Last edit: 01/08/2023
THE DOUBT: In the ideal world, Machinery and Production Lines are engineered, manufactured, installed, commissioned and, finally, CE marked by a Manufacturer. Every time a modification is required, the Employer asks the original manufacturer to do the modification so that the original CE marking remains valid.
In the real world, the CE marked Production Line is subject to several modifications, made by different entities so that the original manufacturer would rarely consider its CE Marking still valid. The issue now is that the employer cannot use the machinery, since it is not anymore CE marked, in other terms it is not guaranteed to be still safe! Another common situation is when the production line is made of different Machinery or Partly Completed Machinery and sombody has to assume the responsibility as the manufacturer of the production line: it can be either one of the supplier or that would normally be assumed by the Employer.
To complete the activity of CE marking of the whole line or to follow the correct implementation of modifications to the line, the careful employer or the diligent new production director would ask a trusted consultancy company to run a risk assessment to highlight possible risks for the operation or the maintenance people. The analysis can be done thoroughly, with reference to C-type standards, as well as B types like EN 60204-1 and EN IEC 62061. Following the analysis, he may add guards or protective devices, also with the help of external companies. At the end, the production line is considered safe and he may decide to CE mark it. The reason for him marking the line, is that he would not find a manufacturer who is willing to CE mark a production line he did not make it by himself.
The question is if an Employer has the right to do it. Is that CE mark fake or real?
1° CONSIDERATION: The domain of Machinery Directive is fascinating since it is not “mathematics”: some aspects are not clearly stated and, therefore, they are subject to interpretations. One interpretation concludes that the CE marking made by the Employer is fake because only a manufacturer can CE mark a production line. That position is coming from the careful reference to Regulation 765/2008: setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.
Hereafter is what the regulation states under the definition of Manufacturer:
[Regulation 765/2008] – Article 2 – Definitions
3. ‘manufacturer’ shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark;
Since the employer has not manufactured the production line, or the machinery he has modified in order to improve its safety, the CE marking with his name is fake.
2° CONSIDERATION: We disagree with that position. Hereafter our point of view. We do not need to refer to that regulation to find a definition of manufacturer. The machinery directive gives the following one.
[Directive 2006/42/EC] – Article 2 – Definitions
(i) ‘manufacturer’ means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer;
From that definition, it seems that a manufacturer shall not necessary have physically engineered, manufactured, installed and commissioned the product. The official guide to the machinery directive helps us further.
[MD Guide Edition 2.2] – §79 Who is the manufacturer?
A manufacturer can be a natural or legal person, that is to say, an individual or a legal entity such as a company or association. The process of design and construction of machinery or partly completed machinery may involve several individuals or companies, but in this case one of them must take the responsibility, as the manufacturer, for the conformity of the machinery or partly completed machinery with the Directive. However, the term manufacturer in this Directive also can apply to other persons who have the responsibilities for conformity assessment and CE marking – see §81: comments on Article 2 (i).
At the end of the same paragraph, the following language is used:
[MD Guide Edition 2.2] – §79 Who is the manufacturer?
[…] Usually, the elements constituting an assembly of machinery are supplied by different manufacturers, however one person must assume the responsibility for the conformity of the assembly as a whole. This responsibility can be assumed by the manufacturer of one or more of the constituent units, by a contractor or by the user. If a user constitutes an assembly of machinery for his own use he is considered as the manufacturer of the assembly.
From all of the above, it is clear that the person who CE Marks a machinery, or a production line, shall not necessary have a development, engineering and production department. In case of a user (employer), he has none of the previous entities and he is still allowed to CE mark the line.
Our conclusion, therefore, is that an employer can CE mark a production line installed by different manufacturers. He can also CE mark a production line modified in order to improve its safety.
However he has to follow the obligations stated in Article 5 of the Machinery Directive!
[Directive 2006/42/EC] Article 5 – Placing on the market and putting into service
1. Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall:
- ensure that it satisfies the relevant essential health and safety requirements set out in Annex I;
- ensure that the technical file referred to in Annex VII, part A is available;
- provide, in particular, the necessary information, such as instructions;
- carry out the appropriate procedures for assessing conformity in accordance with Article 12;
- draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery;
- affix the CE marking in accordance with Article 16.
In other terms, before the CE marking, the user has to do a thorough risk assessment, for which he needs competences, that do not belong to the original manufacturer only.
[MD Guide Edition 2.2] – §105 Means of ensuring the conformity of machinery?
[…] The means may include, for example, access to the necessary qualified personnel who have knowledge of both the Machinery Directive and relevant standards, access to the necessary information, the competency and the equipment needed to carry out the necessary design checks, calculations, measurements, functional tests, strength tests, visual inspections and checks on information and instructions to ensure the conformity of the machinery with the relevant essential health and safety requirements. When machinery is designed and constructed according to harmonised standards, the standards normally specify the means to be used to verify the conformity of the machinery with their specifications . Access to the relevant standards is required in this case.
3° CONSIDERATION: The New Machinery Product Regulation confirms that approach by giving a different definition of Manufacturer, in line with the definitinìon that has always been in the Blue Guide.
[Machinery Product Regulation – May 2023] – Article 3 – Definitions
(18) ‘manufacturer’ means any natural or legal person who:
(a) manufactures products within the scope of this Regulation or who has those products designed or manufactured, and markets those products under its name or trademark;
or
(b) manufactures products within the scope of this Regulation, and puts those products into service for its own use;
That definitionis now in line with what stated in the Blue Guide.
[Blue Guide – 2022] – 3. THE ACTORS IN THE PRODUCT SUPPLY CHAIN AND THEIR OBLIGATIONS
3.1. Manufacturer
— The manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and places it on the market under his own name or trademark.
CONCLUSION: A user or an employer can CE mark a machinery or a production line, provided he has the competences to run an in depth risk assessment, that relies as much as possible on the harmonised standards to the Machinery Directive. Provided he has done a proper analysis, the CE declaration of conformity he signs is real and official. True that, if he does a rough analysis and simply signs a Declaration of conformity, that document is fake.