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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionnote, and in particular Article 9(2) and Article 13(2) thereof,Whereas:
(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and modifying such authorisation.
(2)Lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta were authorised for 10 years as feed additives for poultry (except turkeys) for fattening and laying and for minor poultry species for fattening and laying by Commission Implementing Regulation (EU) 2020/1097note. In addition, a preparation of lutein-rich extract of Tagetes erecta L. was authorised for 10 years as a feed additive for turkeys for fattening by Commission Implementing Regulation (EU) 2025/1928note.
(3)In the context of the submission of the application for the authorisation of a new use of the additive lutein-rich extract from Tagetes erecta in feed for turkeys for fattening in accordance with Article 7 of Regulation (EC) No 1831/2003, the European Food Safety Authority (‘the Authority’) considered in its opinion of 18 September 2024note that the manufacturing process and the composition of the additive were not substantially changed in comparison with the lutein-rich extract as authorised by Implementing Regulation (EU) 2020/1097. The first part of the manufacturing process, which is similar to that used for the production of lutein/zeaxanthin extract, as mentioned in the Authority’s opinion of 3 April 2019note, is the extraction with hexane of the dried flower petals of Tagetes erecta. In its opinion of 18 September 2024 regarding the specifications of the additive lutein-rich extract, the Authority recommended that the presence of hexane in the additive should be below the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) Guideline limit of 290 mg/kg. The Authority, in its plenary meeting of the Panel on Additives and Products or Substances used in Animal Feed (‘FEEDAP’) of 24-26 June 2025note, stated that the same recommendation would also apply to the lutein/zeaxanthin extract currently authorised in the Union.
(4)In order to ensure that the additives lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta still meet the conditions provided for in Article 5 of Regulation (EC) No 1831/2003, the specification regarding the limit of 290 mg/kg of hexane in those additives should be reflected in the respective authorisations granted by Implementing Regulation (EU) 2020/1097, and hexane should be mentioned as solvent used in the extraction during the manufacturing process. Implementing Regulation (EU) 2020/1097 should therefore be amended accordingly.
(5)Implementing Regulation (EU) 2020/1097 also provides that the additives lutein-rich extract and lutein/zeaxanthin extract of Tagetes erecta must be placed on the market and used as additives consisting of a preparation, but the composition of such preparations has erroneously not been specified in the terms of the authorisation. A more accurate description of the additives authorised as preparations by Implementing Regulation (EU) 2020/1097 should be provided for, by specifying that the composition of the additives includes a total carotenoid content equal to or above 0,5 %, as specified in the Authority’ opinion of 3 April 2019. It is also appropriate to indicate the possible forms of the preparations, which may be liquid or solid, instead of the form of the active substance. Implementing Regulation (EU) 2020/1097 should therefore be corrected accordingly.
(6)Implementing Regulation (EU) 2020/1097 also provides that the mixture of the additives lutein-rich extract and lutein/zeaxanthin extract of Tagetes erecta with other authorised carotenoids and xanthophylls should not exceed the maximum content set for the corresponding animal categories. That provision should not refer to xanthophylls, in accordance with the recommendation in the Authority’s opinion of 3 April 2019, since xanthophylls are a subgroup of carotenoids. Implementing Regulation (EU) 2020/1097 should therefore be corrected accordingly.
(7)Implementing Regulation (EU) 2020/1097 was corrected by Implementing Regulation (EU) 2021/420 as regards certain provisions thereof. The end of the period of authorisation was changed in error to 30 September 2031, whereas it should not have been modified. Implementing Regulation (EU) 2020/1097 should therefore be corrected accordingly.
(8)The authorisation of the additive lutein-rich extract of Tagetes erecta by Implementing Regulation (EU) 2020/1097 and by Implementing Regulation (EU) 2025/1928 provides for similar terms of authorisation of that additive and should therefore include the same identification number. Implementing Regulation (EU) 2025/1928 should therefore be amended accordingly.
(9)On 15 January 2025, the Reference Laboratory set up by Regulation (EC) No 1831/2003 updated the report on the methods of analysis of lutein. The new method also applies to lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta as authorised by Implementing Regulation (EU) 2020/1097. Implementing Regulation (EU) 2020/1097 should therefore be amended accordingly.
(10)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from those modifications.
(11)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1Correction and amendment to Implementing Regulation (EU) 2020/1097#
The Annex to Implementing Regulation (EU) 2020/1097 is replaced by the Annex to this Regulation.
Article 2Amendment to Implementing Regulation (EU) 2025/1928#
In the first column of the Annex to Implementing Regulation (EU) 2025/1928, the identification number ‘2a161bii’ is replaced by ‘2a161b’.
Article 3Transitional measures#
1.The feed additives lutein-rich extract of Tagetes erecta and lutein/zeaxanthin extract from Tagetes erecta, as authorised by Implementing Regulation (EU) 2020/1097, and the feed additive lutein-rich extract from Tagetes erecta L., as authorised by Implementing Regulation (EU) 2025/1928, and premixtures containing those additives, which are produced and labelled before 10 February 2027 in accordance with the rules applicable before 10 August 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
2.Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 10 August 2027 in accordance with the rules applicable before 10 August 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
Article 4Entry into force#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
| 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:Preparation of lutein-rich extract of Tagetes erecta L. with total carotenoids ≥ 0,5 %Benzene ≤ 2 mg/kgHexane ≤ 290 mg/kgSolid or liquid formCharacterisation 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/kgLutein ≥ 75 % of total carotenoids (TC)Zeaxanthin ≥ 4 % of total carotenoids (TC)Chemical formula: C40H56O2CAS number 127-40-2 (lutein)CAS number 144-68-3 (zeaxanthin)CoE number: 494Analytical methodnoteFor 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 SpecificationsFor 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-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 |
| Laying hens and minor poultry for laying | - | - | 80 | |||||
| 2a161bi | Lutein/zeaxanthin extract | Additive composition:Preparation of lutein/zeaxanthin extract of Tagetes erecta L. with total carotenoids ≥ 0,5 %Benzene ≤ 2 mg/kgHexane ≤ 290 mg/kgSolid or liquid formCharacterisation 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/kgLutein ≥ 37 % of TC;Zeaxanthin ≥ 36 % of TC.CAS number 127-40-2(lutein)CAS number 144-68-3 (zeaxanthin)CoE number: 494Chemical formula: C40H56O2Analytical methodnoteFor 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 SpecificationsFor 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 |
| Laying hens | - | - | 80 | |||||
| Minor poultry for laying | - | - | 50 |
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