India’s new functional food and supplements rules: The key requirements every firm needs to know
The rules cover health supplements, nutraceuticals, food for special dietary use, food for special medical purposes, functional foods and novel foods.
You can read here how the laws have been warmly welcomed by industry, which believes the rules offer much needed clarity and fill a long-standing regulatory vacuum.
The rules will be enforced from January 1, 2018 but FSSAI says it is starting to ‘operationalise’ them now.
It is hoped the rules will put India on a similar regulatory level to leading nations while also establishing a strong, science-based environment for the industry in the country.
We’ve waded through the document to provide the key rules that food and nutrition companies operating in the sector need to know.
1) General requirements
The quantity of nutrients added to any product must not exceed the recommended daily allowance (RDA) as set by the Indian Council of Medical Research. Should this not exist, Codex limits will apply.
For food products that fall under the health supplement category, the nutrient content must not be les that 15% of the RDA if a nutrient claim is being made. For high nutrient claims, the nutrient content must not be below 30% of the RDA.
Botanicals and plants in their normal or naturally occurring forms, or in cooked form or juices, cannot be classes and a health supplement, nutraceutical, food for special dietary use or food for special medical purposes.
All labels must specify the purpose, the target consumer, the condition it seeks to address, the recommended duration of use, and detailed instructions and precautions for its use.
2) Functional food rules
The health claim for a food product may include nutritional claims, enhanced function claims, disease risk reductions claims, health maintenance claims, immunity claims and anti-ageing claims. Other claims may be allowed upon approval of FSSAI.
Solid scientific support is required for all claims, but where it does not exist for a novel ingredient, FSSAI will make a judgement based on ‘adequate scientific evidence’. Firms must also periodically review its supporting data and have it scrutinised by a ‘scientist or expert’.
In terms of labelling, implied claims for curing diseases are prohibited, either in text or pictorial form.
3) Health supplements regulations
The rules state health supplements may be used to supplement the diet of a person over the age of five and must not contain any food product covered elsewhere in the regulations.
The quantity of nutrients must not exceed national RDAs, or where they don’t exist, Codex levels. This must be labelled as a percentage figure of the RDA along with a warning ‘not to exceed the RDA’.
Each package must contain the words ‘Health Supplement’ and ‘Not for medicinal use’ prominently displayed. It must also state a warning of any known side effects and a statement that it should be stored out of the reach of children.
4) Nutraceuticals rules
Nutraceuticals must provide a physiological benefit and help maintain good health. The nutrient quantity rules are the same as those for supplements. For an ingredient where daily minimum and maximum levels have not been specified, the firm must adopt a level based on ‘relevant scientific data’.
All packages must contain the word ‘Nutraceutical’ and a quantity declaration of the ingredient which has a nutritional or physiological effect. It must also contain the warnings stipulated for supplements.
5) Food for special dietary uses
This does not include infant nutrition products, and instead refers to products that can satisfy dietary requirements relating to low weight, obesity, high blood pressure, pregnancy, lactating women, the geriatric population and celiac disease.
The product must be targeted to consumers with specific disease conditions and is permitted to contain nutrients at a higher level than the RDA, but must not exceed the limits set separately by FSSAI.
Formulas designed to replace all daily meals for weight loss/control must provide energy between 800 and 1,200 kcal. The individual servings must contain approximately one-third or one-fourth of the total daily energy, depending on the number of daily servings. A formula to replace one or more daily meals must provide between 220 and 400 kcal per meal.
No less than 25% and no more than 50% of the energy can come from protein, and no more than 30% from fat. The words ‘food for special dietary uses’ followed by ‘food for [the particular health condition]’ must be stated on pack.
6) Food for special medical purposes
This includes food prepared for weight reduction and intended as a total replacement of normal diet.
It must be a formula food for a very low energy diet of between 450-800 kcal and contain not less than 50g of protein.
The packaging must contain the wording ‘recommended to be used under medical advice only’ and, where appropriate, ‘nutritionally complete’.
7) Food with added probiotic ingredients
Only probiotic cultures specified by FSSAI may be used, although it may approve additional probiotic microorganisms from time-to-time.
The labelling must not claim that the probiotic food can prevent, treat or cure disease and the packaging must contain the words ‘probiotic food’. The strain, its shelf-life and the level at which efficacy is claims must always be stated.
Similar rules apply to prebiotic rules.
8) Speciality food containing botanical ingredients with safe history of use
If a plant or botanical is not specified in the regulations, but has a history of safe use in India or elsewhere, the FSSAI may grant approval for its use subject to the filing of a product information file containing testing information, published literature and quality details.
9) Novel foods
A novel food must not have a history of human consumption, either in terms of the total product or an ingredient it contains. It may also have been obtained by a new technological process. The novel food must not be manufactured or imported on a commercial scale without FSSAI approval.
The full regulations can be found here.