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EC SCCS addresses Questions over the use of three Nanomaterials as UV Filters

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) has recently made available three documents related to the use of nanomaterials as UV filters in cosmetic products. One is an opinion on the nano form on titanium dioxide; one is an addendum to its September 2012 opinion on the nano form of zinc oxide; and one is a revision of its March 2013 opinion on the nano form of MBBT.

Opinion on titanium dioxide (SCCS/1516/13)

The Committee concluded that ‘on the basis of the available evidence, […] the use of TiO2 nanomaterials […], at a concentration up of 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’. It is based on ‘the currently available scientific evidence’.

The safe use of this material only covers the characteristics specified by the Committee in this opinion. Those not specified, such as characteristics that ‘might lead to inhalation exposure’, are not covered. Additionally a note is made that ‘the potential ecotoxilogical impact’ of the material’s release into the environment had not been made in the formulation of this opinion.

This opinion is the result of efforts to address the EC’s Scientific Committee on Consumer Products’ (SCCP) call to review the safety of nano-TiO2. The call was made following the Committee’s adoption of an opinion on the Safety of Nanomaterials in Cosmetic Products back in December 2007.

Addendum to opinion on zinc oxide (SCCS/1489/13)

In September 2012 the SCCS published its opinion that ‘the use of ZnO nanoparticles with the characteristics indicated […], 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 […]’.

Upon review, the SCCS published this addendum and concluded that ‘ZnO nanomaterials with the following characteristics can be considered similar to [those evaluated earlier] and thus pose no or limited risk for use as UV filter in sunscreen formulation:

  • 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
  • ZnO nanoparticles with a median diameter of the particle number size distribution above 30 nm, and the D1 above 20nm
  • 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
  • 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 addendum indicates that in January 2013 a document was submitted for review which proposed a broader interpretation of this zinc oxide opinion. Following doubts expressed by both the Commission’s services and Member States over this interpretation, a clarification was sought from the SCCS; this clarification resulted in the publishing of the addendum.

Revision of the opinion on MBBT (2,2’-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)) (SCCS/1443/11)

Freshly revised by the SCCS, this opinion states that ‘regarding systemtic effects there seems no concern for the dermal application of the material’. More generally, however, it states that ‘no conclusions on the safety of this substance can be drawn’; this is because ‘no appropriate data on genotoxicity’ was provided to the Committee.

Concerns are raised, however, over the potential environmental effect of the chemical. It states that MBBT is currently considered to potentially ‘cause long term effects on the aquatic environment’. Consequently MBBT’s use as ‘an ingredient in sunscreen products might lead to environmental exposure’.

MBBT was looked at by the Committee as the recast of the European Cosmetic Directive meant that it could now fulfil the definition of a nanomaterial.

 

Follow this link to access all of the opinions.

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