Scientific Opinion on re-evaluation of calcium carbonate (E 170) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of calcium carbonate (E 170). Calcium carbonate is an inorganic salt authorised as a food additive in the EU, and is also included in the list of substances that may be added for specific nutritional purposes in foods for particular nutritional uses and in Directive 2002/46/EC relating to food supplements. Calcium carbonate was previously evaluated by JECFA in 1965, when the Committee established an ADI not limited. The SCF evaluated calcium carbonate in 1990 as part of a group of carbonates, when the Committee assigned a group ADI not specified. 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 noted that the available toxicological database on calcium carbonate is limited, but does not give rise to concern. The few effects seen in studies in humans and animals are associated with high calcium carbonate intakes, and are also seen with other calcium salts. The Panel agrees with the group ADI “not specified” assigned by the SCF to a group of carbonates including calcium carbonate, when considering the use of calcium carbonate as a food additive. The Panel notes that the estimated exposures to calcium from all sources, including the use of calcium carbonate as a food additive, taken together with intakes of calcium from supplements and from food fortification are below the UL of 2500 mg/day for calcium from all sources established by the SCF in 2003. The Panel concludes that trace levels of adventitious nanoscale material within macroscale calcium carbonate are not of toxicological concern.