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 ANNEX I RISK MANAGEMENT PLAN FOR INSTALLATIONS

Article 1

Subject matter and scope

1. This Regulation lays down obligations for the handling of plastic pellets to prevent losses at all stages of the plastic pellet supply chain, with the aim of achieving zero plastic pellet losses.

1. This Regulation applies to the following natural and legal persons:

(a)

economic operators handling plastic pellets in the Union in quantities equal to or above a threshold of 5 tonnes in the previous calendar year;

(b)

economic operators operating installations in the Union for the cleaning of plastic pellet containers and tanks;

(c)

EU carriers and non-EU carriers transporting plastic pellets in the Union; and

(d)

shippers and operators, agents and masters of seagoing vessels transporting plastic pellets in freight containers leaving or calling at a port of a Member State.

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

(1)

‘plastic pellets’ means 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;

(2)

‘spill’ means a one-off or prolonged escape of plastic pellets within an installation’s boundaries or within road vehicles, rail wagons, or inland waterway vessels transporting plastic pellets from primary containment;

(3)

‘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 road vehicles, rail wagons, inland waterway vessels or seagoing vessels leaving or calling at a port of a Member State, transporting plastic pellets;

(4)

‘installation’ means any premises, structure, location, site or place within which one or more economic activities involving the handling of plastic pellets are carried out;

(5)

‘economic operator’ means any natural or legal person who operates or controls in whole or in part the installation, or, where this is provided for in national law, to whom decisive economic power over the technical functioning of the installation has been delegated;

(6)

‘EU carrier’ means any natural or legal person established in a Member State, engaged in the transport of plastic pellets as part of its economic activity by using road vehicles, rail wagons or inland waterway vessels;

(7)

‘non-EU carrier’ means any natural or legal person established in a third country, engaged in the transport of plastic pellets as part of its economic activity in the Union by using road vehicles, rail wagons or inland waterway vessels;

(8)

‘shipper’ means any natural or legal person by whom or in whose name or on whose behalf a contract of carriage of goods has been concluded with any natural or legal person engaged in the transport of plastic pellets as part of its economic activity by using seagoing vessels;

(9)

‘operator’ means the owner or manager of a seagoing vessel;

(10)

‘agent’ means any person mandated or authorised to supply information on behalf of the operator;

(11)

‘micro-, small or medium-sized enterprise’ means a micro-, small or medium-sized enterprise within the meaning of the Annex to Commission Recommendation 2003/361/EC (18);

(12)

‘large enterprise’ means an enterprise that is not a micro-, small or medium-sized enterprise;

(13)

‘competent authority’ means an authority or a body designated by a Member State to carry out its obligations under this Regulation;

(14)

‘authorised representative’ means a natural or legal person established in the Union who has been designated by a written mandate from a non-EU carrier pursuant to Article 4, to act on its behalf in relation to specific tasks with regard to the obligations laid down in Article 3(2) and (3), Article 5(6), third subparagraph, and Article 15(1);

(15)

‘certifier’ means any of the following natural or legal persons:

Article 3

General obligations

1. Economic operators, EU carriers and non-EU carriers shall ensure that losses are avoided. Where losses occur, economic operators, EU carriers and non-EU carriers shall take immediate action to contain and clean up those losses in accordance with environmentally sustainable practices.

1. Economic operators shall notify the competent authorities of the Member State about each installation located in that Member State which they operate or control, or, where applicable, for which they have been delegated decisive economic power over its technical functioning. For each installation notified, they shall specify whether the installation handles plastic pellets in quantities below, or equal to or above, a threshold of 1 500 tonnes per year. Before the transport of plastic pellets in the Union for the first time, EU carriers or authorised representatives referred to in Article 4, as applicable, shall notify the competent authorities of the Member State in which the EU carrier or the authorised representative is established about their involvement in the transport of plastic pellets within the Union and the means of transport used.

