Through a notification dated 11 September 2017, the FSSAI has notified the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. These regulations have been finalized after consideration of the comments received from stakeholders and these will come into force on their final publication in the Official Gazette of India.
After the order of the Hon’ble Supreme Court dated 19 August 2015, it became imperative for the FSSAI to discontinue the existing advisory based product approval system. In its place, the FSSAI knew there was a requirement for a legitimate process for the use of non-standardized food products/ingredients. This regulation, therefore, lays down the rules and procedure for grant of prior approval of non-specified food and food ingredients which will replace the former product approval system, which was prevalent for food products and products containing ingredients for which there were no standards.
Some important steps that the FSSAI took to address the situation in the absence of a product approval system are as follows:
- Revised the definition of proprietary foods in Food Safety and Standards (Food Product Standards and Food Additives) Ninth Amendment Regulations, 2016
- Notified the Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for special dietary uses, Foods for medical purposes, Functional foods and Novel foods) Regulations, 2016
- Amended the Food Safety and Standards (Food Product Standards and Food Additives) Seventh Amendment Regulations, 2016 relating to harmonization of food additives
The above-mentioned regulations have covered a number of products that would have otherwise required specific approvals. However, there are still many products or ingredients that have not been covered under these regulations. In order to regulate such products, including novel foods and to provide an opportunity to FBOs to innovate food products the FSSAI has made the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. This regulation covers the following foods or food ingredients
- Novel food or novel food Ingredients or processed with the use of novel technology
- New additives
- New processing aids including enzymes
- Articles of food and food ingredients consisting of or isolated from microorganisms, bacteria, yeast, fungi or algae
In the new regulation, FSSAI has defined Non-specified food as “any food other than proprietary food or food ingredients, including additives, processing aids and enzymes for which standards have not been specified in any regulation made under the Act.”
FBOs will need to take prior approval for manufacture, storage, sale, distribution, import, etc. of any non-specified food or food ingredient according to the guidelines in the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017. These regulations are in addition to and not in derogation of any other rules and regulations made under the Act.
Procedure for grant of prior approval
The step by step procedure is as follows
- The manufacturer or importer of non-specified food has to first submit an application in FORM – I the format for which has been given in the regulation.
- Along with the Form – 1 all necessary documents and fee have to also be submitted to the Food Authority (The fee may be reviewed from time to time).
- After scrutiny of Form – I and other documents it is possible that the Food Authority could ask for additional documents, data or clarifications if required.
- The Food Authority may then grant approval or reject the application on FORM-II and which will be based on the safety assessment of the article of food.
- If approval is granted, the next step for the FBO is to 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.
- After grant of approval, FBO must apply for license as per the procedure specified in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011
Rejection of Application
The FBO can file an appeal before the Chairperson, Food Authority against any decision of rejection of the application. If FBO is still aggrieved about the decision of the Chairperson, Food Authority then they may file a review petition to be placed for consideration at the meeting of the Food Authority. The Food Authority may suspend or revoke any approval granted to any FBO with reasons recorded in writing.
Provision for Recall
If an FBO has reason to believe that the food for which the approval has been granted poses any risk to health, he has to immediately suspend the manufacture, import, sale, or distribution of such article of food and take steps to recall the same under intimation to Food Authority in accordance with the provisions of the Food Safety and Standards (Food Recall) Regulations, 2017.
All Food Safety Officers and Designated Officers must immediately inform the Food Authority of any complaint received regarding the safety of any product approved by the Food Authority under these regulations.
FORM – I
(Application for approval of non-specified food and food ingredient)
- Application for type of food (Please tick √):-
O Novel food, novel food Ingredients or processed with the use of novel technology
O New additives
O New processing aids including enzymes
O Articles of food and food ingredients consisting of or isolated from bacteria, yeast, fungi, algae or microorganisms.
