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Wednesday, November 12, 2014SCCS

SCCS: Opinion on formaldehyde in nail hardeners

© CosmeticOBS-L'Observatoire des Cosmétiques

The SCCS adopted by written procedure on 7 November 2014 its Opinion on the safety of the use of formaldehyde in nail hardeners. The text is open for comments until 8 December 2014.

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This Opinion has been modified by the SCCS on December 16, 2014: see the article .


Nail hardeners are very specialized cosmetics used to harden or strengthen natural nails, especially soft, brittle or fragile nails. Formaldehyde is used in nail hardeners for its specific cross-linking functionality with keratin. The use of formaldehyde in nail hardeners is currently restricted as specified in the Entry 13 of Annex III of Regulation (EC) No 1223/2009 – i.e., a maximum concentration in the finished products of 5% (as formaldehyde); labelled as ‘contains formaldehyde’ when the finished cosmetic product contains formaldehyde in a concentration above 0.05% and with the warning ‘protect cuticles with grease or oil’

The substance formaldehyde (CAS: 50-00-0) is anticipated to be classified as a carcinogen category 1B under the CLP Regulation 1272/2008, following a qualified majority in favor of the Committee opinion adopted on 17 December 2013. This classification shall apply by 1st April 2015.
Regulation 1223/2009 foresees that the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) substances, of category 1A or 1B, under Part 3 of Annex VI to the Regulation 1272/2008, is prohibited.
However, such substances may be used in …

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