GMM Residue Detection in Products

GMM Residue Detection in Products

1. Background Introduction

As an important application of modern biotechnology, Genetically Modified Microorganisms (GMMs) play an increasingly crucial role in the food industry. Microorganisms modified through genetic engineering technologies are widely used to produce food additives, enzymes, nutritional fortifiers, functional proteins, and other products, bringing significant economic benefits and technological progress to the food industry. The global market scale of GMM products for the food industry continues to expand, and it is expected to exceed 50 billion US dollars by 2030.

However, the safety evaluation of GMM-derived products has always been a key concern in food regulatory fields. Although inactivation and removal measures are usually adopted in production processes, the presence of residual viable GMMs and exogenous gene residues in final products is directly related to product biosafety and consumer health. International organizations and countries have different safety management requirements for GMMs and related products used in the food industry, and have formulated various regulatory laws and regulations.

1.1 Increasingly Stringent Domestic Regulatory Requirements

China attaches great importance to the safety management of genetically modified microorganisms and related products used in food processing. In 2024, the National Health Commission issued the "Requirements for Application Materials for Safety Evaluation of Genetically Modified Microorganisms Used in Food Processing (Trial)", which systematically standardized the safety evaluation requirements for GMM products for the first time. The document explicitly stipulates:

(1) Detection of Exogenous Gene Residues: Products must be free of residual exogenous genes. Polymerase Chain Reaction (PCR) methods shall be used to detect specific DNA fragments of production strains, with a detection threshold not higher than 10 ng DNA/g (mL) sample;

(2) Detection of GMM Residues: Products must be free of residual viable GMM cells. Microbial culture methods shall be used for detection;

(3) Environmental Risk Control: A letter of commitment for no environmental release risk and effect evaluation data shall be provided, including detection data of no propagable and transferable GMM residues in waste gas, wastewater, and solid waste from at least 3 batches.

These stringent regulatory requirements have set high standards for the marketing authorization of GMM products for the food industry, and put forward higher requirements for the accuracy, sensitivity, and standardization of detection technologies.

1.2 International Regulatory Trends

In November 2025, the European Food Safety Authority (EFSA) issued the updated "Guidance on the Characterization of Microorganisms Used for Risk Assessment of Food Chain Products", which systematically revised the scientific requirements for risk assessment of various regulated products, including genetically modified (GM) and non-genetically modified (non-GM) microorganisms. The updated guidance explicitly requires:

(1) Quantitative detection of microbial residues in final products;

(2) Confirmation of the presence of propagable cells or strain DNA;

(3) If no viable bacteria and their DNA are detected, and other safety conditions are met, the product can be deemed "risk-free".

For substances certified as GRAS (Generally Recognized As Safe) by the US FDA, detailed production methods, purity standards, and residue detection data are also required. For substances of microbial origin, their potential allergenic and toxic risks need to be evaluated.

Faced with increasingly stringent regulatory requirements and complex technical challenges in detection, food enterprises are in urgent need of professional and reliable third-party detection services to support product safety evaluation and regulatory filings. To address this industry pain point, Shutong Technology has developed a comprehensive GMM residue detection technology platform, providing a reliable solution for the safety evaluation of GMM products used in the food industry.

2. Detection Principle

The microbial culture method is based on the characteristic that microorganisms can grow and reproduce under suitable conditions. Product samples are inoculated into appropriate culture media and cultured under the optimal growth conditions (temperature, pH, aerobiosis, etc.) of the production strain to observe the growth of colonies. Through colony counting, morphological observation, and molecular biological identification, the presence of viable production strains is confirmed.

Figure 1. Detection of Viable Cell Residues by Microbial Culture Method

3. Core Advantages

3.1 Core Technological Innovations

(1) Multi-Strain Adaptive Culture System: Established a standardized culture protocol library for different types of GMMs such as aerobic bacteria, anaerobic bacteria, and spore-forming bacteria, covering solutions including differentiated culture conditions, spore activation, and customized culture media;

(2) Matrix Interference Removal Technology: Optimized pretreatment methods for complex food matrices such as high-sugar, high-fat, and viscous samples. Eliminated matrix interference on detection through dilution and dispersion, neutralization of antibacterial components, homogenization, and other technologies;

(3) High-Sensitivity Detection System: Supports the detection of large-volume samples (25g/mL), sets 10 parallel samples per batch, extends the culture time to 7 days, and achieves a minimum detection limit of 10 CFU/g, enabling accurate identification of low-frequency residues;

(4) Molecular Identification Confirmation System: Ensured the accuracy of strain identification and reduced the false positive rate through multi-level identification including 16S rRNA gene sequencing, whole-genome sequencing, and specific PCR verification.

