Introduction to the requirements for machinery
If you manufacture, import or sell machines, you are subject to certain statutory obligations. These obligations aim to ensure that machines sold in the EU are safe and otherwise comply with legal requirements.
- In the eyes of legislation, what kind of products are considered machines?
- What are the requirements for machines?
- What are the obligations of the machine manufacturer?
- What if the importer wants to market the machine under their own brand?
The purpose of this section is to provide answers to the above questions, as well as to clarify other issues relevant to the marketing of machines.
To make the text more readable, some matters had to be compressed and/or simplified in some respects. You can find the detailed requirements for operators in the legal texts to which we have provided links in this section.
Machinery placed on the market or put into service in the EU must comply with the requirements of the Machinery Directive 2006/42/EC. The aim of harmonising the requirements is to ensure the free movement of machinery and a standardised high level of safety.
The Machinery Directive has been implemented nationally in Finland by the Government Decree on the safety of machinery (400/2008, the “Machinery Decree”). Machinery sold or put into service in Finland must therefore comply with the requirements of the Machinery Decree.
In the future, this text will mainly refer to national legislation, namely the Machinery Decree. However, these requirements stem from the EU Machinery Directive, and it is natural to refer to the directive instead of national regulation in matters outside Finland.
The Machinery Decree determines
- the obligations of the manufacturer of the machinery
- the essential health and safety requirements relating to the design and construction of the machinery
- the procedures for demonstrating the conformity of the machinery and placing the machinery on the market.
Who and what the requirements cover?
The manufacturer of the machinery is responsible for its conformity. Importers and distributors are also subject to certain requirements for ensuring the conformity of the machinery.
The Machinery Decree is applied to
- new machinery that is placed on the market or imported or manufactured for own use in the EU
- second-hand machinery imported from a third country, i.e. from outside the EU.
Requirements in a nutshell
All machinery is subject to certain minimum requirements. These include:
- machinery must be designed and constructed in accordance with the essential health and safety requirements specified in the Machinery Decree.
- machinery must bear the CE marking and certain other markings specified in the Machinery Decree, such as the designation of the machinery, the name and address of the manufacturer and the markings for identifying the machinery.
- machinery must be accompanied by appropriate operating and maintenance instructions and the EC declaration of conformity, which in Finland must be in Finnish and Swedish.
What does conformity mean?
Conforming machinery is a machine that meets all the statutory requirements that apply to it. In other words, the machine is legal. Non-conforming machinery is a machine which does not meet one or more of the statutory requirements that apply to it. Non-conforming machinery must not be sold or put into service.
Authorities supervising the machinery
Finnish Safety and Chemicals Agency (Tukes) supervises the compliance of machinery intended for consumer use. The occupational safety and health authorities supervise the safety of machinery intended for professional use. Occupational safety and health authorities include the TTO department of the Ministry of Social Affairs and Health and the OSH divisions in Regional State Administrative Agencies.
Although the responsibility for supervising consumer and professional machinery in Finland has been allocated to different authorities, the Machinery Decree and its requirements apply to all machines, regardless of the user group.
Guide to application of the Machinery Directive
The guide to application of the Machinery Directive is a useful tool for the interpretation and application of the Machinery Directive and Decree. The guide produced by the European Commission is intended for all the parties involved in the application of the Machinery Directive; the manufacturers, importers and distributors of machinery, as well as the supervisory authorities. The purpose of the guide is to explain the concepts and requirements of the Machinery Directive and to promote its uniform interpretation and application. However, it is important to note that only the Machinery Directive and its related national legislation (the Machinery Decree in Finland) are legally binding.
Guide to application of the Machinery Directive, 2nd edition, Finnish
Guide to application of the Machinery Directive, 2.1 edition, EnglishGuide to application of the Machinery Directive, 2.2 edition, English