In April 2025, the European Chemicals Agency (ECHA) published Version 1.1 of its detailed guidance document outlining the reporting requirements under Entry 78 of the EU REACH Regulation's restrictions on microplastics. Below are the key points of the document:
Definition of Synthetic Polymer Microparticles (SPM)
SPMs are defined as solid polymers that meet both of the following criteria:
- Composition: Contained within particles (constituting ≥1% of the particle weight) or forming a continuous surface coating on particles.
- Size Specifications: At least 1% of the particles described in Criterion 1 must meet either of these conditions:
- All dimensions ≤5 mm;
- Length ≤15 mm and a length-to-diameter ratio >3.
Exempted polymers
- Naturally occurring polymers formed by polymerization without chemical modification.
- Polymers demonstrated to be degradable per Annex 15.
- Polymers with solubility >2 g/L per Annex 16.
- Polymers containing no carbon atoms in their chemical structure.
Exempted Uses
- SPMs for Industrial Sites: SPMs used as substances or mixtures in industrial settings.
- Pharmaceutical Products: Human medicines under Directive 2001/83/EC and veterinary medicines under Regulation (EU) 2019/6.
- Food Additives: Substances within the scope of Regulation (EC) 1333/2008.
- In Vitro Diagnostic Devices: Equipment covered by Regulation (EU) 2017/746.
Preparing for Reporting
- Identify Reporting Entities:
- Manufacturers, industrial downstream users, and suppliers first placing SPMs on the market.
- A single legal entity may have multiple reporting obligations, with separate submissions required per entity.
- Define Reportable Uses:
- Select applicable uses from predefined lists (e.g., industrial use of granules/flakes/powders, consumer/professional uses in pharmaceuticals).
- Collect Required Information:
- Usage descriptions, polymer identities, emission estimates, etc.
Submitting Reports
- Reporting Tool: Use the IUCLID platform, which provides templates for structured data entry (e.g., dossier headers, substance identity).
- Submission via REACH-IT:
- Each legal entity must submit its own IUCLID dossier.
- Third-party submission is permitted, but the original entity retains accountability.
- Format: A single IUCLID dossier per legal entity covering all applicable uses (no multiple submissions for the same entity).
Data Handling & Sharing
- Confidentiality: Legal entity and site information, as well as data requested by Member States, are accessible only to ECHA and national authorities. Aggregated, non-confidential data will be publicly disclosed.
- Member State Access: Full IUCLID dossiers are available to Member States. National authorities may request additional details (e.g., polymer identity/function), which can be appended as attachments.
Reporting Timeline
- 2026 Deadlines:
- Manufacturers and downstream users of SPMs used as raw materials (granules/flakes/powders) in industrial plastic production must report 2025 calendar year emission estimates by May 31, 2026.
- 2027 Deadlines:
- Other SPM manufacturers and downstream users in industrial settings, plus suppliers placing SPM-containing products under Article 78(4)(b, d, e) and Article 78(5) on the market for professional/public use, must report 2026 calendar year data by May 31, 2027.
Updates & Publication
- Dossier Updates: The reporting tool allows dossier amendments and reuse of prior-year data for efficiency.
- Public Disclosure: From May 2026, ECHA will publish aggregated SPM emission data on its website. The publication format is under development and will be finalized after the first reporting cycle.
The reporting system is expected to be operational by December 2025. Global supply chain entities, particularly those in exempt sectors like industrial, medicinal, and food industries, should promptly prepare for compliance.
Further Information
