New EU rules on plastic pellet losses will apply across the plastics supply chain from 17 December 2027.

The Regulation is not limited to companies that manufacture polymer materials. It also covers recyclers, compounders, converters, storage operators, distributors, container-cleaning facilities and transport companies.

An operator handling at least five tonnes of plastic pellets during the previous calendar year can fall within scope. Carriers transporting pellets within the EU are covered separately and are not subject to the same five-tonne threshold.

Affected companies will need to prevent pellet spills, contain them before they escape into the environment and clean up any losses. For installations, this will require a site-specific risk management plan, technical measures, staff training, annual records and notification to the competent national authority.

The scale of the additional conformity assessment depends on both the quantity handled and the size of the enterprise.

What changes on 17 December 2027?

Regulation (EU) 2025/2365 establishes binding rules intended to prevent plastic pellet losses throughout the supply chain.

It entered into force on 16 December 2025 and will generally apply from 17 December 2027. The provisions applying to certain maritime actors will follow one year later, on 17 December 2028.

The Regulation aims to address the accidental release of pellets during activities such as:

• production and recycling;
• masterbatching and compounding;
• processing and conversion;
• packaging and storage;
• loading and unloading;
• distribution and transport;
• cleaning of pellet containers and tanks.

The legal objective is to move progressively towards zero plastic pellet losses.

The Regulation does not create a general licence for handling pellets. It creates operational, documentary and conformity obligations for the companies and locations already involved in the supply chain.

What is a plastic pellet?

The legal definition is broader than the small cylindrical granules commonly associated with plastics manufacturing.

A plastic pellet is a mass of polymer-containing material, irrespective of its shape, form or size, produced for moulding in plastic-product manufacturing operations.

The definition can therefore cover different forms of pre-production plastic material where they are produced for use in moulding operations. The actual commercial name or final use is not decisive.

Plastic pellet dust that arises as an industrial residue and is not used in plastic-product manufacturing is treated differently and does not fall within the definition of a pellet under this Regulation. Other occupational health, emissions or waste rules may still apply to that dust.

Businesses should assess the physical material and its intended manufacturing function rather than rely only on descriptions such as granulate, resin, compound or recycled feedstock.

Which installation operators are covered?

The Regulation applies to economic operators that handled at least five tonnes of plastic pellets in the EU during the previous calendar year.

An economic operator is the person that operates or controls the relevant installation, or that has decisive economic power over its technical functioning where national law recognises such an arrangement.

Potentially covered businesses include:

• virgin polymer manufacturers;
• plastics recyclers producing recycled pellets;
• masterbatch and compound manufacturers;
• moulders and plastics converters;
• packaging manufacturers using polymer feedstock;
• distributors and stockists;
• warehouses and logistics terminals;
• manufacturers using pellets to produce components or finished goods;
• operators cleaning pellet tanks and containers.

The Regulation applies irrespective of the final product manufactured from the pellets. It is not limited to packaging production or to products that will later fall under EPR legislation.

A manufacturer producing household goods, automotive components, medical products or construction materials can therefore be covered in the same way as a packaging producer if it handles the relevant pellet quantities.

How does the five-tonne threshold work?

The five-tonne threshold determines whether the general installation-related scope applies.

The relevant quantity is the amount of plastic pellets handled during the previous calendar year. Handling is broader than purchasing or owning the material and may include receiving, storing, transferring, processing, packing or otherwise managing pellets at an installation.

A company should not assess the threshold based only on its year-end stock or the quantity physically lost.

The amount handled can be much higher than the inventory held at any one time because the same storage or production location may receive and process repeated deliveries throughout the year.

The Regulation refers to economic operators handling pellets in the EU. Companies with several installations should determine both the total legal scope and the site-specific obligations carefully. Each installation must be notified and requires its own risk management plan.

Operators below the five-tonne threshold are outside the principal EU scope, although Member States remain able to introduce or retain stricter protective measures under the conditions of EU law.

