Explanatory Memorandum to COM(2023)645 - Preventing plastic pellet losses to reduce microplastic pollution

Please note

This page contains a limited version of this dossier in the EU Monitor.



1. CONTEXT OF THE PROPOSAL

In 2018, the EU Strategy for Plastics in a Circular Economy1 acknowledged the risks posed by microplastics and advocated innovative solutions targeting different sources. In 2019, the European Commission’s group of Chief Scientific Advisers recognised the potential risks posed by microplastics and encouraged precautionary action.2 In 2020, as a follow-up action of the European Green Deal3, the Circular Economy Action Plan 2.04 committed the Commission to tackling the presence of microplastics in the environment by:


- restricting intentionally added microplastics in products;
- addressing unintentional releases of microplastics by developing inter alia, standardisation, certification and regulatory measures as well as harmonising methods for measuring their releases.


In 2021, in its Action plan: ‘Towards zero pollution for Air, Water and Soil’5, the Commission proposed that, by 2030, the EU should reduce (intentional and unintentional) microplastic releases into the environment by 30%.


On 25 September, the European Commission adopted a Regulation restricting microplastics intentionally added to products.6 This proposal on preventing plastic pellet losses to the environment and its accompanying Impact Assessment (IA) stems from the Commission’s commitments on unintentional releases of microplastics.

1.1 Reasons for and objectives of the proposal

Plastic pellet losses to the environment are the 3rd source of all unintentional microplastic releases. Other main sources include paints, tyres, textiles, geotextiles and, to a lesser degree, detergent capsules. Preventing microplastic releases from these sources may require major substitutions or changes to product characteristics. In contrast, plastic pellet losses are due to a lack of awareness and poor handling and therefore can be abated by swift measures to prevent such avoidable pollution. This makes plastic pellets a primary candidate for policy intervention.


Plastic pellets, also referred to as nurdles, nibs, preproduction pellets, and resin pellets, are the industrial raw material used for all plastic production. Current practices for handling pellets lead to losses at all supply chain stages, notably production (virgin or recycled), processing, transport and other logistics and waste management operations. Once in the environment, they are almost impossible to capture. Their mobility is an aggravating factor. Like all microplastics, plastic pellets that escape from industrial installations or during transport are easily transported through the air and by land surface waters and marine currents and can also be found in soil (including agricultural lands).


Four types of adverse impacts can be observed from pellet losses: on the environment; on climate; potentially on human health; and on the economy. Some of these impacts are specifically related to pellets, others are related to microplastics in general. Pellets are known to be eaten by a range of marine and coastal species (e.g. sea turtles, seabirds and shellfish). Once ingested, they can cause physical harm or death. If they cannot pass through the digestive system, they can lead to malnutrition or starvation. Like all microplastics, their potential to act as a carrier for adsorbed toxicants or pathogenic microorganisms is an integral part of the problem. Plastics and microplastics contribute to climate change by being an additional source of both greenhouse gas (GHG) emissions and pressure on ecosystems and biodiversity. Indeed, GHGs are emitted throughout the plastic life cycle, from production to degradation processes, and plastics in the oceans may also interfere with the oceans’ capacity to absorb and sequester carbon dioxide. Humans are exposed to microplastics via air and food consumption. There are potential negative economic impacts from microplastics, including plastic pellets, on local activities such as commercial fishing and agriculture (e.g., reduced fishing harvest due to impacts on marine habitats, eco-systems and wildlife) as well as tourism and recreation (e.g. reduced attractiveness or closing of beaches and vulnerable areas like national parks, rivers and lakes).


High volumes of pellets are produced and handled every year, both globally and in the EU (around 57 million tons in the EU in 2021). Estimates show that between 52 140 tonnes and 184 290 tonnes of pellets were lost to the environment in the EU in 2019. This is equivalent to between 2100 and 7300 trucks full of pellets per year.


The evidence collected to support the accompanying IA and the inception IA, as well as the public consultation and an additional consultation targeting SMEs, suggest that stakeholders are in favour of all levels of public authorities undertaking action to reduce microplastic pollution. Stakeholders also refer to the industry’s voluntary work in this field as a course of action, notably the Operation Clean Sweep® programme (OCS).


