
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.Done at Brussels, 5 September 2011.
For the Commission
The President
José Manuel BARROSO
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
4a12 Roal Oy 6-phytase EC 3.1.3.26 
 Additive composition:
Preparation of 6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (CBS 122001) with a minimum activity of:
 40 000 PPU /g in solid form
 10 000 PPU /g in liquid form
 Characterisation of the active substance:
of 6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (CBS 122001)
 Analytical method:
Colorimetric method quantifying the activity of 6-phytase by measuring released inorganic phosphate from sodium phytate by analysing the colour formed by reduction of a phosphomolybdate complex. Sows — 250 PPU — 
1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

2. Maximum recommended dose per kilogram of complete feed for sows: 1 000 PPU.

3. For use in feed containing more than 0,23 % phytin- bound phosphorus.

4. For safety: breathing protection, glasses and gloves shall be used during handling.
 26 September 2021

