FSSAI has released a direction dated 29th January 2021, in which the regulator has mandated import conditions of specialty foods for conditions like IEM (Inborn Errors of Metabolism) and Hypoallergenic Conditions.
Inborn errors of metabolism (IEMs) are rare genetic or inherited disorders resulting from an enzyme defect in biochemical and metabolic pathways affecting proteins, fats, carbohydrate metabolism, hence babies suffering from IEM require specially formulated foods that help them to mitigate the inborn errors.
FBOs shall comply with all standards for Foods for infants with IEM and Hypoallergenic infant milk substitutes given under Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020 by July 1st 2021.
Import of foods for IEM has been allowed under the below conditions:
- The importing firm should submit all product related documents related to composition, label, claims to FSSAI.
- FSSAI after thorough examination, will allow the import of specialty foods.
- The Label should clearly mention the medical condition for which the food should be consumed.
- The importer/ Manufacturer should ensure that specialty foods are consumed only under supervision of medical professionals.
- The above condition is applicable for domestically produced specialty food products approved by FSSAI.
Read the letter here.
