On November 5, 2026, the Scientific Committee on Consumer Safety (SCCS) of the European Commission published preliminary Scientific Advice SCCS/1690/26, adopted on November 4, 2026, on Phytonadione Epoxide (Vitamin K1 oxide) in cosmetic products placed on the European Union market. EU formulators of cosmetic products containing Phytonadione Epoxide (Vitamin K1 oxide), EU importers of cosmetic products containing Vitamin K1 oxide, EU distributors and retailers of cosmetics with Vitamin K1 oxide, and brands marketing under-eye and skin care products with Vitamin K1 oxide must review product portfolios for Phytonadione Epoxide content, prepare safety data or comments for the SCCS consultation, and begin reformulation planning by January 11, 2027, or products containing Vitamin K1 oxide may face restriction or prohibition under a Regulation (EC) No 1223/2009 annex amendment if the final SCCS opinion confirms the preliminary conclusion, requiring withdrawal or reformulation.
The advice answers three questions from the European Commission. It finds the ingredient not safe when used at a concentration up to 1%, states that no safe maximum concentration can be derived, and records that mutagenicity and genotoxicity cannot be excluded because no experimental data were provided. Cite the preliminary version of November 4, 2026, SCCS/1690/26, on the Commission publication page and in sccs_o_312.pdf. The contact on the file is [email protected].
What does SCCS/1690/26 conclude on Vitamin K1 oxide?
SCCS/1690/26 concludes that Phytonadione Epoxide is not safe in cosmetic products at a concentration up to 1%, and that no safe maximum concentration can be set on the data submitted. Phytonadione Epoxide (Vitamin K1 oxide) is the cosmetic ingredient CAS 25486-55-9 and EC 247-022-9 assessed in preliminary Scientific Advice SCCS/1690/26.
| Commission question | SCCS answer in SCCS/1690/26 |
|---|---|
| Safe up to a maximum concentration of 1%? | Not safe at a concentration up to 1%. Case reports and SUEs show serious allergic skin reactions that often require medical treatment. |
| What maximum concentration is safe? | None can be set. No quantitative data support a point of departure, including for skin sensitisation, and consumer exposure information is missing. |
| Any further scientific concern? | No mutagenicity or genotoxicity data were provided, in the call for data or in the published literature, so that potential cannot be excluded without experimental data. |
The text is preliminary scientific advice, requested by the European Commission and adopted on November 4, 2026. It is not an annex amendment. The Commission amends Annexes II to VI of Regulation (EC) No 1223/2009 by implementing or delegated act after an SCCS opinion. The official text of the regulation is on EUR-Lex.
Who has Vitamin K1 oxide on the European Union market?
EU formulators, importers, distributors, retailers and brands that place cosmetic products containing Phytonadione Epoxide on the European Union market are the actors this preliminary conclusion hits, including brands of under-eye and skin care products with Vitamin K1 oxide. The opinion publishes no finished-product list and no notified volume.
Obsidian tracks 9 regulatory texts, in force, amended or in preparation, for the Cosmetics and Personal Care Products Regulation industry in the European Union, as of November 2026. A company that still uses Vitamin K1 oxide, including through a contract manufacturer or an imported finished good, is inside the audience the Commission calls stakeholders and applicants. A formula without CAS No. 25486-55-9 is outside that comment exercise.
What should those companies file by January 11, 2027?
Stakeholders and applicants may send clarifications and comments until January 11, 2027, and the companies named above should use that window for the data the SCCS says are missing: a quantitative point of departure, including skin sensitisation, consumer exposure information, and experimental mutagenicity and genotoxicity data.
- Screen formulas, raw-material specifications and imported finished goods for Phytonadione Epoxide, CAS No. 25486-55-9 and EC No. 247-022-9.
- Where the ingredient is present, record the concentration against the 1% level the Commission asked the SCCS to assess.
- Assemble quantitative hazard data, skin sensitisation data, exposure information, and mutagenicity or genotoxicity studies that were not in the call for data.
- Send comments before January 11, 2027, using the route on the publication page ([email protected]).
- Start reformulation planning where no compliant concentration would remain if the final opinion repeats this conclusion.
What happens if the final opinion confirms the preliminary conclusion?
If the final SCCS opinion confirms that Phytonadione Epoxide is not safe and that no safe concentration can be set, products containing Vitamin K1 oxide may face restriction or prohibition by an amendment of the annexes of Regulation (EC) No 1223/2009, and the companies concerned would have to withdraw or reformulate. SCCS/1690/26 sets no restriction, no transition period and no penalty figure. Until an amending act is adopted, the annex status of the ingredient is unchanged. The date in front of formulators and importers is the comment deadline of January 11, 2027.
Continuous, per-jurisdiction monitoring surfaces an annex amendment the day the Commission publishes it.
Verify whether any formula, raw material or imported finished good contains Phytonadione Epoxide, match the data you can file to the January 11, 2027 comment deadline, and brief regulatory affairs and the reformulation team on the three SCCS answers. Obsidian keeps this consultation, and any later annex act, on one European Union cosmetics watch.