Container and tank cleaning is covered separately

Installations used to clean plastic pellet containers and tanks are expressly covered.

The ordinary five-tonne threshold does not provide the same exclusion for these cleaning operations.

Cleaning facilities can present a particular loss risk because pellets and pellet residues may remain inside containers, silo tanks, hoses or associated equipment. If rinse water, air-cleaning systems or residues are not properly controlled, pellets can enter drainage systems or the environment.

Covered cleaning facilities will need to consider appropriate filtration, catchment and waste-management arrangements within their risk management plans.

Companies outsourcing cleaning should also address the activity in supplier controls and contractual procedures, particularly where the operator’s own pellets remain in a container after unloading.

Ownership of the pellets is not decisive

The Regulation focuses on control of the installation and the activity involving the pellets.

A warehouse, terminal or contract manufacturer can therefore be covered even if the pellets belong to a customer throughout the process.

The same applies to transport companies. A carrier does not need to own, buy or sell the material to have obligations.

This distinction is relevant to businesses that consider themselves service providers rather than plastics companies. The legal question is whether they handle or transport pellets as part of their economic activity, not whether they are the commercial owner of the material.

Commercial contracts can allocate costs, information duties and liability between the parties. They cannot remove the direct regulatory responsibilities imposed on the installation operator or carrier.

Each installation needs a risk management plan

An operator within scope must establish a risk management plan for each installation.

The plan must reflect the actual site, operations and risk points. A generic group policy can provide a common framework, but it is unlikely to be sufficient on its own where it does not address the physical conditions at the individual location.

The plan must include information such as:

• a plan of the site;
• the annual quantity of pellets handled;
• locations where spills may occur;
• points from which pellets could escape into the environment;
• surrounding areas that could be affected;
• high- and low-risk handling operations;
• estimated spill and loss quantities;
• activities involving suppliers, contractors and off-site storage;
• the member of staff responsible for recording and investigating incidents;
• the equipment and procedures used to prevent, contain and clean up pellets.

The operator must implement the measures described in the plan and keep it updated in light of operational experience, identified weaknesses and incidents.

The risk management plan and a self-declaration of conformity must be notified to the competent authority in the Member State where the installation is located.

A group-wide policy does not replace site analysis

Many companies already maintain environmental management procedures or participate voluntarily in initiatives such as Operation Clean Sweep.

These systems can provide useful foundations. The Regulation nevertheless requires the risk management measures to correspond to the individual installation.

Two sites operated by the same company may have different risks because of differences in:

• drainage and surface design;
• indoor and outdoor handling;
• bulk or packaged delivery;
• loading systems;
• storage methods;
• proximity to waterways;
• use of contractors;
• cleaning procedures;
• traffic routes;
• processing technology.

A central compliance manual should therefore be supplemented by site-specific plans, inspections and responsibilities.

Voluntary certification does not automatically replace the statutory process unless it fits one of the recognised permit or environmental-management routes under the Regulation.

Prevention takes priority over clean-up

The Regulation establishes a clear hierarchy.

Operators and carriers must first prevent spills. If a spill occurs, they must contain it before it becomes a loss to the environment. Any spilled or lost pellets must then be cleaned up.

This means that a supply of brooms and collection bags is not sufficient where foreseeable losses could have been prevented through better infrastructure or procedures.

Depending on the installation, relevant controls can include:

• sufficiently strong and sift-proof packaging;
• protection against overfilling;
• sealed connections and transfer systems;
• spill trays beneath transfer points;
• pellet-retaining drain covers;
• barriers around high-risk areas;
• suitable industrial vacuum systems;
• filters for air and rinse water;
• protected loading and unloading zones;
• closed containers for recovered pellets.

The measures must be proportionate to the nature and size of the site and the scale of its activities.

The plan should also address what happens to recovered pellets. Material that remains suitable for its intended use may be returned to the process where this can be done safely. Contaminated material that is discarded must be managed under the applicable waste rules.

