Commission Implementing Regulation (EU) 2025/278 of 12 February 2025 concerning the authorisation of cedarwood Texas essential oil from Juniperus deppeana Steud. as a feed additive for all animal species

Official Journal EN of the European Union L series 2025/278 13.2.2025 COMMISSION IMPLEMENTING REGULATION (EU) 2025/278 of 12 February 2025 concerning the authorisation of cedarwood Texas essential oil from Juniperus deppeana Steud. 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 cedarwood Texas essential oil from Juniperus deppeana Steud. 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 cedarwood Texas essential oil from Juniperus deppeana Steud. 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 18 April 2024(3)that cedarwood Texas essential oil from Juniperus deppeana Steud. is safe for all animal species at certain maximum concentrations further specified for each species. Furthermore, it concluded that no safety concern would be expected from the use of cedarwood Texas essential oil from Juniperus deppeana Steud. for consumers up to the maximum proposed use level in feed and that it would not pose a risk to the environment at the maximum proposed use level in feed. The Authority concluded that cedarwood Texas essential oil from Juniperus deppeana Steud. should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The Authority further concluded that since the individual components of cedarwood Texas essential oil from Juniperus deppeana Steud. 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):8799.

ELI: http://data.europa.eu/eli/reg_impl/2025/278/oj 1/5EN OJ L, 13.2.2025

(6) In view of the above, the Commission considers that cedarwood Texas essential oil from Juniperus deppeana Steud. 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. 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) The Commission considers that safety reasons do not require the setting of maximum levels for cedarwood Texas essential oil from Juniperus deppeana Steud. In order to allow better control, the recommended maximum content should be indicated on the label of the feed additive. Where the recommended maximum content is exceeded, certain information should be indicated on the label of the premixtures concerned.

(8) 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.

(9) 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 cedarwood Texas essential oil from Juniperus deppeana Steud., 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.

2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/278/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/2025/278/oj 3/5ANNEX Minimum Maximum content content End of Identification Species or Composition, chemical formula, description, Maximum period of number of the Additive category mg of additive/kg of Other provisions analytical method age authorisa- feed additive of animal complete feedingstuff tion with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds 2b91722-eo Cedarwood Additive composition All — — — 1. The additive shall be incorporated 5 March Texas Essential oil from the wood of Juniperus deppeana animal into the feed in the form of a 2035 essential oil Steud. (synonym: Juniperus mexicana Schiede) species premixture.

Liquid form 2. In the directions for use of the additive and premixtures, the Characterisation of active substance storage conditions and stability to heat treatment shall be indicated.

Cedarwood Texas essential oil

3. On the label of the additive, the Essential oil as defined by the Council of

following shall be indicated:

Europe(1)obtained from the wood of Juniperus ‘Recommended maximum content deppeana Steud by steam distillation and further of the active substance per kg of condensation of volatile constituents and complete feedingstuff with a separation from the aqueous phase by moisture content of 12 %:

decantation. — 7 mg for turkeys for fattening; — 5 mg for chickens for fattening,

CAS number: 91722-61-1 other poultry for fattening or

Einecs number: 294-461-7 reared for laying or breeding;

Specifications — 5 mg for ornamental birds; — 8 mg for all poultry for laying or — cis-Thujopsene: 25-35 % breeding; — (+)-Cedrol: ≥ 20 % — 12 mg for pigs for fattening; — α-Cedrene: 15-25 % — 10 mg for piglets (suckling and — β-Cedrene: 3-8 % weaned) of all Suidae;

— 10 mg for pigs for fattening of Analytical method(2) minor Suidae;

For the determination of cis-thujopsene — 14 mg for all Suidae for (phytochemical marker) in the feed additive: reproduction; — gas chromatography coupled with flame — 15 mg for calves for fattening up ionisation detection (GC-FID) (ISO 4725) to 6 months;

— 15 mg for sheep and goats; — 15 mg for cattle for fattening, other ruminants for fattening except sheep and goats, and Camelidae for fattening;

4/5

ELI:

http://data.europa.eu/eli/reg_impl/2025/278/oj EN OJ L,

13.2.2025Minimum Maximum content content End of Identification Species or Composition, chemical formula, description, Maximum period of number of the Additive category mg of additive/kg of Other provisions analytical method age authorisa- feed additive of animal complete feedingstuff tion with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds — 14 mg for all other ruminants, and all other Camelidae; — 15 mg for Equidae; — 8,5 mg for rabbits; — 15 mg for Salmonids and minor fin fish;

— 15 mg for dogs; — 4 mg for cats; — 15 mg for ornamental fish; — 4 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.

(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.

ELI:

http://data.europa.eu/eli/reg_impl/2025/278/oj 5/5 OJ L,

13.2.2025 EN