These regulations are particularly relevant for businesses that manufacture, process, store, handle, or transport plastic pellets, flakes, or powders. A key challenge is understanding that these two regulatory frameworks address different issues and therefore require different compliance measures.

Two Regulations – Two Distinct Focus Areas

Regulation (EU) 2025/2365: Preventing Pellet Losses

Regulation (EU) 2025/2365 focuses on preventing the unintentional loss of plastic pellets throughout the entire supply chain.

Its objective is to stop plastic pellets from entering the environment, where they can become a significant source of microplastic pollution. As a result, companies must assess their operations, identify potential loss points, and implement appropriate measures to prevent, control, and document pellet losses.

Typical questions companies should address include:

• Where are plastic pellets manufactured, processed, stored, or transferred?
• At which stages of operations could pellet losses occur?
• What technical and organizational measures are necessary to prevent releases?
• How should these measures be documented and monitored?

REACH Annex XVII, Entry 78: Restrictions on Microplastics

REACH Annex XVII, Entry 78 takes a different approach. Its focus is on the placing on the market and use of synthetic polymer microparticles.

In addition to restrictions for certain applications, the regulation introduces various compliance requirements, including:

• Customer information obligations
• Documentation requirements
• Reporting obligations
• Notifications to the European Chemicals Agency (ECHA)

Companies therefore need to evaluate whether their products fall within the definition of synthetic polymer microparticles and determine which specific obligations apply.

Which Companies Are Affected?

Organizations potentially impacted include those involved in:

• Plastic manufacturing
• Compounding operations
• Plastic processing
• Logistics and transportation
• Warehousing and storage
• Recycling activities
• Manufacturing of products containing microplastics

Because these requirements can apply throughout the value chain, not only producers but also downstream operators should review their processes and compliance responsibilities.

Key Actions for Affected Companies

To prepare for the new requirements, companies should take a structured approach.

1. Establish Transparency on Volumes and Locations

The first step is to gain a clear understanding of relevant material flows:

• What quantities are being handled?
• At which sites?
• Which facilities are affected?

Reliable data is the foundation for all further assessments and compliance activities.

2. Assess Applicability and Volume Thresholds

Special attention should be paid to the regulatory thresholds defined in the legislation.

One particularly important threshold is 5 tonnes of plastic pellets per installation per year.

For installations handling 1,500 tonnes or more annually, additional requirements may apply, potentially leading to more extensive organizational and documentation obligations.

3. Identify Potential Loss Points

Companies should systematically analyze their operations for potential pellet loss risks, including:

• Loading and unloading activities
• Conveying systems
• Storage areas
• Packaging operations
• Transport routes

4. Develop Risk Management and Documentation Processes

An effective management system should include:

• Risk assessments
• Action plans
• Operating procedures
• Monitoring and control measures
• Documentation and record-keeping processes

5. Train Employees

Technical measures alone are not sufficient. Employees must understand the requirements and consistently apply them in their day-to-day activities.

Training programs should be tailored to the relevant functions and updated regularly to reflect changing requirements.

6. Evaluate Information and Reporting Obligations

Particularly under REACH, companies need to determine:

• Which information must be communicated to customers
• What documentation requirements apply
• Whether reporting obligations to authorities or ECHA exist

7. Prepare for ECHA Notifications

Depending on the specific application and use case, recurring reporting obligations may apply. Early preparation helps ensure timely compliance while reducing future administrative burdens.

Why Companies Should Act Now

Even though some transition periods remain in place, early preparation is highly recommended.

Many of the required data points already exist within organizations but are often scattered across different systems, departments, and locations. Companies that begin now can establish the necessary data structures, responsibilities, and processes more efficiently and avoid costly implementation challenges later.

At the same time, addressing these requirements proactively provides an opportunity to strengthen existing compliance and data management frameworks while creating synergies with other regulatory initiatives.

How imds professional Supports Compliance Efforts

imds professional helps organizations integrate these new requirements into their existing compliance and business processes in a practical and efficient manner.

Our services include:

• Applicability assessments
• Structuring material, quantity, and site data
• Evaluation of relevant obligations and deadlines
• Development of effective compliance processes
• Support with documentation and reporting
• Training for involved departments and stakeholders

By combining expertise in material compliance, regulatory requirements, and data management, we help companies implement sustainable and efficient compliance solutions.

Feel free to schedule an appointment for a free initial consultation.