FREE SHIPPING over $40
OVER 9000 FIVE-STAR REVIEWS
5% OFF ALL SUBSCRIPTIONS
100% HAPPINESS GUARANTEE
Analyze Diet
0
Home / Equine Research Bank / EFSA J / Safety and efficacy of an additive consisting of synthetic v...
EFSA journal. European Food Safety Authority2021; 19(4); e06538; doi: 10.2903/j.efsa.2021.6538

Safety and efficacy of an additive consisting of synthetic vitamin K1 (phytomenadione) for horses (JARAZ Enterprises GmbH & Co. KG).

Abstract: Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of vitamin K1 (phytomenadione) produced by chemical synthesis when used as a nutritional additive in complementary feed of horses at a maximum supplemental level of 14 mg vitamin K1/horse per day. The use of vitamin K1 is safe when used as a feed additive for horses under the proposed conditions of use. The use of vitamin K1 in nutrition of horses under the proposed conditions of use is considered safe for the consumer and the environment. No exposure of users by inhalation is expected. The Panel cannot conclude on the potential of the additive to be a skin and eye irritant. Vitamin K1 is considered a moderate dermal sensitiser. Vitamin K1 is an effective source of vitamin K in horse nutrition. The Panel recommends that the specifications of the additive refer to the substance-related impurities listed in the most updated monograph of the European Pharmacopoeia.
© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Get Full Text
Publication Date: 2021-04-30 PubMed ID: 33968245PubMed Central: PMC8085961DOI: 10.2903/j.efsa.2021.6538Google Scholar: Lookup
The Equine Research Bank provides access to a large database of publicly available scientific literature. Inclusion in the Research Bank does not imply endorsement of study methods or findings by Mad Barn.
LinkedInCopy
  • Journal Article

Summary

This research summary has been generated with artificial intelligence and may contain errors and omissions. Refer to the original study to confirm details provided. Submit correction.

The research is about the safety and effectiveness of using synthetic vitamin K1, or phytomenadione, as an additive in horse feed. The study concludes that using vitamin K1 is safe for horses, consumers, and the environment.

Objective of the Research

  • The purpose of this study by the FEEDAP panel was to assess the safety and effectiveness of using synthetic vitamin K1 as a nutritional additive in horse feed.
  • This additive was examined specifically for use in complementary horse feed at a maximum supplemental level of 14 mg per horse per day.

Findings on Safety

  • The research found that the usage of synthetic vitamin K1 is safe for horses under the conditions proposed for its use.
  • Not only is it safe for the horses consuming the additive, but it is also safe for the consumers of the horses’ produce and the environment.
  • There’s no expected exposure of users to the feed’s additive through inhalation, reducing potential risks.
  • However, the panel could not draw a conclusion on whether the additive could irritate the skin or eyes.
  • Despite this, they found that Vitamin K1 is considered a moderate dermal sensitizer, meaning it could potentially cause skin allergies.

Findings on Efficacy

  • The panel also concluded that synthetic Vitamin K1 is an effective source of vitamin K in horse nutrition.
  • This suggests that the additive fulfills its intended function of supplementing the horses’ diet with necessary nutrients.

Recommendations

  • The FEEDAP panel advised that the specifications of the synthetic Vitamin K1 additive should refer to the substance-related impurities listed in the most updated monograph of the European Pharmacopoeia.
  • This would ensure that the product is up to standard and safe for consumption.

Cite This Article

APA
Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, Fašmon Durjava M, Kouba M, López-Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Groop J, Anguita M, Galobart J, Holczknecht O, Manini P, Pettenati E, Pizzo F, Tarrés-Call J. (2021). Safety and efficacy of an additive consisting of synthetic vitamin K1 (phytomenadione) for horses (JARAZ Enterprises GmbH & Co. KG). EFSA J, 19(4), e06538. https://doi.org/10.2903/j.efsa.2021.6538

Publication

EFSA journal. European Food Safety Authority
ISSN: 1831-4732
NlmUniqueID: 101642076
Country: United States
Language: English
Volume: 19
Issue: 4
Pages: e06538

Researcher Affiliations

Bampidis, Vasileios
    Azimonti, Giovanna
      Bastos, Maria de Lourdes
        Christensen, Henrik
          Dusemund, Birgit
            Fašmon Durjava, Mojca
              Kouba, Maryline
                López-Alonso, Marta
                  López Puente, Secundino
                    Marcon, Francesca
                      Mayo, Baltasar
                        Pechová, Alena
                          Petkova, Mariana
                            Ramos, Fernando
                              Sanz, Yolanda
                                Villa, Roberto Edoardo
                                  Woutersen, Ruud
                                    Groop, Jürgen
                                      Anguita, Montserrat
                                        Galobart, Jaume
                                          Holczknecht, Orsolya
                                            Manini, Paola
                                              Pettenati, Elisa
                                                Pizzo, Fabiola
                                                  Tarrés-Call, Jordi

