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
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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%
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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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Commission Restricts the Use of HEMA and Di-HEMA TMHDC in Nail Products SafeGuardS.
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