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

• CELEX: Implementing Regulation (EU) 2025/281
• Articles: 4

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 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 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.

Schedules & Appendices

ANNEX

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 .