LegalizeCommission Implementing Regulation (EU) 2020/164 of 5 February 2020 concerning the authorisation of 6-phytase produced by Schizosaccharomyces pombe (ATCC 5233) as a feed additive for all avian species and all swine species and repealing Regulation (EC) No 379/2009 (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 authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed as additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2
Repeal of Regulation (EC) No 379/2009
Regulation (EC) No 379/2009 is repealed.
Article 3
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 |
|---|---|---|---|---|---|---|---|---|---|
| Unit of activity/kg of complete feedingstuff with a moisture content of 12 % | |||||||||
| Category of zootechnical additives. Functional group: digestibility enhancers | |||||||||
| 4a1640 | Genencor International B.V. | 6-phytase EC 3.1.3.26 | Additive composition Preparation of 6-phytase (EC 3.1.3.26) produced by Schizosaccharomyces pombe (ATCC 5233) having a minimum activity of:10 000 FTU (1) /g Liquid and solid coated form ----------- Characterisation of the active substance: 6-phytase (EC 3.1.3.26) produced by Schizosaccharomyces pombe (ATCC 5233) ----------- Analytical method (2) Determination of 6-phytase in feed additive: colorimetric method based on the quantification of inorganic phosphate released by the enzyme from sodium phytate. Determination of 6-phytase in premixtures and feedingstuff: colorimetric method based on the quantification of inorganic phosphate released by the enzyme from sodium phytate (after dilution with heat-treated whole grain flour) (EN ISO 30024) | All avian species other than laying birds | — | 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. 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 breathing protection. | 26 February 2030 |
| All avian species for laying | — | 150 FTU | — | ||||||
| Piglets (weaned) Pigs for fattening | — | 250 FTU | — | ||||||
| All porcine species other than weaned piglets and pigs for fattening | — | 500 FTU | — | ||||||
| (1) One FTU is the amount of enzyme which liberates one 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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