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All 3D printers must meet the requirements of machinery legislation

16.12.2019 10.06 | Published in English on 13.1.2020 at 13.22
News item

All 3D printers must meet the legal requirements set for machinery. The Finnish Safety and Chemicals Agency (Tukes) advises companies importing or selling 3D printers to ensure that their products comply with the Finnish legislation.

The prices of 3D printers have come down and their availability has expanded significantly over the past few years. According to Tukes' observations there is confusion about the applicable legislation particularly among companies selling 3D printers intended for consumer use in the Finnish market

“Big 3D printers used by the industrial sector are production machinesjust like any other machines using other manufacturing methods. It may be harder to understand that the same legislation also applies to the much smaller and simpler printers intended for consumer use,” says Senior Officer Soili Huttunen.

According to a market survey conducted by Tukes, 3D printer manufacturers place the 3D printers intended for consumer on the market mainly as LVD products subject to the Low Voltage Directive or as products subject to the Radio Equipment Directive if the 3D model is transferred to the device using wireless network, for example. Finland has investigated the issue at the EU level. Based on the conversation conducted, the final result is that the Machinery Directive shall be applied to all 3D printers, meaning that they must be placed on the market as machinery and meet the requirements of the relevant directive.  

In addition to the Machinery Directive, other EU directives or regulations applicable to 3D printers could include not only the Radio Equipment Directive, but also the EMC, RoHS, WEEE and Ecodesign Directives and the REACH Regulation. The EMC Directive regulates electromagnetic compatibility of electrical equipment, the RoHS Directive places restrictions on certain hazardous substances in electrical and electronic equipment, the WEEE Directive is applied to waste electrical and electronic equipment, and the Ecodesign Directive sets rules for the environmental impact and energy efficiency of products related to energy. The REACH Regulation sets rules for registration, evaluation, authorisation and restrictions concerning chemical substances and exchange of information in supply chains.

Requirements for machinery in short

In Finland, the Machinery Directive is implemented by the Government Decree on the Safety of Machinery (400/2008). The Machinery Decree defines, among other things, the general safety requirements that machinery must satisfy. The safety requirements related to 3D printers may concern such matters as hot surfaces, moving parts or electrical safety. A machine must also have a CE marking, and it must be accompanied with instructions and the EU Declaration of Conformity in Finnish and in Swedish.

Companies selling printers intended for consumers should also note that assembly kits are also considered as machinery, which means that they must meet the same requirements.

In addition, when a Finnish company buys printer components from various suppliers and assembles a machine using these components, the company in question is considered the manufacturer of the machinery, in which case the obligations applied to the machinery manufacturer also apply to the company in question.

Tukes advises companies importing or selling 3D printers to ensure that their printers meet the legal requirements. The manufacturer, importer and distributor are responsible for ensuring that the products are safe and comply with the requirement applied to them.

Tukes is monitoring the situation and may perform supervision in the form of spot-checks of the product group. Tukes may, for example, order machines not meeting the legal requirements to be removed from the market.

Table 1 specifies the responsibilities and obligations of the manufacturers, importers and distributors of 3D printers.

Table 1. The responsibilities and obligations of the manufacturers, importers and distributors of 3D printers before the sale of the products
  Manufacturer (or authorised representative) EU importer Distributor/seller

Place on the market1) 3D printer meeting the relevant requirements

x (x, private label)  

ensure that the printer complies with the relevant essential health and safety requirements of the Machinery Directive, Annex 1

x    

ensure that the appropriate conformity assessment procedure has been carried out to the printer

x    

ensure that technical file has been written for the printer

x    

Make available on the market2) 3D printer meeting the relevant requirements3)

x x x

Equip the printer with relevant markings, incl. CE marking

x    

Ensure the printer is equipped with relevant markings, incl. CE marking and contact details of the manufacturer

  x x

Write relevant EU Declaration of Conformity for the printer

x    

Ensure that a relevant EU Declaration of Conformity is delivered with the printer (all the way to the consumer) not only in original but also in Finnish and in Swedish

  x x

Write relevant user, installation and maintenance instructions for the printer, including:

what materials the printer can use for printing

appropriate assembly instructions for DIY 3D printer kits

information about potential additional parts that may need to be installed in the printer afterwards, and provision of such installation or installation instructions

x

x

x

x

   

Ensure that relevant user, installation and maintenance instructions are delivered with the printer not only in original but also in Finnish and in Swedish

  x x

1) Place on the market: Making available on the EU market for the first time. The product may be placed on the market by the manufacturer or the importer.

2) ‘Make available on the market’ shall mean any supply of the product for distribution, consumption, or use on the EU market in the course of commercial activity, whether in return for payment or free of charge.

3) The regulation concerning 3D printers intended for consumer use is also complemented by the Consumer Safety Act. The act obliges all supply chain actors to ensure in accordance with their role that the product does not endanger anyone’s health or property.

More information:

Soili Huttunen, Senior Officer, tel. +358 29 5052 024, email. [email protected]

Requirements for machinery at tukes.fi

Commission statement from 2013 about the safety of 3D printers being governed by the EU Machinery Directive