The Feed Additives (Authorisations) (Scotland) Regulations 2023

Regulation 3(1)

SCHEDULE 10Renewal of authorisation of a preparation of 6-phytase (EC 3.1.3.26) produced from Trichoderma reesei (CBS 122001) (identification number 4a12) as a feed additive for poultry for fattening, poultry for breeding, poultry for laying and pigs

This schedule has no associated Policy Notes

Authorisation

1.  The preparation specified in the table, 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 set out in the table(1).

Table

Column 1Column 2
Additive6-phytase (EC 3.1.3.26)
Identification number4a12
Authorisation holderRoal Oy
Additive categoryZootechnical additives
Functional groupDigestibility enhancers
Additive compositionPreparation of 6-phytase (EC 3.1.3.26) produced by fermentation with Trichoderma reesei (CBS 122001) having a minimum enzyme activity of 40 000 PPU(2)/g for the solid form and 5000 PPU/g for the liquid form
Characterisation of the active substance(s)6-phytase (EC 3.1.3.26) produced by fermentation with Trich oderma reesei (CBS 122001)
  • CAS No: 9001-89-2(3)

  • EC (IUBMB) No: 3.1.3.26(4)

  • EINECS No: 232-630-9(5)

Analytical methods(6)For the quantification of phytase activity in the feed additive, premixtures, feed materials and compound feed:
  • Colorimetric method quantifying the enzymatic activity of 6-phytase by measuring released inorganic phosphate from sodium phytate by analysing the colour formed by reduction of a phosphomolybdate complex

Species or category of animal
  • Pigs

  • Poultry for breeding

  • Poultry for fattening

  • Poultry for laying

Maximum ageNo maximum
Content of 6-phytase (units of activity (PPU/kg) of complete feed with a moisture content of 12%)Minimum content

Pigs

Poultry for breeding

Poultry for fattening

250 PPU/kg
Poultry for laying125 PPU/kg
Maximum contentNo maximum
Other provisionsThe storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture
(1)

This authorisation is a renewal (with modification) of the authorisations granted under Commission Regulation (EU) No 277/2010, Commission Regulation (EU) No 891/2010 and Commission Implementing Regulation (EU) No886/2011. Those Regulations are revoked by regulation 7, and schedule 14, of these Regulations. The explanatory note to these Regulations sets out the modification made to those authorisations.

(2)

Enzyme activity is expressed in PPU units, where one PPU is the amount of enzyme which liberates 1 micromole (μmol) of inorganic phosphate from sodium phytate per minute at pH 5.0 and 37°C.

(3)

This is a reference to the CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.

(4)

This is the identification number assigned by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org.

(5)

The EINECS number is given in the European Inventory of Existing Commercial Substances, as published in O.J. No. C146A, 15.6.90, p. 1.

(6)

Details of the analytical methods are set out in the document referenced “D08/FSQ/CVH/SY/D/Ares(2009)173372” and last updated on 6 June 2016. The document is available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-2008-0040_en.