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July 26, 2013

EC Committee Documents on Zinc Oxide and Titanium Dioxide Available for Comment

Lynn L. Bergeson

On July 26, 2013, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) posted two documents for comment. The SCCS addendum to its opinion on zinc oxide (nano form) includes the following conclusion:

The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for use on the skin as UV filter in sunscreen formulations:

  1. ZnO nanoparticles of purity ≥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 are less than 1% in total.
  2. ZnO nanoparticles with a median diameter (D50: 50% of the number below this diameter) of the particle number size distribution above 30 nm, and the D1 (1% below this size) above 20nm.
  3. ZnO nanoparticles that are either uncoated or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane, and/or coated with other cosmetic ingredients as long as these cosmetic ingredients are accepted by the regulatory authorities and/or have been demonstrated to be safe for use as cosmetic ingredient.
  4. ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier).

The submitted 90 days inhalation study resulted in a NOAEL of 0.3mg/m3.

However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects.

The SCCS opinion on titanium dioxide (nano form) includes the following overall conclusion:

1.  Does SCCS consider that use of titanium dioxide in its nanoform as an UV-filter in cosmetic products in a concentration up to maximum 25.0 % is safe for the consumers taken into account the scientific data provided?

On the basis of the available evidence, the SCCS has concluded that the use of TiO2 nanomaterials with the characteristics as indicated below, at a concentration up to 25% as a UV-filter in sunscreens, can be considered to not pose any risk of adverse effects in humans after application on healthy, intact or sunburnt skin. This, however, does not apply to applications that might lead to inhalation exposure to TiO2 nanoparticles (such as powders or sprayable products). Furthermore, this assessment applies to 13 out of the 15 TiO2 nanoparticles presented in the submission, but may also be applicable to other TiO2 nanomaterials that have a close-similarity to the parameters in Tables 1-3.

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2.  In order for the COM to differentiate in the regulation between materials in its nanoform and its non-nano form, can the SCCS give quantitative and qualitative guidance on how this differentiation should be given based on the particle size distribution or other parameters?

A detailed SCCS guidance on risk assessment of nanomaterials in cosmetics has recently been published (SCCS/1484/12). The guidance provides a detailed account of the important nano-related parameters that should be considered in relation to physicochemical characterisation, hazard identification, exposure assessment and risk assessment of nanomaterials.

Comments on both documents are due September 6, 2013.