FSSAI Issues Rules for Functional Foods and Health Supplements
SAFEGUARDS | Food NO. 196/16
On November 24, 2016 Food Safety and Standards Authority of India (FSSAI) issued its rules on health supplements, nutraceuticals, foods for special dietary use, food for special medical purpose, functional food and novel food . These rules will be enforced January 1 2018.
Plants and botanicals, as specified in this rule, and foods and ingredients referred to in Food safety and Standards Regulations 2011 offered in normal or naturally occurring forms, even if cooked or as a juice, shall not be considered a health supplement or nutraceutical, or food for special dietary use or food for special medical purpose. One must add a vitamin, mineral, etc. to these foods to be classified as such. For the categories to which this applies, the quantity of the nutrients added must not exceed the recommend daily allowance (RDA) as set by the Indian Council of Medical Research and if not specified by the council, then standards from Codex Alimentarius Commission shall apply. All labels must specify the purpose, the targeted consumer, what condition the product will affect, the usage amount and length of usage, instruction for use, precautions, side effects and known drug interactions. For compliance purposes the amount will have to be within 10% of that declared. Claims must be support by scientific evidence.
This is defined as a product that supplements the diet of a person over the age of five. The health supplement is to be amino acids, enzymes, minerals, proteins, vitamins or other dietary substance that provides a nutritional or beneficial physiological effect. The product must not exceed the RDA or Codex maximum levels. The label must list a percentage of that level and a warning “Not to exceed the recommended daily usage”. The label must state “health supplement”, “Not for Medicinal use”, necessary warnings and precautions, and that this is to be kept out of reach of children.
The nutraceutical shall provide a physiological benefit and help maintain good health. Nutraceuticals are listed in schedule VI of this rule. To sell a nutraceutical that is not listed in this rule proof will have to be submitted to the FSSAI that it is safe and effective for the level and function proposed, prior to its sale in India. The label must state “nutraceutrical”, “not for medicinal use”, declare the common name of the nutraceuticals and the amount of each nutraceutical, and have the same precautions and warnings as noted for health supplements.
Foods for Special Dietary Use
These are foods that are specially processed or formulated for a certain physiological or specific health condition, such as low weight, obesity, diabetes, high blood pressure, pregnant and lactating women, geriatric population, celiac disease or other health condition. The label must state if the product is to be taken under medical advice or not. These are not to be normal foods for general consumption, intended for general health, or for day to day use that are just enriched or modified for that purpose. For slimming products, specific levels of energy and protein have been established. These are to be labeled as “food for special dietary use” followed by food for the specific condition. If for weight control it must state, close to the name, “for weight control and management”. The label must have the required warnings, precautions and instructions.
Food for Special Medical Purpose
This category includes foods specially prepared for weight reduction and intended as a total replacement for a normal diet, but it does not apply to infant foods. If nutritionally complete, a product must state “Nutritionally complete”. The label must state “food for special medical purpose” near the name or brand. The label will have an advisory warning in bold letters “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY”. Advertising of these foods for use by the general public is prohibited.
This includes foods with added probiotic, prebiotic, safe plant or other botanical ingredients. Probiotic ingredients are those microorganisms listed in Schedule VII and must have a viable number of organisms added that are equal to or greater than 100 million colony forming units per gram. Labels must list the culture or culture collection, viable numbers of organism, as applicable at the end of a product’s shelf life. Prebiotic substances are those listed in Schedule VIII and plant and botanical ingredients are those listed in Schedule IV. The benefits of the ingredients added must be listed, as well as instructions, usage and applicable warnings/precautions, if any. Prebiotics and probiotics must state that near the name or brand. Other ingredients can be approved if evidence of 15 years of safe and effective use in India is provided to the FSSAI for approval, and evidence of 30 years safe use from any other country of origin.
Foods that may not have a history of human consumption, ingredients that are derived from a food that may not have a history of human consumption, or a food or ingredient obtained by a new technology that provides some physiological or beneficial effect on humans. Prior approval from the FSSAI is required before novel foods can be manufactured, imported or sold in India.
What Does This Mean For The Food Industry?
Since there is no consistency between each country’s labeling approach one must rely on food labeling experts that know the difference between what is required and allowed in each country.
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