Inborn Errors of Metabolism (IEM) and Hypoallergenic conditions require specialty foods which are not available in India. Hospitals require these foods for the management of infants and children suffering from these medical conditions. A direction for the import of these specialty foods had been given by the FSSAI through a notification dated 2 November 2016. Through a published FAQ the FSSAI has further clarified its stand regarding the import of these specialty foods.
The special foods are intended for infants and young children who are suffering from various forms of IEM and other Hypoallergenic conditions. The FSSAI directions regarding their import are to be followed by Central and State Food Authorities and FBOs who intend to manufacture these foods domestically or import them. These directions will be effective for a period of two years or till their standards are developed and notified, whichever is earlier.
The FSSAI has clarified that these foods do not come under the category of foods defined in Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply, and Distribution) Act 1992. Therefore, they are not to be considered as infant substitute foods or as infant food. They are specialty foods that are required to meet the special medical needs of children with rare disorders or medical conditions. They are to be consumed only under medical supervision and are covered under the special category of foods defined as ‘Foods for Special Medical Purposes (FSMP)’.
The import of these special foods will be allowed only after FSSAI has given special permission for their import on due consideration of composition, label, and claims. Once permission has been granted consignments that adhere strictly to the permitted composition, label and claim can be imported without re-examination. If there is any change in the composition, label information or claims then the importing FBO has to submit the information and documents to the FSSAI for examination well before import.
Since the products in the category are considered life-saving products the shipments will be examined on priority by the Authorised Officers or other relevant authority. The shipments will be cleared only after due procedure related to import like examination of shipping documents, label, certificate of analysis and testing and other relevant food safety parameters have been satisfactorily examined.
The labeling on the article of foods shall be in accordance with the Food Safety and Standards (Packaging and Labelling) Regulations 2011. Labeling as required for Infant milk substitutes and infant food is not applicable to these products. Rectifications as provided in the Food Safety and Standards (Import) Regulations, 2017 for FSSAI logo and license number, name, and address of the importer, veg/ non-veg logo are permitted if there is any deviation in these. In fact, the importer can submit the rectified labels in advance to FSSAI with a special request.
Foods for IEM disorders will not be required to have the special BIS certification as these products are customized to address the specific needs arising from specific IEM disorders. IEM foods do not have to follow the pack sizes as prescribed in the Second Schedule of Legal Metrology (Packaged Commodities) Rules 2011. These foods will be permitted to be imported only from the Delhi and Mumbai ports so as to enable a smooth clearance.