FOOD SAFETY LAWS

A. Licensing or Registration Requirements

1.1. A registration or license (Central or State) is required to be obtained to operate a food business in India. The registration or licensing requirements are determined in the following manner:

• (a) The registration or licensing requirements are prescribed for different kinds of food business activities i.e., manufacture, import, sale (wholesale, retail), packaging, etc.

• (b) Further, the requirement for obtaining either Central license or State license or a simpliciter registration is determined based on the annual turnover or production/ storage capacity of a food business as prescribed under the Food Safety and Standards (Licensing and Registration of Food Business) Regulations, 2011 (“L&R Regulations”). The details pertaining to eligibility criteria and fee structure for the said registration or license is readily available on the Food Safety Compliance System’s portal.

Note: The registration or license under the food safety laws is issued for a premise or place of business. Thus, a single integrated registration or license can be issued for multiple activities undertaken from one premise or place of business by a food business operator.

1.2 The licensees shall ensure to keep the licensing authority updated with respect to their food business establishment.

1.3 The licensee under L&R Regulations shall submit a return on or before 31 May each year (separate for each license issued to it), to the licensing authority in respect of each class of food articles handled by him during the previous financial year.

1.4 The L&R Regulations also stipulate the requirements inter alia with respect to (i) the hygiene of the premises, containers, equipment and material (raw material and packaging material) used in manufacturing, packing and storing of food articles and vehicles used to transport the same; (ii) facilities including water supply, drainage, waste disposal, ventilation, lighting, food testing, pest control; (iii) personnel facilities and their personal hygiene; (iv) audit, documentation and records; (v) training of the food handlers; and (vi) storage, transportation and handling of the food articles, for the following FBOs under Schedule – 4 of the L&R Regulations [General Hygienic and Sanitary practices to be followed by Food Business Operators]:

• (a) Petty FBOs applying for registration (Part I of Schedule – 4).

• (b) All FBOs applying for license under L&R Regulations (Part II of Schedule – 4).

• (c) FBOs engaged in manufacture, processing, storing and selling of milk and milk products (Part III of Schedule – 4).

• (d) FBOS engages in manufacture, processing, storing and selling of meat and meat products (Part IV of Schedule – 4).

• (e) FBOs engaged in catering or food service establishment (Part V of Schedule – 4).

1.5 On the basis of Schedule – 4 of the L&R Regulations, the guidance documents to implement GMP/GHP requirements for food articles such as spices , health supplements and nutraceuticals and milk and milk products have been issued by FSSAI as part of food safety management systems.

B. Packaging Requirements

2.1 In this regard, the FSSAI has issued the Food Safety and Standards (Packaging) Regulations, 2018 (“Packaging Regulations”).

2.2 The requirements stipulated for the manner of packaging are provided in Regulation 3 of the Packaging Regulations which includes:

(a) Packaging materials shall be suitable for the type of product, the conditions provided for storage, and the equipment for filling, sealing, and packaging of food as well as transportation conditions.

(b) Packaging materials shall be able to withstand mechanical, chemical, or thermal stresses encountered during normal transportation. In the case of flexible or semi-rigid containers, overwrap packaging may be necessary.

(c) Food articles shall be packed in a clean, hygienic, and tamperproof package or container.

(d) Printing inks for use on food packages shall conform to IS: 15495.

(e) In the case of multilayer packaging the layer which comes in direct contact with food or layers likely to come in contact with food shall meet the requirements of packaging materials specified in Schedule I (Paper and board materials intended to come in contact with food articles), II (Metal and Metal Alloys intended to come in contact with food articles) and III (Plastic Materials intended to come in contact with food products) of the Packaging Regulations.

2.3 The Packaging Regulations framework provides a list of suggestive packaging materials corresponding to the product category in Schedule IV of the Packaging Regulations.

C. Labelling and Display Requirements

3.1 To manufacture, distribute, sell, or expose for sale or despatch or deliver to any agent or broker for sale, every pre-packaged food article shall be marked and labelled in accordance with Food Safety and Standards (Labelling and Display) Regulations, 2020 (“Labelling Regulations”).

