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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) 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 renewing such an authorisation.
(2)Tocopherol extracts from vegetable oils, tocopherol-rich extracts from vegetable oils (delta rich) and alpha-tocopherol were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) 2015/1152note.
(3)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of tocopherol extracts from vegetable oils, tocopherol-rich extracts from vegetable oils (delta rich) and alpha-tocopherol as feed additives for all animal species, requesting the additives to be classified in the additive category ‘technological additives’ and in the functional group ‘antioxidants’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2026note that, the use of vitamin E in the form of tocopherol extracts from vegetable oils, tocopherol-rich extracts from vegetable oils (delta rich) and alpha-tocopherol remains safe for the target species, consumers and the environment under the conditions of use currently authorised. It also concluded that tocopherol extracts from vegetable oils, tocopherol-rich extracts from vegetable oils (delta rich) and alpha-tocopherol, should be considered skin and respiratory sensitisers. Exposure of users by inhalation and dermal routes is considered a risk. It could not conclude on the eye irritation potential due to the lack of data. The Authority also stated that the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additives. Therefore, it concluded that there is no need for assessing the efficacy of the additives in the context of the renewal of the authorisation.
(5)The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinions of 12 June 2012note,note are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005note, an evaluation report of the Reference Laboratory was therefore not required.
(6)In view of the above, the Commission considers that the tocopherol extracts from vegetable oils, tocopherol-rich extracts from vegetable oils (delta rich) and alpha-tocopherol satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of those additives should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.
(7)As a consequence of the renewal of the authorisation of tocopherol extracts from vegetable oils, tocopherol-rich extracts from vegetable oils (delta rich) and alpha-tocopherol as feed additives, Implementing Regulation (EU) 2015/1152 should be repealed.
(8)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of tocopherol extracts from vegetable oils, tocopherol-rich extracts from vegetable oils (delta rich) and alpha-tocopherol for all animal species, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
(9)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 1Renewal of the authorisation#
The authorisations of the substances specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘antioxidants’, are renewed subject to the conditions laid down in that Annex.
Article 2Repeal#
Implementing Regulation (EU) 2015/1152 is repealed.
Article 3Transitional measures#
1.Tocopherol extracts from vegetable oils, tocopherol-rich extracts from vegetable oils (delta rich) and alpha-tocopherol, as authorised by Implementing Regulation (EU) 2015/1152, and premixtures containing those additives, which are intended for all animal species, and which are produced and labelled before 11 April 2027 in accordance with the rules applicable before 11 October 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 intended for all animal species and which are produced and labelled before 11 October 2027 in accordance with the rules applicable before 11 October 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.
3.Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are intended for all animal species and which are produced and labelled before 11 October 2028 in accordance with the rules applicable before 11 October 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.
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 | Name of the 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/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: antioxidants. | ||||||||
| 1b306i | Tocopherolextracts fromvegetable oils | Additive compositionAlpha-, beta-, gamma- and delta-tocopherols.with total tocopherols min. 30 %.Liquid oily formCharacterisation of the active substanceAlpha-, beta-, gamma- and delta-tocopherols:C29H50O2C28H48O2C28H48O2C27H46O2CAS No:59-02-916698-35-454-28-4119-13-1Tocopherol extracts, produced by extraction from vegetable oils.Purity criteria: total tocopherols min. 30 %.Impurities:ZearalenonenoteAnalytical methodnoteFor the determination of tocopherol forms (alpha-, beta-, gamma- and delta-tocopherol) in the feed additive:Gas Chromatography coupled to Flame Ionisation Detection, GC-FID (AOAC 988.14).For the determination of tocopherol forms (alpha-, beta-, gamma- and delta-tocopherol) in premixtures and compound feed:High-Performance Liquid Chromatography coupled to Ultraviolet or Fluorescence Detection, HPLC-UV/FLD (Commission Regulation (EC) No 152/2009) | All animal species | — | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2. 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 protective equipment, including skin, eye and breathing protection. | 11 October 2036 |
| Identification number of the additive | Name of the 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/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: antioxidants. | ||||||||
| 1b306ii | Tocopherol-rich extractsfrom vegetable oils (deltarich) | Additive compositionAlpha-, beta-, gamma- and delta-tocopherols.with total tocopherols min. 80 % with delta-tocopherol min. 70 %.Liquid oily formCharacterisation of the active substanceAlpha-, beta-, gamma- and delta-tocopherols:Chemical formula:C29H50O2C28H48O2C28H48O2C27H46O2CAS No:59-02-916698-35-454-28-4119-13-1Tocopherol-rich extracts (delta rich), produced by extraction from vegetable oils.Purity criteria: total tocopherols min. 80 % with delta-tocopherol min. 70 %.Analytical methodnoteFor the determination of tocopherol forms (alpha-, beta-, gamma- and delta-tocopherol) in the feed additive:Gas Chromatography coupled to Flame Ionisation Detection, GC-FID (AOAC 988.14).For the determination of tocopherol forms (alpha-, beta-, gamma- and delta-tocopherol) in premixtures and compound feed:High-Performance Liquid Chromatography coupled to Ultraviolet or Fluorescence Detection, HPLC-UV/FLD (Regulation (EC) No 152/2009). | All animal species | — | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2. 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 protective equipment, including skin, eye and breathing protection. | 11 October 2036 |
| Identification number of the additive | Name of the 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/kg of complete feed with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: antioxidants. | ||||||||
| 1b307 | Alpha-tocopherol | Additive compositionAlpha-tocopherol min. 96 %Liquid oily formCharacterisation of the active substanceAll-rac-alpha-tocopherol.C29H50O2CAS No: 10191-41-0Alpha-tocopherol, produced by chemical synthesis. Purity criteria: min. 96 %.Analytical methodnoteFor the determination of all-rac-alpha-tocopherol in the feed additive:Gas Chromatography coupled to Flame Ionisation detection, GC-FID, including several identification tests (European Pharmacopeia monograph 0692)For the determination of alpha-tocopherol in premixtures and compound feed:High-Performance Liquid Chromatography coupled to Ultraviolet or Fluorescence Detection, HPLC-UV/FLD (Regulation (EC) No 152/2009). | All animal species | — | — | — | 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2. 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 protective equipment, including skin, eye and breathing protection. | 11 October 2036 |
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