Venturing into the “mouth-watering” and diverse food and beverage industry in India, be it through a restaurant or a food manufacturing / processing unit or even an online food delivery service, you must first ensure that you are fulfilling the regulations and guidelines set by the Food Safety and Standard Authority of India (FSSAI). As daunting as it may sound, fear not, for in this blog, we will walk you through the whole process and requirements for obtaining product approval(s) and everything else connected to this.

What is FSSAI?

Food Safety and Standards Authority of India (FSSAI) is an autonomous body established under the Ministry of Health & Family Welfare, Government of India. FSSAI has been established under the Food Safety and Standards Act, 2006 (Act) which is a consolidating statute related to food safety and regulation in India. By and large  FSSAI is responsible for protecting and promoting public health through the regulation and supervision of food safety.

FSSAI performs the following functions:

• Framing of Regulations to lay down the Standards and guidelines in relation to articles of food and specifying appropriate system of enforcing various standards thus notified.
• Laying down mechanisms and guidelines for accreditation of certification bodies engaged in certification of food safety management system for food businesses.
• Laying down procedure and guidelines for accreditation of laboratories and notification of the accredited laboratories.
• Collect and collate data regarding food consumption, incidence and prevalence of biological risk, contaminants in food, residues of various, contaminants in foods products, identification of emerging risks and introduction of rapid alert system.
• Creating an information network across the country so that the public, consumers, Panchayats etc receive rapid, reliable and objective information about food safety and issues of concern.
• Provide training programmes for persons who are involved or intend to get involved in food businesses.
• Contribute to the development of international technical standards for food, sanitary and phyto-sanitary standards.
• Promote general awareness about food safety and food standards.

How being registered with the FSSAI helps you as owner?

FSSAI wants to be more than just a Food & Beverage (F&B) industry regulator. They play the role of a collaborator to F&B business owners. So as a manufacturer / retailer, you already have a ready network in place which is keen to work with you and help you be compliant.

What is FSSAI product approval?

The FSSAI has, through the Food Safety and Standards Act and various regulations made thereunder, set standards for different kinds of food products available throughout the country. These cover a wide range of food products. However, there are several food products/ingredients which are still not covered in any of the regulations made under Food Safety and Standards Act, 2006. Such products require the approval of FSSAI and appropriate authorities before they are introduced to the market. Also, if the product has a health claim; that is, the product is marketed as ‘good for the heart or liver’ then Food Business Operators[1] (“FBO”) are required to apply for  product approval. The NAB-Accredited lab test reports must be provided to validate such  claims.

In order to regulate such products and provide the opportunity to Food Business Operators to innovate food products, FSSAI came up with Food Safety and Standards (Approval of non-specified food and food ingredients) Regulations, 2017 (“Regulations”). This regulation lays down the rules and procedure for grant of prior approval of non- specified food and food ingredients. The regulation covers the following articles of food or food ingredients:

1. Novel food or novel food Ingredients or processed with the use of novel technology

2. New additives

3. New processing aids including enzymes

4. Articles of food and food ingredients consisting of or isolated from microorganisms, bacteria, yeast, fungi or algae.

In the present time, in order to expedite the process of obtaining approvals for food products, the FBOs do not have to physically submit the application for obtaining product approval. As an alternative, the FBOs can apply for the FSSAI product approval online. The online product approval procedure is very simple and brings transparency in the system. Food Business Operators can submit and track their application status online. Also, at the FSSAI website, one can get the required and detailed information about the Food Product Approval System, FSSAI guidelines and documentation details required during the application.

The Process for obtaining Food Product Approval[2]:

• The manufacturer or importer of non-specified food is required to submit an application in FORM – I of these regulations along with necessary documents and fee to the Food Authority.
• Scrutiny of the application and information provided by the applicant.
• Submission of additional supporting documents, data or clarifications, if required.

[1]  Under section 3 (n) of the Food Safety and Standards Act 2006, ‘food business’ has been defined as any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of manufacture, processing, packaging, storage, transportation, distribution of food, import and includes food services, catering services, sale of food or food ingredients.

Under section 3 (o) of the Food Safety and Standards Act 2006, ―’food business operator’ in relation to food business means a person by whom the business is carried on or owned and is responsible for ensuring the compliance of this Act, rules and regulations made thereunder.

[2]  Regulation 3 and 4 pertaining to   Prior approval for manufacture, storage, sale, distribution, import of any non-specified food or food ingredient and Procedure for grant of prior approval respectively, of the Food Safety and Standards (Approval of non-specified food and food ingredients) Regulations, 2017.

• The Food Authority may either grant approval or reject the application, as per FORM-II, on the basis of the safety assessment of the article of food.
• Where approval is granted, the food business operator must submit to the Food Authority, a certificate of analysis in respect of the chemical, physical, microbiological and nutritional parameters of the food manufactured or imported.

General Information which must be submitted to FSSAI in FORM – I for obtaining Product Approval are as follows:

1. Name of the applicant.
2. Name of the authorised person.
3. Mobile No. / Phone No.
4. E-mail (All communications will only be made through the above email and phone number).
5. Name of the organisation.
6. Address of the organisation/registered office.
7. Licence number, if any.
8. Nature of business.
9. Name of the food product/ ingredient/additive/enzyme/processing aid, and proprietary name, if any.
10. Justification of the name.
11. Proposed product category.
12. Source of food ingredient(s) (animal, chemical, botanical or micro-biological).
13. In case of animal, botanical or micro-biological source, genus and species of the organism shall be mentioned.
14. Functional use.
15. Intended use.
16. Certificate of analysis from third party National Accredited Board of Laboratories (NABL) or International Laboratories Accreditation Cooperation (ILAC) recognised laboratories must be provided. The certificate of analysis must include physical, chemical and microbiological parameters relevant to the product along with the validated test method and other test methods, if any with references wherever applicable.
17. Manufacturing process in brief.
18. Regulatory Status (Mention the countries where the product is permitted for direct or indirect human consumption as food. If so, provide the level and purpose of consumption by the consumers with the relevant regulations along with the documentary evidence.)
19. Copy of agreement of relationship of applicant and manufacturer and other entities involved in the food business of the proposed product, namely, marketer, importer, re-packer.
20. Safety Information(Documents on risk assessment or toxicity studies)  (a) The information shall be based on safety or risk assessment review from published studies and safety studies conducted on the ingredient and food product by the applicant (b) Provide evidence to demonstrate that the proposed product or the ingredient will not adversely affect any specific population groups that is pregnant women, lactating mothers, children, elderly or any other vulnerable groups.

How Product Approvals can benefit you:

• Your product will be completely safe for consumption and therefore preferred over products that are not.
• The inspection process has been standardized to ensure minimal loss of time and repute.
• As the safety and quality tests are highly precise and in accordance with the global standards, you will attract international customers.

Author:

Anurag Mitra, Associate, Legal Operations

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