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isotr-24476-test-method-selection-for-cosmetic-product-microbiology
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/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

Complete Guide to ISO/TR 24476 Test Method Selection for Cosmetic Product Microbiology Testing Services

Provided by Eurolab

ISO/TR 24476 is a Technical Report that provides guidelines for the selection of test methods for cosmetic product microbiology testing. This report is developed by the International Organization for Standardization (ISO) and is published in collaboration with other standard development organizations, including ASTM (American Society for Testing and Materials), EN (European Standardization Committee), TSE (Turkish Standards Institution), and others.

The legal and regulatory framework surrounding ISO/TR 24476 Test Method Selection for Cosmetic Product Microbiology testing is governed by various international and national standards. Some of the key standards that apply to this specific laboratory test include:

  • ISO 11133:2014 - Microbiology of food, animal feeding stuffs and pharmaceutical products Preparation of samples, removal of microbial contamination and enumeration of microorganisms

  • ASTM E2197-01(2020) - Standard Guide for Testing and Evaluating the Performance of Microbiological Test Kits

  • EN ISO 11133:2014 - Microbiology of food, animal feeding stuffs and pharmaceutical products Preparation of samples, removal of microbial contamination and enumeration of microorganisms

  • TSE ISO 11133:2014 - Mikrobiyoloji Testleri için Örnek Hazırlama ve Analiz

    • Standard development organizations play a crucial role in the development and maintenance of standards. These organizations work together to ensure that standards are developed, reviewed, and updated regularly to reflect changes in technology, regulations, and industry practices.

    Standards evolve over time as new technologies emerge, and regulatory requirements change. This evolution ensures that standards remain relevant and effective in addressing emerging issues and challenges.

    Some key standard numbers and their scopes for ISO/TR 24476 Test Method Selection for Cosmetic Product Microbiology testing are:

  • ISO/TR 24476:2019 - Microbiological test methods for cosmetics Guidelines for the selection of test methods

  • ISO 11133:2014 - Microbiology of food, animal feeding stuffs and pharmaceutical products Preparation of samples, removal of microbial contamination and enumeration of microorganisms

    • Standard compliance requirements vary across industries. For example:

  • In the European Union (EU), the Cosmetics Regulation (EC) No. 1223/2009 requires that cosmetic products be safe for human use.

  • In the United States (US), the Food and Drug Administration (FDA) regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FDCA).

  • In Turkey, the Turkish Standards Institution (TSE) is responsible for developing and enforcing standards for cosmetics.

    • ISO/TR 24476 Test Method Selection for Cosmetic Product Microbiology testing is necessary to ensure the safety and quality of cosmetic products. The business and technical reasons for conducting this test are:

  • To prevent the introduction of microbiological contaminants into cosmetic products, which can lead to product failure, recalls, or even consumer harm.

  • To comply with regulatory requirements and industry standards.

  • To maintain product quality and consistency.

  • To ensure that products meet customer expectations and preferences.

    • The consequences of not performing this test are:

  • Reduced product safety and quality.

  • Increased risk of product failures and recalls.

  • Non-compliance with regulatory requirements and industry standards.

  • Damage to brand reputation and customer trust.

    • Industries and sectors that require this testing include:

  • Cosmetic manufacturers and suppliers.

  • Regulatory agencies and government departments.

  • Quality assurance and control professionals.

  • Research and development teams.

    • Risk factors and safety implications associated with cosmetic products include:

  • Presence of microbiological contaminants, such as bacteria, viruses, and fungi.

  • Contamination from equipment, personnel, or raw materials.

  • Inadequate product formulation or manufacturing processes.

    • Quality assurance and quality control aspects of ISO/TR 24476 Test Method Selection for Cosmetic Product Microbiology testing involve:

  • Use of validated test methods and equipment.

  • Training and qualification of laboratory personnel.

  • Regular calibration and maintenance of equipment.

  • Implementation of quality control measures during testing.

  • Documentation and reporting of test results.

    • This test contributes to product safety and reliability by:

  • Ensuring the absence or presence of microbiological contaminants.

  • Verifying compliance with regulatory requirements and industry standards.

  • Providing quality assurance and control data for manufacturing processes.

    • Competitive advantages of having this testing performed include:

  • Enhanced brand reputation and customer trust.

  • Improved product safety and quality.

  • Compliance with regulatory requirements and industry standards.

  • Increased market access and trade facilitation.

    • Cost-benefit analysis of performing this test shows that the benefits far outweigh the costs.

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