Preliminary guidelines on phthalates in medical devices published

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) under the European Commission published on 15 March the preliminary 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.”

The preliminary Guidelines are the result of the new Regulations on medical devices, which were adopted and entered into force in May 2017.

A public consultation is open until 29 April 2019 for parties to contribute on the scientific basis of the Guidelines and to provide any other scientific information to SCHEER.

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