Microplastics – macroproblems. EU regulation and new obligations already in effect
Selected provisions of Regulation (EU) 2025/2365 on preventing plastic pellet losses to reduce microplastic pollution have been applicable since 16 December 2025. Many more are awaiting application.
As early as 2019 scientific advisors to the European Commission signalled that there were “serious reasons for concern and precautionary measures” in this area. After six years, regulations aimed at eliminating plastic pellet loss have finally been adopted.
The Regulation is directly applicable in all EU Member States. So, what should you know about it?
Quick facts
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Applicable immediately, installations and carriers must ensure that plastic pellet losses are avoided and take urgent mitigating action in the event of a loss.
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Six months after the publication of harmonised standards, operators and carriers should estimate the amount of pellet loss in accordance with a standardised methodology.
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Modelled on the waste management hierarchy, a set of priorities will be introduced for the management of plastic pellets and microplastics.
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From 17 December 2027, requirements will apply regarding the preparation of risk management plans, incident response procedures, certification, record-keeping, and reporting.
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Failure to comply with the new obligations will incur administrative fines.
Who is affected?
The Regulation applies only to economic operators:
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handling plastic pellets in the EU in quantities equal to or above a threshold of 5 Mg in the previous calendar year,
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operating installations in the EU for the cleaning of plastic pellet containers and tanks,
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transporting plastic pellets in the EU (both EU and non-EU carriers),
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shippers and operators, agents and masters of seagoing vessels transporting plastic pellets in freight containers leaving or calling at an EU port (subject from 17 December 2028).
Basics and definitions
The new Regulation addresses the problem of microplastic pollution primarily through measures aimed at preventing the loss of plastic pellets. It is therefore worth referring first to the definitions introduced in this regard:
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“plastic pellets” mean a mass of polymer-containing material (regardless of its shape, form, or size) that is produced for moulding in plastic product manufacturing operations, irrespective of its actual use,
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“spill” means a one-off or prolonged escape of plastic pellets from primary containment within an installation’s boundaries or within means of transport,
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“loss” means a one-off or prolonged escape of plastic pellets to the environment at any stage of the supply chain, either from the installation’s boundary or from means of transport.
Avoiding losses
Economic operators who operate or control in whole or in part an installation, as well as carriers, shall ensure that losses of plastic pellets are avoided. Where losses occur, such entities shall take immediate action to contain and clean up those losses in accordance with environmentally sustainable practices.
This obligation applies from 16 December 2025.
Hierarchy of microplastic action
Economic operators, including carriers, should apply the following hierarchy of priorities no later than 17 December 2027.
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Actions to prevent spills.
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Actions to contain spills to avoid them becoming a loss.
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Actions to clean up after a spill or loss.
Reporting and record-keeping
From 17 December 2027, economic operators shall notify the competent authorities about each installation which they operate or control, or for which they hold decisive economic power over its technical functioning. In this regard, they shall specify whether the installation handles plastic pellets in quantities below, or equal to or above, a threshold of 1 500 Mg per year. This obligation will also include notifying authorities about any significant changes in what was previously notified.
Carriers will have to notify the competent authorities about their involvement in the transport of plastic pellets within the EU and the means of transport used prior to the first transport of plastic pellets in the EU.
It will also be mandatory to keep records of annually estimated quantities of losses and of the total quantities of plastic pellets handled.
Risk management plans
The Regulation will introduce an obligation to establish a risk management plan for each installation, taking into account the nature and size of the installation as well as the scale of its operations. According to Annex I, such a plan shall include (1) the number of tonnes of plastic pellets handled per year, (2) the locations within the installation’s boundaries where spills or losses could occur, (3) the annual estimation of the quantities of spills and losses from these locations; (4) a description of the packaging, equipment, and procedures put in place to prevent, contain and clean up spills and losses.
The plan should also define one specific role of a member of staff responsible for recording, investigating and following up on spills and losses of plastic pellets.
Risk management plans will be made publicly available on the websites of the competent authorities.
Certification
New obligations are also planned for the certification of plastic pellet operations, including the obligation to obtain a certificate demonstrating the fulfilment of the requirements set out in Annex I by:
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large enterprises – by 17 December 2027, and every three years thereafter,
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medium-sized enterprises – 17 December 2028, and every four years thereafter,
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small enterprises – by 17 December 2030.
Compliance through permits
Member States may exempt economic operators from certain obligations, including the obligation to obtain a certificate, provided that the operation of the installation is subject to a permit, which has been preceded with an analysis or reviewed in terms of plastic pellets, and that the installation is subject to regular inspections of relevant environmental effects, including those of spills and losses.
Entities registered in the eco-management and audit scheme (EMAS) may also be exempted from these obligations.
Incidents and accidents
Without prejudice to Directive 2004/35/EC on environmental damage, in the event of an incident or accident that causes a loss affecting human health or the environment, economic operators and carriers will be required to:
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immediately inform emergency services, where relevant,
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immediately take all possible measures to minimise the human health or environmental consequences,
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take measures to prevent further incidents or accidents,
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without delay, no later than 30 days after the incident or accident, provide the competent authorities with information on (1) the estimated quantities of the loss, (2) the causes of the loss, (3) the preventive measures taken.
The application of the above procedures should be ensured no later than 17 December 2027.
Sanctions and penalties
The Regulation itself does not provide for sanctions for infringements – legislation in this area is at the discretion of Member States. However, it is clear that these sanctions will primarily include administrative fines and should take due account of nature, gravity and scale of the infringement, its frequency and the population or environment affected.
Conclusions
Regulation 2025/2365 introduces a new quality in terms of environmental protection and business responsibility for plastic pellet losses. In addition to the obligations already in force, companies should begin preparations for the implementation of new requirements, particularly in terms of equipment, technology, planning, documentation, staff training, and incident response.
Should you need support in adapting to the upcoming changes, we will be glad to assist you.