There are an ever growing number of substance information requests around DEHP (bis ethylhexyl phthalate) and BPA (bisphenol A).
So what is behind this?
We asked expert industry chemist Dr Paul Goodman of ERA Technology for his thoughts on the matter.
The Canadian Government has required manufacturers and importers to provide information on the presence of DEHP and BPA since 2008.
The information is required for all types of medical device including electrical and non-electrical equipment. Information on DEHP is required if it is used in the product at a concentration of greater than 0.1% of the equipment (not homogeneous material as with the RoHS Directive). Information on BPA is required for any amount so is needed even if traces are present. However, this is only required if the equipment comes into physical contact with patients or fluids such as for blood transfusions and drips.
DEHP is a REACH SVHC (Substance of Very High Concern) that is widely used as a plasticiser in flexible PVC, some rubbers and in other materials such as sealants, inks and lacquers. PVC is used for medical tubing, bags for fluids and electrical wiring insulation.
BPA’s main uses are to make epoxy resins and polycarbonate and also in the synthesis of polysulfones and polyetherketones (PEK) as an antioxidant with some plasticisers, and as a polymerisation inhibitor in PVC. It is also used to make TBBPA (Tetrabromobisphenol A) which is the most common PCB laminate flame retardant.
Where BPA is used to make polymers, there are usually traces remaining and so the Canadian Health authorities will expect to be notified where BPA is used as a reactant as well as an additive in materials.
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