Regulation (EU) 2025/2365 of the European Parliament and of the Council of 12 November 2025 on preventing plastic pellet losses to reduce microplastic pollution

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Having regard to the opinion of the Committee of the Regions (2),

Acting in accordance with the ordinary legislative procedure (3),

Whereas:

(1) Microplastics are ubiquitous, persistent and transboundary. They are detrimental to the environment and potentially harmful to human health. The harm caused by microplastics to the environment and potentially to human health can be further increased when harmful chemical additives and other substances of concern added during production and conversion are present. Microplastics are easily carried through the air and by land surface waters and ocean currents, and their mobility is an aggravating factor. They are found in soil, including agricultural lands, lakes, rivers, estuaries, beaches, lagoons, seas, oceans and in remote, once pristine regions. Their presence in soil has effects on soil properties and triggers soil alterations which negatively impact the growth of some plants. Impacts of microplastics on the marine environment have been extensively documented. Once in the marine environment, microplastics are nearly impossible to collect, and are known to be ingested by a range of organisms and animals and cause harm to biodiversity and ecosystems. The persistence of plastic pellets in the aquatic environment can be measured over decades, and ingestion of plastic pellets by marine wildlife, in particular seabirds and sea turtles, can cause physical harm or death. Microplastics also contribute to climate change as an additional source both of greenhouse gas emissions and of pressure on ecosystems. Microplastics’ potential to act as a carrier for adsorbed toxicants or pathogenic microorganisms is an integral part of the problem. Humans are exposed to microplastics via the air and food consumption. The growing awareness of microplastics’ presence in the food chain can undermine consumer confidence and have economic consequences. There could be negative economic impacts on activities such as commercial fishing and agriculture as well as recreation and tourism in areas affected by the releases.

(2) In its opinion of 30 April 2019 entitled ‘Environmental and health risks of microplastic pollution’, the Commission’s Group of Chief Scientific Advisors considered that ‘there are significant grounds for concern and for precautionary measures to be taken’.

(3) Plastic pellets are any polymer-containing moulding materials, of primary or secondary origin, or both, regardless of whether they are derived from biomass or intended to biodegrade over time. Plastic pellets are primarily intended to be used in plastic product manufacturing operations via moulding, which encompasses moulding stricto sensu, extrusion, foaming, film forming, compression or injection. Alternatively, plastic pellets can be used in product manufacturing operations of non-plastic products, where such pellets are chemically encapsulated in a matrix, such as in lightweight concrete, or physically contained by the product, such as asphalt. Plastic pellets can contain chemical additives and can come in multiple shapes and forms, such as plastic nurdles, granules, flakes, resins, cylinders, beads, powders, micro-powder, microspheres and agglomerates. Their size typically ranges from 2 to 5 millimetres in diameter, though a small portion of plastic pellets are smaller or larger.

(4) Plastic pellet dust is the industrial residue from the handling, grinding or processing of plastic pellets that is not used in plastic product manufacturing operations and therefore does not fall within the scope of the plastic pellets definition in this Regulation. The generation of such dust is difficult to avoid but can be minimised. Such dust should be extracted by means of filters or catchment devices as a health and safety measure at work.

(5) Plastic pellet losses constitute the third largest source of microplastics unintentionally released to the environment in the Union and occur due to poor handling practices at all stages of the plastic pellet supply chain, which includes production including recycling, master batching, compounding, conversion, processing, distribution, transport, including by sea, and other logistic operations, storage, packaging, and the cleaning of plastic pellet containers and tanks. Hence, a supply-chain approach is essential for ensuring that all economic actors involved in the handling of plastic pellets are committed to loss prevention. Since 2015, the European plastic manufacturing industry has progressively adopted the international Operation Clean Sweep® (OCS) programme as a voluntary pledge. Under that programme, each enterprise producing or handling plastic pellets recognises the importance of having zero plastic pellet losses and commits to adopting best practices. While such practices are generally well understood by OCS signatories, they have not been comprehensively implemented. The uptake of the OCS programme by the plastic industry remains low.

(6) Concerns about the impacts of microplastic pollution on the environment and on human health have been raised in most parts of the world. Some Member States have adopted or proposed dedicated measures. However, a patchwork of national restrictions could potentially hamper the functioning of the internal market.

(7) In a bid to tackle plastic pollution, the Commission has in its communication of 16 January 2018 entitled ‘A European Strategy for Plastics in a Circular Economy’ acknowledged the risks posed by microplastics and called for innovative solutions targeting the different sources of microplastics to be taken. The Commission renewed that commitment in its communications of 11 December 2019 on the European Green Deal, of 11 March 2020 on the new Circular Economy Action Plan and of 12 May 2021 on the Zero Pollution Action Plan. The Zero Pollution Action Plan includes, among its 2030 targets, reducing the amount of microplastics released into the environment by 30 %.

