Commission Implementing Regulation (EU) 2015/1415 of 20 August 2015 concerning the authorisation of astaxanthin as a feed additive for fish, crustaceans and ornamental fish (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/1415
• Articles: 4

Article 1

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants’ is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 10 March 2016 in accordance with the rules applicable before 10 September 2015 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 10 September 2016 in accordance with the rules applicable before 10 September 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for fish.

3.   Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 10 September 2017 in accordance with the rules applicable before 10 September 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for ornamental fish.

Article 3

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

mg/kg of active substance of complete feedingstuff with a moisture content of 12 %

Category of sensory additives. Functional group: a. colourants (ii) substances which, when fed to animals, add colours to food of animal origin

2a161j

—

Astaxanthin

Additive composition

Astaxanthin

Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg

Dichloromethane ≤ 600 mg/kg

Characterisation of the active substance

Astaxanthin

C 40 H 52 O 4

CAS No: 7542-45-2

Astaxanthin, solid form, produced by chemical synthesis

Purity criteria:

—

Assay (expressed as astaxanthin): min 96 % of total colouring matters.

—

Carotenoids other than astaxanthin: max 5 % of total colouring matters.

Method of Analysis

( 1 )

—

For the quantification of Astaxanthin in the feed additive preparation: spectrophotometry at 431 nm.

—

For the quantification of Astaxanthin in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 470 nm).

Fish

—

—

100

1.

Astaxanthin may be placed on the market and used as an additive consisting of a preparation.

2.

In the directions for use of the additive and premixtures, indicate the stability and storage conditions.

3.

The mixture of astaxanthin with other carotenoids and xanthophylls shall not exceed 100 mg/kg of complete feed (moisture content 12 %).

4.

For safety: breathing protection, safety glasses and gloves shall be worn during handling.

10 September 2025

Crustaceans

—

—

100

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

mg/kg of active substance of complete feedingstuff with a moisture content of 12 %

Category of sensory additives. Functional group: a. colourants (iii) substances which favourably affect the colour of ornamental fish or birds

2a161j

—

Astaxanthin

Additive composition

Astaxanthin

Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg

Dichloromethane ≤ 600 mg/kg

Characterisation of the active substance

Astaxanthin

C 40 H 52 O 4

CAS No: 7542-45-2

Astaxanthin, solid form, produced by chemical synthesis

Purity criteria:

—

Assay (expressed as astaxanthin): min 96 % of total colouring matters.

—

Carotenoids other than astaxanthin: max 5 % of total colouring matters.

Method of Analysis

( 2 )

—

For the quantification of Astaxanthin in the feed additive preparation: spectrophotometry at 431 nm.

—

For the quantification of Astaxanthin in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 470 nm).

Ornamental fish

—

—

100

1.

Astaxanthin may be placed on the market and used as an additive consisting of a preparation.

2.

In the directions for use of the additive and premixtures, indicate the stability and storage conditions.

3.

The mixture of astaxanthin with other carotenoids and xanthophylls shall not exceed 100 mg/kg of complete feed (moisture content 12 %).

4.

For safety: breathing protection, safety glasses and gloves shall be worn during handling.

10 September 2025

( 1 )   Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.

( 2 )   Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.