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

(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.

(24)

To enable competent authorities to verify compliance with the risk management plan’s requirements, economic operators should provide the competent authority with the risk management plan they have established, together with a self-declaration of conformity or a certificate, as applicable.

(25)

Economic operators should be able to determine through a risk-based approach the specific equipment to install or the procedures to implement. Nevertheless, competent authorities, while verifying compliance, should be able to require economic operators to amend the risk management plan including by taking, in a given timeframe, any of the actions listed in this Regulation to ensure adequate implementation of the requirements of this Regulation.

(26)

In order to evaluate the adequacy of the risk management plan designed for each installation, economic operators should keep a record of estimates of the quantity of the plastic pellets lost per year, together with the total quantities handled. To reduce the burden on economic operators, the competent authorities and certifiers should be able to use information on estimates of quantities released in the framework of the reporting requirement under Annex XVII to Regulation (EC) No 1907/2006.

(27)

Due to the characteristics of their activity, carriers should not be mandated to establish and implement a risk management plan. Instead, they should be required to undertake tangible measures aimed at preventing, containing, and addressing spills and losses. These measures should be subject to verification by competent authorities, primarily during the transportation process. Some of these measures should be implemented during loading and unloading operations, which are hotspots for spills and losses. These operations are typically carried out under the responsibility of both the economic operators and the carriers, while the carriers are the only responsible party for the transportation journey.

(28)

Non-EU carriers should designate an authorised representative, which should act on behalf of the non-EU carrier and should be able to be addressed by any competent authority. The authorised representative should be explicitly designated by a written mandate of the non-EU carrier with regard to specific obligations under this Regulation. The designation of such representative does not affect the responsibility or liability of the non-EU carrier under this Regulation. The authorised representative should be subject to enforcement proceedings, as far as its mandate is concerned, in the event of non-compliance by the non-EU carrier.

(29)

The successful implementation of the actions required to prevent, contain and clean up plastic pellet losses requires the full cooperation and commitment of economic operators’, EU carriers’ and non-EU carriers’ employees. Economic operators, EU carriers and non-EU carriers should be required to train their staff according to their employees’ specific roles and responsibilities in order to ensure they are aware of and are able to install, use and maintain the equipment and execute the procedures necessary to ensure compliance with the requirements laid down in this Regulation, including how to monitor and report plastic pellet losses. Where appropriate, economic operators, EU carriers and non-EU carriers should adopt corrective measures including, where necessary, the improvement of equipment and procedures in place. They should also be required to monitor and keep records of annually estimated quantities of losses to help fill persisting knowledge gaps.

(30)

Medium-sized and large enterprises typically have a more complex structure due to their size. In cases where they operate installations where plastic pellets are handled in quantities equal to or above a threshold of 1 500 tonnes per year, they should be required to implement, for each installation, extra actions such as carrying out an annual internal assessment and adopting a training programme addressing specific training needs and arrangements for the training programme. The internal assessment could cover subjects, such as the estimated quantities and causes of losses, the preventive, containment and clean-up equipment or procedures implemented to avoid future losses, and their effectiveness, discussions with the personnel, inspections of equipment and procedures in place and revision of any relevant documentation.

(31)

Microenterprises and small, medium-sized and large enterprises operating installations where plastic pellets in quantities below a threshold of 1 500 tonnes per year have been handled should be required to be subject to a self-declaration of conformity. They should also be given sufficient time to demonstrate their compliance.