1. Economic operators, EU carriers and authorised representatives shall notify the competent authorities referred to in paragraph 2 of any significant change in what was previously notified in accordance with paragraph 2 regarding the concerned installations and activities related to handling and transporting plastic pellets, including any closure of an existing installation, cessation of transport activities or where they are no longer subject to this Regulation, and any changes in the quantities of plastic pellets handled that are relevant for the application of the obligations associated with the thresholds.

Article 4

Authorised representatives of non-EU carriers

1. Non-EU carriers shall designate in writing an authorised representative in at least one Member State where the non-EU carrier is engaged in the transport of plastic pellets.

1. Non-EU carriers shall mandate in writing the authorised representative to act on their behalf for the purpose of ensuring compliance with Article 3(2) and (3), Article 5(6), third subparagraph, and Article 15(1) of this Regulation. Such authorised representative may be addressed in addition to the non-EU carriers or instead of them. The authorised representative’s mandate shall be valid only when accepted in writing by the authorised representative. The designation of an authorised representative shall be without prejudice to legal actions which could be initiated against the non-EU carriers.

1. The non-EU carrier shall simultaneously inform the competent authorities of the Member State referred to in paragraph 1 and the Commission of the designation of an authorised representative and its mandate before the first transport of plastic pellets in the Union.

Article 5

Obligations regarding the handling of plastic pellets

1. Economic operators shall take the following actions:

(a)

establish a risk management plan for each installation in accordance with Annex I, taking into account the nature and size of the installation as well as the scale of its operations;

(b)

install the equipment and execute the procedures described in the risk management plan; and

(c)

notify the risk management plan to the competent authority of the Member State where the installation is located together with a self-declaration of conformity issued in accordance with the model form set out in Annex II.

Economic operators shall keep the risk management plan up to date, taking into account in particular the weaknesses identified through their experience in handling plastic pellets, and shall make it available to competent authorities on demand.

1. Economic operators that are small, medium-sized or large enterprises operating installations where plastic pellets in quantities below a threshold of 1 500 tonnes have been handled in the previous calendar year or that are microenterprises shall notify an update of the risk management plan for each installation as well as a renewal of the self-declaration of conformity to the competent authority of the Member State where the installation is located every 5 years from the last notification.

1. Competent authorities may require economic operators to take the following actions:

(a)

change risk management plans notified in accordance with paragraphs 1 and 2 to ensure that the losses can effectively be prevented and, where appropriate, contained and cleaned up and that requirements set out in Annex I are complied with; and

(b)

implement any of the actions listed in Annex I in a timely manner.

1. EU carriers and non-EU carriers shall ensure that the actions set out in Annex III are implemented.

1. When economic operators implement the actions set out in the risk management plan and the EU carriers and non-EU carriers implement the actions laid down in Annex III, they shall do so in the following order of priority:

(a)

actions to prevent spills;

(b)

actions to contain spills to avoid them becoming a loss;

(c)

actions to clean up after a spill or loss.

1. Economic operators, EU carriers and non-EU carriers shall have the following obligations:

(a)

ensure that their staff are trained according to their specific roles and responsibilities and that they are aware of and are able to use the relevant equipment and execute the procedures set out to ensure compliance with this Regulation; and

(b)

keep records of annually estimated quantities of losses and of the total quantities of plastic pellets handled.

As from six months after the publication of the relevant harmonised standard in the Official Journal of the European Union or from the date of application of the implementing act referred to in Article 18(3) economic operators, EU carriers and non-EU carriers shall estimate the quantities of losses referred to in point (b) of the first subparagraph of this paragraph, in accordance with the standardised methodology referred to in Article 18.

Article 6

Certification

1. By 17 December 2027, and every three years thereafter, economic operators that are large enterprises shall demonstrate that the handling process at each installation where plastic pellets in quantities equal to or above a threshold of 1 500 tonnes have been handled in the previous calendar year is compliant with the requirements set out in Annex I, by obtaining a certificate issued by a certifier.

1. By 17 December 2028, and every four years thereafter, economic operators that are medium-sized enterprises shall demonstrate that the handling process at each installation where plastic pellets in quantities equal to or above a threshold of 1 500 tonnes have been handled in the previous calendar year is compliant with the requirements set out in Annex I, by obtaining a certificate issued by a certifier.

