Major Regulatory Update for Food Businesses, Importers & Nutraceutical Companies
The Food Safety and Standards Authority of India (FSSAI) has issued an Office Order dated 06 May 2026 introducing a Single Window System through ePAAS (electronic Product and Claim Approval Application System) for applications related to prior approval and risk assessment.
The system has been introduced to ensure:
- Transparency in approval mechanisms
- Uniformity in risk assessment procedures
- Centralized digital processing of applications
- Streamlined monitoring and review process
- Efficient appeal and review mechanism
Effective from 01 June 2026, all applications covered under this order must be submitted only through the ePAAS portal.
FSSAI has further clarified that:
- Manual applications will not be accepted
- Offline submissions will not be accepted
- Email-based submissions will not be accepted after the effective date
Scope of ePAAS System
The ePAAS portal will act as a unified digital interface for:
- Submission of applications
- Processing of applications
- Monitoring of application status
- Risk assessment activities
- Appeal and review procedures
The portal applies to products, ingredients, and claims requiring prior approval under applicable FSSAI regulations.
Applications Covered Under Mandatory ePAAS Filing
The following applications must now be submitted exclusively through the ePAAS portal:
- Approval of Non-Specified Food and Food Ingredients (NSF&FI)
- Authorization of r-PET
- Approval of Health Claims
- Approval of Ayurveda Aahara
- Food for Special Medical Purpose (FSMP)
- Vegan Endorsement
- Notification of esters, derivatives, and salts of vitamins
- Notification of salts and chelates of minerals
- Notification of esters, derivatives, isomers, and salts of amino acids
- Any other food, product, process, or system requiring prior approval under the Food Safety and Standards Act, 2006 or regulations made thereunder
Application Forms and Formats
Unless otherwise specified under the relevant Food Safety and Standards Regulations (FSSR):
- Application forms will remain the same
- Filing formats will remain the same
- Documentation structure will continue as prescribed under the Food Safety and Standards (Approval of Non-Specified Food and Food Ingredients) Regulations, 2017
Important Regulatory Areas Mentioned in Annexure-I
The advisory specifically lists regulatory provisions requiring prior approval or notification in the following areas:
Food Products Standards and Food Additives Regulations, 2011
- Vanaspati prepared using edible vegetable oils requiring prior approval
- Additional ingredients in caffeinated beverages requiring safety assessment and scientific substantiation
- Herbs used in non-carbonated water-based beverages requiring toxicological data and approval
Health Supplements, Nutraceuticals, FSMP, and Novel Food Regulations, 2016
- Health benefit claims for cereals, legumes, fruits, vegetables, and spices
- Single purified chemical entities sold as nutraceuticals or health supplements
- Ingredient based health claims under Advertising and Claims Regulations
- Product claims requiring prior approval
- Product-led health claims requiring notification to FSSAI
- Inclusion of new nutrients or substances with nutritional or physiological function
- Nutraceuticals not specified in regulations but established as safe in India or other countries
- Products containing higher Recommended Dietary Allowances (RDA)
- Dietary management statements supported by scientific, clinical, or epidemiological evidence
- Plant or botanical ingredients not specified in regulations
- Vitamin D3 from Lichen or Algae sources requiring prior approval
- Use of esters, derivatives, salts, isomers, and chelates of nutrients requiring notification
- Chemically synthesized nutraceutical ingredients requiring prior approval
Approval of Non-Specified Food and Food Ingredients Regulations, 2017
- Manufacture of non-specified food
- Import of non-specified food
- Storage, sale, and distribution of non-specified food and ingredients requiring prior approval
Advertising and Claims Regulations, 2018
- Disease risk reduction claims requiring prior approval from FSSAI
Foods for Infant Nutrition Regulations, 2020
- Infant formula containing L(+) lactic acid producing bacteria requiring prior approval
Compliance Impact on Food Businesses
This regulatory update is important for:
- Food manufacturers
- Nutraceutical companies
- Food importers
- Product development teams
- Regulatory affairs teams
- D2C food brands
- Startups introducing innovative food products
- Marketers using product or health claims
Businesses should now ensure:
- Timely migration to ePAAS filing system
- Proper dossier preparation
- Scientific substantiation of claims
- Correct product classification
- Regulatory review before product launch or import
- Proper documentation for ingredients and claims
Failure to comply may result in:
- Delays in approval
- Rejection of applications
- Regulatory non-compliance
- Delay in product launch or import clearance
How Regacats Solutions Can Help
Regacats Solutions provides regulatory assistance for:
- FSSAI Prior Approval Applications
- Non-specified food & food ingredient Approval Services
- Claim Approval and Compliance
- FSMP Applications
- Ayurveda Aahara Compliance
- Vegan Endorsement
- Nutraceutical Regulatory Compliance
- Product Classification
- Scientific Dossier Preparation
- Regulatory Documentation and Strategy
Official Advisory Reference
Official FSSAI Office Order dated 06 May 2026: Click here
About Regacats Solutions
Regacats Solutions is an India-based regulatory consulting firm specializing in CDSCO cosmetic import licensing, medical device import registration, and FSSAI regulatory compliance. With extensive experience supporting Indian importers and global cosmetic brands, we assist with COS-1 and COS-2 registration, labeling compliance, Legal Metrology requirements, and post-approval regulatory obligations. Our team focuses on India-specific compliance frameworks to ensure faster approvals, accurate documentation, and long-term regulatory compliance.
Content Reviewed by
Regulatory Experts at Regacats Solutions
Specialists in CDSCO cosmetic import licensing, Legal Metrology compliance, EPR authorization, medical device import registration, and FSSAI regulatory consultant in India.
Conclusion
The mandatory implementation of ePAAS from 01 June 2026 marks an important regulatory change for food businesses in India. All covered prior approval and risk assessment applications must now be filed only through the ePAAS portal, with no offline or email-based submissions accepted thereafter.
Businesses should ensure timely compliance, proper documentation, and accurate dossier preparation to avoid delays or regulatory issues under the new digital approval framework.
To understand how these changes apply to your products and to ensure full compliance, explore our FSSAI Consultancy Services for Nutraceuticals & Dietary Supplements Import in India and get expert support tailored to your business needs.
