REGULATORY SCRUTINY BOARD OPINION Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on preventing plastic pellet losses to reduce microplastic pollution

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    EUROPEAN COMMISSION
    Brussels, 12.6.2023
    SEC(2023) 346 final
    REGULATORY SCRUTINY BOARD OPINION
    Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
    COUNCIL on preventing plastic pellet losses to reduce microplastic pollution
    {COM(2023) 645 final}
    {SWD(2023) 330 final}
    {SWD(2023) 332 final}
    {SWD(2023) 333 final}
    Offentligt
    KOM (2023) 0645 - SEK-dokument
    Europaudvalget 2023
    ________________________________
    Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
    regulatory-scrutiny-board@ec.europa.eu
    EUROPEAN COMMISSION
    REGULATORY SCRUTINY BOARD
    Brussels,
    RSB
    Opinion
    Title: Impact assessment / Measures to reduce the release of
    microplastics in the environment
    Overall 2nd
    opinion: POSITIVE WITH RESERVATIONS
    (A) Policy context
    Microplastics are considered pollutants in the environment. Some microplastics are
    intentionally added to products (e.g. in cosmetics, detergents, paints) or serve as input for
    further processing (e.g. plastic pellets). Other microplastics originate from the abrasion of
    larger plastic objects (e.g. painted surfaces, geotextiles, tyres, textile fibres).
    This initiative focuses on the unintentional release of pellets and stems from the EU Action
    Plan towards zero pollution for air, water and soil which aims to reduce microplastics
    released into the environment by 30% by 2030.
    (B) Summary of findings
    The Board notes the improvements made to the report responding to the Board’s
    previous opinion.
    However, the report still contains significant shortcomings. The Board gives a
    positive opinion with reservations because it expects the DG to rectify the following
    aspects:
    (1) The report does not sufficiently justify why only measures for pellets are
    proposed at this stage and not for other sources, given that the precautionary
    principle is invoked.
    (2) The design of the options does not bring out clearly all available policy choices.
    (3) The impact analysis is not sufficiently developed. The comparison of options is
    not based on an assessment of their effectiveness, efficiency, coherence and
    proportionality.
    (4) The analysis of the impacts on SMEs and EU sector competitiveness is
    inadequate.
    Ref. Ares(2023)4068166 - 12/06/2023
    2
    (C) What to improve
    (1) The report should reinforce the narrative as to why this impact assessment focusses
    solely on pellets given that it states that the need to act is justified by the precautionary
    principle. The report should clarify what additional information would be needed to trigger
    action for the other sources of unintentional microplastic pollution to improve the analysis.
    (2) The report should discuss the contribution of action on pellets to solving the entire
    problem of microplastics released in the environment, including from the degradation of
    macroplastics and define the relative scale of the microplastics from pellets problem. It
    should discuss if taking measures on pellets first would be most effective and efficient to
    reach the target of 30% reduction of microplastics from the Action Plan or if measures on
    other sources would be more urgent and contribute more to this target. Moreover, it should
    clarify if this 30% target refers to microplastics in general (including degradation of
    macroplastics) or if it is for intentionally and unintentionally added microplastics, i.e.
    excluding degradation from macroplastics.
    (3) The report should further discuss the magnitude of the environmental impact of pellets
    and the reliability of the estimates, including reference to scientific studies to support
    anecdotal evidence. It should identify the potential harmful climate and human health
    impacts from pellets specifically and be clear about the strength of scientific evidence in
    this area, justifying the invocation of the precautionary principle.
    (4) The design of options should bring out clearly the available policy choices. On the one
    hand, the report should identify and clarify which actors in the supply chain are responsible
    for most losses.. It should be more specific on the measures proposed, in particular, on the
    operational controls, the equipment and the lighter regimes for SMEs, and consider if more
    targeted alternative options would be feasible regarding some of these measures.. It should
    explain how these measures go beyond existing environmental management systems. On
    the other hand, if combinations of options are considered necessary to tackle all identified
    problems (such as Option 1 and 2b and potentially different requirements within option 2b)
    these should be identified up-front and subsequently compared to the other options.