1. By 17 December 2030, economic operators that are small enterprises shall demonstrate that the handling process at each installation where plastic pellets in quantities equal to or above a threshold of 1 500 tonnes have been handled in the previous calendar year is compliant with the requirements set out in Annex I, by obtaining a certificate issued by a certifier. That certificate shall be valid for 5 years.

The economic operators referred to in the first subparagraph of this paragraph shall comply with Article 5(2) after the expiry period of the certificate unless they choose to renew it in accordance with the first subparagraph of this paragraph.

1. Certifiers shall carry out spot checks, including, if accessible, at immediately surrounding areas, to ensure that the risk management plan is adequate to prevent plastic pellet losses and that all measures included therein are duly implemented.

1. Certificates shall meet the following requirements:

(a)

they are issued in accordance with the model form set out in Annex IV and in electronic form;

(b)

they specify the economic operator, the installation covered by the certificate, the date of each spot check carried out, and the period of validity;

(c)

they certify conformity of the installation covered by the certificate with the requirements set out in Annex I;

1. Without undue delay, certifiers shall notify the competent authority of the following:

(a)

certificates issued;

(b)

certificates suspended or withdrawn;

(c)

changes in certificates.

Article 7

Compliance through permits

1. Member States may exempt economic operators from the obligations laid down in Article 5(1), point (c), and Article 5(2) as well as from the obligation to obtain a certificate pursuant to Article 6(1), (2) and (3) in respect of each installation, provided that:

(a)

the operation of the installation is subject to a permit;

(b)

the economic operator has notified the authority competent for the issuance of permits about its risk management plan as well as its updates every 3 years for large, 4 years for medium-sized, and 5 years for micro- and small enterprises;

(c)

the permit has been granted or reviewed and, if necessary, updated on the basis of verification of the economic operator’s compliance with the requirements set out in Annex I following the notification of a risk management plan and subsequent updates, as referred to in point (b); and

(d)

the installation is subject to regular inspections by competent authorities, including site visits, examining the full range of relevant environmental effects, including those of spills and losses, with the periodicity referred to in Article 5(2) and the periodicity equivalent to that resulting from the application of Article 6(1), (2) and (3).

1. The Member State shall notify the exemption of the economic operators and national rules on permits to the Commission.

Article 8

Compliance through environmental management systems

1. Economic operators which are registered with the Community eco-management and audit scheme (EMAS) in accordance with Regulation (EC) No 1221/2009 shall be exempt from compliance with the obligations laid down in Article 5(2) and in Article 6(1), (2) and (3) of this Regulation provided that the environmental verifier as defined in Article 2(20) of Regulation (EC) No 1221/2009 has checked that requirements set out in Annex I to this Regulation have been included in the environmental management system of the economic operator and have been implemented.

1. Member States may exempt economic operators from compliance with Article 5(2) and Article 6(1), (2) and (3) if they have prepared and implemented an environmental management system (EMS) for each installation, and provided that:

(a)

an accredited certifier has conducted a conformity assessment to verify, including through spot checks, that the EMS and the way it is implemented are compliant with the requirements set out in Annex I;

(b)

the economic operator notifies the competent authorities about the conformity assessment of the EMS referred to in point (a), including information about the economic operator, the installation for which compliance is verified, the date on which spot checks are carried out, and the period for which the conformity assessment is valid; and

(c)

the regular conformity assessments of the EMS include, at least every three years, an evaluation of its implementation in accordance with the requirements set out in Annex I.

