ITALY – The Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA), at its 97th meeting in Rome, has not only reaffirmed the safety of titanium dioxide but also paved the way for the acceptance of 21 flavoring agents, dismissing safety concerns for these additives.

Titanium dioxide, a ubiquitous white food coloring agent found in an array of products from bakery decorations to chewing gum, has been a subject of contention.

Despite a ban scare in California in 2023, a legal tussle in the EU, and the European Food Safety Authority (EFSA) flagging it as unsafe, JECFA stands by its previous “not specified” acceptable daily intake (ADI).

The committee, delving into exhaustive toxicological studies, found that the poor absorption of titanium dioxide by the gastrointestinal tract in mice and rats exhibited no adverse effects in short-term studies.

Noted no observed adverse effect levels (NOAELs) of 15,000 mg/kg BW per day for mice and 5,000 mg/kg BW per day for rats—the highest doses tested—underscored its safety.

While acknowledging uncertainties in genotoxicity data, JECFA emphasized the lack of carcinogenicity in two-year studies in rodents.

Human studies and postmortem analyses suggested low oral bioavailability. Considering these findings and estimating a maximum 95th percentile exposure of 10 mg/kg BW per day, JECFA confidently reaffirmed the “not specified” ADI established at its 13th meeting.

A palette of approvals

In a separate triumph, JECFA concluded that 21 flavoring agents spanning three classes posed no safety concerns. This includes compounds such as (±)-6-Methoxy-2,6-dimethylheptanal, Ethyl 5-formyloxydecanoate, and a mixture of ricinoleic acid, linoleic acid, and oleic acid, which, based on current dietary exposure estimates, received the coveted “no safety concern” designation.

Other additives on the list comprise various aldehydes and acids, such as (4Z,7Z)-Trideca-4,7-dienal, cis-5-Dodecenyl acetate, and (E)-3-Methyl-4-dodecenoic acid.

The safety assessment extends to compounds like Acetaldehyde di-isobutyl acetal and Acetaldehyde ethyl isobutyl acetal. This conclusion of “no safety concern” is grounded in the evaluation of current estimated dietary exposure, providing assurance regarding the safety profile of these additives in food products.

However, the committee deferred the assessment of some flavoring agents pending additional information. JECFA emphasized the need for complete data submissions from sponsors for thorough safety evaluations.

In the wake of these decisions, JECFA navigates a delicate balance, addressing concerns surrounding a widely used food additive while advancing the safety considerations of a diverse range of flavoring agents.

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