3.2 Every pre-packaged / pre-packed food should carry a label containing the information prescribed under Regulation 4 of the Labelling Regulations which include the following details:

(a) Particulars of labelling declarations should be in Hindi or English language;

(b) Label should be applied on pre-packaged or pre-packed food in such a manner that it cannot be separated from the container;

(c) Where the container is wrapped in a wrapper, then the wrapper shall carry the necessary information or label so that readily legible by consumers under normal conditions of purchase and use; and

(d) License number shall be displayed on the principal display panel in the prescribed format.

3.3 Further, the information required to be declared on every label of a pre-packaged or pre-packed food has been prescribed under Regulation 5 of the Labelling Regulations, which includes the following:

(a) Name of the food – This shall include the trade name or description;

(b) List of ingredients;

(c) Nutritional information;

(d) Calculation of nutrients;

(e) Declaration regarding the vegetarian or non-vegetarian nature of the food;

(f) Declaration regarding food additives;

(g) Name and complete address of the manufacturer – In addition to the above, for imported food articles, the name & address of the importer along with the details of the bottling or packing unit, if any;

(h) FSSAI logo and license number;

(i) Net Quantity – by weight, volume, or number, as the case may be, retail sale price and consumer care details;

(j) Lot/ Code/ Batch identification reference;

(k) Date of manufacturing or packing and expiry / use;

(l) Country of Origin details for imported foods;

(m) Instructions for use – wherever necessary;

(n) Declaration regarding food allergen; and

(o) If the food material is not meant for human consumption, the package shall bear a declaration to this effect by a symbol consisting of a cross inside a square in black colour.

3.4 The relevant information / declarations are required to be made on the principal display panel (“PDP”) and can be given in the following manner:

(a) All information should be grouped and given in one place; or

(b) The pre-printed information can be grouped together and given in one place and Online information or those not pre-printed be grouped together in another place.

3.5 The PDP area shall adhere to of the Labelling Regulations including Regulation 6 of the Labelling Regulations. The Labelling Regulations also allow certain exemption from requirements which are provided in Regulation 8 of the Labelling Regulations.

D. Importing Requirements

4.1 An import license is required to be obtained from the Central Licensing Authority to import any article of food as per the Food Safety and Standards (Import) Regulations, 2017 (“Import Regulations”). The imported food article shall be imported in the manner prescribed under Regulation 5 of the Import Regulations.

4.2 The compliance with standards for packaging and labelling has been prescribed in Regulation 6 of the Import Regulations.

4.3 No-objection certificate (Form 3) provided under the Import Regulations) shall be issued to the importer if the Authorised Officer is satisfied that the food articles conform to the standards stipulated under the Import Regulations. The no objection certificate is valid for thirty days from receipt of the said certificate within which the importer shall remove the food articles from the customs area.

E. Organic Foods Requirements

5.1 The organic food meant for sale shall comply with the applicable provisions of one of the following systems:

(a) National Programme for Organic Production (NPOP);

(b) Participatory Guarantee System for India (PGS-India); and

(c) Any other system or standards as may be notified by the Food Authority from time to time.

5.2 The organic food marketed through direct sales by a small original producer or producer organization to the end customer and such intermediaries or aggregators who collect organic food from such producers are exempted from the above requirement.

5.3 Packaging and labelling of organic food: The label shall convey the organic status of the food article by carrying a logo therefore with the dimensions (in mm) provided in Regulation 5 of the Organic Foods Regulations; Schedule I to the Labelling Regulations Display for sale of organic food: The seller of the organic food shall display such food in a manner distinguishable from the display of non-organic food.

5.4 Import of organic food: The organic food imported under bilateral or multilateral agreements on the basis of equivalence of standards between that of NPOP and the exporting country, is not required to be re-certified on import. However, the organic food consignment shall be accompanied by a transaction certificate issued by the accredited certification body.

F. Vegan Foods Requirements

6.1 The vegan foods shall not involve animal testing for any purpose of safety evaluation unless provided by any regulatory authority.

