Tag Archive: Machinery Directive

  1. UK Government Extends CE Mark Recognition

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    During the summer holidays, the UK Department for Business and Trade (DBT) has announced an indefinite extension of the use of CE marking for businesses in the whole of the UK.

    CE marking, which signifies conformity with European technical legislation, will continue to be allowed alongside the UKCA (UK Conformity Assessed) mark. Originally the idea was to abolish CE marking and replace it completely with UKCA in Great-Britain. For Northern-Ireland, the plan was always to maintain CE marking only.

    The extension of the validity of the CE marking comes after extensive consultations with industry stakeholders, addressing their concerns and aligning with their growth objectives. By allowing businesses to continue using CE marking, the government allegedly aims to provide them with the clarity needed to focus on innovation and expansion, rather than navigating regulatory complexities. The extension should provide businesses with flexibility and choice to use either the UKCA or CE approach to sell products in Great Britain.

    However, it’s unclear what the effect will be once the legislation behind the respective marks will start to deviate from each other. The best example is the replacement of the Machinery Directive by the Machinery Regulation. As of end December 2026, in the EU the current Directive will be replaced by a Regulation with a number of new and amended requirements. The UK will not implement the new Machinery Regulation but will stay with the Machinery Directive. Consequently, the CE marking and the UKCA marking will stand for two different things. Since the UKCA marking will not cover the additional and amended requirements of the new Regulation, it may then be attractive to opt for the UKCA marking for the Brittish market. As times moves on, the CE and UKCA markings will only grow further apart.

    Another issue relates to the fact that the UK continues its participation in European standards. If standards get harmonized under the new Machinery Regulation, this harmonization will have no legal value in the UK, which will not implement that Regulation. All these are difficult questions which the current government has clearly decided to pass on to their successors.

  2. New Machinery Regulation: adverse effects on Light Electric Vehicles Business

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    End of last year, the European Parliament, Council and Commission reached an agreement on the future Machinery Regulation. Parliament and Council went against the Commission’s proposal to exclude all vehicles from the future legislation. That will have particularly adverse effects on electric cycles, e-scooters and self-balancing vehicles.

    Originally, the Commission proposed to exclude all “vehicles which have as their only objective the transport of goods or persons by road, air, water of rail (…).” The justification was that Machinery legislation was “not meant to regulate risks other than those stemming from the machinery function (such as sawing, excavating, etc.) and not the risks exclusively relating to its transport function of persons or goods.” If they had been excluded, they would have come under the General Product Safety Directive (GPSD), just like conventional cycles. More importantly, this would only have been a temporary solution in anticipation of a specific Regulation for Light Electric Vehicles.

    Unnecessary Machinery Directive

    The intermediate solution of the GPSD would have been so much better for LEVs because this Directive only has very general requirements. In addition, there are already several European standards with specific technical safety requirements in place, i.e. the EN 15194 for EPACs, the EN 17128 for PLEVs (e-scooters & self-balancing vehicles) and the EN 17404 for EPAC mountain bikes. The fact that these vehicles present no structural safety risks shows that the standards offer adequate technical requirements and that the Machinery Directive is unnecessary to ensure that safety.

    On the contrary, in recent years, in standardisation it has become increasingly clear how much the current Machinery Directive is an obstacle to Light Electric Vehicles (LEVs). The Directive contains hazards that are totally irrelevant to LEVs, for instance noise, vibrations or protection against risks from moving parts.

    HAS consultants

    Originally, there were in-house CEN consultants, who worked together with the technical committees to ensure that the draft standards met the requirements of the Machinery Directive in the best possible way to maximize the chances of harmonization. The harmonization of standards under the Machinery Directive offers manufacturers presumption of conformity in case of a dispute, or worse, a court-case. This presumption of conformity is an important guarantee of legal certainty.

    With these in-house consultants, there was room to negotiate which requirements were relevant or not. One very important agreement for the EN 15194 (EPACs) for instance was that the requirements for moving parts were not relevant for cycle wheels. Without that agreement, the standard would have required all wheels to be covered.

