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The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Miscellaneous Amendment) (Scotland) Regulations 2024
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Authorisation
This section has no associated Policy Notes
1. The substance specified in the table, belonging to the additive category “nutritional additives” and to the functional group “vitamins, pro-vitamins and chemically well-defined substances having a similar effect”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.
| Additive | Vitamin K1 or Phytomenadione | |
| Identification number | 3a712 | |
| Authorisation holder(1) | None | |
| Additive category | Nutritional additives | |
| Functional group | Vitamins, pro-vitamins and chemically well-defined substances having similar effect | |
| Additive composition | Produced by chemical synthesis:
| |
| Characterisation of the active substance(s) | 2-methyl-3-[(E-7R,11R)-3,7,11,15-tetramethylhexadec-2- enyl] naphthalene-1,4-dione (phytomenadione) (C31H46O2): with the following components:
| |
| Analytical methods(4) | For determination of phytomenadione (vitamin K1) in the feed additive:
| |
| For determination of phytomenadione in the additive preparation and in complimentary feed:
| ||
| Species or category of animal | Horses | |
| Maximum age | No maximum | |
| Content of phytomenadione (vitamin K1) (mg/kg of complete feed with a moisture content of 12%) | Minimum content | No minimum |
| Maximum content | No maximum | |
| Other provisions | The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture | |
(1)
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.
(2)
This is a reference to the CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.
(3)
European Inventory of Existing Commercial Substances, as published in OJ No C146A, 15.6.90, p.1.
(4)
Details of the analytical methods are set out in the document referenced “Ares(2021)145311 – 07/01/2021” and “JRC F.5/CvH/SB/AS/Ares”, and last updated on 17 February 2021. Available at https://joint-research-centre.ec.europa.eu/publications/fad-2020-0006_en.
(5)
European Pharmacopoeia monograph – Ph. Eur. 8.0, 01/2014:1036. Published online by the European Directorate for the Quality of Medicines and Healthcare on 1st January 2024. Available at: https://pheur.edqm.eu/home.
(6)
BS EN 14148:2003 “Foodstuffs. Determination of vitamin K1 by HPLC”. Published by the British Standards Institution on 25 July 2003 (ISBN 0 580 42317 4). Available at: https://knowledge.bsigroup.com.
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