Article 1Authorisation#
The preparation 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’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Entry 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 feed 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 total carotenoids/kg complete feed with 12 % moisture content | ||||||||
| 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 compositionPreparation 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 substanceLutein from a saponified extract of Tagetes erecta L. (dried flowers petals) obtained via extraction with hexane and saponification:Total carotenoids (TC): ≥ 60 g/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 for 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 | Turkeys for fattening | 80 | 1. In the directions for use of the additive and premixtures, 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin and breathing protective equipment. | 16 October 2035 |
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