Background

The European Commission issued a proposal for classification of titanium dioxide as a suspected carcinogen of category 2 by inhalation on 4 October 2019.  This decision followed a scientific opinion of 14 September 2017, published by ECHA’s Committee for Risk Assessment (RAC).

The recently accepted proposal has faced opposition from the industry, arguing that the classification of titanium dioxide as a carcinogen is not related to substance’s chemistry but rather the physical characteristics of the particles, such as shape and size of the particles and poor solubility – characteristics not specific to titanium dioxide but rather shared with many other substances.

New requirements

The Regulation sets out a requirement of cancer warning labels for mixtures in powder form containing 1% or more of titanium dioxide particles with an aerodynamic diameter of ≤ 10 µm. Although, other forms and mixtures do not fall under this classification, there are specific warnings that need to be applied to those that contain more than 1% of titanium dioxide.

However, under Cosmetic Regulation (EC) No 1223/2009, a substance classified as CMR substance of category 2, under Regulation (EC) No 1272/2008, is prohibited for use in cosmetic products, unless an exemption applies. That means sunscreen products and other cosmetic products which contain titanium dioxide and pose a risk of inhalation by the consumer may not be allowed on the EU market.

In light of the recent classification of the substance as a carcinogen, the Scientific Committee on Consumer Safety (SCCS) will reconsider the safety of titanium dioxide. On 5 February, the SCCS issued a request for a scientific opinion on titanium dioxide used in cosmetic products and now has six months to prepare its opinion. According to the Cosmetic regulation, a category 2 substance is permitted in cosmetic products, if the SCCS has evaluated the substance and found it safe for use.

The Regulation will enter into force 20 days after its publication in the Official Journal of the European Union and will apply from 9 September 2021.

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