Is Machinery in Scope of the RoHS Directive?

My machine is industrial machinery, do I have to comply with RoHS for CE marking?” We are frequently asked this question. The answer is – yes, unless you fall into one of the exclusions available from the RoHS Directive 2011/65/EU. We will pull this apart in this following article.

Let’s take it from the top. The RoHS Directive 2011/65/EU is for the Restriction of Hazardous Substances… colloquially known as “RoHS”. Pronounced “Ross” or “ROH-hass”. The RoHS Directive applies to anything with any electric or electronic function.

First, let’s define what is in scope and then we will look at the exclusions. RoHS is applicable per Article 2, 1:

This Directive shall, subject to paragraph 2, apply to EEE falling within the categories set out in Annex I.

See the list from Annex I:

  1. Large household appliances.
  2. Small household appliances.
  3. IT and telecommunications equipment.
  4. Consumer equipment.
  5. Lighting equipment.
  6. Electrical and electronic tools.
  7. Toys, leisure and sports equipment.
  8. Medical devices.
  9. Monitoring and control instruments including industrial monitoring and control instruments.
  10. Automatic dispensers.
  11. Other EEE not covered by any of the categories above.

Then – let’s see what “EEE” means. See the definition in Article 3, (1):

‘electrical and electronic equipment’ or ‘EEE’ means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current;

Summary – if your equipment has any electric or electronic function and it matches any of the equipment listed in Annex I… you are in scope and must comply with the RoHS Directive. This means that every single part of your build must meet the substance level restrictions indicated in Annex II (Note: Annex II was updated by Commission Delegated Directive (EU) 2015/863):

ANNEX II
Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials
Lead (0,1 %)
Mercury (0,1 %)
Cadmium (0,01 %)
Hexavalent chromium (0,1 %)
Polybrominated biphenyls (PBB) (0,1 %)
Polybrominated diphenyl ethers (PBDE) (0,1 %)
Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)
Butyl benzyl phthalate (BBP) (0,1 %)
Dibutyl phthalate (DBP) (0,1 %)
Diisobutyl phthalate (DIBP) (0,1 %)
…’

The machinery above is in scope of RoHS, unless we can fit it into an exclusion. For the purposes of this article, assume it is in scope. What this means for this build is that every single part and every single piece of every part must comply with the substance restrictions identified in Annex II above. This means the blue and orange plastic, the screws, the cutting blade, housing, tool head, and every piece inside the housing (the board and all of its components) must individually comply with the restriction levels for the above ten identified substances.

Next, we will look at the exclusions dealing with large equipment. Depending upon your equipment – you may or may not be able to exclude it as ‘large-scale”. It depends on a few factors, including how large your equipment is and how large the final installation to which it will be fitted is, and how ‘custom’ your build is.

See RoHS 2011/65/EU, Article 2, 4., (c), (d), and (E):

This Directive does not apply to:

(c) equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment;
(d) large-scale stationary industrial tools;
(e) large-scale fixed installations;

OK, first let’s key in on (d) and (e) and what they really mean. See the definitions in Article 3, (3) and (4):

3) ‘large-scale stationary industrial tools’ means a large-scale assembly of machines, equipment, and/or components, functioning together for a specific application, permanently installed and de-installed by professionals at a given place, and used and maintained by professionals in an industrial manufacturing facility or research and development facility;

(4) ‘large-scale fixed installation’ means a large-scale combination of several types of apparatus and, where applicable, other devices, which are assembled and installed by professionals, intended to be used permanently in a pre-defined and dedicated location, and de-installed by professionals;

Next we see consider the two above definitions against Article 2, 4., (c) – defined above and summarized as equipment specifically designed for and permanently mounted to an excluded category of equipment… like large-scale stationary industrial tools and large-scale fixed installations. This does not mean that you can exclude your small device if it can be fitted to any large scale equipment. It means it can be excluded if your small device is custom made for a specific application (one machine, meaning… one unit) that is also excluded. If you make a thermostat that can be fitted to different HVAC systems you are unable to use the Article 2, 4., (c) exclusion. But, if you custom design a thermostat for a very large HVAC system that is custom made for a building or factory… and it is only made for that particular installation then, yes, it can be excluded.

But, what about larger equipment? The European Commission published very specific guidance about this in 2012 and it is still the reference material. That guidance is available at the Euorpean Commission’s RoHS page, here.

Download the FAQ at the link. The document you want is on that web page as a direct download link indicated by the green arrow above. The entire document is worth reading but for this article we want to look at the specific guidance in Section 3. Scope – Large-scale Exclusions starting on page 9. Section 3 elaborates on criteria for large-scale exclusions on page 11, see below:

One possible way of introducing a direct size criterion relates to transportation. The following guidance metrics and qualitative criteria can be applied for installations. If the installation exceeds the minimum requirements for one of the following criteria, it can be considered large-scale:

  • If, when installing or de-installing the installation, it is too large to be moved in
    an ISO 20 foot container because the total sum of its parts as transported is
    larger than 5,71m x 2,35m x 2,39m, it can be considered large-scale.
  • The maximum weight of many road trucks is 44 tonnes. Thus if, when installing
    or de-installing the installation, it is too heavy to be moved by a 44 tonne road
    truck, because the total sum of its parts as transported weighs more than the
    truck’s load capacity, it can be considered large-scale.
  • If heavy-duty cranes are needed for installation or de-installation, the
    installation can be considered large-scale.
  • An installation that does not fit within a normal industrial environment, without
    the environment needing structural modification, can be considered large-scale.

    Examples for modifications are modified access areas, strengthened
    foundations etc.
  • If an installation has a rated power greater than 375 kW, it can be considered
    large-scale.

    This is only an indicative list.

If your equipment can fit in one tractor trailer load then it is in scope. If your equipment can fit in a 20-foot ISO container it also is in scope. See the truck below. Can your device fit in it when it is crated up? You are in scope and must comply if the answer is yes. In fact, just placing a CE marking on your machine is a claim of compliance to RoHS, if it is in scope. There are penalties for non-compliance. In the case of RoHS especially, compliance is much less expensive than the penalties. In almost all RoHS projects at F2 Labs we are able to get through the evaluation with a positive conclusion (compliant EN 63000:2018 report) and without testing.

Finally, see also Q6.3 from the linked RoHS guidance document below:

Q6.3 Does RoHS 2 apply to EEE for professional and industrial use?
Yes. RoHS 2, just as RoHS 1, does not distinguish between EEE for consumer use and EEE for professional and industrial use. In some cases however specific exclusions (Article 2(4)) or timelines (Article 4(3), 4(4) and 4(5)) may apply.

Our advice is that if you cannot exclude your equipment per the above, you are in scope.

CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.

You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.

This entry was posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, International Testing, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Product Testing, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU. Bookmark the permalink.