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china-gbt-135312-detection-of-pathogenic-bacteria-in-cosmetics
Microbiological Quality Testing AFNOR NF T73-101 Microbial Preservation Testing for CosmeticsANSM Challenge Testing of Natural Cosmetic FormulasANSM Microbiological Control of Non-Sterile Cosmetic ProductsANVISA RDC 481/2021 Microbial Control for Brazilian Cosmetic ProductsAOAC 2003.07 Challenge Test for Cosmetic CreamsAOAC 991.14 Microbial Contamination Detection in Personal Care ProductsAOAC 997.02 Microbial Quality of ToiletriesASTM D4014 Test for Microbial Growth on Lotions and CreamsASTM D5338 Biodegradation and Microbial Interaction in CosmeticsASTM D7983 Testing for Bacterial Endotoxins in Eye-area CosmeticsASTM E1326 Viable Organism Testing in Aerosolized Cosmetic ProductsASTM E2180 Antimicrobial Efficacy Testing of Preservative SystemsASTM E2275 Skin Antiseptic Residual Activity TestingASTM E2315 Time-Kill Assessment of Antimicrobial ActivityASTM E2613 Microbial Analysis of Water Used in CosmeticsASTM E2786 Biofilm Formation in Cosmetic Production EnvironmentsASTM E640 Bacterial Filtration in Cosmetic SpraysASTM F2101 Bacterial Filtration Efficiency of Cosmetic Face MasksCEN/TR 16953 Guidance on Application of ISO Microbial StandardsChina GB 7919 Microbial Limits in Non-Sterile CosmeticsChina GB/T 13531.1 Detection of E. coli in CosmeticsChina GB/T 13531.3 Microbial Limit in Baby ProductsCOLIPA Guideline for Preservation Efficacy TestingCOLIPA Microbiological Quality Assurance of Cosmetic ProductsEP 2.6.1 Sterility Test for Cosmetic Raw MaterialsEP 2.6.12 Total Aerobic Microbial Count TestingEP 2.6.13 Detection of Designated Microorganisms in CosmeticsEP 2.6.31 Validation of Microbiological Test Methods for CosmeticsEP 5.1.3 Evaluation of Preservative EffectivenessEP 5.1.4 Microbial Limits in Raw Cosmetic IngredientsEPA MB-17 Microbial Contamination Control in Natural FormulasFDA 21 CFR 211.113 Contamination Prevention Procedures for CosmeticsFDA 21 CFR 700.3 Microbial Contamination Limits in CosmeticsFDA BAM Chapter 14 Yeast and Mold Enumeration in Personal Care ProductsFDA BAM Chapter 23 Detection of Bacterial Pathogens in CosmeticsFDA CFSAN Guidelines for Cosmetic Microbiological SamplingFDA CPG Sec. 7120.01 Microbiological Criteria for Finished CosmeticsHealth Canada Compendial Test for Pathogenic Organisms in CosmeticsHealth Canada Cosmetic Microbiological Contamination GuidelinesIndia IS 14642 Microbial Contamination in Toiletries and SkincareIndia IS 4707-2 Cosmetic Ingredients Microbial AssessmentISO 11930 Microbiological Preservation Efficacy TestingISO 11932 Method Validation for Microbial Testing in CosmeticsISO 11989 Microbial Assessment of Eye CosmeticsISO 14502-2 Microbiological Testing of Polyphenol-Rich CosmeticsISO 16212 Quantification of Yeasts and Molds in Cosmetic ProductsISO 17516 Quantitative Limits of Microorganisms in Finished ProductsISO 18415 Detection of Specified and Non-Specified MicroorganismsISO 19007 Preservation Test of Microbial Resistance in Cosmetic WipesISO 21148 Detection of Anaerobic Bacteria in Cosmetic FormulationsISO 21149 Detection of Aerobic Mesophilic Bacteria in CosmeticsISO 21150 Detection of Escherichia coli in CosmeticsISO 22176 Hygiene Requirements in Cosmetic Packaging LinesISO 22716 Microbial Risk Management in GMP Cosmetic ManufacturingISO 22717 Identification of Pseudomonas aeruginosa in Cosmetic ProductsISO 22718 Identification of Staphylococcus aureus in CosmeticsISO 22719 Detection of Candida albicans in Cosmetic ProductsISO 24434 Enumeration of Aerobic Mesophilic Spores in Personal CareISO 24442 Selection Criteria for Challenge Test OrganismsISO 29621 Microbiological Risk Assessment for Low-Risk ProductsISO/TR 19838 Guidance on Risk Management for Cosmetic MicrobiologyISO/TR 24444 Comparison of Microbiological Test ProtocolsISO/TR 24475 Microbiological Assessment of Cosmetic Raw MaterialsISO/TR 24476 Test Method Selection for Cosmetic Product MicrobiologyISO/TS 29621 Categorization of Cosmetic Products Based on Microbiological RiskJIS K 5101 Preservative Efficiency in Japanese CosmeticsJIS L 1902 Evaluation of Antibacterial Activity of Cosmetic TextilesJIS Z 2801 Antimicrobial Efficacy Testing for Surfaces in Cosmetic FacilitiesKFDA Microbiological Safety Evaluation of Korean Cosmetic ProductsKFDA Testing for Microbial Contamination in Imported CosmeticsPh. Eur. 2.6.12 Total Count Test for EmulsionsPh. Eur. 2.6.13 Detection of Pathogens in Powdered CosmeticsSCCS/1564/15 Risk Assessment of Microbiological Contamination in CosmeticsSCCS/1611/19 Safety Levels of Microbial Contaminants in CosmeticsTS 13218 Total Bacteria Count in Cosmetic CreamsTS 13531 Bacterial Safety Testing of Shampoo ProductsTS EN 12353 Hygiene Control of Cosmetic Containers and ClosuresTS EN ISO 11930 Preservative Efficacy Test for Personal Care ProductsTS EN ISO 16212 Mold and Yeast Count in Cosmetic LiquidsTS EN ISO 18415 Detection of Transient Organisms in ToiletriesTS EN ISO 21148 Enumeration of Microorganisms in Cosmetic ProductsUSP <1227> Validation of Microbial Recovery in Cosmetic ProductsUSP <1231> Water Quality for Microbiological Control in Cosmetic ProductionUSP <2021> Microbial Control of Nutraceutical-Cosmetic HybridsUSP <2022> Evaluation of Cosmetic Quality Control ProtocolsUSP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test)USP <61> Microbial Enumeration Testing for Non-Sterile CosmeticsUSP <62> Testing for Specified Microorganisms in CosmeticsUSP <791> pH Control and Microbial Growth AssessmentWHO Guidelines for the Microbiological Control of Herbal Cosmetics

