Who is the manufacturer of an assembly of machinery?

Table of contents

1. The answer in one paragraph
2. When is a group of machines one machine?
3. Who is the manufacturer? Four cases
4. What you have to do as manufacturer of the assembly
5. What happens when you modify it later
6. And if it is not an assembly
7. What to ask your suppliers for
8. Frequently Asked Questions

The answer in one paragraph

Whoever combines machines into something that functions as one machine is the manufacturer of that whole. It can be the supplier who delivers and commissions the complete line, the main contractor, or the engineering firm that does both the design and the integration. It can equally be the factory owner. If you buy machines separately and have them built together into one production line, you are the manufacturer of that line. This follows from Article 3(1)(d) of Regulation (EU) 2023/1230, which treats assemblies of machinery that are arranged and controlled so that they function as an integral whole in order to achieve the same end as machinery in their own right. It is a matter of fact, not of contract. As manufacturer of the assembly you carry the risk assessment for the whole, the conformity assessment, the EU declaration of conformity, the CE marking, and the instructions for use for the line as a whole.

When is a group of machines one machine?

Not every row of machines is an assembly. The test sits in Article 3(1)(d) of Regulation (EU) 2023/1230 and was worked out by the European Commission in paragraph 38 of the Guide to application of the Machinery Directive. Three criteria, and all three have to hold at once:

• the constituent units are assembled together in order to carry out a common function, for example the production of a given product;
• the constituent units are functionally linked in such a way that the operation of each unit directly affects the operation of other units or of the assembly as a whole, so that a risk assessment is necessary for the whole assembly;
• the constituent units have a common control system.

Three examples make this land faster than the text does.

A packaging line where the filler, the sealer, the labeller and the palletiser run on one PLC and one emergency stop circuit is an assembly. Common function, functional link, common control. All three present.

Two production lines that share nothing but a buffer conveyor, each keeping its own control system and its own emergency stop zones, are not an assembly. The Commission is explicit here. A group of machines that are connected to each other but where each machine functions independently of the others is not considered an assembly of machinery.

A line with a manual step in the middle, where an operator carries a semi-finished product from machine A to machine B, while both machines sit on one control system and read each other’s status, usually is an assembly. The criterion is not whether material moves through automatically. It is whether the machines affect each other’s operation and safety and are controlled together.

What it is not: a whole factory. The definition of an assembly does not extend to a complete industrial plant made up of several production lines, even where those lines are controlled together by a single production control system.

Who is the manufacturer? Four cases

The supplier who delivers and commissions the complete line. He designs the configuration, connects the machines, builds the common control system and hands over a working line. He is then the manufacturer of the assembly, and there should be one declaration of conformity and one CE marking for the line.

The main contractor or system integrator. He buys in from third parties, decides the layout and handles the integration. The manufacturer’s role sits with him regardless of whether he built any of the machines himself.

The engineering firm, but only when it also does the integration. A firm that draws a layout and then leaves has not made an assembly. A firm that produces the design, sets the safety architecture and supervises commissioning has.

The owner. This is the case that gets missed most often. You buy four machines from four suppliers, have your own maintenance department or an installation partner connect them, and put one control system on top. You have built a new machine and you are its manufacturer. The fact that you only use it yourself and never sell it changes nothing, because the Regulation attaches obligations to putting machinery into service, not only to placing it on the market.

Then the misconception that most of these discussions run aground on: our main supplier CE marks the line anyway. In my experience, half the time that was never written down anywhere, and the other half his marking covers only his own machines. A CE marking on a filling machine says nothing about the interaction between that filler and another supplier’s palletiser. Contractually arranged is not the same as assumed. Ask for the declaration, check whether it is a declaration of conformity or a declaration of incorporation, and read where the product description stops.

See this case study of Morssinkhof Plastics, in which the engineering firm integrated several machines into a single line.

What you have to do as manufacturer of the assembly

Five obligations, and the fifth is the gap.

You produce a risk assessment for the whole in line with ISO 12100, covering the hazards that only come into existence through the connection between the machines. You run the conformity assessment for the assembly. You draw up one EU declaration of conformity, the content of which is set out in Annex V of the Regulation. You affix the CE marking to the assembly. And you write the instructions for use for the whole, in line with Annex III, point 1.7.4.

The last one is where it breaks down, because no supplier manual can stand in for it. What has to be in it, and appears in none of the supplier manuals: which emergency stop acts on which zone, and therefore which parts keep running when it is pressed; how to isolate the line safely across every energy form; the start-up and shutdown sequence for the line; what happens on a partial stop and how to restart afterwards without product or tooling left behind; and fault finding at line level, where a failure in machine A only shows itself as a fault in machine C.

Laying your suppliers' manuals side by side does not produce those answers. It cannot, because none of them knew the rest of your line. 

What happens when you modify it later

This hits existing plants as hard as new build. Article 18 of the Regulation provides that a person who carries out a substantial modification of machinery or a related product is considered to be a manufacturer and becomes subject to the manufacturer’s obligations set out in Article 10.

