Commission Implementing Regulation (EU) 2020/998 of 9 July 2020 concerning the renewal of the authorisation of astaxanthin-dimethyldisuccinate as a feed additive for fish and crustaceans and repealing Regulation (EC) No 393/2008 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/998
• Articles: 4

Article 1

The authorisation of the additive specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants: (ii) substances which, when fed to animals, add colours to food of animal origin’ for all salmon and trout species, is renewed and the terms of its authorisation are modified subject to the conditions laid down in that Annex.

Article 2

Regulation (EC) No 393/2008 is repealed.

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

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

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

2a165

Astaxanthin-dimethyldisuccinate

Additive composition:

Astaxanthin-dimethyldisuccinate

Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg

Dichloromethane ≤ 600 mg/kg

Characterisation of the active substance:

Astaxanthin-dimethyldisuccinate

Chemical formula: C 50 H 64 O 10

Solid form produced by chemical synthesis.

CAS number 578006-46-9

Purity criteria

Astaxanthin-dimethyldisuccinate (all-E, 9-Z and 13-Z isomers) ≥ 96 %

Other carotenoids ≤ 4 %

Analytical method

( 1 )

For the quantification of astaxanthin dimethyldisuccinate in the feed additive:

—

spectrophotometry at 486 nm.

For the quantification of astaxanthin dimethyldisuccinate in the feed additive, premixtures and feedingstuffs:

—

normal phase high performance liquid chromatography coupled to UV/VIS detection (HPLC-UV/VIS).

Fish and crustaceans

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-

138

1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

2.

Astaxanthin-dimethyldisuccinate must be placed on the market and used as an additive consisting of a preparation

3.

If astaxanthin- dimethyldisuccinate is mixed with canthaxanthin and other astaxanthin sources, the total content of the mixture shall not exceed 100 mg astaxanthin equivalent  ( 2 ) /kg in complete feedingstuffs.

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use, including the risks of those additives included in the preparation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eye, skin and breathing protection.

30.7.2030

( 1 )   https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

( 2 )   1,38 mg astaxanthin- dimethyldisuccinate is equivalent to 1 mg astaxanthin.