FSSAI Issues Directions Regarding Inborn Errors of Metabolism Conditions

The FSSAI has issued directions dated 30 June, 2021 regarding Inborn Errors of Metabolism (IEM) conditions. Here FSSAI has drawn reference to its earlier directions dated 19 January, 2021 regarding import and manufacturing of foods required for management of Inborn Errors of Metabolism (IEM) and Hypoallergenic Conditions which is applicable up to 30 June 2021.

The standards for Foods for Infants for IEM and Hypoallergenic infant milk substitutes are now notified under the Food Safety and Standards (Foods for Infant Nutrition) Regulations 2020, which shall come into force on the date of their publication in the Official Gazette and Food Business Operators shall comply with the provisions of these regulations by 1 July 2021. However, the FSSAI has extended the date for compliance of the said regulations up to 1 April 2022.

Since the date of compliance of Food Safety and Standards (Foods for Infant Nutrition) Regulations 2020, having standards for IEM has been extended to 1 April 2022 and earlier direction is only up to 30 June 2021, the FSSAI has decided to allow import of foods for IEM conditions, as listed in Annexure-1 till 31 March 2022, under the following conditions.

1. The importing firm would submit to the FSSAI, well in advance, all the necessary documents related to the composition, label claims for the product they intend to import. FSSAI, after due examination, would allow the import of such foods on a case-to-case basis. Once a particular composition, label and claims is permitted by FSSAI for import, future consignments strictly adhering to the requirements can be imported on the basis of this one-time permission.
2. The labels on these foods shall clearly mention the medical conditions for which they have to be used
3. The importer/manufacturer of such foods shall ensure that they are consumed only under the supervision of health care professionals.

The above-mentioned conditions shall also apply to domestically produced speciality food products for which FSSAI shall grant permission after due examination.

Annexure -1

Source : FSSAI