Commission Implementing Regulation (EU) 2021/1409 of 27 August 2021 concerning the authorisation of phytomenadione as a feed additive for horses (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
The substance specified in the Annex, 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 a feed additive in animal nutrition, subject to the conditions laid down in that Annex.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX Identification number of the additive Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of active substance/kg of complete feedingstuff with a moisture content of 12 % Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a712 ‘Phytomenadione’ or ‘Vitamin K 1 ’ Additive composition Preparation containing ≥ 4,2 % of phytomenadione. Solid form Characterisation of active substance 2-methyl-3-[(E,7R,11R)-3,7,11,15-tetramethylhexadec-2-enyl] naphthalene-1,4-dione Chemical formula: C 31 H 46 O 2 CAS number: 84-80-0 Purity: ≥ 97 % for the sum of E-phytomenadione, E-epoxyphytomenadione and Z-phytomenadione isomers Purity criteria: — ≥ 75 % E-phytomenadione; — ≤ 4 % E-epoxyphytomenadione Produced by chemical synthesis Analytical method ( 1 ) For the determination of phytomenadione in the feed additive: – High Performance Liquid Chromatography – European Pharmacopoeia (8.0, 01/2014:1036). For the determination of phytomenadione in the additive preparation and in complementary feed: – High Performance Liquid Chromatography with Fluorescence detection (HPLC-FLD) Horses - - - 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, skin and eye irritation and dermal sensitization, resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including skin, eyes and breathing protection. 19.9.2031 ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
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