Commission Implementing Regulation (EU) 2025/630 of 31 March 2025 concerning the authorisation of geranium rose essential oil from Pelargonium graveolens L‘Hér., eucalyptus essential oil from Eucalyptus globulus Labill. and lemongrass essential oil from Cymbopogon flexuosus (Nees ex Steud.) Will. Watson as feed additives for all animal species

Official Journal EN of the European Union L series 2025/630 1.4.2025 COMMISSION IMPLEMENTING REGULATION (EU) 2025/630 of 31 March 2025 concerning the authorisation of geranium rose essential oil from Pelargonium graveolens L‘Hér., eucalyptus essential oil from Eucalyptus globulus Labill. and lemongrass essential oil from Cymbopogon flexuosus (Nees ex Steud.) Will. Watson as feed additives 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 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 substances geranium rose essential oil from Pelargonium graveolens L‘Hér., eucalyptus essential oil from Eucalyptus globulus Labill. and lemongrass essential oil from Cymbopogon flexuosus (Nees ex Steud.) Will. Watson were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of Feed Additives as existing products, 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 geranium rose essential oil from Pelargonium graveolens L‘Hér., eucalyptus essential oil from Eucalyptus globulus Labill. and lemongrass essential oil from Cymbopogon flexuosus (Nees ex Steud.) Will. Watson as feed additives for all animal species, requesting the additives 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 substances concerned 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 these additives in water for drinking should not be allowed.

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 4 July 2023(3)(4)(5)that geranium rose essential oil from Pelargonium graveolens L‘Hér. is safe up to the maximum proposed use level in feed, and that eucalyptus essential oil from Eucalyptus globulus Labill. and lemongrass essential oil from Cymbopogon flexuosus (Nees ex Steud.) Will. Watson are safe at certain maximum concentrations further specified for each species. It also found that the use of geranium rose essential oil from Pelargonium graveolens L‘Hér, eucalyptus essential oil from Eucalyptus globulus Labill. and lemongrass essential oil from Cymbopogon flexuosus (Nees ex Steud.) Will. Watson in animal feed is not expected to pose a risk to the environment. The Authority concluded that geranium rose essential oil from Pelargonium graveolens L‘Hér, eucalyptus essential oil from Eucalyptus globulus Labill. and lemongrass essential oil from Cymbopogon flexuosus (Nees ex Steud.) Will. Watson should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The Authority further concluded that since geranium rose oil from Pelargonium graveolens and its preparations, the preparations of the leaves of Eucalyptus globulus including its oil, and the aerial

(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, 21(7), e08161. https://doi.org/10.2903/j.efsa.2023.8161.

(4) EFSA Journal, 21(7), e08178. https://doi.org/10.2903/j.efsa.2023.8178.

(5) EFSA Journal, 21(7), e08180. https://doi.org/10.2903/j.efsa.2023.8180.

ELI: http://data.europa.eu/eli/reg_impl/2025/630/oj 1/11EN OJ L, 1.4.2025 part of Cymbopogon flexuosus and its 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6) In view of the above, the Commission considers that geranium rose essential oil from Pelargonium graveolens L‘Hér., eucalyptus essential oil from Eucalyptus globulus Labill. and lemongrass essential oil from Cymbopogon flexuosus (Nees ex Steud.) Will. Watson satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003.

Accordingly, the use of those substances 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 additives.

(7) The Commission considers that safety reasons do not require the setting of maximum levels for geranium rose essential oil from Pelargonium graveolens L‘Hér., eucalyptus essential oil from Eucalyptus globulus Labill. and lemongrass essential oil from Cymbopogon flexuosus (Nees ex Steud.) Will. Watson. In order to allow better control, the recommended maximum content should be indicated on the label of the feed additives. 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 substances 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 substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Transitional measures

1. The feed additives geranium rose essential oil from Pelargonium graveolens L‘Hér., eucalyptus essential oil from Eucalyptus globulus Labill. and lemongrass essential oil from Cymbopogon flexuosus (Nees ex Steud.) Will. Watson, as authorised pursuant to Directive 70/524/EEC and premixtures containing these additives, which are produced and labelled before 21 October 2025in accordance with the rules applicable before 21 April 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 additives referred to in paragraph 1, which are produced and labelled before 21 April 2026in accordance with the rules applicable before 21 April 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 additives referred to in paragraph 1, which are produced and labelled before 21 April 2027in accordance with the rules applicable before 21 April 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.

