On December 2, 2020, the European Commissions new restriction on the use of HEMA and Di-HEMA TMHDC in cosmetics products came into effect. This means that on the following dates products containing these substances and not complying with the conditions in Regulation (EU) 2020/1682 must:
June 2, 2021 not be placed onto the market in the EU
September 3, 2021 not be made available on the market in the EU
Regulation (EU) 2020/1683 of November 12, 2020, amends Annex III of Regulation (EC) 1223/2009. This follows opinion of the Scientific Committee on Consumer Safety (SCCS), which found that both substances were not likely to pose a risk of sensitization when applied correctly to the nail plate in concentrations up to:
The opinion also noted that both substances are weak to moderate sensitizers and pose a risk of sensitization when the product is misused either through inappropriate application or unintentional contamination of the skin adjacent to the nails under normal and reasonably foreseeable conditions of use.
Products containing these substances are therefore only for professional use as they must be applied with a high level of precision. These products must therefore carry a message that states the following conditions of use and warning For professional use only. Can cause an allergic reaction.
The chemical names for these substances are:
HEMA 2-Hydroxyethyl Methacrylate
Di-HEMA-TMHDC 11,14-Dioxa-2,9- diazaheptadec-16- enoic Acid, 4,4,6,16- tetramethyl-10,15- dioxo, 2-[(2-methyl- 1-oxo-2-propenyl) oxy]ethyl ester
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For further information contact:
Queenie Ho-yan TSE
Assistant Technical Service Manager
Tel: +852 2765 3672
SGS is the worlds leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.