DALE'S DIARY New EU Machinery Regulation finalised

The CEA’s Senior Technical Consultant, Dale Camsell, charts the progress of the major regulatory update of what was the Machinery Directive and will metamorphosise into a formal EU Regulation. This is relevant to all companies selling machines into the EU…..

State of play – 2022 ends in agreement

In December 2022, the EU legislative bodies (European Commission, European Council and European Parliament) came to a provisional agreement on the final content of the new Machinery Regulation. Compliance with this piece of legislation, which will replace the current Machinery Directive, is fundamental to being able to sell machinery into the EU market, hence it is of significant interest to machine manufacturers.

December’s agreement was classed as provisional because it was agreed only by the negotiating representatives of the three institutions and still required full endorsement by the European Council and European Parliament before it could be considered finalised. However, further progress has since been made and, in January this year, the European Council approved the agreement. Following this endorsement, the text was made public; the CEA has made an initial analysis of the text and is sharing the details with members.

Complete endorsement by the institutions is expected to occur when the European Parliament votes on the acceptability of the negotiated text during a plenary session planned for mid-April. Once that is complete all that remains is for certain internal procedural matters to be dealt with. For example, translations into all official EU languages is required before it can formally published. Our best guess is for this to happen during the latter part of Q2 2023.

Until publication, industry can prepare itself for the implementation of the new regulation on the basis of January’s provisional text - since this is highly unlikely to be modified prior to its formal release.

General outlook

When the European Commission first published its initial proposal for the content of this regulation back in April 2021, it contained a great many requirements that industry felt were disproportionate, overly burdensome, or simply unworkable. However, through CECE, the CEA has tirelessly advocated for a fairer, more reasonable set of requirements and I'm pleased to report that, as a result of this successful advocacy campaign, the end result is a regulation that is, on the whole, better balanced. This underlines the value of concerted and co-operative effort from the representative trade associations.

Key implications – timing and content

The European Commission’s proposal originally was a cause of concern as it offered an unreasonably short transition period - just 30 months. This would have meant that any product modifications needed in order to comply with the new requirements would have to be completed within that time period after the regulation’s publication. The good news is that following successful advocacy through CECE, the institutions agreed a 42 month transition period, which industry has warmly welcomed.

It is expected that the new Machinery Regulation will be fully implemented during the latter part of 2026. Thus, any machinery within scope must be compliant with its requirements by that date in order for it to be able to be sold on the EU market.

One notable difference in the new regulation compared with the current directive is that the regulation explicitly allows manufacturers to provide operator manuals in either digital or paper form. From a legal perspective, this had previously been a highly divisive matter but industry, with CECE at the forefront, had promoted the many benefits of operator manuals being provided in digital form. In addition to this, the new regulation also allows the declaration of incorporation to be provided in digital form. Another win for manufacturers.

In keeping with other recently published legislation, this regulation includes provisions that give the European Commission certain empowerments. These include the ability to modify the content of Annex I (more on that later) and also to publish so-called common specifications (more on that later too). Whilst industry in general did not object to the principle of this empowerment, there were significant concerns about the lack of transparency and lack of stakeholder engagement during the development of such common specifications. Due to these concerns, CECE had asked for greater industry involvement in these matters. This resulted in changes being made to the legal text that guarantees stakeholder involvement should any of these empowerment provisions be invoked.

One of the most controversial requirements in the Commission's original proposal concerned conformity assessment procedures, especially for machine types listed in Annex I. The issue was that any machines included in the list would require the conformity assessment to be performed by a notified body, even where harmonised standards were available. The original list had 25 machine types included but, following industry pressure, this has been reduced to just 6. The only machinery of concern to CEA members being those that include an artificial intelligence element that provides a safety function.

