Introduction
The Indian food industry thrives on innovation and dynamism, hence ensuring the safety of food products remains a top priority for the Indian authorities. The Food Safety and Standards Authority of India (“FSSAI”) serves as the guardian of public health, that introduced the Food Safety and Standards Act, 2006 (“FSS Act”). This legislation read with its compendium of regulations, rules, and guidelines meticulously outlines the framework for every step of the food supply chain from its origin to your table. While the FSS Act provides a foundational framework, the nuances of the regulatory framework are recorded in the regulations and guidelines, which have been established over time to encompass and regulate the expansive and ever-changing world of food products. This blog post delves into the legalities that govern the key aspects of the food industry; namely, production, distribution, import, advertising, labelling, and the safety testing standards.
Manufacture and Distribution[1]
Various regulations as prescribed under the FSS Act govern food product manufacturing and distribution in India, but obtaining a license or registering with the Food Safety and Standards Authority of India (“FSSAI”) is the one crucial requirement for all food business operators (“FBOs”) to operate legally and in compliance with the terms and conditions of the registration/license. The type of license (state or central) depends on the size and turnover of the business. Although exempt from licensing, small-scale FBOs (e.g., petty manufacturers, street vendors, and temporary stallholders) must register with the appropriate authority.[2] Larger FBOs must apply for a license from a designated officer assigned to evaluate the application based on public health considerations. A single license can cover multiple products or establishments in the same area, but different locations require separate licenses. Further, FBOs engaging in the online sale of food products must obtain approval for the same. Licenses are valid for the period specified and may be renewed by submitting an application with the renewal fee.
FBOs must maintain high standards of hygiene and safety, including compliance with the Good Manufacturing Practices (GMP)[3] and Good Hygienic Practices (GHP)[4] outlined in the relevant regulations. Certain food businesses must also implement food safety management systems (FSMS) to ensure compliance.
Import[5]
Importing food into India necessitates adherence to specific protocols to ensure imported products meet the same standards as domestically produced food. Importers must first register with the Directorate General of Foreign Trade (“DGFT”) and obtain an Importer Exporter Code (“IEC”), along with acquiring an import license[6] to facilitate the import of food products.
Imported food products must conform to Indian labelling standards, including being labelled in either English or Hindi, and featuring essential information such as the importer’s name and address, FSSAI license number, and nutritional details. Food importers are responsible for ensuring appropriate storage conditions, packaging, and labelling for imported food items.
Upon arrival, all imported food consignments undergo inspection and sampling by FSSAI officials at ports of entry to verify compliance with Indian food safety standards. Packaging should facilitate easy access for inspection purposes. Additionally, food importers must promptly address any labelling discrepancies within a specified timeframe. Officials have the authority to draw samples for testing and can reject consignments with labelling non-compliance issues.
Product Composition
The FSSAI is tasked with establishing food standards across the industry. In line with this responsibility, the FSS Act acknowledges special categories of food that deviate from conventional food products/ components standards set out in terms of the Food Products Standards and Food Additives) Regulations, 2011 (“Food Standards”). Such special food categories include:
- Proprietary food[7] which are required to adhere to the specific terms and conditions outlined in the Food Standards and any food product prepared using those ingredients which are either standardized or permitted to be used in standardized products does not require any separate approval. However, the safety requirements as prescribed under the Food Standards require strict compliance;
- Foods for special dietary uses or functional foods or nutraceuticals or health supplementsare requiredto adhere to the requirements laid down in 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;
- Organic foods[8] require compliance with the requirements laid down under the Food Safety and Standards (Organic Foods) Regulations, 2017 in addition to the requirements laid down under the other relevant FSS Act regulations; and
- Non specified food and food ingredients[9] require prior approval of the FSSAI before the same can be manufactured or imported for commercial use in terms of the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017.
Further, it is pertinent to note that any person that commercially utilizes biological resources, or knowledge associated thereto for their products is required to obtain the appropriate approval from the biodiversity authorities[10].
Advertising and Claims[11]
The regulation of food product advertising in India aims to prevent misleading assertions and safeguard consumer interests. It strictly prohibits false, misleading, or deceptive claims regarding the quality, characteristics, or advantages of food items, which includes scientifically unsubstantiated claims that mislead consumers; assertions related to the prevention, treatment, or cure of diseases unless expressly permitted by regulations; medical endorsements; deceptive practices (e.g., nutrient/ingredient deception); special dietary claims; fear-based marketing; unhealthy nutrient claims; and comparative advertising. Nutritional and health claims must adhere to specific FSSAI-established conditions. FBOs are obligated to obtain approval for claims from the FSSAI by submitting an application along with the requisite fees.
