The Food Safety and Standards Authority of India (FSSAI) has planned to allow food businesses to import food products for Inborn Errors of Metabolism (IEM) conditions until June 2021, after which the FBOs need to abide by the notified guidelines.

The FSSAI has issued regulation in this regard stating that previous direction is superseded by this notification, and it has been planned to permit the import of foods products for IEM condition, till 30th June, 2021.

As per the FSSAI, in the absence of the standards, as an interim measure, IEM foods were allowed on the basis of direction under Section 16 (5) of Food Safety and Standards Act, 2006.

“However, the newly notified Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020 includes the standards of Foods for Infants with IEM and Hypoallergenic infant milk substitutes and the same will be implementable from 1st July, 2021. Thus, the direction is made applicable till 30th June, 2021. Thereafter, FBOs including importers are given permission to market these foods in accordance with the specified standards under aforesaid regulations,” FSSAI’s statement asserted.

The FSSAI has also laid condition for the import of such food products, which says that the importing firm, in advance, would submit to FSSAI all the necessary documents related to the composition, label and claims for the product they intend to import. FSSAI after due examination, would give consent to the import of such foods on a case to case basis.

Once a particular composition, label and claims is allowed by FSSAI for import, future consignments strictly adhering to the requirements can be imported based on this on time permission.

The laid condition also added that labels on these foods shall clearly state the medical conditions for which they have to be used. And, the importer/manufacturer of such foods shall make sure that they are consumed only under health care professionals’ prescription.

It is relevant to mention that under Section 16 (5) of Food Safety and Standards Act, 2006 dated 2nd November, 2016 for two years or till their standards are notified, whichever is earlier regarding import and production of foods needed for management of Inborn Errors of Metabolism (IEM) and Hypoallergenic Conditions.

The compliance was extended till 1st May, 2021 or till their standards are notified, whichever is earlier.


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