Article 9

Accreditation of certifiers

The accreditation of certifiers referred to in Article 2, point (15)(a), shall include an evaluation of compliance with the following requirements:

(a)

the certifier shall be established under the law of a Member State and shall have legal personality;

(b)

the certifier shall be a third-party body independent of the economic operator;

(c)

the certifier, its senior management and the personnel responsible for the conformity assessment shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to the certification activities;

(d)

the certifier and its personnel shall operate in a non-discriminatory manner and carry out their activities with the highest degree of professional integrity and the requisite technical competence and shall be free from all pressures and inducements, including financial, which might influence their judgement or the results of their certification activities, especially as regards persons or groups of persons with an interest in the results of those activities. The impartiality of the certifiers, their senior management and the personnel responsible for carrying out the certification and tasks shall be guaranteed;

(e)

the certifier shall have the expertise, equipment and infrastructure required to perform the conformity assessment in relation to which it has been accredited;

(f)

the certifier shall have a sufficient number of suitably qualified and experienced personnel responsible for carrying out the conformity assessment tasks;

(g)

without prejudice to the powers of the competent authorities under Article 16(3), point (b), the personnel of a certifier shall observe professional secrecy with regard to all information obtained in carrying out the conformity assessment tasks;

(h)

where a certifier subcontracts specific tasks connected with certification or has recourse to a subsidiary, it shall take full responsibility for the tasks performed by subcontractors or subsidiaries and shall assess and monitor the qualifications of the subcontractor or the subsidiary and the work carried out by them. Only the tasks that fall within the scope of accreditation of the certifier may be performed by subcontractors or subsidiaries. Certifiers shall ensure that the activities of their subcontractors or subsidiaries do not affect the confidentiality, objectivity or impartiality of their certification activities.

Article 10

Obligation to provide information

Without prejudice to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (20) and Regulation (EC) No 1907/2006, any manufacturer, importer, downstream user or distributor placing on the market plastic pellets which are synthetic polymer microparticles under entry 78, paragraph 7, of Annex XVII to Regulation (EC) No 1907/2006 shall provide the information as referred to in Annex V to this Regulation on the label, the packaging, the package leaflet, or on the safety data sheet. The information shall be clearly visible, legible and indelible. The text information shall be provided in the official languages of the Member States where the plastic pellets are placed on the market, unless the Member States concerned provide otherwise. The manufacturer, importer, downstream user or distributor may provide that information when carrying out the obligations pursuant to entry 78, paragraph 7, of Annex XVII to Regulation (EC) No 1907/2006.

Article11

Public access to information

1. Competent authorities shall make available to the public, including systematically via the internet, on a website which is easy to find, free of charge and without restricting access to registered users, while ensuring that confidential business information is safeguarded, the following:

(a)

the information they have received in accordance with Article 3(2) and (3) and Article 4;

(b)

the risk management plans they have received in accordance with Article 5(1) and (2);

(c)

the self-declarations of conformity they have received in accordance with Article 5(1) and (2);

(d)

the certificates issued pursuant to Article 6 and notifications they have received in accordance with paragraph 6 of that Article;

(e)

the content of the decision granting a permit, including a copy of the permit and any subsequent updates or a link to other existing publicly accessible registers or websites, established at Member State level, that provide access to such permits and their subsequent updates; and

(f)

the content of the conformity assessment of the EMS they have received in accordance with Article 8(2), point (b).

1. Competent authorities, when making the risk management plans referred to in paragraph 1, point (b), of this Article, available to the public, shall not publicly disclose the information referred to in Annex I, paragraph 1, point (b). Competent authorities may omit parts of other information referred to in paragraph 1, points (a) and (b), of this Article, if its disclosure would adversely affect the safety of the installations concerned or safety of the local population, or any of the interests listed in Article 4(2), points (a) to (h), of Directive 2003/4/EC of the European Parliament and of the Council (21). Competent authorities may require economic operators to identify the parts of the information they consider are not to be publicly disclosed.

1. The Commission shall publish the list of national websites as referred to in paragraph 1 on its website, provided that the necessary information is submitted by Member States.

Article 12

Obligations regarding the transport of plastic pellets by sea in freight containers

1. Shippers shall ensure that:

(a)

plastic pellets are packed in good-quality packaging that is strong enough to withstand the shocks and loadings normally encountered during transport and is constructed and closed so as to prevent any loss of contents which could be caused by vibration or acceleration forces under normal transport conditions;

(b)

transport information identifying the freight containers containing plastic pellets is delivered to the operator, agent and master of the seagoing vessel as an addition to the cargo information required by Regulation VI/2 of the International Convention for the Safety of Life at Sea (SOLAS), before plastic pellets are taken on board; and

(c)

cargo information referred to in point (b) of this paragraph is accompanied by a special stowage request requiring stowage of the freight containers containing plastic pellets in accordance with paragraph 3.

