European Commission experts will reconsider the safety of titanium dioxide in cosmetics in light of the classification of the substance as a carcinogen.
The Scientific Committee on Consumer Safety (SCCS) approved a mandate from the Commission to evaluate the safety of the substance on 5 February.
Currently, under the EU
cosmetic products Regulation, the substance is authorised for use in two
1) as a UV-filter, at a
concentration of up to 25%; and
2) as a colourant.
Meanwhile, the substance is
also used as a filler in cosmetics, but this use is not subject to any specific
restriction under the Regulation.
However, the current situation is predicated on titanium dioxide not being carcinogenic, mutagenic or reprotoxic, and the substance is facing a category 2 carcinogenicity classification under the CLP.
The European Commission is expected to publish its delegated Regulation containing the classification on 17 February, having adopted it last year.
Under the cosmetic products Regulation, a substance with a category 2 or higher carcinogenicity, mutagenicity or reproductive toxicity classification under the CLP is automatically banned from use in cosmetics, unless an exemption applies.
Use of a category 2 substance is permitted under Article 15 if the SCCS has evaluated it and found it safe.
According to the request from the Commission, trade association Cosmetics Europe submitted a dossier in January to support the safety of using titanium dioxide according to the terms of Article 15.
The dossier covers only the non-nanoform in cosmetic products that may give rise to consumer exposure by inhalation because the nanoform is already restricted under entry 27a of Annex VI.
The SCCS will evaluate whether
– in light of the classification – titanium dioxide is safe:
1) when used as a UV-filter in
cosmetic products up to a maximum concentration of 25%, according to entry 27
of Annex VI;
2) as a colourant, according to
entry 143 of Annex IV; and
3) as an ingredient in all other
In the event that it considers a maximum concentration of 25% unsafe, the committee will also determine what concentration is considered safe for use in cosmetic products.
The committee has six months to prepare its Opinion.
The SCCS has also approved mandates to evaluate the safety of three organic UV filters, prioritised by the Commission as potential endocrine disrupting chemicals:
2) homosalate; and
The committee has nine months
to prepare its Opinions on these.
Selected suppliers of titanium dioxide from OKCHEM:
Hangzhou Ruijiang Chemical Co., Ltd
HANGZHOU PRATIQUE PERFORMANCE MATERIAL
Guangxi Bluestar Dahua Chemical Co.,