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

Type Implementing Regulation

Publication 2025-02-12

State In force

Department European Commission, SANTE

Source EUR-Lex

Reform history JSON API

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

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.

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: C10H1205 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.	5 March 2035
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.

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