Zinc oxide (nano form): opinion of the EU Scientific Committee on Consumer Safety (SCCS)
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This news contains references also to other Substances
Overall conclusions extracted from the opinion of the EU Scientific Committee on Consumer Safety (SCCS) on Zinc oxide (nano form) adopted this opinion at its 16th plenary meeting of 18 September 2012.
In summary, the evidence presented in this submission and the available literature showed that:
- There is no evidence for the absorption of ZnO nanoparticles through skin and via the oral route. Even if there was any dermal and/or oral absorption of ZnO nanoparticles, continuous dissolution of zinc ions would lead to complete solubilization of the particles in the biological environment. In the MoS calculation, the calculation of the exposure to ZnO nanoparticles assuming Zn2+ uptake results in acceptable MoSs for both the oral and dermal routes.
- Nano ZnO-containing cosmetic formulations are likely to contain a small proportion of solubilized zinc, a further small proportion of which may be absorbed through skin and other routes. The rate and amount of the absorbed zinc is, however, likely to be insignificantly small compared to the large zinc pool already present in the body.
- Although the current evidence in relation to potenial genotoxicity of ZnO is not conclusive, the use of nano ZnO in cosmetic products should not pose a risk to the consumer in the absence of a significant systemic exposure.
- Based on the parameters described in the dossier, the different particle sizes, surface modifications, and crystalline structures and morphologies investigated do not significantly alter the uptake, bioavailability and overall safety profile.
- The different typical formulations as described in this submission also do not change the overall safety profile of the tested ZnO nanoparticles.
In summary, it is concluded on the basis of available evidence that the use of ZnO nanoparticles with the characteristics as indicated below, at a concentration up to 25% as a UV-filter in sunscreens, can be considered not to pose a risk of adverse effects in humans after dermal application. This does not apply to other applications that might lead to inhalation exposure to ZnO nanoparticles (such as sprayable products).
Link to SCCS opinion:
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_103.pdf
