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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 3-phytase produced with Komagataella phaffii CECT 13171. 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 3-phytase produced with Komagataella phaffii CECT 13171 as a feed additive for chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening, minor poultry species for breeding, minor poultry species reared for laying, pigs for fattening and minor porcine species for fattening, 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 opinions of 27 September 2022note and 17 September 2024note that, under the proposed conditions of use, the preparation 3-phytase produced with Komagataella phaffii CECT 13171 in its both liquid and solid formulations is considered safe for the target species, consumers and environment. Regarding the safety for the user, the Authority concluded that the preparation 3-phytase produced with Komagataella phaffii CECT 13171 in either form is not an irritant to the eyes and skin. It further stated that the liquid formulation of the preparation is not a dermal sensitiser, while its solid formulation is a dermal sensitiser, and that the two formulations should be considered potential respiratory sensitisers. The Authority concluded that the preparation 3-phytase produced with Komagataella phaffii CECT 13171 is efficacious at 500 FTU/kg feed in poultry species for fattening or reared for laying or breeding, pigs for fattening and minor porcine species for fattening and at 1000 FTU/kg feed in laying hens. It did not consider that there is a need for specific requirements of post-market monitoring.
(5)In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005note, the Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the previous assessment concerning the same additive are valid and applicable for the current application.
(6)In view of the above, the Commission considers that the preparation of 3-phytase produced with Komagataella phaffii CECT 13171 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for poultry species for fattening or reared for laying or for breeding, minor poultry species for breeding, laying hens and pigs for fattening of all Suidae 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)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 feed additive | Name of the holder of authorisation | 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 feedingstuff with a moisture content of 12 % | |||||||||
| Category: zootechnical additives. Functional group: digestibility enhancers. | |||||||||
| 4a50 | Fertinagro Biotech S.L. | 3-phytase(EC 3.1.3.8) | Additive compositionPreparation of 3-phytase produced with Komagataella phaffii CECT 13171 having a minimum activity of:Solid form: 10000 FTUnote/gLiquid form: 1000 FTU/mL.Characterisation of the active substance3-phytase produced with Komagataella phaffii CECT 13171.Analytical methodnoteFor the quantification of 3-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 species for fattening or reared for laying or for breedingMinor poultry species for breedingPigs for fattening of all Suidae species | — | 500 FTU | — | 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. | 5 August 2035 |
| Laying hens | 1000 FTU |
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