Commission Implementing Regulation (EU) 2023/341 of 15 February 2023 concerning the renewal of the authorisation of vitamin E as a feed additive for all animal species and repealing Regulation (EU) No 26/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/341
• Articles: 5

Article 1

The authorisation of the substance and preparations specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemical well-defined 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Regulation (EU) No 26/2011 is repealed.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 specified in the Annex and premixtures containing them, which are produced and labelled before 8 September 2023 in accordance with the rules applicable before 8 March 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance and preparations specified 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 stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substance and preparations specified 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 market and used until the existing stocks are exhausted if they are intended for non-food producing animals.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

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 additive/kg of complete feedingstuff with a moisture content of 12 %

Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect

3a700

‘Vitamin E’ or ‘all-rac-alpha-tocopheryl acetate’

Additive composition

All-rac-alpha-tocopheryl acetate

Liquid form

Characterisation of active substance

All-rac-alpha-tocopheryl acetate

C 31 H 52 O 3

CAS number: 7695-91-2

Purity: > 93 %

Produced by chemical synthesis

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.

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 contents shall be used:

—

1 mg all-rac-alpha-tocopheryl acetate = 1 IU

4.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin protection.

8 March 2033

Analytical method

( 1 )

1.

For the determination of vitamin E (oil form) in feed additives: European Pharmacopoeia Ph. Eur. 07/2011:0439.

2.

For the determination of vitamin E (powder form) in feed additives: European Pharmacopoeia Ph. Eur. 01/2011:0691.

3.

For the determination of the level of authorised vitamin E in compound feed: Commission Regulation (EC) No 152/2009  ( 2 ) .

3a700i

‘Vitamin E’ or ‘all-rac-alpha-tocopheryl acetate’

Additive composition

Preparation containing ≥ 50 % all-rac-alpha-tocopheryl acetate

Solid form

Characterisation of active substance

All-rac-alpha-tocopheryl acetate

C 31 H 52 O 3

CAS number: 7695-91-2

Purity: > 93 %

Produced by chemical synthesis

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.

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 contents shall be used:

—

1 mg all-rac-alpha-tocopheryl acetate = 1 IU

4.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin protection.

8 March 2033

Analytical method

( 1 )

1.

For the determination of vitamin E (oil form) in feed additives: European Pharmacopoeia Ph. Eur. 07/2011:0439.

2.

For the determination of vitamin E (powder form) in feed additives: European Pharmacopoeia Ph. Eur. 01/2011:0691.

3.

For the determination of the level of authorised vitamin E in compound feed: Regulation (EC) No 152/2009  ( 2 ) .

3a700ii

‘Vitamin E’ or ‘RRR-alpha-tocopheryl acetate’

Additive composition

Preparation containing ≥ 25 % RRR-alpha-tocopheryl acetate

Solid form

Characterisation of active substance

RRR-alpha-tocopheryl acetate

C 31 H 52 O 3

CAS number: 58-95-7

Purity: > 40 %

Chemically synthesised from vegetable oils.

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.

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 contents shall be used:

—

1 mg RRR-alpha-tocopheryl acetate = 1,36 IU

4.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin protection.

8 March 2033

Analytical method

( 1 )

1.

For the determination of vitamin E (oil form) in feed additives: European Pharmacopoeia EP-1257.

2.

For the determination of vitamin E (powder form) in feed additives: European Pharmacopoeia Ph. Eur. 01/2011:0691.

3.

For the determination of the level of authorised vitamin E in compound feed: Regulation (EC) No 152/2009  ( 2 ) .

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.

( 2 )   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 ).