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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 endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536, was authorised for 10 years as a feed additive for poultry, weaned piglets and pigs for fattening by Commission Implementing Regulation (EU) No 290/2014note, and for sows by Commission Implementing Regulation (EU) No 1138/2014note.
(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 endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 as a feed additive for all poultry species, weaned piglets, pigs for fattening and sows, 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 26 November 2024note that the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 in all its formulations remains safe for all poultry species, weaned piglets, pigs for fattening and sows, the consumers and the environment under the conditions of use currently authorised. It also concluded that the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536, in all its formulations, is non-irritant to the eyes and skin but should be considered a respiratory sensitiser, and all solid formulations should also be considered dermal sensitisers. It also indicated that there is no need for assessing the efficacy of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536, 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 endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 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 endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 satisfies the conditions 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 endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 as a feed additive, Implementing Regulations (EU) No 290/2014 and (EU) No 1138/2014 should be repealed.
(8)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 3Entry 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 feed 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: zootechnical additives. Functional group: digestibility enhancers. | |||||||||
| 4a1604i | Adisseo France S.A.S. | Endo-1,3(4)- beta-glucanase (EC 3.2.1.6) Endo-1,4- beta-xylanase (EC 3.2.1.8) | Additive compositionPreparation of endo-1,3(4)-beta-glucanase (EC 3.2.1.6) and endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Talaromyces versatilis IMI CC 378536 having a minimum activity of:solid form: endo-1,3(4)-beta-glucanase 30000 VU/g and endo-1,4-beta- xylanase 22 000 VU/g;liquid form: endo-1,3(4)-beta-glucanase 7500 VU/ml and endo-1,4- beta-xylanase 5500 VU/ml.Characterisation of the active substanceEndo-1,3(4)-beta-glucanase (EC 3.2.1.6) and endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Talaromyces versatilis IMI CC 378536Analytical methodnoteFor the quantification of endo-1,3(4)- beta-glucanase activity in the feed additive, premixture and compound feed:viscosimetric method based on decrease in viscosity produced by action of endo-1,3(4)-beta-glucanase on the glucan substrate barley betaglucan at pH = 5,5 and 30 °C.For the quantification of endo-1,4-beta- xylanase activity in the feed additive, premixture and compound feed:viscosimetric method based on decrease in viscosity produced by action of endo-1,4-beta-xylanase on the xylan containing substrate wheat arabinoxylan at pH = 5,5 and 30 °C. | All poultry speciesPiglets (weaned)Pigs for fatteningSows | — | Endo-1,3(4)-beta-glucanase 1500 VUEndo-1,4-beta- xylanase1100 VU | — | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2. For use in sows from one week before farrowing until the end of the lactation period.3. 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 and skin (only for the solid formulations of the additive) protective equipment. | 7 August 2035 |
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