For the first time in our sector, the new regulation includes the provision for the European Commission to produce common specifications. These are equivalent in status to a harmonised standard, i.e. they provide a presumption of conformity. However, industry had concerns that common specifications will diminish the value of the harmonised standard process and could lead to a lack of stakeholder engagement in the development of future harmonised standards. However, under the terms of the empowerment, the European Commission can only produce common specifications where the European Standardisation Organisations (e.g. CEN) have failed to develop a harmonised standard when requested by the European Commission. The Commission has assured stakeholders that the development of common specifications is most certainly a last resort and that they have no intention of undermining the harmonised standards process.

With regard to the technical requirements contained in the regulation, these remain broadly unchanged, with the majority being copied over from the current Machinery Directive. Of course, some have been modified and there are some additional provisions, which mostly deal with new hazards such as cyberattack. Compliance with the cyber requirements of the Machinery Regulation can be achieved by complying with the, currently in development, Cyber Resilience Act. This new piece of legislation will set requirements for the robustness of a product to cyberattack and it specifically states that compliance with its provisions will automatically confer a presumption of conformity with the Machinery Regulation. The main issue for industry is that there are currently no harmonised standards available for compliance with the Cyber Resilience Act and they are unlikely to be available in time for its publication. CECE is firmly advocating for a more reasonable timeline for the implementation of the Act to allow sufficient time for the relevant harmonised standards to be developed.

Another proposal of concern to CEA members is the requirement that, where relevant due to its height, machinery shall be equipped to prevent the risk of contact with overhead power lines or prevent the risk of creating an electric arc between the operator and power line. This is an entirely new requirement, meaning that there are no harmonised standards available that describe state of the art protection measures. These standards can and will be produced but there is a great deal of concern as to whether they’ll be ready in time.

Finally, there are new requirements demanding that manufacturers provide repeated shock vibration information to which the hand-arm system is subjected. This is another new requirement for which no harmonised standards exist. Again, industry fears that development of such standards will take some time, meaning that they might not be ready for when the regulation is implemented.

Guidance

It is customary that, after the publication of a new piece of EU legislation, the European Commission produces an official guide to the directive/regulation. Since this document is a guide, it has no legal status but it proves to be extremely helpful to stakeholders in understanding the intent of the various requirements contained within the legislation.

Such a guide exists for the current Machinery Directive, hence stakeholders were anticipating that the European Commission would immediately begin the process to revise the existing guide once the new regulation was published. However, the Commission is not prioritising the revision of the guide; in fact it shows little interest in taking on this task any time soon. CECE, as well as other industry associations, believe that the guide is an essential element in the smooth and uniform application of the new regulation. Many EU member states, including some of the major players, have also raised their concerns with the Commission. We expect to hear further from the Commission in late March as to whether they’ve changed their view on the development of a guide.

Given the Commission’s position, industry has decided that it will produce its own guidance document. Orgalim will lead the drafting of this guide and the CEA, through CECE, will provide significant input. Work on this task is due to commence imminently.

The UK situation

One big question that remains unanswered is whether the UK will adopt the new EU regulation. As a reminder, since the end of the Brexit transition period the UK has been free to implement its own laws, independent from the EU. However, to date, it has adopted all EU product compliance legislation relevant to the construction equipment sector without any technical modification. Once the EU Machinery Regulation is published we await with interest how the UK government will react. The CEA has previously raised this query with BEIS but, as expected, the response was vague. We will, however, continue to engage with BEIS in the hope that we can get a clear understanding of the future GB market situation in a timely manner.

Of course, the UK government only has jurisdiction over the product compliance laws affecting the sales of machinery into the GB market; all EU product related legislation, including the new Machinery Regulation, will continue to apply in Northern Ireland since that remains in the EU Single Market by virtue of the terms of the Northern Ireland Protocol. At time of writing there are political efforts underway to revise the terms and interpretation of the Protocol which may change the situation.

Further information

Dale Camsell provides detailed briefings on regulatory and standardisation issues to quarterly meetings of the CEA’s General Technical Committee (GTC). CEA members may nominate representatives to participate in the work of the GTC by contacting Dale via dale.camsell@thecea.org.uk