Microplastics: Advisory and Regulatory Compliance Services
Discover our tiered solutions for microplastics management and plastic pellet loss prevention.
Regulation (EU) 2023/2055 requires manufacturers, converters, industrial users and suppliers of microplastics to report their estimated releases annually to ECHA no later than 31 May each year. In addition, Regulation (EU) 2025/2365 introduces the obligation to implement risk management plans to prevent plastic pellet losses by 17 December 2027.
At AIMPLAS, we provide technical and regulatory support to help your company comply with both regulations on time.
Regulation (EU) 2023/2055: Restriction on intentionally added microplastics
This Regulation restricts the placing on the market of products containing intentionally added microplastics. In addition, manufacturers and users handling plastic pellets, flakes and powders are required to calculate and annually report estimated releases to the environment to the European Chemicals Agency (ECHA).
This obligation applies to plastic manufacturers, converters, recyclers, intermediate industrial users and suppliers of articles containing microplastics. It also affects sectors such as cosmetics, fertilisers and plant protection products, which must demonstrate biodegradability or solubility in accordance with Appendices 15 and 16 of the Regulation.
From 2027 onwards, the annual reporting obligation for estimated environmental releases will also apply to manufacturers of human and veterinary medicinal products, as well as manufacturers of food additives and in vitro diagnostic products containing intentionally added microplastics.
Level 1 — Advisory support and training
Designed for companies that wish to understand their obligations and prepare their own notification independently.
- Context assessment: analysis of the company’s activities and products to determine applicable obligations.
- Regulatory framework: review of applicable requirements, including labelling and Safety Data Sheets (SDS).
- Training: 2.5-hour online session covering the notification process and the use of REACH-IT and IUCLID6.
Outcome: Full autonomy to prepare and submit the notification to ECHA.
Level 2 — Notification preparation (turnkey solution)
Includes Level 1. AIMPLAS manages the complete preparation of the notification dossier.
- Technical calculation: mass balance assessment to estimate microplastic releases to the environment based on the company’s operational data.
- Practical implementation: full completion of the IUCLID6 dossier.
- Final review: joint clarification of any outstanding questions prior to formal submission.
Outcome: A fully completed dossier submitted through REACH-IT.
Regulation (EU) 2025/2365: Prevention of plastic pellet losses
This Regulation requires economic operators handling plastic pellets in quantities equal to or greater than 5 tonnes per year — including manufacturers, converters, compounders, recyclers, transport operators and distributors — to implement risk management plans incorporating preventive measures throughout all industrial and logistical stages. The deadline for submitting the plan to the competent authority is 17 December 2027.
In addition, companies handling 1,500 tonnes per year or more must undergo audits and obtain certification.
Level 1 — Assessment and gap analysis
Designed for companies wishing to evaluate their level of compliance before developing a full risk management plan.
- Preliminary review: document review of existing procedures and practices.
- Compliance assessment: evaluation against the Regulation’s requirements.
- Guidance: roadmap to address identified gaps and prepare the Risk Management Plan.
Outcome: A clear understanding of regulatory priorities and required actions.
Level 2 — Risk Management Plan (development and implementation)
Includes Level 1. AIMPLAS develops and implements the Risk Management Plan required under the Regulation.
- On-site audit: detailed analysis of plant processes and material flows.
- Risk mapping: assessment of each stage (receipt, production and transport) to identify critical pellet loss points.
- Technical development: drafting of the specific operational procedures required by the Regulation.
Outcome: A completed Risk Management Plan ready for implementation.
Not sure which obligations apply to your company or where to start? Tell us about your situation and we will be happy to advise you with no obligation.
Frequently asked questions about microplastics compliance
Companies that manufacture, import or use intentionally added microplastics in their products are subject to notification requirements, including plastic manufacturers, converters, intermediate industrial users and suppliers of articles containing microplastics.
Regulation (EU) 2025/2365 requires economic operators handling plastic pellets in quantities of 5 tonnes per year or more — including manufacturers, converters, recyclers, compounders and transport operators — to implement risk management plans to prevent pellet losses to the environment. The deadline for submitting the Risk Management Plan is 17 December 2027. Facilities handling more than 1,500 tonnes per year will subsequently be required to undergo the relevant audit and certification process.
Until the European Commission publishes an official methodology (expected within two years), estimates are generally based on mass balance calculations using company operational data, including inputs, outputs, waste streams and emissions at each stage of the process. AIMPLAS performs these technical calculations as part of its ECHA notification preparation service.
Level 1 provides training, regulatory context and compliance assessment, enabling companies to manage their own notification or risk management plan. Level 2 is a turnkey solution that includes Level 1 plus the full preparation and implementation of the notification dossier or Risk Management Plan by the AIMPLAS team.
