Bisphenol A in plastic

Check technical documentation or test protocols, demonstrating that the requirement is fulfilled.

In addition, the contracting authority can take random samples for analysis to check compliance with the criteria.

Membranes, filters or tubes are parts that could entail leakage of bisphenol to the patient, either through direct contact with the patient, or through contact with liquid/medication, transferred to the patient. 

Bisphenol A (BPA) is a substance with hormone-like properties, used in manufacturing of polycarbonate plastics and epoxy plastics. Bisphenol A is classified as toxic for human reproduction and can be endocrine-disrupting for humans. It is present in almost all human urine and blood samples. Bisphenol A needs to be minimized in our everyday lives.

In recent years, new regulation that limit the use of bisphenol A have been adopted both within the EU and in Sweden. Since January 2017, bisphenol A is included on the EU candidate list on substances of very high concern. Under the new Medical Regulation, MDR EU 2017/745, the use of reproductive toxicants, including bisphenol A, is severely limited. Continued use of bisphenol A over 0.1% by weight will require extensive motivation from medical device manufacturers.

Moreover, it cannot be ruled out that BPA concentrations below 0.1% by weight may pose a risk to patients. In 2015, a Scientific Committee (SCENIHR) convened by the EU Commission published a report on the risks associated with BPA in medical devices. The report concludes that there is a risk of adverse health effects of BPA in medical devices that are in contact with tissue of body fluids. Dialysis patients are expected to be highly exposed to bisphenol A.

In the report “Bisphenols – a survey and analysis”, the Swedish Chemicals Agency identifies more than 200 substances with an equivalent structure to Bisphenol A that may occur on the European market. According to results from data simulations, 37 of these substances could have endocrine-disrupting characteristics, equivalent to Bisphenol A, and can be used in a way that may led to humans being exposed if these substances replaces Bisphenol A. The information on how these substances are used, and their negative effects to health, is however insufficient.

The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.