Changes from report parliamentary committee draft to plenary report

Change 3

RemovedSHORT JUSTIFICATION

AddedRecital 1: (1) Microplastics are ubiquitous, persistent and transboundary. They are detrimental to the environment and harmful to human health, particularly due to the presence of harmful chemical additives and other substances of concern added during production and conversion, such as phthalates, bisphenol A, or flame retardants1a. Microplastics are easily transported through the air and by land surface waters and ocean currents, and their mobility is an aggravating factor. They are found in soil (including agricultural lands), lakes, rivers, estuaries, beaches, lagoons, seas, oceans and in remote, once pristine regions, and their presence in soil have effects on soil properties and trigger soil alterations which negatively impact the growth of some plants. Impacts of microplastics on the marine environment have been extensively documented. Once in the marine environment, microplastics are nearly impossible to collect, and are known to be eaten by a range of organisms and animals and cause harm to biodiversity and ecosystems. The persistence of a plastic pellet in the aquatic environment may be measured over decades or more, and ingestion of plastic pellets by marine wildlife, notably seabirds and sea turtles, may cause physical harm or death. Microplastics also contribute to climate change as an additional source both of greenhouse gas emissions and of pressure on ecosystems. Microplastics’ potential to act as a carrier for adsorbed toxicants or pathogenic microorganisms is an integra…

RemovedThe Council position at first reading reflects the agreement reached between Parliament and the Council in interinstitutional negotiations at early second-reading stage.

AddedThe inclusion of additives and substances of concerns is aligned with the definition of plastic pellets developed in the OSPAR Recommendation 2021/06 on the reduction of plastic pellet loss into the marine environment, OSPAR 21/13/1, Annex 30.

AddedRecital 4: (4) The impacts of microplastic pollution on the environment and on human health have raised concerns in most parts of the world. Some Member States have adopted or proposed dedicated measures. However, a patchwork of national restrictions could potentially hamper the functioning of the internal market.

AddedRecital 7: (7) In 2021, the parties to the Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR) adopted the non-binding Recommendation 2021/068 to reduce the loss of plastic pellets into the marine environment by promoting the timely development and implementation of effective and consistent pellet loss prevention standards and certification schemes for the entire plastic supply chain. Measures for minimizing the risk associated with the transport of plastic pellets by sea are under examination at the International Maritime Organization (IMO) in light of the significant risk of catastrophic pollution associated with maritime transport of plastic pellets. In this context, the Union should follow closely the developments at the IMO, and play a leading role in ensuring a high-level of environmental protection on this issue.

AddedRecital 7 a (new): (7a) Several accidents leading to plastic pellet spills and losses have been registered in the Union with transboundary impacts, highlighting the urgent need for ambitious, holistic measures to significantly reduce the risk of plastic pellet pollution while strengthening response capabilities in relation to plastic pellet spills throughout Union territories and waters.

AddedRecital 7 b (new): (7b) Nearly 90 % of the world's goods are transported by sea, including plastic pellets. However, poor handling practices or a lack of supervision of certain routine operations, such as cleaning hulls or containers, can lead to such pellets leaking out and spilling into the ocean. Furthermore, many maritime pellet disasters have been reported, making maritime transport a high-risk activity in relation to plastic pellet pollution. The impact of such pellet losses is catastrophic for marine and coastal ecosystems as well as the species that comprise them, and the extreme mobility of plastic pellets makes effective containment and clean-up operations difficult. The handling of such pellets is regulated at international level by the 1972 Convention for Safe Containers, and supplemented by the 2023 Sub-Committee on Carriage of Cargoes and Containers circular on the obligation to report lost containers, but they do not provide the guarantees needed to prevent pollution by plastic pellets. The inclusion of maritime transport in the scope of this Regulation, as well as of provisions relating to the handling of plastic pellets specific to this mode of transport, is therefore essential if the objectives of this Regulation are to be achieved.

AddedThese elements are developed in several international reports, including the Report 'Stemming the tide: putting an end to plastic pellet pollution' published by the NGO Fauna and Flora International in 2022’ and the OSPAR Background document on pre-production Plastic Pellets (2018).

AddedRecital 9: (9) Despite Union legislation concerning the prevention of waste, pollution, marine litter and chemicals, there are no specific Union rules preventing pellet losses as a source of microplastic pollution along the entire supply chain. Directive 2008/98/EC of the European Parliament and of the Council10 lays down basic waste management principles and imposes general obligations for Member States to take measures to prevent waste generation. Those general obligations should be complemented by addressing specific aspects and requirements for the careful handling of plastic pellets in order to prevent them from escaping into the environment.

