The main regulatory framework for the placing of cosmetic products on the EU market is Cosmetic Regulation 1223/2009, applicable as from 11 July 2013.
In the Cosmetic Regulation it is reported that ‘nanomaterial’ means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm. According to the art. 16 of the Cosmetic Regulation n. 1223/2009 all cosmetic products containing nanomaterial shall be notified to the Commission by the responsible person by electronic means six months prior to being placed on the market. The provisions of this Article do not apply to nanomaterials used as colorants, UV-filters or preservatives regulated under Article 14, unless expressly specified.
The SCCS was requested to perform a safety assessment of Zinc Oxide in nano form and delivered an opinion on 18 September 2012 , followed by an addendum of 23 July 2013 . The SCCS concluded, on the basis of available evidence, that the use of Zinc Oxide nanoparticles with the characteristics as indicated, at a concentration up to 25% as a UV-filter, can be considered not to pose a risk of adverse effects in humans after dermal application.
The characteristics indicated by the SCCS in its opinion concern the physico-chemical properties of the material and whether it is uncoated or coated with specific chemicals. In particular, the purity should be greater or equal to 96%, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities should be less than 1% in total. The median diameter (D50: 50% of the number below this diameter) of the particle number size distribution should be above 30 nm, and the D1 (1% below this size) above 20nm. The solubility should be below 50 mg/L.
As regards coatings, the SCCS indicates that Zinc Oxide nanoparticles should be either uncoated or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane. Other cosmetic ingredients can be used as coatings as long as they are demonstrated to the SCCS to be safe and do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in the relevant SCCS opinion.
The SCCS considered that, on the basis of available information, the use of Zinc Oxide nanoparticles in spray products cannot be considered safe.
Taking into account all the information provided above, we inform you that the Commission’s service are preparing the legislation to allow the use of Zinc Oxide nano when used as UV filter on the basis of the conclusion reported in the mentioned opinions:
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_103.pdf
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_137.pdf
Regarding the opinion (SCCS/1539/14) for clarification of the meaning of the term "sprayableapplications/products" for the nano forms of Carbon Black CI 77266, Titanium Oxide and Zinc,
we can say that the opinion has been discussed at last SCCS plenary on 16th of December 2014 and it will be finalized and published on SCCS website in the next weeks. The conclusion of this opinion will be used as well for the clarification of the term "sprayableapplications/products" for nano form ZnO2.
You can consult the draft opinion (SCCS/1539/14) at following link:
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_163.pdf
We hope you will find this information useful.
Best regards,
Federica de Gaetano, PhD
Scientific officer
cid:
[email protected]
European Commission
DG Health and Consumers
Unit B2 - Health Technology and Cosmetics
DM24 - 2/092
Rue de Mot 24, Brussels, Belgium
