Commission Implementing Regulation (EU) 2026/91 of 14 January 2026 concerning the renewal of the authorisation of a preparation of 6-phytase produced with Trichoderma reesei CBS 126897 as a feed additive for poultry, weaned piglets, pigs for fattening and sows, the authorisation of a preparation of 6-phytase produced with Trichoderma reesei CBS 126897 as a feed additive for ornamental birds, suckling piglets and minor porcine species (holder of authorisation: AB Enzymes Finland Oy) and repealing Implementing Regulation (EU) No 292/2014

Official Journal EN of the European Union L series 2026/91 15.1.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/91 of 14 January 2026 concerning the renewal of the authorisation of a preparation of 6-phytase produced with Trichoderma reeseiCBS 126897 as a feed additive for poultry, weaned piglets, pigs for fattening and sows, the authorisation of a preparation of 6-phytase produced with Trichoderma reeseiCBS 126897 as a feed additive for ornamental birds, suckling piglets and minor porcine species (holder of

authorisation: AB Enzymes Finland Oy) and repealing Implementing Regulation (EU) No 292/2014 (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 and renewing such an authorisation.

(2) A preparation of 6-phytase produced with Trichoderma reeseiCBS 126897 was authorised for a period of 10 years as a feed additive for poultry, weaned piglets, pigs for fattening and sows by Commission Implementing Regulation (EU) No 292/2014(2).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of 6-phytase produced with Trichoderma reeseiCBS 126897 as a feed additive for poultry other than laying birds, laying birds, weaned piglets, pigs for fattening, and sows, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. In accordance with Article 7 of Regulation (EC) No 1831/2003, that application also concerned the authorisation of a new use of the same preparation as a feed additive for suckling piglets and other porcine species and ornamental birds, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. That application was accompanied by the particulars and documents required under Article 14(2) and Article 7(3) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 May 2025(3) that, under the current authorised conditions of use and considering the fact that the manufacturing and composition of the additive have not been substantially modified, the preparation of 6-phytase produced with Trichoderma reesei CBS 126897 remains safe for poultry, weaned piglets, pigs for fattening and sows, consumers and the environment. In addition, it concluded that the additive is safe for ornamental birds at 2 500 FTU/kg complete feed and for suckling piglets and other porcine species at 1 750 FTU/kg complete feed. The extension of use to these species is safe for the consumers and the environment. The Authority further concluded that the preparation in all its forms should be considered as respiratory sensitisers, and any exposure by inhalation should be considered a risk. However, the solid forms are dust-free, and the exposure of users by inhalation is unlikely. No conclusions can be reached on the potential of the different formulations to be irritants to skin and eyes or skin sensitisers. The Authority stated that the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additives. Therefore, it concluded that there is no need for assessing the efficacy of the additives in the context of the renewal of the authorisation. It considered that the conclusions reached in the original authorisation can be extended to other

(1) OJ L 268, 18.10.2003, p. 29. ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) Commission Implementing Regulation (EU) No 292/2014 of 21 March 2014 concerning the authorisation of a preparation of 6-phytase produced by Trichoderma reesei (CBS 126897) as a feed additive for poultry, weaned piglets, pigs for fattening and sows (holder of the authorisation ROAL Oy) (OJ L 87, 22.3.2014, pp. 90, ELI: http://data.europa.eu/eli/reg_impl/2014/292/oj).

(3) EFSA Journal. 2025;23:e9463. https://doi.org/10.2903/j.efsa.2025.9463.

ELI: http://data.europa.eu/eli/reg_impl/2026/91/oj 1/4EN OJ L, 15.1.2026 species and therefore concluded that the additive has the potential to be efficacious in in ornamental birds at 250 FTU/kg complete feed, in suckling piglets and in suckling and weaned piglets of minor porcine species at 500 FTU/kg, and in minor porcine species for fattening or reared for reproduction and reproductive animals at 250 FTU/kg complete feed. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of 6-phytase produced with Trichoderma reesei CBS 126897 as a feed additive in the context of the previous authorisations are valid and applicable for the current applications. In accordance with Article 5(4), points (a) and (c), of Commission Regulation

(EC) No 378/2005(4), an evaluation report of the Reference Laboratory is therefore not required.

