Impending machinery changes to the Restriction of Hazardous Substances (RoHS) Directive
05 June 2019
In 2002, the European Union first introduced the RoHS Directive 2002/95/EC – the restriction on hazardous substances in electronic and electrical equipment (EEE), with all applicable products having to pass RoHS compliance since 1 July 2006. However, since 3 January 2013, Directive 2011/65/EU, or RoHS 2, has superseded this. Paul Taylor of TÜV SÜD UK explains the new directive and the major changes it will usher in, with a particular focus on machinery.
If your equipment can be used on its own or as part of an assembly it will need to comply with RoHS
Besides expanding the scope and clarifying some definitions, RoHS 2 is now also a CE marking Directive. It was also one of the first regulations to incorporate the New Legislative Framework (NLF) for the marketing of products, which lays down obligations for all operators within the supply chain. In addition, the new Directive also ensures that additional restricted substances to be included under RoHS 2 will be coherent with other chemical regulations such as REACH.
To briefly summarise, RoHS 2 introduced five key changes:
1. The scope was expanded in two ways: clarification of definition and additional product categories. The definition of EEE now includes all EEE that require electrical currents or electromagnetic fields to fulfil at least one intended function. This means products that were previously excluded from the scope are now included. The list of product categories has also increased from the previous eight to eleven.
2. Technical documentation, Declaration of Conformity (DoC) and RoHS CE marking are now mandatory.
3. Manufacturers are also responsible for their supply chain and how they use restricted chemicals. RoHS 2 defines the specific obligations for each “economic operator” – the manufacturer, the authorised representative, the importer and the distributor (which includes the retailer).
4. New restricted substances have been included in the list.
5. Automatic expiry of exemptions – unless an application for renewal has been submitted and approved, all exemptions will eventually expire.
RoHS’s aim is to eradicate certain hazardous substances from new electrical and electronic equipment (EEE). It therefore restricts the use of certain hazardous substances in EEE, specifying maximum levels for 10 of them:
• Hexavalent Chromium
• Polybrominated Biphenyls
• Polybrominated Diphenyl Ethers
• Bis(2-Ethylhexyl) phthalate
• Benzyl butyl phthalate
• Dibutyl phthalate
• Diisobutyl phthalate
Under the RoHS Directive, manufacturers are required to replace these chemicals in their products with less hazardous alternatives. The Directive also requires that EEE products must not contain more than 0.1% of any of these listed substances, with cadmium being restricted to no more than 0.01%.
Becoming RoHS compliant is essential for businesses wishing to sell any kind of electronic products on the EU and European Economic Area (EEA) market. As a RoHS CE mark is a mandatory requirement, it is illegal to sell products in the EU without this mark. Not only does a RoHS CE mark give purchasers and regulators confidence that a product is safe, testing also helps product manufacturers to discover problems, avoiding fines and expensive product recalls.
Permanent exclusions from RoHS include military equipment, space equipment, equipment designed to be part of another piece of equipment falling outside the scope of RoHS, large scale industry tools, large scale fixed installations, transport, non-road mobile machinery, assembly equipment that is only available business-to-business (it cannot be sold to general consumers). Spare parts for electronic equipment that was on the market before July 1, 2006 is also excluded.
Machinery and RoHS
If you are building machinery that can only be used as part of an assembly of machines, you may not have to comply as the overall assembly does not need to comply. However, if your equipment can be used on its own or as part of an assembly, then you will have to comply.
Until now RoHS has not been a concern for the Machinery Industry. However, from 22 July 2019 it will apply to all EEE products that are “dependent on electric current or electromagnetic fields for at least one intended function”. This means that in order to place a CE marking on it, any industrial equipment will have to comply with the RoHS Directive, just like it does with the Machinery Directive, Low Voltage Directive and the EMC Directive.
Any business that sells applicable electrical or electronic machinery, sub-assemblies, cables, components, or spare parts directly to RoHS countries, or sells via resellers, distributors or integrators, is impacted if their products contain any of the restricted substances.
The European Commission has made these updates as it identified a number of issues related to the scope which needed to be addressed to avoid the legislation having unintended effects. Of particular relevance to the machinery industry is that it identified that after 22 July 2019 there would be a different, and distorting treatment of cord-connected non-road mobile machinery in comparison to otherwise identical machinery powered by a battery or an engine, the latter of which is currently excluded from RoHS scope. This means that traction-driven machinery is now captured within the scope of RoHS.
This essentially means that the CE marking of machinery, which depends on electricity to run, must include the requirements of the RoHS Directive. Only fixed installations, such as complex assemblies of machines, will be exempted - necessitating smaller machines, which can be moved around a site with relative ease, to meet RoHS compliance requirements for the first time.
Certainly smaller equipment, such as packing machines and labellers will fall within RoHS’s scope within the next 18 months, and it will apply to every part of the machinery, including the paint and labels. While the RoHS requirements apply to end products, as a final product is made up of components and sub-assemblies, it is imperative that these do not contain any of the restricted substances above, in the defined maximum concentration values. The technical file must also contain the analysis and component data, and be kept for at least four years from the date that the equipment was put on the market. If an exemption is claimed, this must be clearly justified within the technical file.
From July 2019, as part of the CE marking process, machinery manufacturers will be required to design and manufacture EEE in compliance with RoHS, produce the required technical documentation and a declaration of conformity.
The addition of RoHS to the machinery compliance mix means that CE marking is becoming increasingly complex. It is therefore advised that machinery builders and owners seek expert guidance if they are wondering whether an exclusion or exemption applies their products.
About the author
Paul Taylor is Head of Industrial Products (UK) at TÜV SÜD. He has more than a decade of hands-on experience in the field of machinery safety, across a range of industry sectors. His areas of expertise include risk assessment, EMC testing, CE marking, functional safety, PUWER inspections, training and project management. At TÜV SÜD, he is responsible for a team of engineers who have extensive experience in electrical and mechanical machinery inspection, offering specialist health & safety advice to enable clients to reach their compliance goals.