(32)

Enterprises that operate installations where plastic pellets are handled in quantities equal to or above a threshold of 1 500 tonnes per year can be responsible for higher risks of plastic pellet losses. Medium-sized and large enterprises that operate installations where plastic pellets are handled in quantities equal to or above a threshold of 1 500 tonnes per year should demonstrate compliance with the requirements laid down in this Regulation by obtaining, and renewing, a certificate issued by certifiers. In line with a supply-chain approach, while limiting the administrative burden, small enterprises that operate installations where plastic pellets are handled in quantities equal to or above a threshold of 1 500 tonnes per year should demonstrate compliance by obtaining a certificate issued by certifiers with a validity of five years. The certification process is also intended to help small enterprises that operate installations where plastic pellets are handled in quantities equal to or above a threshold of 1 500 tonnes per year to identify the actions needed to be compliant with the requirements laid down in this Regulation. After the expiry period of the certificate, such small enterprises should demonstrate compliance by notifying an update of their risk management plan as well as a self-declaration of conformity to the competent authority every five years from the last notification, unless such small enterprises choose, in a timely manner, to continue to demonstrate compliance by renewing a certificate issued by certifiers.

(33)

Certifiers, in particular consultancy services, should not engage in any activity that could conflict with their independence of judgement or integrity in relation to the certification activities for which they are accredited. Certifiers can either be an accredited conformity assessment body, or an environmental verifier licensed to carry out verification and validation in accordance with Regulation (EC) No 1221/2009 of the European Parliament and of the Council (11). The certificate should correspond to a unique format in order to ensure homogeneous information.

(34)

To enable competent authorities to verify compliance more efficiently under this Regulation, certifiers should notify competent authorities about the outcome of their assessments. Certificates should not prejudge the assessment of compliance by competent authorities.

(35)

In order to ensure transparency, competent authorities should make certain information publicly available. This includes the notification on installations operated, involvement in the transport of plastic pellets in the Union including significant changes to what was previously notified, the establishment of an authorised representative, risk management plans, self-declarations of conformity, certificates and permits, which should be accessible on an easy-to-find, free and unrestricted website. However, to ensure safety and confidentiality, competent authorities should be able to withhold specific details if their release would jeopardise the safety of the installations concerned, the safety of the local population, or other public interests. The Commission should also publish lists of national websites and authorised representatives of non-EU carriers to ensure wide access to this information while safeguarding business confidentiality.

(36)

In order to be registered with community eco-management and audit scheme (EMAS), economic operators are required to comply with environmental legislation, including this Regulation. Consequently, economic operators which are registered with EMAS should be considered compliant with the requirements laid down in this Regulation provided that an environmental verifier has verified that requirements laid down in this Regulation have been included in their environmental management system and implemented. Such economic operators should therefore be exempted from the obligations of certification and notification to competent authorities when renewing self-declarations and updating the risk management plan. In addition to the exemption provided for operators registered with EMAS and for the purpose of decreasing the burden on other high-integrity systems, it should be possible for economic operators that prepare and implement other environmental management systems for each installation to be exempted from compliance in this Regulation upon meeting certain criteria as laid down in this Regulation.

(37)

Competent authorities should verify economic operators’, EU carriers’ and non-EU carriers’ compliance with the obligations laid down in this Regulation using, if appropriate, the findings provided as part of the certification process or self-declarations. Such verification should be based, as appropriate, on environmental inspections or other verification measures, and should follow a risk-based approach. Inspections should, where possible, be coordinated with those required under other Union legal acts. Competent authorities should provide the Commission with information on the implementation of this Regulation.

(38)

Member States should be able to ensure compliance with this Regulation through permits based on a system of regular inspections of installations to examine the full range of relevant environmental effects, including spills and losses. For installations located in a Member State that decides to enforce and verify compliance through such a system of permits and regular inspections, economic operators should be exempted from obtaining a certificate or submitting a self-declaration of conformity for those installations for which they hold a permit that imposes the conditions necessary for compliance with this Regulation. For installations for which such exemption applies, economic operators should notify the relevant competent authority about the risk management plan and its regular updates. When compliance is ensured through permits, Member States should take the steps necessary to revise the conditions of existing permits and issue new permits such that compliance with this Regulation is ensured in due time.

