Scientific Opinion on the food additive E 153

The EFSA ANS Panel provides a scientific opinion re-evaluating the safety of vegetable carbon (E 153). Vegetable carbon has been evaluated previously by the SCF (1977, 1983) and by JECFA (1970, 1977, 1987). Neither Committee established an ADI for vegetable carbon, but the SCF concluded that vegetable carbon could be used in food.

The Panel was not provided with a newly submitted dossier and based its evaluation on previous assessments and additional literature. The available toxicological data were considered too limited to establish an ADI for vegetable carbon.

The Panel noted that data on the genotoxicity and carcinogenicity of carbon blacks of hydrocarbon origin have been linked to their content of polycyclic aromatic hydrocarbons (PAHs). However, it also observed that the margins of exposure for benzo[a]pyrene from vegetable carbon were considerably higher than those estimated from overall dietary exposure to benzo[a]pyrene.

The Panel concluded that, at the reported use levels, vegetable carbon (E 153) containing less than 1.0 µg/kg of residual carcinogenic PAHs expressed as benzo[a]pyrene is not of safety concern. This conclusion was further supported by the long history of safe medicinal use and the fact that vegetable carbon is an inert substance that is essentially not absorbed from the gastrointestinal tract after oral intake.

The Panel considered that it may be appropriate to include in the specifications for vegetable carbon a limit for residual carcinogenic PAHs expressed as benzo[a]pyrene, using a validated analytical method with appropriate sensitivity (e.g. a limit of detection of 0.1 µg/kg).

Estimated dietary exposure of European children to vegetable carbon ranged from 3 to 29.7 mg/kg bw/day at the mean, and from 15.3 to 79.1 mg/kg bw/day at the 95th/97.5th percentile. For UK adults, the estimated exposure was 3.8 mg/kg bw/day at the mean and 28.1 mg/kg bw/day for high-level (97.5th percentile) consumers.