The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Miscellaneous Amendment) (Scotland) Regulations 2024 No. 330

SCHEDULES

SCHEDULE 16 Authorisation of the substance vitamin K₁ or Phytomenadione (identification number 3a712) as a feed additive for horses

Authorisation

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: Solid preparation containing a minimum of 4.2% of phytomenadione (vitamin K1)
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): CAS number: 84-80-0(2) EINECS number: 201-564-2(3) with the following components: E-phytomenadione: 75% minimum E-epoxyphytomenadione: 4% maximum Total purity of E-phytomenadione, E-epoxyphytomenadione and Z-phytomenadione isomers: 97% minimum
Analytical methods(4)		For determination of phytomenadione (vitamin K1) in the feed additive: High performance liquid chromatography (HPLC) in accordance with the European Pharmacopoeia monograph(5)
		For determination of phytomenadione in the additive preparation and in complimentary feed: High performance liquid chromatography with fluorescence detection (HPLC-FLD) in accordance with BS EN 14148:2003(6)
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.