Food safety is becoming a growing global concern with regulatory regimes worldwide facing the challenge of minimising food safety risks. With India being one of the biggest markets for the import of various kinds of food products from across the globe, food safety has become a major concern for India. The government is focussing on the delivery of safe and wholesome food to its citizens by setting up a single unified established standard. Enactment of the Food Safety and Standards Act, 2006 (FSSA) is a major step taken by the government in this direction.
The FSSA was introduced to establish a single statutory body for governing food laws, setting standards of enforcement so as to remove confusion from the minds of consumers, traders, manufacturers and investors pertaining to multiple food laws prevailing in the country. FSSA, 2006, integrates and consolidates all food safety related legislations.
An FBO needs to apply for product approval before licensing when the ingredient(s) and / or additive(s) used by him are those for which standards are not specified under FSS Act, 2006, Rules and Regulations and are different from those of the product which are detailed in the FSS Act, 2006, Rules and Regulations. All imports of food articles are subjected to scrutiny under the FSSA. As per the FSSA, all imports will come under Central Licensing. An existing importer will need to be registered with the Central Authority and all imported products will be screened for safety parameters by FSSAI.
Scope of Product Approval
Standardised foods do not require Product Approval – Food for which standards are prescribed in FSS Regulations and the food product conforms to the prescribed standards (both for product categories and those which may apply across all products), it is termed as Standardised Food and does not require Product Approval.
Non-standardised foods require Product Approval – Excluding the above major category, all other Food Products are termed as non-standardised and need to be subjected to risk/safety assessment and require Product Approval.
Products for which Product Approval is required:
○ The food product(s) including food ingredient (s) or food additive(s) for which there are no standards notified by FSSAI will require Product Approval.
○ Product Approval is also required in cases where the product is already approved under the Product Approval System but there are minor compositional changes in ingredients provided that FSS Regulations have been defined for that ingredient.
○ Every product which has different ingredient (s) and /or additive(s) needs separate Product Approval (except any number of flavours or colours can be accommodated in one application).
○ Organic Food Product, ingredients and additives are treated in the same manner as non-organic products for the purpose of the Product Approval.
○ If the intermediary or premix which are not meant for consumer contain ingredients or additives which are not specified or do not have standards in the FSS Regulations will require Product Approval.
○ The permissible amount of vitamins and minerals is as per RDA of ICMR guidelines and, however the applications will get rejected wherein vitamins and minerals have been added above RDA.
○ Product Approval will be required for a food product, all ingredients of which are approved or allowed by FSSAI under its various regulations, but the product per se is not standardised.
○ In case the product contains ingredient (s) and /additive(s) which are not mentioned in the Indian Standards but their safety and usage limits are established by Codex and other regulatory bodies like EU/USFDA then such products may be given Product Approval.
○ Product Approval is required for products where added colours or flavours are not approved in the FSSR.
○ If all ingredients are approved by FSSR but a new additive which is not allowed under FSSR is added then Product Approval is required. The application should be submitted in Form 1 (a) giving all relevant data on Status of Approval in Codex/USFDA/EU/FSANZ etc. If it is not approved by these regulatory bodies, then it will be forwarded to Scientific Panel on Additives for evaluation.
○ Ayurvedic ingredients are not permitted by FSSR but have been approved and authorised for use since ages. Such Ayurvedic ingredients will require Product Approval if it is not normally consumed as conventional food and will fall under 1A category of PA Advisory.
○ If the NOC has been granted for a certain product, it is mandatory for the FBO to carry out trading of that product with the exact name as given in the NOC otherwise any other fancy name used on the product label keeping the composition same will require Product Approval.
○ Product Approval is required if a proprietary ingredient (having NOC) is added to a standardised product as the final product will also become proprietary.
○ When a company has sought Product Approval under Brand A and then wishes to manufacture the same product under a different brand, will require to obtain Product Approval again with the formulation remaining same, however, no additional fee needs to be paid.
○ The Product Approval is required for the manufacturing of food products by 100% Export Oriented Units which sell and distribute a part of the food products domestically.The units covered under the Special Economic Zones (SEZs) as defined by the ministry of commerce are not required to apply for Product Approval.
Products for which Product Approval is not required:
○ Product approval is not required for products with same composition but different nomenclature except in cases where different claim is made on the label.