This proposal aims to reduce pellet losses to the environment and would lead to a 54% to 74% decrease compared to the baseline, equivalent to a 6% reduction in the total amount of unintentional microplastic releases. In line with the Commission’s 30% overall reduction target for microplastics released to the environment, it will help preserving ecosystems and biodiversity, decreasing potential health impacts and benefiting local economic activities. It also has the potential to improve information on the magnitude of pellet losses throughout the pellet supply chain. Lighter requirements for SMEs will ensure the appropriate mitigation of potential impacts on their operations.


1.2 Consistency with existing EU policies

The proposal on preventing pellet losses to the environment supports the objectives of the European Green Deal contributing to resolving the triple crises of climate change, pollution, and biodiversity loss. It will also reinforce overarching strategies such as the Plastics Strategy, the Circular Economy Action Plan and the Zero Pollution Action Plan. Microplastic pollution originates from:

1.

1. the abandoned, discarded or improper disposal of larger plastic products and their degradation into smaller plastic pieces in the environment;

2. microplastics added intentionally to certain products, such as cosmetics, which ultimately find their way into the environment; and
3. microplastics released unintentionally, mainly due to abrasion during use or to poor handling.


On ‘macroplastics’, the Union has already taken a number of regulatory measures to tackle pollution coming from larger plastic products that leak into the environment, including the Single Use Plastics Directive (SUPD)7, the Waste Framework Directive (WFD)8, the Packaging and Packaging Waste Directive (PPWD)9 and the Marine Strategy Framework Directive (MSFD)10. These measures contribute to reducing the generation of plastic waste, improving its collection and recycling, and incentivising the use of recycled content in new products, thus reducing the amount of plastic litter in the environment.


Regarding ‘unintentionally released microplastics’, beyond plastic pellets, the Commission has examined several other main sources of unintentional release, such as paints, tyres, synthetic textiles, geotextiles and, to a lesser degree, detergent capsules. Measures tackling microplastic releases from tyres have already been included in the EURO 7 Regulation proposal. The preliminary analysis of the other sources revealed uncertainties and data gaps and concluded that other policy instruments may be better suited to tackle them. More information and additional analysis are needed in order to define the most appropriate interventions. For these sources, separate impact assessments may be prepared, where appropriate and necessary, to support possible proposals to tackle microplastic emissions from these sources.


Regarding industrial emissions, the Industrial Emissions Directive (IED)11 is the piece of legislation that regulates and manages emissions from large industrial plants. Plastic pellet losses are not specifically addressed in existing Best Available Technique conclusions. The rules set out in this Regulation should apply without prejudice to the application of the IED.


The proposal on preventing pellet losses to the environment complements the pellet provisions contained in the REACH restriction on intentionally added microplastics. This restriction addresses plastic pellets as an avoidable source of releases, by imposing two obligations on economic operators: (1) to provide information on the use and disposal of pellets e.g. via labelling, and (2) to report on estimates of quantities released on an annual basis. While increasing information on pellet uses and losses, these obligations are not further specified and a methodology on how to estimate losses is not introduced. The comprehensive obligations and standardised methodology included in this new proposal will help prevent pellet losses at the source and improve the information collected on estimated releases.


The proposal is consistent with the non-binding Recommendation of the Convention for the Protection of the Maritime Environment of the North-East Atlantic (OSPAR) on plastic pellets, promoting prevention standards and certification schemes for the entire plastic supply chain.12 The International Maritime Organisation (IMO) is looking at the carriage of plastic pellets by sea in freight containers and is assessing both voluntary and mandatory measures, which would subject pellet-handling operators to stricter requirements.


