LegalizeCommission Implementing Regulation (EU) 2024/2177 of 2 September 2024 concerning the authorisation of a preparation of 6-phytase produced with Aspergillus oryzae DSM 33737 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding, sows of all Suidae species and all fin fish (holder of authorisation: DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.)
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 feed 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the feed additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Units of activity/kg of complete feedingstuff with a moisture content of 12 % | Units of activity/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation | |||||||
| Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | |||||||
| 4a48 | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Novozymes A/S | 6-phytase (EC 3.1.3.26) | Other provisions | End of period of authorisation | Additive composition Preparation of 6-phytase (EC 3.1.3.26) produced with Aspergillus oryzae DSM 33737 having a minimum activity of: Solid form: 10 000 FYT [^E0001]/g. Liquid form: 20 000 FYT/g. Characterisation of the active substance 6-phytase (EC 3.1.3.26) produced with Aspergillus oryzae DSM 33737 Analytical method [^E0002] 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 feed: — colorimetric method based on the enzymatic reaction of phytase on the phytate – EN ISO 30024. | All poultry species for fattening or reared for laying or reared for breeding | - | 200 FYT | - | 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 the 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 eye (only for the two solid formulations), breathing and skin protective equipment. | 23 September 2034 |
| 4a48 | Sows of all Suidae species | 200 FYT | ||||||||||||||
| 4a48 | All fin fish | 1 000 FYT |
One Phytase Unit (FYT) is defined as the amount of enzyme that releases 1 μmol of inorganic phosphate from phytate per minute (concentration of 5,0 mM) at pH 5,5 and 37 °C.
Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/publications/feed-2021-2299_en.
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