FSSAI Approval For Non-Specified Food & Food Ingredients First Amendment Regulations 2022

Regulatory amendments for approving 'non-specified' food products have been notified by the Food Safety and Standards Authority of India (FSSAI) 2022. Food businesses can appeal against the decision to reject their applications within the deadline set by the regulation.

A Food Business Operator can appeal a rejection of an application to the Chief Executive Officer (CEO) within 30 days of receiving the rejection letter, according to the regulations. Any delay beyond 30 days will be allowed, with reasons to be spelled out in writing by the Chief Executive Officer. The Chief Executive Officer will dispose of such an appeal within 30 days of receipt. The Chief Executive Officer can allow the appeal after 30 days if there's a good reason.

As a result of the decision of the Chief Executive Officer of the Food Authority, a Food Business Operator who feels aggrieved may file a review petition with the Chairperson of the Food Authority within 30 days of the appellate order being issued. Upon receipt of such review, it shall be resolved within 30 days. Any delay beyond that period shall be justified with written reasons. As long as there are sufficient reasons for the delay, the Chairperson may allow the appeal after 30 days.

Prior approval is granted according to these regulations, which prescribe the approval form 'Form-1'. In addition, the Food Authority has asked food businesses to provide post-market surveillance data on the 'non-specified' food products.

A Food Business Operator shall conduct post-market surveillance on relevant safety and efficacy parameters within one year of placing the product on the market whenever requested by the Food Authority after the Food Authority has approved the product. The regulations notified by the FSSAI state that

The Form-1 requires the food businesses to detail the type of food (whether it was a novel food product, novel food ingredient or processed using novel technology), additive not listed by the FSSAI, new processing aid/enzyme, new botanical, new fruit, probiotics & prebiotics, etc.

What Is the Process for Obtaining FSSAI Approval?

• The process for obtaining FSSAI approval for non-specified food and ingredients begins with applying to the Authority
  
• The application must be accompanied by a fee as specified in the regulations and must contain the following information:
• Name and address of the applicant;
• Description of the food or food ingredient;
• Intended use of the food or food ingredient; and
• Any other information as may be prescribed

To get approval, food businesses must provide all documentation detailing the safety of their products within 30 days if clarification is needed. The FBO can appeal against any rejection decision by the Food Authority. FBOs can file a review petition if they're still upset about the decision of the Chairperson, Food Authority so that the Food Authority can consider it at their next meeting. For reasons spelled out in writing, the Food Authority can suspend or revoke any approval given to an FBO.

An FBO must also submit supporting documents, including scientific studies that involve human interventions or human clinical studies, for the functional benefits of their products, such as health benefits. The FSSAI defines a novel food as something that doesn't have a history of human consumption or may have ingredients or sources that were never used before. Foods or ingredients that humans haven't consumed; or food or ingredients produced with cutting-edge technology and innovative engineering processes, where the process changes the composition, the structure or the size of the food or food ingredients, which may change nutrition, metabolism, or levels of bad stuff.

How Will These Regulations Impact the Food Industry?

The FSSAI has published the draft of the first amendment to the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations.

• The proposed amendment will impact the food industry in the following ways:
• It will bring more food products and ingredients under the purview of these regulations
• It will make it mandatory for food businesses to seek approval from the FSSAI for any new food product or ingredient they wish to introduce
• It will provide a level playing field for all food businesses, regardless of size or turnover
• It will ensure that only safe and quality food products are made available to consumers.

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