(6) In view of the above, the Commission considers that the preparation of 6-phytase produced with Trichoderma reesei CBS 126897 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed for poultry, weaned piglets, pigs for fattening and sows.

Furthermore, the use of that preparation should be authorised for ornamental birds, suckling piglets and minor porcine 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. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.

(7) As a consequence of the renewal of the authorisation of the preparation of 6-phytase produced with Trichoderma reesei CBS 126897 as a feed additive for poultry, weaned piglets, pigs for fattening and sows, Implementing Regulation (EU) No 292/2014 should be repealed.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of 6-phytase produced with Trichoderma reesei CBS 126897 for poultry, weaned piglets, pigs for fattening and sows, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of 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 Renewal of the authorisation The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed for poultry, weaned piglets, pigs for fattening and sows, subject to the conditions laid down in that Annex.

Article 2 Authorisation The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition for ornamental birds, suckling piglets and minor porcine species, subject to the conditions laid down in that Annex.

(4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/ 2005/378/oj).

2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/91/ojEN OJ L, 15.1.2026 Article 3 Repeal Implementing Regulation (EU) No 292/2014 is repealed.

Article 4 Transitional measures

1. The feed additive 6-phytase produced with Trichoderma reeseiCBS 126897, as authorised by Implementing Regulation

(EU) No 292/2014, and premixtures containing that additive, which are intended for poultry, weaned piglets, pigs for fattening and sows and which are produced and labelled before 4 August 2026 in accordance with the rules applicable before 4 February 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 poultry, weaned piglets, pigs for fattening and sows, and which are produced and labelled before 4 February 2027 in accordance with the rules applicable before 4 February 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.

Article 5 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, 14 January 2026.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2026/91/oj 3/4ANNEX Minimum Maximum Identification content content Name of the Species or End of period number of Name of the Composition, chemical formula, Maximum holder of category of Other provisions of the feed additive description, analytical method age Units of activity/kg of authorisation animal authorisation additive complete feed with a moisture content of 12 %

Category: zootechnical additives. Functional group: digestibility enhancers.

4a19 AB 6-phytase (EC Additive composition Poultry other - 250 FTU - 1. In the directions for use 4 February Enzymes 3.1.3.26) Preparation of 6-phytase than for of the additive and 2036 Finland Oy produced with Trichoderma laying or premixtures, the storage reeseiCBS 126897 having a reproduction conditions and stability

minimum activity of: 5 000 to heat treatment shall Ornamental FTU(1)/g. be indicated. birds Solid form and liquid forms Poultry for 150 FTU 2. For users of the additive Characterisation of the active laying or and premixtures, feed substance reproduction business operators shall 6-phytase (EC 3.1.3.26) establish operational produced with Trichoderma Piglets 500 FTU procedures and reeseiCBS 126897 (suckling and organisational Analytical method(2) weaned) of measures to address the For the determination of porcine potential risks resulting 6-phytase in the feed additive, species from their use. Where premixtures and compound those risks cannot be Porcine 250 FTU

feed: eliminated by such species for — colorimetric method based procedures and fattening on the enzymatic reaction measures, the additive of 6-phytase on the phytate Sows of and premixtures shall be – EN ISO 30024. porcine used with personal species breathing protective equipment.

(1) One phytase unit (FTU) is the quantity of enzyme that liberates 1 μmol of inorganic phosphate per minute from sodium phytate at 37 °C, pH 5,5, under standard assay conditions.

(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.

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http://data.europa.eu/eli/reg_impl/2026/91/oj EN OJ L,

15.1.2026