Key takeaways:
The text explains the difference between significant and non-significant modifications and indicates when CE recertification may be required under 2006/42/EC.
- Upgrading a machine may require a new conformity assessment and CE marking if the changes materially affect safety.
- The CE marking is the manufacturer’s declaration that the product complies with EU requirements on health, safety, and environmental protection.
- Directive 2006/42/EC on machinery sets the minimum occupational health and safety requirements for machinery placed on the market or put into service in the EU.
- A substantial modification includes, among other things, changes to control systems, the addition of safety functions, or structural modifications.
- Minor changes (e.g., color changes or replacing worn parts with identical ones) usually do not require CE recertification.
Implementing technological changes and machine modernization is essential to improve performance, safety, and compliance with current regulations. One of the most important aspects to consider during machine modernization is compliance with the Machinery Directive 2006/42/EC and obtaining the CE mark. This article explains when machine modernization requires renewed CE certification, what criteria are used to assess a significant modification, and how to carry out the recertification process. Understanding these issues is crucial to ensuring safety and legal compliance, which matters to both machine manufacturers and users.
What is the CE mark?
The CE mark is the manufacturer’s declaration that the product meets all relevant European Union requirements for health, safety, and environmental protection. It is mandatory for products covered by EU directives and allows them to circulate freely on the European market.
Why the CE mark matters:
- User safety: The CE mark confirms that the product has undergone conformity assessment and is safe to use.
- Free market access: Products bearing the CE mark may be freely sold and used in all EU Member States without additional testing or certification.
- Consumer protection: It gives consumers confidence that products meet European quality and safety standards.
Rules for affixing the CE mark:
- Manufacturer or authorized representative: Only the manufacturer or its authorized representative may affix the CE mark to a product.
- Conformity assessment: Before the CE mark is affixed, the product must undergo conformity assessment procedures, which may include tests, inspections, and other forms of verification.
- Technical documentation: The manufacturer must maintain complete technical documentation confirming the product’s compliance with the directive requirements.
Machinery Directive 2006/42/EC
The Machinery Directive 2006/42/EC sets out the minimum health and safety requirements that machinery placed on the market or put into service in the EU must meet.
Legal basis:
- Context and purpose: The Directive was introduced to harmonize machinery safety regulations across EU Member States, facilitating the free movement of machinery while ensuring a high level of health and safety protection.
- Scope: The Directive covers all machinery, except for certain categories such as machinery specifically designed for nuclear or military purposes.
Scope of the Directive:
- Machinery: Defined as an assembly of linked parts or components, at least one of which moves, joined together for a specific application.
- Interchangeable equipment: Devices mounted on machinery or a tractor to change its function.
- Safety components: Components that perform a safety function, are placed on the market independently, and whose failure endangers the safety of persons.
Machine modernization
Machine modernization means making changes intended to improve functionality, safety, or compliance with current standards. Modernization may include replacing components, adding new functions, modifying existing systems, or adapting the machine for new applications.
Definition of modernization:
- Technical changes: Machine modernization may involve introducing new technologies, replacing outdated components with modern ones, improving energy efficiency, or adding new functions.
- Functional changes: Modifications may involve changing how the machine operates, adding new operating modes, or expanding its range of applications.
Examples of modernization:
- Replacing the control system: Replacing an old control system with a modern, more advanced one, in line with the latest industrial automation standards.
- Adding safety guards: Introducing additional guards and protective barriers that reduce the risk of accidents, in line with harmonized standards and often verified through a machinery and production line safety audit.
- Drive system upgrade: Replacing old motors with modern, more efficient drive units, which may form part of a broader production automation process.
Major and minor machine modifications
A major modification is one that may affect the machine’s fundamental safety aspects and therefore requires a renewed conformity assessment under the Machinery Directive. Examples of major modifications include changes to control systems, the addition of new safety functions, or structural changes to the machine.
Machine modification may require renewed CE certification if the changes introduced significantly affect safety and compliance with Machinery Directive 2006/42/EC.
Assessment criteria:
- Changes affecting safety: If a machine modification introduces changes that may affect the safe use of the machine, it is considered major.
- Examples: Adding new functions that may increase the risk of accidents, replacing key components that directly affect safety, or making structural changes to the machine.
