Regulation (EU) 2023/2055, which introduces the Restriction of microplastics intentionally added to products, was published in the Official Journal of the European Union on September 25, 2023. Until recently, its implementation relied solely on the legislative text and a few industry guidelines, making the regulatory framework complex and at times confusing for the companies involved. However, two important documents have now been made available, providing regulatory clarity and valuable support during the implementation phase.
On March 31, 2025, the European Commission, in collaboration with ECHA and the Member States, published the “Explanatory Guide” to Regulation 2023/2055
This guide is divided into three sections:
- Part 1: General overview of the provisions under the Restriction;
- Part 2: “Questions & Answers” section;
- Part 3: Decision trees, obligations for different actors in the supply chain, and practical examples.
Additionally, a few days ago ECHA published a document titled “Implementation of the reporting requirements of the REACH restriction on microplastics”
ECHA – Implementation of the reporting requirements of the REACH
which specifies the information to be reported to ECHA and the procedures for preparing and submitting annual notifications. As stated in paragraphs 11 and 12 of the Restriction, there is an obligation to annually report to ECHA the estimated environmental emissions for certain uses of microplastics falling under specific derogations. The timelines vary depending on the product categories and the actors involved:
- From May 31, 2026 for manufacturers and industrial downstream users of synthetic polymer microparticles (pellets, flakes, powders) used as raw materials in plastic production at industrial sites.
- From May 31, 2027 for:
- Manufacturers and downstream users handling microparticles at industrial sites (Par. 4a),
- Suppliers of medicinal and veterinary products (Par. 4b), food additives (Par. 4d), and in vitro diagnostic medical devices (Par. 4e),
- Suppliers of products containing microplastics “contained by technical means” (Par. 5a), whose properties are permanently modified during end use (Par. 5b), and those permanently incorporated into a solid matrix (Par. 5c).
Companies will be required to:
- Estimate emissions for each specific use
- Provide detailed use descriptors
- Select the polymer entity from a predefined list based on the Harmonized System (HS Code)
- Indicate the quantity of particles or synthetic polymers for each use
- Use IUCLID software to prepare the notifications
- Submit the information to ECHA via the REACH-IT portal
According to ECHA, the platform for preparing and submitting notifications will be operational starting December 2025. It is important for companies to start collecting and organizing all necessary information about their products and their uses now, in order to be prepared for the upcoming obligations. For support and further details, you can contact TEAM mastery at: ilariageremia@team-mastery.eu.