COMMISSION IMPLEMENTING REGULATION (EU) 2025/630

| Official Journal of the European Union | EN 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 2003 on 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 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 2025 in accordance with the rules applicable before 21 April 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 additives referred to in paragraph 1, which are produced and labelled before 21 April 2026 in accordance with the rules applicable before 21 April 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 additives referred to in paragraph 1, which are produced and labelled before 21 April 2027 in accordance with the rules applicable before 21 April 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, 31 March 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, 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. * * * 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 2b324-eo | Geranium rose essential oil | Additive composition Essential oil from the herbaceous parts of Pelargonium graveolens L’Hér. (synonym: Pelargonium graveolens L’Herit. Ex Ait.) Liquid form Characterisation of active substance Geranium rose essential oil Essential oil, as defined by the Council of Europe (1), obtained from the herbaceous parts of Pelargonium graveolens L’Hér. by steam distillation and further condensation of volatile constituents and separation from the aqueous phase by decantation. CAS number: 8000-46-2 Einecs: 290-140-0 FEMA number: 2508 CoE number: 324 Specifications: Citronellol: 25-36 % Geraniol: 10-18 % Citronellyl formate: 4-9 % Linalool: 4-8,5 % d,l-Isomenthone (cis-menthone): 4-8 % 2-(2-Methylprop-1-enyl)-4-methyl tetrahydropyran (rose oxide): 0,7-1,5 % Analytical method (2) For the determination of citronellol (phytochemical marker) in the feed additive: | — | Gas chromatography coupled with flame ionisation detection (GC-FID) (ISO 4731) ---|--- 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 %: 5 mg.’ ---|--- 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. ---|--- 21 April 2035 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 2b185-eo | Eucalyptus essential oil | Additive composition Essential oil from the leaves and twigs of Eucalyptus globulus Labill. Liquid form Characterisation of active substance Eucalyptus essential oil Essential oil, as defined by the Council of Europe (3) 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 the aqueous phase by decantation. CAS number: 8000-48-4 Einecs: 283-406-2 FEMA number: 2466 CoE number: 185 Specifications: 1,8-Cineole (eucalyptol): 70-87 % d-Limonene: 2-15 % α-Pinene (pin-2(3)-ene): 1-10 % Methyleugenol: maximum 0,005 % Analytical method (4) For the determination of 1,8-cineole (phytochemical marker) in the feed additive: | — | Gas chromatography coupled with flame ionisation detection (GC-FID) (ISO 770) ---|--- 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 %: | — | 12 mg for chickens for fattening and minor poultry for fattening; ---|--- — | 12 mg for all poultry reared for laying or breeding; ---|--- — | 12 mg for ornamental birds; ---|--- — | 16 mg for turkeys for fattening; ---|--- — | 18 mg all poultry for laying or breeding, ---|--- — | 26 mg for pigs for fattening; ---|--- — | 22 mg for piglets (suckling and weaned) of all Suidae; ---|--- — | 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.’. ---|--- 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. ---|--- 21 April 2035 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 2b38-eo | Lemongrass essential oil | Additive composition Essential oil from the aerial parts of Cymbopogon flexuosus (Nees ex Steud.) Will. Watson (synonym: Cymbopogon flexuosus (Nees ex Steudel) J.F. Watson). Liquid form Characterisation of active substance Lemongrass essential oil Essential oil, as defined by the Council of Europe (5), 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 decantation. CAS number: 8007-02-1 Einecs: 289-752-0 FEMA number: 2624 CoE number: 38 Specifications: trans-3,7-Dimethylocta-2,6-dienal (Geranial): 35-47 % Neral: 25–35 % Geraniol: 1,5-8 % Geranyl acetate:0,5-6 % β-Caryophyllene: 0,2-3,5 % Methyleugenol and elemicin: maximum 0,01 % Analytical method (6) For the determination of neral and trans-3,7-dimethylocta-2,6-dienal (geranial) (phytochemical markers) in the feed additive: | — | Gas chromatography coupled with flame ionisation detection (GC-FID) (ISO 4718) ---|--- 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 %: | — | 41 mg for chickens for fattening and minor poultry for fattening; ---|--- — | 41 mg for all poultry reared for laying or breeding; ---|--- — | 41 mg for ornamental birds; ---|--- — | 55 mg for turkeys for fattening; ---|--- — | 61 mg for all poultry for laying or breeding; ---|--- — | 88 mg for pigs for fattening; ---|--- — | 74 mg for piglets (suckling and weaned) of all Suidae; ---|--- — | 74 mg for pigs for fattening of minor Suidae; ---|--- — | 100 mg for all Suidae for reproduction; ---|--- — | 75 mg for calves for fattening up to 6 months; ---|--- — | 75 mg for sheep and goats; ---|--- — | 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.’. ---|--- 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. ---|--- 21 April 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. (3) Natural sources of flavourings – Report No 2 (2007). (4) 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. (5) Natural sources of flavourings – Report No 2 (2007). (6) 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 ISSN 1977-0677 (electronic edition) * * *