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The Feed Additives (Authorisations) (Wales) Regulations 2022
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Regulation 3(1)
SCHEDULE 4E+WRenewal of authorisation of pyridoxine hydrochloride (vitamin B6) (identification number 3a831) as a feed additive for all animal species
Commencement Information
I1Sch. 4 in force at 24.11.2022, see reg. 1(2)(c)
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) | |
| Analytical methods(3) | For determination of pyridoxine hydrochloride (vitamin B6) in the feed additive:
|
| For determination of pyridoxine hydrochloride (vitamin B6) in premixtures:
| |
| For determination of pyridoxine hydrochloride (vitamin B6) in feed and water:
| |
| 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.
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