COMMISSION IMPLEMENTING REGULATION (EU) 2026/528

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2026/528 | 12.3.2026 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2026/528 of 11 March 2026 concerning the authorisation of patchouli essential oil from Pogostemon cablin Benth. 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 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 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 patchouli essential oil from Pogostemon cablin Benth. 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 patchouli essential oil from Pogostemon cablin Benth. 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 19 March 2025 (3) that, up to certain maximum concentrations, further specified for each species, patchouli essential oil from Pogostemon cablin Benth. is safe for the target species, consumers and the environment. The Authority concluded that patchouli essential oil from Pogostemon cablin Benth. should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The Authority further concluded that since the patchouli essential oil from Pogostemon cablin Benth. 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 patchouli essential oil from Pogostemon cablin Benth. 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 contents for patchouli essential oil from Pogostemon cablin Benth. 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 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 patchouli essential oil from Pogostemon cablin Benth., as authorised pursuant to Directive 70/524/EEC, and premixtures containing that additive, which are produced and labelled before 1 October 2026 in accordance with the rules applicable before 1 April 2026 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 1 April 2027 in accordance with the rules applicable before 1 April 2026 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 1 April 2028 in accordance with the rules applicable before 1 April 2026 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, 11 March 2026. 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 feeding-stuffs (OJ L 270, 14.12.1970, p. 1, ELI: http://data.europa.eu/eli/dir/1970/524/oj). (3) EFSA Journal, 23(4), e9357. https://doi.org/10.2903/j.efsa.2025.9357. * * * ANNEX Identification number of the additive | Name of the 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 feed with a moisture content of 12 % Category: Sensory additives. Functional group: Flavouring compounds 2b353-eo | Patchouli essential oil | Additive composition Essential oil from the leaves of Pogostemon cablin Benth. Liquid form Characterisation of active substance Patchouli essential oil: Essential oil, as defined by the Council of Europe (CoE) (1), obtained from the dried leaves of Pogostemon cablin Benth. by steam distillation and further condensation of volatile constituents and separation from the aqueous phase by decantation. CAS number: 8014-09-3 EINECS numbers: 282-493-4, 692-003-4, 616-944-7 FEMA number: 2838 CoE number: 353 Specifications: Patchouli alcohol: 27-35 % 1(5),11-Guaiadiene: 11-16 % β-Caryophyllene: 2-5 % α-Bulnesene: 13-21 % Analytical method (2) For the determination of patchouli alcohol (phytochemical marker) in the feed additive: | — | gas chromatography coupled with flame ionisation detection (GC–FID) (ISO 3757) ---|--- 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 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 feed with a moisture content of 12 %: | — | 7,5 mg for turkeys for fattening; ---|--- — | 7,5 mg for chickens for fattening and minor poultry for fattening; ---|--- — | 7,5 mg for all poultry reared for laying or breeding; ---|--- — | 7,5 mg for ornamental birds; ---|--- — | 7,5 mg for all poultry for laying or breeding; ---|--- — | 7,5 mg for pigs for fattening; ---|--- — | 24 mg for piglets (suckling and weaned) of all Suidae; ---|--- — | 24 mg for pigs for fattening of minor Suidae; ---|--- — | 35 mg for all Suidae for reproduction; ---|--- — | 60 mg for calves for fattening up to 6 months; ---|--- — | 53 mg for sheep and goats; ---|--- — | 53 mg for cattle for fattening, other ruminants for fattening except sheep, goats and calves for fattening up to 6 months; Camelidae for fattening; ---|--- — | 34 mg for all other ruminants; all other Camelidae; ---|--- — | 7,5 mg for Equidae; ---|--- — | 7,5 mg for Leporidae; ---|--- — | 7,5 mg for salmonids and minor fin fish; ---|--- — | 7,5 mg for dogs; ---|--- — | 7,5 mg for cats; ---|--- — | 7,5 mg for ornamental fish; ---|--- — | 7,5 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 levels on the label of the premixture would result in exceeding the levels 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 April 2036 * * * (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/2026/528/oj ISSN 1977-0677 (electronic edition) * * *