Following the implementation of the directive by the EU member states on August 5, 2009 the sale of products containing vitamin K1 (INCI: phytonadione) will be banned effective November 5, 2009.
The ban stated in directive 2009/6/EC dated February 4, 2009 is justified as follows: "Following restrictive measures taken by one Member State on the basis of Article 12 of Directive 76/768/EEC regarding the use of phytonadione in cosmetic products, the SCCP [see below] was consulted. The scientific committee is of the opinion that use of phytonadione in cosmetic products is not safe, since it may cause cutaneous allergy and individuals so affected may be denied an important therapeutic agent. Therefore the substance should be banned".
The history behind: According to the reports RT 8/2005 (January 2005) and RT 65/2006 (June 2006) of the German Cosmetic, Toiletry, Perfumery and Detergent Association (IKW) there have been observed several severe cases of cutaneous allergy from cosmetic creams with the brand names Ekyced (LABORATOIRES DERMATOLOGIQUES D'URIAGE, France) and Auriderm (AURIGA INTERNATIONAL S.A., Belgium). As a result, France banned vitamin K1 on April 26, 2005 with immediate effect. The ban was justified with the concern that individuals affected with this specific kind of allergy from cosmetic products cannot be medicated with vitamin K1 if needed in case of medical emergencies.
Also in 2005, the Federal Institute for Risk Assessment (BfR) noted the risk of a reduced anticoagulant potential for consumers treated with anticoagulants which will consequently lead to an increased risk of thrombosis. No evidence has been reported yet for such risk. The German Cosmetic, Toiletry, Perfumery and Detergent Association (IKW) mentioned in its report RT 100/2006 (September 2006): "If necessary, the Federal Minister (at that time the Federal Minister of Food, Agriculture and Consumer Protection) will suggest examining a voluntary allergy labeling of cosmetic products that contain vitamin K1". Down to the present day however, no such initiative has been observed.
Evaluation of the SCCP (Scientific Committee on Consumer Products): On September 28, 2007, the SCCP published an English document entitled "Opinion on vitamin K1 (INCI name: phytonadione)". In summary, it said that:
The data available to the SCCP are incomplete and do not allow a final evaluation of vitamin K1 and "oxidized" vitamin K1. Since 2005, the latter mentioned substance has been used instead of vitamin K1 in a variety of products.
No data has been provided about the chemical formula of the "oxidized" vitamin K used.
The vitamin K1 substance used in the above mentioned products contained 75 % of vitamin K1 but also a cis isomer and an epoxide ("oxidized" vitamin K1, up to 4 %).
The experimental data available cannot provide clear evidence for a sensitizing potential.
Unlike vitamin K2 which is synthesized by intestinal bacteria, vitamin K1 is regularly assimilated with vegetable food. The SCCP came to the conclusion that "although there is only a low allergenic potential, the lifesaving therapeutic (medical) use of vitamin K1 may be at risk after a pre-existing sensitization with a vitamin K1 containing cosmetic product". The explanation is hardly understandable even for experts though.
Pharmaceutical quality: According to the Pharmacopoea Europaea or abbreviated Ph. Eur. the composition of vitamin K1 is clearly stated. "Phytomenadion" which is identical with phytonadione consists of:
trans- Phytomenadion ≥ 75.0% (HPLC)
cis-Phytomenadion ≤ 21.0% (HPLC)
trans-Epoxyphytomenadion ≤ 4.0% (HPLC)
Accordingly, the "oxidized" vitamin K1 which found fault with the SCCP unmistakably is trans-Epoxyphytomenadion. In Germany vitamin K1 is produced by Merck KGaA, Darmstadt (Germany).
With banning this valuable natural substance from cosmetic and physiological applications the European Commission has evidently taken the easy way out. The same directive RL 2009/6/EG classifies toluene in concentrations of up to 25 per cent as a harmless substance in nail products although it is a proved CMR substance of category 3 (CMR means carcinogenic, mutagenic and toxic for reproduction). Obviously there was not enough lobbying for vitamin K1.
Cosmetic applications: Vitamin K1 is a very effective cosmetic substance for the skin care of individuals suffering from couperosis, spider veins, rosacea and erythema (caused by sun burns e.g.), traumatic purpura (capillary bleeding) and dark eye rings. The issue has repeatedly been covered, e.g. in:
KOKO has been offering vitamin K1 worldwide as active agent concentrate "Vitamin K1 nanoparticles" in pharmaceutical quality according to the Ph. Eur. Main markets are South East Asia, Russia and Germany. Since its introduction in mid 2003 until 2009 not a single and verifiable case of allergic reaction to vitamin K1 has been reported.
Dr. Hans Lautenschläger