REGULATORY SCRUTINY BOARD OPINION Impact assessment / Revision of the Directive on the structure and rates of excise duty applied to manufactured tobacco products

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    EUROPEAN COMMISSION
    07/07/2025
    SEC(2025) 560
    {COM(2025) 580}
    {SWD(2025) 560-561}
    REGULATORY SCRUTINY BOARD OPINION
    Impact assessment / Revision of the Directive on the structure and rates of excise
    duty applied to manufactured tobacco products
    Offentligt
    KOM (2025) 0580 - SEK-dokument
    Europaudvalget 2025
    ________________________________
    This opinion concerns a draft impact assessment which may differ from the final version.
    Commission européenne, B-1049 Bruxelles - Belgium. Office: BERL 02/352. E-mail: regulatory-scrutiny-board@ec.europa.eu
    EUROPEAN COMMISSION
    Regulatory Scrutiny Board
    Brussels,
    RSB/
    Opinion
    Title: Impact assessment / Revision of the Directive on the structure and
    rates of excise duty applied to manufactured tobacco products
    Overall opinion: POSITIVE
    (A) Policy context
    Council Directive 2011/64/EU lays down the EU rules for the taxation of manufactured
    tobacco products by setting the structure and minimum rates of excise duty. It aims to
    ensure the proper functioning of the internal market and to provide a high level of health
    protection. In recent years, new tobacco products have emerged (such as e-cigarettes,
    heated tobacco products), but the current scope and provisions of the Directive are not
    adapted to cope with these new market developments. The Directive also falls short in
    reducing illicit manufacturing of tobacco products in the EU and fighting tax fraud and tax
    evasion due to illegal trade.
    This revision aims to address the current shortcomings and is part of a wider review of the
    existing acquis in the area of tobacco control, including reviewing the Tobacco Products
    Directive, updating the Council Recommendation on Smoke-Free Environments, linked to
    the Beating Cancer Plan, and to implementing the WHO Framework Convention on
    Tobacco Control.
    (B) Summary of findings
    The Board notes the useful additional information provided in advance of the
    meeting and commitments to make changes to the report.
    The Board gives a positive opinion. The Board also considers that the report should
    further improve with respect to the following aspects:
    (1) The report does not sufficiently assess the expected impacts on economic
    operators, in particular Small and Medium-sized Enterprises. Regional and social
    impacts are not sufficiently assessed. The risk of unintended consequences
    including the increase of illicit trade in tobacco products is not sufficiently
    analysed.
    (2) The report does not sufficiently detail all costs and benefits of the options under
    each policy area nor the combined impacts of the preferred option.
    (3) The report does not sufficiently indicate how future-proof the revision is.
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    (C) What to improve
    (1) The report should make better use of the available evidence to better demonstrate how
    taxation can be an effective and critical policy instrument to reduce tobacco
    consumption on health grounds. The problem section should more clearly link the
    problems and their drivers with the scope and objectives of the revision. The report
    should add a visual setting out the intervention logic underpinning the revision of the
    Directive.
    (2) The report should further assess how economic operators will be impacted. The
    impacts should be presented in a more detailed and systematic way whenever
    disaggregated data is available. This should include the assessment of the impacts on
    SMEs on the basis of the SME test. The mitigation measures should be made more
    explicit. The analysis should also include a territorial impact analysis, since tobacco
    producers seem to be concentrated in a limited number of geographic clusters. Given
    this concentration, the report should assess potential labour and social impacts for the
    regions concerned.
    (3) The report should better explain the risk of potential unintended consequences. In
    particular, the risk of the increase in the illicit trade of tobacco products caused by
    higher prices should be assessed, taking into account the importance of other, non- tax
    specific, factors.
    (4) The report should better explain the econometric modelling of the expected reduction
    in tobacco consumption and additional tax revenue, integrating it with the recent
    available evidence of consumers’ behaviour during the Covid-19 emergency. It should
    explain how the expected reduced sales and reduced demand were factored into the
    estimates of additional tax revenues. It should clarify how the potential increase in
    illicit trade was included in the modelling.
    (5) The report should improve the cost benefit analysis with a more systematic and
    comparable approach and clearer presentation. It should provide the assessment of all
    types of relevant impacts for all options. It should be clearer about the health benefits
    and explain why they were not estimated for the options related to enlarging the scope
    to new products and raw tobacco. The report should provide overview tables of costs
    and benefits under each policy area and for the preferred option, including costs and
    cost savings in scope of the One In, One Out approach.