Staff, suppliers and contractors form part of the system

Operational controls depend on the people handling the pellets.

Economic operators and carriers must train staff according to their specific responsibilities. Employees must understand the relevant equipment and procedures and be able to respond to spills and losses.

For higher-volume installations, the risk management plan must include a structured awareness and training programme. It must also address how drivers, suppliers and subcontractors are informed about applicable procedures.

This makes contractor management a direct part of compliance.

A well-designed loading area will not prevent losses where third-party drivers open valves incorrectly, damaged bags are accepted without controls or contractors sweep pellets into ordinary drainage systems.

Companies should therefore review site-entry instructions, loading rules, contractor induction, incident escalation and responsibility for cleaning shared areas.

Annual quantity and loss records are required

Operators and carriers must retain annual records of:

• the total amount of plastic pellets handled; and
• the estimated quantity of pellet losses.

The records must generally be retained for five years and made available to competent authorities on request.

Estimating losses can be difficult because many releases are small, repeated and dispersed rather than the result of one major accident.

The Commission must request the development of a harmonised standard for estimating loss quantities by 17 December 2026. Once the relevant standard has been published in the Official Journal, or an alternative EU implementing methodology becomes applicable, companies will need to use the standardised approach after the specified transition period.

Until then, operators should establish a consistent and documented internal method. Relevant sources may include spill logs, recovered quantities, drain inspections, waste data, cleaning records and investigation results.

A record showing zero losses should be supported by the monitoring system used to reach that conclusion.

What does the 1,500-tonne threshold change?

The 1,500-tonne threshold does not determine whether the Regulation applies.

It determines whether additional conformity, training and internal assessment requirements become relevant.

An operator handling 200 tonnes can still require:

• authority notification;
• a risk management plan;
• a self-declaration;
• preventive and containment measures;
• staff training;
• annual records;
• incident procedures.

Installations handling at least 1,500 tonnes are subject to a more demanding conformity structure, depending on the size of the enterprise.

Medium-sized and large enterprises above the threshold must also perform an annual internal assessment for each relevant installation. This assessment should examine whether the plan and its measures remain effective, including the causes of losses, equipment performance, procedures and corrective actions.

The records of these internal assessments must be retained for five years.

When is third-party certification required?

Certification obligations depend on both annual pellet volume and enterprise size.

Large enterprises

Large enterprises operating installations that handled at least 1,500 tonnes during the previous calendar year must obtain a certificate by 17 December 2027.

The certificate must then be renewed every three years.

Medium-sized enterprises

Medium-sized enterprises above the same threshold must obtain their first certificate by 17 December 2028.

Certification must then be renewed every four years.

Small enterprises

Small enterprises above the threshold must obtain a certificate by 17 December 2030.

The initial certificate is valid for five years. After it expires, the company can follow the five-year risk-plan and self-declaration route unless it chooses to renew the certificate.

Microenterprises and lower-volume installations

Microenterprises, together with small, medium-sized and large companies operating below 1,500 tonnes, generally follow the self-declaration route.

They must submit updated risk management plans and renewed self-declarations every five years.

Certification is performed at installation level. A certificate covering one plant does not automatically demonstrate conformity at another location.

Existing permits and environmental systems may affect the process

The Regulation allows Member States to recognise certain alternative compliance structures.

An installation operating under a suitable environmental permit may be exempt from parts of the notification and certification process where the permit has been issued or reviewed on the basis of the pellet-loss requirements and the facility is subject to equivalent inspections.

EMAS-registered companies can also receive exemptions from specified renewal and certification obligations where an environmental verifier has confirmed that the Regulation’s requirements are incorporated and implemented.

Member States may additionally recognise qualifying environmental management systems that have undergone an appropriate accredited conformity assessment.

These routes do not provide a general exemption from preventing pellet losses. They can change how compliance is demonstrated and verified.

Companies should wait for the relevant national implementation details before assuming that an existing ISO or environmental permit automatically replaces certification.

