The draft added, “Only such articles of food or food ingredients which have not been permitted to be manufactured, stored, sold, distributed or imported under any other regulation under the Act shall require prior approval for being manufactured, stored, sold, distributed or imported under the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2016.”
A source relating to standards from the FSSAI, said, “With releasing the draft, we want to make the necessary alterations and framing to bring in the clarity regarding the regulations. Since last year, we have tried to bring in clarity in terms of regulations which has helped food business operators (FBO) to operate with clarity.”
The draft enlisted the food ingredients which are not covered under any regulations of the Food Safety and Standards Act, 2006. They are:
- Novel foods or foods containing novel ingredients not having a history of human consumption in the country
- Food ingredients with a history of human consumption in the country, but not specified in any other Regulation under the Act
- New additives and processing aids Foods manufactured or processed with the use of novel technology
Further, the draft cited the requirements that needed to be specified while making an application for approval.
The requirements prescribed under novel foods or foods containing novel ingredients or those processed with the use of novel technology, stated, “The source of ingredient (animal, chemical, botanical or micro-biological) has to be specified. In case of animal, botanical or micro-biological source, the genus and species may be mentioned.
(a) Any new ingredient, specify if the products had one or more new ingredients – meaning any ingredient which, as on date, is not listed in the Food Safety and Standards Regulations (FSSR), 2011, or an ingredient which has been introduced for the first time in India.
(b) Evidence proving that the product/ingredient is safe.”
While specifying the needs on certification the draft states that the certificate of analysis (COA) from third-party National Accreditation Board for Testing and Calibration Laboratories (NABL)/ International Laboratory Accreditation Cooperation(ILAC)-recognised laboratories must be provided which demonstrates the compliance of the ingredients/products to the specifications as claimed by the applicant. Such COA should include chemical parameters, nutrient levels, calorific value, metal contaminants, naturally-occurring toxic substances, aflatoxins, pesticide residues, TPC,Y&M, E-Coli, Coli Form and freedom from pathogenic organisms, etc. Validated test methods as needed for the analysis (with information on LOD, LOQ, sensitivity, repeatability, specificity etc.) shall be provided with references.
“The FBO shall submit a certificate of analysis of the product on parameters relating to chemical, nutritional, microbiological, heavy metals, pesticide residues and naturally-occurring toxicants to FSSAI,” stated the draft.
The draft proposed to mention the history of consumption of product attaching supporting documents:
(a) Geographical area of use with established history of safe use in at least two countries, regulated by the food regimes prevalent in the European Union (EU), the United States of America (USA), Canada, Australia, Japan and China.
(b) Average quantity of consumption
(c) Positive effects
(d) Negative/adverse effects
Meanwhile, the draft also prescribed the requirements necessary while applying for approval of food ingredients with a history of human consumption in the country, but not specified in any regulation under the Act, new additives, processing aids and enzymes and foods and food ingredients consisting of or isolated from microorganisms, fungi or algae.
The source also said, “Recently, FSSAI has brought clarity with regard to alcoholic beverages, non-specified food ingredients, e-commerce guidelines, standards for vegetables and fruits, etc.”