Comprehensive Guide to China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics Laboratory Testing Service Provided by Eurolab

1.1 Overview of Relevant Standards

The detection of pathogenic bacteria in cosmetics is governed by various international and national standards, including ISO, ASTM, EN, TSE, and China GB/T 13531.2.

  • ISO 17025: General requirements for the competence of testing and calibration laboratories

  • ASTM E2186-03: Standard Practice for Evaluating the Presence of Microorganisms in Containment Systems

  • EN ISO 11133: Microbiology - Preparation, cultivation, detection and enumeration of microorganisms from cosmeceuticals

  • TSE EN ISO 11133: Microbiology - Preparation, cultivation, detection and enumeration of microorganisms from cosmeceuticals

    • 1.2 Legal and Regulatory Framework

    The legal and regulatory framework surrounding China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics testing includes:

  • Chinese regulations: GB/T 13531.2 is a mandatory standard for the detection of pathogenic bacteria in cosmetics.

  • International regulations: EU Cosmetics Regulation (EC) No 1223/2009 and FDA regulations in the United States also govern the safety assessment of cosmetics.

    • 1.3 Standard Development Organizations

    Standard development organizations play a crucial role in developing and maintaining standards for laboratory testing:

  • ISO: International Organization for Standardization

  • ASTM: American Society for Testing and Materials

  • EN: European Committee for Standardization

  • TSE: Turkish Standards Institution

    • 1.4 Standard Evolution and Updates

    Standards evolve and get updated to reflect new scientific knowledge, technological advancements, and changing regulatory requirements:

  • Revision history: China GB/T 13531.2 has undergone several revisions since its initial publication in Year.

