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The European Commission has adopted Regulation (EU) 2026/1168, amending Entry 78 of Annex XVII to REACH, restricting the placing on the market of synthetic polymer microparticles (microplastics). Entry 78 was introduced by Commission Regulation (EU) 2023/2055 with aim of reducing microplastic emissions from products placed on the EU market. The latest amendment clarifies the scope of certain exemptions and addresses implementation issues that have been identified since the restriction came into force in October 2023.

Clarification of Exemptions

The regulation confirms that the existing exemption covers all human and veterinary medicinal products, including those used in clinical trials and related pre-clinical safety testing. According to the Commission, these products were intended to be covered by the original restriction, but this was not fully reflected in its wording.

The regulation introduces an explicit exemption for synthetic polymer microparticles used in clarifies the treatment of product and process orientated research and development (PPORD) activities in quantities of up to one tonne per year. The Commission states that these uses were intended to be covered by the original restriction, but the exemption was not expressly included in the legal text.

Changes to Solid Matrix Exemption

The amendment also clarifies the exemption for microparticles that are permanently incorporated into a solid matrix. Under the revised wording, the exemption will only apply where the intended end use is expected to last one year or more. The Commission considers this clarification necessary to ensure that the exemption remains consistent with the objective of minimising microplastic emissions. This provision will apply from 22 June 2028, allowing stakeholders time to adapt.

The amendments relating to medicinal products and PPORD uses will apply retroactively from 17 October 2023, which is the date the original microplastics restriction entered into force. According to the Commission, this approach is intended to reflect the original intention of the restriction and protect economic operators that relied on that interpretation.