EU narrows REACH microplastics solid-matrix derogation and widens medicinal and research exemptions
EU restricts microplastics solid-matrix exemption to end uses lasting a year or longer from 22 June 2028
Change
On 1 June 2026 the European Commission adopted Regulation 2026/1168 (published 2 June 2026) amending REACH Annex XVII entry 78, restricting the synthetic polymer microparticle solid-matrix derogation to intended end uses of one year or longer with effect from 22 June 2028, and retroactively widening the medicinal-products and PPORD derogations from 17 October 2023.
Why it matters
The solid-matrix derogation in entry 78 of REACH Annex XVII previously exempted synthetic polymer microparticles permanently incorporated into a solid matrix during end use. Regulation 2026/1168 limits that exemption to end uses foreseen to last one year or longer, excluding short-duration uses where the matrix is frequently removed or replaced; this applies from 22 June 2028 to allow reformulation and stock disposal. Two further amendments apply retroactively from 17 October 2023: the medicinal-products derogation is corrected to cover all human and veterinary medicinal products including those in clinical trials and pre-clinical safety testing, and a new derogation exempts microparticles used in product and process-orientated R&D in quantities of one tonne per year or less, including outside industrial sites. The Regulation is directly applicable across Member States.
Implications
- — Product compliance and reformulation teams at manufacturers and importers relying on the solid-matrix derogation for short-lived applications must reformulate or clear stocks before 22 June 2028 — after that date microparticles in end uses foreseen to last under one year no longer qualify for the exemption and fall under the entry 78 placing-on-the-market prohibition.
- — Regulatory affairs teams at pharmaceutical and veterinary medicine manufacturers can treat microparticles in clinical-trial and pre-clinical safety-testing products as covered by the derogation back to 17 October 2023 — placing on the market for those uses is not non-compliance with entry 78.
- — R&D operators at hospitals, universities and other non-industrial sites conducting PPORD at one tonne per year or less can rely on the new derogation retroactively from 17 October 2023, removing prior exposure under the entry 78 restriction for those activities.
Who is affected
- — Product compliance and reformulation teams at manufacturers and importers using synthetic polymer microparticles in short-duration solid-matrix applications
- — Regulatory affairs teams at human and veterinary pharmaceutical manufacturers
- — PPORD operators at hospitals, universities and other non-industrial research sites
What to watch
- — 22 June 2028: the narrowed solid-matrix derogation takes effect; microparticles in end uses foreseen to last under one year lose the exemption.
- — 17 October 2023: retroactive effective date for the corrected medicinal-products derogation and the new PPORD derogation.