Changes from adopted text to adopted text

Removed(19) To enable competent authorities to verify compliance with the risk assessment plan’s requirements, economic operators should provide the competent authority with the risk assessment plan they have conducted, together with a self-declaration of conformity.

Removed(20) Economic operators should be able to chooseput in place the specific equipment to install or the procedureprocedures to execute. Nevertheless, competent authorities, while verifying compliance, should be able to require economic operators to amend the risk assessment 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. Economic operators should be able to be exempted from installing certain types of equipment or from adopting certain measures if they duly justify such exemptions to the competent authorities, taking into account the nature and size of the installation and the scale of its operations. Micro enterprises should consider at least the specific equipment to be installed or the procedures to be executed, taking into account the nature and size of the installation as well as the scale of its operations. [Am. 12]

Removed(21) In order to evaluate the adequacy of the risk assessment plan carried out for each installation, economic operators should keep record of an estimate of the quantity of the pellets released to the environment per year, together with the total volume handled. To reduce burden on economic operators, the information on estimates of quantities released may be used in the framework of the reporting requirement under Commission Regulation (EU) 2023/2055.

Removed(22) Due to the characteristics of their activity, carriers should not be mandated to conduct a risk assessment 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.

Removed(23) The successful implementation of the actions required to prevent plastic pellet losses and to achieve zero plastic pellet losses requires the full cooperation and commitment of economic operators’, EU carriers’ and non-EU carriers’ employees. Economic operators and 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 use the equipment and execute the procedures necessary to ensure compliance with the requirements laid down in this Regulation. Economic operators and EU carriers should also be required to monitor and keep records of the relevant actions to implement the requirements set out in this Regulation, for instance, the placement of new catchment devices. Where appropriate, they should adopt corrective actions including, where necessary, the improvement of equipment and procedures in place. [Am. 13]

Removed(24) Small, medium and large-sized enterprises that operate installations where plastic pellets are handled in quantities above 1 000 tonnes may bring higher risks of pellet losses to the environment. For this reason, these enterprises should be required to implement, for each installation, extra actions like carrying out an annual internal assessment, and adopting a mandatory training programme addressing specific training needs and modalitiesissues in relation to prevention, practices, workers protection, clean-up technologies, use and maintenance of equipment, the execution of procedures, as well as the monitoring and reporting of plastic pellet losses. In addition, for these enterprises, compliance with the requirements laid down in this Regulation should be demonstrated by obtaining, and renewing, a certificate issued by certifiers. These certifiers can either be an accredited conformity assessment body, or an environmental verifier licenced to carry out verification and validation in accordance with Regulation (EC) No 1221/2009 of the European Parliament and of the Council on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS). The certificate should correspond to a unique format in order to ensure homogeneous information. Small enterprises operating installations where plastic pellets in quantities above 1 000 tonnes have been handled should obtain certification only once. Such certification should be valid for 5 years after which they should notify an update of their risk assessment plan as well as a self-declaration of conformity every 5 years. [Am. 14]

Removed(25) Micro and small-sized enterprisesSmall, and medium and large-sized enterprises operating installations where plastic pellets in quantities below 1 000 tonnes have been handled and micro enterprises should be required to be subject to a self-declaration of conformity. They should also be given sufficient time to demonstrate their compliance. [Am. 15]

Removed(26) To enable competent authorities to more efficiently verify compliance under this Regulation, certifiers should notify competent authorities about the outcome of their assessments. Certificates should not prejudge the assessment on compliance by competent authorities.

Removed(27) In order to be EMAS registered, economic operators are required to comply with environmental legislation, including this Regulation. Consequently, economic operators which are registered to 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. These economic operators should therefore be exempted from the obligations of certification and notification to competent authorities when renewing self-declarations and risk assessments.

Removed(28) Competent authorities should verify economic operators’, EU carriers’ and non-EU carriers’ compliance with the obligations arising from this Regulation using, if appropriate, the findings provided as part of the certification or as self-declarations, based on either environmental inspections or other verification measures, on a risk-based approach. Inspections should, where possible, be coordinated with those required under other Union legislation. Competent authorities should provide the Commission with information on the implementation of this Regulation.

