The European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published on January 24, 2018, its final opinion on titanium dioxide (nano form) as an ultraviolet (UV)-filter in sprays.  The EC asked SCCS to address the following questions:

1. In light of the data provided, does SCCS consider titanium dioxide (nano) safe when used as a UV-filter in sunscreens and personal care spray products at a concentration up to 5.5 percent; and

2. Does SCCS have any further scientific concerns regarding the use of titanium dioxide (nano) when used as a UV-filter in sunscreens and personal care spray products.

SCCS reviewed data submitted by industry in July 2015 and concluded that “the information provided is insufficient to allow assessment of the safety of the use of nano-TiO₂ in spray applications that could lead to exposure of the consumer’s lungs.”  According to the final opinion, the dossier provides exposure studies that were conducted with water-based sprayable products with low alcohol content, which according to the market overview currently represent around 80 percent of the sprayable sunscreen products on the European Union (EU) market.  For the non-water-based formulations or formulations that contain alcohol >10 percent per weight, which currently may represent around 20 percent of the sprayable sunscreen products on the EU market, no exposure data were submitted, so these products could not be evaluated.  The final opinion states that the submission “also does not provide adequate toxicological evaluation of nano-TiO₂ relevant to the inhalation route, which would allow deriving a point of departure for the safety evaluation using worst-case assumptions.”  During the comment period on SCCS’s preliminary opinion, the applicant provided a new submission.  SCCS states that its analysis “showed that it has also not addressed the SCCS concerns over the safety of titanium dioxide (nano) when used as UV-filter in sunscreen and personal care sprayable products.”  SCCS notes that it has been made aware by the applicant’s new submission that there are already sprayable products on the market containing nano forms of titanium dioxide.  SCCS cautions that “[s]uch uses need to be carefully evaluated so that the chance of harmful effects through consumer’s lung exposure by inhalation is avoided.”