SCCS assessment could now mean formaldehyde in nail hardeners will be exempt from ban

By Michelle Yeomans

- Last updated on GMT

SCCS assessment could now mean formaldehyde in nail hardeners will be exempt from ban

Related tags Personal care products European union

The European Commission has given the go ahead for formaldehyde to be used at a maximum concentration of 2.2% when used in cosmetics that claim to harden or strengthen nails.

Formaldehyde is added to nail hardeners for its cross-linking functionality with keratin. 

Back in April, the Commission announced that the substance was to be listed as a category 1B carcinogen, banning its use in European cosmetics; but that it was also seeking opinions on whether to allow an exception on its’ continued use.

However, this SCCS assessment could now mean that formaldehyde used in nail hardeners will be exempt from the ban, which will please Cosmetics Europe, who submitted a full application to support this use of the substance last year.


Substances exempt from CLP Regulation will be permissible providing it meets three criteria: there are no suitable alternatives available, the application is made for a particular use with known exposure, and its use fulfills relevant safety requirements.

With this evaluation of formaldehyde, the SCCS notes concerns about the sensitisation potential but concludes that the risk of local effects in the skin can be minimised if products are used “properly” and labelled with instructions, as outlined in the EU cosmetics Regulation.

A consultation period for this Opinion will run until 8 December, after which it is expected to adopt its final Opinion.

Use in cosmetics

Formaldehyde and formaldehyde-releasing preservatives (FRPs), according to the Campaign for Safe Cosmetics, are currently used in many personal care products, particularly in shampoos and liquid baby soaps.

These formaldehyde-related chemicals can function as a preservative for water-based products, as they restrict bacteria growth.

However, due to their ability to be absorbed through the skin, the chemicals have been linked to allergic skin reactions and cancer in various studies, including those carried out by the Australian Government Department of Health an Ageing, and the International Agency for Research on Cancer.


At present, the status of the chemicals varies geographically: they are banned from use in cosmetics and toiletries in Japan and Sweden, and there are concentration restrictions in place on them in Canada.

In the EU, they are currently restricted in personal care products, with labeling required on products that do contain them.

If listed as a category 1B carcinogen in Europe, formaldehyde can be proposed as a substance of very high concern based under Article 57 of REACH; it would not, however, be considered a chemical of 1A level, or a ‘known human carcinogen’.

Related topics Regulation & Safety Skin Care

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