(8) Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4) addresses microplastic pollution by imposing a restriction on the placing on the market of microplastics that are intentionally added to products, as considerable microplastic pollution arises from the use of synthetic polymer microparticles on their own or when intentionally added to products, and such pollution poses an unacceptable risk to the environment.

(9) OSPAR Recommendation 2021/06 on the reduction of plastic pellet loss into the marine environment (‘OSPAR Recommendation 2021/06’) was adopted in June 2021 by the contracting parties to the Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR Convention) with the aim of reducing marine litter by promoting the timely development and implementation of effective and consistent pellet loss prevention standards and certification schemes for the entire plastic supply chain. Measures for minimising the risk associated with the transport of plastic pellets by sea are under examination at the International Maritime Organization (IMO) which issued the non-binding circular MEPC.1/Circ 909 on recommendations for the carriage of plastic pellets by sea in freight containers (‘MEPC.1/Circ 909’). In this context, the Union and its Member States are to follow closely any future developments at the IMO, and play a leading role in ensuring a high level of environmental protection on this issue, by, for example, setting a high standard of protection.

(10) In the Union submission to the United Nations (UN) Environment Programme prior to the second session of the Intergovernmental Negotiating Committee on an international legally binding instrument on plastic pollution (INC-2), the Union and its Member States stressed the need for the future instrument to include measures to reduce unintentional releases of microplastics.

(11) While there are Union legal acts concerning the prevention of waste, pollution, marine litter and chemicals, there are no specific Union rules preventing plastic pellet losses as a source of microplastic pollution along the entire supply chain. Directive 2008/98/EC of the European Parliament and of the Council (5) lays down basic waste management principles and imposes general obligations on Member States to take measures to prevent waste generation. Those general obligations should be complemented by addressing specific aspects and requirements for the careful handling of plastic pellets in order to avoid them becoming waste.

(12) While the production of polymeric materials on an industrial scale falls under the scope of Directive 2010/75/EU of the European Parliament and of the Council (6), other activities like the conversion, transport or storage of plastic pellets, usually operated by small and medium-sized enterprises, are not covered by that Directive. Moreover, the Reference Document on Best Available Techniques in the Production of Polymers of August 2007, established pursuant to Council Directive 96/61/EC (7), does not address the specific issue of plastic pellet losses.

(13) Directive 2008/56/EC of the European Parliament and of the Council (8) addresses the monitoring and assessment of the impacts of micro-sized litter, including microplastics, in coastal and marine environments. An update of the first guidance on monitoring marine litter has been developed with a view to harmonising methodologies, including in respect of monitoring the presence and distribution of plastic pellets along the coastline. However, Directive 2008/56/EC does not include specific requirements concerning the prevention or reduction of plastic pellet losses at source.

(14) Commission Regulation (EU) 2023/2055 (9), amending Annex XVII to Regulation (EC) No 1907/2006, addresses losses of synthetic polymer microparticles, i.e. plastic pellets, for use at industrial sites as avoidable releases and introduces a reporting requirement for an estimated quantity of microplastics released to the environment on an annual basis. While lacking a methodology to estimate losses, that requirement is intended to increase information on plastic pellet losses and improve the quality of the information collected to assess the risks deriving from these microplastics in the future.

(15) To ensure that plastic pellets are handled safely and responsibly at all stages of the plastic pellet supply chain, so that losses to the environment are prevented and the ambition of zero plastic pellet losses is achieved, it is necessary to establish requirements on the handling of plastic pellets along the entire supply chain, namely in production, including output from recycling, master batching, compounding, conversion, processing, distribution, transport, storage, packaging, and tank and container cleaning at cleaning stations. This Regulation should apply to all entities handling plastic pellets along the entire supply chain, irrespective of their end use.

(16) Handling requirements should take into account internationally recommended good handling practices as well as existing requirements on the handling of plastic pellets established by the industry in the Union. In this regard, it is important that the Union and its Member States pursue efforts to make the recommendations in MEPC. 1/Circ 909 mandatory at international level. Furthermore, the Union can promote discussion at international level on the obligation for carriers to notify competent authorities when transporting plastic pellets in a country different from the one in which they are established.

(17) In light of the harmful nature of plastic pellets when lost to the environment and considering the general obligation on economic operators and carriers to avoid plastic pellet losses as set out in this Regulation, it is appropriate to set out specific information requirements in the form of a pictogram and a warning statement. In order to reduce the burden on economic operators and carriers, such requirements should be possible to implement by taking into consideration the already existing obligations under Annex XVII to Regulation (EC) No 1907/2006. Paragraphs 7 and 10 of entry 78 of that Annex set out information requirements for suppliers of synthetic polymer microparticles. For the purposes of this Regulation, suppliers of synthetic polymer microparticles should be understood as any manufacturer, importer, downstream user or distributor placing on the market plastic pellets which are synthetic polymer microparticles. They should provide relevant information on the label, the packaging, the package leaflet or on the safety data sheet. They should be able to provide that relevant information when providing the information as laid down in entry 78, paragraph 10, of Annex XVII to Regulation (EC) No 1907/2006. As the different possible means of providing that relevant information can vary in their effectiveness with regard to contributing to achieving the general obligation of avoiding losses, it is appropriate for the Commission to assess their relative effectiveness in the context of its review of this Regulation.

