Regulation 3(2)

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 and minor porcine species for fattening or reproduction

Authorisation

1.  The preparation specified in the table in this schedule, 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 in this schedule.

Table

Column 1		Column 2
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) In granular, coated and liquid forms, minimum activity 5000 FTU/g(1)
Characterisation of the active substance(s)		6-phytase (EC 3.1.3.26) produced by Komagataella phaffii (DSM 32854)
Analytical methods(2)		1. For quantification of phytase activity in the feed additive:
		Colorimetric method based on the enzymatic reaction of phytase on the phytate in accordance with the VDLUFA Method Book, Volume III, Part 27.1.4(3)
		2. For quantification of phytase activity in feed materials and compound feed:
		Colorimetric method based on the enzymatic reaction of phytase on the phytate in accordance with international standard BS EN ISO 30024:2009 entitled “Animal feeding stuffs. Determination of phytase activity”(4)
		3. For quantification of phytase activity in premixtures:
		Colorimetric method based on the enzymatic reaction of phytase on the phytate in accordance with the VDLUFA Method Book, Volume III, Part 27.1.3(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		Not applicable
Content of 6-phytase (units of activity/kg of complete feed with a moisture content of 12%)	Minimum content	250 FTU
	Maximum content	No maximum
Other provisions		In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.

(1)

FTU means 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 are set out in the document referenced “Ares(2020)762221 – 06/02/2020” and last updated on 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, the Chemical Analysis of Feedingstuffs (ISBN 978 3 941273 14 6) is available at the following address: Method book Volume III Feedingstuffs (vdlufa.de). Copies of a translated version of Part 27.1.4 may be obtained from Food Standards Scotland, Pilgrim House, Old Ford Road, Aberdeen, AB11 5RL.

(4)

ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. Under reference BS EN ISO 30024:2009, it was published as a UK standard by the British Standards Institution on 30 September 2009 (ISBN 0 580 62651 7).

(5)

The Association of German Agricultural Analytical and Research Institutes (VDLUFA) Method book, Volume III, the Chemical Analysis of Feedingstuffs (ISBN 978 3 941273 14 6) is available at the following address: Method book Volume III Feedingstuffs (vdlufa.de). Copies of a translated version of Part 27.1.3 may be obtained from Food Standards Scotland, Pilgrim House, Old Ford Road, Aberdeen, AB11 5RL.