AddedRecital 9 a (new): (9a) This Regulation provides for measures to prevent, contain and clean up plastic pellet pollution occurring following the entry into force of this Regulation, but does not provide for measures to address existing pollution. Cleaning up soil, rivers and streams, and restoring degraded terrestrial, marine, littoral and coastal ecosystems is essential to achieving the 30 % reduction target by 2030, in accordance with the objectives set out in Regulation (EU) 2024/... of the European Parliament and of the Council1a, and the objectives of the European Green Deal. The Commission should develop a set of measures to map and clean up those already polluted areas, and implement them either as part of a European strategy for depolluting microplastics, or through support and accompanying measures for Member States. More broadly, the Union should be involved in promoting solutions along the entire value chain, and should include such solutions in the ongoing negotiations on the development of an international Treaty on Plastic Pollution, as well as in the upcoming 81st session of the Marine Environment Protection Committee of the IMO (IMO MEPC). / 1a Regulation (EU) 2024/… of the European Parliament and of the Council on nature restoration and amending Regulation (EU) 2022/869 (OJ L, ....).

AddedRecital 12: (12) Commission Regulation (EU) 2023/2055 addresses losses of synthetic polymer microparticles for use at industrial sites i.e. plastic pellets as avoidable releases. For these releases, a reporting requirement for an estimated quantity of microplastics released to the environment on an annual basis is introduced. However, that reporting requirement lacks a methodology to estimate losses, and only provides annual estimates. While this requirement will increase information on pellet losses and improve the quality of the information collected to assess the risks deriving from these microplastics in the future, it is not sufficient to have an overview of the specific nature of the losses and the causes thereof.

AddedRecital 15: (15) Economic operators, EU carriers and non-EU carriers should implement the requirements on the handling of plastic pellets by following a priority order of action with the paramount goal of preventing the release of pellets in the environment as the top priority. Therefore, preventing spills of plastic pellets from containment during routine handling, thus reducing the risk of spills to the lowest possible level, should be the first step, including by avoiding any unnecessary handling (for instance by reducing the transfer points) and by labelling all storage and transport containers containing plastic pellets as well as by using appropriate packaging, followed by containment of spilled pellets to make sure they do not become a loss to the environment, and eventually by clean up after a spill or loss event as the final step.

AddedRecital 16: (16) While the aim is to achieve zero plastic pellet losses to the environment for all economic operators, obligations for micro enterprises and enterprises that handle under 1 000 tonnes of plastic pellets annually should be adjusted to mitigate the burden on them.

AddedRecital 18: (18) In order to prevent plastic pellet losses and to achieve zero plastic pellet losses, economic operators should establish, implement, and update at all times a risk assessment plan identifying potential for spills and losses and documenting in particular specific equipment and procedures in place to prevent, contain and clean up pellet losses, taking into consideration the installation size and the scale of operations.

AddedRecital 20: (20) Economic operators should put in place the specific equipment to install or the procedures 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.

AddedRecital 23: (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.

AddedRecital 24: (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 issues 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 Council15 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…

AddedRecital 25: (25) Small, 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.

AddedRecital 32: (32) As micro, small and medium-sized enterprises (SMEs) account for an important share of the pellet supply chain, they should comply with the relevant obligations laid down in this Regulation, while taking into consideration the possible different challenges linked to that compliance and the possible proportionally higher costs. 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 economic 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 support and specialised training to all 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 ru…

AddedRecital 33: (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 Council16. Pending the adoption of the standardised methodology, economic operators should indicate the methodology used when reporting losses of plastic pellets.

AddedWhile it is of course preferable to have a standardised reporting methodology for pellet losses, absence of such a method should not lead to economic operators not reporting pending the adoption of the standardised methodology. It should therefore be clarified that pending the adoption of the standardised methodology, economic operators should indicate the methodology used when reporting losses of plastic pellets.

AddedRecital 38: (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.

AddedRecital 39: (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 3% of the economic annual turnover in the Union.

AddedArticle 1 – paragraph 1: 1. 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.

AddedArticle 2 – paragraph 1 – point a: (a) ‘plastic pellet’ means a small mass of preformed polymer-containing moulding material, regardless 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;

AddedArticle 2 – paragraph 1 – point a a (new): (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.

AddedArticle 2 – paragraph 1 – point b: (b) ‘spill’ means a one-off or prolonged escape of plastic pellets from primary containment;

AddedArticle 2 – paragraph 1 – point c: (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 the transport of plastic pellets;

AddedArticle 2 – paragraph 1 – point d: (d) ‘installation’ means any premises, structure, site or place within which one or more economic activities involving the handling of plastic pellets are carried out;

AddedArticle 2 – paragraph 1 – point f: (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;

AddedArticle 2 – paragraph 1 – point g: (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;

AddedArticle 3 – paragraph 1: 1. 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.

AddedArticle 3 – paragraph 3: 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 and transport of plastic pellets, including of any closure of an existing installation, as applicable.

