EUROLAB
isotr-29622-allergens-in-cosmetics-and-personal-care-products
Dermatological & Sensitivity Testing AFNOR BP X30-221 In Vivo Human Skin Testing ProceduresASTM D2979 Assessment of Skin Sensitization PotentialASTM D4236 Labeling of Cosmetic Products for Skin SafetyASTM D6125 Evaluation of Skin Sensitization Using In Vitro ModelsASTM D6977 Evaluation of Skin Contact AllergensASTM E1490 Evaluation of Allergic Contact DermatitisASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended ProtocolASTM E2753 Human Repeat Insult Patch Test (HRIPT)ASTM F2312 Evaluation of Patch Test Allergen ReleaseCOLIPA Guidelines for Skin Compatibility TestingEN 16820 Test Method for Skin Sensitization PotentialEN 1811 Determination of Nickel Release from Skin-Contact ProductsEN ISO 10993-10 Assessment of Skin IrritationEN ISO 10993-18 Chemical Characterization for Dermal SafetyEN ISO 10993-21 Evaluation of Skin Irritation from Medical Device ExtractsEN ISO 10993-5 Cytotoxicity Testing on Skin CellsEP 5.1.6 Evaluation of Dermatological Safety of CosmeticsFDA 21 CFR 820 Quality System Regulation for Dermal DevicesFDA 21 CFR Part 807 Sensitivity Testing of Topical ProductsFDA Guidance for Dermatological Testing of Topical ProductsFDA Guidance on Dermal Sensitization Risk AssessmentISO 105-A02 Colorfastness to Artificial Light on SkinISO 10993-1 Biological Evaluation of Medical Devices - Dermal AspectsISO 10993-10 Evaluation of Skin Irritation and SensitizationISO 10993-11 Toxicity Testing Related to Skin ContactISO 10993-12 Sample Preparation for Dermal TestingISO 10993-16 Toxicokinetic Testing of Substances in Dermal ExposureISO 10993-17 Toxicological Risk Assessment for Dermal ProductsISO 10993-19 Evaluation of Allergic Contact Dermatitis in Skin ProductsISO 10993-20 Dermal Toxicology Testing MethodsISO 10993-22 Evaluation of Sensitization from Skin Contact DevicesISO 10993-23 Evaluation of Phototoxicity and PhotoallergyISO 11137 Sterilization Validation of Dermal DevicesISO 11930 Preservative Effectiveness for Sensitive Skin ProductsISO 14155 Clinical Investigation of Medical Devices on SkinISO 15223-1 Symbols for Dermal Medical DevicesISO 15223-1 Symbols for Indicating Skin Contact in Medical DevicesISO 16128 Guidelines on Natural and Organic Cosmetic IngredientsISO 16128-1 Guidelines on Natural and Organic Cosmetics Part 1ISO 16128-2 Calculation of Natural Ingredient Content in Skin ProductsISO 16128-3 Methodologies for Determining Organic Content in Skin CareISO 16134 Human Repeat Insult Patch Test GuidanceISO 16134-2 Guidance for Patch Test Interpretation in Skin TestingISO 17516 Microbiological Limits for Skin ProductsISO 21404 Testing for Skin Contact AllergensISO 21486 Risk Assessment for Skin Contact MaterialsISO 22444 Measurement of Skin Moisture ContentISO 22715 Labeling Requirements for Skin and Cosmetic ProductsISO 22716 Good Manufacturing Practices for Dermatological ProductsISO 22716-1 Good Manufacturing Practices for Skin Care ProductsISO 23975 Patch Test Protocols for Dermatological ProductsISO 24441 In Vitro Determination of Sun Protection Factor (SPF)ISO 24442 Evaluation of Human Skin Irritation PotentialISO 24443 In Vitro Assessment of Sunscreen Efficacy on SkinISO 24443 In Vitro SPF Testing for SunscreensISO 24443 In Vitro UV Protection Factor Testing for SunscreensISO 24443 UV Protection Testing for Sensitive Skin FormulationsISO 3160-2 Compression Testing on Skin Contact MaterialsISO 3175-4 Analysis of Volatile Components Affecting Skin SensitivityISO 8124-6 Safety Requirements for Toys Affecting SkinISO/TR 16181 Guidelines on Skin Compatibility of CosmeticsISO/TR 16271 Guidelines on Safety Assessment for Skin Contact MaterialsISO/TR 19218 Dermatological Safety Data ManagementISO/TR 19930 Development of Dermal Sensitization AssaysISO/TR 22219 Testing of Skin Barrier FunctionJIS K 5600-5-7 Patch Test Methods for Skin SensitivityOECD TG 405 Acute Dermal Irritation/Corrosion TestOECD TG 406 Skin Sensitization in AnimalsOECD TG 406 Skin Sensitization Testing in AnimalsOECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin SafetyOECD TG 439 In Vitro Skin Irritation Testing for CosmeticsOECD TG 442B Local Lymph Node Assay for Skin SensitizationOECD TG 442C In Chemico Skin Sensitization Assay (DPRA)OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens™)OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin SensitizationOECD TG 442E In Vitro Skin Sensitization Assay (h-CLAT)USP <151> Evaluation of Skin Irritation for Topical Dosage FormsUSP <151> Skin Sensitization Studies in Pharmaceuticals

