Commission Implementing Regulation (EU) 2015/1104 of 8 July 2015 amending Implementing Regulation (EU) No 237/2012 as regards a new form of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) (holder of authorisation Kerry Ingredients and Flavours) (Text with EEA relevance)
Date: 2015-07-08
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, market approval, poultry




L_2015181EN.01006101.xml










9.7.2015   


EN


Official Journal of the European Union


L 181/61








            COMMISSION IMPLEMENTING REGULATION (EU) 2015/1104
of 8 July 2015
         
amending Implementing Regulation (EU) No 237/2012 as regards a new form of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) (holder of authorisation Kerry Ingredients and Flavours)
(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)


The use of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) was authorised for 10 years for chickens for fattening by Commission Implementing Regulation (EU) No 237/2012 (2), and for minor poultry species for fattening and for chickens reared for laying by Commission Implementing Regulation (EU) No 1365/2013 (3).












(3)


In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation to include a liquid form of alpha-galactosidase and endo-1,4-beta-glucanase to be used as a feed additive for chickens for fattening. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (‘the Authority’).












(4)


The Authority concluded in its opinion of 28 October 2014 (4) that the liquid form of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) does not have an adverse effect on animal health, human health or the environment, and that it has a potential to favourably affect animal performance in chickens for fattening. 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 alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the existing authorisation should be modified in order to include the new form.












(6)


Therefore, the Annex to Implementing Regulation (EU) No 237/2012 should be amended accordingly.












(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 1
The Annex to Implementing Regulation (EU) No 237/2012 is replaced by the text set out in the Annex to this Regulation.


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, 8 July 2015.


For the Commission


The President

Jean-Claude JUNCKER
            





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

(2)  Commission Implementing Regulation (EU) No 237/2012 of 19 March 2012 concerning the authorisation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) as a feed additive for chickens for fattening (holder of authorisation Kerry Ingredients and Flavours) (OJ L 80, 20.3.2012, p. 1).

(3)  Commission Implementing Regulation (EU) No 1365/2013 of 18 December 2013 concerning the authorisation of a preparation of alpha-galactosidase produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604) as a feed additive for minor poultry species for fattening and for chickens reared for laying (holder of authorisation Kerry Ingredients and Flavours (OJ L 343, 19.12.2013, p. 31).

(4)  
            EFSA Journal 2014; 12(11):3897.




ANNEX




                     ‘ANNEX














Identi-fication 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






4a17


Kerry ingredients and flavors


Alpha-galactosidase
EC 3.2.1.22
Endo-1,4-beta-glucanase
EC 3.2.1.4



Additive composition

Preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) with a minium activiy of:






 


Solid form:






—


1 000  U (1) alpha-galactosidase/g










—


5 700  U (2) endo-1,4- beta-glucanase/g














 


Liquid form:






—


500 U alpha-galactosidase/g










—


2 850  U endo-1,4- beta-glucanase/g.









Characterisation of the active substance

Alpha-galactosidase produced by Saccharomyces cerevisiae (CBS 615.94) Endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604).

Method of Analysis
 (3)

Determination:






—


Alpha-galactosidase: colorimetric method measuring p-nitrophenol released by action of alpha-galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate,










—


endo-1,4-beta-glucanase: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate.






Chickens for fattening


—


50 U alpha-galactosidase
285 U endo-1,4-beta-glucanase


—








1.


In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.










2.


Maximum recommended dose:






—


100 U alpha-galactosidase/kg;










—


570 U endo-1,4-beta-glucanase/kg.














3.


For safety: breathing protection glasses and gloves shall be used during handling.






9 April 2022









(1)  1 U is the amount of the enzyme which liberates 1 μmol of p-nitrolphenol per minute from p-nitrophenyl-alpha-galactopyranoside (pNPG) at pH 5,0 and 37 °C.

(2)  1 U is the amount of the enzyme which liberates 1 mg of reducing sugar (glucose equivalent) per minute from beta-glucan at pH 5,0 and 50 °C.

(3)  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’