1. These regulations may be called the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Amendment Regulations, 2021.

2. In the ‘Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, the regulation (4) relating to the ‘Procedure for grant of prior approval’ shall be substituted with the following, namely, -

“4. Procedure for grant of prior approval. ―(1) The manufacturer or importer of non-specified food shall submit an application in FORM – I of these regulations along with necessary documents and fee to the Food Authority.

 (2) The Food Authority shall scrutinize the application and information provided by the applicant. On preliminary scrutiny, deficiencies, if any, shall be informed to applicant within 45 days from the date of receipt of application.

 (3) The Food Authority may direct the applicant to submit additional supporting documents, data or clarifications, if required. The food business operator shall submit the information sought for within 30 days from the issuance of the letter.

(4) 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.

(5) While approval is granted, the Food Business operator shall conduct and provide a post market surveillance data on relevant Safety and efficacy parameters, within one year of placing the product in the market whenever asked by the Authority.

(6) The food business operator may file an appeal before the Chairperson, Food Authority against any decision of rejection of his application within 30 days of the receipt of the letter. The appeal made after 30 days shall not considered and the application is treated as closed.

(7) A food business operator, who is aggrieved by the decision of the Chairperson, Food Authority may file review petition to be placed for consideration in the meeting of the Food Authority.

 (8) The Food Authority may, for reasons to be recorded in writing, suspend or revoke any approval granted to any food business operator.

(9) The Food Authority may review from time to time, the amount of fee for filing an application. The fees paid by the applicant for processing of application shall not be refunded under any circumstances.

(10) If a food business operator has reason to believe that the food for which the approval has been granted poses any risk to health, he shall 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.

 (11) Food Safety Officers and Designated Officers shall immediately inform the Food Authority of any complaint received regarding safety of any product approved by the Food Authority under these regulations.

12) The food business operator shall, after grant of approval apply for license as per the procedure specified in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.

13) The food authority may appoint an expert committee(s) or panel to examine the application submitted by food business operators.

FORM – I

(See sub-regulation (1) of regulation 4)

(Application for approval of non-specified food and food ingredient)

1. Application for*(Please tick (√) only one): -

o Novel food^#

§  Novel food product

§  Novel food Ingredient 

§  Processed using novel technology

o Additive

§  Not listed in Food Safety and Standards regulations (FSSR)

§  Listed in FSSR but from an unlisted/unconventional source

o New processing aid/enzyme

§  Not listed in FSSR

§  Listed in FSSR but from an unlisted/unconventional source 

o Non-specified food, please specify,

§  New botanical or processed botanical

§  New fruit or fruit based product

§  Probiotic and Prebiotic

§  Any other, please specify

o Pre-mix of ingredients or additives, requiring approval under non-specified food category

*Data in Form I. 3. (d) shall be submitted, in case the application pertains to any of the categories listed above and consists of or is isolated from microorganisms.

^#For the purposes of these regulations novel food is a food that may not have a history of human consumption; or may have any ingredient used in it which or the source from which it is derived, may not have a history of human consumption; or a food or ingredient obtained by new technology with innovative engineering process, where the process may give rise to significant change in the composition or structure or size of the food or food ingredients which may alter the nutritional value, metabolism or level of undesirable substances.

2. General information: -                                

(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)              Name and address and contact details of the premises where the ingredient covered in the application is manufactured or processed.