Removed(29) In order to minimise the effects of any loss, the economic operator, EU carrier and non-EU carrier should take the measures necessary to restore compliance. The corrective action 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 about the infringement detected and require that corrective measures are taken to restore compliance.

Removed(30) 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 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.

Removed(31) Competent authorities should be able to use all facts and circumstances of the case as evidence for the purpose of their inspection.

Removed(32) As micro, small and medium-sized enterprises (SMEs) inaccount for an important share of the pellet supply chain, they should comply with the relevant obligations laid down in this Regulation, however they could facewhile taking into consideration the possible different challenges linked to that compliance and the possible proportionally higher costs and difficulties when complying with some of the obligations. The Commission and the competent authorities should raise awareness among economic operators and carriers regarding the necessity of preventing pellet losses. Additionally, the Commission and the competent authorities should develop training materials, in consultation with all relevant stakeholders, to assist themeconomic operators and carriers in fulfilling their obligations, particularly with respect to the requirements of the risk assessment. That should be done by taking into account the non-binding Recommendation adopted by the parties to the Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR). Member States should provide access to information and assistance regarding compliance with obligations and the risk assessment requirements. Regarding the assistance of Member States, this could include technical and financial support as well asand specialised training to SMEsall personnel handling plastic pellets, as well as financial support and access to finance for micro and small enterprises as well as for installations handling plastic pellets in smaller quantities. Member States actions should be taken in respect of applicable State aid rules. [Am. 16]

Removed(33) In order to facilitate common grounds to estimate the losses of plastic pellets to the environment, 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. Pending the adoption of the standardised methodology, economic operators should indicate the methodology used when reporting losses of plastic pellets. [Am. 17]

Removed(34) 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 this Regulation.

Removed(35) In order to ensure that the objectives of this Regulation are achieved, and the 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, in order to ensure effective exercise of the duties of the competent authorities, Member States should ensure close cooperation between all designated competent authorities.

Removed(36) In order to ensure compliance, competent authorities should also take the necessary steps, including inspections and hearings when in possession of and based on relevant information, including 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.

Removed(37) 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. 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 on European Union requires Member States to provide remedies that are sufficient to ensure effective judicial protection in the fields covered by Union law. In this respect, Member States should ensure that the public, including natural or legal persons in accordance with 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 (the ‘Aarhus Convention’).

Removed(38) In order to ensure that economic operators are effectively dissuaded from non-compliance with the requirements laid down in this Regulation, Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that those rules are implemented. The penalties provided should be effective, proportionate and dissuasive. To facilitate a more consistent application of penalties, it is necessary to establish common criteria for determining the types and levels of penalties to be imposed in case of infringement. Those criteria should include, inter alia, the nature and gravity of the infringement as well as the economic benefits derived from the infringement in order to ensure that those responsible are deprived of those benefits. Member States should endeavour to ensure that the revenue generated from the penalties, or its equivalent financial value, is used to support projects aimed at cleaning up areas polluted by plastic and avoiding plastic pellet pollution. [Am. 18]

Removed(39) When setting penalties and measures for infringements, the Member States should foresee that, based on the gravity of the infringement, the level of fines should effectively deprive the non-compliant economic operator, EU carriers and non-EU carriers from the economic benefit derived from non-compliance with the obligations deriving from this Regulation, including in cases of repeated infringements. The gravity of the infringement should be the leading criterion for the measures taken by the enforcement authorities. The maximum amount of fines should, in case of an infringement committed by a legal person, represent at least 4%3% of the economic annual turnover in the Member State concernedUnion. [Am. 19]

Removed(40) 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 and, where appropriate, from the relevant competent authorities responsible for the infringement. Such rules on compensation contribute to pursuing the objectives of preserving, protecting and improving the quality of the environment and protecting human health as laid down in Article 191 of the Treaty on the Functioning of the European Union. 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 of Fundamental Rights of the European Union 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 does not give private parties a right of compensation as a consequence of environmental damage or of an imminent threat of such damage.

