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Product Declarations - a Statutory Guideline

-By Divya Sharma, Associate, New Delhi Office

We all have seen declarations on product packages. These declarations are mandatory in nature for all packaged commodities, be it a package of eatables, a package of a television set, a package of milk, a package of a radio set, a packet of chocolates, etc. A close observation on all these labels will draw our attention to some of the common set of information declared on all packages. In a world where the consumers are savvy, health conscious and informed, it becomes necessary to cater to their increasing demands & needs. A manufacturer/ packer/ importer of packaged goods in India should also be aware of these mandatory declarations from the perspective of consumer’s requirement and also from the legal perspective.
In this Article, we have attempted to simplify the law relating to these mandatory declarations on a package, which must be printed on the product before it is brought into the market for sale purposes.There are broadly three legislations that govern the domain of packaged declarations:
1. The Legal Metrology Act, 2009 along with its Rules;
2. The Food Safety & Standards Act, 2006 along with its Rules; and
3. The Drugs & Cosmetics Act, 1940 along with its Rules.

DECLARATIONS ON PACKAGES, OTHER THAN FOOD / DRUG PACKAGES
When it comes to packages other than that of the foodsand drugs, the Legal Metrology (Packaged Commodities) Rules, 2011 comes into play. Rule 6 of the Packaged Commodity Rules enlist the following declarations to be mentioned on a package:

  • the name and address of the manufacturer, packer and or the importer, as the case may be;
  • the common or generic names of the commodity so packaged;
  • The number (net quantity) of products contained in each package;
  • the month and year in which the commodity is manufactured, pre-packaged or imported;
  • the Maximum Sale Price (MRP), inclusive of all taxes, of the package;
  • the name, address, telephone number, e-mail address of Consumer Care Cell, which can be contacted in case of consumer complaints;
  • dimensions of the commodity, if applicable to the commodity so packaged;
  • Technical and other specifications of the commodity contained in the package;

While the first 6 declarations are mandatory for each packaged commodity, the remaining 2 are not mandatory.
DECLARATION ON FOOD PACKAGES
When it comes to food packages, the Food Safety & Standards (Packaging and Labelling) Regulations, 2011 (hereinafter the “Food Labelling Regulations”) come into play. Under the Food Labelling regulations, label requirements are mandatory for a pre-packaged food.
Regulation 1.2.1 defines “Prepackaged food” as:
“8. Prepackaged” or “Pre-packed food”, means food, which is placed in a package of any nature, in such a manner that the contents cannot be changed without tampering it and which is ready for sale to the consumer.”
Regulation 2.2.1 of the Food Labelling Requirements list some of the General Requirements which must be adhered to while making declaration on a label:

  • All declarations to be specified on the label should be in English or in Hindi in Devnagri script, provided that nothing shall prevent the use of any other language in addition to the language required under this regulation;
  •  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;
  • Label in pre-packaged foods shall be applied in such a manner that 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;
  • The FSSAI logo and license number shall be displayed on the label of food package in contrast color to the background as below:


Moving forward, the list of declarations on a package are as under;

  • Name of the food i.e. the trade name or description of the food contained in the package;
  • List of Ingredients contained in the food, which should be listed in the descending order of their composition by weight or volume, as the case may be, at the time of its manufacture;
  • Nutritional Informationor nutritional facts per 100 gm or 100ml or per serving of the product shall be given on the label;
  • Declaration regarding the food being Vegetarian[Green Dot] or Non-Vegetarian [ Brown Dot];
  • Declaration regarding the presence of food additives should be specified on the label;
  • Name and complete address of the manufacturer/ packer/ importer;
  • Net Quantity by weight or volume;
  • Lot/ Code/ Batch identification number;
  • Date of manufacturing or packing;
  • Special declaration as to whether or not the Food is meant for the Infants;
  • Best Before and Use by Date;
  • In case of imported food items, the country of origin should be declared on the label;

[It is clarified that when a food undergoes processing in a second country which changes its nature, the country in which the processing is performed shall be considered to be the country of origin for the purposes of labelling.]

  • Instructions for use.

Instructions for use, including reconstitution, where applicable, shall be included on the label, if necessary, to ensure correct utilization of the food.
It must be kept in mind that the above declarations on a package should be read in light of specific legislations. The astuteness with which a consumer analyses a product, it compels the manufacturers/ packers/ importers to be wary when making declarations on a package. All information must be there on the package.
DECLARATION ON DRUG PACKAGES
When it comes to Labelling and Packing of Drugs, the provisions of Drugs and Cosmetics Rules, 1945(herein after referred to as the ‘Drug Rules’) come into play especially the rules contained in Part IX (for all Drugs other than Homoeopathic drugs) and Part IX-A (for Homoeopathic medicines). These declarations are mandatory in nature and include the following:

  • The name of the Drug;
  • Net quantity in terms of weight, measure or volume;
  • The content of active ingredients;
  • The name of the manufacturer;
  • Address of the premises where manufactured;
  • The License No under which the drug is manufactured;
  • Distinctive Batch or Lot No;
  • Date of Expiry.
  • Whether it is a free sample not meant for sale.  In the alternative, the Maximum Retail Price thereof;
  • Percentage of alcohol contained therein;
  • Besides, the drug must contain instructions as specified by the Drug Authorities, including, but not limited to, the Caution Notice / Schedule-H or H1 / Schedule-X / Schedule-L/ Schedule-P / Schedule-C-1 / etc., and other warnings like For External Use only / Not for human use / for animal treatment only, etc.;
  • Besides, there are regulations providing printing of conspicuous red vertical line on the left side running throughout the body of the label for certain drugs;
  • It is also mandatory to specify the ingredients of the drug, including the active ingredient and further whether the same is listed in Indian Pharmacopoeia or in any other official compendia of drug standards.

It may be noted that both the patent or proprietary medicines and the general medicines must be labeled as above.
Rule 95 of the said Drug Rules specifically prohibits sale and distribution of a drug, unless it is labeled in accordance with the Drug Rules.  There are more stringent provisions for labeling and selling of drugs that fall in the category of Narcotic Drugs or Psychotropic Substances.  

Disclaimer: The views and opinions expressed in this article are derived from very limited and open source information. These should not be treated as an advice and are only for information. The client/ user may or may not utilize the same subject to their prudent discretion.