ISO/TR 29622 Allergens in Cosmetics and Personal Care Products Laboratory Testing Service Provided by Eurolab

The International Organization for Standardization (ISO) has developed a series of standards to ensure the safety and quality of cosmetics and personal care products. One such standard is ISO/TR 29622, which provides guidelines for the identification and quantification of allergens in these products.

Legal and Regulatory Framework

Cosmetic and personal care products are subject to various regulations and laws across different countries. In the European Union (EU), for example, the Cosmetics Regulation (EC) No 1223/2009 sets out strict requirements for the safety assessment and labeling of cosmetics. Similarly, in the United States, the Federal Food, Drug, and Cosmetic Act (FDCA) governs the safety and labeling of personal care products.

International and National Standards

The ISO/TR 29622 standard is based on international and national standards, including:

  • EN 16536:2015 - Safety assessment of substances in cosmetics
  • ASTM E2537-14 - Standard Practice for Identification of Allergenic Ingredients in Personal Care Products
  • TSE (Turkish Standards Institution) EN ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories
  • Standard Development Organizations

    Standard development organizations (SDOs), such as the International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM), play a crucial role in developing and maintaining standards. These SDOs work with experts from various industries to ensure that standards are up-to-date, relevant, and meet the needs of stakeholders.

    How Standards Evolve and Get Updated

    Standards evolve over time as new technologies emerge, regulatory requirements change, or consumer demands shift. The standard development process involves:

    1. Identification of a need for a new standard

    2. Formation of a working group to draft the standard

    3. Public review and comment period

    4. Balloting by member bodies

    5. Finalization and publication of the standard

    Standard Numbers and Scope

    Some relevant standard numbers and their scope are as follows:

  • ISO/TR 29622:2018 - Guidelines for the identification and quantification of allergens in cosmetics and personal care products
  • EN 16536:2015 - Safety assessment of substances in cosmetics (scope: safety assessment, labeling, and information requirements)
  • ASTM E2537-14 - Standard Practice for Identification of Allergenic Ingredients in Personal Care Products (scope: identification, quantification, and labeling)
  • Compliance Requirements

    Different industries have varying compliance requirements. For example:

  • Cosmetics manufacturers must comply with EU Regulation No 1223/2009
  • Personal care product manufacturers must comply with FDA regulations under the FDCA
  • Standard Compliance in Different Industries

    Some industries require stricter standard compliance than others. For instance:

  • Pharmaceuticals: strict adherence to GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice)
  • Food industry: compliance with food safety regulations, such as HACCP (Hazard Analysis and Critical Control Points)
  • Standards Evolution and Regulatory Updates

    Regulatory updates often necessitate changes to standards. For example:

  • The EUs REACH Regulation has led to the development of new standards for chemical safety
  • The US FDA has updated its guidelines for personal care product labeling
  • Business and Technical Reasons for Conducting ISO/TR 29622 Testing

    The business and technical reasons for conducting ISO/TR 29622 testing are as follows:

    1. Risk assessment: ensure compliance with regulatory requirements and minimize the risk of adverse reactions

    2. Product safety: guarantee the safe use of cosmetics and personal care products

    3. Quality control: maintain product quality and consistency

    4. Regulatory compliance: meet international and national standards and regulations

    Consequences of Not Performing ISO/TR 29622 Testing

    Failure to conduct ISO/TR 29622 testing can result in:

    1. Regulatory penalties: fines, recalls, or even shutdowns due to non-compliance

    2. Reputation damage: loss of customer trust and market share

    3. Product liability: legal action against manufacturers for adverse reactions

    Industries and Sectors Requiring ISO/TR 29622 Testing

    The following industries and sectors require ISO/TR 29622 testing:

    1. Cosmetics industry: skin care, hair care, colorants, fragrances, etc.

    2. Personal care products industry: soaps, shampoos, conditioners, lotions, creams, etc.

    3. Pharmaceuticals industry: topical medications, ointments, creams, etc.

    Risk Factors and Safety Implications

    The risk factors associated with allergens in cosmetics and personal care products include:

    1. Skin irritation: redness, itching, swelling

    2. Allergic contact dermatitis: delayed hypersensitivity reactions

    3. Phototoxicity: skin damage due to sunlight exposure

    Product Liability and Regulatory Compliance

    Manufacturers must ensure compliance with regulations and standards to avoid product liability claims.

    Conclusion

    ISO/TR 29622 provides guidelines for the identification and quantification of allergens in cosmetics and personal care products. Manufacturers must conduct regular testing to ensure compliance with regulatory requirements, maintain product safety, and minimize risks associated with adverse reactions.

    Business and Technical Reasons for Conducting ISO/TR 29622 Testing

    The business and technical reasons for conducting ISO/TR 29622 testing are as follows:

    1. Risk assessment: ensure compliance with regulatory requirements and minimize the risk of adverse reactions

    2. Product safety: guarantee the safe use of cosmetics and personal care products

    3. Quality control: maintain product quality and consistency

    4. Regulatory compliance: meet international and national standards and regulations

    Consequences of Not Performing ISO/TR 29622 Testing

    Failure to conduct ISO/TR 29622 testing can result in:

    1. Regulatory penalties: fines, recalls, or even shutdowns due to non-compliance

    2. Reputation damage: loss of customer trust and market share

    3. Product liability: legal action against manufacturers for adverse reactions

    Industries and Sectors Requiring ISO/TR 29622 Testing

    The following industries and sectors require ISO/TR 29622 testing:

    1. Cosmetics industry: skin care, hair care, colorants, fragrances, etc.

    2. Personal care products industry: soaps, shampoos, conditioners, lotions, creams, etc.

    3. Pharmaceuticals industry: topical medications, ointments, creams, etc.

    Risk Factors and Safety Implications

    The risk factors associated with allergens in cosmetics and personal care products include:

    1. Skin irritation: redness, itching, swelling

    2. Allergic contact dermatitis: delayed hypersensitivity reactions

    3. Phototoxicity: skin damage due to sunlight exposure

    Product Liability and Regulatory Compliance

    Manufacturers must ensure compliance with regulations and standards to avoid product liability claims.

    Conclusion

    ISO/TR 29622 provides guidelines for the identification and quantification of allergens in cosmetics and personal care products. Manufacturers must conduct regular testing to ensure compliance with regulatory requirements, maintain product safety, and minimize risks associated with adverse reactions.

    Next Section: Testing Methodologies and Equipment

    The following is a continuation of the previous section:

    Testing Methodologies and Equipment

    ISO/TR 29622 provides guidelines for the identification and quantification of allergens in cosmetics and personal care products. Manufacturers must conduct regular testing to ensure compliance with regulatory requirements, maintain product safety, and minimize risks associated with adverse reactions.

    Test Methods

    The following test methods are commonly used for identifying and quantifying allergens:

    1. High-Performance Liquid Chromatography (HPLC): separates and detects allergenic compounds

    2. Gas Chromatography-Mass Spectrometry (GC-MS): identifies and quantifies allergenic compounds

    3. Immunoassays: detects specific antibodies or antigens

    Equipment

    The following equipment is commonly used for testing:

    1. HPLC systems: high-performance liquid chromatographs

    2. GC-MS systems: gas chromatography-mass spectrometers

    3. Microplate readers: measures absorbance, fluorescence, or luminescence

    Calibration and Validation

    All testing equipment must be calibrated and validated to ensure accuracy and reliability.

    Quality Control and Assurance

    Manufacturers must implement quality control and assurance procedures to ensure the accuracy and reliability of test results.

    Next Section: Data Analysis and Reporting

    The following is a continuation of the previous section:

    Data Analysis and Reporting

    ISO/TR 29622 provides guidelines for the identification and quantification of allergens in cosmetics and personal care products. Manufacturers must conduct regular testing to ensure compliance with regulatory requirements, maintain product safety, and minimize risks associated with adverse reactions.

    Data Analysis

    The following steps are involved in data analysis:

    1. Raw data processing: convert raw data into usable format

    2. Statistical analysis: apply statistical methods to analyze data

    3. Data visualization: present results using charts, graphs, or tables

    Reporting Requirements

    Manufacturers must report test results accurately and transparently.

    Conclusion

    ISO/TR 29622 provides guidelines for the identification and quantification of allergens in cosmetics and personal care products. Manufacturers must conduct regular testing to ensure compliance with regulatory requirements, maintain product safety, and minimize risks associated with adverse reactions.

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