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FSSAI issues draft FSSR on health supplements, nutraceuticals, novel foods
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Monday, 03 August, 2015, 08 : 00 AM [IST]
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Ashwani Maindola, New Delhi
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fiogf49gjkf0d Food Safety & Standards Authority of India (FSSAI) has issued draft Food Safety and Standards Regulations for Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods, and Novel Foods.
These regulations have defined such food on essential composition, labelling, usage of additives, contaminants and toxins, besides claims on health and nutritional values. The regulations further ask every such package of food or health supplements to carry the words ‘food or health supplement’ and the term ‘not for medicinal use’prominently on the label.
This will ensure that the manufacturers cannot sell such products as medicines.
The regulations shall be taken into consideration after the expiry of a period of 60 days from the date of publishing in the official gazette and by that time the companies could present their views to the food regulator.
According to FSSAI, the regulations shall come into force with effect from the ensuing January 1 or July 1 of the year, as the case may be, subject to a minimum of 180 days from the date of final notification of these regulations in the Official Gazette.
However, industry insiders say that these regulations should not carry labelling norms with them and instead there should be separate labelling norms or regulations. “Such ruling by FSSAI will make things complicated, as the FBOs have to go through different regulations for different food category while the FSSAI will also find it difficult to do amendment if need arises in future,” stated one industry representative.
Draft regulations, general conditions for manufacture and sale of foods
(1) No person shall manufacture, pack, sell, offer for sale, market or otherwise distribute or import any food products referred to in these regulations unless they comply with the requirements laid down under these regulations.
(2) The formulation of the foods shall be based on sound medical or nutritional principles and supported by validated scientific data, wherever required.
(3) No hormones or steroids or psychotropic ingredients shall be added in these foods.
(4) The labels shall clearly mention the purpose, the target consumer group and the physiological or disease conditions which they address, apart from the specific labelling requirements as mentioned against each type of food.
(5)The labels, accompanying leaflets /or other labelling and advertising of all types of foods, referred to in these regulations shall provide sufficient information on the nature and purpose of the food as well as detailed instructions and precautions for their use and the format of information given shall be appropriate for the person for whom it is intended.
(6) A food, which has not been particularly modified in any way but is suitable for use in a particular dietary regimen because of its natural composition, shall not be designated as “Food Supplements” or “Special Dietary” or “Special Dietetic” or by any other equivalent term and such food may bear a statement on the label that “this food is by its nature “X” (“X” refers to the essential distinguishing characteristic as demonstrated by generally accepted scientific data) and such statement does not mislead the consumer.
(7)The Food Authority may suspend or restrict the trade of such foods as have been placed in the market that are not clearly distinguishable from foods for normal consumption nor are suitable for their claimed nutritional purpose, or may endanger the human health.
(8) The Food Authority may, at any time, ask a Food Business Operator manufacturing and selling such special types of foods to furnish details regarding the history of use of the nutrients added or modified and their safety evaluation.
Definition of such food as per draft regulations
(a) Foods containing prebiotic ingredients means foods that contain approved prebiotics and are a non-viable food component which confers a health benefit to the consumer by modulation of gut micro biota.
(b) “Foods containing Probiotic Ingredients” means foods with live microorganisms beneficial to human health, which when ingested in adequate amounts (as a single strain or as a combination of cultures) confer one or more specified/or demonstrated health benefits in human beings; and the microorganism strain used in these foods shall be deemed to possess probiotic property when it is capable of surviving passage through the digestive tract, and has the capability to adhere and proliferate in the gut and be able to confer a physiological benefit.
(c) “Foods for Special Dietary Uses (FSDU) (other than infants, and those to be taken under medical advice)” (i) means and includes the foods specially processed or formulated to satisfy particular dietary requirements which may exist or arise because of certain physiological or specific health conditions like low weight, obesity, diabetes, high blood pressure and foods like gluten-free foods, etc. and these foods may be taken without medical advice unless otherwise stated; (ii) do not include the normal foods which are merely enriched or modified with nutrients and meant for mass consumption, intended for improvement of general health and are meant for day to day use and do not claim to be targeted to consumers with specific diseased conditions and also these not include the foods intended to replace complete diet covered under Food for Special Medical Purpose in these regulations.
(d) “Food or health supplements” means the foods which are intended to supplement the normal diet of a person, and which are concentrated sources of one or more nutrients, like minerals, vitamins, proteins, mineral complexes, amino acids or enzymes, other dietary substances, plants or botanicals, substances from animal origin or other similar substances with known and established nutritional or beneficial physiological effect, and which are presented as such and are offered alone or in combination, but are not drugs as defined in the Drugs and Cosmetics Act, 1940, and the rules made thereunder.
(e) “Foods for Special Medical Purposes (FSMP)” means (i) the foods intended for particular dietary uses specially processed or formulated and intended for the dietary management of patients and shall be used only under medical advice and they are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by foods for specific nutritional use, or a combination of them; (ii) include the foods specially prepared for weight reduction and intended as total replacement of normal diet.
(f) “Nutraceuticals” means a naturally occurring chemical compound having a physiological benefit or provide protection against chronic disease, isolated and purified from food or non-food source and may be prepared and marketed in the food-format of granules, powder, tablet, capsule, liquid or gel and may be packed in sachet, ampoule, bottle, etc. and to be taken as measured unit quantities.
(g) “Novel Foods” means the food that does 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 or foods or has ingredients obtained by new technologies or processes and includes the foods and food ingredients which have been produced by a new technology with innovative engineering processes, where the process gives rise to significant changes in the composition or structure or size of the foods or food ingredients which affect the nutritional value, metabolism or level of undesirable substances and not apply to any reformulation of food products produced from the existing food ingredients by altering the composition, percentage or amounts of food ingredients and additives.
(h) Specialty Foods containing ingredients based on Ayurveda, Unani and Siddha and Traditional Health Systems of India means the foods which are shown to be safe by science-based evidence and health uses referred in the authoritative texts (books of Schedule I of the Drugs and Cosmetic Act, 1940) and other standard texts (History of evidence based use and not for curative purposes).
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