EUROLAB
fda-21-cfr-7003-microbial-contamination-limits-in-cosmetics
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 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 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

Complete Guide to Eurolabs FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics Laboratory Testing Service

The FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing service provided by Eurolab is governed by a range of international and national standards. These standards ensure that the testing is conducted with the highest level of precision, accuracy, and reliability.

ISO Standards

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories
  • ISO 9001:2015 - Quality management systems
  • ASTM Standards

  • ASTM E55:2018 - Standard Practice for Sampling Water from Wells
  • ASTM D4452-12(2020) - Standard Test Method for Determination of Microbial Contamination in Cosmetics
  • EN Standards

  • EN ISO 17025:2005 - General requirements for the competence of testing and calibration laboratories
  • EN 71:2018 - Safety of toys
  • TSE Standards

  • TSE-ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories
  • TSE-EN 71:2018 - Safety of toys
  • Standard Development Organizations (SDOs)

  • International Organization for Standardization (ISO)
  • American Society for Testing and Materials (ASTM)
  • European Committee for Standardization (CEN)
  • Turkish Standards Institution (TSE)
  • Evolution of Standards

    Standards are continually evolving to reflect changes in technology, regulations, and industry practices. Eurolab stays up-to-date with the latest standards and updates through its membership in SDOs.

    Standard Numbers and Scope

    The following standard numbers and scopes apply to the FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing service:

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories (Scope: Applies to all testing and calibration laboratories)
  • ASTM E55:2018 - Standard Practice for Sampling Water from Wells (Scope: Applies to water sampling from wells)
  • ASTM D4452-12(2020) - Standard Test Method for Determination of Microbial Contamination in Cosmetics (Scope: Applies to microbial contamination testing in cosmetics)
  • Standard Compliance Requirements

    Compliance with standards is mandatory for industries that require FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing, including:

  • Cosmetic manufacturers
  • Personal care product manufacturers
  • Pharmaceutical companies
  • Standard-Related Regulations and Guidelines

    Regulations and guidelines related to standard compliance include:

  • US FDA regulations (21 CFR Part 700)
  • EU cosmetics regulation (EU) No. 1223/2009
  • Turkish cosmetics regulation (TSE Regulation on Cosmetics)
  • Business and Technical Reasons for Conducting Testing

    The business and technical reasons for conducting FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing include:

  • Ensuring product safety and reliability
  • Preventing product recalls and regulatory actions
  • Meeting industry standards and regulations
  • Maintaining customer trust and confidence
  • Consequences of Not Performing Testing

    The consequences of not performing FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing include:

  • Product contamination and spoilage
  • Regulatory actions and fines
  • Damage to brand reputation and customer trust
  • Loss of business and revenue
  • Industries and Sectors That Require Testing

    The industries and sectors that require FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing include:

  • Cosmetic manufacturers
  • Personal care product manufacturers
  • Pharmaceutical companies
  • Food manufacturers (for food-contact applications)
  • Risk Factors and Safety Implications

    The risk factors and safety implications of microbial contamination in cosmetics include:

  • Skin irritation and allergic reactions
  • Eye irritation and vision problems
  • Respiratory problems and other health issues
  • Quality Assurance and Quality Control Aspects

    The quality assurance and quality control aspects of FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing include:

  • Ensuring accurate and precise test results
  • Maintaining laboratory calibration and validation
  • Implementing quality management systems (QMS)
  • Conducting regular audits and assessments
  • Competitive Advantages of Having Testing Performed

    The competitive advantages of having FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing performed include:

  • Ensuring product safety and reliability
  • Preventing product recalls and regulatory actions
  • Meeting industry standards and regulations
  • Maintaining customer trust and confidence
  • Cost-Benefit Analysis of Performing Testing

    The cost-benefit analysis of performing FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing includes:

  • Cost savings through reduced product recalls and regulatory actions
  • Increased revenue through improved brand reputation and customer trust
  • Reduced risk of product contamination and spoilage
  • Testing Process

    The testing process for FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics involves the following steps:

    1. Sample collection and preparation

    2. Testing using validated methods (e.g., ASTM D4452-12(2020))

    3. Data analysis and reporting

    Test Report

    The test report includes the following information:

  • Test method used
  • Sampling location and time
  • Test results, including limits of detection and quantification
  • Conclusion and recommendations for corrective actions
  • Turnaround Time

    Eurolabs turnaround time for FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing is typically within 5-7 business days.

    Price

    The price for FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing varies depending on the scope of work, sample volume, and other factors.

    Method Validation

    Eurolab has validated its methods for FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics testing using a combination of statistical analysis and inter-laboratory comparisons.

    Certification and Accreditation

    Eurolab is certified to ISO/IEC 17025:2017 and accredited by the International Accreditation Forum (IAF).

    Continuing Education and Training

    Eurolabs personnel receive regular training and education on the latest testing methods, technologies, and regulations.

    Quality Management System (QMS)

    Eurolab has implemented a QMS that includes:

  • Document control
  • Records management
  • Corrective action and preventive action
  • Internal audits and assessments
  • Audit Trails

    Eurolab maintains audit trails for all test data, including sampling location, testing methods, and results.

    Record Retention

    Eurolab retains records of all test data for a minimum of 5 years.

    Complaint Handling

    Eurolab has a complaint handling process in place to address any issues or concerns related to its services.

    Confidentiality Agreement

    Eurolab has a confidentiality agreement in place to protect sensitive information and intellectual property.

    Data Protection

    Eurolab ensures that all data is handled and stored in accordance with relevant regulations, including GDPR.

    This comprehensive guide provides an overview of Eurolabs FDA 21 CFR 700.3 Microbial Contamination Limits in Cosmetics laboratory testing service, including standard-related information, business and technical reasons for conducting testing, industries and sectors that require testing, risk factors and safety implications, quality assurance and quality control aspects, competitive advantages of having testing performed, cost-benefit analysis of performing testing, testing process, test report, turnaround time, price, method validation, certification and accreditation, continuing education and training, quality management system (QMS), audit trails, record retention, complaint handling, confidentiality agreement, and data protection.

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