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 the Annex.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEXSupplementary provisions
ANNEX
Identi-fication 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
4a29
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 28088) having a minimum activity of:
—
1,6 × 10 8 U ( 1 ) /g solid form;
—
5,9 × 10 8 U/g liquid form.
Characterisation of the active substance
endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088)
Analytical methods
( 2 )
For the quantification of endo-1,4-beta-mannanase in the feed additive, premixtures and feedingstuffs:
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 other than laying birds
—
32 000 U
—
1.
In the directions for use of the additive and premixtures, the storage conditions and stability 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 to their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment including skin and breathing protections.
3.
For use in weaned piglets until approximately 35 kg.
8 November 2028
Turkeys for fattening
Turkeys reared for breeding
48 000 U
Weaned piglets
48 000 U
Pigs for fattening
Minor porcine species for fattening
32 000 U
( 1 ) 1 U is the amount of enzyme which liberates 0,72 micrograms of reducing sugars (mannose equivalents) from a mannan-containing substrate (locust bean gum) per minute at pH 7,0 and 40 °C.
( 2 ) Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports