Statement of EFSA on the Evaluation of a new study related to the bioavailability of aluminium in food

The European Food Safety Authority (EFSA) was asked to evaluate a new study provided by industry that reports on the bioavailability of aluminium from several aluminium compounds in the rat. EFSA was asked whether the scientific data provided by the study could trigger the revision of the safety evaluation performed by EFSA in 2008, for the different aluminium based food additives investigated in this report (in particular SALP acidic, also known as sodium aluminium phosphate, acidic form or E 541). In the new study, the oral bioavailability of aluminium was determined as the ratio of the fraction of radioactivity left in the carcass seven days after oral administration of the ²⁶Al-labelled compound of interest over the fraction of radioactivity left in the carcass seven days after intravenous administration of ²⁶Al-labelled aluminium citrate using accelerator mass spectrometry (AMS). The results from the study show that the oral bioavailability of aluminium from twelve different aluminium-containing compounds, including the food additives aluminium sulphate, Allura Red AC aluminium lake (FD&C red 40 aluminium lake) and sodium aluminium silicate, ranges from 0.02 to 0.21%, and therefore falls within the overall 10-fold range of previously reported oral bioavailability values for aluminium from aluminium containing compounds. In the case of the two sodium aluminium phosphates, SALP acidic and SALP basic (KASAL), and aluminium metal, the measurements were below the limit of detection by AMS. In conclusion, the new study does not provide any additional information on the bioavailability of aluminium from aluminium-containing compounds that could modify the conclusions reached in 2008 by the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials. Therefore, EFSA concludes that this study does not give reason to reconsider the previous safety evaluation of aluminium-based food additives authorised in the European Union performed by EFSA in 2008.