#32026R1168EU updates microplastics restriction exemption for medicines in clinical testing
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This regulation adjusts the EU’s REACH restriction on synthetic polymer microparticles so the medicines exemption clearly covers products used in clinical trials and related pre-clinical testing. The change fixes a drafting gap in the existing microplastics restriction, which already exempted authorised human and veterinary medicines but did not clearly include investigational products and testing materials. Pharmaceutical companies, veterinary medicine developers, clinical trial sponsors, testing laboratories and suppliers should benefit from clearer treatment under the rules. The practical effect is narrow: it does not reopen the wider microplastics restriction, but it reduces legal uncertainty for medicine development and testing activities.
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Key Changes
- Clarifies that the REACH microplastics restriction exemption covers medicinal products used in clinical trials.
- Extends the exemption wording to pre-clinical safety and quality testing linked to those trials.
- Keeps the broader restriction on synthetic polymer microparticles unchanged for other products.