Commission Implementing Regulation (EU) 2025/281 of 12 February 2025 concerning the authorisation of propyl gallate as a feed additive for all animal species

Official Journal EN of the European Union L series 2025/281 13.2.2025 COMMISSION IMPLEMENTING REGULATION (EU) 2025/281 of 12 February 2025 concerning the authorisation of propyl gallate as a feed additive for all animal species (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 2003on 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 an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2).

(2) Propyl gallate was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That substance was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(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, an application was submitted for the re-evaluation of propyl gallate as a feed additive for all animal species. The applicant requested the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘antioxidants’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4) The applicant requested the additive to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of technological additives for use in water for drinking. Therefore, the use of the additive in water for drinking should not be allowed.

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 17 March 2020(3)and 31 January 2024(4)(as readopted on 26 June 2024) that propyl gallate is safe for all animal species and for consumers at certain maximum concentrations further specified in the opinions and for the environment. The Authority also concluded that propyl gallate is irritant to skin and eyes, it is a dermal sensitiser and that exposure via inhalation is possible and it is considered a hazard. The Authority further concluded that the additive has the potential to act as an antioxidant in feedingstuffs for all animal species. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6) In view of the above, the Commission considers that propyl gallate satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance 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 additive.

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

(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1, ELI: http:// data.europa.eu/eli/dir/1970/524/oj).

(3) EFSA Journal 2020;18(4):6069.

(4) EFSA Journal. 2024;22:e8638.

ELI: http://data.europa.eu/eli/reg_impl/2025/281/oj 1/5EN OJ L, 13.2.2025

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

(8) 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 substance specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘antioxidants’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Transitional measures

1. The feed additive propyl gallate, as authorised pursuant to Directive 70/524/EEC and premixtures containing this additive, which are produced and labelled before 5 September 2025 in accordance with the rules applicable before 5 March 2025may continue to be placed on the market and used until the stocks concerned are exhausted.

2. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 5 March 2026in accordance with the rules applicable before 5 March 2025may 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 additive referred to in paragraph 1, which are produced and labelled before 5 March 2027in accordance with the rules applicable before 5 March 2025may 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 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, 12 February 2025.

For the Commission The President Ursula VON DER LEYEN 2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/281/ojANNEX Minimum Maximum Identifica- content content End of tion Composition, chemical formula, description, Species or category Maximum period of number Additive mg active substance/kg Other provisions analytical method of animal age authorisa- of the feed complete feedingstuff tion additive with 12 % moisture content

Category: technological additives. Functional group: antioxidants 1b310 Propyl gallate Additive composition Bovines - - 40 1. In the directions for use of the Propyl gallate ≥ 97 % additive and premixtures, the Sheep storage conditions and stability to Solid form heat treatment shall be indicated.

Goats Sulphated ash < 0,1 % Gallic acid < 0,5 % Cervids Chlorinated organic compounds < 100 mg/ Camelids kg 2. For users of the additive and Sows of all premixtures, feed business Characterisation of the active substance Suidae species operators shall establish Propyl gallate operational procedures and organisational measures to address Equines Produced by esterification of gallic acid from potential risks resulting from their gallnuts use. Where those risks cannot be Salmonids and eliminated by such procedures and

Chemical formula: C 10H 120 5 minor fin fish measures, the additive and premixtures shall be used with Ornamental fish 100

CAS No: 121-79-9 personal skin, eye and breathing protective equipment.

ELI:

http://data.europa.eu/eli/reg_impl/2025/281/oj 3/5 OJ L,

13.2.2025 ENMinimum Maximum Identifica- content content End of tion Composition, chemical formula, description, Species or category Maximum period of number Additive mg active substance/kg Other provisions analytical method of animal age authorisa- of the feed complete feedingstuff tion additive with 12 % moisture content

Category: technological additives. Functional group: antioxidants Analytical method(1) Chickens for 15 For the quantification of propyl gallate in the fattening

feed additive:

Minor poultry for fattening and — Spectrophotometry at 275 nm reared for laying (European Pharmacopoeia monograph or reared for

1039) reproduction For the quantification of propyl gallate in

premixtures and compound feed: Ornamental birds — Reversed Phase High Performance Turkeys for 20 Liquid Chromatography coupled to fattening UltraViolet-Diode-Array Detection (RP-HPLC-UV(DAD), 285 nm) Laying hens Minor poultry species for laying or for reproduction Leporids 4/5

ELI:

http://data.europa.eu/eli/reg_impl/2025/281/oj EN OJ L,

13.2.2025Minimum Maximum Identifica- content content End of tion Composition, chemical formula, description, Species or category Maximum period of number Additive mg active substance/kg Other provisions analytical method of animal age authorisa- of the feed complete feedingstuff tion additive with 12 % moisture content

Category: technological additives. Functional group: antioxidants Piglets of all 27 Suidae species All Suidae species for fattening and reared for reproduction Dogs 71 Cats All other animal 15 species

(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/2025/281/oj 5/5 OJ L,

13.2.2025 EN