Commission Implementing Regulation (EU) 2020/1376 of 1 October 2020 concerning the authorisation of a preparation of 6-phytase, produced by Komagataella phaffii (CGMCC 12056) as feed additive for turkeys for fattening, turkeys reared for breeding, piglets (suckling and weaned) and minor porcine species (holder of the authorisation Andrés Pintaluba S.A) (Text with EEA relevance)
Date: 2020-10-01
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, fattening, food additive, market approval, poultry, swine








L_2020319EN.01002601.xml










2.10.2020   


EN


Official Journal of the European Union


L 319/26








            COMMISSION IMPLEMENTING REGULATION (EU) 2020/1376
of 1 October 2020
         
concerning the authorisation of a preparation of 6-phytase, produced by Komagataella phaffii (CGMCC 12056) as feed additive for turkeys for fattening, turkeys reared for breeding, piglets (suckling and weaned) and minor porcine species (holder of the authorisation Andrés Pintaluba S.A)
(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 authorisation.












(2)


In accordance with Article 7 of Regulation (EC) No 1831/2003, two applications were submitted for the authorisation of a preparation of 6-phytase, produced by Komagataella phaffii (CGMCC 12056). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.












(3)


Those applications concern the authorisation of the preparation of 6-phytase produced by Komagataella phaffii (CGMCC 12056) as a feed additive for turkeys for fattening, turkeys reared for breeding, piglets (suckling and weaned) and minor porcine species to be classified in the additive category ‘zootechnical additives’.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinions of 7 October 2019 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced by Komagataella phaffii (CGMCC 12056) does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be regarded as a respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority concluded that the additive showed improvements on the phosphorus utilisation and content. This conclusion can be extended to turkeys reared for breeding. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It 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)


The assessment of the preparation of 6-phytase produced by Komagataella phaffii (CGMCC 12056) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.












(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
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
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, 1 October 2020.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  
            EFSA Journal 2019;17(11):5893 and EFSA Journal 2019;17(11):5894.




ANNEX














Identification number of the 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




Unit of activity/kg of complete feedingstuff with a moisture content of 12 %





Category of zootechnical additives. Functional group: digestibility enhancers





4a31


Andrés Pintaluba S.A.


6-phytase
EC 3.1.3.26



Additive composition

Preparation of 6-phytase (EC 3.1.3.26)
produced by Komagataella phaffii (CGMCC 12056) having a minimum activity of:
Solid form: 20 000  U (1)/g
Liquid form: 20 000  U/ml


Turkeys for fattening
Turkeys reared for breeding


-


250 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 potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.







22 October 2030





Piglets
(suckling and weaned)
Minor porcine species (suckling and weaned)


-


1000 U


-





Characterisation of the active substance:

6-phytase (EC 3.1.3.26) produced by Komagataella phaffii (CGMCC 12056)





Analytical method
 (2)

For the quantification of phytase activity in the feed additive:






—


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




For the quantification of phytase activity in premixtures:






—


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




For the quantification of phytase activity in feedingstuffs:






—


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










(1)  One unit is the amount of enzyme which releases one micromole 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://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports