EUROLAB
ph-eur-2613-detection-of-pathogens-in-powdered-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 2.6.13 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 EmulsionsSCCS/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 Ph. Eur. 2.6.13 Detection of Pathogens in Powdered Cosmetics Laboratory Testing Service

Ph. Eur. 2.6.13 Detection of Pathogens in Powdered Cosmetics is a laboratory testing service governed by the European Pharmacopoeia (Ph. Eur.) standards. The relevant standard, Ph. Eur. 2.6.13, outlines the requirements for detecting pathogens in powdered cosmetics.

The legal and regulatory framework surrounding this testing service is primarily based on EU regulations, specifically:

  • Regulation (EC) No 1223/2009 on Cosmetic Products

  • Directive 76/768/EEC on Cosmetics

    • These regulations mandate that cosmetic products, including powdered cosmetics, be safe for human use. The detection of pathogens in these products is a critical aspect of ensuring product safety.

    International standards applicable to this specific laboratory test include:

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

  • ASTM E2599-11 (Standard Practice for Testing Microbiological Quality of Ophthalmic Products)

    • National standards that apply to this testing service include:

  • EN 14644-1:2009 (Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness)

  • TSE (Turkish Standards Institution) standards

    • Standard development organizations, such as ISO, play a crucial role in developing and updating standards. These organizations ensure that standards remain relevant and effective in protecting public health.

    The standard compliance requirements for different industries are outlined below:

    Industry Standard Compliance Requirements

    --- ---

    Cosmetics Ph. Eur. 2.6.13, EU Regulation (EC) No 1223/2009, Directive 76/768/EEC

    Pharmaceutical ISO 11133:2014, ASTM E2599-11

    Food and Beverage EN 14644-1:2009, TSE standards

    Ph. Eur. 2.6.13 Detection of Pathogens in Powdered Cosmetics testing is required for several reasons:

  • Ensuring product safety

  • Compliance with regulations

  • Building customer trust and confidence

  • Facilitating international trade

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

  • Product recalls

  • Financial losses

  • Damage to brand reputation

    • This testing service is particularly important in industries where powdered cosmetics are used extensively, such as:

  • Cosmetics

  • Pharmaceuticals

  • Food and Beverage

    • Risk factors and safety implications associated with pathogens in powdered cosmetics include:

  • Infection and illness

  • Contamination of other products

  • Economic losses

    • Quality assurance and quality control aspects of this testing service involve:

  • Validation of methods

  • Calibration of equipment

  • Regular maintenance and calibration

  • Training and certification of personnel

    • This test contributes to product safety and reliability by detecting potential pathogens, thereby ensuring that powdered cosmetics meet regulatory requirements.

    Competitive advantages of having this testing performed include:

  • Enhanced customer trust and confidence

  • Improved brand reputation

  • Compliance with regulations

  • Reduced risk of product recalls and financial losses

    • Cost-benefit analysis of performing this test demonstrates significant benefits, including cost savings and efficiency improvements.

    The Ph. Eur. 2.6.13 Detection of Pathogens in Powdered Cosmetics testing service involves the following steps:

    1. Sample preparation

    Weighing and homogenization

    Sterilization and aseptic transfer

    2. Testing parameters and conditions

    Temperature: 20-25C (68-77F)

    Humidity: 40-60

    Pressure: 100-105 kPa

    3. Measurement and analysis methods

    Microbiological assays (e.g., culturing, PCR)

    4. Calibration and validation procedures

    Equipment calibration

    Method validation

    Quality control measures during testing involve:

  • Regular monitoring of equipment performance

  • Verification of test results

  • Review of quality management systems

    • Data collection and recording procedures include:

  • Use of standardized templates and reports

  • Electronic data storage and retrieval

    • Testing timeframes and duration vary depending on the specific requirements of each project.

    Sample size requirements and statistical considerations involve:

  • Determining minimum sample sizes for reliable testing

  • Applying statistical methods to analyze test results

    • Test results are documented and reported in accordance with EU regulations and Ph. Eur. standards.

    The report format and structure include:

  • Test name and description

  • Sample identification and handling information

  • Test parameters and conditions

  • Results, including any deviations or anomalies

  • Conclusion and recommendations

    • Regular maintenance and calibration of equipment ensure accuracy and reliability of test results.

    Training and certification of personnel are essential for ensuring compliance with regulations and standards.

    Conclusion

    Eurolabs Ph. Eur. 2.6.13 Detection of Pathogens in Powdered Cosmetics laboratory testing service is a critical aspect of ensuring product safety, compliance with regulations, and building customer trust and confidence. Our team of experts provides comprehensive testing services, adhering to EU regulations, Ph. Eur. standards, and international standards.

    By choosing Eurolabs Ph. Eur. 2.6.13 Detection of Pathogens in Powdered Cosmetics laboratory testing service, you can ensure that your powdered cosmetics meet regulatory requirements, thereby reducing the risk of product recalls, financial losses, and damage to brand reputation.

    Appendix

    Regulatory References:

  • Regulation (EC) No 1223/2009 on Cosmetic Products

  • Directive 76/768/EEC on Cosmetics

    • Standards:

  • Ph. Eur. 2.6.13

  • ISO 11133:2014

  • ASTM E2599-11

  • EN 14644-1:2009

  • TSE standards

    • Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers