The machinery sector is an important part of the engineering industry. Machinery and related products consist of an assembly of components, at least one of which moves, joined together for a specific application. The drive system of machinery is, in principle, powered by energy other than human or animal effort. Notable exceptions apply to manual operation of machinery for lifting loads or cases where repeated manual operation results in energy accumulation before release.
EU machinery legislation
One of the main legislations governing the harmonisation of essential health and safety requirements for machinery at EU level is the current Machinery Directive 2006/42/EC.
The Machinery Directive
- promotes the free movement of machinery within the single market
- guarantees a high level of protection for EU workers and citizens
As it is a 'new approach' directive, it promotes harmonisation through a combination of mandatory essential health and safety requirements and voluntary harmonised standards reflecting the state-of-the-art. The Directive applies to products that are placed on the EU market for the first time or when existing machinery is modified to such extent that it becomes de facto new machinery.
The Machinery Directive was amended a few times to take account of technical progress. See the latest consolidated version of the Machinery Directive.
The Machinery Regulation
The new Machinery Regulation (EU) 2023/1230 was adopted on 14 June 2023. A corrigendum has been issued to address a clerical error as regards the application dates in the original version. See the latest consolidated version of the Machinery Regulation.
The Regulation aligns with the New Legislative Framework. It continues to promote harmonisation through a combination of mandatory essential health and safety requirements and voluntary harmonised standards, as with the current Machinery Directive.
- increases legal certainty, through uniform application
- integrates provisions for machinery with safety functions that are AI-powered
- integrates provisions for cyber-safety for compliance-relevant software data and safety control systems
- addresses the conformity assessment of machinery presenting a higher risk factor
- updates certain product category-specific provisions
- applies on a mandatory basis as of 20 January 2027
Compliance and conformity
All machinery placed on the EU market before 20 January 2027 must comply with the current Machinery Directive 2006/42/EC. Manufacturers are allowed to state on an EU Declaration of Conformity that such machinery also conforms with Machinery Regulation (EU) 2023/1230 if applicable.
The Guide to the application of the Machinery Directive 2006/42/EC is available in English. It consists of useful examples and explanations covering virtually the entire scope of applying the Directive. The guide includes a thematic index to make it easier to navigate.
- Machinery Directive application guide edition 2.2 (published October 2019)
- Application guide: ergonomic health and safety requirements
This document above guides you through applying ergonomic essential health and safety requirements mentioned in section 1.1.6 of Annexe I to the Machinery Directive and the corresponding harmonised standards.
Market surveillance ensures that products on the EU market do not endanger EU workers and citizens. It also ensures the protection of other public interests, such as the environment, security and fairness in trade.
See the lists of national market surveillance authorities linked below.
European cooperation on market surveillance takes place through informal groups of market surveillance authorities, called Administrative Cooperation groups (AdCos). The Commission supports these groups. The AdCo on machinery generally meets twice per year, either in Brussels or in another European location. The group works autonomously to a great extent.
Administrative Cooperation group on machinery market surveillance (access is limited to representatives of national market surveillance authorities and other authorised stakeholders)
EU countries inform the Commission and the other EU countries about which notified bodies are designated to carry out conformity assessment according to the machinery legislation. Notification of notified bodies and their withdrawal are the responsibility of the notifying EU country.
- Find bodies notified under Machinery Directive 2006/42/EC as well as Machinery Regulation (EU) 2023/1230 through the NANDO information system
- European coordination of notified bodies (access is limited to representatives of notified bodies and other authorised stakeholders)
'Recommendation for use' (RfU) sheets
The following 'recommendation for use' sheets reflect the common position of the notified bodies in the machinery sector. They assist notified bodies in their tasks with the conformity assessment of machinery, as linked to the EU type-examination procedure, and in accordance with the terms of the machinery legislation. All stakeholders involved in implementing this legislation are encouraged to use this helpful information.
Horizontal RfU sheets are prefixed by 00 and apply to all types of machinery listed in Annexe IV of the Machinery Directive.
Vertical RfU sheets apply more specifically to a particular category of machinery listed in Annexe IV. For example, sheets prefixed by 01 deal with woodworking machinery, and sheets prefixed by 04 deal with injection or compression moulding machines.
In the spotlight
Unregulated certificates warning
Unregulated certificates, which are often called ‘voluntary certificates’ besides other names, are often issued for some products covered by EU harmonisation legislation by certification bodies not acting in their capacity as notified bodies under EU law. These practices are misleading since only notified bodies may issue certificates of compliance for harmonised products and only in the area for which they are notified. For example, if a body is notified to issue certificates for machinery, it should not issue certificates (voluntary or other) for non-machinery products (such as personal protective equipment – masks).
Please note that, under EU law, voluntary or other additional certificates are not a recognised means to prove compliance. Consequently, they have no value in the case of checks by market surveillance authorities or customs. However, an exception arises in instances where voluntary certification is outlined in specific legislation. In such cases, while the certificate is not obligatory, it must adhere to explicit requirements if chosen to be acquired.
Voluntary certificates can create the impression that the product conforms with applicable EU harmonisation legislation, although such certificates are not issued by an authorised body.
Voluntary certificates must not be confused with third-party conformity assessment certification by notified bodies within the area for of competence for which they are notified, due to the use of terms such as ‘certification’ or ‘independent third party’ or the presence of the CE marking on the certificate.
CE marking can only be affixed after testing the product and performing the conformity assessment procedure prescribed by the applicable EU harmonisation legislation. It is not acceptable for voluntary certificates to bear a CE marking.