Brazilian Health Regulatory Agency (Anvisa in Portuguese) position is in accordance with the indication of the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO), which also decided to re-evaluate the substance, based on the expanded data collection expected to be completed in 2024.

In this regard, the Agency included in the Regulatory Agenda 2021-2023 the re-evaluation of the authorization for the use of the additive titanium dioxide. The review process began with the publication of scientific reviews on the safety profile of additives. Despite conflicting scientific opinions, Anvisa considered it appropriate to initiate the review.

Since 2021, the Agency has not issued new authorizations for the use of titanium dioxide, while the issue is still under review.

Titanium dioxide is a food additive with coloring function, used in several countries and for decades without evidence of risk to human health. This additive has been evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in its various aspects on several occasions (1959, 1964, 1969, 1977, 1984, 1992 and 2002).

In the toxicological field, the Committee defined, in 1969, an “unlimited” Acceptable Daily Intake (ADI), a situation attributed to substances that, according to existing information, are of very low toxicity, especially those found in food constituents or that can be considered as normal food or metabolites (residues that remain after the body uses the useful part of food) in humans. Studies indicate that the substance is eliminated virtually entirely unchanged in the feces, with approximately 0.001% absorbed orally and available systemically.