Standards Development

Scope

This document specifies a method to identify and quantify trace chemicals potentially present in singleuse AHPs. It is applicable for the investigation of single-use baby diapers, single-use menstrual products and single-use adult incontinence products. The results of this method are dependent on the prescribed extraction conditions, in which simulated body fluids are used exclusively.

Purpose

With millions of AHPs (absorbent hygiene products, baby diapers, menstrual products and adult incontinence products) in daily use around the world, including the more vulnerable populations of infants and the elderly, there has been an interest for many years by regulatory authorities to test these products for the potential presence of trace chemicals. This is also in response to consumer concerns raised by published reports and the media.

The published reports so far show a wide range of analytical approaches, reflecting the European Commission’ Risk Assessment Committees recent recognition of the lack of a harmonised analytical method for investigating possible traces of chemicals in complex products such as AHPs. The use of an agreed and harmonised test method amongst all stakeholders is critical because the choice of the test method significantly affects the results, which is even more important when testing very low concentrations, close to the level of quantification, as is by default the case with trace chemicals. Methods must be easy to use, robust and applicable to any laboratory operating to Good Laboratory Practice (GLP). Solid analytical methods are also the prerequisite for performing toxicological assessments.

To mitigate these challenges the industry has devised a method, based on scientific principles, that is getting traction amongst a growing number of stakeholders.

The method eventually developed by EDANA is based on extracting finely divided, homogenized material from milled AHPs with a single aqueous-based body fluid simulant (urine for baby diapers, adult incontinence and menses for menstrual products). The concentration of any trace chemical present in the extract is then analyzed via one or more analytical instrumental analyses. The method has proven to be easy to handle across a range of competent laboratories, is robust (repeatable and reproducible), and reflects consumer relevant aspects:

• Relevant. Products are tested under circumstances that reflect aspects of typical consumer usage.

• Robust. The method delivers consistent results independent of the operator or the laboratory that is running the test. In effect, the method is repeatable and reproducible within a tolerable level of uncertainty.

• Validated. The method delivers reliable results within the operating parameters of the method (considering variable environmental background levels).

• Deployable. Any laboratory with state-of-the-art analytical equipment and well-trained staff can run the method in a transparent and accessible manner.

The method is currently known as a CEN workshop agreement, CWA 18062. Considering the limited lifetime of a CWA and the need to have a credible and agreed test method, both for manufacturers, as well as for enforcing authorities, EDANA proposes to draft an ISO standard building on CWA 18062: 2023.