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

• CELEX: Implementing Regulation (EU) 2025/276
• Articles: 4

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 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 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 of additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b188-t

Clove tincture

Additive composition

Tincture from the dried flower buds of Syzygium aromaticum (L.) Merr. & L.M. Perry (synonym: Eugenia caryophyllata Thunb.)

Liquid form

Characterisation of active substance

Clove tincture

Tincture as defined by the Council of Europe  ( 1 ) obtained from the dried flower buds of Syzygium aromaticum (L.) Merr. & L.M. Perry by extended extraction with a water/ethanol solvent mixture, pressing and filtration.

CoE number: 188

Specifications

—

Dry matter content: 1,57–1,77 %

—

Total polyphenols  ( 2 ) : ≤ 0,541 %

—

Flavonoids: ≤ 0,0418 %

—

Eugenol: ≤ 0,00497 %

—

Eugenyl acetate: < 0,00017 mg/mL

—

Methyleugenol: ≤ 0,00022 %

—

Estragole: ≤ 0,00009 %

Analytical method

( 3 )

For the characterisation of the feed additive:

—

spectrophotometry for the determination of total polyphenols and total flavonoids

—

gas chromatography coupled with flame ionisation detection (GC-FID) for the determination of eugenol (phytochemical marker), estragole, methyleugenol and eugenyl acetate

All animal species except Equidae

—

—

50

1.

The additive shall be incorporated into the feed in the form of a premixture.

2.

In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.

3.

Mixture of clove tincture with other botanical additives is permitted provided that the amounts of methyleugenol and estragole 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.

4.

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

Equidae

—

—

200

( 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 .