    (5) The report should further clarify and develop the impact analysis. It should quantify
    the costs to businesses related to the implementation (testing and reporting) of the
    mandatory standardised methodology to measure pallet losses or better explain why it is
    considered that those costs are accounted for under the upcoming REACH proposal given
    the likely broader scope of businesses covered by this initiative. It should also quantify the
    costs to businesses of the notification of the outcomes of the certification to demonstrate
    compliance with the defined mandatory requirements to prevent and reduce pellet losses or
    better explain why those costs are considered “minimal”. The report should make an effort
    to further quantify and monetise the expected benefits. It should monetise the estimated
    reduction in CO2 emission. It should also explore whether it is possible to monetise the
    expected reduction in the spill clean-up costs and improvements in work safety. It should
    provide clear overview tables of costs and benefits. The report should better explain the
    qualitative scoring of the environmental, economic and social impacts. As most of the
    impacts are not monetised, it should justify the conclusions on “Low”, “Medium” and
    “High” Benefit Cost Ratios for each option.
    (6) Once the impact analysis is improved, the report should compare all relevant
    (combinations of) options in terms of effectiveness, efficiency, coherence and
    proportionality and present this comparison in a clear comparison table. It should better
    justify the selection of the preferred option given the high uncertainties around the scale of
    3
    the problem and their impacts. These uncertainties should be clearly set out throughout and
    included when addressing and qualifying the costs and benefits of the measures. When
    selecting the preferred option, the report should better justify its proportionality. It should
    explain how it was concluded that the benefits significantly outweigh the costs given that
    the monetised costs are much higher than the monetised benefits.
    (7) The concerns of SMEs, even for the lighter regimes, should be highlighted throughout
    the report. The report should explain why not all SMEs would be included in the lighter
    regime, in particular in light of the response of SME stakeholders to the specific
    consultation. The report should analyse the impact of the preferred option on international
    competitiveness of the sector as well as SME competitiveness. For the development of the
    measuring methodology, full coherence with REACH requirements should be further
    discussed.
    (8) The report should quantify the administrative costs and differentiate those that are in
    scope of the ‘One In, One Out’ approach.
    (9) As the report is now focused on pellets, this approach should be coherently adopted in
    the annexes, which should also focus on supporting the assessment for this specific source.
    The Board notes the estimated costs and benefits of the preferred option in this initiative,
    as summarised in the attached quantification tables.
    (D) Conclusion
    The DG must revise the report in accordance with the Board’s findings before
    launching the interservice consultation.
    If there are any changes in the choice or design of the preferred option in the final
    version of the report, the DG may need to further adjust the attached quantification
    tables to reflect this.
    Full title Measures to reduce the release of microplastics in the
    environment
    Reference number PLAN/2020/8355
    Submitted to RSB on 17 May 2023
    Date of RSB meeting Written procedure
    4
    ANNEX: Quantification tables extracted from the draft impact assessment report
    The following tables contain information on the costs and benefits of the initiative on
    which the Board has given its opinion, as presented above.
    If the draft report has been revised in line with the Board’s recommendations, the content
    of these tables may be different from those in the final version of the impact assessment
    report, as published by the Commission.
    I. Overview of Benefits (total for all provisions) – Preferred Option
    Description Amount Comments
    Direct benefits
    Reduction in pellet losses Measures under the preferred option could
    potentially result in the reduction of pellet losses
    to the environment in the range of 25 142 to
    140 621 tonnes by 2030, which will reduce
    adverse impacts on water resources (both marine
    and freshwater and management wastewater).
    As the reduction potential of all
    measures under the preferred option
    cannot be calculated, this estimation
    is conservative. All stakeholders will
    benefit because this will result in
    better environmental quality.
    Improved understanding
    of pellet loss pathways
    and mechanisms in
    reaching the environment
    The measurement standard and reporting will
    improve the availability of data on pellet losses.
    This benefit will be mostly for the
    industry and public authorities. This
    will be of much use in designing
    better products, monitoring the
    effectiveness of reduction measures.
