FSSAI responds to a few FAQs on Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food Regulations

FSSAI responds to a few FAQs on Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food Regulations

July 2, 2018 Manufacturing, OPS, states 0

The Food Safety and Standards Authority of India (“FSSAI”) has lately responded to several Frequently Asked Questions (“FAQs”) on the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 (“Regulations”).

Few important FAQs have been listed below:

1. What is the date of compliance of these regulations?

Ans: Food Business Operator shall comply with all the provisions of these regulations by January 1, 2018.

2. What is the scope of these regulations?

Ans: These regulations will be applicable to food covered under the following categories:

i. Health Supplements
ii. Nutraceuticals
iii. Food for Special Dietary Use (FSDU)
iv. Food for Special Medical Purposes (FSMP)
v. Food with added Probiotic ingredients
vi. Food with added Prebiotic ingredients
vii. Specialty Food containing plant or botanical ingredients with safe history of use
viii. Novel Food

3. What are the packaging and labelling requirements for products covered under these regulations?

Ans: In addition to the specific labelling requirements under these regulations, the products shall also comply with the Food Safety and Standards (Packaging and Labelling) Regulations, 2011.

4. Is there any change in the import requirement of products covered under these regulations?

Ans: No. Import requirement will remain the same as that of standardized foods. Import of products complying with these regulations shall be allowed in accordance with the Food Safety and Standards (Imports) Regulations, 2017.

5. Is there any change in the licensing requirement of such products?

Ans: No. Licensing requirement will remain the same as that for standardized foods. License for products complying with these regulations shall be granted for the food category as requested by the FBO in the application form in accordance with the FSSR licensing regulation without any requirement of product approval except novel foods.

6. Does FBO need to submit any documents regarding purity criteria?

Ans: The FBOs need to submit information on the purity criteria at the time of application for license or when demanded by the Food Authority.

7. Whether prior approval of FSSAI is needed to make claims under these regulations?

Ans: (i) the claims other than the ones listed under regulation 4 which are not drug claims;
(ii) claims where scientific evidence does not exist or if novel ingredient is to be introduced; and
(iii) product led health claims,
need prior approval of the Food Authority by submitting the relevant documents as mentioned under regulation 4 of these regulations.

However, nutrition and nutrient content claim can be made without any prior approval of FSSAI, in respect of foods that fall under these regulations. Such content claims would need to be based on supporting data related to that food and the content of nutrient or nutrition.

Source: Food Safety and Standards Authority of India

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