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EU: ISO 16181-1:2021 supercedes ISO/TS 16181:2011 for phthalates

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ISO 16181-1:2021 supercedes ISO/TS 16181:2011 for phthalates determination with solvent extraction IN footwear

MAY 2021 - SOFTLINES

Determining phthalates content in footwear with solvent extraction and analysis by Gas Chromatography–Mass Spectrometry (GC-MS)

ISO 16181-1:2021 requires the replacement of the extraction solvent from n-hexane/acetone mixture to toluene (optional: THF for PVC). This change could lead to a different result, despite using the same sample or material provided. Hence, in order to ensure a consistency in the testing methods, a prior agreement would need to be made between the manufacturer and testing body (TÜV SÜD) on when to make the switch to the new standard, as the change is immediately effective.

For a clearer comparison of the main technical attributes between the two methods, please refer to Appendix A

Internal Impact on product safety / certification validity, related documentation

The main impact will be on the consistency of conclusion as stated in the test reports for footwear article/SKU made of the same materials but using either testing method for different productions. A sunset date of using the superseded method shall be agreed between manufacturer and testing body (TÜV SÜD).

Laboratory Impact on accreditation, test equipment, procedures, TRF/PPP

There is a minor impact on the instrumentation and the related testing process in the CHN lab. The CHN labs will add this new standard into their accreditation scope. A GTP will be published at the division level to align the testing practice.

FREQUENTLY ASKED QUESTIONS

For PVC, if THF can be used as an alternative to toluene as an extraction solvent, will this yield different results?

The results for phthalates in PVC will be comparable either if toluene or THF were used.

However, the limit of quantification for phthalates is different whether THF or toluene are used. With THF, phthalates can only be quantified if the concentration is above 0.01 % (100 mg/kg) whereas if toluene was used, phthalates can be quantified if the concentration is above 0.005 % (50 mg/kg). Therefore, it is advisable to test with toluene.
Our articles were tested free of Phthalates. Will this change with the new solvent?
No, this is most unlikely to be changed. The old 2011-method would have revealed the presence of phthalates in the material.
One material contains Phthalates below the legal limit according to the old 2011-method. Will the limit be exceeded with the new method?
This depends on the legal requirement and on the material tested.

It is advisable to re-test materials in which phthalates were found in the past, especially if a material contained more than 50% phthalates of permitted concentration, e.g. more than 0.05% (500 mg/kg) if the legal limit is 0.1% (1000 mg/kg).

If a material, in which phthalates were found, consists of PVC and was tested according to the old 2011-method, it is likely to determine higher phthalate concentrations.

If a material, in which phthalates were found, consists of non-PVC polymers and was tested with THF as extraction solvent according to EN ISO 14389:2014 or CPSC-CH-C1001-09.4, it is likely to determine higher phthalate concentrations.

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