COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/1409 
of 27 August 2021
concer ning the author isation of phyt omenadione as a feed additiv e for horses 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the author isation 
of phytomenadione. (2)That application was accompan ied by the particulars and documents required under Article 
7(3) of Regulation (EC) No 1831/2003.
(3) The application concer ns the author isation of phytomenadio ne as a feed additive for horses. The applicant requeste d 
this additive to be classif ied in the additive categor y ‘nutr itional additives’.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 17 March 2021 (3)that, under the 
proposed conditions of use, phytomenadio ne does not have adverse effects on animal health, consumer safet y or the 
environment. The Author ity concluded that users will not be exposed by inhalation when the additive is presented in 
solid form or viscous liquid. Data from the Scientific Committee on Consumer Safety indicates that vitamin K1 can 
be catego rised as a dermal sensitiser . For preparations, the Auth ority could not conclude on their potential to be 
toxic by inhalation or on their potential as skin/e ye irritant. Theref ore, the Commission considers that appropr iate 
prote ctive measures should be taken to prevent adverse effects on human health, in particular as regar ds the users 
of the additive and its preparations. The Author ity concluded that phytomenadione is considered as an efficacious 
source of vitamin K1 for horses, when added to feed. The Author ity does not consider that there is a need for 
specifi c requirements of post-marke t monitori ng. It also verified the repor t on the method of analysis of the feed 
additives in feed submitted by the Reference Laborat ory set up by Regulation (EC) No 1831/2003.
(5) The assessment of phyt omenadione shows that the conditions for author isation, as provided for in Article 5 of 
Regulation (EC) No 1831/2003, are satisfi ed. According ly, the use of phyt omenadione should be author ised. The 
measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, 
Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
The substance specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional group 
‘vitamins, pro-vitamins and chemically well-def ined substances having a similar effect’, is author ised as a feed additive in 
animal nutr ition, subject to the conditions laid down in that Annex.
(1)OJ L 268, 18.10.2003, p. 29.
(2)Also known as vitamin K1.
(3)EFSA Journal 2021;19(4):6538EN Offi cial Jour nal of the European Union 30.8.2021                                                                                                                                           L 304/5  Article 2
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 August 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 304/6                                                                                                                                           30.8.2021  ANNEX 
Identif ica-
tion 
number of 
the 
additiv eAdditiv eComposition, chemical formula, descr iption, 
analytical methodSpecies 
or 
categor y 
of animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of 
period of 
author isa-
tionmg of activ e subst ance/kg 
of complete feedings tuff 
with a moisture content 
of 12 %
Categor y of nutr itional additiv es. Functional group: vita mins, pro-vita mins and chemically well-def ined subst ances having similar effect
3a712 ‘Phytomenadione ’ 
or ‘Vitamin K1’Additiv e composition
Preparation containing ≥ 4,2 % of 
phytomenadione.
Solid form
Character isation of activ e subst ance
2-methyl - 
3-[(E,7R,11R)-3,7,11,15-tetr amethylhexadec- 
2-enyl ] naphthalene-1,4-dione
Chemical formula: C31H46O2
CAS number: 84-80-0
Purity: ≥ 97 % for the sum of E-phyt omenadione, 
E-epo xyphyt omenadione and Z-phy tomenadione 
isomers
Purity criteria:
— ≥ 75 % E-phy tomenadione;
— ≤ 4 % E-epo xyph ytomenadione
Produced by chemical synthesis
Analytical method (1)
For the determination of phytomenadione in the 
feed additive: – High Performance Liquid 
Chromatograph y – European Phar macopoeia (8.0,  
01/2014:1036).
For the determination of phytomenadione in the 
additive preparation and in compl ementar y feed:  
– High Performance Liquid Chromatograp hy with 
Fluorescence detec tion (HPL C-FLD)Horses - - - 1.In the directions for use of the ad­
ditive and premixtures, the storage 
conditions and stability to heat 
treatment shall be indicated .
2.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks by inhala ­
tion, skin and eye irritation and der­
mal sensitization, resulting from its 
use. Where those risks cannot be 
eliminated or reduced to a mini ­
mum by such procedures and mea ­
sures, the additive and premixtures 
shall be used with appropr iate per­
sonal protective equipment, includ ­
ing skin, eyes and breathing prote c­
tion.19.9.2031
(1)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor tsEN Offi cial Jour nal of the European Union 30.8.2021                                                                                                                                           L 304/7