    (6) The report should indicate in more detail to what extent the preferred option is future-
    proof. It should better explain the effect of inflation on the success of a PPP-based EU
    excise duty system. It should clarify which other variants or combinations of the
    proposed partial PPP system have been assessed and better justify the one included in
    the preferred option.
    (7) The report should more systematically present the views of different stakeholder
    categories throughout the text, in particular on the problems, options and their impacts.
    The Board notes the estimated costs and benefits of the preferred option(s) in this
    initiative, as summarised in the attached quantification tables.
    Some more technical comments have been sent directly to the author DG.
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    (D) Conclusion
    The DG must take these recommendations into account 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 Revision of the Council Directive 2011/64/EU of 21 June 2011
    on the structure and rates of excise duty applied to
    manufactured tobacco products
    Reference number PLAN/2020/8656
    Submitted to RSB on 22 June 2022
    Date of RSB meeting 19 July 2022
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    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 Options
    Description Amount Comments
    Direct benefits
    Public health, and
    healthcare system
    Long-term savings on the social costs of smoking, correlated with the extent of the
    tax increase.
    Harmonised taxation of new products will reduce affordability, especially for
    young people.
    Introduction excise duty rates for new products, higher excises for traditional
    tobacco product will leads to potentially lower substitutability, cross-border flows
    and affordability.
    Introduction of the raw tobacco in the scope of the Directive potentially will reduce
    availability of low-price illegal products.
    Tax revenues for traditional
    tobacco products
    9 600 Introduction excise duty rates for traditional tobacco products will lead to increase
    of revenues for traditional tobacco products EUR 9 600 million.
    Reduction in foregone tax revenues due to new category for raw tobacco – EUR 1
    000 million.
    Tax revenues for new
    products
    2 400 Introduction excise duty rates for new products will lead to increase of revenues
    EUR 2 500 million.
    Reduction of tax evasion
    and fraud
    The expected increase of excise duty revenues, caused by higher rates, could be
    largely offset the foregone revenues due a potential increase of illicit trade of
    tobacco products.
    Introduction of holding, movement and control requirements for new products and
    raw tobacco will improve monitoring of cross-border movements of tobacco
    products. Less scope for tax evasion and avoidance.
    Legal certainty Less scope for misclassification of ‘borderline’ products. Clarifications and
    harmonised EU-wide approach to new products and raw tobacco will reduce the
    divergent interpretations, administrative difficulties, disputes and associated costs
    for Member States and economic operators.
    Indirect benefits
    Impact on market,
    competition and SMEs
    Potentially lower substitution between traditional tobacco and new products will
    lead to less market and competition distortions.
    Harmonisation of taxation of new products will improve market integration and
    monitoring of market trends. Economic operators who are currently compliant with
    the tax rules will benefit from ensuring their competitors also pay their fair share.
    Greater transparency and legal certainty may result in fairer competition and
    improve the ease of doing business cross-border. The proposed harmonisation for
    new products would help establish a level playing field, whose benefits will be
    mostly reaped by small players.
    Introduction of control requirements EU level for raw tobacco will reduce the
    availability of illicit tobacco and tobacco products in the market, so that legal
    players will experience lower competitive pressure from the illegal value chain.
    The competitiveness of economic operators will be enhanced because of reduced
    availability of low-price illegal products.
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    Administrative cost savings related to the ‘one in, one out’ approach
    Harmonised EU rules It will eliminate current market barriers preventing economic operators (especially
    SME’s) to access other Member States markets (e.g. due to the need to understand
    national rules, engage with foreign tax administration, in another language etc.)
    Harmonised movement
    control requirements
    under the Horizontal
    Directive
    - For new products: it will reduce administrative burden (e.g. in the present
    cases, where the shipment is between Member States, one of which treats HTP
    as harmonised excise category (OST) and the other - with ad hoc tax regime.
    - For raw tobacco: it will lead to the abandonment of part of national control
    measures (registration of all entities involved in growing, selling and
    manufacturing, registration of buyers, additional control measures (e.g.
    additional reporting requirements).
    Adoption of appropriate
    definitions and tax regime
    - For new products: it will remove unintended effect on other products and the
    risk of legal and classification uncertainties between HTP and smoking tobacco
    products and across new products, what may cause administrative issues.