2/11 ELI: http://data.europa.eu/eli/reg_impl/2025/630/ojEN OJ L, 1.4.2025 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, 31 March 2025.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2025/630/oj 3/11ANNEX 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 2b324-eo Geranium rose Additive composition All - - - 1. The additive shall be incorporated 21 April 2035 essential oil animal into the feed in the form of a Essential oil from the herbaceous parts of species premixture.

Pelargonium graveolens L’Hér. (synonym:

Pelargonium graveolens L’Herit. Ex Ait.) Liquid form

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

Essential oil, as defined by the Council of Europe(1), obtained from the herbaceous parts of Pelargonium graveolens L’Hér. by steam

3. On the label of the additive, the distillation and further condensation of

following shall be indicated: volatile constituents and separation from the ‘Recommended maximum aqueous phase by decantation. content of the active substance per kg of complete feedingstuff with a

CAS number: 8000-46-2 moisture content of 12 %: 5 mg.’

Einecs: 290-140-0

FEMA number: 2508

CoE number: 324

4. The functional group, the

Specifications: identification number, the name

Citronellol: 25-36 % and the added amount of the active

Geraniol: 10-18 % substance shall be indicated on the

Citronellyl formate: 4-9 % label of the premixture, where the

Linalool: 4-8,5 % use level on the label of the d,l-Isomenthone (cis-menthone): 4-8 % premixture would result in exceeding the level referred to in point 3.

4/11

ELI:

http://data.europa.eu/eli/reg_impl/2025/630/oj EN OJ L,

1.4.2025Minimum 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 % 2-(2-Methylprop-1-enyl)-4-methyl 5. For users of the additive and tetrahydropyran (rose oxide): 0,7-1,5 % premixtures, feed business operators shall establish Analytical method(2) operational procedures and organisational measures to For the determination of citronellol address potential risks resulting (phytochemical marker) in the feed additive: from their use. Where those risks — Gas chromatography coupled with flame cannot be eliminated by such ionisation detection (GC-FID) (ISO 4731) 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/2025/630/oj 5/11 OJ L,

1.4.2025 ENMinimum 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 2b185-eo Eucalyptus Additive composition All - - - 1. The additive shall be incorporated 21 April 2035 essential oil animal into the feed in the form of a Essential oil from the leaves and twigs of species premixture.

Eucalyptus globulus Labill.

Liquid form Characterisation of active substance

2. In the directions for use of the additive and premixtures, the Eucalyptus essential oil storage conditions and the stability Essential oil, as defined by the Council of to heat treatment shall be indicated.

Europe(1)obtained from the fresh or dried leaves and twigs of Eucalyptus globulus Labill. by steam distillation and further condensation of volatile constituents and separation from

3. On the label of the additive, the the aqueous phase by decantation.

following shall be indicated: ‘Recommended maximum content

CAS number: 8000-48-4 of the active substance per kg of

Einecs: 283-406-2 complete feedingstuff with a

FEMA number: 2466 moisture content of 12 %:

CoE number: 185 — 12 mg for chickens for fattening and minor poultry

Specifications: for fattening;

1,8-Cineole (eucalyptol): 70-87 % — 12 mg for all poultry reared for d-Limonene: 2-15 % laying or breeding; α-Pinene (pin-2(3)-ene): 1-10 % — 12 mg for ornamental birds;

Methyleugenol: maximum 0,005 % — 16 mg for turkeys for fattening;

6/11

ELI:

http://data.europa.eu/eli/reg_impl/2025/630/oj EN OJ L,

1.4.2025Minimum 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 % Analytical method(2) — 18 mg all poultry for laying or breeding, For the determination of 1,8-cineole — 26 mg for pigs for fattening;

