On June 2, 2026, the European Commission adopted Commission Regulation (EU) 2026/1168, amending Annex XVII of the REACH Regulation regarding restrictions on synthetic polymer microparticles (microplastics). The regulation revises provisions introduced under Commission Regulation (EU) 2023/2055 to clarify the scope of existing derogations and ensure consistent implementation of the microplastics restriction across the European Union. The amendment expands the derogation for medicinal products to cover all human and veterinary medicinal products, including those used in clinical trials and related pre-clinical safety testing. It also introduces a new derogation for synthetic polymer microparticles used in product and process-oriented research and development (PPORD) in quantities of one tonne per year or less, regardless of whether the research is conducted at industrial sites or other locations such as hospitals and universities. In addition, the regulation clarifies that the exemption for synthetic polymer microparticles permanently incorporated into a solid matrix applies only when the intended end use lasts for one year or longer. Certain amendments relating to medicinal products and PPORD uses apply retroactively from October 17, 2023, while the revised solid-matrix provision will apply from June 22, 2028. The amendments aim to align the legal text with the original policy intent of the restriction, facilitate enforcement, and provide greater regulatory certainty for affected stakeholders.
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