The Feed Additives (Authorisations) (Scotland) Regulations 2022 No. 288

Regulation 3(2)

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

Authorisation

1.  The additive specified in the table in this schedule, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is authorised as an additive in animal nutrition, subject to the conditions set out in the table in this schedule(1).

Table

Column 1		Column 2
Additive		Pyridoxine hydrochloride (vitamin B6)
Identification number of the additive		3a831
Authorisation holder(2)
Additive category		Nutritional additives
Functional group		Vitamins, pro-vitamins and chemically well-defined substances having similar effect
Additive composition		Pyridoxine hydrochloride: C8H11NO3.HCI Purity criteria not less than 98.5%
Characterisation of the active substance(s)		Pyridoxine hydrochloride CAS no:58-56-0(3) EINECS no:200-386-2(4)
Analytical methods(5)		1. For the determination of pyridoxine hydrochloride (Vitamin B6) in the feed additive:
		Titration with perchloric acid (Ph.Eur. 10th edition, monograph 0245)
		2. For the determination of pyridoxine hydrochloride (Vitamin B6) in premixtures:
		Reversed phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV) in accordance with the VDLUFA Method Book, Volume III, 13.9.1(6)
		3. For the 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 in accordance with European standard EN 14164:2014 entitled “ Foodstuffs – Determination of vitamin B6 by high performance chromatography”(7)
Species or category of animal		All animal species
Maximum age		Not applicable
Content of Pyridoxine hydrochloride (Vitamin B 6 ) in mg/kg of complete feed with a moisture content of 12%	Minimum content	No minimum
	Maximum content	No maximum
Other provisions		1.	In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
		2.	Pyridoxine hydrochloride (Vitamin B 6) 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 11 of these Regulations.

(2)

There is no requirement to include the name of the holder of this authorisation as this authorisation does not fall within the scope of Article 9(5) of Regulation (EC) 1831/2003.

(3)

This is a reference to the CAS Registry Number assigned to this additive by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.

(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 methods are set out in the document referenced “JRC.DG.D.6/CvH/GB/ag/ARES(2011)356822” and last updated on 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.

(6)

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 13.9.1 may be obtained from Food Standards Scotland, Pilgrim House, Old Ford Road, Aberdeen, AB11 5RL.

(7)

This standard was approved by the European Committee for Standardization (CEN) on 17 April 2014.