The proposal aims to pave the way for provisions on microplastics in the context of the ongoing negotiations on a Global Treaty on Plastic pollution. The EU and its Member States “stress the need for the future instrument to include measures to reduce unintended release of microplastics. This could include, for example, measures to minimise the risk of leakages of plastic pellets from production, handling and transport”.13


The proposal contributes to the implementation of the UN 2030 Agenda for Sustainable Development guided by the 17 Sustainable Development Goals (SDG), specifically: goal 12 on sustainable consumption and production, goal 14 on the conservation and sustainable use of the oceans, seas and marine resources for sustainable development and goal 15 on life on lands, together with goals 3 on good health, 9 on industry, innovation and infrastructure, and 13 on climate.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

2.1 Legal basis

This initiative is based on Article 192(1) of the Treaty on the Functioning of the European Union (TFEU) as it will increase the level of environmental protection across the EU. While it will also lead to further harmonisation of pellet handling, thus preventing market fragmentation due to different national approaches across Member States, the environmental protection dimension is predominant.

2.2 Subsidiarity

A common set of requirements for pellet handling within the Union is essential to ensuring a high level of environmental protection. Like all microplastics, pellets are readily transported from one geographical place to another and can be found in all environments including the most remote places. While pellet losses are usually concentrated at first in one geographical area (petrochemical or polymer industrial areas, logistic platforms like ports, etc.), they are extremely mobile and can then be dispersed by land surface waters and ocean currents, as well as through the air. The transboundary nature of the problem is the most important reason to act at EU level. If Member States act individually, the action would be less cost-effective, and the level of environmental protection would remain suboptimal. There is also a risk that competing different legislation would be established.

2.3 Proportionality

The requirements in the proposal do not exceed what is necessary to enable economic operators running installations where plastic pellets are handled in quantities higher than 5 tonnes per year, as well as EU and non-EU carriers, to safely and responsibly handle such pellets. They are based on existing best handling practices, notably the industry Operation Clean Sweep® programme (OCS) and the non-binding Recommendation adopted by the parties to the Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR). The proportionality of the requirements is ensured by introducing lighter requirements for SMEs, where necessary, as the result of thorough stakeholder consultation. National competent authorities in charge of verifying industry compliance will be supported by the work of certifiers that will be tasked with certification. This system will provide a high degree of legal certainty and facilitate enforcement activities.

2.4 Choice of the instrument

The proposal is a stand-alone legal instrument that would not amend existing legislation. It sets requirements to be implemented by the entire pellet supply chain as well as rules on a compliance system based on third-party certification, self-declaration, and compliance verification by national public authorities. Given that it aims to ensure a high level of environmental protection through changes to economic operators’ handling behaviour, a Regulation is considered the most appropriate legal instrument.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

No ex-post evaluation was carried out as there is no existing regulatory framework at EU level addressing plastic pellet pollution across the entire pellet supply chain.

3.1 Stakeholder consultations

2.

The Commission consulted stakeholders via:



1. A public consultation on the originally identified sources with the highest known unintentional releases of microplastics, i.e. plastic pellets, synthetic textiles, tyres, paints, geotextiles and detergent capsules for laundry and dishwashers, from 22 February to 17 May 2022. During the consultation, 410 contributions were made. All stakeholders agreed on the hazardous nature of microplastic pollution in the Union, its negative impact on the environment and human health, and the need to take action at all levels of authority. Regarding pellet losses, stakeholders agreed that improper handling was the major factor.


2. A second consultation targeting SMEs handling pellets from January to February 2023. During this second consultation, 330 contributions were made. A majority of the respondents was in favour of making the requirements mandatory if requirements are lighter for smaller companies. Several requirements were estimated to be too burdensome for micro (less than 10 persons employed) and small (10-49 persons employed) enterprises, as well as firms with capacities below 1000 tonnes per year (average annual tonnage handled by small enterprises). SMEs did not favour the obligation of being externally audited. Among the best handling practices, the mandatory use of specific equipment and packaging (i.e. airtight, puncture-resistant and environmentally sealed) was identified as the most expensive measure. Finally, respondents identified financial support and a standardised methodology to measure pellet losses as the best ways to support them.