O Any other non-specified food, please specify
- General information to be filled in the application form
(1) Name of the applicant
(2) Name of the authorized 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 organization
(6) Address of the organization/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 microbiological)
(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) recognized laboratories shall be provided. The certificate of analysis shall 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 group.
- Additional specific information required
In the case of Novel food or novel food Ingredients or food processed with the use of novel technology, the following information has to be provided.
- The target group for the said proposed food, if any
- Detailed composition of the product including quantity of the ingredients and additives added in the product
- Any new ingredient(s) and need to specify if the product has one or more new ingredients which as on date is not listed in Food Safety and Standards Regulation, or an ingredient which has been introduced for the first time in India
- Details of new technology to be used if any
- Safety Information (Documents on risk assessment or toxicity studies to be attached)
(a) Information on human studies including dietary exposure, nutritional impact and potential impact on the consumer if any
(b) Toxicological studies including results of Ame’s tests to test mutagenicity, chromosomal aberration tests, studies for reproductive toxicity, prenatal developmental toxicity studies.
(c) Allergenicity (published or unpublished reports of allergenicity or other adverse effects in humans associated with the food consumption; may include reports prepared by World Health Organisation or by other national or international agencies responsible for food safety or public health )
- History of consumption of food product/food ingredient, (attach supporting documents)
(a) Geographical area of use (with established history of safe use in at least two countries, with well-established regulatory status)
(b) Quantity of consumption
(c) Duration of consumption (in years)
In case of new additives, the following information must be provided
- Chemical name and INS No.
- Purity (food grade or equivalent)
- Acceptable Daily Intake (ADI) specified by JECFA or any other risk assessment body
- Proposed level of use in food category
- In case of coloring agent provide (Colour Index) color number, where applicable
In case of new processing aids including enzymes, the following information is required
- Enzyme activity
- Residual limit in the final product (in case of processing aid)
The following information is required if articles of food and food ingredients consist of or isolated from microorganisms, bacteria, yeast, fungi or algae
|S.No||Data required for microorganisms used as Food (Directly Fed) or used as a source of food ingredients|
|(1)||Nature of microbe||Bacterium/Yeast/Fungus/Algae|
|(2)||Name of the microbe||Genus||Species||Strain|
|(4)||Of locally isolated||Isolated|
|Deposited in the national culture collection center (eg-Microbial Type Culture Collection and Gene Bank, (MTCC), National Collection of Dairy Cultures (NCDC) Indian Type Culture Collection (ITCC))||Yes||No|
|(5)||If deposited in a national culture collection centre||Name and address of Culture collection centre||Reference
|(6)||If bought from national culture collection centre||Name and address of Culture collection centre||Reference
|(7)||If imported and privately
|Country of origin||Reference
|Name and address of
the Foreign organization/Industry
|(8)||If bought from an
international culture collection center (e.g. American Type Culture Collection center (ATCC), European Culture Collections Organisation (ECCO))
|Name and address of
International Culture Collection Centre
Agreement between exporter/foreign entity and importer/manufacturer in India
|(10)||If the organism has been genetically manipulated.||Yes||No|
|(11)||Any institutional bio safety mechanism in place|
|(12)||Safety / Generally Recognised as Safe status (GRAS) of the microbe||Copy|
|(13)||Declaration by the
manufacturer or importer regarding safety and end use
|The undersigned verifies that all ingredients are approved for use by the Export Country National Regulator or appear on their Generally Recognised as Safe list (Name of the Regulatory Agency), and each product is intended for human consumption and is available for sale in the country of origin without restriction|
Note: (1) Mention “not applicable” (NA) wherever necessary.
All data documentary evidence provided by the applicant shall be from international peer reviewed journals, international bodies including World Health Organization (WHO) and Food and Agricultural Organization (FAO). Only complete records or studies shall be provided.
FORM – II is approval/ rejection given by the Food Authority.
This article provides just a synopsis of the main features of the FSSAI Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017.