EU Restricts Two Substances Used in Nail Products

The European Commission has followed opinion SCCS/1592/17 and restricted the use of HEMA and Di-HEMA TMHDC in nail products.
( | Press Release | 2020-12-05 11:26:51 )
On December 2, 2020, the European Commission’s 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:
• HEMA – 35%
• Di-HEMA-TMHDC – 99%

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

SGS Cosmetics & Personal Care Testing Services
SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors, and importers to ensure a high level of product quality in every area. A global network of state-of-the-art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. Learn more about SGS’s Cosmetics & Personal Care Testing Services. (

In addition, SGS Digicomply is an advanced regulatory compliance management platform that helps manufacturers stay informed on regulatory and legislative changes. []

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For further information contact:

Queenie Ho-yan TSE
Assistant Technical Service Manager
Tel: +852 2765 3672
LinkedIn: sgs-consumer-goods-&-retail

About SGS
SGS is the world’s 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.

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Ben Christie

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