IPEC: Revised REACH Guide for Excipients

In December 2025, the IPEC (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl) announced the new version 1 of its 'Best Practices Guide for European REACH Restriction on Synthetic Polymer Microparticles (SPM) for Pharmaceutical Excipients (Version 1, 2025)' in a notice on its website. This is currently only available and accessible in the IPEC members' area. After a period of three months (expected to be 18 March 2026), the updated guide will be published in full. It can be assumed that, as usual, it will be available under the 'Resources' section in the 'Guidelines' area of the IPEC website. At present, the summary and table of contents are available. According to the advance notice, the new guide is now an 'IPEC Federation Document', whereas the 2022 guide was a joint draft of the 'IPEC-Americas' and 'IPEC Europe Guide'.

The table of contents for version 1 of the new guide from 2025 includes the following chapters, with chapters 1, 2, 3, 5 and 7 containing further subchapters and sub-sections. An overview of the main chapters and appendices can be found here:

ACKNOWLEDGEMENTS
1 INTRODUCTION
2 DEFINITION OF SYNTHETIC POLYMER MICROPARTICLES
3 EXCIPIENT SCOPE
4 MEDICINAL PRODUCTS AND DEROGATION
5 INFORMATION REQUIREMENTS FOR SUPPLIERS FOR SPM
6 REPORTING REQUIREMENTS FOR EXCIPIENT MANUFACTURERS AND USERS
7 PROVISION OF ADDITIONAL SPM IDENTIFIERS TO ENFORCING AUTHORITIES (Paragraph 13 and 14)
8 PARAGRAPH 15 - DEMONSTRATION OF COMPLIANCE WITH EXEMPTION CRITERIA
9 REFERENCES
ANNEX 1 Assessment of Excipients for Use in Medicinal Products
ANNEX 2 Link to legal text
ANNEX 3 Definitions and Abbreviations

Furthermore, there is a list of all tables and figures included in this version.

The advance notice of version 1 of the 'Best Practices Guide for European REACH Restriction on Synthetic Polymer Microparticles (SPM) for Pharmaceutical Excipients (Version 1, 2025)' and the complete table of contents can be found on the IPEC website.