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EC Expert Committee separates ‘nano’ from ‘non-nano’
Published: Thursday 5 February 2009
The European Commission’s expert Scientific Committee on Consumer Products (SCCP) published a Clarification on its Opinion SCCNFP/0932/05(document: ‘COLIPA n° S76’).
The original Opinion, entitled ‘Statement on Zinc oxide used in sunscreens’, had been published on the 20th September 2005; it made reference to a recommendation made by the 2004 Royal Society report (i.e. ‘Nanoscience and nanotechnologies: opportunities and uncertainties’ - published on 29 July 2004’ ), which states (page 73): ‘We recommend that industry submit the additional information on microfine zinc oxide that is required by the SCCNFP as soon as reasonably practicable so that the SCCNFP can deliver an opinion on its safety. The uncertainties about the safety of nanoparticles of zinc oxide are not just applicable to its use as a UV filter. …… Further information from industry may demonstrate that microfine zinc oxide does not penetrate the skin or that the activity seen in vitro does not occur in vivo, in which case the SCCNFP will be able to deliver a positive opinion on its safety. However, until the safety dossier is provided to the SCCNFP the uncertainties remain.’
In its 2005 ‘Statement on Zinc oxide used in sunscreens’ (document SCCNFP/0932/05), the SCCP (then called ‘SCCNFP’) originally commented ‘hitherto, the requested safety dossier has not been provided. It is understood that microfine and ultrafine zinc oxide is widely used in sunscreen products on the European market. The safety to the consumer of this use remains to be assessed. The attention of the Commission and the Member States is drawn to this.’
The current Clarification on its Opinion SCCNFP/0932/05 answers to a request of 16 January 2009, was asked the SCCP to provide clarification on call for further data on ‘micronised zinc oxide’; the opinion adopted by the SCCP during the 19th plenary meeting on 21 January 2009 delivers the requested clarification :
'The SCCP considers that on basis of the dossier reviewed in 2003 the use of ZnO in its non-nano form (pigment grade, with particle sizes above 100 nm) is considered safe. The concern expressed in the SCCNFP opinion 0693/03 with regard to phototoxicity is not relevant for this form of ZnO due to the absence of dermal penetration.'
Follow these links to find out more about the SCCP, to download the SCCNFP’s 2005 opinion on zinc oxide, or to download the SCCP’s Clarification on Opinion SCCNFP/0932/05.