Commission Implementing Regulation (EU) 2026/2084 of 18 September 2026 concerning 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 and repealing Implementing Regulation (EU) 2015/1152

Official Journal EN of the European Union L series 2026/2084 21.9.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/2084 of 18 September 2026 concerning 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 and repealing Implementing Regulation (EU) 2015/1152 (Text with EEA relevance) 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 nutrition(1), 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) 2015/1152(2).

(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 2026(3)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.

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) Commission Implementing Regulation (EU) 2015/1152 of 14 July 2015 concerning 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 (OJ L 187, 15.7.2015, p. 5, ELI: http://data.europa.eu/eli/reg_impl/2015/1152/oj).

(3) EFSA Journal2026;24:e9917, https://doi.org/10.2903/j.efsa.2026.9917.

ELI: http://data.europa.eu/eli/reg_impl/2026/2084/oj 1/7EN OJ L, 21.9.2026

(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 2012(4),(5) are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(6), 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 1 Renewal 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 2 Repeal Implementing Regulation (EU) 2015/1152 is repealed.

(4) EFSA Journal2012;10(7):2783, https://doi.org/10.2903/j.efsa.2012.2783.

(5) EFSA Journal2012;10(7):2784, https://doi.org/10.2903/j.efsa.2012.2784.

(6) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation

(EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/ 2005/378/oj).

2/7 ELI: http://data.europa.eu/eli/reg_impl/2026/2084/ojEN OJ L, 21.9.2026 Article 3 Transitional 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 4 Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 September 2026.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2026/2084/oj 3/7ANNEX Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period of number of the category of Other provisions additive analytical method age mg of active substance/kg of authorisation additive animal complete feed with a moisture content of 12 %

Category: technological additives. Functional group: antioxidants.

1b306i Tocopherol Additive composition All animal — — — 1. In the directions for use of the 11 October extracts from Alpha-, beta-, gamma- and delta- species additive and premixtures, the 2036 vegetable oils tocopherols. storage conditions and stability with total tocopherols min. 30 %. to heat treatment shall be indicated.

Liquid oily form

2. For users of the additive and Characterisation of the active substance premixtures, feed business Alpha-, beta-, gamma- and delta- operators shall establish

tocopherols: operational procedures and — C H O 29 50 2 organisational measures to — C H O 28 48 2 address potential risks — C H O 28 48 2 resulting from their use. Where — C H O 27 46 2 those risks cannot be

CAS No: eliminated by such procedures — 59-02-9 and measures, the additive and — 16698-35-4 premixtures shall be used with — 54-28-4 personal protective — 119-13-1 equipment, including skin, eye Tocopherol extracts, produced by and breathing protection.

extraction from vegetable oils.

Purity criteria: total tocopherols min. 30 %.

Impurities:

Zearalenone(1) Analytical method(2) For 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).

4/7

ELI:

http://data.europa.eu/eli/reg_impl/2026/2084/oj EN OJ L,

21.9.2026Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period of number of the category of Other provisions additive analytical method age mg of active substance/kg of authorisation additive animal complete feed with a moisture content of 12 % 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(3))

(1) It should be ensured that the vegetable oils, from which the tocopherol extracts are produced, are produced from corn and oilseeds that comply with the guidance value levels established for zearalenone in corn and oilseeds destined for feed.

(2) 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

(3) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1, ELI: http://data.europa.eu/eli/reg/ 2009/152/oj).

Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period of number of the category of Other provisions additive analytical method age mg of active substance/kg of authorisation additive animal complete feed with a moisture content of 12 %

Category: technological additives. Functional group: antioxidants.

1b306ii Tocopherol- Additive composition All animal — — — 1. In the directions for use of the 11 October rich extracts Alpha-, beta-, gamma- and delta- species additive and premixtures, the 2036 from tocopherols. storage conditions and stability vegetable oils with total tocopherols min. 80 % with to heat treatment shall be (delta delta-tocopherol min. 70 %. indicated.

rich) Liquid oily form

ELI:

http://data.europa.eu/eli/reg_impl/2026/2084/oj 5/7 OJ L,

21.9.2026 ENMinimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period of number of the category of Other provisions additive analytical method age mg of active substance/kg of authorisation additive animal complete feed with a moisture content of 12 % Characterisation of the active substance 2. For users of the additive and Alpha-, beta-, gamma- and delta- premixtures, feed business

tocopherols: operators shall establish

Chemical formula: operational procedures and — C H O organisational measures to 29 50 2 — C H O address potential risks 28 48 2 — C H O resulting from their use. Where 28 48 2 — C H O those risks cannot be 27 46 2

CAS No: eliminated by such procedures — 59-02-9 and measures, the additive and — 16698-35-4 premixtures shall be used with — 54-28-4 personal protective — 119-13-1 equipment, including skin, eye and breathing protection.

Tocopherol-rich extracts (delta rich), produced by extraction from vegetable oils.

Purity criteria: total tocopherols min. 80 % with delta-tocopherol min. 70 %.

Analytical method(1) For 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).

(1) 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.

6/7

ELI:

http://data.europa.eu/eli/reg_impl/2026/2084/oj EN OJ L,

21.9.2026Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period of number of the category of Other provisions additive analytical method age mg of active substance/kg of authorisation additive animal complete feed with a moisture content of 12 %

Category: technological additives. Functional group: antioxidants.

1b307 Alpha- Additive composition All animal — — — 1. In the directions for use of the 11 October tocopherol Alpha-tocopherol min. 96 % species additive and premixtures, the 2036 storage conditions and stability Liquid oily form to heat treatment shall be indicated.

Characterisation of the active substance All-rac-alpha-tocopherol.

2. For users of the additive and C H O 29 50 2 premixtures, feed business

CAS No: 10191-41-0 operators shall establish Alpha-tocopherol, produced by chemical operational procedures and synthesis. Purity criteria: min. 96 %. organisational measures to address potential risks Analytical method(1) resulting from their use. Where For the determination of all-rac-alpha- those risks cannot be

tocopherol in the feed additive: eliminated by such procedures — Gas Chromatography coupled to Flame and measures, the additive and Ionisation detection, GC-FID, including premixtures shall be used with several identification tests (European personal protective Pharmacopeia monograph 0692) equipment, including skin, eye For the determination of alpha-tocopherol and breathing protection.

in premixtures and compound feed: — High-Performance Liquid Chromatography coupled to Ultraviolet or Fluorescence Detection, HPLC- UV/FLD (Regulation

(EC) No 152/2009).

(1) 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.

ELI:

http://data.europa.eu/eli/reg_impl/2026/2084/oj 7/7 OJ L,

21.9.2026 EN