    Since, the Commission has changed the system. They replaced the in-house consultants by so-called Harmonised Standards (HAS) consultants. The contract was outsourced to a private company, i.e. Ernst & Young. The task of these consultants is to support the Commission to verify whether the requirements for harmonisation are met. However, HAS consultants are no longer involved in the actual drafting processes and therefore technical committees can no longer make use of HAS consultants services to fill any potential gaps in the technical or legal expertise, nor to negotiate.

    Harmonisation impossible

    What’s worse for LEVs, HAS consultants make all Machinery Directive requirements applicable to LEVs, whether relevant are not. As a result, in the new system none of the LEV- standards has achieved harmonisation.  To this end, nonsensical tests should be introduced such as on the noise level the vehicles produce or on vibrations, which for LEVs obviously come from the road surface not from the vehicle itself. As for the future standards for electric cargocycles, it is already clear that no harmonisation will be requested because it is simply not feasible.

    The new Machinery Regulation will only exacerbate these issues. Indeed, the new legal text will now explicitly state that the Regulation applies only to risks arising from the machinery function, not the transport function. However, who will determine what is a machinery function and what is a transport function? In our view, LEVs don’t have machinery functions, only transport functions. That is exactly why the Commission thought it necessary to exclude them. Unfortunately, the European Parliament and Council literally twisted the Commission’s words, the result being an unworkable mess.

    Disastrous impact

    One party that argued hard to keep LEVs, more specifically electric bikes, in the new legal text was CONEBI, the trade association for the (electric) bike industry. We quote from their position paper: “The EU Machinery Directive is of high importance to the EU Bicycle Industry as it legislates the essential health and safety requirements relating to the design and construction of electrically power assisted cycles (EPACs). The fact that EPACs are within the scope of the Machinery Directive was officially acknowledged in the first Edition of the Guide to Application of the Machinery Directive 2006/42/EC of December 2009.

    CONEBI clearly does not question the adequacy of the essential health and safety machinery requirements for EPACs. Also, the CONEBI memory is somewhat lacking here. in 2006, yours truly and a representative of CONEBI (called COLIBI at that time) had a meeting with the Commission to ask if there was still any chance of avoiding the Machinery Directive for electric bicycles excluded from type-approval. In other words, originally CONEBI was not in favour of having electric bikes in the Machinery Directive. Their current efforts to keep EPACs in the new Machinery Regulation clearly shows that the association has no understanding of the impact on standardisation for EPACs AND for other light, electric vehicles, nor of the consequences for the businesses concerned. Hopefully their understanding will grow as the disastrous impact of the new legislation on LEVs becomes a reality. In the meantime, LEVA-EU will continue its efforts for a specific LEV-Regulation designed in consultation with the LEV-business for the LEV-business.

    Photo by Jonathan Borba on Unsplash

  3. EU Standardization News

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    HAS assessment contract re-established
     The European Commission has signed a new contract with Ernst & Young for the HAS (Harmonised Standards) assessment process. Ernst & Young was the previous contractor until the beginning of 2022. This means that the HAS consultants system will be restored shortly and Technical Committees will therefore be able to request assessments of harmonised standards. CEN and CENELEC have stated they will request HAS assessments in the following order:

    • Documents received for Formal Vote;
    • Documents received for Enquiry and or which Enquiry has started;
    • On ad-hoc basis: all other documents (e.g first working drafts, documents not assessed previously and before publication).

    Webinar on how to draft machinery harmonised standards
     On 6 October, from 14.00 till 16.30, CEN and CENELEC will organise a webinar with practical information on how to prepare harmonised standards under the Machinery Directive. The workshop will provide advice on how to write the informative annex (Annex Z) with information on the relation between the essential requirements of the Machinery Directive and the clauses of the standard providing presumption of conformity with those requirements (once the reference of the standard reference is published in the Official Journal).
    Registration is mandatory and is available here: https://cencenelec.zoom.us/webinar/register/WN_C22eFvsoRmC99VhY_xmUNA

  4. New Machinery Regulation: SBS backs LEVA-EU plea for LEV-exclusion

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    Recently, SBS has published a position paper on the proposal for a revision of the Machinery Directive. The proposal, published in April, is currently under discussion in the Committee on the Internal Market and Consumer Protection (IMCO) of the European Parliament.