(phytochemical marker) in the feed additive: — 22 mg for piglets (suckling and — Gas chromatography coupled with flame weaned) of all Suidae; ionisation detection (GC-FID) (ISO 770) — 22 mg for pigs for fattening of minor Suidae;

— 32 mg for all Suidae for reproduction; — 55 mg for calves for fattening up to 6 months; — 48 mg for sheep and goats; — 48 mg for cattle for fattening, other ruminants for fattening except sheep, goats and calves for fattening up to 6 months;

Camelidae for fattening; — 31 mg for all other ruminants and all other Camelidae; — 48 mg for Equidae; — 19 mg for rabbits; — 55 mg for salmonids and minor fin fish; — 58 mg for dogs; — 75 mg for ornamental fish;

— 10 mg for cats; — 10 mg for other species and categories.’.

ELI:

http://data.europa.eu/eli/reg_impl/2025/630/oj 7/11 OJ L,

1.4.2025 ENMinimum 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 %

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.

8/11

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http://data.europa.eu/eli/reg_impl/2025/630/oj EN OJ L,

1.4.2025Minimum 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 2b38-eo Lemongrass Additive composition All - - - 1. The additive shall be 21 April 2035 essential oil animal incorporated into the feed in the Essential oil from the aerial parts of species form of a premixture.

Cymbopogon flexuosus (Nees ex Steud.) Will.

Watson (synonym: Cymbopogon flexuosus (Nees ex Steudel) J.F. Watson).

Liquid form

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

Essential oil, as defined by the Council of Europe(1), obtained from the fresh or dried aerial parts of Cymbopogon flexuosus (Nees ex Steud.) Will. Watson by steam distillation and further condensation of volatile constituents and separation from the aqueous phase by 3. On the label of the additive, the decantation. following shall be indicated:

‘Recommended maximum

CAS number: 8007-02-1 content of the active substance

Einecs: 289-752-0 per kg of complete feedingstuff

FEMA number: 2624 with a moisture content of 12 %:

CoE number: 38 — 41 mg for chickens for fattening and minor

Specifications: poultry for fattening; — 41 mg for all poultry reared trans-3,7-Dimethylocta-2,6-dienal (Geranial): for laying or breeding;

35-47 % — 41 mg for ornamental birds;

Neral: 25–35 % — 55 mg for turkeys for

Geraniol: 1,5-8 %

Geranyl acetate:0,5-6 % fattening; β-Caryophyllene: 0,2-3,5 % — 61 mg for all poultry for laying or breeding; — 88 mg for pigs for fattening;

ELI:

http://data.europa.eu/eli/reg_impl/2025/630/oj 9/11 OJ L,

1.4.2025 ENMinimum 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 %

Methyleugenol and elemicin: maximum — 74 mg for piglets (suckling 0,01 % and weaned) of all Suidae; — 74 mg for pigs for fattening Analytical method(2) of minor Suidae; — 100 mg for all Suidae for For the determination of neral and reproduction;

trans-3,7-dimethylocta-2,6-dienal (geranial) — 75 mg for calves for (phytochemical markers) in the feed additive: fattening up to 6 months; — Gas chromatography coupled with flame — 75 mg for sheep and goats;

ionisation detection (GC-FID) (ISO 4718) — 75 mg for cattle for fattening, other ruminants for fattening except sheep, goats and calves for fattening up to 6 months;

Camelidae for fattening; — 75 mg for all other ruminants and all other Camelidae; — 100 mg for Equidae; — 65 mg for rabbits; — 125 mg for salmonids and minor fin fish; — 50 mg for dogs; — 50 mg for ornamental fish;

— 33 mg for cats; — 33 mg for other species and categories.’.

10/11

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http://data.europa.eu/eli/reg_impl/2025/630/oj EN OJ L,

1.4.2025Minimum 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 %

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/2025/630/oj 11/11 OJ L,

1.4.2025 EN