Commission Implementing Regulation (EU) 2023/2645 of 28 November 2023 concerning the authorisation of a preparation of endo–1,4-beta-mannanase produced by Paenibacillus lentus DSM 33618 as a feed additive for all poultry species for fattening and reared for laying or breeding, weaned piglets, weaned piglets of minor porcine species, pigs for fattening and minor porcine species for fattening (holder of authorisation: Elanco GmbH)

• CELEX: Implementing Regulation (EU) 2023/2645
• Articles: 3

Article 1 Authorisation

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 2 Entry 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.

Schedules & Appendices

ANNEX

ANNEX

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

4a45

Elanco GmbH

Endo–1,4-beta-mannanase (EC 3.2.1.78)

Additive composition:

Preparation of endo–1,4-beta-mannanase produced by Paenibacillus lentus DSM 33618 having a minimum activity of 1,60 × 10 5 U  ( 1 ) /g, and ≤ 1 % food-grade mineral oil

Solid form.

Characterisation of the active substance:

Endo–1,4-beta-mannanase (EC 3.2.1.78) produced by Paenibacillus lentus DSM 33618

Analytical method

( 2 ) :

For the quantification of endo–1,4-beta-mannanase activity in the feed additive, premixtures and compound feed: colorimetric methods based on enzymatic hydrolysis and the reaction of reducing sugars (mannose equivalent) with 3,5-dinitrosalicylic acid (DNS)

Chickens for fattening

Chickens reared for laying

Minor poultry species for fattening

Minor poultry species reared for laying or breeding

Pigs for fattening

Minor porcine species for fattening

—

32 000 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 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.

19 December 2033

Turkeys for fattening

Turkeys reared for breeding

Weaned piglets

Weaned piglets of minor porcine species

48 000 U

( 1 )   One unit of endo-1,4-beta-mannanase activity (U) is the amount of the enzyme which generates 0,72 micrograms of reducing sugars per minute from a mannose containing substrate at pH 7,0 and 40 °C.

( 2 )   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