    SBS is a non-profit association co-financed by the European Commission and EFTA Member States. Its goal is to represent and defend small and medium-sized enterprises’ (SMEs) interests in the standardisation process. With Eddie Eccleston, LEVA-EU has an SBS-expert in CEN TC 333

    SBS is generally supportive of the Commission’s proposal and is optimistic regarding the ongoing discussion in the European Parliament. However, SBS warns that several points require improvement in order to create a piece of legislation that supports SMEs. One of those points is the exclusion of all means of transport from the new Machinery Regulation.

    On that point, SBS supports the position of LEVA-EU unreservedly. We quote from the SBS-position paper: “SBS welcomes the exclusion of light, electric vehicles (LEVs) from the Machinery Regulation and deeply regrets all IMCO amendments aimed at preventing such exclusion. This exclusion is essential to allow for electric cycles and LEVs in general to realise their full potential and contribute to cutting GHG emissions. The exclusion is further justified by the fact that Machinery legislation is not meant to regulate risks exclusively related to the transport of persons or goods.

    Exclusion from the Machinery Regulation will not create a legal vacuum since the vehicles will temporarily come under the General Product Safety Directive. Manufacturers will be able to continue to use existing EU standards such as EN 15194:2017 and EN 17128:2018. For the LEV sector, where SMEs are a majority, it is important to be able to rely on standards to be able to put their products on the market. However, the harmonisation of these standards under the Machinery Directive is becoming increasingly difficult because the EHSRs have not been developed specifically for means of transport such as LEVs.

    As things stand, both the Machinery Directive and Regulation 168/2013 prove to be inadequate for LEVs, and the development of a horizontal legal text with general safety requirements for means of transport not subject to type-approval complemented with harmonised standards is by far the preferable option. In a recent study on 2 and 3-wheel vehicles, quadricycles and Personal Mobility Devices (PMDs), carried out at the request of the European Commission the conclusion is that “a dedicated system for the harmonised approval of PMDs that is separate from both Regulation (EU) No 168/2013 and the Machinery Directive” is the preferred way forward. Therefore, the exclusion of LEVs from the Machinery Regulation should be only the first step towards the development of effective, tailored European legislation on LEVs. SBS calls for the European Commission to urgently take such a step and propose as soon as possible a new proposal for legislation specifically covering LEVs.”

    The IMCO amendments were inspired by parties who predict that moving vehicles from the Machinery Directive to the GPSD, in anticipation of specific LEV-legislation will “lead to uncertainty in the industry”, as stated in the CONEBI position. The trade association for the bicycle industry also argues that the current Machinery Directive is “a key legislation for the EU Bicycle Industry” and the harmonisation of EN 15194:2017 has “consistently ensured that a safe product is being place on the European market.” CONEBI also intimates that exclusion of vehicles from the new Machinery Regulation may “undo years of standardisation work of the industry”.

    All these assertions and predictions are unfounded and factually incorrect. EN 15194:2017 has not consistently ensured that a safe product is placed on the EU market. The common sense and sense of responsibility of the assemblers in this sector has consistently ensured those safe products.

    CONEBI conveniently fails to mention that there have been several national objections against the standard for failing or missing requirements. The Dutch objection against the battery requirements was the fiercest objection. Exclusion from the Machinery Regulation will hardly have an impact on the standardisation work done throughout the years. The EN 15194:2017 will survive with all its flaws. It will only loose its harmonisation under the Machinery Regulation.

    Again, for convenience, CONEBI forgets to mention that the standard for electric mountain bikes and for PLEVs never made harmonisation under the Machinery Directive. This is primarily because the Machinery Directive was never intended for vehicles. We are now continuously confronted with this problem in TC333/WG9, where we are developing standards for electric cargocycles. If vehicles were to be excluded from the Machinery Regulation, then we will no longer have to waste time on developing  requirements just for the sake of the Machinery Directive, which do not have much to do with the safety of electric cargocycles.

