The Food Safety and Standards Authority of India on 6th September 2021 has published the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) first Amendment Regulations, 2021 which shall be effective from 6th September 2021 and the Food Business Operator shall comply with all the provisions of these regulations with effect from 1st April, 2022.
As per regulation 3 the articles of food sold in capsule format, hard or soft or vegetarian, shall comply with the general monograph and quality requirements specified for them in Indian Pharmacopoeia.
As per the amendment, regulation 3(21) states that, The combination of vitamins and minerals, including use of single vitamin and mineral, in dosage formats such as tablets, capsules, syrups, at levels equal to a maximum of one Recommended Dietary Allowances or below shall be covered under these regulations.
Further, these regulations shall not be applicable to infants up to the age of 24 months. Foods intended for infants up to the age 24 months are specified under the Food safety and Standards (Food for infant nutrition) Regulations, 2020. The products covered under these regulations intended for children 2 to 5 years of age shall only be given under medical advice by any physician or certified dietician or nutritionist.
Products covered under these regulations may also contain such additional ingredients, other than additives, which are either standardized or permitted for use in preparation of the other standardised foods as specified in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.
As per regulation 3(32) the food business operator may use water, ethyl alcohol or hydro alcoholic process of extraction for obtaining plants or botanicals extract used in the products covered under these regulations.
Further the Food business operator shall seek approval of the claims for the ingredients or products covered under these regulations as per the Food Safety and Standards (Advertising and Claims) Regulations, 2018.”
The food business operator shall add the quantity of the nutrients at levels equal to a maximum of one Recommended Dietary Allowances or below.
Provided that product with higher Recommended Dietary Allowances in food format (except tablet, capsule, syrup) may be allowed subject to prior approval of the Food Authority which shall be based on adequate scientific evidence.
