The process has now moved beyond the initial Call for Data launched by the European Commission in May 2025. Following the collection of scientific and technical information, the Commission has formally requested the Scientific Committee on Consumer Safety (SCCS) to assess the safety of phytonadione epoxide.
This is an important development for cosmetic manufacturers and suppliers, but it is equally important to understand what it does — and does not — mean at this stage. There is currently no final SCCS Opinion on phytonadione epoxide, and no new EU restriction or prohibition has been adopted as a result of this assessment. The scientific evaluation is still in progress.
What is it used in cosmetics for?
To understand the current regulatory interest in phytonadione epoxide, it is useful to first distinguish it from phytonadione, or vitamin K1.
Phytonadione is the natural, fat-soluble form of vitamin K1. It has an important biological role in the activation of several proteins involved in blood coagulation and is also used as a medicinal substance to prevent or treat vitamin K deficiency and certain coagulation disorders.
Phytonadione epoxide, also known as vitamin K1 oxide or vitamin K oxide, is a different but closely related substance. Chemically, it is the epoxidised form of phytonadione and is also produced naturally as an intermediate in the vitamin K cycle. For regulatory purposes, the substance currently under assessment is identified by CAS No. 25486-55-9 and EC No. 247-022-9.
In cosmetic products, phytonadione epoxide has been used primarily for skin-conditioning and appearance-related purposes. According to the European Commission, it can be found in products such as eye creams, anti-ageing serums and formulations intended to improve the appearance of dark circles, redness or uneven skin tone. It has also been used in products intended to reduce the appearance of bruising or redness following aesthetic procedures.
Why is phytonadione epoxide now being assessed?
The European Commission’s decision to investigate phytonadione epoxide is primarily linked to concerns about its sensitisation potential.
The Commission’s 2025 Call for Data specifically referred to reports of allergic contact dermatitis associated with phytonadione epoxide, including severe skin reactions and photo-induced responses. It also highlighted reports of increasing numbers of cases in Spain, particularly involving products applied around the eyes.
The issue is not simply whether a consumer can experience irritation after applying a product. Sensitisation is an immune-mediated process: an individual who becomes sensitised may subsequently develop an allergic reaction when exposed again to the substance. This makes the quality and extent of the available sensitisation data particularly important when evaluating an ingredient intended for repeated use in cosmetic products.
There is also a wider regulatory consideration. Because phytonadione epoxide is closely related to vitamin K1, sensitisation to the cosmetic ingredient may be relevant to people who subsequently require vitamin K1 as a medicinal treatment. The European Commission specifically identified this concern in the context of the previous assessment of vitamin K1 and the subsequent use of its oxidised form.
From Call for Data to SCCS mandate
The European Commission launched its Call for Data on 19 May 2025, asking stakeholders to provide information relevant to the safety assessment of phytonadione epoxide in cosmetics. The consultation remained open until 18 May 2026.
The Commission requested data covering the substance’s physicochemical properties, toxicokinetics and toxicological endpoints, as well as information on consumer exposure and, where available, indications of safe concentration levels in cosmetic products. The Commission explained that comprehensive information was needed in view of potential health concerns, including the substance’s sensitisation potential.
A Call for Data is essentially an evidence-gathering stage. It does not constitute a regulatory restriction and should not be interpreted as a conclusion that an ingredient is unsafe.
The next step has now taken place. On 25 June 2026, the SCCS mandate concerning phytonadione epoxide was adopted, and the European Commission published the formal Request for a scientific Opinion on the safety of Phytonadione Epoxide (Vitamin K1 oxide) on 26 June 2026. Phytonadione epoxide is now listed among the active SCCS mandates.
In other words, the regulatory status can be summarised as follows:
Call for Data: closed → SCCS mandate: issued → SCCS Opinion: pending.
This distinction is particularly important when communicating the status of the ingredient.
What has the SCCS been asked to assess?
The mandate is the point at which the European Commission formally defines the scientific questions that the SCCS needs to address.
