The guidelines provide a framework to perform a BRA to justify the presence of CMR or ED phthalates in medical devices.
They also describe the evaluation of possible alternatives for these phthalates used in medical devices.
Manufacturers are encouraged to generate data that are needed for the BRA on potential alternatives to be used in medical devices.

The Scientific Committee on Health, Environmental and Emerging Risks of the European Commission adopted this document at plenary meeting on 18 June 2019.
NIOM Scientist and Head of Laboratory, Hilde M. Kopperud served as external expert.

The European Commission’s independent Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) recently published its risk assessment of exposure to BPA via medical devices that are manufactured with materials that potentially leach BPA leading to oral (via dental material), subcutaneous and intravenous (e.g. during hemodialysis) routes of exposure.

Bisphenol A (BPA) is a key building block of polycarbonate plastic and a precursor for the manufacturing of monomers of epoxy resins. The BPA exposure of the general population is via food as a result of the use of BPA in food packaging and via skin as a result of contact with thermal paper. The vast majority of the population (91–99%) has detectable levels of BPA-conjugates in their urine. BPA is also present in medical devices including implants, catheters, tubing, and some dental materials.

This Guidance addresses the use of nanomaterials in medical devices and provides information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. According to the EU Recommendation for the definition of a nanomaterial (Commission Recommendation 2011/696/EU, EC 2011) any particulate substance with at least one dimension in the size range between 1 and 100 nm is considered a nanomaterial.