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Commission Implementing Regulation (EU) 2023/1417 of 5 July 2023 concerning the authorisation of butyric acid, ethyl butyrate, ethyl isobutyrate, ethyl isovalerate, methyl isovalerate, 2-methyl-2-pentenoic acid, 6-methylhept-5-en-2-one, undecan-2-one, octan-2-one, nonan-2-one, octan-3-one, tridecan-2-one, 5-methylhept-2-en-4-one, dodecano-1,5-lactone, tetradecano-1,5-lactone, 5-methylfurfural, 4-phenylbut-3-en-2-one, p-anisyl alcohol, 4-methoxybenzaldehyde, piperonal, vanillin, p-anisyl acetate, benzyl benzoate, isobutyl salicylate, isopentyl salicylate, benzyl salicylate and diphenyl ether as feed additives for all animal species (Text with EEA relevance)

Type Implementing Regulation

Publication 2023-07-06

State In force

Text As published

Department European Commission, SANTE

Source EUR-Lex

articles 3

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

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6.7.2023	EN	Official Journal of the European Union	L 171/11

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 such authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC ².

(2) The substances butyric acid, ethyl butyrate, ethyl isobutyrate, ethyl isovalerate, methyl isovalerate, 2-methyl-2-pentenoic acid, 6-methylhept-5-en-2-one, undecan-2-one, octan-2-one, nonan-2-one, octan-3-one, tridecan-2-one, 5-methylhept-2-en-4-one, dodecano-1,5-lactone, tetradecano-1,5-lactone, 5-methylfurfural, 4-phenylbut-3-en-2-one, p-anisyl alcohol, 4-methoxybenzaldehyde, piperonal, vanillin, p-anisyl acetate, benzyl benzoate, isobutyl salicylate, isopentyl salicylate, benzyl salicylate and diphenyl ether were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of Feed Additives as existing products belonging to the functional group of flavouring compounds, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.

(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, several applications were submitted for the authorisation of the above-mentioned substances as feed additives for all animal species. The applicant requested the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4) The applicant requested the additives to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the applicant withdrew the application for water for drinking for all the substances concerned.

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 25 April 2012 ³, 13 June 2012 ⁴, 26 October 2012 ⁵, 12 March 2013 ⁶, 20 October 2015 ⁷, 26 January 2016 ⁸, 25 May 2016 ⁹, 10 January 2020 ¹⁰, 28 January 2020 ¹¹ and 7 January 2023 ¹² that, under the proposed conditions of use, the substances concerned are safe for all animal species, consumers and the environment.

(6) The Authority also indicated that the safety data sheets required in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council ¹³ demonstrate that for butyric acid, ethyl butyrate, ethyl isobutyrate, ethyl isovalerate, methyl isovalerate and 2-methyl-2-pentenoic acid, 6-methylhept-5-en-2-one, undecan-2-one, octan-2-one, nonan-2-one, octan-3-one, tridecan-2-one, for dodecano-1,5-lactone, tetradecano-1,5-lactone, p-anisyl alcohol, 4-methoxybenzaldehyde, piperonal, vanillin, p-anisyl acetate, benzyl benzoate, isobutyl salicylate, isopentyl salicylate, benzyl salicylate and diphenyl ether some hazards are identified for skin and eye contact and respiratory exposure. As regards 5-methylhept-2-en-4-one, 5-methylfurfural and 4-phenylbut-3-en-2-one, the Authority concluded that due to the lack of new evidence on the effects of those additives on the respiratory system, skin and eyes it is not in a position to conclude on the safety for the use of those three substances.

(7) The Authority finally concluded that all the substances concerned are recognised to flavour food and their function in feed would be essentially the same as that in food. Therefore, no further demonstration of efficacy is considered necessary. The Authority considered that there was no need for specific requirements of post-market monitoring. It also checked the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(8) Certain conditions should be provided for to allow better control. In particular, a recommended maximum content should be indicated on the label of the feed additives. Where such content is exceeded, certain information should be indicated on the label of premixtures.

(9) The fact that the substances concerned are not authorised for use as flavourings in water for drinking does not preclude their use in compound feed which is administered via water.

(10) The assessment of all the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised. 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.

(11) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(12) 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

Authorisation

The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Transitional measures

The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 26 January 2024 in accordance with the rules applicable before 26 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

Compound feed and feed materials containing the substances specified in the Annex, which are produced and labelled before 26 July 2024 in accordance with the rules applicable before 26 July 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.

Compound feed and feed materials containing the substances specified in the Annex, which are produced and labelled before 26 July 2025 in accordance with the rules applicable before 26 July 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 3

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, 5 July 2023.

For the Commission

The President

Ursula VON DER LEYEN

OJ L 268, 18.10.2003, p. 29.

Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

EFSA Journal 2012;10(5):2678.

EFSA Journal 2012;10(7):2785.

EFSA Journal 2012;10(10):2928.

EFSA Journal 2013;11(4):3169.

EFSA Journal 2015;13(11):4268.

EFSA Journal 2016;14(2):4389.

EFSA Journal 2016;14(6):4512.

EFSA Journal 2020;18(2):6002.

EFSA Journal 2020;18(2):6017.

EFSA Journal 2023;21(1):7713.

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

ANNEX

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