GB/T 45992-2025 in English

Background and Significance of Standard Development

The release of the national standard GB/T 45992-2025, "Collagen and Its Hydrolysates," marks a new phase of standardized development for my country's collagen industry. Proposed by the China Light Industry Federation and co-drafted by over 30 organizations, including Beijing University of Chemical Technology, the standard will officially come into effect in 2025. This standard fills a gap in domestic collagen product standards and provides a unified technical basis for production, testing, and sales.

Term Definition and Product Classification

The standard clearly defines two core concepts: collagen and collagen hydrolysate:

Analysis of Key Technical Requirements

Sensory Requirements

The standard clearly stipulates the sensory characteristics of the product: collagen should be an off-white to light brown solid or semi-solid, and collagen hydrolysate should be a white or light yellow solid. This requirement reflects the purity of the product and the level of processing technology.

Physical and chemical index requirements

The standard strictly controls product quality through 7 key indicators:

Molecular weight distribution requirements

The standard specifically stipulates that the proportion of components with a relative molecular mass of less than 10,000 in collagen hydrolysate should be ≥90.0%. This indicator is directly related to the bioavailability and functional properties of the product.

Detailed Explanation of the Test Methods

Solubility and Structure Identification

The standard provides two identification methods: Method 1 is a solubility test (observation in a 65±1°C water bath), and Method 2 (arbitration method) uses circular dichroism (CD) spectroscopy to detect the triple helix structure, performed in accordance with YY/T 1849-2022.

Hydroxyproline Assay

Hydroxyproline is a characteristic amino acid in collagen, and its content is an important indicator for determining product authenticity and purity. Testing is conducted in accordance with GB/T 9695.23, "Determination of Hydroxyproline Content in Meat and Meat Products."

Molecular weight distribution detection

Appendix A specifies the method for detecting molecular weight distribution by high performance size exclusion chromatography (HPSEC) in detail:

The standard series includes five peptide standards with different molecular weights, including cytochrome C (MW 12384), aprotinin (MW 6512), and bacillidin (MW 1423), which are used to establish an accurate molecular weight calibration curve.

Quality Control and Inspection Rules

Factory Inspection and Type Inspection

The standard stipulates a strict inspection system: factory inspection includes four items: moisture, transmittance, ash content, and water-insoluble matter; type inspection covers all technical requirements in Chapter 5 and is conducted every six months.

Judgment Rules

Products are considered qualified when all inspection results meet the standard requirements. If any item fails, double sampling and re-inspection are allowed. If the re-inspection still fails, the entire batch of products will be considered unqualified.

Packaging, Storage and Transportation Requirements

The standard requires products to be double-packed, with the inner layer being a tightly sealed plastic film bag or plastic bottle, and the outer material being clean, dry, and secure. Clean tools must be used during transportation to prevent moisture, and mixing with toxic substances is not allowed.

Storage conditions differentiate between collagen and collagen hydrolysate: collagen needs to be stored in an indoor warehouse with suitable temperature and humidity conditions; collagen hydrolysate requires to be stored in a dry indoor warehouse.

Implementation Recommendations and Application Guidance

Implementation Recommendations for Manufacturers

1. Establish a comprehensive quality management system to ensure quality control throughout the entire process, from raw material procurement to finished product delivery

2. Equip with necessary testing equipment, especially HPLC for molecular weight distribution testing

3. Strengthen personnel training and master the various testing methods specified in the standard

Application Guidance for Testing Agencies

1. Conduct dispute testing strictly in accordance with the arbitration methods specified in the standard

2. Establish a standard product traceability system to ensure the accuracy of test results

3. Regularly participate in proficiency testing to maintain testing technology standards

User Selection Guide

1. Identify products that comply with GB/T 45992-2025

2. Pay attention to molecular weight distribution indicators and select products that meet application requirements

3. Check the test report to ensure that all indicators meet the standard requirements.

Technological Evolution and Standard Outlook

The formulation of GB/T 45992-2025 fully considers the current technological development status and future trends of the collagen industry. With the advancement of biotechnology, new products such as recombinant collagen continue to emerge, and the standard reserves room for development. Future revisions to the standard will further improve the testing methods, enhance the scientific nature of the technical requirements, and promote the high-quality development of the collagen industry.

The implementation of this standard will play an important role in regulating market order, improving product quality, and protecting consumer rights, providing strong technical support for the healthy development of my country's collagen industry.