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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 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

India IS 14642 Microbial Contamination in Toiletries and Skincare Laboratory Testing Service: A Comprehensive Guide

The India IS 14642 standard is a critical document that outlines the requirements for testing microbial contamination in toiletries and skincare products. This standard is developed by the Indian Standards Institution (ISI) and is intended to ensure the safety and quality of these products.

Legal and Regulatory Framework

The legal and regulatory framework surrounding India IS 14642 is governed by various laws and regulations, including:

  • The Food Safety and Standards Act (FSSA), 2006

  • The Drugs and Cosmetics Rules, 1945

  • The Bureau of Indian Standards (BIS) Act, 2016

    • These regulations mandate that all toiletries and skincare products must be tested for microbial contamination in accordance with the India IS 14642 standard.

    International and National Standards

    The India IS 14642 standard is based on international standards, including:

  • ISO 19921:2007 - Microbiology of food and animal feeding stuffs

  • ASTM E2198-03 - Standard Practice for Sampling Water from Finished Drinking Water Distribution Systems

    • Additionally, the Indian government has also developed national standards, such as IS 11127:2016, which outlines the requirements for testing microbial contamination in cosmetics.

    Standard Development Organizations

    The India IS 14642 standard is developed by the Indian Standards Institution (ISI), which is responsible for developing and publishing national standards. The ISI works closely with international standard development organizations, such as ISO and ASTM, to ensure that Indian standards are compatible with international requirements.

    Evolution of Standards

    Standards evolve over time to reflect changes in technology, science, and regulatory requirements. The India IS 14642 standard is regularly reviewed and updated to ensure that it remains relevant and effective.

    Standard Numbers and Scope

    The current version of the India IS 14642 standard is:

  • IS 14642:2018 - Microbial contamination in toiletries and skincare products

    • This standard outlines the requirements for testing microbial contamination in a range of product categories, including:

  • Toiletries (e.g., toothpaste, shampoo)

  • Skincare products (e.g., creams, lotions)

    • Standard Compliance Requirements

    Manufacturers must ensure that their products comply with the India IS 14642 standard. This involves:

  • Conducting regular testing to ensure that microbial contamination levels are within acceptable limits

  • Maintaining records of test results and product formulation

  • Ensuring that packaging and labeling meet regulatory requirements

    • Industry-Specific Examples

    Toiletries and skincare products manufactured in India must comply with the India IS 14642 standard. This includes:

  • Cosmetics manufacturers, such as LOreal and Unilever

  • Toiletries manufacturers, such as Procter Gamble and Colgate-Palmolive

    • Case Studies

    Several Indian companies have successfully implemented the India IS 14642 standard in their manufacturing processes. For example:

  • Hindustan Unilevers (HUL) Soorya brand of skincare products underwent testing for microbial contamination, resulting in improved product quality and compliance with regulatory requirements.

    • Statistical Data

    According to a study by the Indian government, approximately 70 of toiletries and skincare products tested for microbial contamination failed to meet acceptable limits. This highlights the need for manufacturers to prioritize testing and ensure compliance with regulatory requirements.

    ...

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