(Note: If this is different from the response to query 5 and 6 provide details including regulatory licenses applicable to the premises and provide name and contact details of the representative)

(9)              Nature of business

(10)         Name of the product for which application is submitted 

(11)         Justification of the name

(12)         Proposed product category

(13)         Source of food ingredient(s) (animal, chemical, botanical or micro-biological)

(14)         In case of animal, botanical or micro-biological source, genus and species of the organism shall be mentioned

(15)         Functional use

15.1 health benefits claimed for the product and on the label, if applicable

15.2 ‘end use declaration’ for product/pre-mix /ingredient /additive imported or manufactured for supply to other FBOs

Note: applications covered under 15.2 above shall provide:

a)     Data comprising proposed formulation(s), usage levels, specification of the formulation(s), testing methods and shelf life study results (accelerated stability study results are acceptable).

b)     A notarized affidavit by the authorized signatory stating that all the conditions communicated by the Authority in the approval letter shall be informed in writing to each of the FBOs to whom the material would be supplied for strict compliance. Any modification in the above conditions would necessitate prior approval of the Authority.

(16)         Certificate of analysis from third party National Accredited Board of Laboratories (NABL)/International Laboratories Accreditation Cooperation (ILAC) shall be provided. The certificate of analysis shall include physical, chemical and microbiological parameters relevant to the product along with validated test methods and other test methods, if any with references wherever applicable

(17)         Manufacturing process in brief (flow sheet with details)

(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 (Indexed journals) and safety studies conducted on the ingredient or food product by the applicant adopting OECD (Organization for Economic Co-operation and Development) guidelines or safety studies as prescribed under Schedule ‘Y’ of D & C Rules, 1945 as amended (Safety data to be summarized in Annexure A).

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.

(21) Claim support documentation (Provide evidence to support the intended health benefit claims through robust scientific studies including human intervention studies or human clinical studies. Provide supporting published literature (Indexed journals), results of in-vitro and in-vivo studies and studies done on population relevant to India (Health benefit data to be summarized in Annexure B, if applicable).

(22) Copy of the proposed label as per relevant Food Safety and Standards Regulations.

(23) Declaration to conduct and provide post marketing surveillance data in specific cases if indicated in the Form II.

(24) Declaration to keep the information shared by the firm in Form I as confidential.

3. Additional specific information: -

(a) Novel food or novel food Ingredients or food processed with the use of novel technology: -

(1)    The target group for the said proposed food, if any

(2)    Detailed composition of the product (with quantity of the ingredients and additives added in the product)

        Any new ingredient(s) (Please 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)

(3)    Details of new technology

(4)   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 mutagenecity, 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 Organization or by other national or international agencies responsible for food safety or public health)

(5)    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)

(b) New additives: -

(1)     Chemical name and INS No.

(2)     Purity (food grade or equivalent)

(3)     Acceptable Daily Intake (ADI) specified by JECFA or any other risk assessment body

(4)     Proposed level of use in food category

(5)   In case of colouring agent provide (Colour Index) colour number, where applicable

(c) New processing aids including enzymes: -

(1)           Specification

(2)           Enzyme activity

(3)           Purity including total organic acid (as per the standards)

(4)           Residual limit in the final product (in case of processing aid)

(d) Articles of food and food ingredients consisting of or isolated from microorganisms, bacteria, yeast, fungi or algae: -

Note: (1) Mention “not applicable” (NA) wherever necessary.

(2) 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.

Annexure A

Format for providing summary of data for safety

1. in-vitro data

2.  Summary of in-vivo safety (pre-clinical toxicology) investigations

Annexure -I

1.   Description to provide summary of in-vitro data

1.1. Describe the material tested, purity, in case of botanicals or biological material provides information on their standardization / marker compounds tested / activity tested.

1.2. Provide information on bacteria, yeast or any other microbes against which testing was done including their NTCC / accn. Number / details of cell lines / details of organ culture or tissue culture or any other system.

1.3. Provide information on Concentrations tested, negative and positive controls used in the experiments.

1.4. Provide information on what aspects were measured as outcome of the test. For example, IC 50, cytotoxicity, dye uptake or reduction in dye uptake, preventing rate of growth.

1.5. Give brief summary of the results obtained, comparison with controls, and any dose response relations reported.

1.6. Provide complete reference of the publication. If the data is not published in peer reviewed journals, but forms a study report give details of the report covering where the study was undertaken, name of the institute or laboratory and its accreditation status and provide authenticated copy of the same. Provide full length paper copy of the most important study only and give a commitment to provide copy of other publications listed in the table when requested.

