Commission Implementing Regulation (EU) 2024/1057 of 10 April 2024 concerning the authorisation of a preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 as a feed additive for all poultry species for fattening or reared for laying and ornamental birds (holder of authorisation: Nutrex N.V.)
Date: 2024-04-10
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, bird, enzyme, fattening, food additive, market approval, poultry








L_202401057EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/1057


11.4.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/1057
of 10 April 2024
         
concerning the authorisation of a preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 as a feed additive for all poultry species for fattening or reared for laying and ornamental birds (holder of authorisation: Nutrex N.V.)
(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.












(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 by Komagataella phaffii CGMCC 7.19 as a feed additive. 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 by Komagataella phaffii CGMCC 7.19 as a feed additive for chickens for fattening, other poultry species for fattening or reared for laying and ornamental birds, 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 30 September 2020 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 in the thermostable granulate formulation and in the granulate formulation is safe for consumers and the environment. The Authority also concluded that the preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 in all its formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance, it should be considered a respiratory sensitiser. The Authority concluded in its opinion of 4 May 2022 (3) that, under the proposed conditions of use, the preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 in the powder formulation and in the liquid formulation is safe for consumers and the environment. It also stated that the preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 in all its formulations is safe for chickens for fattening, other poultry species for fattening or reared for laying and ornamental birds. The Authority further concluded in its opinion of 27 September 2023 (4) that the preparation of 6-phytase produced by Komagataella phaffii CGMCC 7.19 has the potential to be efficacious for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds, at the minimum recommended level of 500 FTU/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 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 by Komagataella phaffii CGMCC 7.19 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 all poultry species for fattening or reared for laying 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 1

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, subject to the conditions laid down in that Annex.


Article 2

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, 10 April 2024.


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)  
            EFSA Journal 2020;18(11):6282.

(3)  
            EFSA Journal 2022;20(6):7343.

(4)  
            EFSA Journal 2023;21(0):8345.




ANNEX














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





4a46


Nutrex N.V.


6-phytase (EC 3.1.3.26)



Additive composition

Preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella phaffii CGMCC 7.19 having a minimum activity of:
Powder form: 100 000  FTU (1)/g.
Granulate form: 10 000  FTU/g
Thermostable granulate form: 10 000  FTU/g
Liquid form: 10 000  FTU/mL

Characterisation of the active substance

6-phytase (EC 3.1.3.26) produced by Komagataella phaffii CGMCC 7.19.

Analytical method
 (2)

For the quantification of 6-phytase activity in the feed additive:






—


colorimetric method based on the enzymatic reaction of phytase on phytate – VDLUFA 27.1.4.




For the quantification of 6-phytase activity in premixtures:






—


colorimetric method based on the enzymatic reaction of phytase on phytate – VDLUFA 27.1.3.




For the quantification of 6-phytase activity in compound feed:






—


colorimetric method based on the enzymatic reaction of phytase on phytate – EN ISO 30024.






All poultry species for fattening
All poultry species reared for laying
Ornamental birds


—


500 FTU


—








1.


In the directions for use of the additive and premixture, 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.






1 May 2034






(1)  One phytase unit (FTU) is the amount of enzyme that releases 1 μmol of inorganic phosphate from phytate per minute at pH 5,5 and 37 °C.

(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




ELI: http://data.europa.eu/eli/reg_impl/2024/1057/oj
ISSN 1977-0677 (electronic edition)