3. Workshops and bilateral contacts from September 2021 to May 2023 during which environmental NGOs strongly supported mandatory requirements for pellet handling at the EU level, along with a comprehensive and transparent certification scheme. The umbrella association of European plastic manufacturers, PlasticsEurope, agreed that the most effective approach to tackling pellet losses is mandatory external auditing and certification building on OCS and applied to all actors. Producers considered a legislative proposal requiring certification of an OCS-like pellet loss prevention system would be very quickly implementable by all actors because it would benefit from the existing industry initiative and would reinforce it. The umbrella association of European recyclers, PRE, favoured an EU-wide legally binding instrument to enable a level-playing field in the single market among all actors. The umbrella association of European converters, EuPC, pointed to limited resources as a barrier to implementing best handling practices.


3.2 Impact assessment

3.2.1 Problem definition & preferred policy option


The proposal is based on the Impact Assessment (IA) accompanying the proposal on preventing pellet losses to the environment. The Commission’s Regulatory Scrutiny Board (RSB) first issued a negative opinion with comprehensive comments on 18 November 2022. After a significant revision of the initial draft, the RSB provided a positive opinion with reservations on 12 June 202314. Annex I of the Impact Assessment explains how the RSB comments were addressed.


The IA identifies the following problem: current practices for handling pellets lead to losses at each stage in the supply chain, causing adverse environmental and potential human health impacts. The following drivers were identified:



- Market failures - prices do not reflect negative externalities and imperfect information for market actors. A lack of specific support and attention for smaller companies, for whom preventive measures are costly to implement, also explains a suboptimal market outcome.



- Regulatory failure - existing relevant regulatory frameworks (governing chemicals, marine litter, water, industrial emissions, waste, packaging and transport activities) do not specifically address the issue of pellet losses and their safe and responsible handling across the entire pellet supply chain.


In the IA, four policy options were assessed to address these problems and drivers:

- Option 1: Mandatory standardised methodology to measure pellet losses

- Option 2: Mandatory requirements to prevent and reduce pellet losses in a new EU law, including three sub-options with lighter requirements for SMEs:

2a: micro-companies;

2b: micro- and small companies;

2c: micro-, small and medium companies;

- Option 3: Improved packaging for pellet logistics

- Option 4: EU target to reduce pellet losses

Based on a cost-benefit analysis, and a qualitative assessment of the proportionality, coherence, effectiveness and efficiency of the various options considered, a combination of two policy options was proposed as the preferred policy option:


- Option 1 - Mandatory standardised methodology to measure pellet losses to address the sub-problem ‘Imperfect information’ and contribute to improve information on the magnitude of pellet losses throughout the pellet supply chain. It will also facilitate the pellet losses reporting requirement under the REACH restriction.


- Sub-option 2b - Mandatory requirements in a new EU law with lighter requirements for micro and small companies to address the drivers ‘Prices do not reflect externalities’, ‘Imperfect information’ and ‘Regulatory failure’. By focusing on prevention, it will contribute to reducing pellet losses, in an economically proportionate manner, to a level consistent with the Commission’s overall reduction target of 30% of microplastic releases by 2030, and also to ensure the appropriate mitigation of impacts on SMEs involved in the pellet supply chain.


Option 3 would entail quite high investment costs for the sector, and its cost effectiveness would be lower than for Option 2. Option 4 would require the establishment of a performant monitoring system first, which would take time. Its implementation would be more challenging, and its costs would be slightly higher than under Options 2 and 2a-c. Sub-option 2b would have a relatively high reduction of pellet losses, and costs would be lower than under Option 2a thanks to lighter requirements for micro- and small enterprises. This option has the highest cost-effectiveness of the (sub)options 2, 2a-c.


3.2.2. Impacts of the preferred policy option

The impacts listed below concern the preferred policy option as a whole and thus encompass provisions from both Option 1 and Sub-option 2b.

- Expected impacts of developing a mandatory standardised measurement methodology

The preferred policy option introduces the development of a standardised methodology to measure pellet losses and mandates its use, once developed, to complement the reporting requirement on estimates of quantities released, introduced in the REACH restriction. This restriction does not provide for a methodology to measure pellet losses.

