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Regulatory
Posted By:
Trace One
CMR products and cosmetics
Article 32 of Regulation 1223/2009 on cosmetic products forbids the use of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A, 1B and 2, based on CLP criteria.
There are nonetheless cases in which the use of CMR substances is allowed, following specific evaluations from the SCCS (Scientific Committee of Consumer Safety) that guarantee their safety in specific cosmetic uses.
When is TiO2 allowed?
Titanium dioxide is a substance that sees common application in any fields, from cosmetics to paints. Right now a discussion is proceeding in Europe concerning its possible harmonised classification as carcinogen category 2 according to the CLP Regulation.
On the other hand, Regulation 1223/2009 shows that titanium dioxide can be used in cosmetics as colouring agent (Annex IV) and as UV filter (Annex VI).
More specifically, TiO2 can be used as UV filter in a maximum concentration of 25% when in a cosmetic formulation. Concerning TiO2 (nano), the only allowed nanomaterials are the ones possessing the characteristics specified in the regulation.
Regulation 1223/2009 also specifies that titanium dioxide cannot be used in applications potentially exposing lungs of the final user via inhalation. This position has been recently reinforced by a SCCS opinion (SCCS/1583/17): “Opinion on Titanium Dioxide (nano form) as UV-Filter in sprays”
Using specific TiO2 based nanomaterials has been deemed safe by the SCCS. As an example, the three nanomaterials described in SCCS/1580/16 “Opinion on Titanium Dioxide (nano form) coated with Cetyl Phosphate, Manganese Dioxide or Triethoxycaprylylsilane as UV-filter in dermally applied cosmetic” can be considered safe in cosmetics applied to healthy skin, be it undamaged or sunburned.
It is still forbidden in applications that might expose lungs to TiO2 particles, such as dust products or spray products.
For more information on Titanium Dioxide and the cosmetic regulation, follow these links:
Newsletter 111