Novel Food Regulations: Approval Process and Market Trends

What is novel food

A food that meets one of the following criteria:

• Humans may not have consumed it in the past, or it may not have been consumed in the area or nation of interest.
• It may not have a history of consumption of the ingredients or its source.
• It may also have been obtained through novel technology or inventive engineering techniques. This process may alter the food’s or its ingredients’ size, composition, or structure, changing its nutritional value, metabolism, and characteristics.

How to know whether a process used for making a Novel Food is novel or not

• A food is deemed to have undergone a significant alteration (apart from natural variation) when it has been produced, prepared, preserved, or packaged using a method that has never been used before.
• A process is not considered novel if it results in no appreciable changes to the end products’ structure or composition that impact their nutritional content metabolism.

Risk Assessment Process for Novel Foods

A decision tree gives a step-by-step overview that emphasizes the crucial details required for a thorough evaluation of the safety of novel foods. Individuals can distinguish between novel and traditional foods using a decision tree based on their safety records.

Evidence or reference to prove historical use of the product

• To determine if a specific product (food) has a “history of safe use” as food or food source, one can refer to several databases. Reports from national food surveys and international, regional, and national surveys of ingredients or source used in food are among them.
• When describing a “history of safe use,” the data should ideally be legible and dependable (such as regulatory documents, peer-reviewed scientific publications, Pharmacopoeias, and expert opinions from the scientific committee).

The requirement to conduct clinical trials for novel foods

• Clinical trials are not always required for all novel foods; this will depend on how the ingredient or substance is characterized for any particular risk and how safe the level of consumption is, considering vulnerable populations. To guarantee consumer safety, a thorough risk assessment of novel foods must be completed before approval.
• Once the novel food is approved, post-market surveillance can be carried out as needed. This offers a way to verify that actual intakes are within the expected range and that no unanticipated effects occur when a large population, comprising individuals with a diverse genetic makeup and those with illnesses, is exposed for potentially extended periods.
• To establish safety in the Indian population, clinical trials are determined by the scientific committee on a case-by-case basis. These trials must be conducted as per the ICMR’s guidelines.

How to apply

• The application for a novel food approval must be submitted under the guidelines provided in the “Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017”. The applicant must apply per FORM-I of these regulations to the Food Authority, with the required documents and government fees.
• While preparing the application, scientific data and information pertinent to the food should be gathered with consideration for the four stages of risk assessment (exposure assessment, hazard characterization, hazard identification, and risk characterization).
• The Food Authority may either approve or reject the application, as per FORM-II, based on the safety assessment of the novel food.

Conclusion

Novel foods do not have a history of consumption, are derived from unfamiliar ingredients or sources, or have been produced through new technologies that significantly alter their composition, structure, or nutritional value.

To determine if a process used in creating a novel food is novel, one must evaluate whether it causes significant changes to the food’s structure or composition. The application for novel food approval must follow the guidelines set forth by the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, including submitting relevant scientific data and information.

The Food Authority will decide on the approval based on a comprehensive safety assessment, ensuring consumer protection before the food enters the market.