1. Operators and masters of seagoing vessels and, where relevant, agents shall ensure that they are in possession of the list or manifest or appropriate loading plan in accordance with the cargo information received from the shipper referred to in paragraph 1, point (b).

1. Operators and masters of seagoing vessels shall ensure that freight containers containing plastic pellets are stowed under deck, wherever reasonably practicable, or inboard in sheltered areas of exposed decks. In both cases, such containers shall be secured to minimise hazards to the marine environment without impairing the safety of the seagoing vessel and persons on board.

Article 13

Verification of compliance and reporting

1. Competent authorities shall verify compliance of economic operators, EU carriers, non-EU carriers and authorised representatives, shippers, and operators, agents and masters of seagoing vessels with the obligations laid down in this Regulation, taking into account, where applicable, the information provided in self-declarations of conformity referred to in Article 5(1) and (2) and collected by certifiers and competent authorities in accordance with Article 6(6) and Article 7(1) in accordance with exemptions granted pursuant to Article 8. The competent authorities shall carry out environmental inspections, including without prior notice, and other verification measures, following a risk-based approach.

1. By 1 January 2030, and every three years thereafter, Member States shall submit a report to the Commission containing qualitative and quantitative information on the implementation of this Regulation during the previous three consecutive calendar years. The information shall include:

(a)

the number of economic operators per size of enterprise under Commission Recommendation 2003/361/EC and per economic activity, their installations, and the number of EU carriers and non-EU carriers and the means of transport used by those carriers for transporting plastic pellets;

(b)

the number of risk management plans and self-declarations notified pursuant to Article 5(1) and 5(2), respectively, the number of certificates notified pursuant to Article 6(6) and the number of economic operators that are registered with EMAS or have implemented an EMS meeting the conditions in Article 8(2);

(c)

the number of permits granted meeting the conditions pursuant to Article 7; and

(d)

the number and results of environmental inspections and other verification measures carried out under paragraph 1 of this Article, as well as the number of incidents and accidents reported in accordance with Article 14(1) and the measures taken in the event of non-compliance with the obligations set out in this Regulation.

1. The Commission shall by means of implementing acts lay down a format for the reports referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2).

1. No later than three months after the reporting date referred to in paragraph 2, the Commission shall make publicly available a Union-wide overview of the application of this Regulation, based on the data submitted pursuant to that paragraph.

Article 14

Incidents and accidents

1. Without prejudice to Directive 2004/35/EC, in the event of an incident or accident that causes a loss affecting human health or the environment, economic operators, EU carriers and non-EU carriers shall:

(a)

immediately inform emergency services, where relevant;

(b)

immediately take all possible measures to minimise the human health or environmental consequences;

(c)

without delay and no later than 30 days after the incident or accident that causes a loss affecting human health or the environment, provide the following information to the competent authorities in whose territories the incident or accident occurred:

(i)

the estimated quantities of the loss;

(ii)

the causes of the loss; and

(iii)

the measures taken pursuant to point (b); and

(d)

take measures to prevent further incidents or accidents.

1. The competent authority in whose territory the incident or accident occurred shall require, where necessary, that economic operators, EU carriers and non-EU carriers take appropriate complementary measures to minimise the human health or environmental consequences and to prevent further incidents or accidents, including by organising specific training.

1. In the event of any incident or accident affecting human health or the environment in another Member State, the competent authority in whose territory the accident or incident occurred shall immediately inform the competent authority of that other Member State.

Article 15

Non-compliance

1. In the event of an infringement of the rules laid down in this Regulation, economic operators, EU carriers, non-EU carriers and authorised representatives, as applicable, shall immediately:

(a)

inform the competent authority;

(b)

take the measures necessary to ensure that compliance is restored within the shortest possible time; and

(c)

comply with any complementary measures determined by the competent authority as necessary to restore compliance.

