Propyl Gallate

What this is

Regulatory reviews treat propyl gallate as a food antioxidant with use limits rather than as a broadly prohibited additive. In the U.S., FDA’s direct-food GRAS listing permits it at good-manufacturing-practice levels, with total antioxidant content capped at 0.02% of the fat or oil portion of the food. Codex lists INS 310 with category-specific maximum levels. EFSA re-evaluated E 310 in 2014 and set an ADI of 0.5 mg/kg bw/day, lower than JECFA’s maintained ADI of 0–1.4 mg/kg bw; EFSA noted uncertainties in the carcinogenicity and reproductive-toxicity databases, but concluded current uses and use levels were not a safety concern. The NTP’s older two-year bioassay did not consider it carcinogenic, while reporting equivocal tumor evidence in male rats and male mice. Current policy attention is state-driven: Oklahoma has a broad pending bill listing propyl gallate, and West Virginia has a pending school-nutrition bill.

Safety Review

The critical endpoints experts review in safety assessments. This is not a prediction of harm.

EFSA set a lower ADI than JECFA and noted uncertainties in carcinogenicity and reproductive-toxicity data, while concluding current uses were not a safety concern. The packet also cites NTP equivocal male-rat/mouse tumor evidence and limited in vitro estrogen-receptor activity whose dietary relevance remains uncertain.