By introducing a standardised methodology, the preferred policy option entails one-off costs to develop and test the methodology. The European Committee for Standardisation (CEN) typically takes 3-4 years to complete the process. Either the industry could bear this cost, or the Commission could provide support through a dedicated study. When developing the methodology, CEN will take into account the work carried out by the industry in this field.

It was estimated that the total cost to develop and test the methodology would be between EUR 1 258 000 and EUR 3 174 000. As the methodology will be based on work done by the industry, it is estimated that the lower end of the cost estimation is more likely. The reporting costs incurred by the industry using the methodology are already considered under the REACH restriction. This applies also to the costs incurred by ECHA to process the information collected.

By providing economic operators with one standardised methodology, instead of several ones that otherwise could be used, the preferred policy option aims at cost savings: (1) economic operators do not have to each develop a methodology; (2) reporting to ECHA is simplified; and (3) the quality of the reporting is higher, as one methodology allows for comparability of data and, ultimately, a better understanding of volumes of pellet losses.

The cost savings are estimated to be higher than the development costs. This approach is fully aligned with the commitment articulated in the Communication entitled “Better regulation: joining forces to make better laws”.15 While there are no direct reductions of pellet losses under Option 1, a standardised methodology to measure losses will enable economic operators and public authorities to better tackle pellet losses by improving information, reporting and monitoring of pellet losses.

- Expected impacts of introducing mandatory requirements to prevent pellet losses and related compliance system

The preferred policy option introduces mandatory requirements to prevent pellet losses to the environment for the entire pellet supply chain, thus maximising the chances of reducing such losses.

In line with the polluter pays principle, the sector bears the costs of the measures required to comply with the requirements and demonstrate compliance via third-party certification or self-declaration. The public authorities in the Member States are responsible for keeping a public register related to compliance, and in the case of non-compliance, for imposing corrective measures and, where relevant, penalties.

By imposing mandatory requirements based on the work carried out by the industry on pellet loss prevention, containment and clean-up, and by introducing the obligation to demonstrate compliance there are direct compliance costs for the sector. Lighter requirements for the smaller enterprises (micro- and small) are expected to mitigate the impacts on these enterprises. Overall, the net cost of implementing Sub-option 2b is expected to be EUR 376 - 491 million per year.

Regarding administrative and enforcement costs for the national competent authorities, these include the setting up and maintenance of a public register, the compliance verification, complaint-handling mechanisms and access to justice as well as the reporting to the Commission on the implementation of this Regulation every three years. Overall, the costs for the Member States are expected to be EUR 313 000 for the first year and then EUR 125 000 per year for the whole EU. These costs will vary across Member States as they would be higher for larger ones and lower for smaller ones.

Since this option may increase the cost of plastic raw materials, the general public may be impacted by an increase in the cost of plastic goods. However, the cost increase, if any, is likely to be limited as the cost of implementing best handling practices is small compared to the turnover of the sector. It is therefore expected that manufacturers will absorb such a slight increase in their production costs leaving consumers unaffected.

There is a significant reduction of pellet losses to the environment, thus reducing microplastic pollution and preserving ecosystems and biodiversity. It also constitutes a precautionary measure against potential human health impacts. The reduction of pellet losses is expected to range from 25 142 tonnes/year to 140 621 tonnes/year. The preferred policy option is thus expected to contribute to around 1/4th of the Commission’s 30% reduction target for microplastics.

Other benefits include a level playing field among economic operators by guaranteeing that the position of companies applying reduction measures is not weakened by competition from companies that do not apply such measures as in the current voluntary system. For businesses owning the pellets, benefits include an estimated economic gain of EUR 25 to 141 million associated with the amount of pellets not lost to the environment.

Reducing pellet losses is expected to have positive knock-on economic impacts on certain sectors such as commercial fishing, agriculture, tourism and recreation in areas affected by the releases. There would be fewer pellets lost to the marine environment and, thus, fewer perturbations to marine species, including economically important ones such as oyster and seabass. Similarly, there will be fewer pellets lost to installations’ wastewater and in the sewage sludge resulting from the wastewater’s treatment, thus fewer pellets lost to the soil after the application of sludge on agricultural land, where this occurs.