1. Where the infringement of the rules laid down in this Regulation poses an immediate danger to human health or threatens to cause an immediate significant adverse effect upon the environment, the competent authority shall, or, where that infringement leads to a significant loss, the competent authority may, suspend the operation of the installation or part of it, and immobilise or prevent the movement of road vehicles, rail wagons or inland waterway vessels until compliance is restored in accordance with paragraph 1, points (b) and (c).

Article 16

Designation and powers of competent authorities

1. Member States shall designate one or more competent authorities for the application and enforcement of this Regulation. Member States shall inform the Commission, without delay after 16 December 2025, of the names, addresses, and contact details of the competent authorities, and also inform it of any subsequent changes to that information.

1. Member States shall confer on their competent authorities the powers of inspection and enforcement necessary to ensure compliance with this Regulation.

1. The powers of competent authorities as referred to in paragraph 2 shall include at least the following:

(a)

the power to access any relevant documents, data or information related to an infringement of this Regulation, in any form or format and irrespective of their storage medium, or the place where they are stored, and the power to take or obtain copies thereof;

(b)

the power to require any natural or legal person to provide any relevant information, data or documents, in any form or format and irrespective of their storage medium, or the place where they are stored, for the purpose of establishing whether an infringement of this Regulation has occurred or is occurring and the details of such infringement;

(c)

the power to start an inspection on their own initiative to bring about the cessation or prohibition of infringements of this Regulation; and

(d)

the power to access installations.

1. Competent authorities may use any information, document, finding, statement or intelligence as evidence for the purposes of their environmental inspections and other verification measures, irrespective of the format or medium on which they are stored.

1. Where there is more than one competent authority in their territory, Member States shall ensure that appropriate communication and coordination mechanisms are established.

Article 17

Information and assistance regarding compliance

1. By 17 December 2026, the Commission shall develop and make available to the public, including via the internet, on a website which is easy to find, free of charge and without restricting access to registered users, awareness-raising and training material on the appropriate implementation of the obligations laid down in this Regulation in consultation with representatives of economic operators, carriers and certifiers, including micro-, small and medium-sized enterprises, and relevant environmental non-governmental organisations and in collaboration with competent authorities. Where appropriate, the Commission shall also consult representatives of authorised representatives, shippers, and operators, agents and masters of seagoing vessels.

1. Member States shall ensure that economic operators, EU carriers and non-EU carriers, authorised representatives, shippers, and operators, agents and masters of seagoing vessels get access to information regarding compliance with this Regulation and that they, especially micro- and small- enterprises, get assistance in that regard.

Without prejudice to applicable State aid rules, the assistance referred to in the first subparagraph may, in particular, take the form of:

(a)

financial support, including for the purposes of certification for small enterprises;

(b)

access to finance;

(c)

specialised management and staff training; and

(d)

organisational and technical assistance.

1. Member States shall encourage the development of training programmes for the qualification of certifiers’ personnel.

Article 18

Standards

1. For the purposes of compliance with the obligation referred to in Article 5(6), point (b), a methodology to estimate quantities of losses shall be developed in harmonised standards in accordance with the procedures established by Regulation (EU) No 1025/2012.

1. The Commission shall submit the request for the development of harmonised standards to one or more European standardisation organisations by 17 December 2026.

1. Where no European standardisation organisation accepts the request to draft a harmonised standard or where the Commission considers that the proposed standard does not satisfy the requirements which it aims to cover, the Commission shall establish the methodology referred to in paragraph 1 of this Article by means of an implementing act. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 24(3).

Article 19

Complaint-handling and access to justice

1. Natural or legal persons regarded under national law as having sufficient interest or those that consider that their rights were impaired shall be entitled to submit substantiated complaints to competent authorities where they deem, on the basis of objective circumstances, that an economic operator, EU carrier, non-EU carrier, or a shipper, or an operator, agent or master of a seagoing vessel is failing to comply with this Regulation.

For the purposes of the first subparagraph, non-governmental entities or organisations promoting the protection of human health or the environment or those promoting consumer protection and meeting any requirements under national law shall be deemed to have sufficient interest.