6.2 The food business operator shall ensure to take appropriate precautions in all stages of production, processing, and distribution with good manufacturing practices and avoid the unintended presence of non-vegan substances.

6.3 Labelling and Packaging of Vegan Foods: The vegan foods package shall be in compliance with the Labelling Regulations. The packaging of the vegan foods shall carry a logo (after approval of the Food Authority) to display the status of vegan products.

6.4 Import of Vegan Foods: Vegan food articles shall be imported with a certificate issued by the recognised authorities of the exporting countries in the format as specified by the Authority is accepted.

G. Health Supplements and Others’ Requirements

7.1 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 (“Health Supplements and Others’ Regulations”) are applicable on food for special dietary use, functional foods, health supplements, nutraceuticals, food for special medical purpose and novel foods.

7.2 The food articles with standard nutrients or nutritionally complete formulation shall deliver desired level of energy, protein, vitamins and minerals and other essential nutrients required for respective age group, gender and physiological stage as per the guidelines made by Indian Council of Medical Research as per Regulation 3 of the Health Supplements and Others’ Regulations.

7.3 The quality of nutrients added to the articles of good shall not be in excess to the recommended daily allowance as specified by the Indian Council of Medical Research. If the standards have not been specified, the nutrients shall comply with the standards laid down by Codex Alimentarius Commission.

7.4 The food articles shall conform to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011.

7.5 The food business operator may use the following with food articles covered under the Health Supplements and Others’ Regulations:

(a) Approved colours and additives.

(b) Natural flavours or nature identical flavours or synthetic flavours. Please note that the addition of flavour shall be declared on the label of such food article in accordance with the Labelling Regulations.

(c) The Health Supplements and Others’ Regulations provides that the ingredients listed in the schedules I, II, III, IV, VI, VII and VIII of the Health Supplements and Others’ Regulations are permitted to be used in food articles.

(d) The Health Supplements and Others’ Regulations permits the use of additives listed in the schedules V-A, V-B, V-C, V-D, V-E and V-F of the Health Supplements and Others’ Regulations in the food articles.

No hormones or steroids or psychotropic ingredients shall be added in any food article covered under the Health Supplements and Others’ Regulations.

7.6 The food articles in the form of capsules, tablets or syrups shall be sold in compliance with the Health Supplements and Others’ Regulation including Rule 3 of the Health Supplements and Others’ Regulation.

7.7 Nutrient claim:

(a) The individual nutrient content of the health supplement shall be in compliance with the Health Supplements and Others’ Regulation including Regulation 3 and 4 of the Health Supplements and Others’ Regulation.

(b) The health claims in respect of an article of food shall be commensurate with the adequate level of documentation and valid proof made available for review by the Food Authority when called for. For health claims where scientific support does not exist, or if a novel ingredient is to be introduced, there shall be a prior approval of the Food Authority.

(c) The other claims in a food article other than drug claims may be allowed subject to prior approval of the Food Authority.

(d) If the health claims are product led, the food business operator shall notify to the Food Authority before putting the same in the market, by submitting relevant documents and copy of the label.

7.8 Labelling Requirements:

(a) The labelling on food articles shall be in accordance with the Labelling Regulations, and the specific labelling requirements provided in the Health Supplements and Others’ Regulation.

7.9 The compliance pertaining to different food articles covered under the Health Supplements and Others’ Regulations has been tabulated below:

H. Food Recall Procedure

8.1 The Food Safety and Standards (Food Recall Procedure) Regulations, 2017 (“Food Recall Regulations”) prescribe the conditions and guidelines for the purpose of recalling food by the food business operator in view of Section 28 of the Food Safety Act. These Regulations are applicable on food or food articles that are determined to be (on prima facie basis as well) unsafe and / or specified by the relevant authority.

8.2 The food recall process may be initiated by the food business operator to fulfil his responsibilities under Section 28 of the Food Safety Act, on directions issued by the Chief Executive Officer, FSSAI or the Commissioner of Food Safety of the State or Union territory or both on the basis of report or complaints from any stakeholder.

