SCCS Opinion In Regulatory Toxicology And Pharmacology- Safety Of Use Of Formaldehyde In Nail Hardeners

References: Opinion Of The Scientific Committee On Consumer Safety (SCCS) – The Safety Of The Use Of Formaldehyde In Nail Hardeners
Regulatory Toxicology and Pharmacology, Volume 72, Issue 3, August 2015, Pages 658–659

Body-care of hands. Woman polishing nails

Authors : Scientific Committee on Consumer Safety (SCCS)
Ulrike Bernauer,Pieter-Jan Coenraads,Gisela H. Degen,Maria Dusinska,Werner Lilienblum,Andreas Luch,Elsa Nielsen,Thomas Platzek,Suresh Rastogi,Christophe Rousselle,Jan van Benthem,Alfred Bernard,Ana M. Giménez-Arnau,Tamara Vanhaecke
Received 24 February 2015, Available online 27 March 2015

SCCS Opinion:


Opinion Conclusion
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.”


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