Scientific Opinion on the re-evaluation of riboflavin (E 101(i)) and riboflavin-5′-phosphate sodium (E 101(ii)) as food additives

The EFSA ANS Panel provides a scientific opinion re-evaluating the safety of riboflavin (E 101(i)) and riboflavin-5′-phosphate sodium (E 101(ii)) which are authorised as food additives in the EU and have been previously evaluated by JECFA and by the SCF. JECFA allocated a group ADI for riboflavin and riboflavin-5′-phosphate sodium of 0–0.5 mg/kg bw/day. The SCF considered that the use of riboflavin-5′-phosphate sodium as a food colour should not alter significantly the average daily intake of riboflavin for which no ADI was established. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. The Panel considered that riboflavin-5′-phosphate sodium is rapidly dephosphorylated to free riboflavin in the intestinal mucosa and then metabolised using normal metabolic pathways. The Panel noted that no adverse effects were observed in two 90-day studies in rat and that riboflavin and riboflavin-5′-phosphate do not raise concern with respect to genotoxicity. The Panel also noted that there are limited data from clinical studies, in which no significant adverse effects were reported. The Panel considered that the use of riboflavins as food additives will result in an exposure above that from the regular diet and that the available database is insufficient to assess whether potential high intakes from all combined sources cause adverse effects or not. Due to the absence of carcinogenicity/chronic toxicity studies and lack of relevant reproductive and developmental toxicity studies, the Panel considered that it is not appropriate to allocate an ADI. The Panel concluded, despite the uncertainties in the database, that riboflavin (E 101(i)) and riboflavin-5′-phosphate sodium (E 101(ii)) are unlikely to be of safety concern at the currently authorised uses and use levels as food additives.