FSSAI has proposed draft regulations relating to Nutraceuticals, Functional Foods, Novel Foods and Health Supplements. These draft regulations will be finalized as soon as all the comments are received by FSSAI from all stakeholders within the stipulated time limit (sixty days from the date of publish of these draft regulations) and incorporated. After this, the final notification will be issued in the Official Gazette of India and the regulations shall come into force w.e.f. the subsequent 1st January or 1st July of the year subject to a minimum 180 days from the date of final notification.
Once notified, these regulations will be called Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical purpose, Functional Foods, and Novel Food) Regulations, 2015.
The Food Industry has been asking the FSSAI for regulatory standards and these proposed guidelines are a step in the right direction. This will to a large extent remove the need for going through the product approval process. It will also help to see a higher degree of growth in the nutraceutical, supplementary and functional food industry, which is the need of the hour.
FSSAI will finalise the standard guidelines after taking into consideration the suggestions and comments of all stakeholders. Some of the main points in the proposed standards are as under:
FSSAI has defined the various categories of all such foods and has proposed that the foods may not be termed medicines. The foods have been categorised as;
- Foods containing prebiotic ingredients which are foods with live micro-organisms beneficial to human health, which when ingested in adequate amounts demonstrate health benefits.
- Foods for Special Dietary Uses (FSDU) are not meant for infants and which need to be taken under medical advice for specific health conditions like low weight, obesity, diabetes, high blood pressure and foods like gluten free foods.
- Foods for Special Medical Purposes (FSMP) are foods intended for particular dietary use specially processed or formulated and intended for patients with dietary needs
- Nutraceuticals means a naturally occurring chemical compound having a physiological benefit or provide protection against chronic disease.
- Novel Foods have been defined as foods that do not have a history of human consumption or has any other ingredient used in it which or the source from which it is derived does not have a history of human consumption as a food ingredient
- Specialty foods are those that contain ingredients based on Ayurveda, Unani and Siddha and Traditional Health Systems of India and are proven to be safe based on scientific evidence and health uses referred in the authoritative texts
Besides defining the foods, FSSAI has proposed that all such foods are required to be based on sound medical and nutritional evidence backed by science. The foods may not contain any steroids and psychotropic ingredients. If the nutraceuticals contain vitamins and minerals, the quantity of the nutrients will not exceed the Recommended Daily Allowance for Indians as laid down by the Indian Council of Medical Research. The RDA is also proposed for ingredients like cow’s milk, buffalo’s milk, camel’s milk, ghee, curd, butter, honey, gold, gold foil, silver, pearl in ayurveda, siddha and unani products,
Detailed labelling requirements have been proposed for each category of food. However, FBOs will need to follow the packaging and labelling requirements as laid down under the Food Safety and Standards (Packaging and Labelling) Regulations, 2011. They will also clearly mention on the label the target consumer group the food is meant for and what disease or physiological condition they address. The leaflets and all advertising will provide full and sufficient information on the nature and purpose of the foods as well as precautions if required.
The foods must also mention an upper safe level of ingredients. According to the category the labels must mention what category of food it is. For example every package of Health Supplement shall be labelled ‘FOOD or HEALTH SUPPLEMENT’ in addition the words ‘NOT FOR MEDICINAL USE’ shall be prominently written on the label. Nutraceuticals should have the term NEUTRACEUTICAL on every package and Probiotic foods will mention ‘PROBIOTIC FOOD” and all categories of foods must mention that “This product is not intended to diagnose, treat, cure or prevent any disease”.
On the other hand Novel Foods and ingredients used in Ayush foods that are not mentioned in regulations will have to go through a product approval process. The FBOs manufacturing these foods will have to furnish details about the product, ingredients used, technology and production process involved and proposed claim or declarations to be made on the label along with sufficient scientific data and documents related to safety and efficacy of the food.
Click Here to view the original notification.
Rahul says
i didn’t get the sufficient information about the food supplement like protein powder
FSH Team says
You can go through the following url – https://www.fssai.gov.in/upload/uploadfiles/files/Nutraceuticals_Regulations.pdf