Ensuring Compliance for a Thriving Microbiome Market
The market for probiotics, prebiotics, postbiotics, and synbiotics is rapidly expanding worldwide due to consumer demand for products that support gut health and strengthen the immune system. However, strict Regulatory compliance is necessary for safety, efficacy, and legal marketing when entering and remaining in new markets. Freyr provides end-to-end Regulatory compliance to help manufacturers navigate complex region-specific regulations and become compliant across the food and dietary supplements Industry.
Product Classification & Claims Regulations
Classifying probiotics, prebiotics, postbiotics, and synbiotics significantly impacts Regulatory restrictions and market access.
Global Regulatory Landscape
Regulatory frameworks for probiotics, prebiotics, postbiotics, and synbiotics Regulatory support vary across markets
Key Regulatory aspects by Region for
Probiotics, Prebiotics, Postbiotics, and Synbiotics
Regulatory Considerations for Claims
![]()
Permitted health claims
Must be scientifically substantiated (e.g., "supports digestive health").
![]()
Prohibited disease claims
Direct disease prevention or treatment claims are strictly regulated.
![]()
Labeling requirements
Clear strain identification, CFU counts, and storage conditions
Safety & Quality Compliance Requirements
Regulatory agencies mandate stringent safety, quality, and labeling standards to ensure consumer safety and product efficacy.
Key Compliance Parameters:
Microbiological Safety
Microbiological Safety
Identification and validation of probiotic strains through genomic sequencing.
Stability Testing
Stability Testing
Shelf-life assessment under real-world storage conditions.
Manufacturing Compliance
Manufacturing Compliance
Adherence to GMP, HACCP, and FSMA guidelines
Labeling & Claims Review
Labeling & Claims Review
Ensuring alignment with local regulations to prevent non-compliance.
Efficacy Testing
Efficacy Testing
Ensures that probiotics, prebiotics, postbiotics, and synbiotics intended health benefits to consumers when consumed in recommended doses.
Toxicological Testing
Toxicological Testing
Ensure that the probiotic strain does not pose health risks to consumers.
How Freyr Can Assist
With expertise in global Regulatory compliance, Freyr supports manufacturers with
![]()
Market specific Compliance checks
![]()
Regulatory Classification & Market Entry Strategy
![]()
Pre-market Registration & Dossier Preparation
![]()
Claims & Labeling Compliance
![]()
Support in Safety & Scientific Validation
![]()
Post-market Surveillance & Compliance Monitoring
Why Choose Freyr?
Do you want to ensure your postbiotics, probiotics, prebiotics, and synbiotics comply with international standards?
