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Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary uses, Foods for Special Medical Purposes, Functional Foods, and Novel Foods) Regulations, 2016
Local Title:
/
Country/Region:
India
Competent Authority:
Food Safety and Standards Authority of India
Type:
Regulation
Status:
In force
Release Date:
2016-12-23
Implementation Date:
2018-01-01
Applicable Scope:
Health food
Document
Language Source Title Access
IN
Official Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary uses, Foods for Special Medical Purposes, Functional Foods, and Novel Foods) Regulations, 2016
EN
Official Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary uses, Foods for Special Medical Purposes, Functional Foods, and Novel Foods) Regulations, 2016
Summary

This regulation is applicable to health supplements, nutraceuticals, foods for special dietary uses, foods for special medical purposes, functional foods, and novel foods. 

Content

1 Short title and commencement

2 Definitions

3 General requirements

4 Claims

5 General principles for query or challenge

6 Health supplements

7 Nutraceuticals

8 Food for special dietary use, other than infants, and those products intended to be taken under medical advice

9 Food for special medical purpose

10 Food with added probiotic ingredients

11 Food with added prebiotic ingredients

12 Special food containing plant or botanical ingredients with safe history of usage

13 Novel food

Schedule-1  List of vitamins and minerals and their components

Schedule-2  List of amino acids and other nutrients

Schedule-3  Values for vitamins, minerals and trace elements allowed to be used in food for special dietary use and food for special medical purpose (other than those intended for use in infant formula)

Schedule-4  List of plant or botanical ingredients

Schedule- 5A  List of food additives for health supplements, nutraceuticals and food with added probiotics and prebiotics

Schedule- 5B  List of food additives for food for special dietary use and food with added probiotics and prebiotics

Schedule- 5C  List of food Additives for foods for special medical purpose (other than those products intended for foods for  infants) and food with added probiotics and prebiotics

Schedule- 5D  List of food additives for foods for special medical purpose (other than those intended for infant foods); formula  for slimming purpose and weight reduction and food with added probiotics and prebiotics  

Schedule- 5E  List of food additives to be used (at GMP levels)

Schedule- 5F  List of food additives to be used in formats such as tablets, capsules and syrups  

Schedule- 6  List of ingredients as nutraceuticals

Schedule- 7  List of strains as probiotics (live micro-organisms)

Schedule- 8  List of prebiotic compounds  

History
2021-09-29
2021-09-08
2016-12-23
Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary uses, Foods for Special Medical Purposes, Functional Foods, and Novel Foods) Regulations, 2016
In force
Release Date: 2016-12-23
Implementation Date : 2018-01-01
User Guide