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isotr-19838-risk-management-of-preservatives-in-cosmetics
Preservative Efficacy Testing AOAC 2003.07 Challenge Testing for Preservative EffectivenessAOAC 2007.01 Microbial Challenge Testing for PreservativesAOAC 991.14 Microbial Contamination Analysis in Preserved ProductsAOAC 997.02 Challenge Test Method for Preservative EffectivenessASTM D4014 Preservative Testing for Creams and LotionsASTM D5412 Microbial Limits Testing in Preserved CosmeticsASTM D6422 Preservative Effectiveness in Personal Care ProductsASTM E2180 Antimicrobial Activity of Preservative SystemsASTM E2181 Preservative Efficacy Testing for CosmeticsASTM E2315 Preservation Challenge Test for Cosmetic ProductsASTM E2315 Time-Kill Method for Preservative AssessmentASTM E2315-16 Time-Kill Kinetics for Preservative EffectivenessASTM E2316 Microbial Assessment of Cosmetic PreservativesASTM E2317 Antimicrobial Efficacy of Cosmetic PreservativesASTM E2709 Challenge Tests for Preservative SystemsASTM E2799 Antimicrobial Effectiveness Testing for CosmeticsCOLIPA Guidelines for Preservative Efficacy in CosmeticsEN ISO 11930 Microbial Preservation Testing for Personal CareEN ISO 11930 Microbial Quality and Preservation AssessmentEP 2.6.12 Enumeration of Microorganisms in Preserved ProductsEP 2.6.13 Detection of Specified Microorganisms in Preserved ProductsEP 5.1.3 Challenge Test for Preservative EfficacyEP 5.1.4 Microbial Limits in Preserved IngredientsEP 5.1.5 Microbial Quality Control in Preserved FormulationsFDA 21 CFR 701.3 Microbial Contamination Limits in Preserved ProductsFDA 21 CFR Part 700 Microbial Limits for Preserved CosmeticsFDA BAM Chapter 23 Microbial Pathogen Detection in Preserved ProductsFDA Cosmetic Microbiological Testing GuidanceFDA Guidance on Preservative Testing for Topical ProductsISO 10993-10 Preservation Efficacy in Dermal ProductsISO 10993-12 Sample Preparation for Preservative TestingISO 11930 Challenge Test of Preservatives in CosmeticsISO 11930 Evaluation of Preservative Efficacy in CosmeticsISO 11930-1 Preservative Challenge Testing for Rinse-off ProductsISO 11930-2 Preservative Testing of Leave-on CosmeticsISO 11932 Validation of Microbial Methods in Preservation TestingISO 11989 Validation of Microbiological Methods in Preserved ProductsISO 16128 Natural and Organic Cosmetic Ingredient PreservationISO 16128-2 Calculation of Natural Preservative ContentISO 16134-3 Testing of Preservative EffectivenessISO 16212 Detection of Yeasts and Molds in Preserved CosmeticsISO 16212 Mold and Yeast Quantification in Preserved CosmeticsISO 17516 Microbial Limits and Preservation TestingISO 18415 Microbial Challenge Test for Personal Care ProductsISO 18593 Microbial Sampling in Preserved ProductsISO 18593 Microbiological Sampling Methods for Preserved ProductsISO 21148 Detection of Anaerobic Microorganisms in Preserved ProductsISO 21148 Detection of Preservative-Resistant MicroorganismsISO 21149 Enumeration of Aerobic Bacteria for Preservative StudiesISO 21149 Enumeration of Microorganisms in Preserved FormulationsISO 21149-1 Enumeration of Aerobic Bacteria in Preserved FormulationsISO 21150 Detection of Pathogens in Preserved CosmeticsISO 21150-1 Microbial Contamination in Cosmetic Raw MaterialsISO 21404 Testing for Microbial Contamination in Preserved CosmeticsISO 21702 Antiviral Efficacy Testing of PreservativesISO 22176 Good Hygiene Practices for Preserved CosmeticsISO 22716 Good Manufacturing Practices for Cosmetic PreservationISO 24434 Enumeration of Aerobic Mesophilic Spores in Preserved ProductsISO 24441 SPF Testing for Preserved SunscreensISO 24442 Enumeration of Aerobic Microbial Spores in ProductsISO 24442 Microbial Spores Enumeration in Preserved ProductsISO 24444 Comparison of Microbiological Test ProtocolsISO 24475 Microbiological Assessment of Preserved Raw MaterialsISO 29621 Categorization of Cosmetic Products by Microbiological RiskISO/TR 19837 Guidelines for Microbiological Risk Assessment of PreservativesISO/TR 19930 Microbiological Test Method Development for PreservativesISO/TR 24476 Selection of Microbiological Test Methods for PreservationISO/TR 29621 Guidelines on Risk Assessment for PreservativesUSP <1227> Validation of Microbial Recovery in Preservative StudiesUSP <1227> Validation of Microbial Recovery in Preservative TestingUSP <1229> Microbial Recovery in Preservative Efficacy TestsUSP <1231> Water Quality for Microbiological Control in Preservative TestingUSP <1625> Microbial Testing of Preserved Topical ProductsUSP <51> Antimicrobial Effectiveness Testing for PreservativesUSP <60> Microbial Limits in Preserved CosmeticsUSP <61> Microbial Enumeration Tests in Preserved Cosmetics

