On 17 September 2025, the European Commission notified a draft Regulation aimed at clarifying the terms of the restrictions applicable to synthetic polymer micro-particles, established by Regulation (EU) 2023/2055, known as the “Microplastics” Regulation.
As explained by the Commission in its notification text, the purpose of this draft Regulation is to amend entry 78 of Annex XVII to the REACH Regulation, introduced by Regulation (EU) 2023/2055 as regards synthetic polymer microparticles.
Indeed, feedback from Member States and stakeholders highlighted that the current enacting terms of entry 78 do not accurately reflect the intention of the regulators
(i) to derogate all medicinal products, including those used in clinical trials,
(ii) to derogate uses for product and process-oriented research and development, and
(iii) not to derogate synthetic polymer microparticles permanently incorporated in a solid matrix that is intended to be frequently removed and replaced.
Planned amendments
As a reminder, Regulation (EU) 2023/2055 establishes the principle, in a new entry 78 of Annex XVII of the REACH Regulation, of a ban on the placing on the market of substances and mixtures containing a concentration equal to or greater than 0.01% by weight of synthetic polymer microparticles.
The currently notified draft amends several points in entry 78.
In paragraph 4 on derogated product types
Point b)
The text concerning the derogation for “medicinal products within the scope of Directive 2001/83/EC and veterinary medicinal products …
