GRAS Services
As the food industry continues to grow and new ingredients are being investigated, achieving GRAS (Generally Recognized as Safe) status has become more valuable. Our strain gene identification platform can help quickly confirm the identity of the strain and ensure that the strains used in your project are of the GRAS level. Usually, a full genome sequencing, potency, Gram staining, sugar fermentation, enzymatic activity, antibiotic strain resistance profile and proteome profile would be included in a GRAS report.
With CNAS certified lab, we staff experts with experience in strain identification and preparing the GRAS documentation and acting as a liaison with the expert panel and FDA, ensuring a successful and timely launch of ingredients.
Direct Support for FDA Submission and Q&A Response
Expertise in GRAS for Fermentation-Derived Ingredients
Full-Spectrum GRAS Support: From Strategy to Submission
Our GRAS Services
GRAS Consultation and Strategic Planning
Preliminary Regulatory Assessment: Evaluate the regulatory feasibility of the client's product to determine suitability for the GRAS (Generally Recognized As Safe) pathway.
GRAS Pathway Strategy: Develop a customized GRAS roadmap: Self-affirmed GRAS vs. GRAS Notification to FDA.
Regulatory Gap Analysis: Identify compliance gaps in product development, manufacturing, and documentation related to GRAS requirements.
Regulatory Pathway Comparison: Compare GRAS with alternative pathways: New Dietary Ingredient (NDI) Notification and Food Additive Petition (FAP).
Literature Review and Safety Data Assessment
Scientific Literature Review: Conduct comprehensive searches and evaluations across major databases such as PubMed, ToxNet, and EFSA to collect existing safety data.
Toxicology and Exposure Analysis: Compile and assess toxicological, metabolic, intake, and historical use data relevant to the substance.
Technical Dossier Preparation: Draft and organize scientific documentation including Substance Identity, Manufacturing Process, and Product Specifications.
Safety Evaluation and Expert Panel Support
GRAS Expert Panel Assembly: Organize an independent GRAS panel consisting of at least three qualified experts in accordance with FDA guidelines.
Expert Consensus Report Development: Prepare a comprehensive GRAS Panel Report summarizing expert consensus on the safety of the ingredient.
Panel Meeting Coordination: Facilitate expert panel meetings, draft meeting minutes, and archive final consensus documents.
Study Design
Toxicological Study Needs Assessment: Determine whether additional toxicology, animal, or long-term exposure studies are necessary.
Analytical Data Support: Provide support with Certificates of Analysis (COAs), stability data, and batch-to-batch consistency evaluations.
GRAS Notification Dossier Preparation and Submission
GRAS Notification (GRN) Document Drafting: Includes preparation of all seven sections required by FDA
FDA-Compliant Formatting: Ensure the dossier meets FDA's formatting and technical requirements for GRAS Notifications. Full-service technical writing, English composition, and professional translation available.
FDA Communication Support
Pre-Submission FDA Interaction: Coordinate informal pre-submission meetings with the FDA to clarify expectations and reduce regulatory risk.
Post-Submission Support: Address FDA Information for Request (IFR) letters and follow-up inquiries in a timely and compliant manner.
End-to-End Project Management: Provide comprehensive timeline oversight and project management throughout the entire GRAS process.
Why Choose Us-Core Advantages
- Deep expertise in microbial fermentation products
- Integrated regulatory & technical team
- Strong network of U.S.-based GRAS experts
- Modular service options with flexible engagement models
Workflow of GRAS Services
1Initial Screening
2Regulatory Route Planning
3Contract Signing
4Data Collection & Document Drafting
5Expert Panel Coordination
6GRAS Dossier Preparation
7FDA Submission (if needed)
8Final Delivery & Post-service Support
Applications of GRAS Services
Fermentation-Based Ingredients
GRAS (Generally Recognized as Safe) assessments are essential for companies developing fermentation-derived ingredients such as enzymes, organic acids, amino acids, and postbiotics. Whether you're producing compounds via microbial fermentation or synthetic biology, FDA-compliant GRAS documentation enables legal marketing of these ingredients in the U.S. food and dietary supplement markets.
Probiotics and Postbiotics
Probiotics, prebiotics, and postbiotic compounds require GRAS determination before inclusion in food, beverages, or functional products sold in the U.S. Our GRAS services support strain-specific assessments, safety data collection, and regulatory filings, ensuring compliance for next-gen gut health solutions.
Food Additives and Functional Ingredients
Flavor enhancers, preservatives, sweeteners, emulsifiers, and other food additives often require GRAS status to enter the U.S. market. We help food ingredient suppliers prepare self-affirmed GRAS dossiers or submit formal notifications to the FDA.
Nutraceuticals and Dietary Supplement Ingredients
While GRAS is not required for dietary supplements directly, many nutraceutical brands pursue GRAS status to support their ingredients' safety in food-like formats such as gummies, powders, and beverages. This helps build regulatory credibility and consumer trust.
Plant-Based and Natural Extracts
Botanical extracts, essential oils, and plant-derived compounds used in food and beverages must demonstrate safety through GRAS self-affirmation or FDA review. We provide literature reviews and expert panel support to help natural ingredient suppliers navigate the regulatory landscape.
Synthetic Biology & Precision Fermentation
Startups in precision fermentation and synthetic biology frequently develop novel food ingredients and bioactives that require a customized GRAS approach. We specialize in helping synbio companies conduct scientific safety assessments and navigate FDA GRAS pathways.
FAQs
01 What is GRAS and why do I need it?
GRAS (Generally Recognized as Safe) is a regulatory status under U.S. FDA that allows ingredients to be used in foods without formal food additive approval, provided there is scientific evidence of safety. GRAS is essential for legally marketing novel food ingredients, especially those produced via fermentation, in the U.S.
02 What's the difference between self-affirmed GRAS and GRAS Notification to the FDA?
Self-affirmed GRAS means your internal or external expert panel determines the ingredient is safe and you document it accordingly, but do not notify the FDA. GRAS Notification (GRN) involves submitting a dossier to FDA, which may issue a "No Questions" letter if they agree with your conclusion. Both are valid routes, but GRN provides more regulatory transparency and confidence for partners or investors.
03 What types of ingredients require GRAS status?
Ingredients used in conventional food, beverages, and functional food products generally require GRAS or food additive approval. Common examples include: Probiotics & postbiotics Fermentation-derived metabolites (e.g. GABA, NMN, amino acids) Enzymes, organic acids, bioactive peptides Plant extracts, sweeteners, fibers