AddedArticle 3 – paragraph 3 a (new): 3a. Without prejudice to Regulation (EC) No 1272/2008 of the European Parliament and of the Council1a, 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. / 1a Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

AddedArticle 3 – paragraph 4: 4. Competent authorities shall establish and maintain a register containing the information they have received in accordance with paragraphs 2 and 3. The register shall be publicly available and easily accessible.

AddedArticle 4 – paragraph 2: 2. Economic operators that are small, 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 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 3 years from the last notification.

AddedArticle 4 – paragraph 2 a (new): 2a. Economic operators that are small enterprises operating installations where plastic pellets in quantities above 1 000 tonnes have been handled in the previous calendar year shall comply with the obligations laid down in paragraph 2 of this Article, unless they hold a valid certificate issued in accordance with Article 5(2a).

AddedArticle 4 – paragraph 3 – point a: (a) to change risk assessment 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 Annex I is complied with;

AddedArticle 4 – paragraph 4: 4. Competent authorities shall establish, maintain, and update a register containing the risk assessment plans, self-declarations of conformity and loss notifications provided in accordance with Annex IVa. The register shall be publicly available on a website.

AddedArticle 4 – paragraph 7 – subparagraph 1 – introductory part: Economic operators, EU carriers and non-EU carriers shall have the following obligations:

AddedArticle 4 – paragraph 7 – subparagraph 1 – point a: (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, including adequate personal protection equipment, and execute the procedures set out to ensure compliance with this Regulation;

AddedArticle 4 – paragraph 7 – subparagraph 1 – point c: (c) keep records of annually estimated quantities of losses and of the total quantities of plastic pellets handled.

AddedArticle 4 – paragraph 8: 8. Where an action taken for the prevention, containment and clean-up of spills and losses fails, economic operators, EU carriers and non-EU carriers shall take corrective actions, without delay.

AddedArticle 4 – paragraph 9 – introductory part: 9. Every year economic operators that are not micro enterprises or 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 shall among others cover the following subjects:

AddedArticle 4 – paragraph 9 – point b: (b) the preventive, containment and clean up equipment and/or procedures implemented to avoid future losses, and an evaluation of their effectiveness;

AddedArticle 4 – paragraph 9 – point c: (c) discussions with and training programmes involving the personnel, inspections of equipment, including adequate personal protection equipment, and procedures in place and revision of any relevant documentation.

AddedArticle 4 – paragraph 9 – subparagraph 1 a (new): The economic operators referred to in the first subparagraph shall maintain records of the assessments and of any actions taken subsequently, and shall make such records available to competent authorities on demand.

AddedArticle 5 – paragraph 2: 2. By … [OP: please insert the date = 36 months after the entry into force of this Regulation], and thereafter every three 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.

AddedArticle 5 – paragraph 2 a (new): 2a. By … [60 months from the entry into force of this Regulation], economic operators that are small 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. That certificate shall be valid for 5 years.

AddedArticle 5 – paragraph 3: 3. Certifiers shall carry out spot-checks and inspections of sites, means of transport and immediately surrounding areas to ensure that all measures included in the risk assessment plan carried out in accordance with Annex I are duly implemented.

AddedArticle 7 – paragraph 1 – introductory part: The accreditation of certifiers referred to in Article 2, point (k)(i) shall include an evaluation of compliance with the following requirements:

AddedArticle 8 – paragraph 1: 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 unannounced environmental inspections and other verification measures, following a risk-based approach.

AddedArticle 8 – paragraph 2 – introductory part: 2. At the latest by … [OP please insert the date = the first day of the month after three 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:

AddedArticle 8 – paragraph 2 – point a: (a) the number of economic operators per size of enterprise according to Commission Recommendation 2003/361/EC and per economic activity, their installations and the quantities of plastic pellets handled by them, and of the EU carriers and their means of transport allocated to transporting plastic pellets and the quantities handled by them;

AddedArticle 8 – paragraph 3 a (new): 3a. Every three years, based on the reports of Member States referred to in paragraph 2, the Commission shall produce a synthesis report on compliance and reporting, setting out the qualitative and quantitative information on the implementation of this Regulation contained in the Member States’ reports.

AddedArticle 9 – paragraph 1 – introductory part: 1. Without prejudice to Directive 2004/35/EC, in the event of an incidental or accidental loss affecting human health or the environment, economic operators, EU carriers and non-EU carriers shall immediately:

AddedArticle 9 – paragraph 1 – point a: (a) inform the competent authority in whose territory the incident or accident occurred, as well as the competent authority of any territory that is likely to be affected, and the estimated quantities of losses in accordance with the form set out in Annex IVa;

AddedArticle 9 – paragraph 1 – point a a (new): (aa) take measures to contain and clean up such losses in an ecologically sensitive manner;

AddedArticle 9 – paragraph 1 – point b: (b) take all possible measures to minimise the health or environmental consequences, and to prevent further incidents or accidents.