(39)

Directive 2008/98/EC provides that Member States are to require recyclers to obtain a permit, the conditions of which ensure that the production of plastic pellets is conducted without endangering human health or harming the environment, particularly avoiding risks to water, air, soil, plants, or animals.

(40)

In order to minimise the effects of any loss, economic operators, EU carriers and non-EU carriers should take the corrective measures necessary to restore compliance with this Regulation. The corrective measures required should be proportionate to the infringement detected and its expected harmful effects on the environment. Where competent authorities detect an infringement of this Regulation, they should notify the economic operator, the EU carrier or the non-EU carrier thereof and require that corrective measures be taken to restore compliance.

(41)

Competent authorities should have a minimum set of inspection and enforcement powers in order to ensure compliance with this Regulation, to cooperate with each other more quickly and more efficiently, and to deter economic operators, EU carriers and non-EU carriers, authorised representatives, shippers, and operators, agents and masters of seagoing vessels transporting plastic pellets, where relevant, from infringing this Regulation. Those powers should be sufficient to tackle the enforcement challenges and to prevent non-compliant economic operators from exploiting gaps in the enforcement system by relocating to Member States whose competent authorities are not equipped to tackle unlawful practices. Competent authorities should be able to use all facts and circumstances of the case as evidence for the purposes of their inspection.

(42)

Micro-, small and medium-sized enterprises account for an important share of the plastic pellet supply chain. When complying with the relevant obligations laid down in this Regulation, they could face specific implementation challenges and proportionally higher costs. The Commission should raise awareness among economic operators and carriers regarding the necessity of preventing plastic pellet losses. Additionally, in consultation with all relevant stakeholders, the Commission should develop training materials, which could take various forms, including guides and courses, to assist economic operators and carriers in fulfilling their obligations, particularly with respect to the requirements of the risk assessment. OSPAR Recommendation 2021/06 should be considered in that regard. Member States should provide access to information and assistance, especially for micro- and small enterprises, regarding compliance with the obligations and the risk assessment requirements. The assistance provided by Member States could include technical support and specialised training for all personnel handling plastic pellets. It could also include financial support, including for the purposes of certification for small enterprises, as well as access to finance. Member States’ actions should be taken in respect of applicable State aid rules.

(43)

In order to achieve a common basis for estimating plastic pellet losses, it is necessary to have a standardised methodology set in a harmonised standard that is adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (12). Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements set out in that Regulation.

(44)

In order to ensure that the objectives of this Regulation are achieved, and its requirements are enforced effectively, Member States should designate their own competent authorities responsible for the application and enforcement of this Regulation. In cases where there is more than one designated competent authority in their territory, Member States should ensure close cooperation between all designated competent authorities in order to ensure that the duties of those authorities are fulfilled effectively.

(45)

In order to ensure compliance, competent authorities should also take the necessary steps, including inspections and hearings based on relevant information, such as substantiated complaints submitted by third parties. Third parties submitting a complaint should be able to demonstrate a sufficient interest or maintain the impairment of a right.

(46)

Member States should ensure that any measures taken by their competent authorities under this Regulation are subject to effective judicial remedies in accordance with Article 47 of the Charter of Fundamental Rights of the European Union (the ‘Charter’). According to settled case law of the Court of Justice of the European Union, it is for the courts of the Member States to ensure judicial protection of a person’s rights under Union law. Furthermore, Article 19(1) of the Treaty of the European Union (TEU) requires Member States to provide remedies that are sufficient to ensure effective legal protection in the fields covered by Union law. In this respect, Member States should ensure that the public, including natural or legal persons covered by this Regulation, has access to justice in line with the obligations that Member States have agreed to as parties to the UN Economic Commission for Europe (UNECE) Convention on access to information, public participation in decision-making and access to justice in environmental Matters of 25 June 1998 (13) (‘Aarhus Convention’).

