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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 Aspergillus oryzae DSM 33737. 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 the preparation of 6-phytase produced with Aspergillus oryzae DSM 33737 as a feed additive for all poultry, all Suidae and all fin fish requesting the additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 February 2024note that the preparation of 6-phytase produced with Aspergillus oryzae DSM 33737 is safe for all poultry, all Suidae and all fin fish at the highest proposed use level of 4000 FYT/kg complete feed, as well as for the consumers and the environment. The Authority also concluded that the preparation of 6-phytase produced with Aspergillus oryzae DSM 33737, in the final formulations of the additive, is not a skin irritant. The two liquid formulations of the additive are not eye irritants, while the two solid ones are considered eye irritants. The Authority was not able to conclude on the skin sensitisation of the final formulations of the additive. Due to the proteinaceous nature of the active substance (6-phytase), the additive is considered a respiratory sensitiser. However, exposure by inhalation is considered unlikely. The Authority further concluded that the preparation of 6-phytase produced with Aspergillus oryzae DSM 33737 has the potential to be efficacious in all poultry for fattening and reared for laying or breeding and in all reproductive Suidae at the minimum proposed use level of 200 FYT/kg complete feed and in all fin fish at the minimum proposed use level of 1000 FYT/kg complete feed and an authorisation for use in feed for these species was granted by Commission Implementing Regulation (EU) 2024/2177note. Due to the lack of sufficient data, the Authority was not able to conclude on the efficacy for laying and reproductive poultry, and for Suidae for fattening or reared for reproduction. After the assessment of newly submitted data by the applicant, the Authority concluded in its opinion of 18 September 2025note that the additive has the potential to be efficacious in all poultry and all porcine species at the minimum proposed use level of 200 FYT/kg complete feed. The Authority did not consider that there is a need for specific requirements of post-market monitoring. 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)In view of the above, the Commission considers that the preparation of 6-phytase produced with Aspergillus oryzae DSM 33737 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for poultry for laying or reproduction, piglets of porcine species and porcine species for fattening or reared for reproduction. 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 | |||||||||
| 4a48 | Novozymes A/S | 6-phytase (EC 3.1.3.26) | Additive compositionPreparation of 6-phytase (EC 3.1.3.26) produced withAspergillus oryzae DSM 33737 having a minimum activity of:Solid form: 10000 FYTnote/g.Liquid form: 20000 FYT/g.Characterisation of the active substance6-phytase (EC 3.1.3.26) produced with Aspergillus oryzae DSM 33737Analytical 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 phytateEN ISO 30024. | Poultry for laying or reproduction | - | 200 FYT | - | 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 eye (only for the two solid formulations), breathing and skin protective equipment. | 28 May 2036 |
| Piglets of porcine speciesPorcine species for fatteningPorcine species reared for reproduction | 200 FYT |
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