Commission Implementing Regulation (EU) 2021/420 of 9 March 2021 correcting Implementing Regulation (EU) 2020/1097 concerning the authorisation of lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta as feed additives for poultry (except turkeys) for fattening and laying and for minor poultry species for fattening and laying (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/420
• Articles: 3

Article 1

The Annex to Regulation (EU) 2020/1097 is replaced by the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

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 total carotenoids/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

2a161b

Lutein-rich extract

Additive composition

Lutein-rich extract of Tagetes erecta

Benzene ≤ 2mg/kg

Chickens for fattening and minor poultry for fattening

-

-

80

1.

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

2.

Lutein-rich extract must be placed on the market and used as an additive consisting of a preparation.

3.

The mixture of lutein-rich extract with other authorised carotenoids and xanthophylls shall not exceed a total carotenoids and xanthophylls content of 80 mg/kg of complete feed.

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. 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 and skin protection

30.3.2031

Characterisation of the active substance

Lutein from a saponified extract of Tagetes erecta (dried flowers petals) obtained via extraction and saponification:

—

Total carotenoids (TC):≥ 60g/kg

—

Lutein ≥ 75 % of total carotenoids (TC)

—

Zeaxanthin≥ 4 % of total carotenoids (TC)

Chemical formula: C 40 H 56 O 2

CAS number 127-40-2 (lutein)

CAS number 144-68-3 (zeaxanthin)

CoE number: 494

Liquid form

Laying hens and minor poultry for laying.

-

-

80

Analytical method

( 1 )

—

For the determination of lutein (all-trans-lutein isomer only), zeaxanthin and total carotenoids and xanthophylls in the feed additive: high Performance Liquid Chromatography (HPLC) with spectrophotometry – Commission Regulation (EU) No 231/2012 referring to FAO JECFA monograph “lutein from Tagetes erecta ” monograph No 3 (2006), Combined Compendium for Food Additive Specifications

—

For the determination of lutein (all-trans-lutein isomer only) in premixtures and feedingstuffs: high Performance Liquid Chromatography with visible detection (HPLC-Vis)

—

For the determination of total carotenoids and xanthophylls in premixtures and feedingstuffs: liquid chromatography with visible detection (LC-Vis) – AOAC official method 970.64

2a161bi

Lutein/zeaxanthin extract

Additive composition

Lutein/zeaxanthin extract of Tagetes erecta.

Benzene ≤ 2mg/kg

Chickens for fattening and minor poultry for fattening

-

-

80

1.

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

2.

Lutein/zeaxanthin extract must be placed on the market and used as an additive consisting of a preparation.

3.

The mixture of lutein/zeaxanthin extract with other authorised carotenoids and xanthophylls shall not exceed a total carotenoids and xanthophylls content of:

a.

80 mg/kg of complete feed for chickens for fattening, minor poultry for fattening and laying hens.

b.

50 mg/kg of complete feed for minor poultry for laying.

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. 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 and skin protection.

30.3.2031

Characterisation of the active substance

Lutein/zeaxanthin saponified/isomerised extract of Tagetes erecta (dried flowers petals) obtained via extraction, saponification and isomerisation:

—

Total carotenoids (TC):≥ 60g/kg

—

Lutein ≥ 37 % of TC;

—

Zeaxanthin ≥ 36 % of TC.

Liquid form

CAS number 127-40-2(lutein)

CAS number 144-68-3 (zeaxanthin)

CoE number: 494

Chemical formula: C 40 H 56 O 2

Laying hens

80

Minor poultry for laying.

50

Analytical method

( 1 )

For the determination of lutein (all-trans-lutein isomer only), zeaxanthin and total carotenoids and xanthophylls in the feed additive:

—

High Performance Liquid Chromatography (HPLC) with spectrophotometry – Commission Directive 2008/128/EC referring to FAO JECFA monograph “lutein from Tagetes erecta ” monograph No 3 (2006), Combined Compendium for Food Additive Specifications

For the determination of lutein (all-trans-lutein isomer only) in premixtures and feedingstuffs:

—

High Performance Liquid Chromatography with visible detection (HPLC-Vis)

For the determination of total carotenoids and xanthophylls in premixtures and feedingstuffs:

—

Liquid chromatography with visible detection (LC-Vis) – AOAC official method 970.64

-

-

’

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