Food Regulations—What is the Current Scenario in India?

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 a number of 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. The standardized food products are those for which standards are prescribed and do not require product approval prior to 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 do not have standards as their safety parameters are either not known or not yet ascertained. Presently 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 working to standardize another 12,000 more foods for which the process is nearing finalization in harmonization with Codex Alimentarius.

Traditional foods also do not require product approval as they are being 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 or food additive or new technologies in preparation, they need product approval.

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

If a new or unknown food article is introduced for import, it is considered non-standardized and requires product approval under the Section 22 of the FSS Act, 2006. The FSS Act, 2006 does not apply to foods being exported out of India. Exporters do not require FSSAI product approval as these food products are not sold 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 for completion of 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 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.

The existing process of product approval for the food articles governed under Section 22 of the FSS Act has been discontinued as updated on August 26, 2015 by FSSAI in response to the ruling by 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 Regulations for 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 businesses operators, manufacturers, importers, distributers, wholesalers, retailers, hotels, restaurants, eateries, as well as petty food businesses to have an FSSAI registration/license so they are in compliance with the FSS Act. Food businesses with an annual turnover 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 central license is issued on the basis of manufacturing capacity, as well as turnover. Those operating food businesses within an Indian state need a state license that is also 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 the 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 FSSAI Compliance Criterion for 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 import. The FSSAI also has stringent regulations for packaging and labeling under 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. For example, all chocolates, as defined in the Food Safety and Standards (Food Product Standards and Food Additives) Regulation, 2011are to be prepared from milk. They cannot contain any vegetable oil or fats. Labels need to mention artificial flavors usedto comply with FSSAI regulations. If these guidelines are not adhered to then chocolates are not permitted to enter Indian markets. Global chocolate manufacturing giants Lindt, Cadbury, Mars, and Ferrero are suffering a huge loss as a consequence.

Alcoholic beverages including beer are suffering the same fate. FSSAI stipulates that all ingredients, including additives need to be mentioned on labels in descending order of their composition by weight and volume, which for alcoholic beverages, is not always possible. Liquor imports have therefore fallen, since labels that fail to mention additives, like color, water, flavoring, and preservatives are all withheld at ports. Another stipulation for food products is to have “inseparable labels” and not stickers. Food products with detachable labels are withheld. FSSAI opines that it is only trying to ensure consumer safety as some of these stickers are only in Chinese and Japanese so consumers cannot understand what’s written. These reasons have compelled many foreign companies to withdraw from India.

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

• Language on labels must be in English as per FSSAI Regulations, 2011.
• “Vegetarian” or “Non-Vegetarian” must be declared by affixing the symbol for “Vegetarian” or “Non-Vegetarian” on packages
• Mention name and complete address of the importer in India;
• Mention net weight or number or measure of volume of contents;
• Mention batch number or lot number or code number, and FSSAI license number;
• Mention month and year in which the commodity is manufactured or prepared;
• Declare “Best Before” date on the package;
• Mention nutritional information or nutritional facts per 100 grams or 100 milliliter per serving of food product on the label;
• Name and address of the manufacturer should be mentioned on the label and
• 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 Codex was formed with the collaborative efforts of the World Health Organization and the Food and Agriculture Organization, two eminent United Nations health and food bodies. 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 regulations are framed on the guidelines of the Codex Alimentarius, they adhere to international standards. Other international standards formulated by global agencies like the European Food Safety Authority, Food Standards Australia New Zealand, and the

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USFDA have also to some extent been assimilated, integrated, and harmonized into the Indian standards, thereby bringing them almost at par with the global standards.

What is the Future of Food Regulations in India?
These are exciting times for food safety regulations in India. The recent proposals mentioned in the new Draft Regulations will soon be finalized to become the new Food Safety and Standards Regulations, 2015. They will provide new directives in areas such as nutraceuticals and health supplements, which 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 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.”

Dr. Saurabh Arora is founder of FoodSafetyHelpline.com and heads the services divisions of Arbro Pharmaceuticals and Auriga Research in India. Reach him at [email protected].