LegalizeCommission Regulation (EC) No 554/2008 of 17 June 2008 concerning the authorisation of 6-phytase (Quantum Phytase) as a feed additive (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 20th day following 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | ||||||
| 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 | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a5 | AB Enzymes GmbH | 6-phytase EC 3.1.3.26 | Additive composition Preparation of 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) having a minimum activity of: Solid form: 2 500 FTU/g [^E0003] Liquid form: 5 000 FTU/ml Characterisation of the active substance 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) Analytical method [^E0004] Colorimetric method based on reaction of vanadomolybdate on organic phosphate produced by reaction on a phytate-containing substrate (sodium phosphate) at pH 5,5 and 37 °C. | Chickens for fattening | — | 500 FTU | — | Other provisions | End of period of authorisation | 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. Recommended dose per kilogram of complete feedingstuff: — chickens for fattening: 500-2 500 FTU, — laying hens: 250-2 000 FTU, — ducks for fattening: 250-2 000 FTU, — turkeys for fattening: 500-2 700 FTU, — piglets (weaned): 100-2 500 FTU. 3. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. 4. For use in weaned piglets up to approximately 35 kg. 5. For safety: breathing protection glasses and gloves shall be used during handling. | 8.7.2018 | ||||
| 4a5 | AB Enzymes GmbH | 6-phytase EC 3.1.3.26 | Additive composition Preparation of 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) having a minimum activity of: Solid form: 2 500 FTU/g [^E0003] Liquid form: 5 000 FTU/ml Characterisation of the active substance 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) Analytical method [^E0004] Colorimetric method based on reaction of vanadomolybdate on organic phosphate produced by reaction on a phytate-containing substrate (sodium phosphate) at pH 5,5 and 37 °C. | Laying hens | — | 250 FTU | — | ||||||||
| 4a5 | AB Enzymes GmbH | 6-phytase EC 3.1.3.26 | Additive composition Preparation of 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) having a minimum activity of: Solid form: 2 500 FTU/g [^E0003] Liquid form: 5 000 FTU/ml Characterisation of the active substance 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) Analytical method [^E0004] Colorimetric method based on reaction of vanadomolybdate on organic phosphate produced by reaction on a phytate-containing substrate (sodium phosphate) at pH 5,5 and 37 °C. | Ducks for fattening | — | 250 FTU | — | ||||||||
| 4a5 | AB Enzymes GmbH | 6-phytase EC 3.1.3.26 | Additive composition Preparation of 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) having a minimum activity of: Solid form: 2 500 FTU/g [^E0003] Liquid form: 5 000 FTU/ml Characterisation of the active substance 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) Analytical method [^E0004] Colorimetric method based on reaction of vanadomolybdate on organic phosphate produced by reaction on a phytate-containing substrate (sodium phosphate) at pH 5,5 and 37 °C. | Turkeys for fattening | — | 500 FTU | — | ||||||||
| 4a5 | AB Enzymes GmbH | 6-phytase EC 3.1.3.26 | Additive composition Preparation of 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) having a minimum activity of: Solid form: 2 500 FTU/g [^E0003] Liquid form: 5 000 FTU/ml Characterisation of the active substance 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) Analytical method [^E0004] Colorimetric method based on reaction of vanadomolybdate on organic phosphate produced by reaction on a phytate-containing substrate (sodium phosphate) at pH 5,5 and 37 °C. | Piglets (weaned) | — | 100 FTU | — |
1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °C.
Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives
OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).
[^E0002]: (2) Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and of the Panel on Genetically Modified Organisms (GMO) on ‘Safety and efficacy of the product Quantum Phytase 5000 L and Quantum Phytase 2500 D (6-phytase) as a feed additive for chickens for fattening, laying hens, turkeys for fattening, ducks for fattening and piglets (weaned)’. The EFSA Journal (2008) 627, pp. 1-27.
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