Commission Implementing Regulation (EU) 2025/281

Contents

Article 1Authorisation#

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 2Transitional 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 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.

Article 3Entry 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.

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 compositionPropyl gallate ≥ 97 %Solid formSulphated ash < 0,1 %Gallic acid < 0,5 %Chlorinated organic compounds < 100 mg/kgCharacterisation of the active substancePropyl gallateProduced by esterification of gallic acid from gallnutsChemical formula: C₁₀H₁₂0₅CAS No: 121-79-9Analytical method^noteFor 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)	BovinesSheepGoatsCervidsCamelidsSows of all Suidae speciesEquinesSalmonids 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.	5 March 2035
Ornamental fish	100
Chickens for fatteningMinor poultry for fattening and reared for laying or reared for reproductionOrnamental birds	15
Turkeys for fatteningLaying hensMinor poultry species for laying or for reproductionLeporids			20
Piglets of all Suidae speciesAll Suidae species for fattening and reared for reproduction	27
DogsCats	71
			All other animal species			15