Microplastics represent one of the most significant environmental priorities of our time, influencing ecosystem health and consumer perception. Scientific research, extensively documented (with over 7,000 recent supporting studies), has confirmed their omnipresence in the environment and the food chain, highlighting the need for rapid action.
This evidence has prompted Europe to transform the regulatory framework into a more structured and strict risk management system. The REACH Regulation, through Restriction 78 (introduced by EU Regulation 2023/2055), now imposes clear and imminent obligations for companies that produce, import or use intentionally added microplastics.
This regulatory evolution is not just a burden but should be seen as a concrete opportunity to stimulate innovation, while simultaneously strengthening the company’s credibility and social responsibility.
In this in-depth analysis, we examine the updated regulatory landscape, the new reporting deadlines and the critical importance of specialized technical-regulatory support, which is essential for managing regulatory risk and achieving the correct implementation of obligations and requirements efficiently.
What Are Microplastics and Why Are They Everywhere
By microplastics (MP), we mean plastic polymer particles with dimensions smaller than 5 millimeters. An even greater concern is posed by nanoplastics, invisible to the naked eye, with dimensions smaller than 100 μm, capable of crossing our body’s protective barriers, including the brain and placenta.
MP are divided into:
- Primary MP: Released directly into the environment (e.g., microbeads in cosmetics, synthetic fibers released from washing clothes, tire wear).
- Secondary MP: Derived from the fragmentation of larger plastic objects, which constitute the majority (up to 81%) of plastic pollution in the oceans.
Their resistance to biodegradation makes them persistent in every environmental matrix: air, soil, drinking water and, consequently, in the food chain. Recent Italian studies have confirmed their presence even in consumer products such as cheeses, highlighting how close the problem has come to our plates.
Reporting Obligations and Pellet Management (Reg. 2025/2365)
The European Union has taken a decisive path to limit the dispersion of microplastics intentionally added to products (as provided for by the REACH restriction). Beyond gradual bans, the focus is now shifting to the transparency and responsibility of producers.
The Reporting Deadline (ECHA)
The crucial point for many companies is the imminent Annual Reporting obligation for intentionally added microplastics:
- Start: The obligation to report environmental data collected in the 2025 calendar year will begin starting from May 31, 2026.
- Platform: Reporting must take place through the ECHA IUCLID platform.
- What to report: Companies must communicate the identity of the polymer, the estimated quantity released into the environment, and any applicable derogations.
In parallel, Regulation (EU) 2025/2365 establishes binding obligations for economic operators to prevent and contain the dispersion of plastic pellets at all stages of the supply chain, reducing microplastic pollution. The provisions will come into force at successive deadlines starting from December 16, 2025, with the main compliance deadlines scheduled for December 17, 2027.
REACH and Microplastics: Classification and Detection for Compliance
To correctly fulfill REACH obligations related to microplastics, it is essential to address two interconnected levels of complexity:
- Correct Regulatory Classification: The first crucial step is determining if a substance falls under the REACH definition of a polymer and, consequently, the definition of a microplastic subject to restriction, as established by Regulation (EU) 2023/2055 (which introduced restriction 78 in Annex XVII). The application of these decision criteria is complex and requires deep technical-regulatory expertise.
- Material Analysis and Characterization: In addition to classification, it is indispensable to proceed with analysis for the quantification and identification of the chemical composition of microplastics and nanoplastics. This process requires advanced instrumentation and methodologies. Precise knowledge of the chemical composition of polymers is fundamental for developing targeted and effective mitigation strategies, in line with the environmental protection goals of Regulation 2023/2055.
The complexity of the upcoming deadlines requires timely planning: mapping your polymers and implementing accurate monitoring systems is the first essential step to successfully managing this transition.
