The methodology developed by the European Food Safety Authority (EFSA) Scientific Committee to assess the safety of botanical ingredients in food supplements is based on the history of safe use in case evidence exists that the historical level of safe human exposure to the botanical ingredient is not exceeded and that no substances of concern have been identified as naturally-occurring in the botanical ingredient under consideration. In case substances of concern ferrous gluconate in pregnancyhave been identified in the botanical ingredient, as indicated by the EFSA Compendium of Botanicals or EFSA chemical hazard database or other available information sources, the safety of the overall exposure to such substances should be evaluated in the context of available health-based guidance values such as Acceptable Daily Intakes (ADI) or Temporary Daily Intakes (TDI)28 ferrous fumarate 210mg tablets.