1. Competent authorities shall assess substantiated complaints as referred to in paragraph 1 of this Article and, where appropriate, take the steps necessary to verify such complaints, including inspections and hearings of the person or organisation. Where the complaint is found to be grounded, the competent authorities shall take the necessary actions in accordance with Article 5(3), Article 14(2) and Article 15(2).

1. Competent authorities shall, as soon as possible, inform the persons referred to in paragraph 1 that submitted the complaint of their decision to accede to or refuse the request for action put forward in the complaint and shall provide the reasons for it.

1. Member States shall ensure that a person referred to in paragraph 1 has access to a court or another independent and impartial public body competent to review the procedural and substantive legality of the competent authority’s decisions, acts or failure to act under this Regulation, without prejudice to any provisions of national law which require that administrative review procedures be exhausted prior to recourse to judicial proceedings. Those review procedures shall be fair, equitable, timely and not prohibitively expensive, and shall provide adequate and effective remedies, including injunctive relief where necessary.

1. Member States shall ensure that practical information is made available to the public on access to the administrative and judicial review procedures referred to in this Article.

Article 20

Penalties

1. Without prejudice to the obligations of Member States under Directive (EU) 2024/1203 of the European Parliament and of the Council (22), Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.

1. The penalties referred to in paragraph 1 shall include administrative financial penalties that effectively deprive those that committed the infringement of the economic benefits derived from their infringements.

1. For the most serious infringements committed by a legal person, the maximum level of the administrative financial penalties referred to in paragraph 2 shall be at least 3 % of its annual Union turnover in the financial year preceding the year in which the administrative financial penalty is imposed.

1. Member States may also, or alternatively, impose criminal penalties, provided that they are equivalently effective, proportionate and dissuasive to the administrative financial penalties referred to in this Article.

1. Member States shall ensure that the penalties established pursuant to this Article take due account of the following, as applicable:

(a)

the nature, gravity and extent of the infringement;

(b)

the population or the environment affected by the infringement, bearing in mind the impact of the infringement on the objective of achieving a high level of protection of human health and the environment;

(c)

the repetitive or one-off character of the infringement.

1. Member States shall without undue delay notify the Commission of the rules and measures referred to in paragraph 1 and of any subsequent amendments affecting them.

Article 21

Compensation

1. Member States shall ensure that, where damage to human health has occurred as a result of an infringement of this Regulation, the individuals affected have the right to claim and obtain compensation for that damage from the natural or legal persons responsible for the infringement.

1. Member States shall ensure that national rules and procedures relating to claims for compensation are designed and applied in such a way that they do not render impossible or excessively difficult the exercise of the right to compensation for damage caused by an infringement pursuant to paragraph 1.

1. Member States may establish limitation periods for bringing claims for compensation referred to in paragraph 1. Such periods shall not begin to run before the infringement has ceased and the person entitled to claim the compensation knows or can reasonably be expected to know that he or she suffered damage from an infringement pursuant to paragraph 1.

Article 22

Amendments to Annexes

1. The Commission is empowered to adopt delegated acts in accordance with Article 23 to amend:

(a)

the technical requirements laid down in paragraphs 2, 3, 4 and 5 of Annex I;

(b)

points (1), (2) and (3) of Annex III to add or remove equipment requirements or procedures or to specify the technical features of the existing equipment and procedures; and

(c)

the details of the forms laid down in Annexes II and IV.

1. The Commission shall adopt the delegated acts referred to in paragraph 1 of this Article on the basis of:

(a)

the experience gained from the implementation of Articles 3, 5, 6, 7, 8, 13 and 14;

(b)

the information made available by economic operators on the annually estimated quantities of plastic pellet losses, as reported pursuant to Annex XVII to Regulation (EC) No 1907/2006;

(c)

relevant international standards;

(d)

the specificities of the sectors of activity;

(e)

the specific needs of micro-, small and medium-sized enterprises; or

(f)

technical progress and scientific developments.

