Titanium dioxide – CMR classification annulled by European General Court

Titanium dioxide was classified as carcinogenic (Cat. 2), leading the European Commission to enacting Regulation (EU) 2020/217[1]. Several manufacturers and other parties such as the Titanium Dioxide Manufacturers Association (TDMA) sued against this Regulation – and were finally successful. With the judgement of 23rd November 2022[2], the European General Court (EGC) concluded that Titanium dioxide in powder form has been incorrectly classified as carcinogenic and the Regulation has been annulled accordingly.

The EGC noted that the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied. The Commission made a manifest error in its assessment of the reliability of the study on which this classification was based. Secondly, it infringed the criterion according to which that classification can relate only to a substance that has the intrinsic property to cause cancer[3].

It is argued by the EGC that Titanium dioxide by itself does not intrinsically (i.e. as part of its general characteristics) has the property of causing cancer but only when inhaled in the form of particles. This hazard is essentially related to the specific shape and size of the particles, as well the exposure to the lung. The classification as carcinogenic is therefore not justified.

Titanium dioxide is well known as white pigment in various cosmetic products, e.g. creams, pastes and powdery decorative cosmetic products. It is also used as UV filter, either in its conventional or its “nano”-form (1 nm- 1000 nm particle size).

In 2016 the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) proposed to the European Chemicals Agency (ECHA) to classify titanium dioxide as CMR Class 1B[4]. In June 2017, ECHA’s Risk Assessment Committee (RAC) concluded that due to the lack of scientific evidence the substance should be classified as CMR of Category 2 on the inhalation route, which is the less severe category[5]. The Commission then followed this recommendation in 2019.

The judgement however does not affect the ban of using titanium dioxide in food. Titanium dioxide was authorized as food additive with the number E 171. This authorization turned into a ban for food products as of the beginning of 2022[6].

[1] https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A32020R0217 (Regulation (EU) 2020/217)

[2] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62020TJ0279 (Judgement of 2022)

[3] https://curia.europa.eu/jcms/upload/docs/application/pdf/2022-11/cp220190en.pdf (press release)

[4] https://echa.europa.eu/harmonised-classification-and-labelling-previous-consultations/-/substance-rev/13832/term (downloaded on 07.02.2018)

[5] https://echa.europa.eu/-/titanium-dioxide-proposed-to-be-classified-as-suspected-of-causing-cancer-when-inhaled  (downloaded on 07.02.2018)

[6] https://eur-lex.europa.eu/eli/reg/2022/63/oj (Regulation (EU) 2022/63)

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