8.3 The initiation of food recall process does not preclude the Chief Executive Officer, FSSAI or the Commissioner of Food Safety of the State or Union territory from taking any further action.

8.4 The food business operator shall maintain the food distribution records including the names and addresses of suppliers and customers, nature of food, date of purchase, date of delivery, lot number, batch code, pack size, brand name, date of manufacture, date of expiry and best before date, for a period of one year from best before date or the expiry date, as applicable.

8.5 The food business operator shall submit information as specified under Schedule I to the concerned Authority immediately but not post 24 hours from the time it comes to his notice that such food is to be recalled. Further, Commissioner of Food Safety of the State or Union territory shall inform the Chief Executive Officer, FSSAI about the initiation of recall procedure within twenty-four hours of receipt of such information.

8.6 The food business operators (including the food retailers) engaged in the manufacture or importation or wholesale supply of food must have an up-to-date recall plan.

8.7 The food retailers and food businesses in the food service sector shall remove the recalled stock from shelves and return it separately from other food to the manufacturer, importer or wholesaler.

8.8 The food business operator initiating a food recall shall promptly inform food business operator(s) in the food chain including consumers about the recall in accordance with Regulation 8 of the Food Recall Regulations. Every Food business operator in the food chain who receives a recall communication shall immediately carry out the instructions detailed therein by the recall initiating food business operator and extend the recall to all concerned stakeholders.

8.9 The food business operator shall determine whether the recall is progressing effectively and shall submit periodic status reports to the Chief Executive Officer, FSSAI or Commissioner of Food Safety of the State or Union territory in accordance with Regulation 9 of the Food Recall Regulations.

8.10 The accurate records of the recovered food including their lot number, batch code, pack size, brand name, date of manufacture, date of expiry, best before date, and all related data shall be maintained. The recovered food shall be stored separately from other food and be identified by a label plate including prominently that “RECALLED PRODUCT NOT FIT FOR HUMAN CONSUMPTION”.

8.11 The report shall be submitted to the Chief Executive Officer, FSSAI after completion of the recall process in accordance with Regulations 11 and 13 of the Food Recall Regulations.

I. Advertising and Claims

9.1 The FBOs and marketers shall comply with the principles prescribed under the Food Safety and Standards (Advertising and Claims) Regulations, 2018 (“Advertising Regulations”) while advertising and publishing the marketing communications meant for promotion or sale of food articles including the labelling claims.

9.2 As per the Advertising Regulations, the claims shall be inter alia truthful, unambiguous, conspicuous and legible accompanied by relevant disclaimers. It shall not encourage or condone excess consumption of the food article. Further, the claims as well as the advertisements shall not undermine the importance of healthy lifestyle. The claims and advertisements shall not be deceptive in nature.

9.3 The compliance pertaining to different claims covered under the Advertising Regulations has been tabulated below:

9.4 The FBO or marketer shall seek prior approval from the FSSAI in accordance with Regulations 11 and 12 of the Advertising Regulations.

J. Infant Nutrition Requirements

10.1 The Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020 (“Infant Nutrition Regulations”) prescribe standards and requirements with respect to the composition of food articles for infant.

10.2 Regulation 3 read with Schedules I(a) [Advisory list of mineral salts for use in foods for infant nutrition under the provisions of the regulations], I(b) [Advisory list of vitamin compounds for use in food for infant nutrition under the provisions of the regulations] and I(c) [Advisory list of amino acids and other nutrients for use in foods for infant nutrition under the provisions of the regulations] of the Infant Nutrition Regulations prescribe general requirements such as variation from declared nutrient levels, presence of algal and fungal oil in foods for infant nutrition, packaging material and manner of packaging.

10.3 Regulation 4 of the Infant Nutrition Regulations stipulates the specific labelling requirements for foods for infant nutrition in addition to provisions of Packaging Regulations.

10.4 The Infant Nutrition Regulations provide for compliance standards for Infant Food articles as tabulated below: