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Understanding Production Line Relocation and CE Compliance
Production line relocation and CE compliance is a complex process involving not only logistical and engineering challenges but also significant legal and technical implications. The new EU Regulation 2023/1230, replacing the Machinery Directive 2006/42/EC from January 2027, introduces the concept of “substantial modification” of machinery. This means that certain relocations or upgrades might classify machines as new under the law. For business owners, managers, and engineers responsible for machinery, this necessitates a thorough risk analysis during relocation and potentially adapting machines to meet current essential requirements. Below, we explore key considerations related to machine relocation.
Relocating a CE-Marked Production Line
Relocating a production line that already carries CE marking raises the question of whether reinstalling the machine in a new location violates the conditions of its original conformity assessment. There are two scenarios: machines commissioned for a specific facility and machines introduced to the market as standard devices. Each case presents different risks and obligations.
Dedicated Machines for Specific Facilities
Machines designed and built for a specific facility are often tailored to local conditions. Moving them elsewhere can create new hazards or change existing risks, such as different workstation configurations, altered surroundings, or integration with other equipment in a new hall. According to the Machinery Directive guidelines, if a used machine undergoes such significant reconstruction that it can be considered new, the Machinery Directive applies again. In other words, a machine subjected to “such substantial transformation or reconstruction” must undergo a full conformity assessment procedure as a new machine (issuing a new declaration of conformity, reapplying CE marking, etc.). The Machinery Regulation 2023/1230, which replaces the Directive, officially introduced the definition of substantial modification as:
“Substantial modification” means a change to a machine or related product made physically or digitally after its introduction to the market or commissioning, not foreseen or planned by the manufacturer, affecting the safety of the machine or related product, creating new hazards or increasing existing risks, requiring:
a) adding guards or protective devices to the machine or related product, necessitating modification of the existing safety-related system; or
b) applying additional protective measures to ensure the stability or mechanical strength of the machine or related product;
Relocating a production line might seem like merely a change of location, but if it requires significant reconstruction of the equipment, modification of safety systems, or changes in usage, it may meet the criteria for substantial modification. Such a case is legally treated as introducing a new product to the market – the entity making the modification assumes the responsibilities of the manufacturer in ensuring compliance with essential requirements and conducting the appropriate conformity assessment procedure.
In practice, this means conducting a new risk analysis and adapting the machine to current standards and requirements of Regulation 2023/1230.
Example: Factory A relocates a robotic assembly station, originally built for Factory A, to Factory B. In the new location, the robot’s position relative to service stations changes, and additional modules are added. This relocation necessitates a new risk assessment – it may require adding guards or safety curtains in areas previously naturally secured by the hall layout. If the original design did not anticipate such changes, the relocated machine must be treated as new. Responsibility for its re-certification (CE) lies with the entity making the modifications, who becomes the manufacturer of the modified machine under the law.
Why is this important? Imagine that the production line manufacturer, after considering the risk of crushing, decided to use a technical protective measure in the form of a minimum clearance to prevent crushing (according to the harmonized standard PN-EN ISO 13854:2020-01) of human body parts in the form of a distance of the moving element from the stationary one – 500mm (e.g., hall wall). The manufacturer may not be able to guarantee the same in the new location!
Therefore, new technical documentation must be prepared, the original instructions and markings updated, and only then can the machine be allowed to operate in the new location. Otherwise, in the event of an inspection or accident, the machine may be accused of non-compliance with regulations, leading to serious legal and financial consequences (including withdrawal from the EU market).
It is worth noting that not every modification during relocation automatically constitutes a “new machine”. If the changes were anticipated by the original manufacturer and included in their risk assessment and documentation, then the original CE marking remains valid. For example, if the machine manufacturer allowed for its relocation and reinstallation according to specified guidelines, and the machine itself has a modular design easy to disassemble and assemble, then relocation strictly following these recommendations should not be considered a substantial modification. Modifications limited to purely restorative actions (e.g., replacing worn parts with identical ones) also do not make the machine a “new” product. However, the boundary between permissible modernization and substantial modification always requires expert assessment – it is recommended to conduct a formal risk assessment after relocation to document whether changes affected the safety of the machine. Such documentation can serve as a defense against potential accusations by supervisory authorities of unlawful modification.
Standard Market Machines
The second category involves machines initially purchased on the market as ready-made devices with CE marking (e.g., lathes, milling machines, presses, packaging machines). Relocating such a machine – whether to another facility or even within the same factory – generally does not invalidate its declaration of conformity, provided the relocation follows the manufacturer’s guidelines and does not involve alterations to the machine’s construction.
However, it is important to remember that:
- The manufacturer usually specifies relocation conditions in the instructions – such as transport methods, assembly, substrate parameters, leveling, power connections, safety rules, etc. Acting contrary to these recommendations can result in losing compliance with original requirements.
- Any change in the machine’s environment (e.g., operator work organization, access to hazardous zones) can generate new risks that did not exist in the previous location. In such cases, a new risk assessment should be conducted. If this analysis reveals that additional safety measures are necessary (e.g., new guards, sensors, locks), the entity introducing these modifications becomes the manufacturer under the regulations.
