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

Authorisation

Article 1

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.

Transitional measures

Article 2

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 2025 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 additive referred to in paragraph 1, which are produced and labelled before 5 March 2026 in accordance with the rules applicable before 5 March 2025 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 additive referred to in paragraph 1, which are produced and labelled before 5 March 2027 in accordance with the rules applicable before 5 March 2025 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.

Entry into force

Article 3

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

ANNEXSupplementary provisions

ANNEX Identification number of the feed 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 active substance/kg complete feedingstuff with 12 % moisture content Category: technological additives. Functional group: antioxidants 1b310 Propyl gallate Additive composition Propyl gallate ≥ 97 % Solid form Sulphated ash < 0,1 % Gallic acid < 0,5 % Chlorinated organic compounds < 100 mg/kg Characterisation of the active substance Propyl gallate Produced by esterification of gallic acid from gallnuts Chemical formula: C 10 H 12 0 5 CAS No: 121-79-9 Analytical method  ( 1 ) For the quantification of propyl gallate in the feed additive: — Spectrophotometry at 275 nm (European Pharmacopoeia monograph 1039) For the quantification of propyl gallate in premixtures and compound feed: — Reversed Phase High Performance Liquid Chromatography coupled to UltraViolet-Diode-Array Detection (RP-HPLC-UV(DAD), 285 nm) Bovines Sheep Goats Cervids Camelids Sows of all Suidae species Equines Salmonids and minor fin fish - - 40 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. 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 by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.   Ornamental fish 100 Chickens for fattening Minor poultry for fattening and reared for laying or reared for reproduction Ornamental birds 15 Turkeys for fattening Laying hens Minor poultry species for laying or for reproduction Leporids     20     Piglets of all Suidae species All Suidae species for fattening and reared for reproduction 27 Dogs Cats 71       All other animal species     15     ( 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 .