(18) When plastic pellets are released and dispersed into the marine environment, they can harm living resources and marine life and can interfere with other legitimate uses of the sea, such as fishing and aquaculture. As plastic pellets look like fish egg to birds, they comprise about 70 % of the plastic eaten by seabirds, despite the fact that only 0,05 % of plastic pieces from surface waters are pellets. Such small plastic pieces have been found in the stomachs of 63 of the world’s approximately 250 species of seabirds. Furthermore, by weight, plastic pellets are estimated to be the second largest direct source of microplastic marine pollution. It is estimated that billions of individual plastic pellets enter the ocean every year. This is due to both small- and large-scale losses and spills occurring on land and sea during all stages of the supply chain, especially while plastic pellets are in transit. Additionally, plastic pellets can wash up on beaches and coastlines and, as a result, negatively impact tourism and shore-based activities. Several incidents involving seagoing vessels resulted in several tonnes of plastic pellets being released in the marine environment with disastrous consequences for the environment and local communities. For example, the Toconao accident impacting the northern coast of Spain in 2023 caused the loss of six freight containers, amongst which one freight container was holding one thousand 25 kg sacks of plastic pellets. This resulted in millions of plastic pellets being washed up on the Galician Coast.

(19) To address this issue from the perspective of maritime transport, the IMO Marine Environment Protection Committee approved in 2024 MEPC.1/Circ.909. However, since those recommendations are not legally binding, the Union, in line with its obligation under the Treaties to preserve, protect and improve the quality of the environment, and to promote measures at international level to deal with worldwide environmental problems, should introduce binding rules through this Regulation to pioneer worldwide a higher level of environmental protection in this field. Shippers should ensure that plastic pellets are packed in good-quality packaging, that transport information is delivered, in a timely manner, to the operator, agent, and master of the seagoing vessel and that a special stowage request is duly completed. Operators, agents, and masters of seagoing vessels should, on the basis of the transport information received from the shippers, ensure that freight containers containing plastic pellets are properly stowed and secured so as to minimise hazards to the marine environment without impairing the safety of the seagoing vessel and persons on board. Specifically, freight containers containing plastic pellets should be stowed under deck wherever reasonably practicable or inboard in sheltered areas of exposed decks. These requirements complement the overall IMO and Union legal frameworks on the safety of maritime transport and the prevention of pollution from ships, in particular Directive 2002/59/EC of the European Parliament and of the Council (10), which established a system to prevent accidents and pollution at sea taking into account the international legal rules.

(20) Economic operators, EU carriers and non-EU carriers should implement the requirements on the handling of plastic pellets by following a priority order of action for preventing the release of plastic pellets in the environment as the top priority. Therefore, preventing spills of plastic pellets from primary containment during routine handling, thus reducing the risk of spills to the lowest possible level, should be the first step, including by avoiding any unnecessary handling, for instance by reducing the transfer points, and by using good-quality packaging, followed by containment of spilled plastic pellets to make sure they are not lost to the environment, and by cleaning up after a spill or loss event as the final step. Containment and clean-up interventions should be carried out in a manner that minimises environmental damage, in particular in sensitive habitats.

(21) While the aim of this Regulation is to prevent plastic pellet losses by all economic operators, EU carriers and non-EU carriers, the obligations for micro-, small and medium-sized enterprises should be adjusted to mitigate the burden on them. Member States, on the other hand, should not be prevented from introducing or maintaining more stringent protective measures. Such measures, including targeting economic operators handling more than 5 tonnes of plastic pellets, are to be compatible with the Treaties.

(22) In order to ensure the traceability of plastic pellets handled and transported in each Member State and to allow competent authorities to perform compliance checks efficiently, it is necessary for installations handling plastic pellets and carriers transporting them to be registered.

(23) In order to prevent plastic pellet losses, economic operators should establish, implement, and keep up to date at all times a risk management plan, including a risk assessment, identifying potential for spills and losses and documenting in particular existing specific equipment and procedures in place to prevent, contain and clean up plastic pellet losses. The risk management plan should also consider the costs and benefits of additional equipment and procedures to address the identified risks taking into consideration the nature and size of the installation as well as the scale of its operations. Where additives have been added to plastic pellets, economic operators should consider the hazard properties of the plastic pellets concerned, and where such additives are likely to increase the harm to human health or the environment in case of plastic pellet losses, economic operators should consider including this information in the risk management plan.