Legal provisions of COM(2023)645 - Preventing plastic pellet losses to reduce microplastic pollution - Main contents
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| dossier | COM(2023)645 - Preventing plastic pellet losses to reduce microplastic pollution. |
|---|---|
| document | COM(2023)645 |
| date | October 16, 2023 |
Article 1
Subject matter and scope
1. This Regulation lays down obligations for the handling of plastic pellets at all stages of the supply chain to prevent losses.
2. This Regulation applies to the following subjects:
(a) economic operators handling plastic pellets in the Union in quantities above 5 tonnes in the previous calendar year;
(b) EU carriers and non-EU carriers transporting plastic pellets in the Union.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(a) ‘plastic pellet’ means a small mass of preformed polymer-containing moulding material, having relatively uniform dimensions in a given lot, that is used as feedstock in plastic product manufacturing operations;
(b) ‘spill’ means a one-off escape of plastic pellets from primary containment;
(c) ‘loss’ means a one-off or prolonged escape of plastic pellets from installation’s boundary to the environment or from road vehicles, rail wagons or inland waterway vessels transporting plastic pellets;
(d) ‘installation’ means any premises, structure, environment or place within which one or more economic activities involving the handling of plastic pellets are carried out;
(e) ‘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;
(f) ‘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;
(g) ‘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;
(h) ‘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/EC37;
(i) ‘large-sized enterprise’ means an enterprise that is not a micro, small or medium-sized enterprise;
(j) ‘competent authority’ means an authority or a body designated by a Member State to carry out its obligations under this Regulation;
(k) ‘certifier’ means any of the following:
(i) a conformity assessment body as defined in Article 2(13) of Regulation (EC) 765/2008 of the European Parliament and of the Council38 or any other association or group of such bodies, which has obtained accreditation in accordance with this Regulation;
(ii) an environmental verifier, as defined in Article 2(20), point (b), of Regulation (EC) No 1221/2009;
(l) ‘conformity assessment’ means the process demonstrating whether an installation fulfils the applicable rules of this Regulation and of the delegated acts adopted on the basis thereof;
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 clean-up those losses.
2. Economic operators and EU carriers shall notify the competent authority, in the manner determined by the latter, of each installation they operate and of when engaging in the transport of plastic pellets, as applicable.
3. Economic operators and EU carriers shall notify the competent authorities of the Member State in which they are established of any significant change in their installations and activities related to handling of plastic pellets, including of any closure of an existing installation.
4. Competent authorities shall establish and maintain a public register containing the information they have received in accordance with paragraphs 3 and 4.
Article 4
Obligations regarding the handling of plastic pellets
1. Economic operators shall take the following actions:
(a) establish a risk assessment 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 assessment plan referred to in point (a);
(c) notify the risk assessment plan referred to in point (a) 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 assessment 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.
2. Economic operators that are medium and large-sized enterprises operating installations where plastic pellets in quantities below 1 000 tonnes have been handled in the previous calendar year or that are micro or small-sized enterprises shall notify an update of the risk assessment plan for each installation as well as a renewal of the self-declaration of conformity to the competent authority every 5 years from the last notification.
3. Competent authorities may require economic operators to take the following actions:
(a) to change risk assessment plans notified in accordance with paragraphs 1 and 2 to ensure that the losses can effectively be prevented or, where appropriate, contained and cleaned up and that Annex I is complied with;
(b) implement any of the actions listed in Annex I in a timely manner.
4. Competent authorities shall establish, maintain, and update a register containing the risk assessment plans and self-declarations of conformity notified in accordance with paragraphs 1 and 2 of this Article. The register shall be publicly available on a website.
5. EU carriers and non-EU carriers shall ensure that the actions set out in Annex III are implemented during loading and unloading operations, transport journeys, cleaning and maintenance operations.
6. When economic operators implement the actions set out in the risk assessment plan established in accordance with Annex I and the EU carriers and non-EU carriers implement the actions laid down in Annex III, they shall take action, in the following priority order:
(a) actions to prevent spills
(b) actions to contain spills to avoid they become a loss;
(c) actions to clean-up after a spill or loss.
