Microplastics: From REACH Restriction to Annual Reporting

wfbadmin — Wed, 14 Jan 2026 20:19:32 +0000

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.

L'articolo Microplastics: From REACH Restriction to Annual Reporting proviene da Carmen Sorice Regulatory Affairs.

Essential Use Concept according to European Commission

wfbadmin — Fri, 23 Aug 2024 15:53:37 +0000

As part of the Chemicals Strategy for Sustainability, on April 22, 2024 the European Commission adopted “Guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals”. The Communication stresses the importance of phasing out these substances and states that no use can be considered essential if alternatives exist.

Harmful Substances

The Communication provides a broad definition of substances with hazardous properties, including not only carcinogenic, mutagenic and toxic for reproduction (CMR) substances, but also persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvB) substances, endocrine disruptors, respiratory sensitizers and toxic to target organs (STOT-RE).

Concept of ‘Essential Uses’

The Commission defines the concept of “essential use” to ensure that the most harmful chemicals are authorised only for specific purposes and for a limited period, provided that:

the use is necessary for health or safety or serve an essential function to society; and
there are no acceptable alternatives.

These criteria serve as guiding principles, to adapt with some flexibility to the specificities and objectives of each legislation in which the concept will be applied. The Commission clarifies that, although technical and economic feasibility will be considered in the analysis of alternatives, existing references in legislation such as REACH will not be changed.

Aim of the Communication

The main aim is to improve the protection of health and the environment by accelerating the decision-making process to phase out non-essential uses of hazardous substances and, where necessary, allowing a transition period for their substitution.

Application of Concept of “Essential Use”

The use of a substance may be essential in one product or context. The Commission specifies that an entire sector, such as healthcare or food packaging, will not be exempted from the essential use concept. Instead, specific individual uses within these sectors will be assessed. The assessment will be “per use” and not “per user”.

Evaluation of alternatives

According to the Commission’s Communication, the assessment of the acceptability of alternatives should consist of:

identifying possible alternatives that can provide the technical function needed for the final product to deliver the intended service and
assessing their acceptability from a social point of view.

It is therefore not necessary that the alternatives offer the same level of performance, as long as they have a function and a level of performance that are acceptable to society (even if lower than the most harmful substance). There are specific requirements for the assessment of alternatives in several pieces of legislation, including technical and economic feasibility. The Commission clarifies that it does not intend to change the existing requirements to align them with its Communication.

Conclusions

The EU Communication has no direct legal effect, but will serve as a guide for future legislation, in particular for the revision of REACH regulation and other chemicals legislation. However, the concept of essential use represents a significant change, shifting the attention from risk assessment to hazard and from safety to essentiality. If integrated into EU legislation, this concept will impact the accessibility of many substances and products currently in use.

L'articolo Essential Use Concept according to European Commission proviene da Carmen Sorice Regulatory Affairs.

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