Commission Implementing Regulation (EU) 2021/1431 of 1 September 2021 concerning the authorisation of muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for weaned piglets (holder of the authorisation DSM Nutritional Products Ltd, represented in the Union by DSM Nutritional Products Sp. z o.o.) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/1431
• Articles: 3

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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

Unit of activity/kg of complete feed with a moisture content of 12 %

Category of zootechnical additives. Functional group: other zootechnical additives (improvement of the feed to gain ratio).

4d16

DSM Nutritional Products Ltd. represented in the Union by DSM Nutritional Products Sp. z o.o.

Muramidase (EC 3.2.1.17)

Additive composition

Preparation of muramidase (EC 3.2.1.17) (lysozyme) produced by Trichoderma reesei (DSM 32338) having a minimum activity of 60 000 LSU(F)  ( 1 ) /g.

Solid and liquid forms.

Piglets (weaned)

-

50 000

LSU(F)

65 000

LSU(F)

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 potential risks resulting from its 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 eyes, skin and breathing protections.

22.9.2031

Characterisation of the active substance:

Muramidase (EC 3.2.1.17) (lysozyme) produced by Trichoderma reesei (DSM 32338).

Analytical method

( 2 )

For the quantification of muramidase:

fluorescence-based enzyme assay method that determines the enzyme-catalyzed depolymerisation of a fluorescein-labelled peptidoglycan preparation at pH 6,0 and 30 °C.

( 1 )   1 LSU(F) is defined as the amount of enzyme that increases the fluorescence of 12,5 μg/ml fluorescein-labelled peptidoglycan per minute at pH 6,0 and 30 °C by a value that corresponds to the fluorescence of approximately 0,06 nmol fluorescein isothiocyanate isomer.

( 2 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.