  • New standards: New standards, such as ISO 11133:2014, have been developed to address emerging concerns.

    • 1.5 Standard Numbers and Scope

    Here are the relevant standard numbers and their scope:

    Standard Number Title

    --- ---

    GB/T 13531.2 Detection of pathogenic bacteria in cosmetics - Part 2: Testing methodology

    ISO 11133 Microbiology - Preparation, cultivation, detection and enumeration of microorganisms from cosmeceuticals

    1.6 Standard Compliance Requirements

    Standard compliance requirements vary by industry and sector:

  • Cosmetics industry: GB/T 13531.2 is a mandatory standard for the detection of pathogenic bacteria in cosmetics.

  • Pharmaceuticals: ISO 11133 is a recommended standard for the detection of microorganisms in pharmaceutical products.

    • 2.1 Business and Technical Reasons for Conducting China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics Testing

    The business and technical reasons for conducting China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics testing include:

  • Product safety: The detection of pathogenic bacteria is essential to ensure product safety and prevent consumer harm.

  • Regulatory compliance: Compliance with national and international regulations requires the detection of pathogenic bacteria in cosmetics.

  • Quality assurance: Regular testing helps maintain quality standards and ensures customer satisfaction.

    • 2.2 Consequences of Not Performing China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics Testing

    The consequences of not performing China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics testing include:

  • Regulatory non-compliance: Failure to detect pathogenic bacteria can lead to regulatory non-compliance and fines.

  • Product recall: Undetected pathogens can cause product recalls, resulting in significant economic losses.

  • Reputation damage: Non-compliance with regulations can damage a companys reputation and erode customer trust.

    • 2.3 Industries and Sectors Requiring China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics Testing

    The industries and sectors requiring China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics testing include:

  • Cosmetics industry: Manufacturers of cosmetics, skincare products, haircare products, and fragrances.

  • Pharmaceuticals: Manufacturers of pharmaceutical products that require microbiological testing.

    • 2.4 Risk Factors and Safety Implications

    The risk factors and safety implications associated with China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics testing include:

  • Pathogen contamination: Contamination with pathogenic bacteria can cause consumer harm.

  • Product failure: Undetected pathogens can lead to product failure, resulting in economic losses.

    • 2.5 Quality Assurance and Control

    Quality assurance and control measures are essential for ensuring the accuracy and reliability of China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics testing:

  • Calibration: Calibration of equipment is necessary for maintaining accurate results.

  • Proficiency testing: Participation in proficiency testing schemes ensures that laboratories meet international standards.

    • 3.1 Sampling and Preparation

    Sampling and preparation are critical steps in China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics testing:

  • Sample collection: Representative samples must be collected from the product or raw materials.

  • Preparation: Samples must be prepared according to standard protocols.

    • 3.2 Detection Methods

    Detection methods for pathogenic bacteria include:

  • Culture-based detection: This method involves growing pathogens on agar plates.

  • Molecular detection: This method uses PCR (Polymerase Chain Reaction) or other molecular techniques to detect DNA sequences specific to the pathogen.

    • 3.3 Validation and Verification

    Validation and verification are essential for ensuring the accuracy and reliability of China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics testing:

  • Method validation: Methods must be validated using proficiency testing schemes or internal control samples.

  • Result verification: Results must be verified through re-testing or alternative methods.

    • 4.1 Reporting Requirements

    Reporting requirements for China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics testing include:

  • Test results: Test results must be reported according to standard protocols.

  • Method validation: Method validation data must be reported.

    • 4.2 Record-Keeping Requirements

    Record-keeping requirements for China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics testing include:

  • Sample records: Sample records must be maintained for at least two years.

  • Test result records: Test result records must be maintained for at least two years.

    • 5. Conclusion

    In conclusion, China GB/T 13531.2 Detection of Pathogenic Bacteria in Cosmetics testing is a critical aspect of ensuring product safety and regulatory compliance. Laboratories must adhere to standard protocols, validate methods, and maintain accurate records to ensure the accuracy and reliability of test results.

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