Last updated on 15 Oct, 2024

Machinery

What is the Machinery Directive?

Directive 2006/42/EC is a key European Union directive established to ensure the safety and efficiency of machinery. Adopted in 2006, it updated previous directives, reflecting advancements in technology. It provides essential safety requirements, facilitating free movement of machinery within the EU.

Machinery may be placed on the market and/or put into service only if it satisfies the relevant provisions of this Directive and does not endanger the health and safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for its intended purpose or under conditions which can reasonably be foreseen.

The Directive was nationally transposed by means of Subsidiary Legislation 430.36. It should be stressed that only the Machinery Directive and the texts implementing its provisions into national law are legally binding.

What Falls Under the Scope of the Machinery Directive?

Article 1 of Directive 2006/42/EC lays out the scope of said directive.

Is it machinery?

Does it have moving parts powered by something other than human or animal effort?

This includes systems like conveyor belts, robotic arms, or any assembly where at least one part moves. If it is designed for a specific task using a drive system, it qualifies as machinery.

Machinery is defined in Article 2(a) of the Directive.

Please refer to Article 2.

Does it change the function of existing machinery?

Is it interchangeable equipment added by the operator to alter functionality?

Examples include attachments for tractors or devices that modify a machine's capabilities. If it can be assembled with machinery to provide new functions, it fits this category.

Is it a safety component?

Does it serve a safety function, is it sold separately, and could it endanger safety if it fails?

This includes items like emergency stop switches, safety barriers and other components listed in Annex V. If the failure of this component could result in harm, it is classified as a safety component.

Does it lift loads?

Is it specifically designed for lifting?

This encompasses lifting accessories such as slings, chains, ropes, and webbing used to hoist or support loads. If it plays a role in lifting operations, it qualifies.

Does it transmit power?

Is it a removable mechanical transmission device that connects machines?

This could include drive shafts or couplings that transmit power from one machine to another. If it facilitates power transfer, it falls under this category.

Is it partly completed machinery?

Is it an assembly that needs additional parts to function?

Examples include engines or components that must be integrated with other machinery to become operational. If it cannot perform a specific task on its own, it is considered partly completed machinery.

What is Excluded?

Your product is excluded from the directive if it falls into any of the following categories:

Amusement Park Equipment: Designed for fairgrounds or amusement parks.
Nuclear, Military, or Police Purposes: Equipment related to nuclear applications or specifically designed for military/police use.
Weapons or Firearms: Any type of weapon, including firearms.
Motor Vehicles: Agricultural tractors and motor vehicles covered by different regulations, especially those with type-approval requirements.
Household Electrical Appliances: Devices intended for home use (e.g., fridges, TVs) and high-voltage electrical equipment like transformers.
Research and Artistic Performance Equipment: Machinery for temporary laboratory use or moving performers during shows.
Marine and Offshore Equipment: Machinery mounted on seagoing vessels or mobile offshore units.

What are the Obligations of the Manufacturer or Authorised Representative?

A manufacturer is any individual or organization that designs or produces machinery or partly completed machinery in compliance with this Directive. If there is no identifiable manufacturer within the EU, the individual or organization that markets or puts the machinery into service will be regarded as the manufacturer.

An authorised representative refers to any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on its behalf all or part of the obligations and formalities connected with this Directive.

Before placing machinery on the market and/or putting it into service the manufacturer or his authorised representative shall:

Ensure that it satisfies the relevant essential health and safety requirements.
Ensure the availability of the technical file for machinery or partly completed machinery.
Provide the necessary information, such as instructions. In the case of partly completed machinery, assembly instructions shall be prepared.
Carry out the appropriate procedures for assessing conformity for the machinery (Article 12) or partly completed machinery (Article 13).
Draw up the EC Declaration of Conformity (DoC) in accordance with Section A and ensure that it accompanies the machinery. In the case of partly completed machinery the manufacturer shall prepare a Declaration of Incorporation (DoI), referred to in Section B. In either case, the manufacturer shall keep the original EC declaration for a period of at least 10 years from the last date of manufacture of the machinery.
Affix the CE marking in accordance with Article 16.
Where machinery is also the subject of other Union legal acts relating to other aspects and providing for the affixing of CE marking, the marking shall indicate that the machinery also conforms to the provisions of those other Union legal acts.
Manufacturers may also be required by other Union legal acts to draw up an EC Declaration of Conformity. To ensure effective access to information for market surveillance purposes, a single EU Declaration of Conformity may be drawn up in respect of all Union legal acts. Make the product conform to the relevant provisions of the Directive and put an end to an infringement if it is found to not conform by a Member State’s market surveillance authority.