ISO/TR 19838 Risk Management of Preservatives in Cosmetics: Eurolabs Laboratory Testing Service

ISO/TR 19838 is a technical report published by the International Organization for Standardization (ISO) that provides guidance on the risk management of preservatives in cosmetics. This document is part of the ISO/TR series, which focuses on providing technical reports and guidelines on various topics related to standardization.

Relevant Standards

The following standards are relevant to ISO/TR 19838 Risk Management of Preservatives in Cosmetics:

  • ISO 9001:2015 Quality management systems Requirements

  • ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes

  • EN 71:2014 Safety of toys Part 1: Safety aspects related to mechanical and physical properties

  • TSE (Turkish Standards Institution) 13387:2020 Cosmetics Preservatives

  • ASTM E2538-17 Standard Practice for Risk Assessment of Chemicals in Personal Care Products

    • Legal and Regulatory Framework

    The use of preservatives in cosmetics is regulated by various laws and regulations worldwide. In the European Union, for example, the Regulation (EC) No 1223/2009 on cosmetic products imposes specific requirements on the use of preservatives.

    In the United States, the FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FDC Act). The agency has established guidelines for the safety evaluation of preservatives in cosmetics.

    International and National Standards

    ISO/TR 19838 provides guidance on the risk management of preservatives in cosmetics at an international level. However, national standards may differ depending on the country or region. For example:

  • In the EU, EN 71:2014 is a harmonized standard that sets out safety requirements for toys, including those containing preservatives.

  • In Turkey, TSE 13387:2020 provides specific requirements for preservatives in cosmetics.

    • Standard Development Organizations

    The ISO/TR series is developed by the International Organization for Standardization (ISO), which is responsible for creating and publishing international standards. Other standard development organizations involved in the development of relevant standards include:

  • ASTM International

  • EN European Committee for Standardization

  • TSE Turkish Standards Institution

    • Evolution of Standards

    Standards are regularly reviewed and updated to reflect changes in technology, science, and regulation. For example, ISO/TR 19838 was published in 2018 as a technical report, providing guidance on the risk management of preservatives in cosmetics.

    Standard Numbers and Scope

    The following standard numbers and their scope are relevant to ISO/TR 19838 Risk Management of Preservatives in Cosmetics:

  • ISO 9001:2015 Quality management systems Requirements

    • Scope: Provides requirements for quality management systems.

  • ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes

    • Scope: Provides requirements for medical device manufacturers to establish a quality management system.

  • EN 71:2014 Safety of toys Part 1: Safety aspects related to mechanical and physical properties

    • Scope: Sets out safety requirements for toys, including those containing preservatives.

  • TSE 13387:2020 Cosmetics Preservatives

    • Scope: Provides specific requirements for preservatives in cosmetics.

  • ASTM E2538-17 Standard Practice for Risk Assessment of Chemicals in Personal Care Products

    • Scope: Provides a practice for assessing the risks associated with chemicals in personal care products.

    Standard Compliance Requirements

    Compliance with standards is essential to ensure safety and quality. Companies must demonstrate compliance with relevant standards through documentation, testing, and certification.

    Standard-Related Services Provided by Eurolab

    Eurolab offers laboratory testing services related to ISO/TR 19838 Risk Management of Preservatives in Cosmetics, including:

  • Testing for preservative efficacy

  • Analyzing preservative levels in cosmetic products

  • Providing guidance on risk management and mitigation

    • Why This Specific Test is Needed and Required

    The use of preservatives in cosmetics is a critical aspect of product safety and quality. Preservatives are added to prevent microbial growth, which can lead to spoilage or even harm consumers.

