LegalizeCommission Implementing Regulation (EU) 2017/896 of 24 May 2017 concerning the authorisation of a preparation of 6-phytase, produced by Trichoderma reesei (ATCC SD-6528) as a feed additive in solid form for all poultry species and all porcine species (other than suckling piglets) (holder of the authorisation Danisco (UK) Ltd) (Text with EEA relevance. )
Article 1
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
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 | |||||||||
| 4a24 | Genencor International B.V. | 6-phytase EC 3.1.3.26 | Additive composition Preparation of 6-phytase, produced by Trichoderma reesei (ATCC SD-6528), having a minimum activity of 20 000 FTU (1)/g. Solid form Characterisation of the active substance: 6-phytase (EC 3.1.3.26), produced by Trichoderma reesei (ATCC SD-6528) Analytical method (2) For the quantification of 6-phytase activity in the feed additive and premixutes: — colorimetric method based on the enzymatic reaction of phytase on the phytate. For the quantification of 6-phytase activity in feedingstuffs: — colorimetric method based on the enzymatic reaction of phytase on the phytate EN ISO 30024. | All poultry species All porcine species (other than suckling piglets) | — | 250 FTU | — | 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. Maximum recommended dose: 2 000 FTU/kg complete feed. 3. For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalator or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment. | 14 June 2027 |
| (1) 1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from a sodium phytate substrate at pH 5,5 and 37 °C. (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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