Vitamin K1 oxide is intended to replace the use of vitamin K1, which has recently been banned for use in cosmetic products because of its allergenic potential. The SCCS has received a request for scientific Opinion on its safety.
Background
Vitamin K1 Oxide (EC no 247-022-9; CAS no 25486-55-9) has the chemical name (2,3-epoxyphytyl)menaquinone and the INCI name Phytonadione Epoxide.
A dossier on vitamin K1 oxide was submitted by the applicant. Vitamin K1 oxide is intended to replace the use of vitamin K1, which has recently been banned for use in cosmetic products as the allergenic potential was considered to pose a risk in the light of its therapeutic use.
There has been a public call for data on Vitamin K1 oxide. No further information on this compound was submitted, but a contribution discussing other Vitamin K compounds like K2, K3 and K4 was received. The assessment of these substances is considered necessary, as the inclusion of Vitamin K1 in Annex II might increase the use of other vitamin K derivatives in cosmetic products.
Questions to SCCS
1. Does SCCS consider the use of Phytonadione Epoxide in cosmetic products safe for the consumers when used in a maximum concentration up to 1.0 %, taking into accounts the data provided?
2. Can the SCCS assess the safety of use of other vitamin K compounds like K2, K3 and K4 in cosmetic products on the basis of the available data? If …
