In the following we answer some questions why the Machinery Directive 2006/42/EC has been revised, what is the current state of negotiations and what will change in terms of content.
Note: This technical article is therefore constantly updated. Do not miss any important updates and register now for our free newsletter, the CE-InfoService.Last update: 2023-07-04
On 18 April 2023, the new Machinery Regulation (EU) 2023/1230 was adopted by a large majority in the EU Parliament, and on 22 May the European Council also gave its final approval. On 14 June 2023, the Presidents of the EU Council and Parliament also signed off on it, and the final publication in the EU Official Journal was on 29 June 2023. Many observers had hoped that a transitional period would be introduced after all. However, the final publication now makes it clear that there is no such thing.
The Machinery Regulation (EU) 2023/1230 provides for a key date regulation, i.e. the current Machinery Directive 2006/42/EC is to be applied until 2027-01-20 and the new Machinery Regulation thereafter. Manufacturers therefore have time to prepare for the new requirements, but must meet the new requirements by the deadline.
The negotiators have agreed that the new regulation is to be applied 42 months after its entry into force (= usually 20 days after publication in the Official Journal of the EU). This means that the new requirements must be applied from January 20, 2027. However, companies must already deal with the new requirements before the effective date, as from the effective date the declaration of conformity, technical documentation, etc. must already have been prepared in accordance with the new regulation.
Some sections of the new regulation must already be applied before 2027-01-20. This primarily affects the member states as well as the EU Commission:
In fact, this is a (binary) key date regulation. The relevant date is the date of placing on the market. This means that if manufacturers are working on a complex project that will not be placed on the market until after 20 January 2027, they should already apply the new Machinery Regulation; in all other cases, they should apply the Machinery Directive. In other words: All machines delivered before 20 January 2027 will receive a declaration of conformity in accordance with the Machinery Directive, all products after this date will receive a declaration of conformity in accordance with the Machinery Regulation.
Of course, manufacturers can already fulfil additional requirements (e.g. with regard to security). A mixture of formal requirements (e.g. conformity assessment procedures) is not envisaged.
Please note that the following is only a rough overview of some of the changes in content. To list all changes in detail would go beyond the scope of a technical paper.
Currently, machinery safety in Europe is regulated by Directive 2006/42/EC (Machinery Directive). By establishing the European requirements as a directive, member states had more flexibility in meeting the directive's objectives. However, this has also led to different interpretations and thus, in part, to legal uncertainties for users of the directive, such as manufacturers. If these exported their machines or plants e.g. into different countries of the EU and there by local authorities details interpreted sometimes somewhat differently.
With the aim of reducing the administrative burden, the directive has now been replaced by a regulation. This must be applied directly in all member states. This means that different national interpretations should be significantly reduced and thus the legal clarity is improved. In addition, the administrative burden for economic operators, such as manufacturers, should also be reduced.
We started preliminary work some time ago to enable our customers to carry out conformity assessment procedures in accordance with the new Machinery Regulation (EU) 2023/1230 as soon as possible after its publication. This is particularly relevant for very complex projects whose date of placing on the market is later than early 2027.
Of course, we will not be able to finalize the functionalities until the official documents are available. Implementing the new requirements in Safexpert has top priority.
When will there be harmonised standards on the new regulation in the EU Official Journal?
There are currently over 800 harmonised standards listed in the EU Official Journal in accordance with the Machinery Directive 2006/42/EC. However, as the new Machinery Regulation will result in amended or new health and safety requirements (EHSRs for short), all documents must be reviewed and, if necessary, adapted to the new requirements.
As things stand, the EU Commission will also fully certify the presumption of conformity under the Machinery Regulation for all standards that are currently listed in the EU Official Journal under the Machinery Directive - provided they cover the same requirements. For the new requirements added under the Machinery Directive, the CEN/CENELEC Technical Committees must carry out a review to determine the extent to which individual standards need to be adapted. The aim is to have an implementing decision with a complete list of harmonised standards in accordance with the Machinery Regulation by the end of 2026 (shortly before the deadline of 20 January 2027).
The EU Commission's standardisation mandate is to be adopted by the European standardisation organisations at the beginning of 2024. This includes the creation of harmonised standards specifically for the new requirements of the Machinery Regulation, such as artificial intelligence and cyber resilience. In addition to the existing Annex ZA (reference of a European standard to the EHSRs to be covered by Directive 2006/42/EC), new publications of European standards that (still) cover the requirements of both sets of regulations will also contain an Annex ZB for Machinery Regulation (EU) 2023/1230. Further information on the status of the harmonised standards can be found in the technical article "New Machinery Regulation: Status of harmonised standards"
The new regulation was published in the EU Official Journal on 2023-06-29. You can access the English language version of the regulation via the following link:
REGULATION 2023/1230 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ON MACHINERY
Footnote:1 See corrigendum to Regulation (EU) 2023/1230 of 2023-07-04: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2023.169.01.0035.01.ENG&toc=OJ%3AL%3A2023%3A169%3ATOC
Posted on: 2023-07-04 (last amendment)
Johannes Windeler-Frick, MSc ETH Managing Director of IBF Solutions AG, the Swiss subsidiary of IBF in Zürich. Johannes is a trainer for both the Machinery Directive (MD) as well as the Low Voltage Directive (LVD). He studied electrical engineering at ETH Zürich with a specialization in energy systems.
Email: firstname.lastname@example.org | www.ibf-solutions.com
You are not yet registered? Register now for the free CE InfoService and receive information by e-mail when new technical papers, important standards publications or other news from the field of machinery and electrical equipment safety or product compliance are available.
CE software for systematic and professional safety engineering
Practical seminars on aspects of risk assessment and ce-marking
With the CE InfoService you stay informed about important developments in the field of product safety.