In India, the Food Safety and Standards Authority of India (FSSAI) is the apex food regulator. It is empowered by and functions under the Ministry of Health and Family Welfare, Government of India. The FSSAI implements and enforces food regulations as prescribed in the Food Safety and Standards Act, 2006 (FSS Act). The FSS Act is an Act of Parliament, popularly known as the Food Act. Previous to the FSS Act there were several food legislations. All these have been consolidated into a homogenous whole in the FSS Act. The regulations of the FSS Act became effective in 2011 with FSSAI as its regulatory body. Though the Act continues to evolve it needs to be further harmonized with standards of international agencies for global parity.

Categorized as Standardized or Non-Standardized

In the FSSAI regulations, food products fall into two categories—standardized and non-standardized. Standardized food products are those for which standards are prescribed and do not require product approval before manufacture, sale, distribution, or import. The first-time manufacturer or importer of standardized foods only requires an FSSAI license to begin a food business.

Non-standardized food products lack established standards because their safety parameters are either unknown or yet to be ascertained. Currently, FSSAI has standardized only 380 articles of food in 16 categories, so all other foods require product approval if they are not listed among these 380 food items. FSSAI is actively working to standardize another 12,000 foods, and the process is nearing finalization in harmonization with Codex Alimentarius.

Traditional foods also do not require product approval as they have been consumed for centuries in India. The ingredients and preparation methods are well known and this guarantees their safety. If, however, traditional foods use any new ingredients food additives or new technologies in preparation, they need product approval.

Imported Foods:

Foods Imported into India have to follow the FSS Act, Rules & Regulations If the food articles are standardized, the importer only needs an FSSAI license to import them. The importer also needs to comply with FSSAI regulations for the sale and distribution of the food products.

Introducing a new or unknown food article for import classifies it as non-standardized, requiring product approval under Section 22 of the FSS Act, 2006. The FSS Act, 2006 does not govern foods exported out of India, hence exporters are not obliged to obtain FSSAI product approval as these food products are not intended for sale to Indian consumers.

Non-standardized food products, awaiting product approval, are assessed for safety in four categories. To expedite product approval, a 90-day outer limit is now in place to complete the application review process. However, if the product is referred to the Scientific Panel for further scrutiny, the time limit could be extended. The 90-day time limit has three, 30-day cycles that constitute the various application review stages. This facilitates applicants in tracking the application status at various stages of the approval process and on approval, they can immediately apply for a license.

What are the New Draft Regulations?

New Draft Regulations have been formulated by FSSAI. Of special interest is Section 22 of the FSS Act, which deals with “Nutraceuticals, Functional Foods, Novel Foods and Health Supplements.” For the first time regulations have been proposed for this category of foods. If these products propound nutritional or medicinal benefits they need to have sound scientific evidence. The products must not contain either steroids or psychotropic drugs. Ingredients like vitamins and minerals must conform to the recommended dietary allowances for Indians, as proposed by the Indian Council of Medical Research.

FSSAI discontinued the existing process of product approval for food articles governed under Section 22 of the FSS Act, as updated on August 26, 2015, in response to a ruling by the Honorable Supreme Court of India. The regulations on such food products are expected soon. And the product approval may be reintroduced through a regulation.

What are the Regulations for the Licensing and Registration of Food Businesses?

According to the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation, 2011, it is mandatory for all food business operators, manufacturers, importers, distributors, wholesalers, retailers, hotels, restaurants, eateries, as well as petty food businesses to have an FSSAI registration/license so they comply with the FSS Act. Food businesses with an annual turnover of up to INR 12,00,000 need a registration certificate. Food businesses, with an annual turnover above this amount, need a license.

There are two types of licenses: a central license, issued by the central government, and a state license, issued by any of the state governments. The issuance of the central license is based on manufacturing capacity and turnover. Those operating food businesses within an Indian state need a state license based on capacity or turnover. Those that operate businesses in two or more states require an additional central license for head office/registered office and separate license/registration for other locations they operate in. Only transporters need a singular license/registration for all vehicles an individual transporter runs. Those food business operators that deal with non-standardized products have to first apply for product approval and only then they can obtain a license under the licensing and registration regulations. All importers and exporters have to obtain a central license from FSSAI.

What is the FSSAI Compliance Criterion for the Import of Food Products to India?

Food articles imported to India from foreign countries and distributed in India need to conform to the FSSAI regulations or suffer restrictions on imports. The FSSAI also has stringent regulations for packaging and labelling under the Food Safety and Standards (Packaging and Labeling) Regulation, 2011. These two reasons serve to demonstrate why imported food articles, worth millions of dollars, languish in various Indian ports.

The Food Safety and Standards (Food Product Standards and Food Additives) Regulation, 2011 defines all chocolates as prepared solely from milk. They cannot contain any vegetable oil or fats. Labels must mention artificial flavours used to comply with FSSAI regulations. If individuals do not adhere to these guidelines, then chocolates cannot enter Indian markets. Global chocolate manufacturing giants Lindt, Cadbury, Mars, and Ferrero are suffering a huge loss as a consequence.

Similarly, alcoholic beverages, including beer, are facing the same fate. FSSAI mandates that labels must include all ingredients, including additives, which should be listed in the descending order of their composition by weight and volume. In the case of alcoholic beverages, this is not always possible. Liquor imports have therefore fallen since labels that fail to mention additives, like colour, water, flavouring, and preservatives are all withheld at ports. Another stipulation for food products is to have “inseparable labels” and not stickers. FSSAI withholds food products with detachable labels. It asserts that it is striving to ensure consumer safety, as some of these stickers are only in Chinese and Japanese, making it difficult for consumers to understand the content. These reasons have compelled many foreign companies to withdraw from India.

Some of the other FSSAI compliance criteria for labelling imported food include the following:

1. Language on labels must be in English as per FSSAI Regulations, 2011.
2. Manufacturers must declare “Vegetarian” or “Non-Vegetarian” by affixing the corresponding symbols on packages.
3. Mention the name and complete address of the importer in India.
4. Mention net weight or number or measure of volume of contents.
5. Mention batch number lot number or code number, and FSSAI license number.
6. Indicate the month and year of manufacture or preparation of the commodity.
7. Declare the “Best Before” date on the package.
8. Mention nutritional information or nutritional facts per 100 grams or 100 millilitres per serving of food product on the label.
9. The label should include the name and address of the manufacturer.
10. The FSSAI logo and license number of the importer should be available on the label.

How Do the Indian Regulations Compare with Global Standards?

The Indian food safety regulations, as implemented by the FSSAI, are primarily based on the Codex Alimentarius. The World Health Organization (WHO) and the Food and Agriculture Organization (FAO), two eminent United Nations health and food bodies, collaborated to form the Codex. The Codex Alimentarius international food standards, guidelines and codes of practice contribute to the safety and quality of the food that reaches consumers. Since the FSSAI frames its regulations based on the guidelines of the Codex Alimentarius, it adheres to international standards. Other international standards formulated by global agencies like the European Food Safety Authority, and Food Standards Australia New Zealand. 

What is the Future of Food Regulations in India?

These are exciting times for food safety regulations in India. They will provide new directives in areas such as nutraceuticals and health supplements. This is the need of the hour as these are becoming popular food categories. Standardization for thousands of foods is on the anvil. Food business operators are certainly anticipating some positive changes in food regulations. Which could ease the product approval process and food operations.

“A harmonization of Indian food standards with global standards is a step in the right direction,” states Vijay Kumar Arora, chairperson—Arbro Group. “Our food regulations will incorporate food standards that are acceptable worldwide.”