Commission Implementing Regulation (EU) 2025/279 of 12 February 2025 concerning the authorisation of cajeput essential oil from Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L. as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2025/279
• 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 cajeput essential oil derived from Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L., 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 of additive/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b276-eo

Cajeput essential oil

Additive composition

Essential oil from the leaves of Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L.

Liquid form

Characterisation of active substance

Cajeput essential oil

Essential oil as defined by the Council of Europe  ( 1 ) extracted by steam distillation from the leaves of Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L.

CAS number: 8008-98-8 for essential oil from Melaleuca leucandendron L .

Einecs number: 931-800-6

FEMA number: 2225

CoE number: 276

Specifications

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1,8-Cineole (eucalyptol): 50-70 %

—

α -Terpineol: 4-12 %

—

d-Limonene: 3-9 %

—

methyleugenol, estragole and safrole: ≤ 0,01 mg/kg

Analytical method

( 2 )

For the determination of 1,8-cineole (phytochemical marker) in the feed additive:

—

gas chromatography coupled with flame ionisation detection (GC-FID) (ISO 11024)

All animal species

—

—

—

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.

On the label of the additive, the following shall be indicated: ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %:

—

23 mg for turkeys for fattening;

—

18 mg for chickens for fattening and minor poultry for fattening;

—

18 mg for all poultry reared for laying or breeding;

—

26 mg for all poultry for laying and breeding;

—

18 mg for ornamental birds;

—

37 mg for pigs for fattening;

—

31 mg for pigs for fattening of minor Suidae ;

—

31 mg for piglets (suckling and weaned) of all Suidae ;

—

30 mg for all Suidae for reproduction;

—

78 mg for calves for fattening up to 6 months;

—

69 mg for sheep and goats;

—

69 mg for cattle for fattening, other ruminants for fattening except sheep and goats, and Camelidae for fattening;

—

45 mg for all other ruminants, and all other Camelidae ;

—

50 mg for Equidae ;

—

28 mg for rabbits;

—

40 mg for salmonids and minor fin fish;

—

30 mg for dogs;

—

5 mg for cats;

—

50 mg for ornamental fish;

—

5 mg for other species and categories.’

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

5.

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

( 1 )   Natural sources of flavourings – Report No 2 (2007).

( 2 )   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