    - For raw tobacco: it will remove the risk of legal and classification uncertainties
    between raw and smoking tobacco (e.g. reduction in litigation costs).
    II. Overview of costs – Preferred option for the revision of the minimum rates for traditional tobacco products (million euros)
    Citizens/Consumers Businesses Administrations
    One-off Recurrent One-off Recurrent One-off Recurrent
    Direct costs
    0.00 For consumers of traditional
    tobacco products because of
    the increase of the excise
    duties (increase of price).
    0.00 Market sales of
    tobacco products
    will decline between
    5% and 16%
    Minor adjustment
    costs for the
    implementation of
    separate categories for
    cigarillos and WPT
    0.00
    Indirect costs 0.00 0.00 0.00 0.00 0.00 0.00
    II. Overview of costs – Preferred option for the introduction in the scope of the Directive of e-cigarettes liquids, HTP, other
    manufactured tobacco and related products (million euros)
    Citizens/Consumers Businesses1
    Administrations2
    One-off Recurrent One-off* Recurrent One-off Recurrent
    Action
    (a)
    Direct adjustment
    costs
    - Set up a tax
    warehouse
    (investment in
    appropriate
    premise): 5.7
    - Movement control
    EMCS (investment
    in an IT system): 2.7
    Movement
    control EMCS
    (updating IT
    infrastructure):
    between 2.7
    and 8.1
    1
    The increase of regulatory costs for operators would be negligible except for SME’s (e-cigarettes sector) for
    which would increase by approximately EUR 17 000 year.
    2
    Regulatory costs incurred by Member States from the extension of holding and movement rules to operators
    and products which are not currently in the Directive’s scope. Where national tax regimes are already in
    place for new products, additional regulatory costs it is considered negligible.
    6
    Direct
    administrative
    costs
    - Registration in
    the excise system
    for new operators
    (manufacturers and
    importers/
    wholesalers of e-
    cigarettes and other
    related products):
    1.8
    - Operate a tax
    warehouse: 25
    - Movement control
    EMCS (transaction
    costs): 0.5
    Registration of
    economic
    operators: 1.5
    Registration
    of economic
    operators:
    0.4
    Movement
    control
    EMCS
    (transaction
    costs): 0.3
    Indirect costs Increase of price
    due to the
    increase of excise
    duty rate.
    - Holding /
    storing guarantee
    (financial cost):
    fixed by MS and
    related to the
    amount of duty
    suspended on the
    excise good held:
    0.1
    - Guarantee on
    movements under
    duty suspension
    (financial costs): 0.1
    Costs related to the ‘one in, one out’ approach
    Total
    Direct
    adjustment
    costs
    8.4
    Indirect
    adjustment
    costs
    Administrative
    costs (for
    offsetting)
    1.8 25.5
    Note: No direct regulatory fees and charges and no direct enforcement costs are anticipated.
    II. Overview of costs – Preferred option for raw tobacco (million euros)
    Citizens/Consumers Businesses Administrations
    One-off Recurrent One-off Recurrent One-off Recurrent
    Action
    (a)
    Direct adjustment
    costs
    - Movement control
    EMCS (investment in
    an IT system): 0.7
    Movement
    control EMCS
    (updating IT
    infrastructure):
    between 2.7
    and 8.1
    Direct
    administrative
    costs
    - Registration in
    the excise system
    for operators
    involved in raw
    tobacco business
    (assuming that in
    the 15 MS where
    the fiscal regimes
    are in place,
    operators are
    already deemed
    compliant): 0.09
    - Movement control
    EMCS (transaction
    costs): 0.3
    Movement
    control
    EMCS
    (transaction
    costs): 0.4
    7
    Indirect costs
    Costs related to the ‘one in, one out’ approach
    Total
    Direct
    adjustment
    costs
    2.2
    Indirect
    adjustment
    costs
    Administrative
    costs (for
    offsetting)
    0.15 0.7
    Note: Considering the zero-rate option, operators are assumed to use the duty-paid procedure instead of duty
    suspension and not to use tax warehouse. Regulatory costs for public administrations linked to registration of
    economic operators are insignificant (one-off cost of €400 per operator plus €100 for annual renovation). It is
    also assumed that collective organisations operate on behalf of individual growers.
    Electronically signed on 22/07/2022 12:08 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121