Contents
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 nutritionnote, 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.
(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of 6-phytase produced with Komagataella phaffii CGMCC 7.370. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3)The application concerns the authorisation of a preparation of 6-phytase produced with Komagataella phaffii CGMCC 7.370 as a feed additive for all avian species and ornamental, exotic and game birds and all pigs, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 November 2022note that, under the proposed conditions of use, the preparation of 6-phytase produced with Komagataella phaffii CGMCC 7.370 is safe for all Suidae and all avian species, as well as for the consumers and the environment. The Authority also concluded that the additive in both formulations, powder and liquid, is considered to be non-irritant to skin or eyes but should be considered a skin and respiratory sensitiser. Furthermore, it concluded that the additive has the potential to be efficacious in laying hens at 1000 U phytase/kg complete feed and this conclusion can be extrapolated to other birds for egg production or breeding. After the assessment of newly submitted data by the applicant, the Authority concluded in its opinion of 26 June 2025note that the additive has a potential to be efficacious as a zootechnical additive for all poultry for fattening and reared for laying/breeding and for reproductive porcine species at 500 U phytase/kg complete feed and for all porcine species for fattening and reared for reproduction at 750 U phytase/kg complete feed. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5)In view of the above, the Commission considers that the preparation of 6-phytase produced with Komagataella phaffii CGMCC 7.370 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for porcine species, poultry and ornamental birds. 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.
(6)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 1Authorisation#
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, subject to the conditions laid down in that Annex.
Article 2Entry 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.
| Identification number of the additive | Name of the holder of authorisation | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Units of activity/kg of complete feed with a moisture content of 12 % | |||||||||
| Category: zootechnical additives. Functional group: digestibility enhancers. | |||||||||
| 4a64 | Victory Enzymes GmbH | 6-phytase (EC 3.1.3.26) | Additive compositionPreparation of 6-phytase (EC 3.1.3.26), produced with Komagataella phaffii CGMCC 7.370, having a minimum activity of:Solid form: 50000 Unote/g additive.Liquid form: 5000 U/g additive.Characterisation of the active substance6-phytase (EC 3.1.3.26), produced with Komagataella phaffii CGMCC 7.370Analytical methodnoteFor the quantification of phytase activity in the feed additive, premixtures and compound feed:colorimetric method based on the enzymatic reaction of phytase on the phytate - EN ISO 30024. | Poultry for laying or reproduction | - | 1000 U | - | 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 the 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 breathing and skin protective equipment. | 17.3.2036 |
| Poultry for fattening and reared for laying or reproduction | 500 U | ||||||||
| Ornamental birds | 500 U | ||||||||
| Sows andboars of porcine species | 500 U | ||||||||
| Piglets of porcine speciesPorcine species for fattening and reared for reproduction | 750 U |
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.