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isots-29621-categorization-of-cosmetic-products-based-on-microbiological-risk
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 13531.2 Detection of Pathogenic Bacteria 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 MicrobiologyJIS 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 ISO/TS 29621 Categorization of Cosmetic Products Based on Microbiological Risk Testing Services by Eurolab

ISO/TS 29621 is a Technical Specification developed by the International Organization for Standardization (ISO) to categorize cosmetic products based on microbiological risk. This standard provides a framework for manufacturers, regulatory bodies, and testing laboratories to assess the microbial quality of cosmetic products.

Legal and Regulatory Framework

The European Unions Cosmetics Regulation (EC) No 1223/2009 sets out requirements for the safety assessment of cosmetic products, including microbiological testing. The regulation mandates that cosmetic products must be safe for human use, and microbiological testing is one way to ensure compliance.

International and National Standards

ISO/TS 29621 is a technical specification developed by ISO, which provides guidance on categorizing cosmetic products based on microbiological risk. Other relevant standards include:

  • EN 14675:2017 (Microbiological evaluation of materials used in the manufacture of medical devices) - This standard provides guidelines for evaluating the microbial quality of materials used in medical device manufacturing.

  • ASTM E2180-15 (Standard Test Method for Detection and Quantitation of Microorganisms by Conductive-Cell Interface Sampling and Measurement) - This standard describes a method for detecting and quantifying microorganisms using conductive-cell interface sampling and measurement.

    • Standard Development Organizations

    ISO is responsible for developing international standards, including ISO/TS 29621. The European Committee for Standardization (CEN) also plays a role in developing standards related to microbiological testing.

    Evolution of Standards

    Standards evolve over time as new technologies and scientific knowledge become available. Updates to existing standards ensure they remain relevant and effective.

    Specific Standard Numbers and Their Scope

  • ISO/TS 29621:2017 - Categorization of cosmetic products based on microbiological risk

  • EN 14675:2017 - Microbiological evaluation of materials used in the manufacture of medical devices

  • ASTM E2180-15 - Standard Test Method for Detection and Quantitation of Microorganisms by Conductive-Cell Interface Sampling and Measurement

    • Industry-Specific Requirements

    Cosmetic manufacturers, regulatory bodies, and testing laboratories must comply with relevant standards to ensure product safety.

    Standard Compliance Requirements

    Compliance with ISO/TS 29621 requires:

  • Manufacturers to categorize their products based on microbiological risk

  • Regulatory bodies to verify the accuracy of product categorization

  • Testing laboratories to conduct microbiological testing according to standardized methods

    • Standard-Related Costs and Benefits

    Conducting microbiological testing according to ISO/TS 29621 can help manufacturers identify potential risks, reduce costs associated with recalls or regulatory non-compliance, and improve customer confidence.

    Why This Standard is Important

    ISO/TS 29621 provides a framework for categorizing cosmetic products based on microbiological risk. Manufacturers must comply with this standard to ensure product safety and regulatory compliance.

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    Business and Technical Reasons for Conducting ISO/TS 29621 Testing

    The main reasons for conducting microbiological testing according to ISO/TS 29621 are:

  • Ensuring product safety and quality

  • Compliance with regulations

  • Reducing costs associated with recalls or regulatory non-compliance

  • Improving customer confidence

    • Consequences of Not Performing This Test

    Not performing microbiological testing can result in:

  • Product recalls

  • Regulatory non-compliance

  • Loss of customer trust and revenue

    • Industries and Sectors Requiring This Testing

    All industries that manufacture cosmetic products must comply with ISO/TS 29621.

    Risk Factors and Safety Implications

    Microbiological contamination can lead to serious health risks for consumers. Manufacturers must ensure their products meet regulatory requirements.

    Quality Assurance and Quality Control Aspects

    Manufacturers must implement quality assurance and control measures to ensure product safety and compliance with regulations.

    How This Test Contributes to Product Safety and Reliability

    ISO/TS 29621 provides a framework for categorizing cosmetic products based on microbiological risk. Manufacturers that comply with this standard can ensure their products meet regulatory requirements.

    Competitive Advantages of Having This Testing Performed

    Conducting microbiological testing according to ISO/TS 29621 can provide manufacturers with:

  • Improved customer confidence

  • Reduced costs associated with recalls or regulatory non-compliance

  • Compliance with regulations

    • Cost-Benefit Analysis of Performing This Test

    The benefits of conducting microbiological testing according to ISO/TS 29621 far outweigh the costs.

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    Testing Equipment and Instruments Used

    Eurolab uses state-of-the-art equipment, including:

  • Microbiological analyzers

  • Incubators

  • Spectrophotometers

    • Standardized Methods for Conducting Microbiological Testing

    Eurolab follows standardized methods according to ISO/TS 29621.

    Sample Preparation and Analysis

    Eurolab prepares samples according to standard protocols and conducts analysis using standardized methods.

    Validation of Test Results

    Eurolab validates test results to ensure accuracy and reliability.

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    ISO/TS 29621 provides a framework for categorizing cosmetic products based on microbiological risk. Manufacturers, regulatory bodies, and testing laboratories must comply with this standard to ensure product safety and regulatory compliance.

    Industry-Specific Requirements

    Cosmetic manufacturers, regulatory bodies, and testing laboratories must comply with relevant standards to ensure product safety.

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    This comprehensive guide provides detailed information about ISO/TS 29621, including the standards framework, requirements, and benefits. Manufacturers, regulatory bodies, and testing laboratories can use this guide to understand their obligations under this standard and implement necessary measures to ensure product safety and compliance.

    Eurolabs Expertise in Microbiological Testing

    Eurolab has extensive experience in microbiological testing according to ISO/TS 29621. Our team of experts provides accurate and reliable results, ensuring manufacturers meet regulatory requirements.

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    I hope this helps! Let me know if you have any further requests or need any additional information.

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