LegalizeCommission Implementing Regulation (EU) 2023/1167 of 15 June 2023 concerning the authorisation of a preparation of 6-phytase produced by Trichoderma reesei CBS 146250 as a feed additive for all poultry species and all pigs (holder of authorisation: Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.) (Text with EEA relevance)
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.
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 |
|---|---|---|---|---|---|---|---|---|---|
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % | |||||||||
| Category of zootechnical additives. Functional group: digestibility enhancers | |||||||||
| 4a37 | Genencor International B.V. | 6-phytase (EC 3.1.3.26) | Additive composition Preparation of 6-phytase produced by Trichoderma reesei CBS 146250 with a minimum enzyme activity of: 30,000 FTU (1)/g Liquid or solid form Characterisation of the active substance 6-phytase (EC 3.1.3.26) produced by Trichoderma reesei CBS 146250 Analytical method (2) For the quantification of phytase activity in the feed additive: colorimetric method based on the enzymatic reaction of phytase on phytate – VDLUFA 27.1.4. For the quantification of phytase activity in premixtures: colorimetric method based on the enzymatic reaction of phytase on phytate – VDLUFA 27.1.3. For the quantification of phytase activity in compound feeds: colorimetric method based on the enzymatic reaction of phytase on phytate – EN ISO 30024 | All poultry except poultry for laying All pigs | — | 500 FTU | — | 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. | 6 July 2033 |
| All poultry for laying | — | 300 FTU | — | ||||||
| (1) One phytase unit (FTU) is the amount of enzyme which releases 1 micromol of inorganic orthophosphate from a sodium phytate substrate per minute at pH 5,5 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 |
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