SUN CARE
The threshold value, i.e. the percentage of particles that are required to be in the nano-scale range in order for the material to be considered a nanomaterial.
Whether the threshold value is defined in terms of number distribution or mass distribution as discussed earlier.
It remains to be seen whether the European Commission will accept Colipa’s interpretation or insist on a stricter definition of “internal structure”, which would place almost all grades of inorganic sunscreens within the nanomaterial definition.
Safety of inorganic sunscreens With all the negative propaganda surrounding nanotechnology, many cosmetic manufacturers have taken a policy decision to avoid the use of nanoparticles. As a result, the sunscreen industry (both finished product manufacturers and ingredient suppliers) has, understandably, become preoccupied with the particle size of inorganic sunscreens and whether or not they should be defined as nanomaterials. Ultimately, though, what we should really be concerned about is whether inorganic
sunscreens are safe. Based on a very large body of evidence, we can say that they are safe.
It is important to recognise the distinction between inorganic sunscreens and other types of nanoparticles. Trying to treat all nanomaterials as though they pose the same degree of hazard and risk is not a reasonable approach. Some nanoscale materials, for example quantum dots, have particle sizes as small as a few nanometres, and hence are orders of magnitude smaller than more conventional forms of the same materials. As such, these nanoparticles can exhibit properties which are fundamentally different from the larger particles. The same is not true of inorganic sunscreens. Materials such as TiO2
and ZnO exist in a continuum of particle sizes above and below 100 nm and the chemical properties of the materials are fundamentally the same whatever their size. Even pigmentary forms of TiO2
and
ZnO, which have mean particle sizes well outside the nanoscale range, include a proportion of particles less than 100 nm. There is no step change in chemical properties between the ‘nano’ forms and the larger TiO2
or ZnO particles.
The fears surrounding nanotechnology are largely based on the premise that nanomaterials are so new that they have
not been properly tested to ensure that they are safe. This may be true of some nanomaterials, but is certainly not the case with inorganic sunscreens. Fine particle TiO2
and ZnO have been in use for over 20 years, and the safety of these materials has been the subject of extensive and exhaustive study. Comprehensive dossiers on sunscreen grades of TiO2
and ZnO were
submitted to the former Scientific Committee on Cosmetic Products and Non- Food Products (SCCNFP) for evaluation and subsequent inclusion in the EU list of approved UV filters (Annex VII to the Cosmetics Directive, Annex VI in the new Cosmetics Regulation). In 2000, the SCCNFP concluded in their opinion for TiO2
:6
“The SCCNFP is of the opinion that titanium dioxide is safe for use in cosmetic products at a maximum concentration of 25% in order to protect the skin from certain harmful effects of UV radiation. This opinion concerns crystalline (anatase and/or rutile) titanium dioxide, whether or not subjected to various treatments (coating, doping, etc.) irrespective of particle size, provided only that such treatments do not compromise the safety of the product. The SCCNFP proposes no further restrictions or conditions for its use in cosmetic products.”
power The ingredients ofSMART C
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