Commission Implementing Regulation (EU) 2025/2502 of 11 December 2025 concerning the authorisation of a preparation of protease produced with Bacillus subtilis CBS 148232 and viable spores of Bacillus velezensis NRRL B-50508, Bacillus velezensis NRRL B-50509 and Bacillus subtilis NRRL B-50510 as a feed additive for pigs for fattening of all Suidae species and weaned piglets of minor Suidae species (holder of authorisation: Genencor International B.V.)

• CELEX: Implementing Regulation (EU) 2025/2502
• 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

Name of the 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 and CFU/kg of complete feed with a moisture content of 12 %

Category: zootechnical additives. Functional group: digestibility enhancers.

4a63

Genencor

International B.V.

Protease (EC 3.4.21.62), Bacillus velezensis NRRL B-50508, Bacillus velezensis NRRL B-50509 and Bacillus subtilis NRRL B-50510

Additive composition

Preparation of:

—

protease (EC 3.4.21.62) produced with Bacillus subtilis CBS 148232 with a minimum activity of: 50 000 U  ( 1 ) /g

—

Bacillus velezensis NRRL B-50508, Bacillus velezensis NRRL B-50509 and Bacillus subtilis NRRL B-50510 containing a minimum total of:

Bacillus spp. 1,5 × 10 9 CFU/g (ratio 1:1:1)

—

Food- grade mineral oil: ≤ 0,4 %

—

Food- grade polyvinyl alcohol: ≤ 3,5 %

Solid form.

Characterisation of the active substance

Protease (EC 3.4.21.62) produced with Bacillus subtilis CBS 148232, and

viable spores of Bacillus velezensis NRRL B-50508, Bacillus velezensis NRRL B-50509 and Bacillus subtilis NRRL B-50510

Analytical method

( 2 )

For the quantification of protease in the feed additive, premixtures and compound feed:

Colorimetric method based on the enzymatic hydrolysis by protease of a dyed cross-linked casein substrate at pH 10,0 and 50 °C.

For the identification of Bacillus velezensis NRRL B-50508, Bacillus velezensis NRRL B-50509 and Bacillus subtilis NRRL B-50510:

Pulsed Field Gel Electrophoresis (PFGE) - CEN/TS 17697 or DNA sequencing methods.

For the enumeration of the overall Bacillus spp. (NRRL B-50508, NRRL B-50509 and NRRL B-50510) in the feed additive, premixture and compound feed: Spread plate method on tryptone soya agar (EN 15784).

Pigs for fattening of all Suidae species

Weaned piglets of minor Suidae species

—

5 000 U Protease And 1,5 × 10 8 CFU Bacillus spp.

—

1.

In the directions for use of the additive and premixtures, 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 skin and breathing protective equipment.

1 January 2036

( 1 )   1 unit of protease activity is defined as the amount of enzyme that liberates, under defined assay conditions, 2,3 μg of phenolic compounds (expressed as tyrosine equivalents) from a casein substrate per minute at pH 10,0 and 50 °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