Carriers have direct obligations

Road, rail and inland-waterway carriers transporting pellets within the EU fall directly within scope.

The five-tonne installation threshold does not apply to carriers in the same way. A transport company can therefore be covered even where it does not operate a pellet warehouse or own the goods.

Before transporting pellets within the EU for the first time, an EU carrier must notify the competent authority in the Member State where it is established. The notification must describe its involvement in pellet transport and the means of transport used.

Carriers must implement the operational measures in Annex III of the Regulation.

These include checking the integrity of packaging, preventing leakage during transport, cleaning loading compartments and containers, securing loading and unloading points and removing pellets from the exterior of vehicles and freight containers before departure.

Vehicles must carry basic response equipment, including portable lighting, cleaning tools, materials for temporary repairs and closed containers or reinforced bags for collected pellets.

Carriers must also train relevant staff, keep annual handling and loss records and take immediate corrective measures where controls fail.

Loading and unloading responsibilities need to be clear

Pellet transfers frequently involve both the installation operator and the carrier.

The operator may control the loading system and the site drainage, while the driver controls the vehicle, valves and condition of the load. A spill can therefore result from failures by more than one party.

The Regulation gives both categories their own duties.

Contracts and site procedures should clarify responsibility for:

• inspecting bags and containers;
• opening and closing transfer systems;
• cleaning loading areas;
• checking vehicle exteriors;
• retaining spilled material;
• reporting incidents;
• providing emergency equipment;
• recording estimated losses.

A standard allocation stating that the carrier bears all transport risk may not be sufficient where the loss originated from equipment controlled by the installation.

Non-EU carriers require an EU representative

A carrier established outside the European Union must appoint an authorised representative in writing in at least one Member State where it transports plastic pellets.

The appointment must take place before the carrier’s first relevant transport within the EU.

The representative must be established in the Union and accept the mandate in writing. The non-EU carrier must inform both the competent national authority and the European Commission of the appointment and the scope of the mandate.

The representative performs specified regulatory tasks, including elements of notification, record evidence and communication concerning non-compliance.

Appointment of a representative does not remove the responsibility or liability of the non-EU carrier.

The requirement can affect carriers based in countries such as the United Kingdom, Switzerland, Türkiye or other third countries where they transport pellets by road, rail or inland waterway within the EU.

The representative is not the same as an EPR authorised representative appointed by a producer under packaging, battery or WEEE legislation. The legal mandate and responsible activities are specific to pellet transport.

Maritime transport follows a separate timetable

The Regulation also introduces requirements for plastic pellets transported by sea in freight containers.

The relevant provisions for shippers, vessel operators, agents and masters will generally apply from 17 December 2028.

Shippers will need to ensure that pellets are packed in sufficiently strong packaging and that the required cargo information identifies the freight containers containing pellets.

The transport information must be provided before loading and accompanied by a special stowage request.

Operators and masters must generally ensure that the containers are stowed under deck where reasonably practicable or in protected inboard areas of exposed decks, while maintaining vessel and crew safety.

These obligations are separate from those applying to road, rail and inland-waterway carriers.

Companies using multimodal routes may therefore need to address several regulated roles within one shipment.

What happens after a significant incident?

Operators and carriers must act immediately when pellets are lost.

Where an incident or accident causes a loss affecting human health or the environment, they must:

• contact emergency services where relevant;
• take immediate measures to minimise the consequences;
• investigate the quantity and cause of the loss;
• implement measures to prevent recurrence;
• provide the required information to the competent authority no later than 30 days after the event.

The report must include the estimated quantity lost, the cause and the corrective action taken.

A significant spill can also trigger additional authority measures, inspections or training requirements.

Where non-compliance creates an immediate danger to human health or a significant environmental threat, the authority can suspend all or part of an installation’s operation. It can also immobilise or prevent the movement of road vehicles, rail wagons or inland-waterway vessels until compliance has been restored.

National authorities will inspect and publish information

Each Member State must designate one or more competent authorities to enforce the Regulation.

