Request a Demo
Update on December 1, 2022 Based on EFSA's reply to ChemLinked, EFSA confirmed that "the ruling of the Court of Justice relates to the carcinogenic potential of TiO2 as a powder via inhalation (i.e. in the case of occupational exposure), and as such has no direct impact on the scientific assessment completed by EFSA on the food additive E171, focussed on dietary exposure (oral ingestion)." |
On November 23, 2022, the Court of Justice of the European Union (CJEU) released a judgment1 to annul the European Commission’s previous decision which classified titanium dioxide as a carcinogen by inhalation in powder form. Read more at Commission Delegated Regulation (EU) 2020/217—Amending Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures2.
As disclosed by CJEU, stakeholders like manufacturers of titanium dioxide brought actions before the General Court for the partial annulment of Regulation 2020/217. The Court found, but not limited to, that “the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied.” Finally, the Court concluded that the Commission committed a manifest error of assessment.
Will it change EU's ban on titanium dioxide as a food additive?
Titanium dioxide is an inorganic chemical substance. For its colorant and covering properties, titanium dioxide is widely used in various products, such as paints, foods, cosmetics, medicinal products, etc. However, in January 2022, the European Commission released Commission Regulation (EU) 2022/63—Amending Regulation (EC) No 1333/2008 as regards the Food Additive Titanium Dioxide (E 171)3, withdrawing the authorization to use titanium dioxide as a food additive. The regulation mainly took the scientific opinion4 by the European Food Safety Authority (EFSA) into consideration. The scientific opinion stated that a concern for genotoxicity could not be ruled out. Given many uncertainties, EFSA concluded that titanium dioxide could no longer be considered safe when used as a food additive.
The release of CJEU's judgment calls some's attention to the safety of titanium dioxide in food again, especially when titanium dioxide is considered safe for consumption in the US, Canada and the UK (excluding the Northern Ireland5, due to the application of the Northern Ireland Protocol). UK’s Food Standards Agency carried out its own risk assessment and the UK committee on toxicity is not convinced that a ban is necessary6.
Since the ban on titanium dioxide in food is a separate regulation, it remains effective at present.
We provide full-scale global food market entry services (including product registration, ingredient review, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
