Commission Implementing Regulation (EU) 2024/778 of 5 March 2024 concerning the authorisation of a preparation of protease produced by Bacillus licheniformis DSM 33099 as a feed additive for all poultry species for fattening, reared for laying and reared for breeding (holder of authorisation: DSM Nutritional Products Ltd)

• CELEX: Implementing Regulation (EU) 2024/778
• 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 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

4a43

DSM Nutritional Products Ltd

Protease (EC 3.4.21.62)

Additive composition

Preparation of protease produced by Bacillus licheniformis DSM 33099 having a minimum activity of 600 000 NFP  ( 1 ) /g.

Solid form.

Characterisation of the active substance

Protease (EC 3.4.21.62, also known as ‘subtilisin’) produced by Bacillus licheniformis DSM 33099.

Analytical method

( 2 )

For the determination of the protease activity in the feed additive, premixtures and compound feed: colorimetric methods based the enzymatic reaction of protease on the N-Succinyl-Ala-Ala-Pro-Phe p-nitroanilide substrate.

All poultry species for fattening

All poultry species reared for laying or reared for breeding

—

30 000 NFP

—

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.

26 March 2034

( 1 )   One protease unit (NFP) is defined as the amount of enzyme that releases 1 μmol of p-nitroaniline from 1 mM substrate (N-Succinyl-Ala-Ala-Pro-Phe p-nitroanilide) per minute at pH 9,0 and 37 °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