The Food Safety and Standards Authority of India vide its notification dated 29th October 2020 has published the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Amendment Regulations, 2020 which shall come into force with effective date for implementation to be either 1st January or 1st July subject to a minimum of 180 days from the date of their final publication in the official Gazette.
Key Highlights from the amended rules:
- As per the amended rules, the article of food sold in capsule format hard or soft or vegetarian, shall comply with the General Monograph, wherever applicable and quality requirements specified for them in Indian Pharmacopoeia, if applicable.
- The products covered under these regulations for children below the age of 5 years shall be given only under medical advice by physician/ certified dietician/nutritionist.
- Flavours for products covered under these regulations may be used in accordance with the provisions of regulation 3.3.1 of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011.
- These regulations shall not apply to the infants of the age group 0 to 6 months.
- Any products which are to be sold as Health Supplement/Nutraceutical/Specialty food containing plant or botanical ingredients with safe history of usage/food with added probiotic ingredients/ food with added prebiotic ingredients for the age above 6 months till 24 months is not permitted without prior approval of the Food Authority
- Food for Special Dietary Use, other than infants, and those products intended to be taken under medical advice of
- physician/ certified dietician/nutritionist.
- A food business operator may formulate an article of food for special dietary use in formats meant for oral feeding through enteral tubes but shall not be used for parenteral use, Provided that Food for Special Dietary Use for Sportsperson shall only be in formats meant for oral consumption.
