Food Safety and Standards Authority of India were established under the Ministry of Health and Family Welfare with a mandate for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale, and import, to ensure the availability of safe and wholesome food for human consumption. Under the Food Safety and Standards Act, 2006, and various regulations made thereunder, FSSAI has set standards for different kinds of food products available in India and is in the process of developing new standards and regulations.
To regulate food products that have not been standardized under any regulations, FSSAI has come up with a regulation called Food Safety and Standards (Approval of Non-Specified Food and Food Ingredients) Regulations, 2017. Food business operators are required to apply their product under a regulation. The regulation lays down the procedure for the grant of prior approval of non-specified food and food ingredients whereby food business operators are required to apply as prescribed along with documents and fees. These regulations broadly cover the following articles of food or food ingredients:
The procedure of product approval
Food business operators FBOs like the manufacturer or importer of non-specified food/non-standardized food shall submit an application in FORM – I of these regulations along with necessary documents and fees to the authority.
On receipt of the application from the FBOs, the authority shall scrutinize the information provided in the application. If required the authority may ask the FBO or applicant to submit additional supporting documents, data, or clarifications. After a thorough examination, the authority may either approve or reject the application, as per FORM-II, based on the safety assessment. After receiving the approval, the applicant shall submit a certificate of analysis of the product to the authority. On receiving a rejection, an FBO may file an appeal before the chairperson against the rejection of his application. The Food Authority may suspend or revoke any approval granted to any applicant.
While applying, documents like a certificate of analysis, manufacturing process, in brief, the regulatory status of the ingredients, copy of the agreement, safety Information (documents on risk assessment or toxicity studies) is required. In the case of Novel food or novel food Ingredients or food processed with the use of novel technology, additional specific information like target group for the food, the detailed composition of the product, details of the new technology, safety information, and history of consumption is to be provided. Similarly, applicants applying new additives have to include the chemical name and INS No., purity (food grade or equivalent), Acceptable Daily Intake (ADI) specified by JECFA, or any other risk assessment body, the proposed level of use in the food category.
Food business operators while applying have to comply with the updated guidelines and regulations. In this case, assistance from expert plays an important role in reducing the time to sail through the process.
