BAKGRUNN (fra kommisjonsforordningen)

(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 and renewing such an authorisation.

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

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the 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 chickens for fattening, minor poultry species for fattening and chickens reared for laying, requesting the additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 July 2023 (4) that the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 remains safe for chickens for fattening, minor poultry species for fattening and chickens reared for laying, the consumers and the environment under the conditions of use currently authorised. It also concluded that the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604, is a skin and eye irritant and a dermal sensitiser, and that it should be considered a respiratory sensitiser. It also indicated that there is no need for assessing the efficacy of the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 as the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisations which would have an impact on the efficacy of the additive. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of the 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 in the context of the previous authorisations are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (5), an evaluation report of the Reference Laboratory is therefore not required.

(6) In view of the above, the Commission considers that the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604, satisfies the conditions, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. 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. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.

(7) As a consequence of the renewal of the authorisation of the 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, Implementing Regulations (EU) No 237/2012 and (EU) No 1365/2013 should be repealed.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,