Authorities will be able to inspect installations, request documents and data and conduct unannounced environmental inspections using a risk-based approach.

Certain compliance information must also be made publicly accessible, subject to protections for confidential business and safety-sensitive information.

This may include:

• notified installations and transport activities;
• authorised representatives;
• risk management plans;
• self-declarations;
• certificates;
• qualifying permits;
• recognised environmental-management assessments.

The Regulation is therefore not designed as a purely internal management standard. Core compliance information will be visible to authorities and, in part, to the public.

Penalties can be material

Member States must establish effective, proportionate and dissuasive penalties.

For the most serious infringements committed by a legal person, the maximum level of administrative financial penalties must be at least 3% of the company’s annual EU turnover in the preceding financial year.

National law will determine the precise penalty system, enforcement procedure and treatment of less serious infringements.

The financial exposure is accompanied by operational risks, including suspension of facilities or immobilisation of transport equipment.

Compliance should therefore not be treated solely as a certification exercise. The practical effectiveness of spill prevention and response measures will remain central.

How does the Regulation relate to REACH?

The pellet-loss Regulation and the REACH restriction on synthetic polymer microparticles address related but different risks.

REACH regulates, among other matters, synthetic polymer microparticles intentionally placed on the market and includes separate information and reporting requirements.

Regulation (EU) 2025/2365 addresses accidental spills and losses during handling and transport.

A company can be subject to both frameworks.

The pellet-loss Regulation also requires specified environmental warning information to be provided on the label, packaging, package leaflet or safety data sheet where the pellets are synthetic polymer microparticles covered by the relevant REACH provision.

The required warning is: “Harmful to the environment – avoid losses.”

The information must be clearly visible, legible and indelible and provided in the relevant official languages, unless a Member State provides otherwise.

Pellet-loss compliance is not EPR

The Regulation is an operational pollution-prevention regime.

It does not create producer registration, take-back or end-of-life financing obligations of the type normally associated with Extended Producer Responsibility.

A plastics converter can therefore have separate obligations under:

• the pellet-loss Regulation for its manufacturing site;
• REACH for the pellet material;
• packaging EPR for packaging placed on national markets;
• waste law for contaminated or discarded pellets;
• industrial emissions or water legislation for the facility.

Compliance with one framework does not satisfy the others.

The responsible legal entity can also differ. The company operating the production site may be responsible for the risk management plan, while another group company is the packaging producer or importer under an EPR system.

Why companies should prepare before 2027

The Regulation will generally become applicable in December 2027, but several elements require substantial preparation.

Companies need to identify covered sites, establish annual pellet quantities, inspect drainage and loading areas, procure suitable equipment, define responsibilities and create site-specific plans.

Large enterprises above the 1,500-tonne threshold must already hold their certificates by the application date.

Businesses using non-EU carriers need to ensure that the required authorised representative is in place before the relevant transport begins.

Contracts with carriers, warehouses, cleaning facilities and other service providers may also need to be revised to reflect notification, training, evidence and incident responsibilities.

The Commission is expected to publish training and awareness material and initiate the development of the standardised loss-estimation methodology by 17 December 2026. These developments should be incorporated into the final compliance system as they become available.

The rules cover the supply chain, not only pellet production

Regulation (EU) 2025/2365 establishes a broad supply-chain approach.

A business does not need to manufacture plastic resin or own the pellets to be covered. Handling at an installation, cleaning pellet containers or transporting pellets within the EU can be sufficient.

The five-tonne threshold determines the main installation scope. The 1,500-tonne threshold primarily determines the additional conformity route rather than whether compliance is required at all.

For affected companies, the practical task is to connect legal scope with individual sites, transport operations and contractors.

Viron Compliance supports international businesses in assessing environmental compliance responsibilities across complex EU supply chains. This includes identifying responsible legal entities, distinguishing operational requirements from EPR obligations and coordinating cross-border authorised-representation and reporting structures.