Labelling[12]
The purpose of regulations governing food labelling is to furnish consumers with accurate details concerning the food they consume. It is mandatory that labels provide crucial information including the food’s name, ingredients, nutritional content, net quantity, manufacturing date, best before/use by date, and the manufacturer’s or importer’s name and address. Labels must also delineate allergen information, highlighting the presence of common allergens (e.g., peanuts, tree nuts, milk, eggs, soy, wheat, fish, and shellfish).
Vegetarian foods must feature a green dot within a green square on their packaging, and non-vegetarian foods should display a brown dot within a brown square. Packaged foods must include a nutritional facts panel providing details on energy (calories), protein, fat, carbohydrates, sugars, and any other nutrient for which a health claim is made. The labelling on food products must be easily readable and use a minimum FSSAI-stipulated font size for the label text/content in English or Hindi.
Testing Standards and Quality Control
The FSS Act framework establishes that all FBOs seeking regulatory approvals adhere to the fundamental requirements for hygienic and sanitary practices. This includes ensuring that the food handling, processing, manufacturing, packaging, storage, and distribution premises meet the specified sanitary and hygienic standards, alongside complying with food safety measures and other pertinent regulations. Upon inspection, and provided they are satisfied with the safety, hygiene, and sanitary conditions of the premises as stipulated in the FSS Act framework, the Registering or Licensing Authority shall grant the registration or license.
Additionally, the FSS Act framework mandates that all FBOs applying for a license have food testing facilities[13] at their premises, which are equipped to conduct physical, microbiological, and chemical analyses of food materials in accordance with specified standards. In cases of suspicion or potential contaminations or upon receipt of complaints, companies may test food materials before dispatch, through either in-house laboratory facilities or accredited labs notified by the FSSAI.
The FSS Act has delineated specific standards for sampling and testing to ensure the safety and quality of food products. These standards, outlined in various FSSAI-issued regulations and guidelines, encompass sampling procedures[14] to ensure that representative samples are collected, preserved, transported, and stored without contamination. Moreover, FSSAI mandates that food samples undergo testing in accredited laboratories[15] with requisite facilities and expertise, ensuring accurate and reliable results.
The FSSAI has established standards for microbiological,[16] chemical,[17] physical,[18] allergen,[19] and nutritional[20] testing to detect pathogens, contaminants, foreign matter, allergens, and nutritional content, respectively. It also provides guidance on sampling plans and criteria to ensure representative sampling and adequate coverage of the food supply chain. Compliance with these standards and procedures is imperative for safeguarding public health, ensuring food safety, and upholding consumer confidence in the food supply chain, thus making it mandatory for food businesses operating in India.
Concluding Thoughts
Compliance with food laws in India is crucial for the successful operation of food businesses, be it domestic manufacturing, distribution, or import. The FSSAI’s regulatory framework encompasses a wide category of food products and mandates that FBOs comply with extremely stringent operational requirements and the highest level of testing standards to ensure that consumers have access to safe, high-quality food products and to protect them from any misleading information. FBOs must remain cognizant of the dynamic regulatory framework in this fast-paced and innovative sector and conduct their business operations in complete compliance with the currently applicable legal requirements to avoid penalties and sustain continuous consumer trust.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
[1] FSS (Licensing and Registration of Food Businesses) Regulations, 2011
[2] Designated Officer/Food Safety Officer or any official in Panchayat, Municipal Corporation or any other local body or Panchayat in an area, notified as such by the State Food Safety Commissioner for the purpose of registration as specified.
[3] FSS (Licensing and Registration of Food Businesses) Regulations, 2011
[4] FSS (Licensing and Registration of Food Businesses) Regulations, 2011
[5] Food Safety and Standards (Import) Regulations, 2017
[6] Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011
[7] Food that has not been standardised under FSS (Food Products Standards and Food Additives) Regulations, 2011, but does not include novel foods, foods for special dietary uses, foods for special medical purposes, functional foods, nutraceuticals, health supplements and such other food articles which the Central Government may notify in this behalf.
[8] Food products that have been produced in accordance with specified standards for organic food production
[9] Food other than proprietary food or food ingredients, including additives, processing aids and enzymes for which standards have not been specified in any regulation made under the FSS Act
[10] Biological Diversity Act, 2002
[11] Food Safety and Standards (Advertising and Claims) Regulations, 2018
[12] Food Safety and Standards (Labelling and Display) Regulations, 2020
[13] Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011
[14] GENERAL_GUIDELINES_ON_SAMPLING.pdf (fssai.gov.in)
[15] 63ac162748495Notice_for_recognition_and_approval.pdf (fssai.gov.in)
[16] Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011
[17] Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011; PESTICIDE RESIDUES (fssai.gov.in)
[18] 638edf17bdbb2Direction_Licensing_28_11_2022_.pdf (fssai.gov.in)
[19] Food Safety and Standards (Labelling and Display) Regulations, 2020
[20] Food Safety and Standards (Labelling and Display) Regulations, 2020
