Contents
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 nutritionnote, 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 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 237/2012note, and for minor poultry species for fattening and chickens reared for laying by Commission Implementing Regulation (EU) No 1365/2013note.
(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 2023note 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 378/2005note, 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,
HAS ADOPTED THIS REGULATION:
Article 1Renewal of authorisation#
The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed subject to the conditions laid down in that Annex.
Article 3Transitional measures#
1.The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 26 September 2024 in accordance with the rules applicable before 26 March 2024 may continue to be placed on the market and used until the existing stocks are exhausted.
2.Compound feed and feed materials containing the preparation specified in the Annex, which are produced and labelled before 26 March 2025 in accordance with the rules applicable before 26 March 2024 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 4Entry into force#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
| 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 | |||||||||
| 4a17 | Kerry Ingredients and Flavours Ltd. | Alpha-galactosidase (EC 3.2.1.22) Endo-1,4-beta-glucanase (EC 3.2.1.4) | Additive compositionPreparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 having a minimum activity of:1000 U alpha-galactosidase/g,5700 U endo-1,4-beta-glucanase/g.Solid form.Characterisation of the active substanceAlpha-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.Analytical methodnoteFor the determination of alpha-galactosidase: in the feed additive, premixtures and compound feed: colorimetric method measuring p-nitrophenol released by action of alpha-galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate.For the determination of endo-1,4-beta-glucanase in the feed additive, premixtures and compound feed: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate. | Chickens for fatteningMinor poultry species for fatteningChickens reared for laying | — | 50 U alpha-galactosidase285 U endo-1,4-beta-glucanase | — | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2. Indicate in the directions for use: Maximum recommended dose: 100 U alpha-galactosidase/kg complete feed570 U endo-1,4-beta-glucanase/kg complete feed3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. | 26 March 2034 |
| Category of zootechnical additives. Functional group: digestibility enhancers | |||||||||
| 4a17 | Kerry Ingredients and Flavours Ltd. | Alpha-galactosidase (EC 3.2.1.22) Endo-1,4-beta-glucanase (EC 3.2.1.4) | Additive compositionPreparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 having a minimum activity of:500 U alpha-galactosidase/g,2850 U endo-1,4-beta-glucanase/g.Liquid form.Characterisation of the active substanceAlpha-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.Analytical methodFor the determination of alpha-galactosidase: in the feed additive, premixtures and compound feed: colorimetric method measuring p-nitrophenol released by action of alpha- galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate.For the determination of endo-1,4-beta-glucanase in the feed additive, premixtures and compound feed: 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-galactosidase285 U endo-1,4-beta-glucanase | — | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2. Indicate in the directions for use: Maximum recommended dose: 100 U alpha-galactosidase/kg complete feed570 U endo-1,4-beta-glucanase/kg complete feed3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. | 26 March 2034 |
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