FSSAI issues directions regarding operationalization of Standards for Nutraceuticals

Sometime back the FSSAI had framed 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. The draft regulations had been made public on 11 September 2015 and FSSAI had invited objections and suggestion. FSSAI had taken into consideration the objections and suggestions while framing these regulations. These regulations were to come into force in January 2018.

The FSSAI has now given directions for operationalization of these standards as of 24 November 2016. These regulations have yet not been published in the Official Gazette as they are being translated into Hindi. The translation will take some time therefore the FSSAI has decided to operationalize these regulations with immediate effect.

In 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 the FSSAI has defined the terms

• Food for special dietary purpose
• Food with added prebiotic ingredients
• Food with added probiotic ingredients
• Functional foods
• Health supplements
• Non-food
• Novel food
• Nutraceuticals
• Nutritional ingredients/pre-mixes
• Speciality food containing plant or botanical ingredients

The following is a summary of the regulations

• The FSSAI states that articles of food sold in the form of capsules, tablets, syrups, hard, soft or vegetarian will need to comply with the general monograph and quality requirements as specified in the Indian Pharmacopoeia, British and US Pharmacopoeia.
• These foods may contain approved colours, permitted additives, natural, nature identical, or synthetic flavours as provided in FSSAI regulations.
• Nutrients must not exceed the recommended daily allowance as specified by ICMR. FSSAI has also laid down the percentage of nutrient content in case of health supplements.
• In absence of standards the standards in the Codex Alimentarius Commission will apply for these foods.
• The formulations of the articles of food must be based on the principles of sound medicine or nutrition and supported by validated scientific data. The foods must not contain hormones, steroids and psychotropic ingredients.

The labelling requirements 

The labelling requirements must be in accordance with the Food Safety and Standards (Packaging and Labelling) Regulations 2011 and some other requirements as mentioned below. The labels on these foods must specify the

• purpose of the food
• target consumer
• physiological or disease conditions which they address
• recommended duration of use
• The label or accompanying leaflet must contain sufficient information on the nature and purpose of the food and detailed precautions for its use

According to these regulations, FSSAI may suspend or restrict the sale of these articles of food if they

• cannot be distinguished from those articles of food that are manufactured for normal food consumption
• are not suitable for their claimed nutritional purpose
• may endanger human health
• The FSSAI may also asks FBOs manufacturing these articles of food to provide details about the history of use of the novel or modified ingredients added as well as their safety evaluation

Health claims may be made on health related benefits of these foods as

• Functional claims of nutrient or nutritional ingredients
• Enhanced functional claims
• Disease risk reduction claims
• Health maintenance claims
• Immunity claims and increased resistance
• Anti-ageing claims

All these claims may be made only if there is scientific literature available including official traditional texts, post market data or consumer studies or cohort or retroactive studies based on eating pattern and health benefits, epidemiological and national data and other documented evidences, validity studies.

Besides these general principles the FSSAI has also individually prescribed regulations and stated for what purpose the foods will be used and their specific labelling requirements.

1. Health supplements are to be used to supplement the normal diet of a person above the age of five years
2. Nutraceuticals are to be used for providing physiological benefits and to help maintain good health
3. Food for special dietary purpose is food used for particular dietary requirements or specific health conditions like

• Low weight, obesity, diabetes, high blood pressure
• For pregnant and lactating mothers
• Geriatric population and celiac disease and other health conditions

4. Food for special medical purpose must be used for special medical purposes like weight reduction or used as oral replacement of normal diet.
5. Food with added probiotic ingredients must contain only those ingredients that are specified in Schedule VII for probiotic cultures of the microorganisms.
6. Food with prebiotic ingredients must be as per those specified in Schedule VIII or those prebiotics approved by FSSAI
7. Speciality food containing plant or botanical ingredients with safe history usage must use plant or botanical ingredients specified in Schedule IV
8. Novel Food is food or ingredient that may or may not have a history of human consumption or food that has been obtained with new technology with innovative engineering process.

Schedules 

The FSSAI has made eight schedules that contain exhaustive lists of ingredients and additives that can be used in foods mentioned in these regulations. These additives and ingredients are not meant for use in infant formula

• Schedule I of these regulations contains a list of vitamins and minerals and their components
• Schedule II contains a lists of amino acids and other nutrients
• Schedule III contains values of vitamins, minerals and trace elements allowed to be used in foods for special dietary use and foods for special medical purposes but not intended for use in infant formula
• Schedule IV lists the plant and botanical ingredients
• Schedule VA contains the list of food additives for health supplements, nutraceuticals and food with added probiotics and prebiotics
• Schedule VB contains the list of food additives for foods for special dietary use and food with added probiotics and prebiotics
• Schedule VC contains the list of foods for special medical purposes and food with added probiotics and prebiotics
• Schedule VD contains the list of food additives used for foods for special medical purposes, formula for slimming purpose and weight reduction and food with added probiotics and prebiotics
• Schedule VE lists food additives to be used at GMP for all foods in this regulation
• Schedule VF lists food additives to be used in formats like tablets, capsules and syrups in all foods mentioned in these regulations
• Schedule VI contains a list of nutraceutical ingredients
• Schedule VII lists the strains as probiotics (live micro-organisms)
• Schedule VIII contains a list or prebiotic compounds

To view the original: fssai.gov.in