Commission Implementing Regulation (EU) 2020/1097 of 24 July 2020 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)

Article 1

The substances 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’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.

Article 2

The authorised substances specified in the Annex 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 16 February 2021 in accordance with the rules applicable before 16 August 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

2. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 16 August 2021 in accordance with the rules applicable before 16 August 2020 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

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 .

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
2a161b
Lutein-rich extract
Additive composition:
Lutein-rich extract of Tagetes erecta
Benzene ≤ 2mg/kg
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
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
Poultry for fattening (except turkeys) 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
16.8.2030
Poultry for laying (except turkeys) and minor poultry for laying
-
-
80
2a161bi
Lutein/zeaxanthin extract
Additive composition:
Lutein/zeaxanthin extract of Tagetes erecta.
Benzene ≤ 2mg/kg
Characterisation of the active substance:
Lutein/zeaxanthin saponified/isomerised extract from dried flowers petals of Tagetes erecta 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
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
Poultry for fattening (except turkeys) and minor poultry for fattening
-
-
50
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 50 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.
16.8.2030
Poultry for laying (except turkeys) and minor poultry for laying.
-
-
50
( 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

Schedules & Appendices

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