This is a call for data on the safety of phytonadione epoxide (Vitamin K oxide) (CAS No. 25486-55-9, EC No. 247-022-9) under Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
Objective of this call for data
The objective of this call for data is to gather comprehensive scientific information to assess the safety of phytonadione epoxide (vitamin K oxide) in cosmetic products.
This initiative aims to provide the Scientific Committee on Consumer Safety (SCCS) with the necessary data to conduct a thorough safety assessment. The findings will inform potential regulatory actions to ensure consumer safety, aligning with the Commission’s commitment to safeguard public health while maintaining market integrity.
Consultation period
19 May 2025 to 18 May 2026 (12 months)
Why consulting
egulation (EC) No 1223/2009 on cosmetic products (CPR) provides a regulatory framework to ensure a high level of protection of human health while ensuring the functioning of the internal market. Environmental concerns from substances used in cosmetic products are considered through the application of Regulation (EC) No 1907/2006 (‘REACH Regulation’).
To address potential risks to human health, the CPR lays down a system of restrictions and prohibitions on the use of certain substances in cosmetics, based on a thorough scientific risk assessment carried out by the Scientific Committee on Consumer Safety (SCCS).
In cosmetics, Vitamin K1 was used for moisturizing, skin lightening, and treating bruising and hyperpigmentation. However, multiple cases of allergic contact dermatitis (ACD) linked to topical vitamin K1 use were reported, leading to its ban in cosmetic products in 2009. To replace it, the cosmetic industry introduced phytonadione epoxide (Vitamin K oxide), but this too has caused ACD, including severe skin reactions and photoinduced responses.
Phytonadione epoxide (Vitamin K oxide) (CAS No. 25486-55-9, EC No. 247-022-9) is a synthetic or naturally occurring oxidized form of Vitamin K1 (phytonadione). It is formed as an intermediate in the Vitamin K cycle, particularly during the biological process of gamma-carboxylation of certain proteins, such as clotting factors. It is structurally related to phytonadione, differing by the epoxidation of the naphthoquinone ring.
In cosmetics, phytonadione epoxide is primarily used as a skin conditioning agent with possible effects in reducing the appearance of dark under-eye circles, redness and improving skin tone uniformity. It is often marketed in eye creams, anti-aging serums, or redness-correcting formulations, sometimes combined with other vitamins to enhance its function.
Recent years have seen a rise in reported ACD cases to phytonadione epoxide in Spain, particularly from eye contour products. Diagnosing ACD to phytonadione epoxide has proven challenging, as standard patch tests sometimes fail to detect sensitivity, requiring higher concentrations for accurate diagnosis.
Given the possible health concerns relevant to its sensitisation potential it is necessary to collect comprehensive data on the safety of Phytonadione Epoxide (Vitamin K oxide) (CAS No. 25486-55-9, EC No. 247-022-9) when used in cosmetic products. This assessment will consider all safety endpoints to ensure consumer protection.
Upon receipt of sufficient and appropriate data, the Commission will assess the respective information and proceed in mandating the SCCS for this safety assessment. If needed, the Commission may take appropriate action for the use of phytonadione epoxide (Vitamin K oxide), when used in cosmetic products. In particular, pursuant to Article 31(1) and (2) of the Cosmetics Regulation, the Commission may, after consulting the SCCS, amend the Annexes to the Regulation for the purposes of adapting them to technical and scientific progress and, where there is a potential risk to human health, arising from the use of substances in cosmetic products. To determine this, relevant scientific information, and data on the safety of phytonadione epoxide (Vitamin K oxide) would be required.
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