CE Marking Machines Guide for Large Plant

Jan 21, 2016

The facts, the myths and your FAQs.

You probably know that new machinery should have a CE mark on it. You might not know the lines of responsibility for that CE mark and its associated requirements. This guide highlights the myths and facts and answers your burning questions around the CE marking of machines with a particular focus on large plant. Large plant will normally be classified as an assembly of machines (AOM) for the purposes of the Machinery Directive (MD).

The failure of the supply chains, supporting functions in project management and user ignorance will too often result in:

• Risk to people with unsafe machinery being put on the market or put in to service
• Risk to the business due to the legal consequences in the event of enforcement action
• Additional costs for rectifying the issues in situ
• Delays (and associated costs)
• Poor quality documentation being reverse engineered

MYTH: CE marking is something we do once the machine has been built and is primarily a paperwork exercise

This is the largest, most destructive myth and leads to a failure to improve for the future and avoid repeated mistakes. The CE marking conformity assessment procedure begins at conception of the machine and continues through to the point of use or putting in to service. It ensures compliance with EN standards where they are used as a presumption of conformity. It is possible to recover the situation but it is hard work in comparison. It can also result in far increased costs with changes being made to existing build designs.

CE Marking Machines Guide for Large Plant

You can think of this as a combination of:

• A procedure identifying roles and responsibilities running in parallel to the entire project duration and the formal records that will be kept
• Records of observations, analysis, evaluations and measures taken from concept through to final assembly
• Records of final specifications
• Records of test results
• Information for use
• All of the above so far as necessary to evidence safety by meeting the essential health and safety requirements (EHSRs)
• A declaration by the manufacturer/responsible person that the machine is safe
• A technical construction file including all the above Beware. If you ignore this procedure until the end of your project then you have a mountain to climb.

FAQ: What is the difference between CE Marking prior to supply vs. CE Marking In-Situ?

When a machine is bought from a manufacturer and delivered to site ready for use (after installation), the expectation of who has responsibility for CE marking is clear as it was CE marked prior to the point of supply. A simple example is a pillar drill (machine) where after some basic assembly and electrical installation it is complete and ready to use.

The user can reasonably expect that the manufacturer, in order to make their machine available for use in the EU, ensured that the machine meets the Essential Health and Safety Requirements (EHSRs) of the Machinery Directive. After all, this was how the machine came to be fitted with a CE mark and be issued with a Declaration of Conformity…. Wasn’t it?

Large projects with in-situ manufacture and CE marking are typically the aggregation of two or more individual machines, each of which may itself be an AOM. These are to be arranged together, functionally linked and with a common control system, for a common purpose so it is necessary to perform a risk assessment of them together. This creates an assembly of machines and the individual machines are known as constituent units (CU).

The constituent units may be partly completed machines with a Declaration of Incorporation, or they may be complete machines with CE marks and Declarations of Conformity. The important point is that, taken as a whole, something new has been produced beyond the scope of that originally anticipated by the original manufacturers of the constituent units (CU).

Large plant and assemblies of machines (AOMs) are rarely CE marked prior to the point of supply and instead rely upon the risk assessment being completed after final assembly in the location where they are intended to be used. This is known as “in situ manufacture” and inevitably results in CE marking in-situ.

MYTH: Our machine is brand new and CE marked. If it is not safe then the manufacturer will be responsible primarily for any inury/loss

Unfortunately, experience has shown that machines are sometimes sold with an incorrect CE mark on. This may result in a machine being brought in to use in an unsafe condition. Unfortunately, CE marking applies at the point of supply. So once you have started using the machine you are responsible for it being correctly CE marked (PUWER, Regulation 10).

FACT: You cannot use a machine with a Declaration of Incorporation.

Machines that are intended to be assembled with another and cannot safely fulfil a function on their own are known as partly completed machinery. Examples include:

• A swarf management system intended to be fitted to a CNC tool or lathe.
• An agitator designed to be fitted to a tank.

Because the machine is essentially incomplete, it is almost certainly incapable of fulfilling all of the EHSRs. In these cases, the machine should not be fitted with a CE mark and should be issued with a Declaration of Incorporation that lists the EHSRs the manufacturer claims to meet.

The person integrating the partly completed machinery will have responsibility for manufacturing and CE marking the overall machine. This includes provision of comprehensive instructions for the assembly of machines (AOMs) that reflect the residual risks.

FAQ: This machine has a CE Mark but it is a partly complete machine…. What does that mean?

Machines that have been fitted with a CE mark, despite the machine obviously being “partly completed machinery”, shows that the manufacturer does not have a robust conformity process in place.

FAQ: Who is responsible for ensuring that the assembly of machines (AOM) is correctly CE Marked?

The manufacturer. However, they can share/delegate some duties to an authorised representative.

For large plant though it is not always clear who the manufacturer is. In order to determine who is responsible for the CE conformity of the machine it is necessary to look at who has the overall control of the project.

