Standardized Format for Submission of Representation Seeking Risk Assessment

File No. SS-G004/1/2024-Standard-FSSAI (Part-I)
FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA
(A Statutory Authority established under the Food Safety & Standards Act, 2006)
(Science and Standards Division)
FDA Bhawan, Kotla Road, New Delhi – 110002

Dated, 24^th December, 2025

OFFICE ORDER

Subject: Implementation of Standardized Format for submission of representation seeking risk assessment – reg.

The Food Safety and Standards Authority of India (FSSAI) is responsible for laying down science-based standards for articles of food and regulating their manufacture, storage, distribution, sale, and import, to ensure availability of safe and wholesome food for human consumption.

2. It is observed that representations submitted to the Science and Standards Division often lack requisite data or a harmonized format. To address this, and to ensure smooth management, tracking, and transparency by the Authority, a standardized format (enclosed) is hereby implemented for compliance. This will enable the Scientific Panels and Scientific Committee to conduct risk assessments in alignment with the Food Safety and Standards Authority of India (Transaction of Business and Procedure for the Scientific Committee and Scientific Panel) Regulations, 2016.

3. FSSAI further invites all stakeholders including FBOs, industry associations, research institutions, professionals, and citizens to voluntarily share data generated through monitoring, internal assessments, or R&D relevant to food safety and nutrition, in the prescribed format. Submissions will be treated as CONFIDENTIAL and utilized solely for scientific evaluation, standard-setting, and policy purposes.

4. Such representations must be submitted exclusively through the NSC portal (https://nsc.fssai.gov.in/) under the ‘Submit Representation’ section, effective from 1st January 2026.

5. FSSAI values stakeholder contributions toward a safer food ecosystem and looks forward to active participation in this collaborative effort.

Enclosure: As above.

Digitally signed by Alka Rao
Date: 24-12-2025 13:44:40
Dr. Alka Rao, Advisor
Science & Standards & Regulations
Food Safety and Standards Authority of India

To,

1. All Food Business Operators and other stakeholders

Copy to:

1. PS to Chairperson, FSSAI
2. PS to CEO, FSSAI
3. JS, FR, MoHFW
4. CTO, with a request to upload it on FSSAI website

---

Annexure

FORMAT FOR SUBMISSION OF REPRESENTATION
(Submit online using NSC portal : https://nsc.fssai.gov.in/)

1. Title of the Proposal: Brief title of the representation
2. Submitted by: Details of Name, Designation & Organisation
3. Type of Submission: New Proposal OR Revision/Amendment request OR Clarification request OR Ease of doing business OR Consumer information/empowerment OR Sector Specific /MSME /State issues OR Any other
4. Purpose of Submission: Standard development, Specific Product Risk assessment, Policy recommendation/suggestion, Any other
5. Reference to FSSAI regulations: Select relevant Food Safety and Standards Regulation.
6. Nature of the concern: Public health related/safety concern, Trade concern, Nutritional concern, Harmonisation with global standards, Any other
7. Scientific/Technical Rationale for proposal: Brief description up to 500 words
8. Any information available on global regulatory status: Select Yes or No. If yes, provide the summary of information up to 500 words.
9. Regulatory impact assessment: Select Yes or No. If yes, enclose supporting document and briefly describe how the proposal will impact the current existing scenario and will include the following: Problem description, Baseline analysis, Cost-benefit analysis, Consideration of alternatives, Evidence based analysis, Monitoring and evaluation framework Name of the country where the proposed regulatory provision already exists, Food Regulatory Agency of the country where the proposed regulatory provision exists, Years of usage, Additional details
10. Scientific Literature/Studies related to the proposal: Select Yes or No. If yes, enclose supporting document and briefly describe the Title of Study, Name of Journal, Year of publication, Place of study, Duration of Study, Brief methodology followed, Sample size and Conclusion/key findings
11. Details of the technology and manufacturing process: Select Yes or No. If yes, enclose supporting document
12. Allergenicity Information: Select Yes or No. If yes, enclose supporting document and briefly describe how the ingredient/final product/additive may be allergenic and describe which section of the population has to avoid/practice caution while consuming the product.
13. Toxicological Studies: Select Yes or No. If yes, enclose supporting document and briefly describe the key findings of the toxicological analysis including Metabolism/ Toxicokinetics, subchronic toxicity, genotoxicity, chronic toxicity, carcinogenicity, reproduction and developmental toxicity, etc. in case of food additives, pesticides, contaminants, antibiotics, etc.
14. History of Consumption in other Countries: Select Yes or No. If yes, enclose supporting document and briefly describe the place and years where history of safe usage is available.
15. Country of Harvest: Select Yes or No. If yes, enclose supporting document on production/harvesting details of the food commodity.
16. Implications on trade and Import & Export and Domestic production details: Select Yes or No. If yes, enclose supporting document and briefly describe the year wise (last 5 years) details of volume and financial implications of domestic production, import and export, place of import/export, etc. and how the proposal will affect trade aspects.
17. Domestic Dietary consumption data: Select Yes or No. If yes, enclose supporting document and provide details of consumption of the proposed product/ingredient/ additive etc., consumption patterns/habits, etc.
18. Nutritional Information: Select Yes or No. If yes, enclose supporting document and provide details of the nutritional information associated with the proposed product/ ingredient.
19. Acceptable Intake/Safe Upper Limit: Select Yes or No. If yes, enclose supporting document and provide details of the available acceptable intake or safe limit of consumption of the proposed product.
20. Testing methodology: Select Yes or No. If yes, enclose supporting document and provide details whether testing method is available in FSSAI manual/ any AOAC/internationally recognised method is available for testing the parameters relevant to the proposed product/ingredient
21. Details of laboratory (ies) where samples analysed, along with NABL accreditation details: Select Yes or No. If yes, enclose supporting document and provide details whether testing method is available in FSSAI manual/ any AOAC/internationally recognised method is available for testing the parameters relevant to the proposed product/ingredient
22. Suggested Action by Panel/Committee: Provide suggestions on the proposal with scientific rationale.
23. Contact person: Details of contact Name, Email and Mobile number.