1) Online FSSAI License – Introduction
Any person who wants to start a business in the food supplement sector, be it food processing or food manufacturing, packaging or distributing, has to register under Food Safety and Standard Authority of India, FSSAI which comes under Ministry of health and get Fssai License or we can say Food License. FSSAI authority monitors these food supplement operators as per the guidelines and regulations listed in FSSAI Regulation Act, 2006. With expert advice from Raag Consultants, get an FSSAI license or Food License in the quickest 4 simple steps only- · Guidance on choosing the right food license. · Verification of your FSSAI License documents. · Filing your online FSSAI License application. · Get the FSSAI food licence as early as possible.
2) What is Food Supplements as per FSSAI Authority?
FSSAI License for Food Supplements means to provide nutrients to provide all the necessary nutrients and non-nutrient chemicals which are biologically beneficial for human body. Supplement includes proteins, vitamins, minerals, amino acids, and many other substances. At present, there are more than 80,000 dietary supplements available in the market. India is rapidly growing market for supplement industry with a massive market size which stood around USD3-4 billion in 2019. With the increase in purchasing power of customers and changing lifestyles, there has been instant increase in the use of health supplements in India for preventing diseases like Diabetes, Blood Pressure, Obesity, Cardio-Vascular diseases and also for maintaining a balanced nutrition and for enhancing their physical appearance, mental sharpness and to become more dynamic and conscious. Looking at this the FSSAI notified the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, and Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016 in its Official Gazette on 23 December 2016. All the Food Business Operators will need to comply with FSSAI regulations from 1 January 2018. Section 22 of the Act deals with genetically modified foods, organic foods, functional foods, proprietary foods, etc. which also includes supplements. It provides for eight categories of foods are covered under these Regulations: Health Supplements Nutraceuticals Foods for Special Dietary Use Food for Special Medical Purpose Specialty Food containing plants or botanicals Foods containing Probiotics Foods containing Prebiotics Novel Foods These supplementary foods are usually manufactured and sold in the form of powders, tablets, capsules and are required to fulfill the quality requirements and standards specified by the Indian Pharmacopoeia, British Pharmacopoeia or the United States Pharmacopoeia. Use of hormones, steroids and other psychotropic ingredients in such supplements are prohibited. As per the order issued by the FSSAI License Authority dated 16th July 2020, any health supplement and nutraceutical product contains the ingredient name PABA (Para Amino Benzoic Acid) is prohibited and banned from immediate effect. Any food supplement operators or FBOs who are dealing in food supplement which contains the prohibited ingredients should stop trading or selling these products, otherwise Surveillance and enforcement team will take action against them. The nutrients added to the food articles are not supposed to exceed the Recommended Daily Allowance (RDA) as provided by the Indian Council of Medical Research. As per the Indian Council of Medical Research, the food products falling under the category of health supplement, the individual nutrient content shall not be less than 15% of RDA. But, If the product claims to have higher nutrient content, the nutrient content shall not be less 30% of RDA Also the use of colors (natural, nature identical), synthetic flavors and additives are permitted only after complying the Food Safety and Standards (FSSAI) Regulations, 2011. Also, the criteria regarding purity for ingredients used in such supplements shall be as determined and notified in the official Gazette by the Food Authority from time to time. The FBO is required to intimate the purity criteria adopted for ingredients to the Food Authority (FSSAI). Any Change in purity criteria shall be made only after giving a prior intimation to the Food Authority.
3) Packaging and labeling of Supplementary Foods
The labels put on such food packing shall be in accordance with the Food Safety and Standards (Packaging and Labelling) Regulations, 2011 and also comply with other specific labeling requirements required for different types of food as provided in the regulations. The labels affixed to package must specify the following information: · Should have the word ‘HEALTH SUPPLEMENT’ or ‘NUTRACEUTICAL’ · The purpose of the foods and the age group for which they are meant · The contents used in such supplements · An advisory warning ‘NOT FOR MEDICINAL USE’ · A statement saying that the health supplement is not be used as a substitute for diet; · Target consumer group · The disease or disorders for which they are used · Warning, precautions and the manner in which they are to be used · Physiological benefits (only for Nutraceuticals) · Any other specific labeling requirements Apart from this, the leaflet or advertisement for such food Supplements must provide sufficient information for their nature and purpose and provide detailed instructions about its use & precautions to be taken while using it, in such a format that is appropriate for the intended consumer. Before selling such products it is necessary to comply with the Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, 2011. Every FBO contravening these provisions shall be punished under Chapter IX of the Act.