LegalizeCommission 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | mg of total carotenoids/kg of complete feedingstuff with a moisture content of 12 % | mg of total carotenoids/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation | ||||||
| Category: Sensory additives. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin | Category: Sensory additives. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin | Category: Sensory additives. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin | Category: Sensory additives. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin | Category: Sensory additives. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin | Category: Sensory additives. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin | Category: Sensory additives. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin | Category: Sensory additives. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin | Category: Sensory additives. Functional group: Colourants. (ii) substances which, when fed to animals, add colours to food of animal origin | ||||||
| 2a161b | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Lutein-rich extract | Additive composition: Preparation of lutein-rich extract of Tagetes erecta L. with total carotenoids ≥ 0,5 % Benzene ≤ 2 mg/kg Hexane ≤ 290 mg/kg Solid or liquid form Characterisation of the active substance: Lutein from a saponified extract of Tagetes erecta L. (dried flowers petals) obtained via extraction with hexane and saponification: — Total carotenoids (TC): ≥ 60g/kg — Lutein ≥ 75 % of total carotenoids (TC) — Zeaxanthin ≥ 4 % of total carotenoids (TC) Chemical formula: C40H56O2 CAS number 127-40-2 (lutein) CAS number 144-68-3 (zeaxanthin) CoE number: 494 Analytical method [^E0001] For the determination of lutein, zeaxanthin and total carotenoids in the feed additive: — High performance liquid chromatography (HPLC) with spectrophotometry – FAO JECFA monograph ‘Lutein from Tagetes erecta’, Combined Compendium of Food Additive Specifications For the determination of total carotenoids (including lutein) in premixtures and compound feed: — Reversed-phase high performance liquid chromatography (HPLC) coupled to UV detection – EN 17550 | Other provisions | End of period of authorisation | 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. The mixture of lutein-rich extract with other authorised carotenoids shall not exceed a total carotenoids content of 80 mg/kg of complete feed. 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 and skin protection | 16.8.2030 |
| 2a161b | Laying hens and minor poultry for laying | - | - | 80 | Lutein-rich extract | Additive composition: Preparation of lutein-rich extract of Tagetes erecta L. with total carotenoids ≥ 0,5 % Benzene ≤ 2 mg/kg Hexane ≤ 290 mg/kg Solid or liquid form Characterisation of the active substance: Lutein from a saponified extract of Tagetes erecta L. (dried flowers petals) obtained via extraction with hexane and saponification: — Total carotenoids (TC): ≥ 60g/kg — Lutein ≥ 75 % of total carotenoids (TC) — Zeaxanthin ≥ 4 % of total carotenoids (TC) Chemical formula: C40H56O2 CAS number 127-40-2 (lutein) CAS number 144-68-3 (zeaxanthin) CoE number: 494 Analytical method [^E0001] For the determination of lutein, zeaxanthin and total carotenoids in the feed additive: — High performance liquid chromatography (HPLC) with spectrophotometry – FAO JECFA monograph ‘Lutein from Tagetes erecta’, Combined Compendium of Food Additive Specifications For the determination of total carotenoids (including lutein) in premixtures and compound feed: — Reversed-phase high performance liquid chromatography (HPLC) coupled to UV detection – EN 17550 | ||||||||
| 2a161bi | Lutein/zeaxanthin extract | Additive composition: Preparation of lutein/zeaxanthin extract of Tagetes erecta L. with total carotenoids ≥ 0,5 % Benzene ≤ 2 mg/kg Hexane ≤ 290 mg/kg Solid or liquid form Characterisation of the active substance: Lutein/zeaxanthin saponified/isomerised extract from dried flowers petals of Tagetes erecta L. obtained via extraction with hexane, saponification and isomerisation: — Total carotenoids (TC):≥ 60 g/kg — Lutein ≥ 37 % of TC; — Zeaxanthin ≥ 36 % of TC. CAS number 127-40-2(lutein) CAS number 144-68-3 (zeaxanthin) CoE number: 494 Chemical formula: C40H56O2 Analytical method [^E0001] For the determination of lutein, zeaxanthin and total carotenoids in the feed additive: — High performance liquid chromatography (HPLC) with spectrophotometry – FAO JECFA monograph ‘Lutein from Tagetes erecta’, Combined Compendium of Food Additive Specifications For the determination of total carotenoids (including lutein) in premixtures and compound feed: — Reversed-phase high performance liquid chromatography (HPLC) coupled to UV detection – EN 17550 | 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. The mixture of lutein/zeaxanthin extract with other authorised carotenoids shall not exceed a total carotenoids 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. 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 and skin protection. | 16.8.2030 | ||||||
| 2a161bi | Lutein/zeaxanthin extract | Additive composition: Preparation of lutein/zeaxanthin extract of Tagetes erecta L. with total carotenoids ≥ 0,5 % Benzene ≤ 2 mg/kg Hexane ≤ 290 mg/kg Solid or liquid form Characterisation of the active substance: Lutein/zeaxanthin saponified/isomerised extract from dried flowers petals of Tagetes erecta L. obtained via extraction with hexane, saponification and isomerisation: — Total carotenoids (TC):≥ 60 g/kg — Lutein ≥ 37 % of TC; — Zeaxanthin ≥ 36 % of TC. CAS number 127-40-2(lutein) CAS number 144-68-3 (zeaxanthin) CoE number: 494 Chemical formula: C40H56O2 Analytical method [^E0001] For the determination of lutein, zeaxanthin and total carotenoids in the feed additive: — High performance liquid chromatography (HPLC) with spectrophotometry – FAO JECFA monograph ‘Lutein from Tagetes erecta’, Combined Compendium of Food Additive Specifications For the determination of total carotenoids (including lutein) in premixtures and compound feed: — Reversed-phase high performance liquid chromatography (HPLC) coupled to UV detection – EN 17550 | Laying hens | - | - | 80 | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. The mixture of lutein/zeaxanthin extract with other authorised carotenoids shall not exceed a total carotenoids 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. 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 and skin protection. | 16.8.2030 | ||||||
| 2a161bi | Lutein/zeaxanthin extract | Additive composition: Preparation of lutein/zeaxanthin extract of Tagetes erecta L. with total carotenoids ≥ 0,5 % Benzene ≤ 2 mg/kg Hexane ≤ 290 mg/kg Solid or liquid form Characterisation of the active substance: Lutein/zeaxanthin saponified/isomerised extract from dried flowers petals of Tagetes erecta L. obtained via extraction with hexane, saponification and isomerisation: — Total carotenoids (TC):≥ 60 g/kg — Lutein ≥ 37 % of TC; — Zeaxanthin ≥ 36 % of TC. CAS number 127-40-2(lutein) CAS number 144-68-3 (zeaxanthin) CoE number: 494 Chemical formula: C40H56O2 Analytical method [^E0001] For the determination of lutein, zeaxanthin and total carotenoids in the feed additive: — High performance liquid chromatography (HPLC) with spectrophotometry – FAO JECFA monograph ‘Lutein from Tagetes erecta’, Combined Compendium of Food Additive Specifications For the determination of total carotenoids (including lutein) in premixtures and compound feed: — Reversed-phase high performance liquid chromatography (HPLC) coupled to UV detection – EN 17550 | Minor poultry for laying | - | - | 50 | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. The mixture of lutein/zeaxanthin extract with other authorised carotenoids shall not exceed a total carotenoids 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. 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 and skin protection. | 16.8.2030 |
Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.
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