EUROLAB
en-15886-stability-testing-of-cosmetic-products
Claim Substantiation COLIPA Guidelines for Cosmetic Claim SupportFDA Cosmetic Labeling Regulations TestingFDA Cosmetic Safety AssessmentFDA Cosmetic Safety Testing GuidanceFDA Guidance for Cosmetic Claim SubstantiationFDA Guidance on Cosmetic TestingFDA Voluntary Cosmetic Registration Program (VCRP) TestingISO 10993-10 Evaluation of Irritation and SensitizationISO 10993-10 Skin Irritation Testing for CosmeticsISO 10993-11 Systemic Toxicity TestingISO 10993-12 Sample Preparation for Safety TestingISO 10993-17 Toxicological Risk AssessmentISO 10993-18 Chemical CharacterizationISO 10993-18 Chemical Characterization of CosmeticsISO 10993-19 Assessment of Allergic Contact DermatitisISO 10993-22 Sensitization TestISO 10993-22 Sensitization TestingISO 10993-23 Assessment of UV-induced PhototoxicityISO 10993-23 Phototoxicity TestingISO 10993-5 Cytotoxicity TestingISO 11930 Challenge Testing for PreservativesISO 11930 Preservative Efficacy Testing for ClaimsISO 11930-1 Challenge Testing for Preservative EfficacyISO 11930-2 Preservative Testing for Leave-on ProductsISO 11989 Validation of Microbiological MethodsISO 15193 Packaging Testing for ClaimsISO 16128 Natural and Organic Cosmetic Ingredient VerificationISO 16128 Natural Ingredient CalculationISO 16128-2 Natural and Organic Content CalculationISO 16128-3 Methodologies for Natural Cosmetic ClaimsISO 16134 Cosmetic Safety GuidelinesISO 16134 Guidelines for Cosmetics SafetyISO 16134-2 Patch Testing for DermatologyISO 16134-3 Patch Test for Dermatological ClaimsISO 16179 Testing of Antioxidants in CosmeticsISO 16212 Detection of Yeasts and Molds in Cosmetic ProductsISO 17516 Microbial Limits for Cosmetic ClaimsISO 17516 Microbial Quality TestingISO 17516 Microbial TestingISO 21148 Anaerobic Microorganism DetectionISO 21148 Detection of Anaerobic MicroorganismsISO 21149 Aerobic Bacteria EnumerationISO 21149 Enumeration of Aerobic Bacteria for Claim SupportISO 21150 Detection of Pathogens in CosmeticsISO 21150 Microbial Contamination TestingISO 21401 Environmental Impact TestingISO 21401 Environmental Label TestingISO 22715 Cosmetic Product Labelling ComplianceISO 22716 Cosmetic Good Manufacturing Practice Compliance TestingISO 22716 GMP for Cosmetic ProductsISO 24434 Antimicrobial Effectiveness TestingISO 24441 SPF Testing for Sun Care ProductsISO 24441 UVA Protection TestingISO 24442 Microbial Spores EnumerationISO 24442 Spore EnumerationISO 24443 UVA Protection TestingISO 24444 SPF Testing ProtocolISO 24444 Sun Protection Factor (SPF) TestingISO 24475 Microbiological Raw Material TestingISO 24475 Raw Material Microbiological TestingISO 24476 Guidelines for Microbiological MethodsISO 24476 Guidelines for Microbiological TestingISO 31661 Photostability TestingISO 31661-2 UV Stability TestingOECD TG 405 In Vivo Eye Irritation TestingOECD TG 431 In Vitro Skin Corrosion TestingOECD TG 439 In Vitro Skin Irritation Testing for ClaimsOECD TG 442C In Vitro Skin SensitizationOECD TG 442D In Vitro Skin Sensitization Assay

Comprehensive Guide to Eurolabs EN 15886 Stability Testing of Cosmetic Products Laboratory Testing Service

The European Standard EN 15886:2013 is a comprehensive standard that outlines the requirements for stability testing of cosmetic products. This standard is part of the CEN/TC 168 series, which deals with safety and performance of personal care products.