What is New in the Machinery Regulation?

The Machinery Regulation (Regulation (EU) 2023/1230) introduces significant updates and changes to Directive (2006/42/EC) governing machinery in the European Union.

Wider Scope: The regulation expands the definition of machinery to cover a wider range of products, including partly completed machinery, safety components, and lifting accessories. The regulation also clarifies the inclusion of interchangeable equipment that alters the functionality of machinery.
Updated Risk Assessment Methods: A greater emphasis on the assessment of potential risks, particularly for new categories of machinery and technologies, acknowledging uncertainties in presently available assessment methods.
Updated Market Surveillance Procedures: The regulation mandates improved market surveillance and reporting measures to address the recurrence of serious accidents or health issues linked to machinery.
New Essential Health and Safety Requirements: The regulation introduces specific requirements that manufacturers must adhere to.
Roles of Importers and Distributors: The present Directive makes no reference to the key role of importers and distributors. Under the new Machinery Regulation, importers and distributors are required to ensure that the machinery they place on the market complies with the regulation. The Regulation also further clarifies the requirements for the manufacturer and authorised representative.

Further Regulations and Directives

In the context of machinery, further regulations may be applicable, most notably, GPSR, EMC, LVD, RED, Batteries, RoHS, Ecodesign and/or Energy Labelling legislation. Machinery may also fall within the scope of other legislations not listed above, that could be either under the remit of MCCAA or other entities such as, but not limited, to cybersecurity. It is the responsibility of the manufacturer / Importer to ensure that the product being placed on the market complies with all applicable Union legal acts.

Timeline

Kindly note that the timeline shown below differs from what was originally indicated in the original Machinery Regulation publication. These dates have been corrected according to a corrigenda.

19^th July 2023:

Articles 6(7) and Articles 48 and 52 of the Regulation took effect.
Chapter VI of the new Regulation applies to products placed on the market under Directive 2006/42/EC, superseding Article 11 of that Directive.

20^th October 2023:

Article 50(1) of the new Regulation took effect.

20^th January 2024:

Articles 26 to 42 in Chapter V of the new Regulation took effect.

20^th July 2024:

Article 6(2) to (6), (8), and (11), along with Articles 47 and 53(3) of the new Regulation took effect.

20^th July 2026:

The Commission shall submit a specific report on the assessment of Article 6(4) and (5) of this Regulation to the European Parliament and to the Council. Such reports will be made available to the public and be reissued every five years thereafter.

20^th October 2026:

Member States shall notify the Commission of rules on penalties applicable to infringements by economic operators.

20^th January 2027:

Directive 2006/42/EC is officially repealed.
The new Regulation fully applies, replacing the repealed Directive.
Member States must allow products that conform to Directive 2006/42/EC (placed on the market before this date) to continue being available on the market.
Chapter VI of the new Regulation applies to these products also, replacing Article 11 of the old Directive.

20^th July 2028:

The Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. Such reports will be made available to the public and be reissued every four years thereafter.

EC type examination certificates (DoC and DoI) issued under Directive 2006/42/EC shall remain valid until they expire.

Further Information and Guidelines

Guide to Application of the Machinery Directive 2006/42/EC

Information About the CE Marking

Guidance on CE Marking for Professionals

Guidance on Conformity Assessment Procedures for 3D Printing and 3D Printed Products

Application Guide: Ergonomic Health and Safety Requirements

The ‘Blue Guide’ on the Implementation of EU Product Rules

List of Notified Bodies

List of Harmonised Standards

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