EU REACH Compliance | Synthetic Polymer Microparticles
Microplastics have become a growing global concern due to their persistence and ability to spread across air, water, and even reach remote regions like the Arctic. In response to this escalating pollution issue, the European Commission adopted a new restriction on microplastics intentionally added to products in September 2023 under Annex XVII, Entry 78 of the EU REACH Regulation.
This page provides a practical overview of the EU microplastics restriction, the definition of SPMs, compliance timelines, exemptions, labeling and reporting duties, and how businesses can ensure conformity with the new requirements.
What Are Microplastics (SPMs)?
Microplastics are tiny plastic particles that often originate from intentionally added ingredients or the degradation of larger plastics. These particles pose environmental concerns due to their persistence and mobility.
Under Commission Regulation (EU) 2023/2055, synthetic polymer microparticles are generally defined as solid, carbon-based synthetic polymer particles where all dimensions of the particles are equal to or less than 5 mm, or fibre-like particles with a length equal to or less than 15 mm and a length-to-diameter ratio greater than 3.
Water-soluble polymers with solubility greater than 2 g/L, biodegradable polymers validated under the relevant testing requirements, natural polymers that have not been chemically modified, and polymers that do not contain carbon atoms in their chemical structure are excluded from this designation. For broader EU chemical obligations beyond SPMs, companies may also need to assess EU REACH registration and compliance requirements.
Compliance note: Whether a product falls within the EU microplastics restriction cannot be determined by the term “microplastics” alone. Companies should assess polymer identity, particle size, physical state, concentration, solubility, degradability, intended function and product use scenario.
Overview of the EU Microplastics Restriction (REACH Annex XVII, Entry 78)
The microplastics restriction targets the intentional use of synthetic polymer microparticles in products placed on the EU market. The restriction applies to SPMs placed on the market as substances on their own or, where SPMs are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0.01% by weight.
While the restriction prohibits certain uses, it also includes transition periods and derogations for specific product categories and use scenarios. Companies should therefore conduct a product-by-product assessment before deciding whether reformulation, labeling, reporting, downstream communication, Safety Data Sheet (SDS) updates or other compliance actions are required.
| Key Item | Requirement / Scope | Business Implication |
|---|---|---|
| Legal basis | Commission Regulation (EU) 2023/2055, amending REACH Annex XVII as regards synthetic polymer microparticles. | Companies supplying the EU market need to assess whether their products contain restricted SPMs. |
| Restriction threshold | SPMs intentionally present in substances or mixtures at 0.01% w/w or above may be restricted. | Formulation review and concentration verification may be required. |
| Particle size | Particles of 5 mm or less, and fibre-like particles of 15 mm or less with a length-to-diameter ratio greater than 3. | Particle size data or supporting documentation may be needed. |
| Potential exclusions | Natural non-chemically modified polymers, biodegradable polymers, soluble polymers and polymers without carbon atoms may be excluded. | Testing and documentary evidence may be required to justify exclusion. |
Exemptions and Delayed Requirements
The regulation provides exemptions, derogations or delayed implementation for specific uses of SPMs. However, being exempt from the placing-on-the-market prohibition does not necessarily mean that no compliance action is required. Information requirements, instructions for use and disposal, labeling, SDS updates and annual reporting may still apply.
Industrial applications: may be exempt from the placing-on-the-market ban, but information and reporting obligations may apply.
In vitro diagnostic devices: are subject to delayed information requirements.
Medicinal and veterinary medicinal products: may be addressed through specific derogations.
Food additives: may fall under specific derogation rules.
Products with low environmental release risk: may require supporting evidence and instructions for use and disposal.
Cosmetics: different transition periods apply depending on product type, including rinse-off products, leave-on products, fragrance encapsulation, make-up, lip and nail products.
Companies relying on exemptions should maintain clear technical and regulatory justification. In some cases, SPM-related obligations may also intersect with EU CLP classification and labeling, SDS communication, or broader EU REACH supply chain duties.
| Product / Use Category | Relevant Timing | Compliance Focus |
|---|---|---|
| Industrial SPMs | Information duties start from 17 October 2025. | Instructions for use and disposal, regulatory statement, quantity or concentration information, polymer identity information. |
| In vitro diagnostic devices | Information duties start from 17 October 2026. | Instructions for use and disposal to prevent environmental release. |
| Rinse-off cosmetics | Restriction applies from 17 October 2027, unless specific exceptions apply. | Formulation review, substitution plan, transition period management. |
| Leave-on cosmetics | Restriction applies from 17 October 2029, unless specific exceptions apply. | Reformulation strategy, supplier documentation, market transition planning. |
| Make-up, lip and nail products | Restriction applies from 17 October 2035. From 17 October 2031 to 16 October 2035, affected products must bear the statement “This product contains microplastics.” | Label planning, claims review, stock control and reformulation roadmap. |
Compliance Obligations of the EU Microplastics Regulation for Companies
Information Requirements and Labeling
Different product categories have different start dates for communicating SPM-related information to downstream users, professional users or the public. Depending on the applicable paragraph of the restriction, companies may need to provide instructions for use and disposal, regulatory statements, quantity or concentration information, generic polymer identity information, or consumer-facing labeling.
Information must be clear, visible, legible and indelible. It may be provided on the product label, packaging, package leaflet, safety data sheet or, where appropriate, through digital tools such as a QR code or website.
Annual Reporting to ECHA
Companies may need to report annual estimates of SPM emissions to the European Chemicals Agency (ECHA), based on the previous calendar year. The reporting obligation is phased depending on the actor type and product category. For more background, see REACH24H’s update on mandatory reporting for synthetic polymer microparticles due by May 2026.
| Reporting Deadline | Who May Be Affected | Information to Prepare |
|---|---|---|
| By 31 May each year, starting from 2026 | Manufacturers and industrial downstream users of SPMs in the form of pellets, flakes and powders used as feedstock in plastic manufacturing at industrial sites. | Description of uses, generic polymer identity, estimated SPM releases to the environment and applicable derogation reference. |
| By 31 May each year, starting from 2027 | Other manufacturers, industrial downstream users and certain suppliers of products containing SPMs placed on the market for the first time. | Description of end uses, generic polymer identity, estimated environmental release and reference to applicable derogations. |
The EU microplastic emission reporting system has already been launched for relevant companies preparing their first submissions. Companies can review REACH24H’s explanation of the EU microplastic emission reporting system and first submission deadline to better understand practical reporting preparation.
What Companies Should Do Now
Screen EU-bound products and formulations for intentionally added SPMs.
Verify polymer identity, particle size, physical state, concentration and intended function.
Assess whether exemptions, derogations or transition periods apply under Regulation (EU) 2023/2055.
Prepare technical evidence for solubility, biodegradability or other exclusion claims where needed.
Update labels, packaging information, safety data sheets, instructions for use and disposal where required.
Establish internal data collection for ECHA annual reporting, if applicable.
Coordinate with EU importers, distributors and downstream users to align compliance responsibilities.
Our Full-Scale EU Microplastics Compliance Services
At REACH24H, we support global businesses in meeting every aspect of the SPMs regulation. Our services cover regulatory applicability assessment, testing and evidence review, labeling and SDS preparation, annual reporting support and EU market access planning. Companies with broader EU chemical obligations may also need integrated support for EU REACH Registration & Only Representative services, EU CLP compliance, and Global GHS/SDS/MSDS/Label compliance.
| Service Module | What REACH24H Supports |
|---|---|
| Regulatory Assessment | Analyze product portfolios to determine whether materials fall under the restriction or qualify for exclusions, exemptions or transition periods. |
| SPMs Testing & Evaluation | Coordinate solubility, biodegradability and supporting technical evaluations to help verify potential exclusion from the SPM designation. |
| Labeling & SDS Preparation | Assist with compliant product labels, packaging information and Safety Data Sheets (SDS) aligned with SPMs requirements and the EU CLP Regulation. |
| Annual Report Filing | Support ECHA annual reporting preparation, including use descriptions, polymer identity information, emission estimates and derogation references. |
| EU Compliance Roadmap | Provide practical recommendations on reformulation, substitution, transition period management, importer communication and long-term EU market access. |
Need to confirm whether your EU-bound products are affected by the microplastics restriction?
Submit your product information to REACH24H for an initial SPMs applicability assessment, compliance gap review and tailored action plan.
Contact Our Regulatory SpecialistsStay Ahead of EU Green Compliance
The new microplastics regulation is a milestone in the EU’s green and circular economy agenda. While the compliance path may be complex, early preparation helps businesses reduce market disruption, manage supply chain responsibilities and maintain compliant access to the EU market. Companies may also refer to the European Commission’s official explanation of the microplastics restriction for regulatory background.
FAQ: EU Microplastics (SPMs) Restrictions
Is the EU microplastics restriction a complete ban?
No. The restriction prohibits certain uses of synthetic polymer microparticles, but it also includes exclusions, derogations and transition periods. Some products may not be immediately banned but may still be subject to labeling, information transfer or reporting obligations.
Do industrial uses of SPMs need compliance actions?
Yes. Industrial uses may benefit from derogations from the placing-on-the-market restriction, but suppliers and users may still need to provide instructions for use and disposal, regulatory statements, polymer identity information and annual reports to ECHA.
What information is needed for ECHA annual reporting?
Depending on the reporting category, companies may need to prepare descriptions of uses or end uses, generic polymer identity information, estimates of SPM releases to the environment and references to applicable derogations. For reporting preparation, companies may also review REACH24H’s update on EU REACH SPM mandatory reporting.
Can soluble or biodegradable polymers be excluded?
Potentially yes. However, exclusion should be supported by appropriate testing or documentary evidence, such as solubility or biodegradability data that meets the relevant criteria under the regulation.
Recommended Reading
EU REACH Compliance: Mandatory Reporting for Synthetic Polymer Microparticles Due by May 2026
EU Microplastic Emission Reporting System Officially Launched
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