LegalizeCommission Implementing Regulation (EU) 2023/1342 of 30 June 2023 concerning the renewal of the authorisation of a preparation of 6-phytase produced by Aspergillus oryzae DSM 33699 as a feed additive for poultry, pigs for fattening, weaned piglets and sows (holder of authorisation: DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.) and repealing Implementing Regulation (EU) No 837/2012 (Text with EEA relevance)
Article 1
Renewal of the authorisation
The authorisation of the preparation of 6-phytase produced by Aspergillus oryzae DSM 33699, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed subject to the conditions laid down in the Annex.
Article 2
Repeal of Implementing Regulation (EU) No 837/2012
Implementing Regulation (EU) No 837/2012 is repealed.
Article 3
Transitional measures
Article 4
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 | |||||||||
| 4a18i | Novozymes A/S | 6-phytase (EC 3.1.3.26) | Additive composition Preparation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 33699 with a minimum activity of: 10 000 FYT (1)/g in solid form, 20 000 FYT/g in liquid form Characterisation of the active substance 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae DSM 33699 Analytical method (2) For the quantification of phytase activity in the feed additive: colorimetric method based on the enzymatic reaction of phytase on the phytate – VDLUFA 27.1.4; For the quantification of phytase activity in premixtures: colorimetric method based on the enzymatic reaction of phytase on the phytate – VDLUFA 27.1.3; For the quantification of phytase activity in compound feeds: colorimetric method based on the enzymatic reaction of phytase on the phytate – EN ISO 30024. | Poultry Piglets (weaned) Pigs for fattening Sows | — | 500 FYT | — | 1. In the directions for use of the additive and premixture, the storage temperature, storage life, 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 by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. | 23 July 2033 |
| (1) 1 FYT is the amount of enzyme which liberates 1 μmol of inorganic phosphate from phytate per minute under reaction conditions with a phytate concentration of 5,0 mM 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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