EUROLAB
ep-2613-detection-of-designated-microorganisms-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 13531.2 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 2.6.31 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 Eurolabs EP 2.6.13 Detection of Designated Microorganisms in Cosmetics Laboratory Testing Service

The detection of designated microorganisms in cosmetics is a critical aspect of ensuring product safety and compliance with regulatory requirements. The European Standard EN 12381:2014A1:2018 specifies the requirements for the detection of specified microorganisms in cosmetic products. This standard is based on the ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories, which ensures that laboratories are competent to perform tests.

The European Unions Cosmetic Regulation (EC) No. 1223/2009 requires manufacturers to ensure that their products comply with certain safety standards, including the detection of microorganisms. The regulation specifies that products must be tested for the presence of specified microorganisms before release onto the market.

In addition to the EU regulations, various international organizations have established guidelines and standards for the detection of designated microorganisms in cosmetics. These include:

  • ISO 11133:2014 Microbiology of food and animal feeding stuffs -- Guidelines on preparation and production of culture media

  • ASTM E2518-09 Standard Test Method for Detection of Designated Microorganisms in Cosmetics by Using a Membrane Filtration Method

  • EN 12381:2014A1:2018 Cosmetic products - Detection of specified microorganisms

    • These standards and guidelines provide a framework for laboratories to follow when testing for designated microorganisms. They specify the equipment, materials, and procedures that must be used to ensure accurate and reliable results.

    The detection of designated microorganisms in cosmetics is essential for ensuring product safety and compliance with regulatory requirements. The presence of these microorganisms can pose a risk to human health, particularly for sensitive skin types or individuals with compromised immune systems.

    Conducting EP 2.6.13 Detection of Designated Microorganisms in Cosmetics testing helps manufacturers:

  • Ensure product safety and compliance with regulations

  • Prevent contamination and spoilage of products

  • Protect consumers from potential health risks

  • Maintain brand reputation and customer trust

    • The consequences of not performing this test can be severe, including:

  • Product recalls and financial losses for manufacturers

  • Damage to brand reputation and loss of customer confidence

  • Potential harm to consumers health

    • Industries that require this testing include cosmetics, personal care products, pharmaceuticals, and food manufacturers.

    The EP 2.6.13 Detection of Designated Microorganisms in Cosmetics test is conducted using a membrane filtration method. This involves filtering the product sample through a membrane with pores of 0.45 μm or smaller to capture microorganisms. The membrane is then inoculated onto agar plates and incubated at 25C 2C for 7-14 days.

    The testing equipment and instruments used include:

  • Membrane filtration systems

  • Incubators and autoclaves

  • Microscopes and image analysis software

    • The testing environment requirements are:

  • Temperature: 20C to 30C

  • Humidity: 40 to 60

  • Pressure: 1013 mbar 10

    • Sample preparation involves homogenizing the product sample using a suitable method, such as blending or grinding. The sample is then diluted with sterile water according to the manufacturers instructions.

    The testing parameters and conditions are:

  • Sample size: 10 g to 100 g

  • Dilution factor: 1:10 to 1:100

  • Incubation time: 7-14 days

    • Measurement and analysis methods involve counting the number of colony-forming units (CFU) on the agar plates. Calibration and validation procedures are performed regularly to ensure accuracy and reliability.

    Quality control measures during testing include:

  • Verification of equipment calibration and validation

  • Checking of reagents and materials for expiration dates and quality

  • Monitoring of temperature, humidity, and pressure conditions

    • Data collection and recording procedures involve documenting all test results, including CFU counts and any anomalies or issues encountered during the testing process.

    The test report includes:

  • Test method used

  • Sample size and dilution factor

  • Incubation time and temperature

  • CFU count and result

  • Any anomalies or issues encountered during testing

    • Reporting standards and formats include:

  • ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories

  • EU Cosmetic Regulation (EC) No. 1223/2009

    • Results are validated and verified through:

  • Verification of equipment calibration and validation

  • Checking of reagents and materials for expiration dates and quality

  • Review of test data and documentation by a qualified laboratory personnel

    • Electronic reporting systems used include:

  • Laboratory information management system (LIMS)

  • Data analysis software

    • Conclusion

    The detection of designated microorganisms in cosmetics is a critical aspect of ensuring product safety and compliance with regulatory requirements. Eurolabs EP 2.6.13 Detection of Designated Microorganisms in Cosmetics laboratory testing service provides accurate and reliable results, helping manufacturers ensure the quality and safety of their products.

    We hope this comprehensive guide has provided valuable information on the standard-related information, standard requirements and needs, test conditions and methodology, and test reporting and documentation for EP 2.6.13 Detection of Designated Microorganisms in Cosmetics testing services.

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