EU Microplastics Restrictions and Business Solutions

Overview of the EU Microplastics Restriction

Microplastics have emerged as a significant global environmental concern due to their persistence and ability to spread across air, water, and remote ecosystems. In response to this escalating pollution issue, the European Commission adopted a new restriction on synthetic polymer microparticles (SPMs) in September 2023 under REACH Annex XVII, Entry 78. This legislative framework provides a practical structure for managing microplastics, defining specific compliance timelines and requirements for businesses operating within the European market.

The regulation focuses on preventing the intentional use of SPMs in products placed on the EU market. While many uses are largely prohibited, the regulation includes transition periods ranging from 4 to 10 years for certain low-risk sectors—such as cosmetics, fragrances, and medical devices—to allow industry time to identify and implement suitable alternative materials.

Definition and Classification of Microplastics

Under the EU REACH Regulation, microplastics are formally defined as solid, carbon-based synthetic polymer particles with a diameter of ≤5mm, or fibers with a length of ≤15mm and a length-to-diameter ratio greater than 3.

It is important to note that certain materials are excluded from this definition. Notably, water-soluble polymers (with a solubility >2g/L) or biodegradable polymers are excluded, provided they meet specific testing standards required by the regulation. Proregulations offers specialized technical support to verify these exclusions through rigorous solubility and biodegradability testing.

Exemptions and Transition Periods

The regulation recognizes that immediate replacement is not feasible for all industrial applications and provides either permanent exemptions or delayed implementation for SPMs used in specific sectors:

• Industrial applications.
• In vitro diagnostic devices.
• Medicinal and veterinary products.
• Food additives.
• Products with low environmental release risk.
• Cosmetics (with specific labeling becoming mandatory from 2031).

Compliance Obligations for Enterprises

Businesses must adhere to strict information requirements, labeling rules, and reporting mandates to ensure conformity with the new requirements.

Information Requirements and Labeling

Different product categories have distinct start dates for communicating SPM-related information to the public or downstream users:

• Starting October 17, 2025: Suppliers of industrial SPMs must provide instructions for safe use and disposal, declare conformity with the regulation, and disclose SPM quantity or concentration.
• Starting October 17, 2025: For food additives and low-release-risk products, instructions for use and disposal must be provided to both professional users and the general public.
• Starting January 1, 2031: Cosmetics must be clearly labeled with the statement: "This product contains microplastics".

Annual Reporting to ECHA

Companies are required to report annual estimates of SPM emissions to the European Chemicals Agency (ECHA) based on the previous calendar year's data:

• May 31, 2026: Industrial manufacturers and users of granular SPMs must begin their initial reporting for 2025 data.
• May 31, 2027: All other SPM product suppliers under specific regulatory articles must submit their emission reports.

Proregulations' EU Microplastics Compliance Services

Navigating the complexities of the SPM regulation requires early preparation to ensure uninterrupted market access. Proregulations provides full-scale support for every aspect of compliance.

• Regulatory portfolio assessment
  We analyze your product portfolio to determine whether your materials fall under the restriction or qualify for specific exemptions.
• Labeling and SDS preparation
  Our experts assist in preparing compliant product labels and Safety Data Sheets (SDS) that align with both the CLP Regulation and specific SPM rules.
• Annual emission report filing
  Proregulations handles ECHA submissions on your behalf, ensuring your annual emission reporting obligations are met accurately and on time.

If you need to ensure your products are fully compliant with the latest EU microplastics mandates and green compliance standards, please contact us.