With a nuance that almost nobody writes out, and that makes the whole difference for production lines. Where the substantial modification has an impact on the safety of only one machine that forms part of an assembly of machinery, the obligations apply to that affected machine, not to the entire assembly. The Regulation attaches one condition to that: it has to be demonstrated in the risk assessment. Without that evidence you do not have the limitation.

That turns the risk assessment for a modification from a formality into the document that determines the size of your obligation. Replace a robot and skip the assessment, and you cannot afterwards show that the rest of the line stayed out of scope.

And if it is not an assembly

Suppose the three criteria do not all hold and you have no assembly. The duty to inform does not disappear. It changes route.

Directive 2009/104/EC, the Work Equipment Directive, places it on the employer. Article 8 requires the employer to take the measures necessary to ensure that workers have at their disposal adequate information and, where appropriate, written instructions on the work equipment used at work. Those instructions must cover at least the conditions of use, foreseeable abnormal situations and the conclusions to be drawn from experience, and they must be comprehensible to the workers concerned.

In that scenario you are not a manufacturer. You are an employer. The escape route does not exist.

What to ask your suppliers for

The question is not how to get out of being the manufacturer. That is settled. The question is whether you obtain, in time, what you need in order to meet the obligation. Ask at the point of order. Once the machine has been delivered, your supplier has no commercial reason left to help you.

Request per machine:

• Which declaration comes with it and of which type: an EU declaration of conformity or a declaration of incorporation. That distinction tells you immediately what you are receiving and what is left for you.
• The residual risks that remain after their protective measures.
• Which safety functions they supply, with performance level or SIL, response time and lifetime.
• Which safety functions they expect from you.
• The assumptions underpinning their risk assessment, so you can check whether those hold in your line.
• The interfaces: mechanical, electrical, pneumatic, hydraulic, control and safety signals.
• What their machine does on an external stop signal, in which stop category, and how it restarts.
• Isolation points per energy form, and where residual energy remains.
• Noise and vibration values, with the measurement basis attached.
• Emission data for hazardous substances.
• Maintenance tasks with intervals and required competence.
• The symbols on their machine and what they mean.
• Content intended for your instructions. For partly completed machinery this is not a favour but a requirement: Annex XI, point 2 provides that the assembly instructions shall contain relevant information to be used in the instructions of the machinery in which the partly completed machinery is to be assembled. For completed machinery you have to ask.
• Language versions and editable source files.
• Permission to reuse their material in your line documentation. Almost everyone forgets this one. Supplier manuals are protected by copyright, and without that agreement you are formally not allowed to lift anything from them.

Record yourself:

• Where the boundaries of your assembly lie, with the reasoning. That is a document in its own right.
• Who performs the risk assessment at line level.
• Who writes the instructions for the whole, and in which languages.
• When those have to be finished. Tie it to commissioning, not to the start of production.
• Who maintains them after a later modification.

Put this list straight into your purchasing conditions. That is the moment when it still costs nothing.

You can outsource who does the work. Not who carries the obligation. 

Not sure whether your production line is an assembly, or who has to produce the file for it? Lay the supplier manuals side by side and look for one document that describes the whole. Usually there is not one.

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FREQUENTLY ASKED QUESTIONS

Is a production line always an assembly of machinery?
No. All three criteria have to hold: a common function, a functional link and a common control system. Machines standing next to each other and operating independently do not form an assembly, even where they pass material to one another.

We only use the line ourselves and never sell it. Does the Regulation still apply?
Yes. Regulation (EU) 2023/1230 attaches obligations to putting machinery into service as well as to placing it on the market. A line you assemble and take into use yourself falls within that.

Our main supplier says he CE marks the line. Is that enough?
Only if it is set down in writing and his declaration of conformity describes the assembly as a whole rather than his own machines. Check the product description on the declaration and the type of declaration.

What is the difference between a declaration of conformity and a declaration of incorporation?
An EU declaration of conformity belongs to completed machinery that may be put into service as it stands. A declaration of incorporation belongs to partly completed machinery, which may only be put into service once it has been built into machinery that is itself fully compliant. Both are covered by Annex V.

Can we reuse text from supplier manuals in our line instructions?
Not without permission. Those manuals are protected by copyright. For partly completed machinery, Annex XI, point 2 requires the assembly instructions to contain information intended for use in the instructions of the machinery it is built into. Secure the reuse right contractually all the same.

We are replacing one machine in an existing line. Do we have to reassess the whole line?
Not necessarily. Where the substantial modification affects the safety of only that one machine within the assembly, the obligations apply to that machine alone. The condition is that the risk assessment demonstrates it.

When do the instructions for the assembly have to be ready?
At commissioning of the line, not at the start of production. In your planning, tie the deadline to the first moment somebody operates the line.

What if there is no assembly at all?
A duty to inform remains, through Directive 2009/104/EC. As an employer you have to provide your operators with adequate information and, where appropriate, written instructions on the work equipment they use.