Microplastics matter: practical implications of the EU REACH restriction for the pharmaceutical industry

Synthetic polymer microparticles (SPMs), commonly referred to as microplastics, are subject to increasing restrictions due to their environmental persistence and uncertainty about potential human health effects. These substances are regulated under Regulation (EC) No 1907/2006 (REACH). Commission Regulation (EU) 2023/2055 amends REACH by introducing a restriction on SPMs in Annex XVII, including phased information and reporting obligations for in-scope uses. Although medicinal products are derogated from the market ban, these obligations have practical implications for pharmaceutical supply chains. Medicinal products containing SPMs are subject to specific reporting obligations under the REACH regulation. These obligations apply when the excipients meet the SPM definition and cannot be excluded based on criteria such as being naturally occurring, or due to their solubility or demonstrated degradability. This paper presents an operational decision-making framework that interprets the EU REACH restriction on SPM for pharmaceutical excipients and drug-delivery systems. The framework integrates regulatory definitions with testing strategies, supplier qualification processes, and downstream compliance workflows. An industry case example illustrates a combined approach using portfolio screening and biodegradation testing. This can generate evidence to support compliance decisions while preserving formulation performance.