    Finally, CONEBI conveniently fails to mention that the amendments tabled in IMCO to get vehicles back into the Machinery Regulation are not limited to EPACs but cover all vehicles currently excluded from Regulation 168/2013. In addition, CONEBI has never advocated specific and accurate technical legislation for EPACs and other LEVs. They just argue in unison for the status quo.

  5. Commission proposes to exclude LEVs from Machinery Directive

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    On 21 April, the European Commission has published a proposal for a new Machinery Regulation. The text holds one crucial point for the LEV-sector: the exclusion of all vehicles for the transport of goods and persons. LEVA-EU is very pleased with this first step towards specific technical legislation for light, electric vehicles.

    The current Machinery Directive entered into force in July 2006. Article 1.2 of that legal text excluded vehicles covered by type-approval from the scope of the Directive. As electric bicycles with pedal assistance up to 25 km/h and 250W were excluded from type-approval, they became subject to the Machinery Directive.  Earlier that year, ETRA and COLIBI, the trade associations for bicycle dealers and for bicycle manufacturers respectively, had a meeting with the Commission to see if there was still any chance of avoiding the Machinery Directive for electric bicycles. The Commission responded that this was impossible. However, they did reassure the two associations that there would be a moratorium for compliance in the field of electric bicycles.

    The EN 15194 was already in place at that time and, immediately after that meeting, CEN TC 333 – WG5 set out to harmonize the standard under the Machinery Directive. Such harmonization results in presumption of conformity. In other words, for electric bicycle manufacturers the standard would be a legally secure tool to comply with the Machinery Directive. However, the process took 11 years. The harmonized standard was only published in 2017.

    In the meantime, the Commission has drastically changed the harmonization procedure. Originally, specialist consultants within CEN assisted technical committees in drafting standards that fulfilled the requirements of the Machinery Directive. In the new system, the Commission has awarded Ernst & Young with a contract to provide and lead a team of so-called Harmonized Standards (HAS) consultants. These no longer assist the technical committees, but only assess the text once completed. It turns out to be much more difficult to produce standards which are accepted for harmonization.

    Recently, the draft standard for electric mountain bikes was rejected for harmonization. The EN 17128 for Personal Light Electric Vehicles, i.e. without a seating position and self-balancing, didn’t make harmonization either but was published anyhow. As a result, a vehicle complying with this standard is not presumed to be in conformity with the Machinery Directive. EN 15194 is also under growing pressure. The Netherlands have lodged a formal objection against the harmonization due to inadequate battery safety requirements, whilst Germany demands a vibration test. In fact, EN 15194 should be fundamentally revised, but in the current circumstances it is unlikely for the revised standard to make it through harmonization. Also, it is becoming increasingly clear that certain requirements are only included in standards just for the sake of complying with the Directive, not because they are absolutely necessary to guarantee safe electric bicycles or other LEVs.

    End of last year, LEVA-EU sent a position paper to the Commission pleading for the exclusion of light, electric vehicles from the new legislation. The trade association argued that the Directive had never been intended to cover vehicles and that the Commission’s proposals for the new Regulation would exacerbate the problems.  The proposal holds new requirements which would be difficult for LEVs to meet and increase the administrative burden, which is already significant, even further.

    LEVA-EU’s plea has finally been heard by the Commission. In the Impact Assessment the Commission concludes: “The MD already excluded means of transport by air, water, rail networks, and means of transport by road regulated in the EU’s type-approval legislation. By default, vehicles that were not regulated by that legislation were covered by the MD. Although a vehicle may fall under the definition of machinery, the purpose of the machinery legislation is to address the risks stemming from the machinery performing its function (such as excavator in a construction site), not the risks related to its circulation on the public roads. This option would make clear that the revised MD does not apply to means of transport, regardless of the speed limits, with the exception of machinery mounted on these means of transport. The means of transport includes all vehicles, the only objective of which is the transport of goods or persons. The following vehicles would therefore be excluded from the revised MD: (i) light vehicles, such as electrically power-assisted cycles, hover boards, or self-balancing scooters; (…)

    The exclusion of LEVs from the Machinery Directive will not necessarily create a legal vacuum. First of all, it will take some time for the European Parliament and the Council to adopt the final text, which will provide for a transitional period. After that, there are two possibilities. Either, the General Product safety Directive, which covers all products not covered by specific safety legislation, can take over. Alternatively, the Commission could develop new specific LEV-legislation. It appears that the Commission Unit that has ordered the TRL-study on so-called Mobility Devices, is considering such a new initiative. LEVA-EU will continue its efforts for LEVs also to be excluded from Regulation 168/2013 and for a new horizontal LEV-Regulation to replace both the Machinery Directive and type-approval legislation.

