Food Safety & Packaging Rules for Health Supplements, Nutraceuticals & Specialty Foods

The Food Safety and Standards Authority of India had 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 Gazette of India on 23.12.2016.

These regulations will be applicable to foods covered under the following categories:

1. Health Supplements
2. Nutraceuticals
3. Food for Special Dietary Use (FSDU)
4. Food for Special Medical Purpose (FSMP)
5. Food with added Probiotic ingredients
6. Food with added Prebiotic ingredients
7. Specialty Foods containing Plant or Botanical Ingredients
8. Novel Food (Need prior approval as per FSS (Approval of non-specified food and food ingredients) Regulations, 2017).

• • The products covered under these regulations cannot claim to prevent or treat or cure any Disease.

• • The products with these claims are more akin to drugs which do not fall under the ambit of FSSAI.

• • Therefore, the labelling, presentation and advertisement of the products covered under these regulations shall not claim that the product has the property of preventing, treating or curing a human disease.

The products falling under these regulations shall also need to comply with the mandatory specific labelling requirements provided under the following Regulations/ Rules applicable to the concerned category.

Food Safety and Standards (Packaging and Labelling) Regulations, 2011[1]

The general labelling requirements as per Regulation 2.2.1 of Food Safety And Standards (Packaging And Labelling) Regulations, 2011 are as under:

Every pre-packaged food shall carry a label containing information as required here under unless otherwise provided, namely,—

The particulars of declaration required under these Regulations to be specified on the label shall be in

1. English or
2. Hindi in Devnagri script:
i) Provided that nothing herein contained shall prevent the use of any other language in addition to the language required under this regulation.
3. Pre-packaged food shall not be described or presented on any label or in any labelling manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character in any respect;
4. Label in pre-packaged foods shall be applied in such a manner that
i) they will not become separated from the container;

Contents on the label shall be

• clear,
• prominent,
• indelible and
• readily legible by the consumer under normal conditions of purchase and use;
• Where the container is covered by a wrapper, the wrapper shall carry the necessary information or the label on the container shall be readily legible through the outer wrapper and not obscured by it.

It is mandatory to declare nutritional values such as

• energy,
• carbohydrate,
• protein etc.
• for tablet, capsule, syrup formats also.

As per Regulation 2.2.2 of Food Safety And Standards (Packaging And Labelling) Regulations, 2011, a list of ingredients shall be declared on the label in the following manner:-

1. 1. The list of ingredients shall contain an appropriate title, such as the term “Ingredients”;
   2. The name of Ingredients used in the product shall be listed in descending order of their composition by weight or volume, as the case may be, at the time of its manufacture;
   3. A specific name shall be used for ingredients in the list of Ingredients

Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 [2]

Health supplements are intended to supplement the normal diet of a person above the age of five years with concentrated sources of one or more nutrients with known or established nutritional or beneficial physiological effect. The kind of products falling under this category includes products such as protein supplements intended for general population, vitamin and mineral formulations with plant or botanical extracts etc.

As per Regulation 6(3) with respect to Health Supplements:

• • The labelling, presentation and advertisement shall not claim that
  • the health supplement has the property of preventing, treating or curing a human disease, or refer to such properties.

The statement by the food business operator relating to the structure or function or the general wellbeing of the body may be allowed by the Food Authority if the statement is supported by the generally accepted scientific data.

Every package of health supplement shall carry the following information on the label, namely:

• • • the words “HEALTH SUPPLEMENT”;
    • the common name of the health supplement, or
    • a declaration as to the amount of the nutrients or substances with a nutritional or physiological effect present in the product;
    • an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written;
    • the quantity of nutrients, where applicable expressed in terms of percentage of the relevant recommended daily allowances as specified by the Indian Council of Medical Research and
    • bear a warning, “Not to exceed the recommended daily usage”;
    • a statement that the health supplement is not be used as a substitute for a varied diet;
    • a warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and published product or drug interactions, as applicable; and
    • a statement that the product is required to be stored out of reach of children.

Nutraceuticals include naturally occurring ingredients that are extracted, isolated and purified from food or non-food sources and upon consumption in measured amounts, provide a physiological benefit and help maintain good health. The kind of products falling under this category includes the products made out of ingredients specified under Schedule VI of the regulations.

As per Regulation 7(4) with respect to Nutraceuticals:

The labelling, presentation and advertisement shall not claim that the nutraceutical has the property of

• preventing,
• treating or
• curing
• a human disease, or refer to such properties.
• A statement by the food business operator relating to the structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data.

Every package of health supplement shall carry the following information on the label, namely:

• the word “NUTRACEUTICAL”;
• the common name of the nutraceutical;
• a declaration as to the amount of each nutraceutical ingredient in the product that either has a nutritional or physiological effect;
• where it is appropriate, the quantity of nutrient shall be expressed in terms of percentage of the relevant recommended daily allowances as specified by the Indian Council of Medical Research even when the nutrient is present along with a nutraceutical as an adjunct and shall bear an advisory warning ‘not to exceed the stated recommended daily usage’;
• an advisory warning for ‘recommended usage’
• an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written;
• an advisory warning in cases where a danger may exist with excess consumption;
• an advisory warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable;
• a statement that the product is required to be stored out of reach of children.

The Legal Metrology (Packaged Commodities) Rules, 2011

As per Rule 6 of the Rules, every package shall bear thereon or on the label securely affixed thereto, a definite, plain and conspicuous declaration made in accordance with the provisions of this chapter as, to –

• the name and address of the manufacturer, or
• where the manufacturer is not the packer, the name and address of the
  1. manufacturer and
  2. packer and
  3. for any imported package the name and address of the importer shall be mentioned.

• The common or generic names of the commodity contained in the package and
  1. in case of packages with more than one product, the name and number or quantity of each product shall be mentioned on the package.

• The net quantity, in terms of the standard unit of weight or measure, of the commodity contained in the package or where the commodity is packed or sold by number, the number of the commodity contained in the package shall be mentioned.

1. manufactured or
2. pre-packed orThe month and year in which the commodity is
3. imported

shall be mentioned in the package.

• • If a package contains a commodity which may become unfit for human consumption after a period of time,
    
    • 1. the `best before or use by the date, month and year’

shall also be mentioned on the label.

• 1. the retail sale price of the package.

“Retail sale”, in relation to a commodity, means the sale, distribution or delivery of such commodity through retail sales shops agencies or other instrumentalities for consumption by an individual or a group of individuals or any other consumer;

“Retail sale price” means the maximum price at which the commodity in packaged form may be sold to the consumer and the price shall be printed on the package in the manner given below; ‘Maximum or Max. retail price Rs/ Rs/ …….inclusive of all taxes or in the form MRP ………incl., of all taxes after taking into account   the fraction of less than fifty paisa to be rounded off to the preceding rupees and fraction of above 50 paise and up to 95 paise to the rounded off to fifty paise.

• Where the sizes of the commodity contained in the package are relevant,

1. the dimensions of the commodity contained in the package, and

• if the dimensions of the different pieces are different,
• 1. the dimensions of each such different piece shall be mentioned.

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