COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/341 
of 15 Febr uary 2023
concer ning the renewal of the author isation of vitamin E as a feed additiv e for all animal species and 
repealing Regulation (EU) No 26/2011 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting and renewing such author isation.
(2) Vitamin E was author ised for 10 years as a feed additive for all animal species by Commission Regulation (EU) 
No 26/2011 (2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, five applications were submitted for the renewal 
of the author isation of vitamin E in the form of all-rac-alpha-toco pher yl acetat e and one for the renewal of the 
author isation of vitamin E in the form of RRR -alpha-toco pher yl acetate as feed additives for all animal species, 
requesting the additives to be classif ied in the additive categor y ‘nutr itional additives ’ and the functional group 
‘vitamins, pro-vitamins and chemical well-def ined substances having similar effect’. Those applications were 
accompan ied by the particulars and documents required under Article 14(2) of that Regulation.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinions of 17 March 2021 (3)and 
10 November 2021 (4)that the applicants have provid ed evidence that vitamin E remains safe for all animal species, 
the consumers and the environment under the conditions of use currently author ised and that no concer n for user 
safety is expecte d from the use of the active substance. The Auth ority could not conclude, due to the lack of 
information, on its skin sensitisation poten tial.
(5) In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (5), the Reference 
Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations 
reach ed in the previous assessments are applicable for the current applications.
(6) The assessment of vitamin E shows that the conditions for author isation, as provid ed for in Article 5 of Regulation 
(EC) No 1831/2003, are satisfied. According ly, the author isation of that additive should be renewed.
(1)OJ L 268, 18.10.2003, p. 29.
(2)Commission Regulation (EU) No 26/2011 of 14 Januar y 2011 concer ning the author isation of vitamin E as a feed additive for all 
animal species (OJ L 11, 15.1.2011, p. 18).
(3)EFSA Journal 2021;19(4):6529, 6530, 6531, 6532 and 6533.
(4)EFSA Journal 2021;19(12):6974.
(5)Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implement ation of Regulation (EC) 
No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference 
Laborato ry concer ning applications for author isations of feed additives (OJ L 59, 5.3.2005, p. 8).EN Offi cial Jour nal of the European Union 16.2.2023 L 48/19  (7) The Commission considers that appropr iate protect ive measures should be taken to prevent adverse effects on 
human health, in particular as regards the users of the additives. Those protective measures should compl y with 
Union legislation on worker safety requirements.
(8) As a consequence of the renewal of the author isation of vitamin E in the form of all-rac-alpha-tocophery l acetat e and 
of vitamin E in the form of RRR -alpha-toco pher yl acetat e as feed additives, as well as the expir y of the author isation 
of vitamin E in the form of RRR -alpha-toco pherol, Regulation (EU) No 26/2011 should be repealed.
(9) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
of vitamin E, it is appropr iate to provide for a transitional period for interest ed parties to prepare themselves to meet 
the new requirements resulting from the renewal of the author isation.
(10) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
The author isation of the substance and preparations specifi ed in the Annex, belonging to the additive categor y ‘nutr itional 
additives ’ and to the functional group ‘vitamins, pro-vitamins and chemical well-def ined substances having similar effect’, is 
renewed subject to the conditions laid down in that Annex.
Article 2
Regulation (EU) No 26/2011 is repealed.
Article 3
1. The substance and preparations specifi ed in the Annex and premixtures containing them, which are produced and 
labelled before 8 Sept ember 2023 in accordance with the rules applicable before 8 March 2023 may continue to be placed 
on the mark et and used until the existing stoc ks are exhaust ed.
2. Com pound feed and feed mate rials containing the substance and preparations specifi ed in the Annex which are 
produced and labelled before 8 March 2024 in accordance with the rules applicable before 8 March 2023 may continue to 
be placed on the market and used until the existing stoc ks are exhausted if they are intende d for food-producing animals.
3. Com pound feed and feed mate rials containing the substance and preparations specifi ed in the Annex which are 
produced and labelled before 8 March 2025 in accordance with the rules applicable before 8 March 2023 may continue to 
be placed on the mark et and used until the existing stoc ks are exhausted if they are intended for non-f ood producing 
animals.
Article 4
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.EN Offi cial Jour nal of the European Union L 48/20 16.2.2023  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 Febr uary 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 16.2.2023 L 48/21  ANNEX 
Identifica -
tion 
number of 
the additiveAdditiveCompo sition, chem ical formula, 
descr iption, analytical methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation mg of additive/kg of 
complet e feedingstuff with a 
moisture conten t of 12 %
Categor y of nutr itional additiv es. Functional group: vitamins, pro-vita mins and chemically well-def ined subst ances havin g similar effect
3a700 ‘Vitamin E’ or ‘all-rac- 
alpha-tocopheryl 
acetate’Additive composition
All-rac-alpha-t ocopher yl acetat e
Liquid form
Char acter isation of active substance
All-rac-alpha-t ocopher yl acetat e
C31H52O3
CAS number: 7695-91-2
Purity: > 93 %
Produced by chemical synthesisAll animal 
species- - - 1.In the directions for use of the 
additive and premixtures, the sto­
rage conditions and stability to 
heat treatment shall be indicated.