○ Traditional / ethnic foods mentioned under Regulation 3.1.1 (2) of FSS (Food Products Standards and Food Additives) Regulations, 2011, which are cooked, served and consumed fresh e.g. Sarson ka saag, raita, dal, dosa or idlis or rasham or sambhar are not required to get Product Approval, provided it contains food additives permitted in Table 2 of appendix of FSS (Food Products Standards and Food Additives) Regulations, 2011. However, the moment someone decides to process these foods with the addition of any preservatives or colours or any fortification with vitamins and proteins etc. for packaging with a given shelf-life, it ceases to be traditional or ethnic food and may require Product Approval, if the same is not in conformity with the prescribed standard.
○ In case one business entity (such as franchise etc.) of a company has obtained the Product Approval for Product X, then another business entity of the same company will not required to file an application for Product Approval for same Product X, only brand owner needs to obtain Product Approval.
○ No separate product approval is required for the organic nature of the standardised product or which has otherwise been granted product approval.
○ The products which are mentioned in Annexure A or in any part of FSS regulations will not require Product Approval.
The Food Authority has recently adopted a two-pronged strategy to make the Product Approval System more responsive i.e. (i) through screening of application on a regular basis i.e. an average of 4 day/week basis to clear the backlog and adhere to a definite time-frame to decide the applications for Product Approvals. (ii) Develop more and more standards and notify the same through regulations so as to cover a wider range of food products within the scope of prescribed standards.
The need for Product Approvals has been partially reduced with the development of more and more food standards by revisiting the existing standards and setting of standards for new food products. The Union ministry of health has approved and finalised harmonisation of more than 11,000 standards of Additives with that of CODEX. FSSAI thus, has issued draft regulations which may be called the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2015, link of which is- http://www.fssai.gov.in/Portals/0/Pdf/Draft_Regulation_on_Food_additives_WTO_23_07_2015.pdf
FSSAI has also issued draft regulations which may be called as the Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical purpose, Functional Foods, and Novel Food) Regulations, 2015. The link for these regulations is-http://www.fssai.gov.in/Portals/0/Pdf/Draft_Regulation_on_Nutraceuticals_WTO_23_07_2015.pdf
○ The move is expected to benefit the food companies as they would not be required to obtain Product Approval for products/ingredients/additives covered in the harmonisation.
○ This will be helpful in absence of national standards and will orient standardised process of food safety, overall development of consumer safety.
○ This will facilitate export to developed markets.
○ This will help in equivalence and facilitation of traceability process.
○ This will help to monitor imported food.
Such incremental notification of food standards and regulations is expected to expand the horizons of standardised food. The notification of about 11,000 horizontal standards for the additive is likely to reduce the need for Product Approvals to some extent. However, as per FSSAI, so long as an FBO prefers to place a product in the market as a ‘Proprietary Food,’ claiming exclusivity to the same, requiring risk and safety assessment, the system of Product Approvals will continue.
Online Food Product Approval System for the FBO
Earlier, the FSSAI Product Approval process used to be manual wherein the Product Approval application and a demand draft for the prescribed fee had to be submitted to the FSSAI office in New Delhi. However, to cope with the increase in Product Approval applications and bring in transparency into the system, FSSAI has recently introduced the Food Product Approval System (FPAS). Product Approval application can now be submitted and tracked online through the FSSAI FPAS online system.
Steps of Online Food Product Approval System for the FBO
FBO Registration in FPAS
New Application
Eligibility Check of the Application
Product Details of the Application
Ingredient Details of the Application
Additive Details of the Application
Supporting Documents of the Application
Summary PDF of the Application
Online Payment
Submission of the Application
Application Reference ID
To make an FSSAI Product Approval application the following information pertaining to the company and product is required: Business Name; Business Address; Email; Phone Number; Manufacturers’ Address; Type of Business (Manufacturer / Importer / Retailer / Marketer); Product Origin; Country of Origin; Existence in the Market; Common Name; Brand Name; Method of Manufacturing; Claim, if any; Shelf Life of the Product; Pack Size; Serving Details; and Ingredients Details.
In addition to the above information, the following documents must also be submitted in the FSSAI Product Approval application: Label for the food product; Method of manufacturing; Accelerated stability datasheet; Realtime stability datasheet; End Use Declaration Document; Certificate of Analysis from NABL Lab; Undertaking and Form-9.
The FSSAI has also prepared the Explanatory Notes with a view to assisting the FBOs about the particulars required to be given in an application. The link for these explanatory notes is -http://www.fssai.gov.in/Portals/0/Pdf/Explanatory_Notes_on_Product_Approvals.pdf
India is slated to be the food factory of the world. Making the regulatory process conducive for innovation will multiply the industry several fold.
