COMMISSION IMPLEMENTING REGULATION (EU) 2026/538

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2026/538 | 12.3.2026 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2026/538 of 11 March 2026 concerning the authorisation of xanthan gum produced with Xanthomonas campestris ATCC SD 7012 or DSM 23730 or CNCM I-4861 or CIP 74.23 as a feed additive for all animal species other than cats, dogs and aquatic 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) | Xanthan gum was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species in the group ‘emulsifying and stabilizing agents, thickeners and gelling agents’. That 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 re-evaluation of xanthan gum as a feed additive for all animal species. The applicant requested the additive to be classified in the additive category ‘technological additives’ and in the functional groups ‘stabilisers’ and ‘thickeners’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. By letter of 27 January 2023, the applicant withdrew the application for the re-evaluation as regards the use of xanthan gum for cats and aquatic species. ---|--- (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 May 2025 (3), which revised its opinion of 24 June 2021 (4), that xanthan gum produced with Xanthomonas campestris ATCC SD 7012 or DSM 23730 or CNCM I-4861 or CIP 74.23 is safe for all animal species, other than cats and aquatic species, at certain maximum use levels according to the different target species concerned and that it is safe for the consumers and the environment. The Authority also concluded that xanthan gum produced with Xanthomonas campestris ATCC SD 7012 or DSM 23730 or CNCM I-4861 or CIP 74.23 is not irritant to the skin and is not a skin sensitiser but it could not reach any conclusions on its potential to be an eye irritant. The Authority further concluded that xanthan gum produced with Xanthomonas campestris ATCC SD 7012 or DSM 23730 or CNCM I-4861 or CIP 74.23 is an efficacious stabiliser and thickener in feedingstuffs under the proposed conditions of use. The Authority 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. ---|--- (5) | The Commission offered the applicant, at its request, the possibility to submit supplementary data concerning the safety of use of xanthan gum produced with Xanthomonas campestris ATCC SD 7012 or DSM 23730 or CNCM I-4861 or CIP 74.23 for dogs, at a maximum level higher than the level set out in the Authority’s opinion of 6 May 2025. The use of xanthan gum produced with Xanthomonas campestris ATCC SD 7012 or DSM 23730 or CNCM I-4861 or CIP 74.23 as a feed additive for dogs will therefore be the subject of new opinion of the Authority on the basis of the supplementary data to be received, which will be considered in view of the adoption of a separate measure concerning its authorisation. ---|--- (6) | In view of the above, the Commission considers that xanthan gum produced with Xanthomonas campestris ATCC SD 7012 or DSM 23730 or CNCM I-4861 or CIP 74.23 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised for all animal species other than cats, dogs and aquatic species. 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) | 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. ---|--- (8) | 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 ‘technological additives’ and to the functional groups ‘stabilisers’ and ‘thickeners’, 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 xanthan gum, as authorised pursuant to Directive 70/524/EEC and premixtures containing this additive, which are intended for all animal species other than cats, dogs and aquatic species, and 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 intended for all animal species other than cats, dogs and aquatic species, and 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 intended for all animal species other than cats, dogs and aquatic species, and 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 2025;23(6), e9466. https://doi.org/10.2903/j.efsa.2025.9466. (4) EFSA Journal 2021;19(7):6710, 13 pp. https://doi.org/10.2903/j.efsa.2021.6710. * * * 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 active substance/kg complete feed with 12 % moisture content Category: technological additives. Functional group: stabilisers 1d415 | Xanthan gum | Additive composition Xanthan gum as the sodium, potassium or calcium salt. Solid form Purity: Loss on drying: ≤ 15 % (105 °C, 2,5 hours) Total ash: ≤ 16 % on the anhydrous basis determined at 650 °C after drying at 105 °C for four hours Pyruvic acid ≥ 1,5 % Nitrogen ≤ 1,5 % Ethanol and propan-2-ol ≤ 500 mg/kg singly or in combination Characterisation of the active substance Xanthan gum (high molecular weight polysaccharide gum which contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid), produced with Xanthomonas campestris ATCC SD 7012 or DSM 23730 or CNCM I-4861 or CIP 74.23. Xanthan gum yields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gum CAS No: 11138-66-2 Analytical method (1) For the characterisation of Xanthan gum (feed additive): | — | FAO JECFA Monograph Xanthan gum, as referred in Commission Regulation (EU) No 231/2012 (2) ---|--- Turkeys for fattening | — | — | 75 | | 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. ---|--- 2. | 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 eye and breathing protective equipment. ---|--- 1 April 2036 Chickens for fattening or reared for laying or for reproduction Minor poultry for fattening or reared for laying or for reproduction Ornamental birds | — | — | 56 Poultry for laying or for reproduction | — | — | 83 Piglets of porcine species | — | — | 100 Porcine species for fattening | — | — | 120 Sows of porcine species | — | — | 146 Veal calves (milk replacer) | — | — | 233 Ovines and caprines Ruminants (other than ovines and caprines) and camelids for fattening or reared for milk production or for reproduction | — | — | 220 Ruminants (other than ovines and caprines) and camelids for milk production or for reproduction | — | — | 143 Equids | — | — | 220 Leporids | — | — | 88 Other species (with the exception of cats, dogs and aquatic animal species) | — | — | 56 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 active substance/kg complete feed with 12 % moisture content Category: technological additives. Functional group: thickeners 1d415 | Xanthan gum | Additive composition Xanthan gum as the sodium, potassium or calcium salt. Solid form Purity: Loss on drying: ≤ 15 % (105 °C, 2,5 hours) Total ash: ≤ 16 % on the anhydrous basis determined at 650 °C after drying at 105 °C for four hours Pyruvic acid ≥ 1,5 % Nitrogen ≤ 1,5 % Ethanol and propan-2-ol ≤ 500 mg/kg singly or in combination Characterisation of the active substance Xanthan gum (high molecular weight polysaccharide gum which contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid), produced with Xanthomonas campestris ATCC SD 7012 or DSM 23730 or CNCM I-4861 or CIP 74.23. Xanthan gum yields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gum CAS No: 11138-66-2 Analytical method (3) For the characterisation of Xanthan gum (feed additive): | — | FAO JECFA Monograph Xanthan gum, as referred in Regulation (EU) No 231/2012 ---|--- Turkeys for fattening | — | — | 75 | | 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. ---|--- 2. | 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 eye and breathing protective equipment. ---|--- 1 April 2036 Chickens for fattening or reared for laying or for reproduction Minor poultry for fattening or reared for laying o for reproduction Ornamental birds | — | — | 56 Poultry for laying or for reproduction | — | — | 83 Piglets of porcine species | — | — | 100 Porcine species for fattening | — | — | 120 Sows of porcine species | — | — | 146 Veal calves (milk replacer) | — | — | 233 Ovines and caprines Ruminants (other than ovines and caprines) and camelids for fattening or reared for milk production or for reproduction | — | — | 220 Ruminants (other than ovines and caprines) and camelids for milk production or for reproduction | — | — | 143 Equids | — | — | 220 Leporids | — | — | 88 Other species (with the exception of cats, dogs and aquatic animal species) | — | — | 56 * * * (1) 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. (2) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/231/oj). (3) 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/2026/538/oj ISSN 1977-0677 (electronic edition) * * *