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Opinion on Titanium Dioxide (nano form) coated with Cetyl Phosphate, Manganese Dioxide or Triethoxycaprylylsilane as UV-filter in dermally applied cosmetic

Final Opinion

Details

Publication date
7 March 2017
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Nanomaterials in Cosmetic products
SCCS members: U. Bernauer, L. Bodin, L. Celleno, Q. Chaudhry, P. Coenraads, M. Dusinska, J. Duus-Johansen, E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, C. Rousselle, M. Stępnik, S. Wijnhoven
SCHEER members: P. Hoet, W. de Jong
External members: N. von Götz
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1580/16
Adopted on: 7 November 2016

Conclusion of the opinion:

(1) In light of the data provided, does the SCCS consider safe the use of Cetyl Phosphate, Manganese Dioxide and Triethoxycaprylylsilane as coatings for Titanium Dioxide (nano) used as UV-filter in dermally-applied cosmetic products?

In view of the above discussion, which indicates a general lack of dermal absorption and low general toxicity of nano-forms of titanium dioxide, the SCCS considers that the use of the three TiO2 nanomaterials (A, B, C), coated with either cetyl phosphate, manganese dioxide or triethoxycaprylylsilane, can be considered safe for use in cosmetic products intended for application on healthy, intact or sunburnt skin. This, however, does not apply to applications that might lead to exposure of the consumer's lungs to the TiO2 nanoparticles through the inhalation route (such as powders or sprayable products).

(2) Does the SCCS have any further scientific concerns regarding the use of the above-mentioned additional coatings for Titanium Dioxide (nano) used as UV-filter in dermally-applied cosmetic products?

The ingredients used in some type of products (e.g. in lipsticks) may be incidentally ingested. The potential harmful effects of manganese dioxide should therefore be taken into account if the MnO2-coated nanomaterials are to be used for applications that could lead to oral ingestion.

This Opinion is based on the currently available scientific evidence which shows an overall lack of dermal absorption of TiO2 nanoparticles. If any new evidence emerges in the future to show that the TiO2 nanoparticles used in a sunscreen formulation can penetrate skin (healthy, compromised, or damaged skin) to reach viable cells, then the SCCS may consider revising this assessment.

As highlighted in the previous SCCS Opinion (SCCS/1516/13, 22 July 2013, Revision of 22 April 2014), there are certain knowledge gaps in regard to potential penetration of nanoparticles through cuts and bruises, or over repeated or long-term applications of a sunscreen formulation.

It should also be noted that the risk assessment of nanomaterials is currently evolving. In particular, the toxicokinetics aspects have not yet been fully explored in the context of nanoparticles (e.g. the size dependency). Also, long-term stability of the coatings remains unclear. At the moment, both the testing of nanomaterials and the present assessment are based on the methodologies developed for substances in non-nano form and the currently available knowledge on properties, behaviour and effects of nanomaterials. This assessment is, therefore, not intended to provide a blue-print for future assessments of other nanomaterials, where depending on the developments in methodological risk assessment approaches and nano-specific testing requirements, additional/different data may be required and/or requested on a case-by-case basis.

It is also important to note that the potential ecotoxicological impacts of nano TiO2 when released into the environment have not been considered in this Opinion.

Keywords:

SCCS, scientific opinion, Titanium Dioxide, coatings, nano form, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on additional coatings for Titanium Dioxide (nano form) as UV-filter in dermally applied cosmetic products, 7 November 2016, SCCS/1580/16.

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