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Like the Machinery Directive, the Machinery Regulation defines health and safety requirements for machines placed on the market or put into service within the European Union.
The new regulation will replace the current 2006 Machinery Directive (transposed into French law in Livre III of the regulatory section of the Code du Travail) as of January 20, 2027.
As it is not a directive, it does not need to be transposed into national law. This avoids delays and the legal uncertainty for economic operators that could result from "divergent implementation by member states".
New technologies taken into account
What is a machine?
Within the meaning of the Directive, a machine is, among other things, an assembly composed of linked parts or components, at least one of which is movable, and which are joined together for a specific application.
Machinery within the meaning of the Machinery Directive also includes :
- All machines or complex installations Complex installations also include production lines, special machines made up of several machines, and interconnected machines.
- Safety components: determining which components should be classified as safety components has been the subject of much controversy. The parties have yet to reach agreement.
- Interchangeable equipment for modifying basic machine functions
- Quasi-machines
Developments
To take account of new emerging technologies (autonomous machines), the definition of "related machine or product" has been extended to include these (e.g. cobots, 3D printers, etc.).
There is also a list of exclusions (means of transport by air, water and rail, with the exception of machinery mounted on these means of transport, motor vehicles and their trailers, etc.).
Substantial changes
Already used in France, a Technical Guide to modification operations on machines or machine assemblies in service provides a definition of modification, as well as examples.
The definition of modification is based primarily on the existing nature of the instruction manual and its contents. If work is carried out on a machine without an instruction manual, it will be considered a modification. If the interventions change the purpose of the machine, or lead to the installation of parts not provided for in the instructions, then they are indeed considered modifications.
The procedure for "substantial modification" of machines is now included in the regulations. In brief, this is a modification not foreseen by the manufacturer which affects the safety of the machine, "by creating a new hazard or increasing the existing risk", making it necessary to add protective devices or take additional protective measures to ensure that the machine remains stable or that its mechanical strength is not affected. The current Machinery Directive does not address this situation.
In the event of a "substantial modification", you become a manufacturer, with all the attendant obligations (setting up technical documentation, conformity assessment, etc.).
Note: this does not apply to private individuals who modify a machine for their own use. It concerns the importer, distributor and user.
Digital documents
The regulations specify that the instruction leaflet may be supplied in digital format. At the customer's request, the manufacturer must supply the instructions on paper. The declaration of conformity can also be supplied in digital format, while partly completed machines can be supplied with a digital assembly manual and a digital declaration of incorporation.
To date, the directive requires manufacturers to provide the necessary information on machines, such as instruction manuals, in paper form.
Players in the design or manufacture of machines and related products
(Related products: interchangeable equipment, safety components, lifting accessories, chains, cables and straps, removable mechanical transmission devices)
Today, the directive considers a manufacturer to be any natural or legal person who designs and/or manufactures a machine, related product or partly completed machine for placing on the market or putting into service in his own name or under his own brand, or for his own use (manufacturer or authorized representative).
The regulation extends the obligations incumbent on manufacturers, importers and distributors if they place a machine or related product on the market under their own name or brand.
The terms "importer" and "distributor" are now part of the market.
Update of the list of machines subject to a conformity assessment procedure
Annex I replaces Annex IV (machines and related products presenting a serious potential inherent risk) and specifies the risk level of machines. The appendix therefore comprises a Part A and a Part B, depending on the level of risk (List A corresponds to machines with a higher risk).
List A :
- Vehicle elevators,
- Removable mechanical transmission devices and their guards,
- Protectors for removable mechanical transmission devices,
- Security components that make full or partial use of machine learning approaches,
- Portable fastening machines with explosive charges and other impact machines.
The machines and related products in this list are subject to conformity assessment by a notified body, whether or not they are manufactured to a harmonized standard.
For machines or related products on list B, manufacturers can continue to declare conformity, without going through a notified body, provided they apply harmonized European standards that also cover all risks.
Note: Manufacturers must comply with EHSRs (essential health and safety requirements). Harmonized standards specify the means by which these requirements are to be met. Compliance with these standards dispenses with the need for third-party certification of conformity.
Other developments...
To meet the challenge of cybersecurity (risks arising from malicious actions by third parties and having an impact on machine safety), a new section has been added to EESS (essential health and safety elements).
To address the issue of autonomous machines and artificial intelligence, the sections of SESA dealing with human-machine contact, namely ergonomics and the risks associated with moving parts and psychological stress, have been revised.
The European Commission will be able to update the regulations for high-risk machines more easily. It will be able to act on its own initiative, or at the request of other parties, to add or remove machines from the list.
The concept of security components now includes not only physical, digital and/or mixed components, but also software.
Mobile machines are dealt with in a virtually new section of Annex III.
The declaration of conformity and the declaration of incorporation for partly completed machines are EU declarations rather than CE declarations.
To sum up
The new regulation harmonizes the essential health and safety requirements applicable to machinery in the EU, facilitating the free movement of machinery and guaranteeing a high level of safety for workers and citizens.
Important fundamental points concerning artificial intelligence and machines are contained in the Machine Regulation. However, a regulation on Artificial Intelligence is also planned.
Photo credit: 609841105 @Westend61