is replaced by the Annex to this Regulation.

Article 2 Transitional measures

1.   The feed additive canthaxanthin, as authorised by Implementing Regulation (EU) No 684/2014 and premixtures containing that additive, which are produced and labelled before 7 February 2026 in accordance with the rules applicable before 7 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.

2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 7 August 2026 in accordance with the rules applicable before 7 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.

Article 3 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

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: C 40 H 52 O 2

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