The preferred policy option helps create new jobs as implementing best handling practices is expected to require additional staff (3 858 full-time equivalent). It also helps prevent certain costs for society such as those related to clean up and remediation activities by local communities in areas affected by the releases. These operations are normally challenging as they require technological, human and financial resources.

The preferred policy option is in accordance with the climate neutrality objectives outlined in the European Climate Law, as well as the Union's 2030 and 2050 targets. Its most significant contribution to climate mitigation lies in its ability to prevent the dispersion of plastic pellets into the environment. Preventing plastic pellet pollution at source is expected to result in lower greenhouse gas emissions since less plastic production will be required. Furthermore, there may be positive indirect effects on plankton growth, which, in turn, contributes to carbon sequestration.

Regulatory fitness and simplification

By introducing one measurement methodology and one set of requirements to prevent pellet losses, the preferred policy option helps reduce the risk of legal fragmentation, thus increasing legal certainty and strengthening the functioning of the internal market. This, in turn, is expected to result in some cost savings for businesses and for national competent authorities responsible for the implementation and enforcement of the law.

The preferred policy option contains a derogation for companies making and handling pellets in quantities lower than 5 tonnes to avoid costly investments with very limited environmental benefits in terms of pellet loss reduction. In addition, in response to the 2023 consultation targeting SMEs handling pellets, lighter requirements for the smaller enterprises (micro- and small) are expected to mitigate direct compliance costs on these enterprises (e.g. enterprises may take into account the nature and size of the installation as well as the scale of its operations, no obligation to invest in more expensive equipment like sewage treatment systems). In addition, the Commission and the Member States should provide technical and financial support to the smaller enterprises (micro- and small), such as SME-specific guidance and training materials and tools.

The preferred policy option contains rules on the submission of information, including from certification, made in both the physical and digital environments and is thus considered digital-ready.

The preferred policy option is likely to only have a minor negative impact on the competitiveness of the EU plastics sector, as the estimated costs only represent a very small part of their turnover (about 0.13%).

The administrative costs of the preferred policy option (setting up systems in businesses for administrative procedures to report pellet losses, internal assessments and certification, notifying public authorities of the certification) for businesses are assessed at EUR 44 million. The related adjustment costs (developing and applying the measurement standard, adapting operations and procedures to the new requirements, implementing pellet loss reduction measures) for businesses are assessed at EUR 332 – 447 million. There might be other minor adjustments costs as the increase in the price of pellets could be passed on to the downstream users and, ultimately citizens because of an increase in the price of plastic products.

The proposal reflects the preferred policy option as described above, both regarding the mandatory requirements and the related compliance system. To further mitigate direct compliance costs on SMEs, the proposal contains additional lighter requirements compared to the preferred policy option. These additional lighter requirements are described further, in Section 6.2. In particular, micro- and small enterprises as well as installations handling plastic pellets in quantities below 1000 tonnes per year, will have to provide a self-declaration to demonstrate compliance instead of being certified. These additional measures will lead to a further reduction of the administrative costs entailed by the preferred policy option of EUR 24.6 million (from EUR 44 million down to EUR 19.4 million) and a further reduction in compliance cost of EUR 16.9 million (from EUR 332 – 447 million down to EUR 315 – 430 million). The sum of the additional reduction of costs of EUR 41.5 million would be around 10% of the total net cost as calculated for the preferred policy option (from EUR 376 – 491 million down to 334 – 450 million). For micro and small enterprises, the additional reduction is equivalent to almost 15% of the net cost.

It is difficult to estimate the consequence of these additional lighter requirements on the reduction of pellets losses. It is probable that the additional lighter requirements would lead to an increase in pellet losses. If assumed that pellet losses would increase with 10%, then these additional lighter requirements would lower the reduction in pellet losses by about 2 500 to 14 000 t/year compared to the preferred policy option.