- The relocation itself (while maintaining the machine’s existing configuration) usually does not cause a substantial modification. However, if a standard machine is enhanced with a new feeder, collaborative robot, packaging module, or other element, creating a machine ensemble, a full conformity assessment for the “new” system may be necessary. In such cases, it is essential to issue a new declaration of conformity for the integrated system.
For instance, a company purchases a used packaging machine (with CE) and then installs it in a new factory along with a conveyor feeder not originally foreseen by the manufacturer. As a result, the operator must simultaneously operate the feeder and packaging machine, creating new exposure zones (e.g., reaching into the conveyor area). This configuration constitutes a machine ensemble not initially described in the documentation. Under Regulation (EU) 2023/1230, this creates a “new” product, necessitating a new conformity assessment.
Relocating Non-CE Marked Machines from Outside the EU
A particular case of relocation involves importing a machine from outside the European Economic Area (EEA) that lacks CE marking. This often occurs when a company purchases used equipment on the American or Asian market or relocates its technology lines from non-EU plants to factories within the Union. Such a machine has not yet been “introduced to the market” in the EU, so its relocation is considered the first introduction to the market in the EU. This involves an absolute obligation to conduct a full conformity assessment with applicable directives/regulations (including machinery, and potentially others – e.g., EMC, low voltage – depending on the machine type).
According to regulations, every machine imported from outside the EU must meet the essential requirements of the relevant legal acts and undergo a conformity assessment procedure before being put into use. This means conducting a risk analysis, checking the machine against all applicable requirements (e.g., from Annex I of Directive 2006/42/EC / Annex III of Regulation 2023/1230), preparing complete technical documentation, translating or developing user instructions in the user’s language, and applying the CE marking and issuing an EU declaration of conformity. This procedure formally makes the entity importing the machine the manufacturer (or importer under the law, with obligations almost equivalent to the manufacturer).
It must be emphasized that failing to fulfill these steps prevents the legal use of the machine. If cooperation with the manufacturer or conducting the conformity assessment independently is not possible, such a machine cannot be introduced to the market or used within the EU.
Using it without certification would be equivalent to breaking the law – the machine could be deemed a dangerous product, leading to a suspension of operation, or even the need to send it outside the EU or scrap it. Additionally, in the event of a workplace accident involving an unmarked machine, the entrepreneur risks severe criminal and civil consequences (lack of insurance, liability for allowing non-compliant equipment to be used).
Production Line Relocation and CE Compliance: Consequences
Production line relocation, whether within a facility, between facilities, or from outside the EU, requires a much broader perspective than before. Maintenance managers and engineers must consider not only logistical and technical aspects but also legal aspects resulting from the new Regulation 2023/1230. The concept of “substantial modification” serves as a crucial link between the technical world and regulations – it defines the point at which a modernized or relocated machine ceases to be an “old user machine” and becomes a “new machine” requiring full compliance with current requirements.
For entrepreneurs, this means planning investments with potential hidden costs in mind (certification, additional safety systems, legal experts). It must be considered that relocating a production line may entail the obligation to thoroughly equip machines and update all documentation. Failure to fulfill these obligations can result in severe consequences: from administrative fines, production suspension, to liability for potential accidents. On the other hand, proper approach to relocation – with risk analysis, consultations, and adherence to conformity assessment procedures – ensures not only legal compliance but, above all, employee safety and the reliability of the relocated line.
Safety engineers and designers should work closely together on relocation projects. Their role is to identify changes that may affect compliance with essential requirements and propose solutions ensuring continuity of compliance.
In summary, relocation and substantial modification is a topic at the intersection of law and technology. Each machine transfer should be considered individually, asking questions: Does the change affect safety? Are new hazards created? Did the manufacturer anticipate such a change? If the answer is “yes” (impact on safety or new risk), the process of re-assessment of conformity must be conducted. Although it involves additional obligations, the final result is a safe, legally compliant machine that can continue to serve production without endangering the company and people.
FAQ: Production Line Relocation and CE Compliance
Not always. If the machine (e.g., lathe, packaging machine) is relocated without structural changes, in accordance with the manufacturer’s recommendations, the declaration of conformity remains valid. Integrating the machine with new elements (e.g., feeder) may be considered a substantial modification, requiring a new declaration of conformity.
Relocation is a substantial modification when it creates new risks or significantly changes the machine’s safety measures. Such a situation requires a full conformity assessment of the new machine ensemble.
It is recommended to perform a risk assessment after every relocation, even without structural changes, to confirm that no new hazards have emerged. This is an important step to protect against legal liability.
Yes, a machine from outside the EU, even with CE marking, must undergo conformity verification with current requirements before being put into use in the EU. This means preparing technical documentation, risk assessment, and issuing a declaration of conformity.
Legal responsibility for the compliance and safety of a machine after relocation lies with the entity performing the transfer or integration, especially if the changes are classified as a substantial modification.