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iso-21148-detection-of-anaerobic-bacteria-in-cosmetic-formulations
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 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 ISO 21148 Detection of Anaerobic Bacteria in Cosmetic Formulations Laboratory Testing Service Provided by Eurolab

ISO 21148:2019 is the international standard that governs the detection of anaerobic bacteria in cosmetic formulations. This standard is developed and published by the International Organization for Standardization (ISO), a non-profit organization that brings together countries to share knowledge, expertise, and resources to develop voluntary international standards.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 21148 testing is based on various national and international regulations. For instance, in the European Union, the Cosmetics Regulation (EC) No 1223/2009 requires that cosmetic products be safe for human use. The regulation also specifies that manufacturers must ensure the safety of their products by conducting necessary tests, including microbiological tests.

International and National Standards

ISO 21148 is an international standard, but it is based on other national standards. For example, in Europe, EN ISO 21148:2019 is a harmonized European standard that replaces the former European Standard EN 14156. In the United States, ASTM E2180-13 (Standard Test Method for Detection of Anaerobic Bacteria) is equivalent to ISO 21148.

Standard Development Organizations

The International Organization for Standardization (ISO), which develops and publishes standards such as ISO 21148, is a non-profit organization that brings together countries to share knowledge, expertise, and resources. Other standard development organizations include the American Society for Testing and Materials (ASTM) in the United States, the European Committee for Standardization (CEN) in Europe, and the Turkish Standards Institution (TSE) in Turkey.

Standard Evolution and Updates

Standards evolve over time to reflect changes in technology, regulations, or industry practices. For instance, ISO 21148 was revised in 2019 to include new methods for detecting anaerobic bacteria. The standard is regularly reviewed and updated by technical experts from around the world.

Standard Numbers and Scope

The scope of ISO 21148 includes the detection of anaerobic bacteria in cosmetic formulations using microbiological tests. The standard specifies the testing equipment, reagents, and procedures required to detect these microorganisms. The standard also provides guidance on sample preparation, testing parameters, and data analysis.

Industry Compliance Requirements

Compliance with standards such as ISO 21148 is mandatory for manufacturers of cosmetic products in various industries, including:

  • Cosmetics

  • Personal care

  • Pharmaceuticals

  • Biotechnology

    • Failure to comply with these standards can result in product recalls, loss of market share, and reputational damage.

    The standard numbers and scope of ISO 21148 are as follows:

    Standard Number Title

    --- ---

    ISO 21148:2019 Detection of anaerobic bacteria in cosmetic formulations

    The industry compliance requirements for ISO 21148 testing include:

  • Cosmetic products must be free from contamination with anaerobic bacteria

  • Manufacturers must conduct regular microbiological tests on their products to ensure safety

  • Results of these tests must be documented and reported as required by the standard

    • Why This Specific Test is Needed and Required

    The detection of anaerobic bacteria in cosmetic formulations is essential for ensuring product safety. These microorganisms can cause spoilage, contamination, and even infections if they are present in high numbers.

    Business and Technical Reasons for Conducting ISO 21148 Testing

    Manufacturers conduct ISO 21148 testing to ensure compliance with regulations, protect their brand reputation, and maintain customer confidence. The test also helps manufacturers to detect potential problems before they occur, reducing the risk of product recalls and costly rework.

    Consequences of Not Performing This Test

    Failure to perform ISO 21148 testing can result in product contamination, spoilage, or even infections. This can lead to loss of market share, reputational damage, and financial losses for manufacturers.

    Industries and Sectors that Require This Testing

    The following industries and sectors require ISO 21148 testing:

  • Cosmetics

  • Personal care

  • Pharmaceuticals

  • Biotechnology

  • Food and beverage

    • Risk Factors and Safety Implications

    The risk factors associated with anaerobic bacteria in cosmetic formulations include:

  • Contamination of products

  • Spoilage or degradation of products

  • Infections or allergic reactions in consumers

    • Quality Assurance and Quality Control Aspects

    Manufacturers must implement quality assurance and quality control measures to ensure compliance with ISO 21148 testing. This includes:

  • Regular microbiological tests on products

  • Monitoring of environmental conditions (temperature, humidity)

  • Training of personnel responsible for testing and handling samples

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

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