7. Economic operators and EU carriers shall have the following obligations:
(a) ensure that their staff is 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;
(b) keep records of the actions taken to comply with the obligations set out in this Article;
(c) keep records of annually estimated quantities of losses and of the total volume 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 13(2) of this Regulation economic operators shall estimate the quantities of losses referred to in the first subparagraph, point (c) in accordance with the standardised methodology referred to in Article 13.
Economic operators and EU carriers shall retain records referred to in points (b) and(c) of this paragraph for a period of five years and make them available to competent authorities and, where applicable, to certifiers on demand.
8. Where an action taken for the prevention, containment and clean-up of spills and losses fails, economic operators, carriers and non-EU carriers shall take corrective actions, as soon as possible.
9. Every year economic operators that are not micro or small-sized enterprises and that operate installations where plastic pellets in quantities above 1 000 tonnes have been handled in the previous calendar year shall, for each installation, carry out an internal assessment on the state of compliance of the installation with the requirements of the risk assessment plan laid down in Annex I. The internal assessment may among others cover the following subjects:
(a) the estimated quantities and causes of losses;
(b) the preventive, containment and clean up equipment and/or procedures implemented to avoid future losses, and their effectiveness;
(c) discussions with the personnel, inspections of equipment and procedures in place and revision of any relevant documentation.
Article 5
Certification
1. By … [OP: please insert the date = 24 months after the entry into force of this Regulation], and thereafter every three years, economic operators that are large-sized enterprises shall demonstrate that each installation where plastic pellets in quantities above 1 000 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.
2. By … [OP: please insert the date = 36 months after the entry into force of this Regulation], and thereafter every four years, economic operators that are medium-sized enterprises shall demonstrate that each installation where plastic pellets in quantities above 1 000 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.
3. Certifiers shall carry out spot-checks to ensure that all measures included in the risk assessment plan carried out in accordance with Annex I are duly implemented.
4. Certificates shall meet the following requirements:
(a) be issued in accordance with the model form set out in Annex IV and in electronic form;
(b) specify the economic operator, the installation covered by the certificate, the date of the spot-checks carried out, and the period of validity;
(c) certify conformity of the installation covered by the certificate with the requirements laid down in Annex I;
5. Without undue delay, certifiers shall notify the competent authority of the following:
(a) certificates issued;
(b) certificates suspended or withdrawn;
(c) changes in certificates.
Competent authorities shall establish and maintain and keep up to date a register of certificates. The register shall be publicly available on a website.
Article 6
Environmental management systems
Economic operators which are registered to the Community eco-management and audit scheme in accordance with Regulation (EC) No 1221/2009 are exempt from compliance with the notification obligation laid down in Article 4(2) and the obligations laid down in Article 5(1) and (2) of this Regulation provided that the environmental verifier as defined in Article 2(20) of Regulation (EC) No 1221/2009 has checked that requirements laid down in Annex I have been included in the environmental management system of the economic operator and have been implemented.
Article 7
Accreditation of certifiers
The accreditation of certifiers referred to in Article 3, point (k)(i) shall include an evaluation of compliance with the following requirements:
(a) the certifier shall be independent of the economic operator;
(b) the certifier, its top-level 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;
(c) the certifier and its personnel shall 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;
(d) the certifier shall have the expertise, equipment and infrastructure required to perform the conformity assessment in relation to which it has been accredited;
(e) the certifier shall have a sufficient number of suitably qualified and experienced personnel responsible for carrying out the conformity assessment tasks;
(f) the personnel of a certifier shall observe professional secrecy with regard to all information obtained in carrying out the conformity assessment tasks;
(g) 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.
Article 8
Verification of compliance and reporting
1. Competent authorities shall verify compliance of economic operators, EU carriers and non-EU carriers with the obligations laid down in this Regulation, taking into account the information provided in self-declarations of conformity referred to Article 4(1) and (2) and provided by certifiers in accordance with Article 5(5). The competent authorities shall carry out environmental inspections and other verification measures, following a risk-based approach.
