GB/T 19626-2025 in English

Standard Revision Background and Technological Evolution

GB/T 19626-2025 "General Technical Requirements for DNA Anti-Counterfeiting Technology Products" marks the first major revision of the 2005 edition, reflecting the rapid development and technological maturity of DNA anti-counterfeiting technology over the past 20 years. This revision not only incorporates structural adjustments and editorial changes, but more importantly, comprehensively upgrades core technical requirements, reflecting the significant transition of DNA anti-counterfeiting from laboratory technology to industrial application.

Major technical changes in the standard revision include the removal of seven outdated term definitions, changes to the definition scope of eight key terms, and the addition of the core concept of "DNA anti-counterfeiting identification characteristics." These changes reflect a greater focus on practical application scenarios in standard development, deemphasizing purely theoretical biological concepts and strengthening the engineering requirements for anti-counterfeiting technology products.

Reconstruction of Terminology Definition System

The new standard systematically reconstructs the terminology system, highlighting two core concepts: DNA anti-counterfeiting technology products and DNA anti-counterfeiting identification features. The DNA anti-counterfeiting identification features are defined as "genetic information such as the DNA double helix structure and specific base sequences as the unique identifier of DNA anti-counterfeiting technology products." This definition lays the theoretical foundation for subsequent technical requirements.

Product Classification System

The standard divides DNA anti-counterfeiting technology products into three categories: DNA anti-counterfeiting labels, DNA anti-counterfeiting materials, and other DNA anti-counterfeiting technology products. DNA anti-counterfeiting labels include printed products such as DNA labels, DNA tickets, and DNA securities; DNA anti-counterfeiting materials include basic materials such as DNA anti-counterfeiting security paper, DNA anti-counterfeiting holographic films, and DNA anti-counterfeiting inks.

Anti-counterfeiting Strength Evaluation System

The new standard establishes a scientific four-factor evaluation system for anti-counterfeiting strength, quantifying scores based on the total length of the DNA sequence, the number of different DNA sequences, uniqueness, and the non-transferability rate. The total score must be at least 60 points.

Technical Requirements for Stability

The standard sets strict requirements for the stability of DNA anti-counterfeiting technology products, including stability during the service life under normal conditions and tolerance in extreme environments. Extreme environment testing covers multiple conditions, including high temperature (70°C), low temperature (-40°C), humidity (60°C, 93% RH), and ultraviolet radiation.

Technical Requirements for DNA Testing

The standard specifies three DNA testing methods: length testing, sequence testing, and testing for other genetic markers. The testing methods are implemented in accordance with standards such as GB/T 34265 (Sanger method) and GB/T 30989 (high-throughput sequencing), requiring the use of positive, negative, and blank controls to ensure the accuracy and reliability of the test results.

Of particular note is the standard's requirement that DNA anti-counterfeiting technology products undergo biosafety testing, including genetic toxicity testing (per GB15193.12) and acute oral toxicity testing (per GB15193.3), to ensure the safety of DNA materials for both humans and the environment.

Implementation Recommendations and Precautions

1. Product Design Phase: The DNA sequence length and diversity configuration should be rationally selected based on the target security level to ensure the anti-counterfeiting strength score meets the desired level.

2. Production Process Control: A technical security and confidentiality system must be established in strict accordance with GB/T 17002 to prevent the leakage of DNA sequence information.

3. Quality Inspection Requirements: Establish a comprehensive testing laboratory equipped with necessary testing equipment, such as a real-time fluorescence quantitative gene amplification instrument and a UV spectrophotometer, to ensure that all products shipped meet standard requirements.

4. Application Environment Assessment: Evaluate the extreme environmental conditions that the product may face based on different application scenarios and conduct corresponding stability tests in advance.

5. Patent Risk Prevention: Pay attention to the patent issues mentioned in the standard and conduct necessary patent searches and risk avoidance in actual applications.

Technological Development Trends

With the development of synthetic biology and nanotechnology, DNA anti-counterfeiting technology is developing towards greater efficiency, security, and cost-effectiveness. In the future, new anti-counterfeiting technologies based on synthetic DNA, as well as complex anti-counterfeiting solutions combined with other anti-counterfeiting technologies, may emerge. Subsequent revisions to the standard may require attention to the development and application of these new technologies.