2.The additive may be used also via 
water for drinking.
3.If vitamin E content is mentioned 
in the labelling, the following 
equivalencies for the units of 
measurement of the conte nts 
shall be used:
—1 mg all-rac-alpha-toco ­
pher yl acetat e = 1 IU
4.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational mea ­
sures to address poten tial risks re­
sulting from their use. Where 
those risks cannot be eliminated 
or reduced to a minimum by such 
procedures and measures, the ad­
ditive and premixtures shall be 
used with personal protective 
equipment, including skin pro­
tectio n.8 March 2033
Analytical method (1)
1.For the deter mination of vitamin 
E (oil form) in feed additives: 
European Phar macopoeia Ph. 
Eur. 07/2011:0439.
2.For the deter mination of vitamin 
E (powder form) in feed additives: 
European Phar macopoeia Ph. 
Eur. 01/2011:0691.
3.For the determi nation of the level 
of author ised vitamin E in com ­
pound feed: Commission Regula ­
tion (EC) No 152/2009 (2).EN Offi cial Jour nal of the European Union L 48/22 16.2.2023  3a700i ‘Vitamin E’ or ‘all-rac- 
alpha-tocopheryl 
acetate’Additive composition
Preparation containing ≥ 50 % all- 
rac-alpha-tocophe ryl acetat e
Solid form
Char acter isation of active substance
All-rac-alpha-t ocopher yl acetat e
C31H52O3
CAS number: 7695-91-2
Purity: > 93 %
Produced by chemical synthesisAll animal 
species- - - 1.In the directions for use of the 
additive and premixtures, the sto­
rage conditions and stability to 
heat treatment shall be indicated.
2.The additive may be used also via 
water for drinking.
3.If vitamin E content is mentioned 
in the labelling, the following 
equivalencies for the units of 
measurement of the conte nts 
shall be used:
—1 mg all-rac-alpha-toco ­
pher yl acetat e = 1 IU
4.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational mea ­
sures to address poten tial risks re­
sulting from their use. Where 
those risks cannot be eliminated 
or reduced to a minimum by such 
procedures and measures, the ad­
ditive and premixtures shall be 
used with personal protective 
equipment, including skin pro­
tectio n.8 March 2033
Analytical method (1)
1.For the deter mination of vitamin 
E (oil form) in feed additives: 
European Phar macopoeia Ph. 
Eur. 07/2011:0439.
2.For the deter mination of vitamin 
E (powder form) in feed additives: 
European Phar macopoeia Ph. 
Eur. 01/2011:0691.
3.For the determi nation of the level 
of author ised vitamin E in com ­
pound feed: Regulation (EC) 
No 152/2009 (2).EN Offi cial Jour nal of the European Union 16.2.2023 L 48/23  3a700ii ‘Vitamin E’ or ‘RRR - 
alpha-tocopheryl 
acetate’Additive composition
Preparation containing ≥ 25 % RRR - 
alpha-tocopheryl acetat e
Solid form
Char acter isation of active substance
RRR -alpha-tocophery l acetat e
C31H52O3
CAS number: 58-95-7
Purity: > 40 %
Chemically synthesised from 
veget able oils.All animal 
species- - - 1.In the directions for use of the 
additive and premixtures, the sto­
rage conditions and stability to 
heat treatment shall be indicated.
2.The additive may be used also via 
water for drinking.
3.If vitamin E content is mentioned 
in the labelling, the following 
equivalencies for the units of 
measurement of the conte nts 
shall be used:
— 1 mg RRR -alpha-toco pher yl 
acetat e = 1,36 IU
4.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational mea ­
sures to address poten tial risks re­
sulting from their use. Where 
those risks cannot be eliminated 
or reduced to a minimum by such 
procedures and measures, the ad­
ditive and premixtures shall be 
used with personal protective 
equipment, including skin pro­
tectio n.8 March 2033
Analytical method (1)
1.For the deter mination of vitamin 
E (oil form) in feed additives: 
European Phar macopoeia 
EP-1257.
2.For the deter mination of vitamin 
E (powder form) in feed additives: 
European Phar macopoeia Ph. 
Eur. 01/2011:0691.
3.For the determi nation of the level 
of author ised vitamin E in com ­
pound feed: Regulation (EC) 
No 152/2009 (2).
(1)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor ts.
(2)Commission Regulation (EC) No 152/2009 of 27 Januar y 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).EN Offi cial Jour nal of the European Union L 48/24 16.2.2023