Hydroxyethylmethacrylate (HEMA) and Di-HEMA Trimethylhexyl Dicarbamate (Di-HEMA TMHDC) are two colorless viscous liquids that readily polymerize when exposed to UV-light. Because of their physical properties, these monomers are typically used in nail enhancement products.
In 2016, Sweden activated the Safeguard Clause (Article 27 of the European Cosmetics Regulation) to prohibit the use of these two ingredients on their market. This decision was taken on the basis of numerous cases of allergic reactions related to the use of HEMA and Di-HEMA TMHDC.
As provided for in Article 27 §3 of the Regulation, the European Commission investigated the issue and mandated the Scientific Committee on Consumer Safety (SCCS) to substantiate these safety concerns. On this basis, the European Commission prepared a regulatory proposal, which has been submitted to the World Trade Organization a few days ago for a 2-month consultation period.
In this regulatory proposal, likely to be adopted, the use of HEMA and Di-HEMA TMHDC is restricted as follows:
- Only to be used in professional nail products. Any other use is prohibited.
- Warnings to be added to the product labels:
- “For professional use only”
- “Can cause an allergic reaction”
The consultation period will end on May 26th, 2020 and about five months should elapse from this date until the adoption of the regulation. Therefore, an entry into force end of November 2020 is expected. Transition periods will be granted by the European Commission:
- For six months after the date of entry into force (namely until end of May 2021), only cosmetic products which comply with this regulation shall be placed on the Union market (namely, no further placing on the market of non-compliant products after this date).
- For nine months after the date of entry into force (namely until end of August 2021), only cosmetic products which comply with this Regulation shall be made available on the Union market (namely, non-compliant products are withdrawn from the market by this date).
Clarification about the transition periods: for the first six months, product items can be imported/distributed as usual. For the last three months, product items remaining on the shelves can be sold but no more product items can be imported/distributed.
We hope that this letter will be of help and stay at your disposal for any questions related to this topic. Should you have any question, please, feel free to contact your dedicated Account Manager.
Dr. Fred Lebreux