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.

In 2020, Health Canada extended the use of potassium phosphate, dibasic to the same foods and at the same maximum levels of use as was permitted for sodium phosphate, dibasic. One of the new uses for potassium phosphate, dibasic was in sour cream as was set out for sodium phosphate, dibasic in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents.

This list also sets out permitted uses for certain other food additives in sour cream. For 14 of the food additives, the list sets out a condition of use in Column 3 that limits the total amount of the food additives permitted in sour cream when they are used in combination. Sodium phosphate, dibasic is excluded from this in-combination condition of use. Potassium phosphate, dibasic should similarly have been excluded when it was authorized for use in sour cream in 2020.

Also, Column 3 of the French version of the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents correctly set outs that carob bean gum and gelatin can each be used singly in sour cream at a maximum level of use of 0.5%. This maximum level of use for these two additives, used singly, was missing from the English version of the list.

This Notice describes the action Health Canada has taken to correct these errors by modifying the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents, effective March 31, 2023.