EU’s Historic PFAS Restriction Looms Over Medical Devices Sector

 
• By Ryan Nelson

The European Chemicals Agency’s committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) are evaluating sector by sector the proposed REACH restriction on PFAS and more than 5,600 public comments, reaching provisional conclusions on cosmetics at their June meetings. A date has not been set to consider PFAS uses in medical devices, which are numerous, essential, and in many cases devoid of alternatives, industry says.

• Source: Shutterstock (Shutterstock)

The European Union’s proposed restriction on per- and polyfluoralkyl substances (PFAS) could eliminate medical devices required for minimally invasive surgeries, among many others, to the detriment of millions of patients, according to MedTech Europe.

MedTech Europe’s views were among more than 5,600 comments submitted by 25 September 2023 to the European Chemicals Agency on the

The comment deluge was record-setting, far exceeding the closest contender, ECHA’s microplastic restriction proposed in January 2018, which drew nearly 500 comments. That restriction was adopted in September 2023 with derogations including 12 years to remove microplastic ingredients from makeup, lip and nail cosmetics, which are low-emitting and currently lack viable alternatives

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