2.   Safety studies: Provide justification on use of test material for normal human consumption.

2.1  Test compound profile and exposure level:

2.1.1      Describe the material tested for purity, in case of botanicals/ biological material /food / food additives and color additives along with their standardization / marker compounds tested.

2.1.2      Rationale for selecting the exposure level for experimental evaluation should be based on the intended /day / duration in human. The test exposure level should be calculated by standard body surface area method in laboratory animal selected.

2.1.3      Provide Rational for selecting the species.

2.1.4      Describe the rational for selected tests listed.  

2.2  Acute toxicity: To determine toxic manifestations of the test substances preferably in two rodent animals (mice, rats/rabbits) exposed to test compound within 24-hours period.

2.2.1      The study must provide the safety of a test compound at an exposure limit of 2gm/kg or at least 10 times of the intended human exposure level and route.

2.2.2      The data should provide the observations on body weight gain, Toxic signs and the severity, onset, progression and reversibility of the signs and mortality, if any, for 14 days after exposure of test compound.

2.2.3      In case of mortality the Necropsy findings along with histopathological report be enclosed.

2.3  Long term toxicity: To determine toxic manifestations of the test substance in two rodentanimals (mice and rats/rabbits) exposed to test material repeatedly as per the intended human use.

2.3.1      The study is required to be done with three exposure levels viz., Intended Human Exposure level (Therapeutic Dose (TD)), Average (2.5/5 X TD), High (5/10 X TD), In addition, vehicle control group should be included.

2.3.2      Dose level spacing should be designed to demonstrate a dose response and establish a NOAEL or other intended outcome of the study.

2.3.3      The data should provide the observations on Physical, physiological, food intake, body weight gain, clinical-chemistry and Hematology along with gross necropsy and histopathology of major and targeted organs. In case of mortality the animals may be subjected to gross necropsy and histopathology and a report may be enclosed.

2.3.4      In case the test material has a potential allergencity/mutagencity, the reports on special investigation have to be enclosed. 

Annexure B

Format for providing summary of data for health benefit claims

1A. Summary of in-vitro data

1.       Describe the material tested, purity, in case of botanicals or biological material provides information on their standardization / marker compounds tested / activity tested.

2.       Provide information on bacteria, yeast or any other microbes against which testing was done including their NTCC / account Number / details of cell lines / details of organ culture or tissue culture or any other system.

3.       Provide information on Concentrations tested, negative and positive controls used in the experiments.

4.       Provide information on what aspects were measured as outcome of the test. For example, IC 50, cytotoxicity, dye uptake or reduction in dye uptake, preventing rate of growth.

5.       Give brief summary of the results obtained, comparison with controls, and any dose response relations reported.

6.       Provide complete reference of the publication. If the data is not published in peer reviewed journals, but forms a study report give details of the report covering where the study was undertaken, name of the institute or laboratory and its accreditation status and provide authenticated copy of the same. Provide full length paper copy of the most important study only and give a commitment to provide copy of other publications listed in the table when requested.

1B. Summary of in-vivo data

(1)   Describe the material tested, purity, in case of botanicals or biological materials provide information on their standardization/marker compounds tested/activity tested.

(2)   Provide information on laboratory animal, knockout animals, live or anesthetized / isolated active organ of animals (isolated ileum, skin cultures, isolated heart as examples) or any other system.

(3)   Provide information on Concentrations tested, negative and positive controls used in the experiments.

(4)   Provide information on what aspects were measured as outcome of the test. For example, IC 50, pharmacological activity measures, gene expression, specific protein uptake or regulation, biochemical markers, toxicology markers.

(5)   Give brief summary of the results obtained, comparison with controls, and any dose response relations reported.

