EFSA Re-evaluates the Safety of Calcium Carbonate as a Food Additive for Infants Under 16 Weeks Old and for the General Population

On July 27, 2023, the European Food Safety Authority (EFSA) announced that its Panel on Food Additives and Flavourings (FAF) has re-evaluated the safety of calcium carbonate (E 170) as a food additive in food for infants below 16 weeks of age belonging to food category 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) and as carry-over in line with Annex III, Part 5 Section B to Regulation (EC) No 1333/2008. The FAF Panel was also requested to address the issues already identified during the re-evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow interested business operators (IBOs) to provide the requested information to complete the risk assessment.

The FAF Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for calcium carbonate and that, in principle, there are no safety concerns with respect to the exposure to calcium carbonate per se at the currently reported uses and use levels in all age groups of the population, including infants below 16 weeks of age. With respect to the calcium intake resulting from the use of E 170 in food for the general population and infants < 16 weeks of age, the Panel concluded that it contributes only to a small part to the overall calcium dietary exposure. However, the unavoidable presence of aluminum in E 170 is of concern and should be addressed. The Panel also concluded that the technical data provided by the IBO support further amendments of the specifications for E 170 laid down in Commission Regulation (EU) No 231/2012.

Overall, the EFSA's re-evaluation confirms the safety of calcium carbonate as a food additive for infants below 16 weeks of age belonging to food category 13.1.5.1 and as carry-over in line with Annex III, Part 5 Section B to Regulation (EC) No 1333/2008, as well as for the general population. However, the presence of aluminum in E 170 should be addressed.

"Calcium carbonate (E 170) was re-evaluated in 2011 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of calcium carbonate (E 170) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) and as carry over in line with Annex III, Part 5 Section B to Regulation (EC) No 1333/2008. In addition, the FAF Panel was requested to address the issues already identified during the re-evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow the interested business operators (IBOs) to provide the requested information to complete the risk assessment. The Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for calcium carbonate and that, in principle, there are no safety concern with respect to the exposure to calcium carbonate per se at the currently reported uses and use levels in all age groups of the population, including infants below 16 weeks of age. With respect to the calcium intake resulting from the use of E 170 in food for the general population and infants < 16 weeks of age, the Panel concluded that it contributes only to a small part to the overall calcium dietary exposure. However, the unavoidable presence of aluminium in E 170 is of concern and should be addressed. In addition, the Panel concluded that the technical data provided by the IBO support further amendments of the specifications for E 170 laid down in Commission Regulation (EU) No 231/2012."