The EN 15886 standard is developed by the European Committee for Standardization (CEN) in collaboration with other international standard development organizations such as the International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM). The standard is widely recognized and adopted across Europe, and its adoption is also increasing globally.

The EN 15886 standard is a mandatory requirement for cosmetic manufacturers to ensure that their products meet the necessary safety and performance criteria. The standard specifies the testing methods and procedures to be followed to evaluate the stability of cosmetic products over time.

Legal and Regulatory Framework

The European Union (EU) has implemented several directives and regulations related to cosmetics, including the Cosmetic Regulation 1223/2009 and the General Safety and Performance Requirements for Medical Devices Regulation 2017/745. These regulations mandate that cosmetic manufacturers comply with certain requirements, including stability testing of their products.

In addition to EU regulations, many countries have their own laws and regulations governing cosmetics. For example, in the United States, the Food and Drug Administration (FDA) regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FDCA). In Canada, Health Canada regulates cosmetics under the Food and Drugs Act.

International and National Standards

The EN 15886 standard is part of a larger framework of international and national standards that govern cosmetic testing. Some of the key standards related to cosmetic stability testing include:

  • ISO 11063:2006 Stability testing of personal care products
  • ASTM D5483-02 Standard guide for stability testing of personal care products
  • TSE EN 15886 Stability testing of cosmetic products (Turkish Standard)
  • USP <661> General information on the stability of pharmaceutical and cosmetic products
  • Standard Development Organizations

    Several standard development organizations contribute to the development of standards related to cosmetic testing. These organizations include:

  • CEN (European Committee for Standardization)
  • ISO (International Organization for Standardization)
  • ASTM (American Society for Testing and Materials)
  • USP (United States Pharmacopeia)
  • These organizations work together to develop and maintain standards that are widely accepted globally.

    How Standards Evolve

    Standards evolve over time as new research and technologies emerge. The standard development process involves several stages, including:

    1. Initiation: A proposal is submitted for a new or revised standard.

    2. Development: The standard is developed by a working group of experts.

    3. Review: The standard is reviewed and commented on by stakeholders.

    4. Adoption: The standard is adopted by the relevant standard development organization.

    Standard Numbers and Scope

    The EN 15886 standard has several related standards, including:

  • EN 15886:2013 Stability testing of cosmetic products
  • EN 1372:1997 Method for determination of pH value of cosmetic products
  • These standards are widely recognized and adopted globally.

    Compliance Requirements

    Cosmetic manufacturers must comply with the relevant standards and regulations in their country or region. Compliance requirements include:

  • Following the standards test methods and procedures
  • Providing documentation of testing results
  • Maintaining records of stability testing
  • Failure to comply can result in product recalls, fines, and reputational damage.

    The EN 15886 standard is widely recognized and adopted globally. Cosmetic manufacturers must comply with the relevant standards and regulations in their country or region. Compliance requirements include following the standards test methods and procedures, providing documentation of testing results, and maintaining records of stability testing.

    The EN 15886 standard is essential for ensuring the safety and performance of cosmetic products. The standard specifies the testing methods and procedures to evaluate the stability of cosmetic products over time. Manufacturers must comply with this standard to ensure product safety and efficacy.

    Business and Technical Reasons

    There are several business and technical reasons why manufacturers should conduct EN 15886 stability testing:

  • Ensures product safety and efficacy
  • Complies with regulatory requirements
  • Enhances brand reputation and customer trust
  • Reduces risk of product recalls and reputational damage
  • Consequences of Not Performing the Test

    Failure to perform the test can result in several consequences, including:

  • Product recalls
  • Fines and penalties
  • Reputational damage
  • Loss of customer trust and loyalty
  • Industries and Sectors

    Several industries and sectors require EN 15886 stability testing, including:

  • Personal care products (skincare, haircare, etc.)
  • Cosmetics (makeup, fragrances, etc.)
  • Pharmaceuticals (medicines, vaccines, etc.)
  • The EN 15886 standard is essential for ensuring the safety and performance of cosmetic products. Manufacturers must comply with this standard to ensure product safety and efficacy.

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