The substance formaldehyde (CAS Number 50-00-0) is anticipated to be classified as a carcinogen category IB under the CLP Regulation (EC) No 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 (EC) No 1223/2009 foresees that the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) substances is prohibited as per certain rules according to regulations.
However, such substances may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances of category 1A or IB under Part 3 of Annex VI to Regulation (EC) No 1272/2008, all of the conditions (hereafter reported) of Article 15.2 of the Cosmetics Regulation are fulfilled:
- they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matter of food safety;
- there are no suitable alternative substances available, as documented in an analysis of alternatives;
- the application is made for a particular use of the product category with a known exposure; and
- they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population subgroups.
The regulatory measures authorizing such exemption for use shall be adopted within 15 months of the classification as CMR 1A or IB of the substance(s) concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
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 Annex III of the Cosmetics Regulation.
Additionally the use of formaldehyde (CAS 50-00-0) as preservative for cosmetics is also allowed under restricted conditions [Entry 5 of Annex V]. In July and November 2013, Cosmetics Europe representing an industry consortium, submitted a full application to support the use of formaldehyde in nail hardeners under the current conditions specified in Entry 13 of the 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 cuticules with grease or oil'.
The industry consortium considers that its application for exemption contains the data supporting the fulfilment of conditions a), b) and c) of Article 15.2. The application contains an evaluation of the toxicological profile of formaldehyde, a global human exposure assessment to formaldehyde and an assessment of the safety of free formaldehyde released by the usage of nail hardeners under the current conditions for use.
The Commission published on 23 May 2013, a call for data on formaldehyde use in cosmetics and/or formaldehyde released by others substances used in cosmetics, seeking also information of the suitable alternatives. The Commission only received information from Cosmetics Europe that is included in the application submitted.
The Commission considered that the substantiation of the three first conditions of Article 15.2 are fulfilled, allowing that the SCCS proceeds now with its scientific assessment.
Terms of reference
In view of above, and taken into account the data provided in the application, and from other sources, SCCS is requested:
- To assess if condition d) of Article 15.2 is fulfilled, in order to confirm or not the safe use of formaldehyde in nail hardeners under the current restricted conditions for use as specified in Annex III of Regulation (EC) No 1223/2009.
- To review as necessary the restriction's conditions set in Annex III - e.g. adding a maximum concentration of free formaldehyde of 2.2% as indicated in the application.
About European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union. The Commission operates as a cabinet government, with 27 Commissioners. There is one Commissioner per member state, though Commissioners are bound to represent the interests of the EU as a whole rather than their home state.
About Scientific Committee on Consumer Safety
The Scientific Committee on Consumer Safety provides opinions on health and safety risks (chemical, biological, mechanical and other physical risks) of non-food consumer products (e.g. cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products) and services (e.g. tattooing, artificial sun tanning).
Source: Scientific Committee on Consumer Safety