A post in the Official Journals of the European Union confirmed that Annex VI governing Cosmetics Regulation in the European Union confirms that both regular and nano-sized titanium dioxide can be included in UV sunscreen formulation, providing they meet with dosing requirements.
The dosing requirements stress that both forms of titanium dioxide can be included in formulations providing they do not exceed a “25 percent maximum concentration in ready-for-use preparation”.
Lung inhalation warning
However, the amendment also stipulates that nano titanium dioxide is not to be used in applications that may lead to exposure to the consumers’ lungs by inhalation.
This stipulation is likely to impact manufacturers of spray sunscreens, where there can be heightened risk of lung inhalation, particularly if spraying occurs in a confined area.
This decision stems from an opinion published by the Scientific Committee on Consumer Safety in September 2014 that concerns of consumer inhalation of spray products containing nano forms of carbon black CI 77266, titanium dioxide and zinc oxide were limited only to titanium dioxide.
End of uncertainty
For sunscreen developers and formulators, the ruling marks an end to years of uncertainty over the formulation of sun care products that include nano titanium dioxide, which is one of the most effective UV filters there is.
The ruling also indicates that the nano titanium dioxide ingredients to be included in formulation should meet with certain physico-chemical properties, including purity, structure, physical appearance and particle number size distribution.
Those properties including a purity rating of no less than 99%, a median particle size of no less than 30 nanometers, and that the nanoparticles are photostable in the final formulation.