JECFA Reaffirms Safety of Titanium Dioxide and Establishes Specifications for 21 Flavoring Agents: Key Findings from the 97th Meeting

The 97th meeting of the Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) recently took place in Rome, Italy. During this meeting, JECFA addressed the safety of titanium dioxide and established specifications for 21 flavoring agents, providing important insights into their use in the food industry.

Titanium dioxide, a common white food coloring agent, is widely employed in various food products such as bakery decorations, soups, broths, sauces, spreads, creamers, candy, and chewing gum. Previous assessments by JECFA had assigned a "not specified" acceptable daily intake (ADI) for titanium dioxide due to its limited absorption and the absence of toxicological effects observed in animal and human studies. However, in recent years, concerns regarding the safety of titanium dioxide have emerged, leading to debates and legal battles in different regions.

At the 97th JECFA meeting, additional toxicological studies were reviewed to further evaluate the safety of titanium dioxide as a food additive. These studies investigated various aspects, including its toxicokinetics, acute toxicity, short-term and long-term toxicity, genotoxicity, reproductive and developmental toxicity, and potential for colon cancer initiation/promotion. It is worth noting that some studies utilized test materials, including nanoparticles, which may not accurately represent real-world usage of titanium dioxide as a food additive. Despite these limitations, JECFA concluded that the results of the relevant studies showed that titanium dioxide is poorly absorbed by the gastrointestinal tract in mice and rats, with no adverse effects observed in short-term studies.

Based on the available data, JECFA determined that no observed adverse effect levels (NOAELs) of 15,000 milligrams per kilogram of body weight (mg/kg BW) per day for mice and 5,000 mg/kg BW per day for rats could be established. Furthermore, the committee noted that there was no convincing evidence of genotoxicity or carcinogenicity in adequately conducted two-year studies in rodents. Studies on humans and postmortem tissue analyses also indicated low oral bioavailability of titanium dioxide. However, JECFA acknowledged the need for additional epidemiological studies to draw definitive conclusions about the association between dietary exposure to titanium dioxide and human health effects.

Regarding flavoring agents, JECFA evaluated 21 substances across three classes and concluded that there were no safety concerns associated with their use as food additives. The committee established specifications for these flavoring agents, ensuring their safe application in food products. However, for some other flavoring agents, the assessment could not be finalized due to insufficient data submissions. JECFA emphasized the importance of complete and comprehensive data for conducting effective safety evaluations.

In summary, the 97th meeting of JECFA reaffirmed the safety of titanium dioxide as a food additive, with a "not specified" ADI based on its limited absorption and absence of toxicological effects. The committee also established specifications for 21 flavoring agents, indicating no safety concerns associated with their current estimated dietary exposure. However, further data submissions are required to complete the assessment for some flavoring agents. These findings contribute to the ongoing efforts of regulatory bodies to ensure the safety of food additives and provide guidance for their appropriate use in the food industry.