    Creation of a level-
    playing field
    Option 2b will create a level playing field
    among different actors within the plastic value
    chain. It will also bring a competitive advantage
    to the EU industry by improving its global
    reputation around environmental protection.
    It could also negatively affect the
    competitiveness of the EU industry if
    a downstream actor in the value chain
    imports pellets from outside the EU,
    which could be cheaper in the
    absence of regulatory requirements.
    Indirect benefits
    Safer work environment The measure will reduce the amount of pellet
    spills and benefit the safety of employees
    working throughout the pellet chain by reducing
    their chances of falling.
    Healthier soil The measure will reduce the quantities of pellets
    in soil due to less losses through direct spills or
    through the use of sewage sludge as a fertiliser.
    Benefits to ecosystem
    services
    The measure will reduce the quantities of pellets
    in affected areas, having knock-on effects on
    sectors such as tourism and recreation (increased
    attractivity of the region), fisheries (less pellets
    being absorbed by marine animals) and
    agriculture (less pellets being released on soils).
    Reduced costs for
    affected populations
    The measure will reduce the need for local
    populations to finance clean-up operations
    following a spill.
    Administrative cost savings related to the ‘one in, one out’ approach
    Verification of data Due to the harmonised measurement standard, it
    will be easier for authorities to collect and verify
    data related to pellet losses, leading to cost
    savings.
    5
    II. Overview of costs – Preferred option
    Citizens/Consumers Businesses Administrations
    One-off Recurrent One-off Recurrent One-off Recurrent
    Action (a)
    Direct adjustment
    costs
    No one-off
    cost
    A possible
    minor 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 businesses
    need to adapt
    their operations
    and
    administrative
    procedures to
    the new
    requirements
    by the
    preferred
    option.
    Developing the
    measurement
    standard
    (option 1) will
    entail
    adjustment
    costs between
    EUR 1.3 – 3.2
    million,
    however
    compensated
    by recurrent
    savings in
    using a single
    method and in
    reporting.
    Costs for
    applying the
    methodology
    developed
    under option 1
    for monitoring
    however
    compensated
    by recurrent
    savings on
    reporting.
    Actions for
    implementing
    pellet loss
    reduction
    measures (EUR
    376 to 491
    million of
    pellets handled
    during
    production,
    processing or
    logistics
    operations).
    Businesses
    could choose to
    absorb these or
    pass them on to
    consumers.
    Administrat
    ions would
    potentially
    directly
    support the
    investments
    needed to
    develop
    new
    methodolog
    ies and
    standards
    (option 1).
    Administratio
    ns will need
    to ensure the
    enforcement
    of EU law on
    pellets and
    review the
    reports
    submitted.
    Direct
    administrative
    costs
    None None
    Putting in place
    administrative
    procedures.
    Minor costs for
    data collection,
    verification,
    correction and
    enforcement,
    but more cost
    savings
    expected in the
    existing
    reporting.
    Putting in
    place
    administrati
    ve
    procedures,
    including
    setting up a
    register of
    certified
    companies.
    Costs for
    enforcement
    and analysis
    of the
    reported data.
    Direct regulatory
    fees and charges
    None None
    None Only if public
    authorities
    decide to put
    fees in place.
    None None
    Direct
    enforcement costs
    None None
    Putting in place
    administrative
    procedures.
    Minor costs for
    notification.
    Putting in
    place
    administrati
    ve
    procedures,
    including
    measures
    for ensuring
    compliance.
    Costs for
    enforcement
    and analysis
    of the
    reported data.
    6
    Costs related to the ‘one in, one out’ approach
    Total
    Direct adjustment
    costs
    n/a n/a Cost savings:
    putting in place
    administrative
    procedures,
    compensated
    by savings on
    the single
    method.
    Minor costs for
    reporting of
    notification.