Fundamental rights

The preferred policy option is in accordance with Article 37 of the Charter of Fundamental Rights, according to which the EU must ensure a high level of environmental protection and a quality environment.

4. BUDGETARY IMPLICATIONS

The proposal does not require new or significant budgetary allocations to be implemented. Advisory initiatives belonging to the InvestEU Advisory hub can be activated to support SMEs to comply with requirements, also in collaboration with the European Enterprise Network. The Commission will factor in any need for support services and studies.

5. OTHER ELEMENTS

Implementation plans and monitoring, evaluation and reporting arrangements

Every three years, Member States are required to supply the Commission with data on the notifications by certifiers about the certificates issued. In addition, in order to better track performance against the Commission’s overall reduction target of 30% by 2030, a commonly validated estimate of total pellet losses is required. An initial estimate has been compiled for the accompanying IA, however further work is needed to expand this in the coming years. This will be enhanced by the standardised measurement methodology and the REACH reporting requirement. Stakeholders largely agree with a system to monitor and report on releases.

6 Detailed explanation of the specific provisions of the proposal

6.1. Purpose and scope of the proposal

Article 1 specifies the subject matter of the proposal i.e., obligations for the handling of plastic pellets at all stages of the supply chain to prevent losses. Article 1 also sets the scope i.e. all economic operators involved in the handling of plastic pellets in the Union in quantities above five tonnes per year, and EU carriers and non-EU carriers transporting plastic pellets in the Union.

6.2 General obligations and requirements

Regardless of the handling requirements outlined in this Regulation, which must be implemented within 18 months of its entry into force, Article 3 establishes a general obligation for economic operators, EU carriers, and non-EU carriers to prevent losses. This obligation applies from the moment the Regulation enters into force. Furthermore, to enable national competent authorities to efficiently carry out compliance checks, economic operators and EU carriers must inform them about their activities involving the handling of plastic pellets. Article 4 requires all economic operators, EU carriers and non-EU carriers to comply with the requirements set out in this Regulation within 18 months of its entry into force. It also requires them to perform action in the following priority order: prevention to avoid any spills of pellets from primary containment; containment of spilled pellets to make sure they do not become a loss to the environment, and, as a final option, clean up after a spill or loss event.

Article 5 details the requirements to comply with. These are based on the industry Operation Clean Sweep® programme (OCS) and the non-binding Recommendation adopted by the parties to the Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR)16. The requirements are the following:

For economic operators operating installations where plastic pellets are handled, to set up, implement and keep up-to-date a risk assessment plan in accordance with Annex I;

For economic operators operating installations where plastic pellets are handled, to send their risk assessment plan to the competent authorities together with a self-declaration of conformity issued in accordance with the model form set out in Annex II;

For EU carriers and non-EU carriers, to implement certain actions in accordance with Annex III;

For installations and EU carriers, to train their staff;

For installations and EU carriers, to monitor and keep records of their relevant implementing actions including, where appropriate, adopting corrective actions, and of the estimates of pellet losses as well as to address significant plastic pellet incidents and accidents;

For economic operators that are medium and large enterprises running installations handling plastic pellets in quantities above 1000 tonnes per year, to carry out an annual internal assessment alongside additional measures within the risk assessment plan, in accordance with Annex 1.

For economic operators that are medium and large enterprises running installations handling plastic pellets in quantities above 1000 tonnes per year, to be certified in accordance with the model form set out in Annex 3.

To further mitigate impacts on SMEs, the proposal contains additional lighter requirements for their installations to those already contained in the preferred policy option. These requirements take the following form for micro-and small enterprises as well as installations handling plastic pellets in quantities below 1000 tonnes per year:

- No obligation of third-party certification but self-declaration of conformity, as well as a longer validity of the self-declaration (five years);

- No obligation to carry out internal assessments;

- No obligation to review compliance assessments at formal management meetings; and

- No obligation to establish an awareness and training programme.

Article 4 requires all economic operators, EU carriers and non-EU carriers to comply with the requirements set out in this Regulation within 18 months of its entry into force. It also requires them to perform action in the following priority order: prevention to avoid any spills of pellets from primary containment; containment of spilled pellets to make sure they do not become a loss to the environment, and, as a final option, clean up after a spill or loss event.

