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Commission publishes Explanatory Guide for microplastics restriction under REACH Annex XVII Entry 78

EU REACH ANNEX XVII Entry 78European CommissionEU
Announced

Mar 26, 2025

Description

The European Commission has published Version 1 of the Explanatory Guide for the REACH restriction of synthetic polymer microparticles (Entry 78 of Annex XVII). The guide provides comprehensive explanations of the restriction scope, definitions, transitional periods, derogations, and reporting obligations under Commission Regulation (EU) 2023/2055. It clarifies that suppliers of medicinal products containing synthetic polymer microparticles derogated under Paragraph 4(b) are subject to reporting requirements from May 31, 2027, with annual reporting thereafter for uses and emissions data.

Key Findings

Commission publishes Explanatory Guide for microplastics restriction under REACH Annex XVII Entry 78

1 REACH restriction of synthetic polymer microparticles (Entry 78 of Annex XVII REACH, as introduced by Commission Regulation (EU) 2023/2055) – Explanatory Guide – Version 1 © European Union 2025 Contents About this document ................................................................................................................ 2 Glossary .......................................................................

Commission publishes Explanatory Guide for microplastics restriction under REACH Annex XVII Entry 78

at? 26 Some pharmaceutical ingredients may be SPM. Pharmaceutical ingredients placed on the market in medicinal and veterinary medicinal products are derogated under Paragraph 4(b). Suppliers of medicinal products containing SPM derogated under Paragraph 4(b), are not subject to IFUD requirements under Paragraphs 7 or 8 of entry 78 but, from 31 May 2027, they are subject to reporting requirements [...] modified (see

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