The European Commission has launched a consultation on the safety of Phytonadione Epoxide (Vitamin K Oxide).

On May 19, 2025, the European Commission launched an official Call for Data to assess the safety of Phytonadione Epoxide (Vitamin K Oxide)—CAS 25486-55-9, EC 247-022-9—used in cosmetic products. This initiative is part of Regulation (EC) No. 1223/2009, which requires ongoing evaluation of substances when concerns arise about their safety for consumers.

Table of contents

• Background: from the use of vitamin K1 to its oxidized form

• A potential risk of awareness that worries the Commission

• Next steps in the regulatory process

• What should manufacturers do?

• Another sign of European proactive surveillance

The European Commission has launched a consultation on the safety of Phytonadione Epoxide (Vitamin K Oxide).

Background: from the use of vitamin K1 to its oxidized form

Vitamin K1 (phytonadione) has been used in cosmetics for its moisturizing properties, its ability to reduce the appearance of bruises and blemishes, and its brightening effect. However, following several documented cases of allergic contact dermatitis (ACD), its topical use in cosmetics was banned in 2009.

As an alternative, the industry introduced phytonadione epoxide, an oxidized form of vitamin K1, used primarily as a skin-conditioning agent in eye contour products, anti-aging serums, and treatments to reduce redness or improve skin tone.

However, in recent years, new cases of sensitization and allergic reactions have been reported, especially with eye products, with reports originating from Spain. In some of these cases, conventional patch tests failed to detect the sensitization, requiring higher concentrations for a reliable diagnosis.

A potential risk of awareness that worries the Commission

In light of these reports, the Commission considers it necessary to thoroughly review the safety profile of this ingredient. The main concern lies in its sensitizing potential, which could pose risks to users with sensitive skin or those exposed repeatedly.

Therefore, all stakeholders—including cosmetics manufacturers, raw material suppliers, academic institutions, national authorities, and consumer associations—have been asked to provide relevant data on:

• Physicochemical properties and purity characteristics.

• Toxicological and toxicokinetic data .

• Assessment of consumer exposure through cosmetic use.

• Proposed safe levels of use (suggested maximum concentrations).

Next steps in the regulatory process

The deadline for submitting data is 18 May 2026, at 23:59 (CET). Once the information has been received and validated, the Commission may request the Scientific Committee on Consumer Safety (SCCS) to issue a scientific opinion on the substance.

Based on the findings, the Commission may adopt regulatory measures, such as limiting the maximum permitted concentration or including the ingredient in the annexes to Regulation 1223/2009 (for example, in Annex III on restricted substances).

What should manufacturers do?

Brands using Phytonadione Epoxide in their formulations should:

• Review your current presence and concentration in products already marketed.

• Evaluate alternatives if there is evidence of risk of sensitization.

• Contribute data to the collection process, especially if you have internal safety studies or toxicological information.

Another sign of European proactive surveillance

This new application confirms the European Commission's policy of acting early on potential emerging risks in cosmetics, ensuring that ingredients on the market remain under up-to-date scientific scrutiny.

Contact with our team of cosmetic regulation experts today.