Overview - EN ISO 16181-2:2021 (Footwear, Phthalate determination)
EN ISO 16181-2:2021 specifies a solvent-free analytical method for determining phthalates in footwear and footwear components (excluding textiles). The standard defines a direct thermal extraction approach using a pyrolyzer/thermal desorption gas chromatography–mass spectrometry (Py/TD‑GC‑MS) system to separate and quantify specific phthalate compounds (see Annex A and CEN/TR 16417 for the list). This edition replaces CEN ISO/TS 16181:2011 and introduces a new technique complementary to ISO 16181-1 (solvent extraction).
Key topics and technical requirements
- Analytical principle: direct introduction of the sample into a pyrolyzer; thermal desorption of phthalates; transfer to GC column and detection by MS.
- Scope: applicable to all footwear materials except uncoated textiles and metallic parts.
- Apparatus: requirements include a Py/TD accessory capable of 40–500 °C and a programmable heating rate (approx. 1 °C to 100 °C per minute), a GC‑MS, cryogenic mill for sample preparation, micro‑tools, and precision balance.
- Reagents & calibrants: use GC‑grade n‑hexane for preparing calibration solutions, high‑purity helium carrier gas, and certified phthalate stock/standard solutions (details in Clause 6 and Annex A).
- Procedure elements: sample preparation, calibration, chromatographic parameters, qualitative/quantitative MS analysis, calculation of phthalate content, performance verification and detection limits.
- Documentation: requirements for the test report and informative annexes (sampling guidelines, chromatography parameters, chromatogram examples, method verification).
Practical applications and users
This standard is aimed at laboratories and stakeholders involved in footwear safety, compliance and quality control:
- Test laboratories performing regulatory or voluntary screening for phthalates in shoes and components.
- Footwear manufacturers and component suppliers validating raw materials and finished products for chemical safety.
- Regulatory bodies and conformity assessors enforcing limits for restricted substances in consumer goods.
- R&D and materials scientists adopting Py/TD‑GC‑MS for rapid, solvent‑free screening and method comparison (ISO 16181‑2 vs ISO 16181‑1).
Benefits include simplified sample handling, avoidance of solvent extraction, reduced chemical waste, and suitability for a wide range of footwear materials.
Related standards
- ISO 16181-1 - Determination of phthalates with solvent extraction (referenced for preference in dispute cases).
- CEN/TR 16417 - List of specific phthalates covered by the method.
- Supersedes CEN ISO/TS 16181:2011; adopted as EN ISO 16181-2:2021 across CEN member states.
Keywords: EN ISO 16181-2:2021, phthalate determination, footwear, Py/TD-GC-MS, pyrolyzer, thermal desorption, gas chromatography-mass spectrometry, solvent-free testing.
