Additional warnings when labelling products containing Titanium Dioxide

On October 2019, the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures suffered an amendment with a significant influence on the labelling of cosmetic products.

One of the substances mentioned in the amendment was titanium dioxide, a common ingredient in several cosmetic products.

Back in 2017, in its scientific opinion on titanium dioxide, the ECHA’s committee for Risk Assessment had proposed to classify it as carcinogen category 2 by inhalation. The deposition of respirable particles of titanium dioxide on the lungs was assumed to be responsible for the observed toxicity in the lung and subsequent tumor development.

Given that using some mixtures containing titanium dioxide can induce the formation of hazardous dust or droplets, it is crucial to inform users of the precautions to follow when using products containing this substance. Hence, specific warnings shall appear on the labels of certain cosmetic products that contain 1 % or more of titanium dioxide particles as per the applicable risk (droplet or dust formation), as mentioned in the amendment. This will need to be respected at the latest from 9 September 2021.

If you are a cosmetics products manufacturer, it is important to verify whether the above amendment is applicable to your products containing 1% Titanium Dioxide, and to make the necessary arrangements to ensure your labels are compliant before the application date.

Ana Rita Falcão

Regulatory Affairs department


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