EUROLAB
isotr-24475-microbiological-assessment-of-cosmetic-raw-materials
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 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 ISO/TR 24475 Microbiological Assessment of Cosmetic Raw Materials Laboratory Testing Service Provided by Eurolab

ISO/TR 24475 is a technical report that provides guidelines for the microbiological assessment of cosmetic raw materials. This document is part of the international standardization effort, and its development involved collaboration among experts from various countries.

Relevant Standards:

  • ISO 11133: Microbiology of food, water, and feed - General guidance on methods by incubation

  • ASTM E691: Standard practice for conducting an interlaboratory study to determine the precision of a test method

  • EN 14675:2005A1:2012 Microbiology of the food chain - Horizontal method for the detection and enumeration of microorganisms in pasteurized milk

  • TSE (Turkish Standards Institution) L.0013/2006: Microbiology of foods, water, and feed - General guidance on methods by incubation

    • Legal and Regulatory Framework:

    The microbiological assessment of cosmetic raw materials is regulated by various international and national standards. These regulations aim to ensure the safety and efficacy of cosmetic products.

  • EU Cosmetics Regulation (EC) No 1223/2009

  • US FDA Good Manufacturing Practice (GMP) for Cosmetic Products

    • International and National Standards:

    The following international and national standards apply to the microbiological assessment of cosmetic raw materials:

  • ISO/TR 24475:2016 Microbiological assessment of cosmetic raw materials - General guidance on methods by incubation

  • EN 13726:2002A1:2010 Microbiology of foodstuffs, water and feed - Horizontal method for the detection and enumeration of microorganisms in pasteurized milk

    • Standard Development Organizations:

    Standard development organizations (SDOs) play a crucial role in developing and maintaining international standards.

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards:

    Standards evolve through revisions, updates, and new editions. This ensures that standards remain relevant and effective in their application.

  • ISO/TR 24475:2016 is the current edition.

  • The next revision will be published by 2024.

    • Compliance Requirements:

    Compliance with international and national standards is mandatory for industries involved in cosmetic production.

  • Cosmetic manufacturers must comply with EU Cosmetics Regulation (EC) No 1223/2009

  • US FDA Good Manufacturing Practice (GMP) for Cosmetic Products

    • Why This Specific Test is Needed:

    The microbiological assessment of cosmetic raw materials is essential to ensure the safety and efficacy of cosmetic products.

  • Cosmetic products can harbor microorganisms that may cause infections or allergic reactions.

  • Microbiological contamination can lead to product spoilage, economic losses, and damage to brand reputation.

    • Business and Technical Reasons for Conducting ISO/TR 24475:

    Conducting ISO/TR 24475 ensures compliance with regulatory requirements and minimizes the risk of microbiological contamination.

  • Cosmetic manufacturers must ensure that their products are safe for human use.

  • Compliance with regulations reduces the risk of product recalls, lawsuits, and financial losses.

    • Consequences of Not Performing This Test:

    Failure to perform the microbiological assessment of cosmetic raw materials can result in severe consequences.

  • Microbiological contamination can lead to product spoilage, economic losses, and damage to brand reputation.

  • Non-compliance with regulations can result in product recalls, lawsuits, and financial losses.

    • Industries and Sectors That Require This Testing:

    The following industries and sectors require the microbiological assessment of cosmetic raw materials:

  • Cosmetic manufacturers

  • Pharmaceutical companies

  • Food processing industries

    • Risk Factors and Safety Implications:

    Microbiological contamination poses significant risks to human health and safety.

  • Microorganisms can cause infections, allergic reactions, and other adverse effects.

  • Microbiological contamination can lead to product spoilage, economic losses, and damage to brand reputation.

    • Quality Assurance and Quality Control Aspects:

    Quality assurance and quality control are critical aspects of the microbiological assessment of cosmetic raw materials.

  • Cosmetic manufacturers must ensure that their products meet regulatory requirements.

  • Compliance with regulations reduces the risk of product recalls, lawsuits, and financial losses.

    • Testing Equipment and Instruments:

    The following testing equipment and instruments are used for the microbiological assessment of cosmetic raw materials:

  • Autoclave

  • Incubator

  • Microbiological analyzer

  • Spectrophotometer

    • Testing Environment Requirements:

    The testing environment must meet specific requirements to ensure accurate results.

  • Temperature: 20-25C

  • Humidity: 50-60

  • Pressure: 1 atm

    • Sample Preparation Procedures:

    Sample preparation involves the following steps:

  • Collection of raw materials

  • Weighing and mixing

  • Sterilization

    • Testing Procedure:

    The testing procedure involves the following steps:

  • Inoculation of samples

  • Incubation

  • Enumeration of microorganisms

    • Test Results and Interpretation:

    Test results are interpreted based on the following criteria:

  • Microbial load: number of microorganisms per gram or milliliter

  • Presence of specific microorganisms: e.g., bacteria, yeast, mold.

    • Validation and Verification:

    Validation and verification involve the following steps:

  • Calibration of testing equipment

  • Verification of test methods

    • Conclusion:

    The microbiological assessment of cosmetic raw materials is a critical aspect of ensuring product safety and efficacy. Compliance with international and national standards requires accurate and reliable testing results. The guidelines outlined in this guide ensure that the testing process meets regulatory requirements and minimizes the risk of microbiological contamination.

    Persuasive Argument:

    Dont compromise on product safety and efficacy! Choose Eurolab for your microbiological assessment needs. Our experienced team ensures accurate and reliable test results, ensuring compliance with regulations and minimizing the risk of microbiological contamination.

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

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