Based on the information gathered through the Call for Data, the SCCS has been asked to assess whether phytonadione epoxide can be considered safe for use in cosmetic products at concentrations up to 1%. If the available evidence does not support safety at that level, the Committee has been asked to consider whether an alternative maximum safe concentration can be established. The assessment is also intended to identify any other relevant scientific concerns and to take realistic exposure conditions and relevant population groups into account.
The 1% concentration should not be confused with an authorised or officially established maximum concentration. It is the concentration presented for scientific assessment within the SCCS mandate. Until the SCCS reaches a conclusion and the European Commission takes any subsequent regulatory action, it should not be described as a newly permitted or newly restricted level.
The SCCS assessment will follow the Committee’s established scientific framework for evaluating cosmetic ingredients. Its Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 12th Revision (SCCS/1647/22) provide the general methodological framework for this type of assessment, including consideration of exposure, toxicological data and the overall weight of scientific evidence.
Has the SCCS reached any conclusions?
No.
As of August 2026, phytonadione epoxide does not appear among the SCCS’s published preliminary or final Opinions. The European Commission’s SCCS Opinions page lists the Opinions currently being finalised and the published final Opinions, while phytonadione epoxide is listed separately under the SCCS mandates as a request for a scientific Opinion dated 25 June 2026.
Consequently, there is currently no SCCS conclusion establishing that phytonadione epoxide is safe at 1%, no SCCS-recommended maximum concentration, and no SCCS recommendation to prohibit the ingredient.
The absence of a conclusion does not mean that the safety concerns have disappeared. It means that the scientific assessment required to determine how those concerns should be addressed has not yet been completed.
Why is this relevant to cosmetic manufacturers?
For companies using phytonadione epoxide, the current situation is best understood as a regulatory watch point rather than an immediate ban or restriction.
Under Regulation (EC) No 1223/2009, cosmetic products placed on the EU market must be safe for human health under normal and reasonably foreseeable conditions of use, and the responsible person must ensure compliance with the Regulation’s requirements. The Regulation also allows the European Commission, where there is a potential risk to human health, to amend the relevant cosmetic-ingredient Annexes after consulting the SCCS.
This means that manufacturers should not wait for a final regulatory amendment before considering the implications of the ongoing assessment.
For products already containing phytonadione epoxide, it is sensible to review the quality and completeness of the safety documentation supporting its use. Particular attention should be given to the identity and specifications of the ingredient, impurity profile, available toxicological and sensitisation data, concentration in the finished product, product type and exposure conditions.
The exposure assessment is especially relevant. A cosmetic ingredient cannot be evaluated simply by looking at its concentration in isolation. The SCCS considers how the ingredient is actually used, including the type of product, frequency and amount of application, route of exposure and the populations that may be exposed. The scientific assessment therefore needs to connect the toxicological evidence with realistic cosmetic-use scenarios.
For manufacturers and raw-material suppliers, this is also an appropriate moment to engage with the supply chain. Safety data held by an ingredient supplier can be important for the responsible person’s assessment, and the ongoing SCCS review may make previously collected information particularly relevant.
What could happen next?
The next major milestone will be the SCCS scientific Opinion.
The Committee will evaluate the evidence available to it and determine whether the proposed use of phytonadione epoxide can be considered safe. Depending on the scientific conclusions, the SCCS could support the proposed use, identify a lower safe concentration, or identify concerns that require further regulatory consideration.
The SCCS Opinion itself would not automatically change the Cosmetics Regulation. If regulatory action is considered necessary, the European Commission would subsequently need to consider the scientific conclusions and, where appropriate, amend the relevant provisions of the Cosmetics Regulation. Article 31 provides the legal mechanism for the Commission to amend the Annexes following consultation with the SCCS where a potential risk to human health needs to be addressed at EU level.
This is why it is too early to predict whether phytonadione epoxide will ultimately be restricted, limited to a lower concentration, or remain without a specific restriction.
