Commission Implementing Regulation (EU) 2023/2850 of 20 December 2023 concerning the authorisation of a preparation of endo–1,4-beta-mannanase produced by Aspergillus niger CBS 120604 as a feed additive for all poultry species for fattening (holder of authorisation: Kerry Ingredients and Flavours Ltd)
Commission Implementing Regulation (EU) 2023/2850of 20 December 2023concerning the authorisation of a preparation of endo–1,4-beta-mannanase produced by Aspergillus niger CBS 120604 as a feed additive for all poultry species for fattening (holder of authorisation: Kerry Ingredients and Flavours Ltd)(Text with EEA relevance) 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 nutritionOJ L 268, 18.10.2003, p. 29., 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 by Aspergillus niger CBS 120604 as a feed additive. 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 by Aspergillus niger CBS 120604 as a feed additive for all poultry species for fattening, 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 11 May 2023EFSA Journal 2023;21(6):8045. that, under the proposed conditions of use, the preparation of endo–1,4-beta-mannanase produced by Aspergillus niger CBS 120604 is safe for all poultry species for fattening, consumers and the environment. It also concluded that the preparation of endo–1,4-beta-mannanase produced by Aspergillus niger CBS 120604 is considered an irritant to skin and eyes, and a dermal and respiratory sensitiser. The Authority further concluded that the preparation of endo–1,4-beta-mannanase produced by Aspergillus niger CBS 120604 has the potential to be efficacious at the level of inclusion of 30 U endo–1,4-beta-mannanase/kg complete feed for all poultry species for fattening. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods 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 by Aspergillus niger CBS 120604 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. 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 1AuthorisationThe 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 forceThis 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, 20 December 2023.For the CommissionThe PresidentUrsula von der LeyenANNEX
One endo-1,4-beta-mannanase unit (U) is defined as the amount of enzyme required to release one micromole of mannose reducing sugar equivalents per minute at 40°C and pH 4,5.Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd 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
4a42Kerry Ingredients and Flavours LtdEndo–1,4-beta-mannanase (EC 3.2.1.78)Additive composition:Preparation of endo–1,4-beta-mannanase produced by Aspergillus niger CBS 120604 having a minimum activity of 265 U/g solid formCharacterisation of the active substance:Endo–1,4-beta-mannanase (EC 3.2.1.78) produced by Aspergillus niger CBS 120604Analytical method:Determination of the endo–1,4-beta-mannanase activity in the feed additive, premixtures and compound feed: colorimetric method based on the enzymatic reaction of endo–1,4-beta-mannanase on the azurine cross-linked-carob galactomannan substrateAll poultry species for fattening—30 U—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 potential risks resulting from its 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.10 January 2034