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)
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Address https://gelex.eu/eli/EU/regulation/2015/1104@2015-07-08/en
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, 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, and for minor poultry species for fattening and for chickens reared for laying by Commission Implementing Regulation (EU) No 1365/2013.
(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 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
ANNEX
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 Chickens for fattening — 50 U alpha-galactosidase 285 U endo-1,4-beta-glucanase — 9 April 2022
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:
1000 U alpha-galactosidase/g
5700 U endo-1,4- beta-glucanase/g
Liquid form:
500 U alpha-galactosidase/g
2850 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
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.
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.