(47)

Member States should lay down rules on penalties applicable to infringements of national provisions adopted pursuant to this Regulation and should ensure that they are implemented. Member States can lay down rules for administrative as well as criminal penalties. In any case, the imposition of criminal and administrative penalties should not lead to a breach of the right not to be tried or punished twice in criminal proceedings for the same criminal offence (ne bis in idem principle), as interpreted by the Court of Justice of the European Union. For the most serious infringements committed by a legal person, such as those of a high level of gravity due to their nature, extent and repetition, or those that pose a significant risk to human health or the environment, Member States should ensure that their national system of penalties includes administrative financial penalties whose maximum amount should be at least 3 % of the annual Union turnover of that legal person in the financial year preceding the year in which the administrative financial penalty is imposed. For such infringements, without prejudice to the obligations of Member States under Directive 2008/99/EC of the European Parliament and of the Council (14), Member States should be allowed to also or alternatively impose criminal penalties, provided that they are effective, proportionate and dissuasive.

(48)

Where appropriate, Member States should support the financing of projects aimed at: cleaning up areas polluted by plastic pellets using environmentally sustainable practices; collecting, processing and providing information on incidents and accidents that cause losses and related responses; improving knowledge of the impacts of plastic pellet losses on human health and the environment; and promoting awareness-raising programmes, especially for the most affected areas such as industrial zones and ports.

(49)

Where damage to human health has occurred as a result of an infringement of this Regulation, Member States should ensure that the individuals affected are able to claim and obtain compensation for that damage from the relevant natural or legal persons. Such rules on compensation contribute to the pursuit of the objectives of preserving, protecting and improving the quality of the environment and the protection of human health as laid down in Article 191 of the Treaty on the Functioning of the European Union (TFEU). They also underpin the right to life, integrity of the person and health care laid down in Articles 2, 3 and 35 of the Charter and the right to an effective remedy as laid down in Article 47 of the Charter. Moreover, Directive 2004/35/EC of the European Parliament and of the Council (15) does not give private parties a right of compensation as a consequence of environmental damage or of an imminent threat of such damage.

(50)

It is therefore appropriate for this Regulation to address the right to compensation for damage suffered by individuals and to ensure that individuals can defend their rights against damage to health caused by infringements of this Regulation and thereby ensure a more efficient enforcement of this Regulation. Procedures relating to claims for compensation should be designed and applied in such a way that they do not render the exercise of the right to compensation for damage impossible or excessively difficult.

(51)

The impact of this Regulation on the procedural autonomy of the Member States should be limited to what is necessary to ensure the objective of protecting human health through a safe environment pursued by it and should not affect other national procedural rules establishing the right to seek compensation for infringements of this Regulation. Such national rules should, however, not hamper the effective functioning of the mechanism for seeking compensation required by this Regulation.

(52)

To ensure that individuals can defend their rights against damage to health caused by infringements of this Regulation and thereby ensure its more efficient enforcement, non-governmental organisations promoting the protection of human health or the environment or those promoting the protection of consumers and meeting any requirements under national law, as members of the public concerned, should be empowered to engage in proceedings, as the Member States so determine, either on behalf or in support of any victim, without prejudice to national rules of procedure concerning representation and defence before the courts. Member States usually enjoy procedural autonomy to ensure an effective remedy against violations of Union law, subject to the respect of the principles of equivalence and effectiveness. However, experience shows that, while there is overwhelming epidemiologic evidence on the negative health impacts of pollution on the population, it is not straightforward to make a direct link between a specific loss of plastic pellets and specific impacts on human health or the environment, and such impacts are generally also not immediate.

(53)

In order to take into account technical progress and scientific developments, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amendments to the Annexes to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (16). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(54)

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of reporting of information on the implementation of this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (17).

(55)

In order to provide economic operators, EU carriers, non-EU carriers, shippers, and operators, agents and masters of seagoing vessels with sufficient time to adapt to the requirements laid down in this Regulation, its application should be deferred.

(56)

Since the objective of this Regulation, namely preventing plastic pellet losses, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.