Overview
EN ISO 21392:2021 (Corrected version 2021-12) specifies an analytical method for the measurement of trace heavy metals in cosmetic finished products using inductively coupled plasma mass spectrometry (ICP‑MS). The standard covers quantification of chromium, cobalt, nickel, arsenic, cadmium, antimony and lead in finished cosmetics after sample pressure digestion. While the ICP‑MS methodology can be adapted for other elements, it is the analyst’s responsibility to demonstrate fitness for purpose. The document is published by CEN/ISO and adopted as a European standard.
Key topics and technical requirements
- Scope and target analytes: Focus on trace levels of Cr, Co, Ni, As, Cd, Sb and Pb in finished cosmetic products.
- Analytical principle: Sample pressure digestion followed by ICP‑MS quantification.
- Sample preparation: Detailed procedures for digestion (including microwave/pressure-assisted digestion) and preparation of measurement solutions.
- Standards and calibration: Preparation of internal standards and mixed calibration standards; use of calibration blanks and calibration solutions.
- Quality control (QC): Requirements for QC during digestion and analysis, sequence examples, and checks to ensure reliable results.
- Method validation and performance: Guidance and annexes for evaluating method performance, including accuracy profile methodology and ISO 5725 statistical evaluation.
- Normative reference: ISO 3696 for laboratory water quality is cited for reagent quality.
- Limits on interpretation: The method maximizes trace detection but does not provide direct assessment of consumer systemic exposure.
Practical applications and users
Who will use EN ISO 21392:2021:
- Cosmetic testing laboratories performing regulatory and routine heavy metal testing.
- Cosmetic manufacturers and contract labs for product release, supplier control and batch verification.
- Regulatory authorities and notified bodies validating compliance of finished cosmetics.
- R&D and quality assurance teams developing formulations that require trace‑metal monitoring.
Practical uses:
- Compliance testing for raw and finished cosmetic products.
- Establishing validated ICP‑MS procedures and QC routines in analytical labs.
- Supporting safety dossiers and technical documentation for market access.
- Extending methodology to additional elements after demonstrating method fit.
Related standards
- ISO 3696 - Water for analytical laboratory use (referenced for reagent quality).
- Annexes in EN ISO 21392:2021 provide performance evaluation using accuracy profile and ISO 5725 statistical approaches.
This standard is essential for labs and manufacturers seeking a harmonized, validated ICP‑MS approach to detect and quantify trace heavy metals in cosmetic finished products.
