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European Commission’s consultation on phthalates in medical devices

Posted on 02.04.2019

The European Commission has launched a public consultation on the Preliminary Guidelines about the benefit-risk assessment of the presence of phthalates in certain medical devices (ie phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR)) or have endocrine-disrupting (ED) properties. These Guidelines describe the methodology on how to perform a benefit-risk assessment (BRA) for the justification of the presence of CMR 1A or 1B and/or ED phthalates (CMR/ED phthalates) in medical devices and/or or parts or materials used therein at percentages above 0.1% by weight (w/w).

During the preparation of these Guidelines for BRA of the use of CMR/ED phthalates in medical devices, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) noticed that several BRA methodologies are theoretically available. In addition, there is a considerable lack of data for potential alternatives to be used in medical devices. Therefore, manufacturers are encouraged to produce (semi)quantitative data on the use of alternatives for CMR/ED phthalates in medical devices.

All interested parties can submit their inputs by 29 April 2019.