    Indirect
    adjustment costs
    n/a n/a None None
    Administrative
    costs (for
    offsetting)
    n/a n/a None None
    7
    EUROPEAN COMMISSION
    Regulatory Scrutiny Board
    Brussels,
    RSB
    Opinion
    Title: Impact assessment / Measures to reduce the release of
    microplastics in the environment
    Overall opinion: NEGATIVE
    (A) Policy context
    Microplastics are considered pollutants in the environment. Some microplastics are
    intentionally added to products (e.g. in cosmetics, detergents, paints) or serve as input for
    further processing (e.g. plastic pellets). Other microplastics originate from the abrasion of
    larger plastic objects (e.g. painted surfaces, geotextiles, tyres, textile fibres).
    This initiative focuses on the unintentional release of microplastics and stems from the EU
    Action Plan towards zero pollution for air, water and soil which aims to reduce
    microplastics released into the environment by 30% by 2030.
    (B) Summary of findings
    The Board notes the additional information provided in advance of the meeting and
    commitments to make changes to the report.
    However, the Board gives a negative opinion, because the report contains the
    following significant shortcomings:
    (1) The report does not set out the exact scope of the initiative. It is not clear upfront
    on the issues that will be dealt with in parallel and future initiatives. It does not
    sufficiently explain the coherence with other legislation.
    (2) The objectives of the initiative are not specific enough and do not clearly relate to
    the problems. The report is not clear on how much this initiative is expected to
    contribute to the 30% reduction target.
    (3) The presentation of measures and options is not sufficiently clear or focussed on
    the precise problems to be tackled by this initiative. The impact analysis is not
    sufficiently clear and the level of uncertainty is not defined.
    (4) The presentation of stakeholder views is too general and does not allow to
    understand their different views.
    (C) What to improve
    (1) The report should clearly frame the scope of the initiative in its wider context, better
    describing its boundaries and limits. It should clearly describe why it focusses on
    8
    unintended emissions at source level and discuss why, for example, the degradation of
    macroplastics is not considered as in scope. It should clearly describe and analyse the
    problems posed by microplastics released in the environment. It should present the risks to
    human health and the environment, including climate impact. This analysis should be
    supported by solid evidence. Where such evidence is lacking or is uncertain, the report
    should indicate this clearly and discuss the robustness of the available evidence.
    (2) The report should better describe the existing and on-going relevant initiatives to
    enable a better understanding of the problems and their scale posed by different sources of
    microplastics. The dynamic baseline should include other EU initiatives, measures already
    taken by Member States, industry-led initiatives, and best practices around circularity. It
    should set out the overlap and complementarity with existing initiatives in reaching the
    30% reduction target and clearly present the specific contribution of this initiative to
    meeting the target.
    (3) The report should clarify upfront that only one specific sectorial issue together with a
    limited horizontal one will be tackled in this initiative and the issues related to
    microplastics releases from other sources are left to future or parallel initiatives, subject to
    further analysis. The specific objectives are not precise enough to link them accurately to
    the revised set of specific problems. They should be expressed in more SMART terms.
    (4) Following a comprehensive problem definition and a clear and redefined scope of this
    initiative, the report should present those measures that remain useful for tackling the
    specific problems to be addressed by the initiative, discarding all measures clearly outside
    the scope upfront. It should then present a clear and consistent intervention logic showing
    how alternative set of measures could deliver on the refined set of specific objectives.
    (5) The report should revise the impact analysis so that it follows the redefined scope of
    the initiative. It should analyse the impacts of the remaining measures in sufficient depth
    and be clear about the stakeholder groups affected. It should ensure analytical consistency
    throughout. It should present the methodologies used for assessing the measures,
    comparing them and constructing the preferred option. The level of certainty in the analysis
    and conclusions should be clear.
    (6) The views of the different stakeholders should be discussed throughout the report from
    the scope of the initiative, the problem definition to the proposed options and their impacts.
    Dissenting views need to be presented and discussed in the main report.
    Some more technical comments have been sent directly to the author DG.
    (D) Conclusion
    The DG must revise the report in accordance with the Board’s findings and resubmit
    it for a final RSB opinion.
    Full title Measures to reduce the release of microplastics in the
    environment
    Reference number PLAN/2020/8355
    Submitted to RSB on 17 October 2022
    Date of RSB meeting 16 November 2022
    Electronically signed on 12/06/2023 20:16 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121