The Feed Additives (Authorisations) (England) Regulations 2023

Regulation 3

SCHEDULE 10 Renewal 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 pigs, poultry for breeding, poultry for fattening and poultry for laying

The preparation of 6-phytase (EC 3.1.3.26), belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table(1).

(1) Enzyme activity 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.
(2) 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.
(3) This is the identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org.
(4) 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.
(5) Details of the analytical method is set out in the document referenced “D08/FSQ/CVH/SY/D/Ares(2009)173372” and last updated on 6th June 2016, available at: https://joint-research-centre.ec.europa.eu/publications/fad-2008-0040_en.
Additive		6-phytase (EC 3.1.3.26)
Identification number		4a12
Authorisation holder		Roal Oy
Additive category		Zootechnical additives
Functional group		Digestibility enhancers
Additive composition		Preparation 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/g for the solid form and 5,000 PPU/g for the liquid form(1).
Characterisation of the active substance(s)		6-phytase (EC 3.1.3.26) produced by fermentation with Trichoderma reesei (CBS 122001) CAS no: 9001-89-2(2) EC (IUBMB) no: 3.1.3.26(3) EINECS no: 232-630-9(4)
Analytical method(5)		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 and poultry for laying
Maximum age		Not applicable
Content of 6-phytase (units of activity (PPU)/kg of complete feed with a moisture content of 12%)	Minimum content	For pigs, poultry for breeding and poultry for fattening: 250 PPU/kg For poultry for laying: 125 PPU/kg
	Maximum content	No maximum
Other provisions		The 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 of the authorisation 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(1) of, and Schedule 14 these Regulations. This renewal differs from the previous authorisation as the minimum level of stock enzyme activity is reduced from 10,000 PPU/g to 5,000 PPU/g in the liquid forms.