EN ISO 16186:2021 (CEN / ISO 16186:2021) specifies an analytical method for the determination of dimethyl fumarate (DMFU) in footwear and footwear components (excluding metal parts). The standard describes sample extraction, calibration, chromatographic analysis and result reporting using gas chromatography with mass spectrometric detection (GC‑MS) or tandem quadrupole GC‑MS/MS. It supersedes CEN ISO/TS 16186:2012 and includes informative annexes on chromatography parameters and method reliability.
Keywords: EN ISO 16186:2021, dimethyl fumarate, DMFU, GC‑MS, GC‑MS/MS, footwear testing, chemical testing.
Key topics and technical requirements
- Scope: Applies to all types of footwear and footwear components except metal parts; intended to detect DMFU, a potent sensitizer.
- Analytical principle: Extraction of DMFU from samples using acetone (ultrasonic bath at ~60 °C), followed by analysis by GC‑MS or GC‑MS/MS.
- Two procedures:
- Standard procedure - for matrices that give simple chromatograms (e.g., textile components) with no purification/concentration.
- Procedure for complex matrices - includes extraction, clean‑up and concentration steps for leather or other interfering matrices.
- Calibration and standards: Use of target compound standards (DMFU and dimethyl maleate, DMMA) and an internal standard (deuterated d‑DMFU). Preparation of stock and working solutions is specified.
- Apparatus and reagents: Lists required laboratory glassware, ultrasonic bath, PTFE filters (0.45 µm), GC vials, and chromatographic instrumentation.
- Results and limits: Clauses cover calculation of DMFU content, expression of results and determination of the method limit of quantification (LOQ).
- Informative annexes: Chromatography parameters for GC‑MS and GC‑MS/MS, rationale on solvent choice, and method reliability data.
Practical applications and users
This standard is essential for:
- Analytical testing laboratories performing chemical safety testing on footwear.
- Footwear manufacturers and component suppliers ensuring products comply with chemical safety limits.
- Regulatory and compliance teams verifying conformity with market restrictions (e.g., EU limit: products containing DMFU > 0.1 mg/kg are not authorized).
- Retailers and importers performing incoming quality control to avoid products containing DMFU.
- Product safety consultants and auditors assessing material risk and documentation.
Use cases include routine QC testing, pre‑market compliance checks, forensic investigation of dermatitis outbreaks linked to DMFU, and supplier verification.
Related standards
- ISO/TS 16186:2012 (superseded)
- ISO 4787 (laboratory glassware - volumetric instruments)
- Relevant national and regional chemical safety regulations (e.g., EU product limits for DMFU)
For laboratories and manufacturers seeking to implement a validated method for DMFU in footwear, EN ISO 16186:2021 provides the procedural and reporting framework required for consistent, defensible GC‑MS / GC‑MS/MS testing.
