INDUSTRY NEWS
The Technical Differences between the EU's New Machinery Regulations and Machinery Directive [Part 1]
The new EU Machinery Regulation 2023/1230, as previously announced, will replace the current 2006/42/EC and be enforced after January 20, 2027.
In order to facilitate a deeper understanding of the requirements of the new regulations, we will analyze the main differences between the new machinery regulations and the current machinery directives from the perspective of technical requirements.
Differences in regulatory structure
From a purely textual perspective, the order of the provisions and appendices of the regulations has changed. The most important one is that the list of high-risk machinery appears in Appendix I instead of Appendix IV as before. The basic health and safety requirements have been moved from Appendix I to Appendix III of the new machinery regulations.
machinery directive 2006/42/EC | EU Machinery Regulations 2023/1230 |
Article 1 | Article 2 |
Article 2 | Article 3 |
Article 3 | Article 9 |
Article 4 (1) and (2) | Article 8 |
Article 4 (3) and (4) | - |
Article 5 | Article 10 and Article 11 |
Article 6 | Article 4 |
Article 7 | Article 20 (1) |
Article 8 (1) | Article 6 (1) and Article 7 (1) |
Article 8 (2) | - |
Article 9 | - |
Article 10 | Article 44 (3) |
Article 11 | Articles 43, 44, and 45 |
Article 12 | Article 25 |
Article 13 | Article 11 |
Article 14 (and Appendix 11) | Articles 26 to 42 |
Article 16 | Articles 23 and 24 |
Article 17 | Article 46 |
Article 18 | Article 49 |
Article 19 | - |
Article 20 | - |
Article 21 a | Article 47 |
Article 22 | Article 48 |
Article 23 | Article 50 |
Article 24 | - |
Article 25 | Article 51 |
Article 26 | - |
Article 27 | - |
Article 28 | Article 54 (1) |
Article 29 | Article 54, paragraphs 2 and 3 |
Appendix I - General Principles and Section 1.1.1 (Definitions) | Appendix III - Part A (Definitions) and Part B (General Principles) |
Appendix 1, Sections 1.1.2-1.1.8 | Appendix III, Section 1 |
Appendix 1, Section 2 | Appendix III, Section 2 |
Appendix 1, Section 3 | Appendix III, Section 3 |
Appendix 1, Clause 4 | Appendix 3, Clause 4 |
Appendix 1, Clause 5 | Appendix 3, Clause 5 |
Appendix 1, Clause 6 | Appendix 3, Clause 6 |
Appendix 2, Parts A and B | Appendix V, Parts A and B |
Appendix III | - |
Appendix IV | Appendix I |
Appendix V | Appendix II |
Appendix VI | Appendix XI |
Appendix VII, Parts A and B | Appendix IV, Parts A and B |
Appendix VIII, together with Article 12, Paragraph 3a | Appendix VI |
Appendix 7 (No. 3) together with Article 12 (3b) | Appendix VIII |
Appendix IX | Appendix VII |
Appendix X | Appendix IX |
Appendix XI | Article 30 |
Differences in product definition under the new EU machinery regulations
Definition: "What is machinery?
The EU Machinery Regulation defines the term "machinery" and the special circumstances familiar to us (now "related products"), such as interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and detachable mechanical transmission devices. The term 'mechanical assembly' is also largely retained, but the term 'software' is also mentioned. The lack of machines for specific application software also falls within the scope of this definition.
Definition: High risk machinery
High risk machinery is now divided into two categories:
Part A of Appendix I lists high-risk machinery that can change behavior through machine learning and other functions and must be evaluated by the notified body.
Appendix IB includes other categories of machinery, which are listed in Appendix IV.
The EU Machinery Regulation lists these six types of machinery in Appendix I, Part A:
1. Detachable mechanical transmission device, including its protective device
2. Protective device for detachable mechanical transmission device
3. Vehicle maintenance elevator
4. Portable magazine type fixing devices and other impact machinery
5. Use machine learning methods to ensure security components with fully or partially adaptive behavior for security functions
6. Using machine learning methods, embedded systems with fully or partially adaptive behavior, ensuring safety functions, and machines that have not been independently launched on the market, only involving these systems
For these machine types, machine manufacturers can no longer independently declare and coordinate standards in accordance with the previous Machinery Directive. In the future, there must be the participation of announcement agencies. The reason why this is necessary is partly due to the artificial intelligence mentioned in the article (described as "using machine learning methods"). This type of machinery always requires the participation of designated institutions. It can certify the machine itself through EU type testing, or certify the basic quality assurance system before actual production of the machine.
However, for the machine categories listed in Part B, machine manufacturers can still declare compliance with the Machinery Regulations through a combination of internal production control and unified standards.
Expansion of the definition of 'significant change'
To ensure mechanical safety, new compliance assessment procedures are always required when major technical modifications are made to the machine. It is explicitly stipulated (Chapter 2, Article 18) that personnel who make significant changes to the machine must fulfill all obligations of the manufacturer.
After the machine is put into use, it is usually unclear whether such modifications will affect the compliance of the machine or whether a new consistency assessment is required in certain situations. There is currently a common explanation in Germany regarding this point: the key is whether the modification will create new or greater risks, and whether it is possible to utilize existing security measures or use new simple security measures to prevent these risks. According to the answers to these questions, the responsibility for the compliance of the modified machine lies with the machine user or machine manufacturer. This viewpoint has been incorporated into the EU Machinery Regulation, such as Article 3, point 16.
It should be noted that even without any physical modifications to the machine, significant changes may occur, such as software modifications. That's why programmers should also be aware of this change request.
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