Update: Future Restriction of HEMA and Di-HEMA Trimethylhexyl Dicarbamate
April 9th, 2020
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which comply with this Regulation shall be made available on the Union market (namely, non-compliant products are withdrawn from the market by this date).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.
Any questions?
An Unexpected Regulatory Development on UV-Hardened Nail Polishes Containing HEMA, HEMA Derivatives and Urethane Acrylates
April 11th , 2016
The Commission was informed of a decision of the Swedish authorities to withdraw and prohibit the sale and delivery of a range of nail polishes, according to Article 27 of Regulation (EC) No 1223/2009 on cosmetic products (‘Cosmetics Regulation’). These products were notified through the RAPEX system, pursuant to Article 12 of Directive 2001/95/EC on general product safety, as posing a serious risk to consumers.
The Swedish authorities consider that the above-mentioned products, which after application are hardened with the use of a LED lamp, constitute a serious risk for consumers as they can result in damage to nails and / or hands. This is all due to the following ingredients: ‘Di-HEMA Trimethylhexyl Dicarbamate’, ‘HEMA’ and the class of compounds ‘Urethane acrylates’, which may be contaminated with monomers.
Pursuant to Article 27(3) of the Cosmetics Regulation, in order to determine whether the provisional measures taken by Sweden are justified or not, the Commission shall consult the interested parties, the Member States and the SCCS, whenever possible. The EU Commission is now collecting scientific data in view to mandate the SCCS for a Scientific Opinion on this issue. The SCCS mandate will probably be issued in September 2016.
BIORIUS informs its clients that UV-hardened nail polishes containing HEMA, HEMA derivatives and Urethane Acrylates are still allowed in the EU although their sale in Sweden is expected to cause problems. There is nothing to do at this stage but staying vigilant and be aware of the potential regulation of this class of ingredients. The use restriction of these ingredients (if any) is not expected to happen before several years.