The Feed Additives (Authorisations) (Wales) Regulations 2023

Regulation 3(1)

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) 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).

(1) Enzyme activity expressed in PPU units, where 1 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) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.
(3) Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org.
(4) European Inventory of Existing Commercial Substances, as published in OJ No C 146A, 15.6.90, p.1.
(5) 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. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2008-0040_en.
(6) Content of 6-phytase (units of activity (PPU)/kg of complete feed with a moisture content of 12%).
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 number: 9001-89-2(2) EC (IUBMB) number: 3.1.3.26(3) EINECS number: 232-630-9(4)
Analytical methods(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 Poultry for laying
Maximum age	None
Minimum content(6)	For pigs, poultry for fattening, and poultry for breeding: 250 PPU/kg
	For poultry for laying: 125 PPU/kg
Maximum content(6)	None
Other provisions	The storage conditions and stability for 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 of, and Schedule 14 to, these Regulations.