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Public Health
Expert opinion

Titanium Dioxide (nano form) as UV-Filter in sprays

Final Opinion

Details

Publication date
19 January 2018
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Nanomaterials in cosmetic products
SCCS members: U. Bernauer (Chairperson), L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads, M. Dusinska, E. Gaffet, C.L. Galli, E. Panteri, C. Rousselle, M. Stępnik, S. Wijnhoven
SCHEER members: P.H.M. Hoet, W.H. de Jong
External expert:N. von Götz (Rapporteur)
Former SCCS members:J. Duus-Johansen, W. Lilienblum, T. Platzek, J. van Benthem
Former SCENIHR members:A. Bernard, O. Bussolati, S. H. Doak, T. Jung
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1583/17
Adopted on: 19 January 2018

Conclusion of the opinion:

1. In light of the data provided, does the SCCS consider Titanium Dioxide (nano) safe when used as UV-Filter in sunscreens and personal care spray products at a concentration up to 5.5%?

From analysis of the submitted dossier, the SCCS has 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.

The dossier provides exposure studies that have been conducted with water-based sprayable products with low alcohol content, which according to the market overview currently represent around 80% of the sprayable sunscreen products on the EU market. For the non-water-based formulations or formulations that contain alcohol >10% per weight, which currently may represent around 20% of the sprayable sunscreen products on the EU market, no exposure data were submitted, so that these could not be evaluated at all. 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 commenting period on the preliminary Opinion, the Applicant provided a new submission, the analysis of which (Section 3.3.13) 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.

2. Does the SCCS have any further scientific concerns regarding the use of Titanium Dioxide (nano) when used as UV-Filter in sunscreens and personal care spray products?

The SCCS has been made aware by the new submission of the Applicant that there are already sprayable products on the market containing nano forms of TiO2. Such uses need to be carefully evaluated so that the chance of harmful effects through consumer's lung exposure by inhalation is avoided.

Keywords:

SCCS, scientific opinion, nano-TiO2, UV-filter, sprays, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Titanium Dioxide (nano form) as UV-filter in sprays, preliminary version of 7 March 2017, final version of 19 January 2018, SCCS/1583/17.

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