Pursuant to Entry 78 of Annex XVII to the REACH Regulation (introduced by Regulation (EU) 2023/2055), legal entities placing products containing Synthetic Polymer Microparticles (SPM) on the EU market must adhere to new mandatory annual reporting obligations. While certain uses are derogated from the general ban on placing on the market, they are now subject to strict transparency requirements. The first regulatory deadline is May 31, 2026, for manufacturers and industrial downstream users of SPM in the form of pellets, flakes, and powders used as feedstock. Failure to submit estimated emission data via IUCLID by this date may result in non-compliance penalties and restricted market access.
Regulatory Framework: Reporting Obligations for Derogated Uses
Under REACH Annex XVII Entry 78, the "Microplastics Restriction" does not merely prohibit certain substances; it establishes a monitoring mechanism for uses that are currently derogated. These reporting requirements are mandatory for entities benefiting from the following derogations:
Industrial Site Uses (Paragraph 4a): SPM used as substances on their own or in mixtures at industrial sites.
Specific Product Categories (Paragraph 4b, 4d, 4e): Including medicinal products, food additives, and in vitro diagnostic devices.
Containment & Physical Modification (Paragraph 5): SPM contained by technical means, those whose physical properties are permanently modified during end-use, or those permanently incorporated into a solid matrix.
Critical Deadlines for ECHA SPM Emission Reporting
The reporting obligation is phased based on the type of use and the actor's role in the supply chain. Reports must cover the estimated emissions for the previous calendar year:
1. By May 31, 2026: Manufacturers and industrial downstream users handling SPM in the form of pellets, flakes, and powders used as plastic manufacturing feedstock (covering 2025 data).
2. By May 31, 2027:
All other manufacturers and industrial downstream users of SPM at industrial sites.
Suppliers placing products containing SPM for professional or consumer use on the market for the first time (under derogations in paragraphs 4b, 4d, 4e, or 5).
Mandatory Data Disclosure Requirements
To fulfill REACH Annex XVII Entry 78 compliance, reporting entities must submit a IUCLID dossier via REACH-IT containing:
Generic Identity of Polymers: Utilizing the Harmonized System (HS) 4-digit codes.
Description of End-Uses: Detailing the technical functions and sectors of use.
Applicable derogation(s) – selected from a picklist corresponding to Entry 78 paragraphs 4(a), 4(b), 4(d), 4(e), 5(a), 5(b) or 5(c)
Estimated Environmental Emissions: A total sum of SPM released across all compartments (air, water, soil), including transportation-related losses (spills, leaks, or residues).
Key Compliance Considerations for EU Manufacturers and Exporters
Emission estimation complexity – Companies must quantify operational losses, intentional releases and transport-related emissions, requiring coordination across production, logistics and EHS functions. Many entities lack standardised internal monitoring processes.
Supply chain data dependencies – Accurate reporting relies on upstream suppliers providing polymer identity information (HS codes, concentration ranges). Where supplier data is incomplete or delayed, downstream users face uncertainty and potential non-compliance.
Distinction between manufacturer and distributor – Pure distributors have no reporting obligation. However, activities such as import, reformulation, repackaging or relabelling establish manufacturer status and trigger reporting duties.
How REACH24H Supports EU REACH Microplastics Reporting Compliance
REACH24H provides comprehensive compliance services for the Entry 78 annual reporting mandate:
Applicability and derogation assessment – Determine whether your polymers meet the SPM definition and which derogations apply to your operations
Emission estimation methodology – Develop defensible release calculation models aligned with ECHA guidance
IUCLID dossier preparation and submission – Prepare complete dossiers and submit via REACH IT before statutory deadlines
Instructions for use and disposal – Draft compliant labelling, SDS and package leaflets for SPM products
Annual reporting system setup – Establish internal data collection and monitoring processes to ensure sustainable year on year compliance
With the 31 May 2026 deadline less than one month away, immediate action is required to avoid non compliance and potential disruption to EU market access. If you have any questions or require professional consultancy services, please feel free to contact us at customer@reach24h.com.
