Guidelines on phthalates in medical devices
Final version of the
Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties
Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided the final version of the Guidelines on the benefit-risk assessment of the presence, in the medical devices specified in the mandate, of phthalates which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction or endocrine-disrupting.
These Guidelines describe the methodology on how to perform a BRA for the justification of the presence of CMR 1A or 1B and/or ED phthalates (CMR/ED phthalates) in medical devices and/or parts or materials used therein at percentages above 0.1% by weight (w/w). They also describe the evaluation of possible alternatives for these phthalates used in medical devices, including alternative materials, designs or medical treatments.
They are intended to be used by the relevant stakeholders e.g. manufacturers, notified bodies and regulatory bodies. The approach of these Guidelines may also be used for a BRA of other CMR/ED substances present in medical devices.
During the preparation of these Guidelines for BRA of the use of CMR/ED phthalates in medical devices, SCHEER noticed that a number of BRA methodologies are theoretically available. However, there is a considerable lack of data needed for the BRA for potential relevant alternatives to be used in medical devices. Therefore, SCHEER encourages manufacturers to generate data of high quality on such alternatives for CMR/ED phthalates in medical devices.
Pending on new scientific evidence, it is recommended to evaluate the use and usefulness of these Guidelines after an application period of three years.
On the basis of the preliminary version, the Commission launched a public consultation where interested parties were invited to submit their comments on the scientific evidence from 18 March to 29 April 2019