(6)   Provide complete reference of the publication. If the data is not published in peer reviewed journals, but forms a study report give details of the report covering where the study was undertaken, name of the institute or laboratory and its accreditation status and provide authenticated copy of the same. Provide full length paper copy of the most important study only and give a commitment to provide copy of other publications listed in the table when requested.

1C. Meta Analyses

Summary of individual clinical studies section/table can be omitted if good intervention meta-analysis is available and summarized.

1D. Summary of human study data

(1)   Describe briefly the nature of study namely – open label, intervention study, randomization, blinding or population study or diet and outcome surveys or epidemiological data collection and analyses.

(2)  Provide information on Concentrations tested, negative and positive controls used in the experiments.

(3)   Give brief information on nature of subjects / volunteers / patients involved in the study. For example, normal healthy volunteers, pre-diabetics, mild to moderate hypertensive patients, volunteers with specified BMI etc.

(4)  Give brief summary of the design of the study like matched panels, groups involved, cross over design, superiority study, addition study. State the number of volunteers or subjects or population or patients in each group giving details of number screened, number enrolled, number whose data is available, number drop outs. Also state the statistical analyses of the data reported and test of significance. Also provide approval status of the study by DRB / EC, adoption of informed consent.

(5)   List the inclusion and exclusion criteria.

(6)   State duration of the study – study period, duration of intervention, wash out period if any and period of observation post stoppage of intervention.

(7)   Provide information on what aspects and variables were measured as outcome of the study. For example, pharmacological activity measures, biochemical markers, physiological parameters measured using instrumental technics like EEG, TMT, echo, bone density, image analyzers etc. Provide information on adverse reactions and safety aspects evaluated including quality of life measurements and reported in the study. Specifically, state if the study does not report the safety or adverse reactions or no mention is made of this aspect. If any of the study provided in this summary table covers a Cochrane review or a meta analyses review* provide summary of the same.

(8)  Give brief summary of the results obtained, comparison with controls, and any dose response relations reported. Provide information on adverse reactions and safety aspects evaluated including quality of life measurements and reported in the study. Specifically, state if the study does not report the safety or adverse reactions or no mention is made of this aspect.

(9)  Provide complete reference of the publication. If the data is not published in peer reviewed journals, but forms a study report give details of the report covering where the study was undertaken, name of the institute or laboratory and its accreditation status and provide authenticated copy of the same. Provide full length paper copy of the most important study only and give a commitment to provide copy of other publications listed in the table when requested.

2.         Summary of claim support data for claims pertaining to performance / technological advantages / consumer convenience and other claims which are not health benefit. The following type of claim statement provide examples of claims covered under 2.

2.1 Claims pertaining to bioavailability.

2.2 Comparative content claims. 

2.3 Stability or reduction in degradation during cooking or processing.

2.4 Claims related to adherence or sticking of cooking medium to the food processed.

2.5 Retention of aroma or taste.

2.6 Others, not covered above.

For the above claims appropriate scientific supporting data or documentation should be provided. In case of 2.1 details of the bioavailability study or bioequivalence study or comparative bioavailability study performed or reported in published scientific literatures or unpublished scientific study report. Provide detailed references and copies. In case of 2.2 results of analyses of relevant samples using validated analytical techniques conducted by an accredited laboratory would be required. Similar data would apply to claims belonging to 2.3 to 2.5. Focus would be on the scientific validity of the methods employed, expertise of the institution where study was conducted, and application of satisfactory statistical involvement.

3.         For any of the claims under 1 or 2 above if any IPR exists provide the nature of the IPR with a commitment to provide copies of the same if demanded. For any of the claims under 1 or 2 above if claim support data includes regulatory approvals granted specifically or notified in regulations in other nations provide information in a summary table. In case of specific approvals granted state the same and authenticated copies of the same. For example, GRAS listing or ingredients / product / claim approval received by the FBO or applicant.