Scientific Opinion on the re-evaluation of vegetable carbon (E 153) as a food additive

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 evaluations and additional literature. The Panel considered the available toxicological data 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 has been related to the PAHs content of these substances. However, the Panel noted that the margins of exposure for benzo[a]pyrene exposure from vegetable carbon were considerably higher than those estimated from the dietary benzo[a]pyrene exposure. 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 was also based on the long history of safe use as a medicinal substance and the knowledge that vegetable carbon is an inert substance which is essentially not absorbed from the gastrointestinal tract following oral administration. The Panel considered that it may be appropriate to introduce in the specifications for vegetable carbon a requirement for residual carcinogenic PAHs expressed as benzo[a]pyrene using a validated analytical method of appropriate sensitivity (e.g. LOD of 0.1 µg/kg). The 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 95^th/97.5^th percentile. The dietary exposure of UK adults was 3.8 mg/kg bw/day at the mean, and 28.1 mg/kg bw/day for high level (97.5^th percentile) consumers.