The Food Safety and Standards Authority of India (“FSSAI”) has issued directions to further re-operationalize provisions of the Draft FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food), Regulations, 2022 (“Regulations”), as the finalisation the Regulations is likely to take some more time before being notified.
The specific provisions which are getting re-operationalized is outlined by FSSAI in the Direction dated 29th March 2022 and Direction dated 10th May, 2022. Some of the compliance obligations have been listed below from the said Directions.
Delivery Format:
- The items in forms such as powders, granules, tablets, capsules, liquids, semi-solids, drops, pills, gummies, jelly, chewable and mouth-dissolving strips, bars, biscuits, candies that are meant to be orally consumed must be packed in specified quantities and durations, unless otherwise restricted for specific categories.
- In case the delivery format is in conventional form (like bar, biscuit or candy), ensure that information on the label does not represent the product as conventional and clear differentiation in this regard is made on the label.
- Prior approval is required if the ingredients deviate from conventional delivery formats, including nano-derived ingredients and modified drug delivery.
Ingredients:
- Approved ingredients, specific to different food categories, will be detailed separately by the Food Authority. Furthermore, for the preparation of other standardized foods, additional ingredients, excluding additives, that are either standardized or permitted are permissible.
- Products covered under these regulations may also contain cereal grains, legumes, fruits and vegetables as mentioned in the latest edition of the Indian Food Composition Tables (IFCT) published by ICMR-National Institute of Nutrition (ICMR-NIN) and spices which are included in the list published by the Spices Board of India either as such or as processed ingredients including extracts.
- Authorization is required for non-specified foods, including novel foods and non-specified ingredients, prior to their use.
Provision for inclusion of ingredients with incident free history of safe use (HoSU):
- Obtain prior approval of FSSAI prior to including ingredients such as plant, botanicals or their extracts which are not provided in the regulations but have documented incident free history of safe use (at least thirty years in the country of origin or fifteen years in India).
- For any other ingredient not falling under the scope of above provision apply for approval of FSSAI as per FSS (approval of non-specified food and food ingredients) Regulations, 2017.
Additives, processing aids and flavours:
- The list of additives/excipients intended specifically for tablet/capsule/syrup/pills format shall be specified separately by the Food Authority from time to time.
- Obtain prior approval of FSSAI under FSS (approval of Non-Specified Food and Food Ingredient) regulations, 2017 before using any additive and processing aid that are not specified under the regulations.
- While using Esters and salts of any mentioned under Additives schedules ensure to comply with the maximum usage level as permitted in product formulations by FSSAI.
Purity criteria for the ingredient:
- Provide information on the purity criteria adopted for ingredients at the time of licensing and any subsequent changes.
- FSSAI shall specific the purity criteria for the ingredients used in the categories of articles of food covered under the regulations from time to time.
Labelling:
- Display the words “HEALTH SUPPLEMENT/ NUTRACEUTICAL/ FOOD FOR SPECIAL DIETARY USE/ FOOD FOR SPECIAL MEDICAL PURPOSE/ PREBIOTIC FOOD /PROBIOTIC FOOD” must be prominently in capital and bold letters in close proximity to the product’s name or brand name. Additionally, essential statements such as “Recommended usage level,” “Duration of usage, where applicable,” and “Not to exceed the recommended daily usage” should be positioned at the front or back of the packaging.
- Provide a declaration detailing the amount of nutrients or substances with a nutritional or physiological effect present in the product. The label, accompanying leaflet, or other forms of labelling and advertisements for each type of food product should provide ample information regarding the nature and purpose of the food item. Include detailed instructions and precautions for use, and the format of information presented should be suitable for the intended use by the consumer.
FSSAI further states that it has been decided to allow the use of additives and GMP table as per Codex in all categories across various formats until the Regulations are notified.
Background:
FSSAI had issued a direction dated 17th November 2023 regarding re-operationalization of certain provisions of the draft FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for pecial Medical Purpose and Prebiotic and Probiotic Food), Regulations, 2022 until 1.01.2024. Now FSSAI has issued the present direction in order to again re-operationalize the provisions of the Regulations with effect from 1.01.2024, as the finalization of Regulations is likely to take some more time before being notified.
A copy of the direction has been hyperlinked below for ease of reference.
Source: Food Safety and Standards Authority of India