2. At the latest by … [OP please insert the date = the first day of the month after four years following the date of entry into force of this Regulation] 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 calendar year. The information shall include:
(a) the number of economic operators per size of enterprise according to Commission Recommendation 2003/361/EC and per economic activity, their installations, and of the EU carriers and their means of transport allocated to transporting plastic pellets;
(b) the number of risk assessment plans, self-declarations notified pursuant to Article 4(1) and 4(2) and certificates notified pursuant to Article 5(5);
(c) the number and results of environmental inspections and other verification measures carried under paragraph 1 of this Article as well as the number of incidents and accidents reported in accordance with Article 9(1) and the measures taken in case of non-compliance with the obligations set out in this Regulation.
3. The Commission shall lay down by means of implementing acts a format for the reports referred to in paragraph 2.
Article 9
Incidents and accidents
1. Without prejudice to Directive 2004/35/EC, in the event of an incidental or accidental loss significantly affecting human health or the environment, economic operators, EU carriers and non-EU carriers shall immediately:
(a) inform the competent authority in whose territory the incident or accident occurred and the estimated quantities of losses;
(b) take measures to limit the health or environmental consequences and to prevent further incidents or accidents.
2. 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 limit the health or environmental consequences and to prevent further incidents or accidents.
3. In the event of any incident or accident significantly 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 10
Non-compliance
1. In the event of an infringement of the rules laid down in this Regulation, economic operators, EU carriers and non-EU carriers shall immediately:
(a) inform the competent authority;
(b) take the measures necessary to ensure that compliance is restored within the shortest possible time;
(c) comply with any complementary measures determined by the competent authority as necessary to restore compliance.
2. 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 may suspend the operation of the installation until compliance is restored in accordance with paragraph 1, points (b) and (c).
Article 11
Designation and powers of competent authorities
1. Member States shall designate one or more competent authorities for the application and enforcement of this Regulation.
2. Member States shall confer on their competent authorities the powers of inspection and enforcement necessary to ensure compliance with this Regulation.
3. The powers referred to in paragraph 2 shall include at least the following:
(a) the power of access to 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 purposes 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;
(d) the power of access to installations.
4. Competent authorities may use any information, document, finding, statement or intelligence as evidence for the purpose of their environmental inspections and other verification measures, irrespective of the format or medium on which they are stored.
5. Where there is more than one competent authority in their territory, Member States shall ensure that appropriate communication and coordination mechanisms are established.
Article 12
Assistance relating to compliance
1. The Commission shall develop awareness raising and training material on the sound 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 in collaboration with competent authorities.
2. Member States shall ensure that economic operators and carriers, especially micro, small and medium-sized enterprises, get access to information and assistance regarding compliance with this Regulation.
Without prejudice to applicable state aid rules, the assistance referred to in the first subparagraph may take the form of:
(a) financial support;
(b) access to finance;
(c) specialised management and staff training;
(d) organisational and technical assistance.
3. Member States shall encourage training programmes for the qualification of certifiers’ personnel.
Article 13
Standardised methodology
1. For the purposes of compliance with the obligation referred to in Article 4(7), first subparagraph, point (c), a methodology to estimate quantities of losses shall be developed in harmonised standards in accordance with the procedures established by Regulation (EU) No1025/2012.
2. 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 by means of an Implementing act.
Article 14
Complaint-handling and access to justice
1. Natural or legal persons or organisations regarded under national law as having a sufficient interest or those who consider that their rights were impaired shall be entitled to submit substantiated complaints to competent authorities when they deem, on the basis of objective circumstances, that an economic operator, EU carrier or non-EU carrier is failing to comply with the provisions of this Regulation.
For the purposes of the first subparagraph, non-governmental entities or organisations promoting human health, environmental or consumer protection and meeting any requirements under national law shall be deemed to have a sufficient interest.
