The Feed Additives (Authorisations) (Wales) Regulations 2022

Regulation 3(1)

SCHEDULE 9 Authorisation of a preparation of 6-phytase (EC 3.1.3.26) (identification number 4a32) as a feed additive for all poultry species, ornamental birds, piglets, pigs for fattening, sows, minor porcine species for fattening or reproduction

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) FTU = phytase enzyme units. One FTU is the amount of enzyme that releases 1 micromole (µm) of inorganic phosphate from sodium phytate per minute under reaction conditions of pH 5.5 and 37°C.
(2) Details of the analytical methods set out in the document referenced “Ares(2020)762221 – 06/02/2020“ and last updated 4 May 2020. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2019-0052.
(3) The Association of German Agricultural Analytical and Research Institutes (VDLUFA) Method Book, Volume III, New single methods 2016, the Chemical Analysis of Feedingstuffs (ISBN 978 3 941273 14 6), https://vdlufa.de.
(4) The Association of German Agricultural Analytical and Research Institutes (VDLUFA) Method Book, Volume III, 8th supplement 2012, the Chemical Analysis of Feedingstuffs (ISBN 978 3 941273 14 6), https://vdlufa.de.
(5) Under reference BS EN ISO 30024:2009 “Animal feeding stuffs. Determination of phytase activity”. Published by the British Standards Institution on 30 September 2009 (ISBN 978 0 580 62651 7). Available from the British Standards Institution https://knowledge.bsigroup.com.
(6) Content of 6-phytase in FTU/kg of complete feed with a moisture content of 12%.
Additive	6-phytase (EC 3.1.3.26)
Identification number of the additive	4a32
Authorisation holder	Huvepharma EOOD
Additive category	Zootechnical additives
Functional group	Digestibility enhancers
Additive composition	Preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella phaffii DSM 32854 with a minimum activity of 5000 FTU (1)/g in granular, coated or liquid forms
Characterisation of the active substance(s)	6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii DSM 32854
Analytical methods(2)	For quantification of phytase activity in the feed additive: Colorimetric method based on the enzymatic reaction of phytase on the phytate (VDLUFA 27.1.4(3)).
	For quantification of phytase activity in premixtures: Colorimetric method based on the enzymatic reaction of phytase on the phytate (VDLUFA 27.1.3(4)).
	For quantification of phytase activity in feed materials and compound feed: Colorimetric method based on the enzymatic reaction of phytase on the phytate (BS EN ISO 30024:2009(5)).
Species or category of animal	All poultry species Ornamental birds Piglets Pigs for fattening Sows Minor porcine species for fattening or reproduction
Maximum age	None
Minimum content(6)	250 FTU/kg
Maximum content(6)	None
Other provisions	In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.