Article 23

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

1. The power to adopt delegated acts referred to in Article 22(1) shall be conferred on the Commission for a period of five years from 2 January 2028. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

1. The delegation of power referred to in Article 22(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

1. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

1. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

1. A delegated act adopted pursuant to Article 22(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 24

Committee procedure

1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

1. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

1. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 25

Evaluation and review

1. By 17 December 2033, the Commission shall conduct an evaluation of the implementation of this Regulation in light of the objectives that it pursues. The Commission shall present a report on the main findings of the evaluation to the European Parliament and to the Council. The report shall include at least:

(a)

the experience gathered from the implementation of this Regulation;

(b)

the information reported by Member States pursuant to Article 13(2);

(c)

the information made available by economic operators on the annually estimated quantities of plastic pellet losses, as reported pursuant to Annex XVII to Regulation (EC) No 1907/2006;

(d)

the contribution of this Regulation to the overall target of reducing microplastic pollution by 30 % by 2030;

(e)

an assessment of whether further actions need to be taken with regard to additional sources of unintentional releases of microplastics with a view to achieving the Union objective of reducing microplastic pollution;

(f)

the latest data and scientific findings;

(g)

an assessment of the latest data and scientific findings on chemical traceability of plastic pellets and of the relevance of introducing a unique chemical signature;

(h)

the interaction of this Regulation with relevant international initiatives addressing plastic pellet losses, in particular with regard to maritime transport;

(i)

an assessment of the impact on the implementation of this Regulation of excluding from certain obligations under this Regulation economic operators handling plastic pellets below certain thresholds, and the relevance of establishing a threshold for carriers;

(j)

an assessment of the effect that the exemptions granted pursuant to Article 7 had in achieving the objective of preventing spills and losses;

(k)

an assessment of the compliance by carriers, in particular non-EU carriers, with the obligations under this Regulation;

(l)

an assessment of the relative effectiveness of the different means of providing information as referred to in Article 10.

1. Where appropriate, the report shall be accompanied by a legislative proposal to the European Parliament and Council.

1. In the event of the adoption by the International Maritime Organization (IMO) of measures for the safe transport of plastic pellets by ships and for the prevention of marine pollution caused by plastic pellets transported by ships, the Commission shall assess those measures, including the need to ensure alignment with those measures, and shall, if appropriate, adopt a legislative proposal.

Article 26

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 17 December 2027. However, Article 3(1), Article 5(6), second subparagraph, Article 16, Article 17(1) and Article 18(2) and (3) shall apply from 16 December 2025.

By way of derogation from the second paragraph of this Article, Article 1(2), point (d), Article 12, Article 13(1), Article 17(2) and (3) and Article 19 shall apply, as far as shippers and operators, agents and masters of seagoing vessels are concerned, from 17 December 2028.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 12 November 2025.

For the European Parliament

The President

R. METSOLA

For the Council

The President

M. BJERRE

(1)

OJ C, C/2024/2487, 23.4.2024, ELI: http://data.europa.eu/eli/C/2024/2487/oj.

(2)

OJ C, C/2024/3675, 26.6.2024, ELI: http://data.europa.eu/eli/C/2024/3675/oj.

(3) Position of the European Parliament of 23 April 2024 (not yet published in the Official Journal) and position of the Council at first reading of 22 September 2025 (not yet published in the Official Journal). Position of the European Parliament of 23 October 2025 (not yet published in the Official Journal).

(4) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).

(5) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3, ELI: http://data.europa.eu/eli/dir/2008/98/oj).

(6) Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial and livestock rearing emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17, ELI: http://data.europa.eu/eli/dir/2010/75/oj).

(7) Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (OJ L 257, 10.10.1996, p. 26, ELI: http://data.europa.eu/eli/dir/1996/61/oj).

(8) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19, ELI: http://data.europa.eu/eli/dir/2008/56/oj).

(9) Commission Regulation (EU) 2023/2055 of 25 September 2023 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards synthetic polymer microparticles (OJ L 238, 27.9.2023, p. 67, ELI: http://data.europa.eu/eli/reg/2023/2055/oj).