Economic operators that are medium-sized enterprises running installations handling plastic pellets in quantities above 1000 tonnes per year, will be subject to the following lighter requirement:

- Certification with a longer transitional period than for large enterprises before first certification (36 months instead of 24) and a longer validity of the certificate (four years instead of three).

Similarly, specific requirements apply to carriers and non-EU carriers transporting plastic pellets in light of the specificities of their pellet-related activities.

6.3 Compliance system

Article 5 details obligations regarding certifications to be carried out, at the site level, to facilitate national competent authorities’ compliance checks. Certifications (resulting in certificates of conformity as described in Article 5 are phased in over a certain period. Annex II provides for the format of the certificate of conformity. Certifiers must be any natural or legal person, or any association or group of such persons, who have obtained a licence to carry out verification and validation in accordance with the EMAS Regulation, or officially accredited bodies, with no conflicts of interest, and with the required expertise, equipment and infrastructure. Article 7 defines provisions for the certifiers to fulfil in order to be accredited by the Member States. When assessing conformity, certifiers must use spot-checks. Once the certifiers have issued a certificate, they are required to notify the competent authority thereof, who must keep a corresponding register. Such register must be publicly available on a website for transparency purposes.

According to Article 6, economic operators that are registered to the Community eco-management and audit scheme (‘EMAS’) will be deemed compliant and therefore exempted from the obligation of obtaining a certificate and of notifying the renewals of the risk assessment plan and self-declaration of conformity pursuant to this Regulation.

Where applicable, economic operators are required to notify the competent authority of their self-declarations of conformity. Competent authorities must keep a corresponding register, which must be publicly available on a website for transparency purposes.

6.4 Enforcement provisions

Article 8 sets out that the national competent authorities are in charge of verifying economic operators’, carriers’ and non-EU carriers’ compliance with the requirements and rules of the Regulation. They are expected to perform environmental inspections or other checks, taking into account information sent by certifiers and economic operators (self-declarations, risk assessment plans) as well as addressing complaints filed by natural or legal persons or organisations according to Article 14. Article 8 also sets out reporting obligations for Member States, namely the submission every three years of a report to the Commission on the implementation of this Regulation.

Article 4 entitles national competent authorities to require economic operators to implement further measures in case those established in the plans and implemented are not considered sufficient. Article 9 empowers them to impose on economic operators, EU carriers and non-EU carriers any appropriate follow-up measures in case of severe incidents and accidents. Article 10 sets out that, in case of non-compliance leading to an immediate danger to human health or significant adverse effects upon the environment, competent authorities should be able to order the suspension of operations. Powers to investigate and enforce are defined in Article 11. Regarding infringements, Article 15 defines a series of obligations for Member States to respect when defining their penalty regime.

Article 16 on compensation aims at securing that, where damage to health has occurred, fully or partially as a result of a violation of this Regulation, the public concerned is able to claim and obtain compensation for that damage from the natural or legal persons responsible for the violation and, where relevant from relevant competent authorities.

Article 17 sets out the exercise of the delegation. The rules of adoption of delegated acts are set out in Article 18.

6.5 Assistance to SMEs

Article 12 ensures initiatives are taken to help SMEs in the pellet supply chain implement the Regulation. In particular, the Commission is required to set up awareness raising and training material on the sound implementation of the requirements laid down in this Regulation. Member States should ensure these enterprises get access to information and assistance regarding compliance with the Regulation. Without prejudice to applicable state aid rules, Member States’ assistance may take the form of: financial support; access to finance; specialised management and staff training; and organisational and technical assistance.

6.6 Standardised methodology

While observable, plastic pellet losses are not routinely measured. The REACH reporting requirement on estimates of pellet lost on a yearly basis will contribute to increased information on pellet losses. However, it does not provide for any methodology to measure pellet losses. Article 13 requires the Commission to request European standardisation organisations to establish a standard to estimate quantities of pellets lost to the environment.