The FSSAI has notified 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 in the Official Gazette on 23 December 2016. These regulations will come into force on their publication in the Gazette of India. However, the FSSAI has stipulated that Food Business Operators will need to comply with these regulations from 1 January 2018.
The regulations cover eight categories of foods and carry detailed requirements about their composition, claims, labels etc. These foods are
- Health Supplements
- Foods for Special Dietary Use
- Food for Special Medical Purpose
- Speciality Food containing plants or botanicals
- Foods containing Probiotics
- Foods containing Prebiotics
- Novel Foods
This category of foods may be manufactured and sold in the form of tablets, capsules and syrups and must fulfil quality requirements and standards as specified in the Indian Pharmacopoeia, British Pharmacopoeia or United States Pharmacopoeia.
The formulation of articles of food shall be based on the principles of sound medicine or nutrition and supported by validated scientific data, wherever required. A mere combination of vitamins and minerals formulated into tablets, capsules or syrup is not food unless vitamins and minerals are added to an article of food based on a food format.
The foods are not permitted to contain hormones, steroids or psychotropic ingredients
The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance (RDA) as specified by the Indian Council of Medical Research. If such standards are not specified, then the standards in the Codex Alimentarius Commission will apply.
The FBOs may use approved colours and additives as permitted in Schedule VF of these regulations, natural, nature identical or synthetic flavours as permitted in the Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011.
Specific labelling requirements
The labelling on the article of food shall be in accordance with the Food Safety and Standards (Packaging and Labelling) Regulations, 2011 and other specific labelling requirements mentioned in each type of food in the regulation which are that the labels must also
- specify the purpose of the foods
- target consumer group
- physiological or disease conditions which they address
- recommended duration of use
- specific labelling requirements as mentioned against each type of article of food
The label, accompanying leaflet or other labelling and advertisement of each type of article of food in these regulations must provide sufficient information on the nature and purpose of the article of food and detailed instructions and precautions for its use and in a format that is appropriate for the intended consumer.
An article of 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 ‘health supplement’ 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’ where ‘X’ refers to the essential distinguishing characteristic as demonstrated by the generally accepted scientific data. The statement must not however, mislead the consumer.
The regulations have been divided into Schedules. The Schedules contain the detailed provisions for the use of vitamins, minerals, amino acids, botanical ingredients, nutraceutical ingredients, food additives, probiotics and prebiotics. One of the schedules has a list of 400 ingredients of plant or botanical origin which can be used as ingredients in the foods that have been covered in these regulations. Any of the ingredients specified in Schedule I, Schedule II, Schedule III, Schedule IV, Schedule VI, Schedule VII, and Schedule VIII may be used in these foods in accordance with the provisions of these regulations, and for the said purpose, may use additives as applicable to categories specified in Schedule VA to Schedule VF.
Nutritional or Health Claims
FBOs may make health or nutritional claim and nutritional claims of ingredients as specified in Schedule I Schedule II, Schedule III, Schedule IV, and Schedule VI. The health claim must be based on
- nutrient or nutritional ingredients
- health related benefits
The health claims on the foods may include the following
- ingredients or nutrient or nutritional function
- enhanced function
- disease risk reduction
- health maintenance claims
- immunity or increased resistance
All health claims must be validated through adequate documentation and on the basis of human studies. If other claims are made they will require the approval of the Food Authority. The FSSAI has also prohibited the use of implied claims for curing diseases or efficacy claims like cure for cancer or prevention of diseases either by name or through pictures, vignettes or symbols, namely, electrocardiogram tracing, and lipid profile.
Restriction on sale or suspension
The FSSAI has also made provision for suspension or restriction of sale of such articles of food as have been placed in the market that
- are not clearly distinguishable from articles of food for normal consumption
- are not suitable for their claimed nutritional purpose
- may endanger human health
The FBO could be asked to furnish details regarding the history of use of the novel or modified ingredients added and their safety evaluation.
The notification of the nutraceutical regulation, as it is called in short, will help FBOs to manufacture, sell and import these products in the domestic market keeping food safety in mind. It will also allow the regulatory body to monitor such products with more efficacy especially as there is a huge demand for them among consumers.