    However, some preservatives have been linked to health concerns, such as skin irritation or allergic reactions. Therefore, it is essential to assess the risks associated with preservatives in cosmetics.

    Business and Technical Reasons for Conducting ISO/TR 19838 Risk Management of Preservatives in Cosmetics Testing

    Conducting this testing is crucial for several reasons:

  • Ensures product safety and quality

  • Complies with regulatory requirements

  • Provides a competitive advantage through risk management and mitigation

  • Enhances customer confidence and trust

    • Consequences of Not Performing This Test

    Failure to conduct ISO/TR 19838 Risk Management of Preservatives in Cosmetics testing can result in:

  • Regulatory non-compliance

  • Product recalls or bans

  • Damage to brand reputation

  • Financial losses due to lawsuits or settlements

    • Testing Services Provided by Eurolab

    Eurolab offers a range of laboratory testing services related to ISO/TR 19838 Risk Management of Preservatives in Cosmetics, including:

  • Testing for preservative efficacy and levels

  • Analyzing microbial growth and spoilage

  • Providing guidance on risk management and mitigation

    • Risk Assessment and Mitigation

    Risk assessment is an essential step in ensuring product safety and quality. Eurolabs experts can help companies assess risks associated with preservatives in cosmetics and develop strategies for mitigation.

    Standard-Related Testing Services Provided by Eurolab

    Eurolab offers laboratory testing services related to ISO/TR 19838 Risk Management of Preservatives in Cosmetics, including:

  • Chemical analysis

  • Microbial analysis

  • Physical analysis

    • The following is a detailed list of standard-related testing services provided by Eurolab:

    1. Chemical Analysis: Eurolab provides chemical analysis services for preservative levels and efficacy.

    2. Microbial Analysis: Eurolab offers microbial analysis services to detect microbial growth and spoilage.

    3. Physical Analysis: Eurolab conducts physical analysis to assess product properties such as texture, appearance, and stability.

    Standard-Related Certifications Provided by Eurolab

    Eurolab provides certifications related to ISO/TR 19838 Risk Management of Preservatives in Cosmetics, including:

    1. ISO 9001:2015 Quality Management System Certification: Demonstrates compliance with quality management system requirements.

    2. EN 71:2014 Safety of Toys Part 1: Safety Aspects Related to Mechanical and Physical Properties Certification: Verifies compliance with safety requirements for toys containing preservatives.

    3. TSE 13387:2020 Cosmetics Preservatives Certification: Confirms compliance with specific requirements for preservatives in cosmetics.

    The following is a detailed list of standard-related certifications provided by Eurolab:

    1. ISO 9001:2015 Quality Management System Certification

    2. EN 71:2014 Safety of Toys Part 1: Safety Aspects Related to Mechanical and Physical Properties Certification

    3. TSE 13387:2020 Cosmetics Preservatives Certification

    Standard-Related Documentation Provided by Eurolab

    Eurolab provides documentation related to ISO/TR 19838 Risk Management of Preservatives in Cosmetics, including:

    1. Test Reports: Detailed reports on testing results and findings.

    2. Certificates of Compliance: Documents confirming compliance with relevant standards.

    3. Risk Assessment Reports: Reports detailing risk assessment and mitigation strategies.

    The following is a detailed list of standard-related documentation provided by Eurolab:

    1. Test Reports

    2. Certificates of Compliance

    3. Risk Assessment Reports

    Conclusion

    ISO/TR 19838 Risk Management of Preservatives in Cosmetics is an essential document for companies involved in the cosmetics industry. This guide provides information on relevant standards, testing services, certifications, and documentation provided by Eurolab.

    By following this guide, companies can ensure compliance with regulatory requirements, product safety and quality, and customer confidence and trust.

    References

    1. ISO/TR 19838:2018 Risk Management of Preservatives in Cosmetics.

    2. ISO 9001:2015 Quality management systems Requirements.

    3. EN 71:2014 Safety of toys Part 1: Safety aspects related to mechanical and physical properties.

    4. TSE 13387:2020 Cosmetics Preservatives.

    5. ASTM E2538-17 Standard Practice for Risk Assessment of Chemicals in Personal Care Products.

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