Top questions on Food Safety & Licensing; Answered by FoodSafetyHelpline

Question: Could you please clarify the latest on customs duty applicable on Vitamins & Minerals – are the all coming under the broader title of Supplements?? Also, are new product approval registrations required with FSSAI for standard vitamins and minerals ‘products? Do Standard Vitamins and Minerals sold as dietary supplements will NOT require product approval registration with FSSAI if there are similar products in the market?? Nor will they require DCGI approval – correct? For instance, products we plan to import and market under our own brand name are very similar to other imported products such as Nature’s Bounty – also being imported from USA.

Answer: Vitamins & Minerals have been defined under Section 22 of the Food Safety & Standards Act, 2006, which requires product approval. Section 22 of the FSS Act covers Vitamins & Minerals as; minerals or vitamins or proteins or metals or their compounds or amino acids (in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits). Vitamins & Minerals have been allowed to be used in foods such as health supplements, dietary supplements etc. under the Food Safety & Standards Regulations but the prior approval of the authority is required to be taken before the manufacture, import, sale/distribution of such food products.

Food products like Dietary Supplements, Health Supplements, Nutraceuticals etc are regulated under Section 22 of FSS Act and the prior approval of the food authority is required to be taken before these are made available for sale in India. One has to take consent byapplying through the product approval process but relatively it would be easier to take approval if the safety assessment data of the food product along with the reference from global recognized organizations is being submitted with the application.

Question: We have a Cold Store at Kundli in Haryana. We have a License under FSSAI Act 2006. My quarry is do we have to submit Annual Return in Form D-1..We don’t manufacture any thing just store fresh fruit.

Answer: Last Year, The Food Safety & Standards Act, Rules & Regulations specified that only the food manufacturers, labellers, packers, re-labellers and re-packers and importers will be required to file their annual return. Rest all food businesses have been exempted from this.

Question: What is normal time line application for food product registration.

Answer: No time lines defined by FSSAI.

Question: Sugar, milk solids are plant and animal origin, so will these be covered under Form 1 (b) of Product Approval?

Answer: These are not considered as plant & animal origin, so, not covered under Food product approval system.

Question: For product approval what are the important parameters mandatory for the label and product approval.

Answer: The label should should be according to the packaging & labelling regulations.

Question: If my company is doing marketing only and product is manufactured by some other company in India, what approval should I have?

Answer: You also have to obtain a license/registration under Food Safety & Standards Act, Rules & Regulations for the marketing of the food product. If the product falls under the category defined Section 22 of the Food Safety & Standards Act, then the brand owner of the food product has to apply for the product approval.