2. Competent authorities shall assess the substantiated complaint referred to in paragraph 1 and, where necessary, take the necessary steps, including inspections and hearings of the person or organisation, with a view to verifying those complaints. If the complaint is found to be grounded, the competent authorities shall take the necessary actions in accordance with Article 4(3).
3. Competent authorities shall, as soon as possible, inform the person or organisation referred to in paragraph 1 that submitted the complaint of its decision to accede to or refuse the request for action put forward in the complaint and shall provide the reasons for it.
4. Member States shall ensure that a person or organisation referred to in paragraph 1 submitting a substantiated complaint shall have access to a court or other independent and impartial public body competent to review the procedural and substantive legality of any decision on that complaint as well as 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 free of charge or not prohibitively expensive, and shall provide adequate and effective remedies, including injunctive relief where necessary.
5. 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 15
Penalties
1. Without prejudice to the obligations of Member States under Directive 2008/99/EC of the European Parliament and of the Council39, Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are applied. The penalties provided shall be effective, proportionate and dissuasive.
2. The penalties referred to in paragraph 1 shall include fines proportionate to the turnover of the legal person or to the income of the natural person having committed the infringement. The level of the fines shall be calculated in such a way as to make sure that they effectively deprive the person responsible for the infringements of the economic benefits derived from those infringements. The level of the fines shall be gradually increased for repeated infringements. In the case of an infringement committed by a legal person, the maximum amount of such fines shall be at least 4 % of the economic operator’s annual turnover in the Member State concerned in the business year preceding the fining decision.
3. 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 intentional or negligent character of the infringement;
(c) 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;
(d) the financial situation of the economic operator, EU carrier and non-EU carrier held responsible.
Article 16
Compensation
1. Member States shall ensure that, where damage to human health has occurred as a result of a infringement of this Regulation, the individuals affected have the right to claim and obtain compensation for that damage from the relevant natural or legal persons and, where appropriate, from the relevant competent authorities responsible for the infringement.
2. Member States shall ensure that, as part of the public concerned, non-governmental organisations promoting the protection of human health or the environment and meeting any requirements under national law are allowed to represent the individuals affected and bring collective actions for compensation. Member States shall ensure that a claim for an infringement leading to a damage cannot be pursued twice, by the individuals affected and by the non-governmental organisations referred to in this paragraph.
3. 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.
4. Where theclaim for compensation referred to in paragraph 1 is supported by evidence from which a causal link may be presumed between the damage and the infringement, Member States shall ensure that the onus is on the person responsible for the infringement to prove that the infringement did not cause or contribute to the damage.
5. Member States shall ensure that the limitation periods for bringing claims for compensation referred to in paragraph 1 are not shorter than 5 years. Such periods shall not begin to run before the infringement has ceased and the person claiming the compensation knows or can reasonably be expected to know that he or she suffered damage from a infringement pursuant to paragraph 1.
Article 17
Amendments to Annexes
The Commission is empowered to adopt delegated acts in accordance with Article 19 to amend Annexes I to IV. in order to take account of the technical progress and scientific developments.
When adopting delegated acts referred to in the first paragraph, the Commission shall take into account:
(a) the experience gained from the implementation of obligations set out in Articles 4 and 5;
(b) relevant international standards;
(c) the specificities of the sectors of activity;
(d) the specific needs of micro, small and medium-sized enterprises.
Article 18
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.
2. The power to adopt delegated acts referred to in Article 17 shall be conferred on the Commission for a period of 5 years from … [OP please insert the date = the first day of the month following the date of entry into force of this Regulation]. 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.
3. The delegation of power referred to in Article 17 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.
4. 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.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 17 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 19
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.
This Regulation shall apply [OP: please insert the date = 18 months after the entry into force of this Regulation]. However, Article 3(1) shall apply from [OP: please insert the date the date of the entry into force of this Regulation].
This Regulation shall be binding in its entirety and directly applicable in all Member States.