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Official Journal EN
of the European Union L series
2025/276 13.2.2025
COMMISSION IMPLEMENTING REGULATION (EU) 2025/276
of 12 February 2025
concerning the authorisation of clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry 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) The substance clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry was authorised without a time limit in
accordance with Directive 70/524/EEC as a feed additive for all animal species. This substance was subsequently
entered in the Register of Feed Additives as an existing product, in accordance with Article 10(1), point (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 authorisation of clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry
as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘sensory
additives’ and in the functional group ‘flavouring compounds’. 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 ‘flavouring compounds’ for use in water for drinking. Therefore,
the use of this additive in water for drinking should not be allowed.
(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 April 2024(3) that clove
tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry is very unlikely to be of safety concern for the target
species at the proposed use level. Furthermore, it concluded that no safety concern would arise for consumers and
the environment from the use of clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry at the proposed
use levels in feed. The Authority concluded that clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry
should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The Authority further
concluded that since the flower buds of Syzygium aromaticum (L.) Merr. & L.M. Perry and their preparations are
recognised to flavour food and their function in feed would be essentially the same as that in food, no further
demonstration of efficacy is considered necessary. It 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.
(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 2024; 22(5):8791.
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OJ L, 13.2.2025
(6) In view of the above, the Commission considers that clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry
satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that
substance should be authorised as specified in the Annex to this Regulation. The Commission considers that the
presence of the substances of concern, methyleugenol and estragole, requires the setting of maximum content in
complete feed and that a mixture of clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry with other
botanical additives is permitted provided that the amounts of the same substances of concern in feed materials and
compound feed are lower than the one resulting from the use of a single additive at the maximum or recommended
content for the species or animal category. 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.
(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 ‘sensory additives’ and to the functional group
‘flavouring compounds’, 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 clove tincture from Syzygium aromaticum (L.) Merr. & L.M. Perry, 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 2026 in accordance with the rules applicable 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 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.
2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/276/ojEN
OJ L, 13.2.2025
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
ELI: http://data.europa.eu/eli/reg_impl/2025/276/oj 3/5ANNEX
Minimum Maximum
content content
Identification Species or
Composition, chemical formula, description, Maximum End of period of
number of the Additive category mg of additive/kg of Other provisions
analytical method age authorisation
feed additive of animal complete feedingstuff
with a moisture content
of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b188-t Clove Additive composition All 1. The additive shall be 5 March 2035
tincture Tincture from the dried flower buds of Syzygium animal incorporated into the feed
aromaticum (L.) Merr. & L.M. Perry (synonym: species — — 50 in the form of a premixture.
Eugenia caryophyllata Thunb.) except
Equidae 2. In the directions for use of
Liquid form the additive and
Equidae — — 200
premixtures, the storage
Characterisation of active substance conditions and the stability
to heat treatment shall be
Clove tincture indicated.
Tincture as defined by the Council of Europe(1) 3. Mixture of clove tincture
obtained from the dried flower buds of Syzygium with other botanical
aromaticum (L.) Merr. & L.M. Perry by extended additives is permitted
extraction with a water/ethanol solvent mixture, provided that the amounts of
pressing and filtration. methyleugenol and estragole
in feed materials and
CoE number: 188 compound feed are lower
than the one resulting from
Specifications the use of a single additive at
— Dry matter content: 1,57–1,77 % the maximum or
— Total polyphenols(2): ≤ 0,541 % recommended content for
— Flavonoids: ≤ 0,0418 % the species or animal
— Eugenol: ≤ 0,00497 % category.
— Eugenyl acetate: < 0,00017 mg/mL
— Methyleugenol: ≤ 0,00022 %
— Estragole: ≤ 0,00009 %
4/5
ELI:
http://data.europa.eu/eli/reg_impl/2025/276/oj
EN
OJ
L,
13.2.2025Minimum Maximum
content content
Identification Species or
Composition, chemical formula, description, Maximum End of period of
number of the Additive category mg of additive/kg of Other provisions
analytical method age authorisation
feed additive of animal complete feedingstuff
with a moisture content
of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
Analytical method(3) 4. For users of the additive and
premixtures, feed business
For the characterisation of the feed additive: operators shall establish
— spectrophotometry for the determination operational procedures and
of total polyphenols and total flavonoids organisational measures to
— gas chromatography coupled with flame address potential risks
ionisation detection (GC-FID) for the resulting from their use.
determination of eugenol (phytochemical Where those risks cannot be
marker), estragole, methyleugenol and eliminated by such
eugenyl acetate procedures and measures,
the additive and premixtures
shall be used with personal
skin, eye and breathing
protective equipment.
(1) Natural sources of flavourings – Report No 2 (2007).
(2) Expressed as gallic acid equivalent (GAE).
(3) 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/2025/276/oj
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