FAQ – Frequently Asked Questions

A. Machines need to be certified in line with the rules that exist in the target market, regardless of where they are built. It’s another thing to figure out who should be in charge of certification, depending on their role.
In summary. Certification is linked to the concept of “placing on the market”, where the word “placing on the market” necessarily refers to the target market where they are installed and then used: the product directives (which regulate certification) in practice establish the requirements that must be met in order to be installed and used in a certain region/country of the world (market).
The fact that the manufacturer shall design and manufacture at his own expense the machines and products according to the standards of that specific market is a more complex issue.
Certainly he shall if he “puts the machine on the market” directly, or through his own sales/marketing network, assuming in this case the role of “exporter”; this is the case, for example, of an Italian machine-building company that has a “representative” in the foreign market (e.g. USA or CHINA): in this case the machine must necessarily be sold in line with the standards of the place of destination, and the responsibility lies with the representative company, which must ascertain the conformity of the project before selling it.
Different scenario if the manufacturer does not have any representative/agent in the place of destination: in that case he is not considered to be the one who “exports”, but it is the final customer (or even a dealer) who “imports” into his own country a product/machine built in another market: for the purposes of regulatory compliance, it is he who guarantees and it is clearly his responsibility not to use products that the standards of that country would consider “non-compliant”.

Ing. Riccardo Federigi, CEO NEMOTEC SRL

Jan 2020 – Obj: Certifications of Industrial Machines – CE Mark

A. The Essential Health and Safety Requirements (EHSR) indicated in Annex I of DM 06/42/CE “Machinery Directive” describe the objectives that the machine shall satisfy in order to be correctly certified: these objectives, however, do not contain references to design details, do not provide specific solutions, and merely describe what the final result must be (e.g.: dangerous mechanical parts must be protected and made inaccessible. How to design the protection and/or safety system is not described in the directive’s requirement).
Why is this? Because having to deal with the context of all types of machines and products, the Directives do not want to create a defined design line: the choice of technical solutions depends on the type of machine, the risks present and therefore the Analysis and Evaluation process, which may lead to choose a design principle rather than another.
On the other hand, harmonized technical standards are specific, written in design and “executive” language, thus defining the principle of “presumption of conformity”.
In practical terms, applying the standards at design level makes it possible to automatically presume the conformity of what is built to the RESS of the Machinery Directive (in fact, they determine the so-called technical “state of the art”); any objections are made to the Manufacturer in a proven and documented manner, based on the application or non-application of the technical standards, going into the merits of the solutions adopted.
In case the harmonized technical standards (EN for what concerns the CE mark) have not been followed during the design phase, the manufactured system could still be considered compliant with the RESS of the Directive, but the burden of proof is reversed, with all that it legally implies: it is up to the Manufacturer to fully prove the compliance of his realization, showing that he has not committed any negligence when applying “internal” solutions instead of what is provided for by the technical standards.

Ing. Riccardo Federigi, CEO NEMOTEC SRL

Jan 2020 – Obj: Certifications of Industrial Machines – CE Mark

A. It depends on what is meant by the word “System”.
Do the machines and groups participate in the system directly, working automatically and jointly, or are they successive stages of production but independent of each other?
Do they have common commands or do they interface only through “product input-output” information signals, leaving the individual machines to manage their own movements and logic independently?
Are the electrical panels and systems in common or are they separate (close together, overlapping, far apart, …)?
Are they part of an integrated layout, perhaps with common security systems (perimeter protections) or are they totally independent?
If these kinds of considerations have some affirmative answer, the system is a complex plant and needs a “whole” certification above those of the individual components and assemblies.
It is clear that if some subsystems are certified as “quasi-machines” (i.e. not completely certified by their manufacturer because they relate to a function that is not complete), it is even more evident that a certification of the whole must be carried out or at least a careful evaluation of the interfaces.
The certification of single “components” does not solve the problem, as it is not enough to guarantee the final result in case of integrated systems.

