Commission Implementing Regulation (EU) 2020/1400 of 5 October 2020 concerning the authorisation of ethyl ester of β-apo-8’-carotenoic acid as a feed additive for chickens for fattening, laying hens and minor poultry species for laying and for fattening (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1400
• Articles: 5

Article 1

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

Article 2

The authorised substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants’, shall not be used in water for drinking.

Article 3

1   The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 26 April 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until 26 October 2021.

2.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 26 October 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until 26 April 2022.

Article 4

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

Maximum residue levels

Other provisions

End of period of authorisation

mg of active substance / 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

2a160f

Ethyl ester of β-apo-8’-carotenoic acid;

Additive composition:

Ethyl ester of β-apo-8’-carotenoic acid.

Triphenyl phosphine oxide (TPPO) ≤ 100 mg/kg.

Chickens for fattening and minor poultry for fattening.

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15

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20 mg ethyl ester of β-apo-8’-carotenoic acid /kg egg yolk (wet tissue).

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8 mg ethyl ester of β-apo-8’-carotenoic acid/kg liver (wet tissue).

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2.5 mg ethyl ester of β-apo-8’-carotenoic acid/kg skin/fat (wet tissue).

1.

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

2.

Ethyl ester of β-apo-8’-carotenoic acid shall be placed on the market and used as an additive consisting of a preparation.

3.

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. 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.

26.10.2030

Characterisation of the active substance:

Ethyl ester of β-apo-8’-carotenoic acid.

Chemical formula: C 32 H 44 O 2

CAS number: 1109-11-1

Solid form produced by chemical synthesis.

Purity criteria: ≥ 97% all isomers.

Laying hens and minor poultry for laying.

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5

Analytical method

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For the quantification of ethyl ester of β-apo-8’-carotenoic acid in the feed additive preparation: spectrophotometry at 446 nm.

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For the quantification of ethyl ester of β-apo-8’-carotenoic acid in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 446 nm).

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