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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
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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
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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
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