ISO 24444:2019/Amd 1:2022

Overview

ISO 24444:2019/Amd 1:2022 is an important amendment to the internationally recognized standard for testing sun protection in cosmetics. Developed by ISO Technical Committee ISO/TC 217 in collaboration with the European Committee for Standardization (CEN/TC 392), this amendment refines the in vivo determination of the Sun Protection Factor (SPF)-a critical metric to assess the effectiveness of sunscreens and related cosmetic products.

This amendment ensures that the tested products meet stringent, reproducible criteria, enhancing consumer confidence and compliance with global regulatory requirements. The update provides more precise guidance on test methods, uniformity requirements of UV radiation devices, statistical evaluation, and reference standards for SPF claims.

Key Updates and Topics

• Uniformity of UV Radiation Beams
  The amendment specifies that the average uniformity of all beams for multiple output UV devices must be at least 90%, with no individual port below 85%. This criterion guarantees consistent and reliable exposure during in vivo SPF tests.

• Reference Standards for SPF Claims
  For SPF claims ≤ 24, any reference standard listed in Annex C of the main document may be used, offering flexibility while maintaining rigor in standardization.

• Statistical Evaluation of SPF Measurements
  The amendment introduces a clear statistical requirement: the 95% confidence interval (CI) around the mean SPF of the test product must be within ±17% of the measured mean SPF. This confidence range ensures reliable test results.

• Number of Test Subjects
  A minimum of ten valid test results is required, but if statistical criteria are unmet or reference sunscreen values fall outside their acceptance ranges, up to twenty valid results may be needed to ensure accuracy.

• Viscosity Measurement Update
  The amendment updates the acceptable viscosity range of test substances, changing from 16,000 mPas to 17,000 mPas at specific test settings, ensuring consistency in product application during testing.

Applications

ISO 24444:2019/Amd 1:2022 serves multiple practical purposes in cosmetics and skincare:

• Sunscreen Efficacy Testing
  Laboratories and manufacturers use the in vivo SPF test method as the gold standard for assessing the protective efficacy of sun care products.

• Regulatory Compliance
  The standard supports cosmetic companies in meeting international regulatory requirements for SPF claims, facilitating product registration and market access globally.

• Product Development and Quality Control
  By following these refined testing procedures, cosmetic formulators can optimize product performance and maintain batch-to-batch consistency.

• Consumer Safety Assurance
  Accurate, statistically validated SPF results promote consumer trust by providing transparent and scientifically sound evidence of product protection against UV radiation.

Related Standards

When working with ISO 24444:2019/Amd 1:2022, consider these related standards and documents that complement sun protection testing and cosmetic product evaluation:

• ISO 24442 – In vivo determination of UVA protection factor
• ISO 22716 – Cosmetics – Good Manufacturing Practices (GMP)
• ISO 14971 – Application of risk management to medical devices, applicable in product safety evaluation
• CEN/TC 392 standards – European standards for cosmetic testing, developed alongside ISO/TC 217

These interconnected standards provide a comprehensive framework to ensure that sunscreens and cosmetic products are both effective and safe for consumer use.

By aligning with ISO 24444:2019/Amd 1:2022, companies and testing labs deliver high-quality, reliable data on sun protection. This contributes to global harmonization of sunscreen testing, empowering manufacturers and protecting consumers worldwide from harmful ultraviolet radiation.