The amendment Annex VI to EC regulation No 1223/2009 from the EU Council on Cosmetics, following an extensive evaluation process that was carried out by the Scientific Committee on Consumer Safety (SCCS).
The process began in June 2003, after the SCCS delivered an opinion that zinc oxide might be considered a non-toxic substance for cosmetics products, giving it general approval for sunscreen use.
What about micronised zinc oxide?
However, the committee also aired its reservation that the evaluation procedures had not considered the potential for absorption, particularly specifying that more data was required on the safety of micronised zinc oxide within this context.
Further clarifications had concluded that the use of non-nano zinc oxide in cosmetic products, including sunscreens was safe up to a maximum formulation concentration of 25%.
Further to this, the SCCS instigated safety assessments of nano form zinc oxide in September 2012 and July 2013, in which it was concluded that the use of nano particle zinc oxide in cosmetic formulations for UV sunscreens at a dosage rate of 25% did not pose an adverse health risk to humans.
Dermal approval for all cosmetic applications
The dermal testing also proved that nanoparticles were not absorbed through the skin and nor orally. Likewise, these findings also gave way to zinc oxide being approved for use in cosmetic products other than sunscreens.
However, from the information in the assessment process, the SCCS did conclude that the use of zinc oxide in spray products cannot be safe, a conclusion that was reiterated in September 2014 referred to sprayable applications for the nano-forms of carbon black CI 77266, titanium dioxide, which could lead to lung inhalation.
The annex concludes that both non-nano and nano-form zinc oxide can be used as UV filters in cosmetic products with a maximum concentration of 25%.