Regulator action: Banned as a food additive in the EU (Commission Regulation (EU) 2022/63, in force 7 Feb 2022; transition ended 7 Aug 2022). Permitted in US food at up to 1% by weight (21 CFR 73.575). EU ban does not extend to medicines or cosmetics.
the concern described here is about EATING titanium dioxide. Where it appears in a non-food product — as a white pigment in a diaper, for example — it is not ingested, and the food findings below do not transfer. Read this record against how the product is actually used.
This is one of the clearest US/EU regulatory divergences on a shelf. In May 2021 EFSA concluded that titanium dioxide can no longer be considered safe as a food additive, because genotoxicity (potential DNA damage) could not be ruled out, particularly for the nanoparticle fraction. The European Commission then adopted Regulation (EU) 2022/63, removing it from the authorised list; it entered into force 7 February 2022, with a sell-through period that ended 7 August 2022. Precision matters here: EFSA did not find proof of harm. It found that available data could not exclude harm, and EU practice in that situation is removal.
The United States reached the opposite conclusion on the same evidence. FDA permits titanium dioxide as a colour additive at up to 1% by weight under 21 CFR 73.575, and has stated it disagrees with EFSA's reading of the nanoparticle data. A petition asking FDA to revoke the authorisation remains pending.
Note the EU ban applies to FOOD only. Titanium dioxide remains authorised in the EU for medicines and cosmetics, partly to avoid medicine shortages. So "banned in Europe" is true of food and not true of every product category.