3.2 Compliance with Latest Regulatory Requirements

(1) Fully covers the requirements of the National Health Commission's "Requirements for Application Materials for Safety Evaluation of Genetically Modified Microorganisms Used in Food Processing (Trial)", EFSA's latest guidelines, as well as FDA GRAS and EFSA certification requirements;

(2) Strictly adheres to national standards such as the GB 4789 series and "Quality Requirements for Culture Media and Reagents for Food Microbiology Testing";

(3) Provides authoritative detection reports meeting the application requirements for "three new foods", directly supporting regulatory filings.

3.3 Advanced Detection Platform and Quality Control System

(1) Hardware Platform: Equipped with automatic microbial culture systems, anaerobic incubators, AI colony counting systems, real-time fluorescent quantitative PCR, digital PCR, and high-throughput sequencing platforms to meet full-process detection needs;

(2) Quality Management: Certified by ISO 9001 and CNAS quality management systems, established a standard strain library, and regularly participates in proficiency testing to ensure reliable and traceable data.

3.4 Professional Technical Service Support

(1) Formed a team of microbiology experts with more than 10 years of experience and a regulatory consultant team familiar with NMPA and FDA regulatory requirements;

(2) Provides one-on-one project management, tracks detection progress throughout the process, and offers comprehensive technical support including detection scheme design, result interpretation, and problem troubleshooting.

4. Application Scenarios

4.1 Support for "Three New Foods" Applications

Provides detection services meeting regulatory requirements for the application of novel food ingredients, new varieties of food additives, and new varieties of food-related products. Covers the detection of viable GMM residues, exogenous gene residues in final products, and GMM detection in production environments, providing complete detection data and analysis reports.

Typical Applications: Functional proteins, enzymes, nutritional fortifiers, food additives, and other products produced by recombinant microorganisms.

4.2 Production Process Validation

Assists enterprises in verifying the effectiveness of inactivation processes (heat treatment, chemical inactivation, etc.) and purification processes (ultrafiltration, chromatography, etc.). Provides process parameter optimization suggestions and validation reports through comparison of residual levels before and after processes and evaluation of inactivation efficiency.

4.3 Product Quality Control

As an important part of the enterprise's quality management system, provides regular detection services. It is recommended to conduct full-item detection for at least 3 batches before the launch of new products, once every quarter or every 10 batches during normal production, and 3 batches of verification detection after process changes.

4.4 Support for International Trade

Provides detection services meeting the regulatory requirements of importing countries such as the US FDA, EU EFSA, and Japan MHLW, issues multi-language reports, and supports international registration needs such as GRAS certification and Novel Food applications.

4.5 Support for R&D Stages

Provides flexible customized detection schemes, quickly feeds back detection results, offers process optimization suggestions for products in the R&D stage, accumulates data required for filings, and reduces subsequent compliance risks.

5. Example Report

Shutong Technology provides comprehensive GMM residue detection and analysis reports compliant with regulatory requirements, with core content including:

(1) Sample Information and Detection Conditions: Basic sample information, detection standards, culture conditions, quality control settings, etc.;

(2) Detection Results of Viable GMM Residues: Complete data such as colony counts and morphological descriptions of 3 batches × 10 parallel samples;

(3) Quality Control Data: Data of positive controls, negative controls, sterility tests, etc., to verify the effectiveness of detection;

(4) Identification Results of Suspected Colonies (if any): Morphological characteristics, biochemical identification, gene sequencing, and comparative analysis;

(5) Detection Results of Exogenous Gene Residues (if required): PCR detection data, electrophoresis patterns, quantitative analysis results;

(6) Detection Results of Environmental Samples (if applicable): Detection data of waste water/waste gas/waste residue from at least 3 batches;

(7) Comprehensive Conclusion and Risk Assessment: Biosafety evaluation, regulatory compliance determination, product quality and process effectiveness evaluation.

Example of Comprehensive Determination: The product meets the requirements for GMM and exogenous gene residues specified in the "Requirements for Application Materials for Safety Evaluation of Genetically Modified Microorganisms Used in Food Processing (Trial)", with good biosafety, and can be used for "three new foods" applications.

6. Service Content

6.1 Service Process

Standard Service Cycle: 15-25 working days (adjusted according to strain characteristics and detection items)

6.2 Service Packages

7. Sample Requirements