Removed(41) To ensure that individuals can defend their rights against damages 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, including 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 effectivity. However, experience shows that while there is overwhelming epidemiologic evidence on the negative health impacts of pollution on the population, in particular as regards air, it is difficult for the victims under the procedural rules on the burden of proof generally applicable in the Member States to demonstrate a causality link between the suffered harm and the violation. Therefore, it is necessary to adapt the burden of proof applicable to such situations. When an individual can provide sufficiently robust evidence to give rise to a presumption that the violation of this Regulation is at the origins of the damage caused to the health of an individual, or has significantly contributed to it, it should be for the defendant to rebut that presumption in order to escape his liability.

Removed(42) 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 to amend the Annexes. 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. 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.

Removed(43) 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.

Removed(44) In order to provide economic operators, EU carriers, and non-EU carriers with sufficient time to adapt to the requirements laid down in this Regulation, its application should be deferred.

RemovedHAVE ADOPTED THIS REGULATION:

RemovedArticle 1 Subject matter and scope

Removed1. This Regulation lays down obligations for the handling of plastic pellets at all stages of the supply chain to prevent losses, with the objective of achieving zero plastic pellet losses. [Am. 20]

Removed2. This Regulation applies to the following subjects:

Removed(a) economic operators handling plastic pellets in the Union in quantities above 5 tonnes in the previous calendar year;

Removed(b) EU carriers and non-EU carriers transporting plastic pellets in the Union.

RemovedArticle 2 Definitions

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

Removed(a) ‘plastic pellet’ means a small mass of preformed polymer-containing moulding material, having relatively uniform dimensions in a given lotregardless of its shape or form, including powders, cylinders, beads and flakes, to which additives might have been added, that is used as feedstock in plastic product manufacturing and plastic recycling operations; [Am. 21]

Removed(aa) 'plastic pellet dust' means the industrial residue from the handling, grinding or processing of plastic pellets, that is not used as feedstock in plastic product manufacturing operations; [Am. 22]

Removed(b) ‘spill’ means a one-off or prolonged escape of plastic pellets from primary containment; [Am. 23]

Removed(c) ‘loss’ means a one-off or prolonged escape of plastic pellets at any stage of the supply chain, including from the installation’s boundary to the environment or from road vehicles, rail wagons or inland waterway vessels transportingthe transport of plastic pellets; [Am. 24]

Removed(d) ‘installation’ means any premises, structure, environmentsite or place within which one or more economic activities involving the handling of plastic pellets are carried out; [Am. 25]

Removed(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;

Removed(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; [Am. 26]

Removed(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; [Am. 27]

Removed(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/EC;

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

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

Removed(k) ‘certifier’ means any of the following:

Removed(i) a conformity assessment body as defined in Article 2(13) of Regulation (EC) 765/2008 of the European Parliament and of the Council or any other association or group of such bodies, which has obtained accreditation in accordance with this Regulation;

Removed(ii) an environmental verifier, as defined in Article 2(20), point (b), of Regulation (EC) No 1221/2009;

Removed(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;

RemovedArticle 3 General obligations

Removed1. Economic operators, EU carriers and non-EU carriers shall ensure that losses are avoided. Where spills and losses occur, economic operators, EU carriers and non-EU carriers shall take immediate action to contain and clean-up those spills and losses. [Am. 28]

Removed2. 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.

Removed3. 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 and transport of plastic pellets, including of any closure of an existing installation, as applicable. [Am. 29]

Removed3a. Without prejudice to Regulation (EC) No 1272/2008 of the European Parliament and of the Council, economic operators shall, for the purposes of this Regulation, label all storage and transport containers containing plastic pellets in accordance with Annex IVb to this Regulation. [Am. 30]

Removed4. Competent authorities shall establish and maintain a public register containing the information they have received in accordance with paragraphs 3 and 42 and 3. The register shall be publicly available and easily accessible. [Am. 31]

RemovedArticle 4 Obligations regarding the handling of plastic pellets

Removed1. Economic operators shall take the following actions:

Removed(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;

Removed(b) install the equipment and execute the procedures described in the risk assessment plan referred to in point (a);

Removed(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.