- 16. detsember 2014
- Scientific Committee on Consumer Safety (SCCS)
WG on Cosmetic Ingredients
SCCS members: U. Bernauer, P.J. Coenraads, G. Degen, M. Dusinska, W. Lilienblum, A. Luch (rapporteur), E. Nielsen, T. Platzek, S.C. Rastogi (chairman), Ch. Rousselle, J. van Benthem
External experts: A. Bernard, A. Giménez-Arnau, T. Vanhaecke
Contact:SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1538/14
Adopted on: 7 November 2014
Conclusion of the opinion:
In view of above, and taken into account the data provided in the application, and from other sources, SCCS is requested:
1) to assess if the use of formaldehyde in nail hardeners at the maximum level of 2.2% (as free formaldehyde) can be considered safe or not
Nail hardeners with a maximum content of about 2.2% free formaldehyde can be used safely to harden or strengthen nails. Although “peak values” of formaldehyde reached in ambient air surrounding the application area may approach the WHO indoor guideline value of 100 μg/m3 formaldehyde (30 minutes exposure), thereby exceeding this concentration level only for a short period immediately after application, formaldehyde levels will rapidly decrease to background levels again within a few minutes. The SCCS has concerns about the sensitisation potential of nail hardeners containing formaldehyde (see question 2).
2) to indicate if there are any further scientific concerns with regard to the use of formaldehyde in nail hardeners.
In order to reduce inhalation exposure to formaldehyde, the room should be ventilated when applying nail hardeners.
The risk of local effects in the skin, such as sensitisation, can be minimised if the products are used properly and according to the present EU Cosmetics Regulation (including the phrase ‘protect cuticles with grease or oil’). In light of the very low concentration of formaldehyde that has been suggested to be capable of elicitating allergy in already sensitized individuals (>0.006%), careful usage and handling of nail hardeners is recommended. Severely damaged nails should not be exposed to nail hardeners containing formaldehyde.
Risk for professionals who offer application of nail hardeners as part of their service and therefore may be more frequently exposed to formaldehyde has not been assessed in this Opinion.
SCCS, scientific opinion, formaldehyde, Regulation 1223/2009, CAS Number 50- 00-0,EC Number 200-001-8
Opinion to be cited as:
SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of the use of formaldehyde in nail hardeners, SCCS/1538/14, written procedure 7 November 2014, revision of 16 December 2014.