European commission grants exemption for the use of phthalates in medical devices


The Commission adopted a delegated directive allowing the use of four phthalates (plasticisers) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, for the purposes of adapting to scientific and technical progress. The permitted substances are bis (2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP). The Commission also granted exemptions for (1) the use of DEHP in ion selective electrodes for analysing human body fluids and/or dialysate fluids and (2) in plastic components in magnetic resonance imaging detector coils. The Commission explained that the total negative environmental and health impacts of substitution were likely to outweigh the total benefits.

In 2015, the European Commission added these phthalates to the list of restricted substances in the Annex of the RoHS Directive 2011/65 on the restriction of the use of certain hazardous substances in electrical and electronic equipment, setting a maximum concentration value by weight in homogeneous materials of 0.1%. The restriction regarding these substances in medical devices and spare parts for their repair, reuse and updating of functionalities has applied since July 2021. The exemptions provided by the recently adopted delegated directives would apply retroactively from one day before these restrictions, and for seven years. The delegated directives are expected to enter into force after a period of scrutiny by the Council and European Parliament of, in principle, two months.

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~sThe National Law Review, 10 September 2021