LegalizeCommission Implementing Regulation (EU) 2020/163 of 5 February 2020 concerning the authorisation of a preparation of muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for turkeys for fattening, turkeys reared for breeding, chickens reared for breeding and other poultry species reared for breeding (holder of authorisation DSM Nutritional Products Ltd. represented in the Union by DSM Nutritional Products Sp. Z o.o) (Text with EEA relevance)
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
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 feedingstuff with a moisture content of 12 % | |||||||||
| Category of zootechnical additives. Functional group: other zootechnical additives. | |||||||||
| 4d16 | Novozymes A/S | 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 form | Chickens reared for breeding Turkeys for fattening | — | 25 000 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 skin and breathing protections. | 26 February 2030 | |
| Characterisation of the active substance: muramidase (EC 3.2.1.17) (lysozyme) produced by Trichoderma reesei (DSM 32338) | Turkeys reared for breeding | ||||||||
| 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. | Other poultry species reared for breeding | ||||||||
| (1) One 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 that22 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 |
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