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.