Following a request from the European Commission, EFSA re-evaluated the safety of the food additive based on previous evaluations and additional literature following its public call for data.
“Owing to the lack of detailed reports on carcinogenicity and chronic toxicity studies with octyl gallate (…), the panel could not reach a definitive conclusion on the presence or absence of a carcinogenic potential of octyl gallate,” it said.
Using available toxicity data for chewing gum, it said a safety concern was unlikely from this single use but that more toxicological data was required to make an adequate safety assessment for the additive in all its permitted food uses.
However, the panel recommended that the permitted levels of metal impurities in octyl gallate – currently set at no more than 3 mg/kg for arsenic, 2 mg/kg for lead and 1 mg/kg for for mercury are revised.
“[This would] avoid the use of food additives [being] considered as an additional source for these toxic elements,” a spokesperson said.
Octyl gallate is found in chewing gum, processed potato products, cake mixes, fats and margarines, peanut butter and breakfast cereals. It can be used on its own or in combination with other food additives.
In its previous evaluation, which took place in 1987, the then-named Scientific Committee of Food established an acceptable daily intake of 0-0.5 mg per kilo body weight for propyl, octyl and dodecyl gallate.