Ing. Riccardo Federigi, CEO NEMOTEC SRL
Jan 2020 – Obj: Certifications of Industrial Machines – CE Mark 

A. The declaration you are referring to is not a “complete” EC Declaration of Conformity, but is called a “declaration of incorporation” (All. IIB dir 06/42/CE) and refers to “partly completed machinery”, i.e. units (which in certain cases can be absolutely comparable to real machines) that must be connected and managed in an integrated manner in a complex system in order to function.
In other words, a working unit of a production line that, even though it has its own moving parts, motors and electrical panel, must be integrated into the general system in order to carry out its function (e.g. a speed control synchronized with other units, a safety system that must depend on access to various areas of the line, etc.) must be considered a “quasi-machine” and clearly cannot meet all the requirements of the Directive on its own. The requirements are “fulfilled”, in fact, by addressing the system as a whole. For this reason, a partial certification is allowed; it is up to the final assembler (often the user himself) to evaluate the interfaces between the partly completed machinery and the complex machine in order to complete the certification process.
If, on the other hand, the supply contract applies to a real independent machine (to be evaluated and possibly demonstrated), the declaration is simply wrong in its typology.

Ing. Giovanni Frediani
Mar 2020 – Obj: Certifications of Industrial Machines – CE Mark

A. SFor the European Community, the natural and legal person responsible for certification must have a legal presence within the Community market, essentially to guarantee the purchaser the possibility of legal recourse in case of discrepancies and non-conformity.
You are therefore effectively the importer of the product and you have the responsibility towards your customers to ensure that the CE mark has been placed in compliance with the requirements of the applicable directives.
Do you trust the foreign manufacturer? Do you have data, documents and evidence that the manufacturer has applied the requirements of the directives during design? Has the manufacturer given you the necessary documentation with the information required by the applicable Directives (e.g. User’s Manual, diagrams, etc.)? Where is the technical file of the machine kept?
In case of dispute, you remain the reference of responsibility towards your purchasers and it will be up to you to make eventual recourse (at this point international) on the Manufacturer in case it is proved that the machine presents eventual non conformities. The real problem, in these cases, is the management of the dispute procedure, since the authority requires some documents (part of the technical file of the machine, precisely, for example the risk analysis and/or the manual in Italian language) that you might not have if not contractually agreed with the Manufacturer.
By way of example: an Apple computer bought in Europe is not purchased (and certified) directly from the US parent company in Cupertino (CA), but, at least to date, is commercially and legally managed by Apple’s European representative based in Dublin (IR). Have you ever wondered why? Precisely because of a question of legal presence on the market.
In your case, you are the one who guarantees this presence to the buyer, so the more the documentation you have “in house” is exhaustive in terms of certification, the more you are able to protect yourself from any disputes.

Ing. Riccardo Federigi, CEO NEMOTEC SRL
Feb 2020 – Obj: Certifications of Industrial Machines – CE Mark

A.

Yes, unfortunately. There can be various potential problems and there is a serious probability of having to modify some parts of the machine, in particular the electrical system.

I’m assuming a machine and not a process plant, a classic industrial machine with moving parts, an electrical panel and a low-pressure air system (otherwise further cases should be considered).

In general, there are three macro aspects to consider assuming the most common cases (without seeing the machine I can only make general considerations):

1. The “mechanical” design, if it is well done, usually follows quite common criteria (in the USA there is the OSHA regulation, quite generic, but then the ISO standards are also applied, almost all of them equivalent to our EN standards), so it is to be hoped that few requirements and/or checks will be necessary.
2. The electrical part may have to be entirely revised because the European standards (in particular EN 60204-1) are substantially different from the USA, UL, CSA, etc. … (in extreme synthesis are really two different electrical worlds, low current high voltage one and high current low voltage the other). So, unless you are in the very few cases where the regulatory requirements are close (for power supply, circuit, and how the machine works) I would say that the electrical panel will have to be analyzed and, alas, modified.
3. The CE certification of the machine will be missing: if it has been imported now, the machine must be CE certified because otherwise it would not be in line with Legislative Decree 81/08 (CE marking is not needed for machines that already existed in Italy before 21.09.1996, but for systems placed on the market today, even imported from outside, CE marking is needed to guarantee workers). So someone has to do the CE certification, either directly your factory or through specialized companies (like ours); this also means putting together the technical file, and all that it implies.

Ing. Riccardo Federigi, CEO NEMOTEC SRL
Feb 2020 – Obj: Certifications of Industrial Machines – USA Market