COMMISSION IMPLEMENTING REGULATION (EU) 2025/1402 of 16 July 2025 concerning the authorisation of tea tree essential oil from Melaleuca alternifolia (Maiden & Betche) Cheel as a feed additive for all animal species (Text with EEA relevance) ANNEX

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 tea tree essential oil from Melaleuca alternifolia (Maiden & Betche) Cheel, as authorised pursuant to Directive 70/524/EEC and premixtures containing this additive, which are produced and labelled before 6 February 2026 in accordance with the rules applicable before 6 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.

1. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 6 August 2026 in accordance with the rules applicable before 6 August 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.

1. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 6 August 2027 in accordance with the rules applicable before 6 August 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 16 July 2025.

For the Commission

The President

Ursula VON DER LEYEN

(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, 22(10), e9026. https://doi.org/10.2903/j.efsa.2024.9026.

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

2b275-eo

Tea tree essential oil

Additive composition

Essential oil from leaves and terminal branchlets of Melaleuca alternifolia (Maiden & Betche) Cheel (synonym: Melaleuca linariifolia var. alternifolia (Maiden and Bet.)

Liquid form

Characterisation of active substance

Tea tree essential oil:

Essential oil, as defined by the Council of Europe (CoE) (1), obtained from the leaves and terminal branchlets of Melaleuca alternifolia (Maiden & Betche) Cheel by steam distillation and further condensation of volatile constituents and separation from water by decantation.

CAS number: 68647-73-4

Einecs number: 285-377-1

FEMA number: 3902

CoE number: 275

Specifications:

—

4-Terpinenol: 30-48 %

—

γ-Terpinene: 10-28 %

—

α-Terpinene: 5-13 %

—

1,8-Cineole (eucalyptol): < 15 %

—

Methyleugenol: ≤ 0,01 %

Analytical method

(2)

For the determination of 4-terpinenol (phytochemical marker) in the feed additive:

—

gas chromatography coupled with flame ionization detection (GC-FID) (ISO 4730)

Turkeys for fattening

1,5

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

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

Mixture of tea tree essential oil with other botanical additives is permitted provided that the amounts of methyleugenol in feed materials and compound feed is lower than the one resulting from the use of a single additive at the maximum or recommended content for the species or animal category.

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.

6 August 2035

Chickens for fattening and minor poultry for fattening