Commission Implementing Regulation (EU) 2017/895 of 24 May 2017 concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens for fattening and laying hens (holder of authorisation Fertinagro Nutrientes S.L.) (Text with EEA relevance. )
Date: 2017-05-24
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, food additive, market approval, poultry




L_2017138EN.01012001.xml










25.5.2017   


EN


Official Journal of the European Union


L 138/120








            COMMISSION IMPLEMENTING REGULATION (EU) 2017/895
of 24 May 2017
         
concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens for fattening and laying hens (holder of authorisation Fertinagro Nutrientes S.L.)
(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 an application was submitted for the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094). 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 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens for fattening and laying hens to be classified in the additive category ‘zootechnical additives’.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 October 2016 (2) that, under the proposed conditions of use, 3-phytase produced by Komagataella pastoris (CECT 13094) does not have an adverse effect on animal health, human health or the environment. The Authority has also concluded that the additive has a potential to be efficacious in improving the availability of phytate phosphorus of the diets for the target species. 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 3-phytase shows that the conditions for authorisation of 3-phytase produced by Komagataella pastoris (CECT 13094), 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, 24 May 2017.


For the Commission


The President

Jean-Claude JUNCKER
            





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

(2)  
            EFSA Journal 2016;14(11):4622.




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




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





Category of zootechnical additives. Functional group: digestibility enhancers






4a25


Fertinagro Nutrientes S.L.


3-phytase
EC 3.1.3.8



Additive composition

Preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) having a minimum activity of: 1 000  FTU (1)/ml
Liquid form

Characterisation of the active substance

3-phytase (EC 3.1.3.8) produced by Komagataella pastoris (CECT 13094)

Analytical method
 (2)

For the quantification of 3-phytase activity in the feed additive:






—


colorimetric method based on the enzymatic reaction of phytase on the phytate




For the quantification of 3-phytase activity in feedingstuffs:






—


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






Chickens for fattening


—


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.


Recommended maximum dose for chickens for fattening and laying hens: 1 000  FTU/kg complete feed.










3.


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.






14 June 2027




Laying hens


1 000  FTU






(1)  1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from a sodium phytate substrate 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