Novel Food – A Dilemma

The Food Safety and Standards Authority of India (FSSAI) first introduced the concept of novel food through the Food Safety and Standards Act, 2006 (FSS Act) and defined it along with the term proprietary food. Food business operators and consumers therefore, till recently, used the terms proprietary food and novel food interchangeably as these kinds of food products were in effect the same.

The FSSAI has however subsequently split the concepts of proprietary food and novel food. In terms of the revised regulations today, these kinds of food products are to exist independently.

The FSSAI has, during the last few months, crystallised the concept of proprietary food products and the regulations in relation to the same and as a consequence these products are now are clearly classifiable.

Novel foods are now being regulated in terms of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. In terms of the aforesaid regulations, the meaning of a novel food is as set out in the FSS Act. The FSSAI, unfortunately, has not amended the FSS Act and novel foods are still defined along with proprietary food retaining the confusion between the two food products. The FSSAI appears to have introduced another level of interpretation difficulties by additionally defining novel foods in the body of the Regulations. Accordingly, one has to now mine through the definitions and meaning of the term in the FSS Act and the Regulations to understand as to whether a product being manufactured would indeed be a novel food.

In addition to the above, the FSSAI has reintroduced requirement of an approval (similar to the earlier approval as was required for proprietary food) in relation to novel food and has stated that no such product can be manufactured or imported into India (for commercial purposes) without the approval of the FSSAI. The application required to be made for this approval and the documents and other details required to be submitted would be specified by the FSSAI from time to time. The FSSAI has however, as on date, not introduced any details in relation to this application.

The FSSAI has unfortunately left a gap in the regulatory framework in relation to innovative foods. Given the lack of clarity, and the reluctance with which the representatives of the FSSAI offer clarifications, a food business operator in relation to such novel foods, is today confronted with a dilemma of either running afoul of the law or simply staying away from such food products. Based on the above, we feel that the FSSAI must understand the difficulties being faced by such food business operators in view of the ambiguous regulations in relation to such food products. It would really help the food industry if the FSSAI could simplify the procedure and process involved in the manufacture of novel foods, as it recently did in relation to proprietary food products.