The Feed Additives (Authorisations) (Wales) Regulations 2022

Regulation 3(1)

SCHEDULE 4 Renewal of authorisation of pyridoxine hydrochloride (vitamin B₆) (identification number 3a831) as a feed additive for all animal species

The substance specified in the table, belonging to the additive category “nutritional additives” and to the functional group “vitamins, pro-vitamins and chemical well-defined substances having a similar effect”, is authorised as an additive in animal nutrition subject to the conditions set out in the table(1).

(1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.
(2) European Inventory of Existing Commercial Substances, number as published in OJ No C 146 A, 15.6.90, p.1.
(3) Details of the analytical methods set out in the document referenced “JRC.DG.D.6/CvH/GB/ag/ARES(2011)356822” and last updated 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2010-0139.
(4) European Pharmacopoeia, European Directorate for the Quality of Medicines and Healthcare, 10th edition. Published 1 July 2019 (ISBN 9789999146111).
(5) The Association of German Agricultural Analytical and Research Institutes (VDLUFA) Method Book, Volume III, 6th supplement 2006, the Chemical Analysis of Feedingstuffs (ISBN 978 3 941273 14 6), https://vdlufa.de.
(6) Under reference BS EN 14164:2014 “Foodstuffs. Determination of vitamin B6 by high performance chromatography”. Published by the British Standards Institution on 30 June 2014 (ISBN 978 0 580 77941 1). Available from the British Standards Institution https://knowledge.bsigroup.com.
(7) Content of pyridoxine hydrochloride(vitamin B6) in mg of additive/kg of complete feed with a moisture content of 12%.
Additive	Pyridoxine hydrochloride (vitamin B6)
Identification number of the additive	3a831
Authorisation holder	None specified
Additive category	Nutritional additives
Functional group	Vitamins, pro-vitamins and chemically well-defined substances having similar effect
Additive composition	Pyridoxine hydrochloride, with a purity criteria not less than 98.5%
Characterisation of the active substance(s)	Pyridoxine hydrochloride: C8H11NO3·HCl CAS number(1): 58-56-0 EINECS number(2): 200-386-2
Analytical methods(3)	For determination of pyridoxine hydrochloride (vitamin B6) in the feed additive: Titration with perchloric acid (Ph. Eur. 10th edition, monograph 0245(4)).
	For determination of pyridoxine hydrochloride (vitamin B6) in premixtures: Reversed phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV) (VDLUFA 13.9.1(5)).
	For determination of pyridoxine hydrochloride (vitamin B6) in feed and water:   Reversed phase High Performance Liquid Chromatography coupled to fluorescence detector (RP-HPLC-FLD) – method based on BS EN 14164:2014(6).
Species or category of animal	All animal species
Maximum age	None
Minimum content(7)	None
Maximum content(7)	None
Other provisions	1. In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment and in water must be indicated.
	2. Pyridoxine hydrochloride (vitamin B6) may be used via water for drinking.

(1)

This authorisation is a renewal of the authorisation granted under Commission Implementing Regulation (EU) No 515/2011. That Regulation is revoked by regulation 8 of these Regulations.