If the end user contracts the entire process to an installer, then it would be the installer that assumes the role of “manufacturer” and must ensure that the EHSRs are met and the CE mark affixed.

If the end user’s own staff design the control circuits and mechanical assemblies, contracting out just the assembly and commissioning, then the end user is the manufacturer and the party responsible for conformity.

MYTH: I am not responsible for CE marking the AOM because the final assembly includes machines that I did not manufacture.

The identity of “the manufacturer” will vary depending upon commercial arrangements and circumstances. It may be an external contractor running the entire project, or it may be the manufacturer of one of the machines.

For example, a CNC machine tool manufacturer supplies a client with a machine tool incorporating a swarf management system. The manufacturer has met that obligation by incorporating a third party system.

In this case, it will be CNC machine tool manufacturer with overall CE responsibility since they are delivering the final assembly to the client for use.

MYTH: We are not responsible for CE Marking the machine because we did not agree to it in writing prior to the project start

It is best practice to have the contractual terms addressing CE marking responsibility included in the arrangements of any project prior to start. However, it is often neglected or not detailed sufficiently.

In the absence of any contractual variation, the company supplying the machine to the end user will be responsible for its CE marking. However, this excludes:

• Distributors
• Suppliers who can demonstrate that they had no leading influence on the design and specification of the line.

In either of these cases, the end user becomes the responsible person for ensuring CE is achieved, evidenced and achieved correctly.

If the end user was not aware of this responsibility early, then it will take them considerable effort and time to create or reproduce the evidence required for inclusion in the technical construction file. See our guide to the contents of the technical construction file.

FAQ: Who is responsible for producing the Instruction Handbook for the AOM in the case of in-situ manufacture and CE marking?

The production of the instruction handbook for an assembly of machines (AOM) manufactured in situ is a common area of difficulty since the images and information required for the handbook were not available until after final assembly. This may involve a very technically complex project such as large manufacturing plant, or something as relatively simple as automating an existing gate.

Note: a manually operated gate would not fall within the scope of the Machinery Directive, but after its automation it would – even if the original gate was being reused. So, it must meet all of the EHSRs as well as carry a CE mark as a new machine has now been created.

FAQ: What/who is an Integrator?

In some larger projects, the end user may contract out the manufacture and assembly of the plant to a specialist system integrator who specifies (if not actually completes the capital purchases themselves) the constituent units and designs the assembly of machines (AOM).

In these projects, it would be the integrator who is the “manufacturer” of the sum of the parts and thus responsible for ensuring that the level of safety achieved for each constituent unit is at least maintained, and confirming that no new hazards have been created.

MYTH: We did not use a third party, large plant AOM was manufactured in-house. So, I don’t have to CE mark it.

Some organisations understand their manufacturing processes well and are sufficiently resourced that they design and specify their own large machines. They buy the constituent units (CUs) with minimal assistance from those manufacturers, relying only on contract assistance in the form of electrical installation, fabricators of supporting structures and specialist lifting contractors.

It is still a common point of confusion that such organisations believe that they are exempt from having to put a CE mark on the completed machine because they are not putting the machine “on the market” in the sense that they aren’t selling it to another user.

However, the Machinery Directive is clear. Article 2, point (h) defines “placing on the market” as:

“Making available for the first time in the Community machinery or partly completed machinery with a view to distribution or use, whether for reward or free of charge.”

So after a machine, including a large plant or assembly, is placed on the market or put into service for its intended use the Machinery Directive will apply and it should be CE marked in full.

In these situations, the new Assembly Of Machines (AOM) almost certainly creates new hazards. There are likely to be new machine behaviours and knowledge required beyond that envisioned by the OEMs. Again, the Machinery Directive is clear:

“The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.”

Machinery Directive. Annex I

Specifically, the areas that have not yet been risk assessed are the:

• Physical interfaces
• Control interfaces (safety and process)
• Effects of the layout of the AOM where it may obstruct paths to operating positions, service positions and information for use such as warnings and markings.

These areas must be reviewed with the utmost care using applicable standards and risk assessment to establish if further action is required such as:

• New or modified safety functions
• Performance level (PL)
• Changes to operating modes
• Information for use
• Means of access and so on.

Like all risk assessment the evaluation of measures for risk reduction must use the three-step method. See our guide on the 3 step method.

After correct application of the 3 step method there will be residual risk. See our guide on residual risk and typical measures taken to address them.

Fact: In order to CE mark a machine you must meet the requirements of ALL applicable directives.

All manufacturers, including the end user if they bear that responsibility, should also remember that there may well be other applicable directives as well as the Machinery Directive. Almost always this will include the Low Voltage Directive. Others key ones are the:

• Pressure Equipment Directive
• Electro Magnetic Compatibility (EMC) Directive
• ATEX Directive for explosive atmospheres.

In any given area of a complex plant, one or more of these directives may apply.

Evidence for conformity with all applicable Directives must be sought and recorded in the Technical Construction File for the machine, another duty falling to the manufacturer.