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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 such an authorisation.
(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-mannanase produced with Thermothelomyces thermophilus DSM 33149. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3)The application concerns the authorisation of a preparation of endo-1,4-beta-mannanase produced with Thermothelomyces thermophilus DSM 33149 as a feed additive for chickens and turkeys for fattening, minor poultry species for fattening and ornamental birds, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 February 2023note that the preparation of endo-1,4-beta-mannanase produced with Thermothelomyces thermophilus DSM 33149 is safe for the environment and has the potential to be efficacious in chickens for fattening, turkeys for fattening, minor poultry species for fattening and ornamental birds at a use level of 800 TMU/kg. After the assessment of newly submitted data by the applicant, the Authority concluded in its opinion of 30 January 2024note that the preparation of endo-1,4-beta-mannanase produced with Thermothelomyces thermophilus DSM 33149 is safe for the target species at the proposed use level, and for the consumer. The Authority also concluded that the preparation of endo-1,4-beta-mannanase produced with Thermothelomyces thermophilus DSM 33149 is not irritant to the eyes or skin. Owing to the proteinaceous nature of the active substance, the additive should be considered a respiratory sensitiser. The Authority was not able to conclude on the potential of the additive to be a skin sensitiser. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority 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)In view of the above, the Commission considers that the preparation of endo-1,4-beta-mannanase produced with Thermothelomyces thermophilus DSM 33149 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for all poultry species for fattening and ornamental birds. 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.
(6)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 1Authorisation#
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Entry 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. | |||||||||
| 4a47 | BASF SE | Endo-1,4-beta-mannanase (EC 3.2.1.78) | Additive compositionPreparation of endo-1,4-beta-mannanase (EC 3.2.1.78) produced with Thermothelomyces thermophilus DSM 33149 having a minimum activity of: 8000 TMU/gnote.Solid form and Liquid formCharacterisation of the active substanceEndo-1,4-beta-mannanase (EC 3.2.1.78) produced with Thermothelomyces thermophilus DSM 33149Analytical methodnoteFor the determination of the endo-1,4-beta-mannanase activity in the feed additive, premixtures and compound feed:Enzymatic hydrolysis of dyed carob galactomannan with endo-1,4-beta-mannanase followed by photometry. | All poultry species for fatteningOrnamental birds | - | 800 TMU | - | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2. 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 protective equipment. | 14 July 2034 |
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