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On June 2, 2026, the European Commission has published Commission Regulation (EU) 2026/1168, which amends Annex XVII to Regulation (EC) No 1907/2006, commonly known as REACH, concerning the restriction of synthetic polymer microparticles.
The amendments primarily clarify and refine certain derogations introduced under the original microplastics regulation, known as the Regulation (EU) 2023/2055. The rationale behinds is to ensure practical and effective implementation of microplastic restrictions without unduly hindering critical research, development, and medical activities.
Key Amendments Introduced by Regulation (EU) 2026/1168
Expanded Derogation for Medicinal Products: The scope of the derogation for synthetic polymer microparticles in medicinal products has been broadened. It now explicitly includes all medicinal products for human and veterinary use, encompassing those utilized in clinical trials and preparatory pre-clinical safety testing. This rectifies an oversight in the previous wording, which did not fully reflect the original intention to exempt these vital applications.
New Derogation for Product and Process-Oriented Research and Development (PPORD): A new exemption has been introduced for synthetic polymer microparticles used in PPORD activities, as defined in Article 3(22) of Regulation (EC) No 1907/2006. This derogation applies even when PPORD takes place outside traditional industrial sites, such as in hospitals and universities.
Clarification on Permanently Enclosed Microparticles: The derogation for synthetic polymer microparticles permanently enclosed in a solid matrix during end use has been clarified. This exemption now explicitly applies only where the end use is foreseen to last for one year or longer. This ensures that the derogation aligns with the objective of emission minimization, preventing its application to short-duration uses where the solid matrix is frequently removed or replaced.
Significantly, the amendments concerning medicinal products and PPORD uses will have retroactive application from 17 October 2023. The clarified derogations for microparticles enclosed in a solid maxtrix shall apply from June 22, 2028.
Industry Impact
The amendment provides significant regulatory relief for the pharmaceutical and research sectors by providing clear legal certainty for clinical trials and reducing compliance costs for R&D institutions.
Conversely, manufacturing sectors—such as coatings and construction—face new pressures as products with a functional lifespan of less than one year will no longer qualify for exemptions. Affected businesses must complete formula adjustments or substitutions by June 22, 2028.
The text of the Commission Regulation (EU) 2026/1168 can be accessed here.