    Photo by Jonathan Borba on Unsplash

  6. LEVA-EU marks victory in fight for light electric vehicle sector as Commission accepts legislation is ‘unsuitable’

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    LEVA-EU, the voice of the light electric vehicle sector, is celebrating a campaigning victory after the European Commission confirmed legislation governing light electric vehicles was unsuitable.

    The Commission has acknowledged that the Machinery Directive, in place to ensure a common safety level for machinery placed on the European market, is not suitable for vehicles.

    LEVA-EU, which has campaigned for the removal of light electric vehicles from the legislation, hailed the landmark ruling, which it said would allow businesses in the sector, previously hindered by the legislation they must navigate, to reach their full potential.  

    The victory comes at the same time as a study for the European Commission by the transport consultancy TRL found that type-approval legislation for light vehicles in Regulation 168/2013, is unfit for light electric vehicles such as electric bikes, e-scooters, hoverboards, etc. and that separate legislation should be drawn up.

    LEVA-EU manager Annick Roetynck said it was now essential that a new regulatory framework specifically dedicated to light electric vehicles (LEV) was created without delay.

    LEVA-EU had previously proposed that LEVs up to 50 km/h should be taken out of both Regulation 168/2013 and the Machinery Directive. Instead, it proposed, the EU should develop a new horizontal Vehicle Regulation, which could be complemented with harmonised standards and, if necessary, for certain vehicles even type-approval.

    She said: “From the day the association was established, LEVA-EU has argued that both the Machinery Directive and Regulation 168/2013 are ill-adapted and inaccurate for light, electric vehicles. TRL has clearly taken on board LEVA-EU’s arguments, which were submitted as proposals to the study.

    It seems to us that, given the urgency of the climate crisis, no further time should be wasted in removing legal bottlenecks to unlock the market potential of light electric vehicles.

    TRL presented its study on what it termed Personal Mobility Devices (PMDs) and type-approval legislation, aimed at helping the Commission decide whether current technical legislation should be changed, during the Spring meeting of the Motorcycle Working Group.

    Some PMDs, such as speed pedelecs or cargocycles with more than 250W of power, currently come under type-approval. Other vehicles, such as electric bikes with pedal assistance up to 25 km/h and 250W, e-scooters or self-balancing vehicles, are excluded from type-approval and come under the Machinery Directive.

    Among the recommendations of the study, TRL proposed the creation of a dedicated regulatory framework for PMDs separate from Regulation 168/2013 and the Machinery Directive.

    It also suggested aligning road circulation regulations for new types of PMD with existing national pedal cycle regulations and regulating maximum speed at an appropriate level for safety and infrastructure (25 or 30km/h).

    The study also said that, if it was necessary to regulate maximum motor power, then this should be done at a level that did not discourage the development of new vehicle configurations (1,000W). It said any fresh proposals should “ensure that regulations do not stifle the development of the cargo bike industry”.

    Ms Roetynck said the confirmation came exactly 15 years after previous organisations had lobbied the Commission in vain to exclude electric bicycles with pedal assistance up to 25 km/h and 250W from the Machinery Directive.

    She said questions remained over how the Commission would follow-up on its conclusion and said LEVA-EU’s proposal for a dedicated new category of Zero Tailpipe Emission Vehicles (ZEVs) was the only fundamental solution.

    She added: “The study is not completed yet and the Commission concluded that if they were to go ahead with a review, that work would not be initiated before the second half of next year. LEVA-EU will continue to ask the Commission about this timing, as we believe the current arrangements are damaging LEV businesses.

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