                                                    References

                                                    This article includes 32 references
                                                    1. Duello TJ, Matschiner JT. Identification of phylloquinone in horse liver. Archives of Biochemistry and Biophysics 138, 640–645.
                                                      pubmed: 5433593
                                                    2. EFSA FEEDAP Panel. Guidance on studies concerning the safety of use of the additive for users/workers. EFSA Journal 2012;10(1):2539, 5 pp.
                                                      doi: 10.2903/j.efsa.2012.2539google scholar: lookup
                                                    3. EFSA FEEDAP Panel. Scientific Opinion on the safety and efficacy of vitamin K3 (menadione sodium bisulphite and menadione nicotinamide bisulphite) as a feed additive for all animal species. EFSA Journal 2014;12(1):3532, 29 pp.
                                                      doi: 10.2903/j.efsa.2014.3532google scholar: lookup
                                                    4. EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Anguita M, Galobart J, Innocenti ML. Guidance on the identity, characterisation and conditions of use of feed additives. EFSA Journal 2017;15(10):5023, 12 pp.
                                                      doi: 10.2903/j.efsa.2017.5023pmc: PMC7010039pubmed: 32625313google scholar: lookup
                                                    5. EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Anguita M, Galobart J, Innocenti ML, Martino L. Guidance on the assessment of the safety of feed additives for the target species. EFSA Journal 2017;15(10):5021, 19 pp.
                                                      doi: 10.2903/j.efsa.2017.5021pmc: PMC7009839pubmed: 32625311google scholar: lookup
                                                    6. EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Anguita M, Dujardin B, Galobart J, Innocenti ML. Guidance on the assessment of the safety of feed additives for the consumer. EFSA Journal 2017;15(10):5022, 17 pp.
                                                      doi: 10.2903/j.efsa.2017.5022pubmed: 0google scholar: lookup
                                                    7. EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Anguita M, Galobart J, Innocenti ML, Martino L. Guidance on the assessment of the efficacy of feed additives. EFSA Journal 2018;16(5):5274, 25 pp.
                                                      doi: 10.2903/j.efsa.2018.5274pmc: PMC7009555pubmed: 32625911google scholar: lookup
                                                    8. EFSA FEEDAP Panel, Bampidis V, Bastos ML, Christensen H, Dusemund B, Kouba M, Kos Durjava M, López‐Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brock T, Knecht J, Kolar B, Beelen P, Padovani L, Tarrés‐Call J, Vettori MV, Azimonti G. Guidance on the assessment of the safety of feed additives for the environment. EFSA Journal 2019;17(4):5648, 78 pp.
                                                      doi: 10.2903/j.efsa.2019.5648pmc: PMC7009194pubmed: 32626279google scholar: lookup
                                                    9. EFSA NDA Panel. Scientific Opinion on the substantiation of health claims related to vitamin K and maintenance of bones (ID 123, 127, 128 and 2879), blood coagulation (ID 124 and 126), and function of the heart and blood vessels (ID 124, 125 and 2880) pursuant to Article 13(1) of Regulation (EC) No 1924/2006 on request from the European Commission. EFSA Journal 2009;7(9):1228, 20 pp.
                                                      doi: 10.2903/j.efsa.2009.1228google scholar: lookup
                                                    10. EFSA NDA Panel, Turck D, Bresson J‐L, Burlingame B, Dean T, Fairweather‐Tait S, Heinonen M, Hirsch‐Ernst KI, Mangelsdorf I, McArdle HJ, Naska A, Nowicka G, Pentieva K, Sanz Y, Siani A, Sjodin A, Stern M, Tome D, Van Loveren H, Vinceti M, Willatts P, Lamberg‐Allardt C, Przyrembel H, Tetens I, Dumas C, Fabiani L, Ioannidou S, Neuhauser‐Berthold M. Scientific Opinion on the dietary reference values for vitamin K. EFSA Journal 2017;15(5):4780, 78 pp.
                                                      doi: 10.2903/j.efsa.2017.4780pmc: PMC7010012pubmed: 32625486google scholar: lookup
                                                    11. EMEA. Opinion on the Scientific Committee for Veterinary Medicinal Products on phytomenadione (vitamin K1) and menadione (vitamin K3) (EMEA, 1998). EMEA/MRL/447/98-Final .
                                                    12. . European Pharmacopoeia, 10th Edition. European Directorate for the Quality of Medicines and Health Monograph 01/2020:3011.
                                                    13. . European Pharmacopoeia, 8th Edition. European Directorate for the Quality of Medicines and Health Monograph 01/2014:1036.
                                                    14. EVM. Safe Upper Levels for Vitamins and Minerals. .
                                                    15. FAO. Chapter 10 Vitamin K. In Human vitamin and mineral requirements. Report of a joint FAO/WHO expert consultation, Bangkok, Thailand p 133‐147.
                                                    16. Griminger P, Donis O. Potency of vitamin K1 and two analogues in conunteracting the effects of dicumarol and sulfoquinoxaline in the chick. Journal of Nutrition 70, 361–368.
                                                      pubmed: 13829376
                                                    17. Hollander D. Vitamin K‐1 absorption by everted intestinal sacs of the rats. American Journal of Physiology 225, 360–364.
                                                      pubmed: 4722398
                                                    18. Ilser O, Brubacher G. Vitamine 1. Fettlösliche Vitamine. 183 pp. Georg Thieme Verlag, Stuttgart, New York 1982.
                                                    19. Nowicka B, Kruk J. Occurrence, biosynthesis and function of isoprenoid quinones. Biochimica et Biophysica Acta 1797, 1587–1605.
                                                      pubmed: 20599680
                                                    20. NRC. Vitamin Tolerance of Animals. The National Academies Press, Washington, DC.
                                                      doi: 10.17226/949google scholar: lookup
                                                    21. NRC. Nutrient requirements of horses. Washington DC, The National Academies Press, Fifth revised edition.
                                                    22. NRC. Nutrient Requirements of Horses, 6th Revised Edition. The National Academies Press, Washington, DC.
                                                      doi: 10.17226/11653google scholar: lookup
                                                    23. Okano T, Shimomura Y, Yamane M, Suhara Y, Kamao M, Sugiura M, Nakagawa K. Conversion of Phylloquinone (Vitamin K1) into menaquinone (Vitamin K2) in mice. Two possible routes for menaquinone‐4 accumulation in cerebra of mice. The Journal of Biological Chemistry 283, 11270–11279.
                                                      pubmed: 18083713
                                                    24. Ronden JE, Drittij‐Reijnders MJ, Vermeer C, Thijssen HHW. Intestinal flora is not an intermediate in the phylloquinone‐menaquinone‐4 conversion in the rat. Biochimica et Biophysica Acta 1379, 16–22.
                                                      pubmed: 9468334
                                                    25. SCCS. Opinion on vitamin K1 (phytonadione), 23 March 2010. .
                                                    26. SCF. Opinion on the tolerable intake level of vitamin K. Health and consumer protection directorate‐General SDF/CS/NUT/UPPLEV/32 Final.
                                                    27. Schurgens LJ, Vermeer C. Determination of phylloquinone and menaquinones in food. Haemostasis 30, 298–307.
                                                      pubmed: 11356998
                                                    28. Shearer MJ, McBurney A, Barkhan P. Studies on the absorption and metabolism of phylloquinone (Vitamin K1) in man. Vitamins and Hormones 32, 513–542.
                                                      doi: 10.1016/s0083-6729(08)60025-4pubmed: 4617407google scholar: lookup
                                                    29. Terachi T, Inoue Y, Ashiara N, Kobayashi M, Ando K, Matsui T. Plasma vitamin K concentration in horses supplemented with several vitamin K homologs. Journal of Animal Science 89, 1056–1061.
                                                      pubmed: 21169510
                                                    30. Thijssen HHW, Drittij‐Reijnders MJ, Fischer MAJG. Phylloquinone and menaquinone‐4 distribution in rats: synthesis rather than uptake determines menaquinone‐4 organ concentrations. Journal of Nutrition 126, 537–543.
                                                      pubmed: 8632229
                                                    31. VKM. Assessment of dietary intake of vitamin K and maximum limits for vitamin K in food supplements. Opinion of the Panel on Nutrition, Dietetic Products, Novel Food and Allergy. VKM Report 2018: 36, ISBN: 978‐82-8259‐300-7, Oslo, Norway.
                                                    32. Weber F, Rüttimann A. Vitamins, 5. Vitamin K. In: Ullmann's Encyclopedia of Industrial Chemistry (ed.) .
                                                      doi: 10.1002/14356007.o27_o08google scholar: lookup
                                                    Subscribe to our newsletter
                                                    Join 99,344 horse owners like you who receive our email updates on horse health and nutrition.