A minor modification, by contrast, includes cosmetic changes or small improvements that do not affect compliance with safety requirements. Examples include changing the machine’s color, replacing worn parts with identical new ones, or minor modifications that improve appearance.
| Criterion | Major modification | Minor modification |
|---|---|---|
| Definition | Changes affecting fundamental safety aspects | Minor improvements that do not affect compliance with requirements |
| Examples | Changes to control systems, addition of safety functions, structural modification | Colour change, replacement of worn parts with identical new ones |
| Certification requirements | Renewed CE certification required | No recertification required |
| Risk assessment | Detailed risk assessment required | Risk assessment not required |
| Technical documentation | Full technical documentation required | No need to update technical documentation |
CE certification for modifications
In some cases, it is possible to obtain the CE mark solely for the machine modification. This applies where the modification is independent of the machine’s original design, while still requiring conformity assessment under the current regulations.
When it is required:
- Major changes: When a machine modification introduces significant changes to the machine’s functionality or safety, renewed CE certification is required.
- Modification as a separate scope: If a machine modification is a standalone project that does not alter the machine’s basic assumptions, but introduces new functions that require conformity assessment.
Formal steps:
- Conformity assessment: Carrying out a full conformity assessment under the Machinery Directive, including review and update of the technical documentation.
- Technical documentation: Preparing or updating the technical documentation, which should cover all machine safety aspects.
- Declaration of conformity: Drawing up a new EC declaration of conformity confirming that the modified machine meets all Directive requirements.
- CE marking: Affixing the CE mark to the machine in accordance with the requirements.
Impact of modification on the CE mark
Machine modification may require new CE certification for machinery if the changes introduced affect the machine’s compliance with the essential requirements of the Machinery Directive. A machine risk assessment should be carried out to identify potential hazards arising from the modification and to take the appropriate steps to ensure regulatory compliance.
Full alignment with Directive requirements
Where a machine modification requires the machine to be fully aligned with the current essential requirements of the Machinery Directive, it is necessary to analyze the safety functions in line with the current legal framework. This may mean recreating the manufacturer’s full technical documentation, including the risk assessment, test reports, operating instructions, and certificates of conformity. For companies planning broader adaptation work, adapting machines to minimum requirements is often part of the same process.
When it is required:
- Major safety changes: When a machine modification introduces changes affecting the machine’s fundamental safety functions.
- Change of intended use: If a machine modification changes the machine’s intended use, it must be adapted to the current requirements of the Directive.
Safety function analysis:
- Hazard identification: Carry out a detailed risk analysis to identify all potential hazards associated with the modification.
- Machine risk assessment: Assess the risk associated with each identified hazard and implement appropriate measures to reduce it.
Recreating the manufacturer’s documentation:
- Technical documentation: Prepare complete technical documentation covering all aspects of the machine’s design, operation, and safety.
- Test reports: Conduct tests and examinations to confirm the machine’s compliance with the requirements of the Directive.
- Certificates of conformity: Obtain the necessary certificates confirming the machine’s compliance with legal requirements.
Recertification procedure
The machine recertification process includes several formal steps:
- Conformity assessment: Carry out a full conformity assessment under the Machinery Directive, including a review and update of the technical documentation.
- Consultation with experts: Work with notified bodies and machine safety specialists to carry out the conformity assessment.
- Risk analysis: Perform a detailed risk analysis related to the changes introduced.
- Technical documentation: Prepare or update the technical documentation, which should cover all aspects of machine safety.
- Operating instructions: Update the operating instructions to reflect the changes made.
- Diagrams and plans: Supplement the documentation with new diagrams, technical plans, and descriptions of safety functions.
- Declaration of conformity: Draw up a new EC declaration of conformity confirming that the upgraded machine meets all Directive requirements.
- Signing the declaration: The declaration must be signed by the manufacturer’s authorized representative.
- Attachments to the declaration: Attach the necessary documents confirming the tests and assessments carried out.
- CE marking: Affix the CE mark to the machine in accordance with the requirements.
- Visible and durable marking: The CE mark must be placed on the machine in a visible and durable location.
- Other markings: Avoid placing any other markings that could mislead users as to the meaning of the CE mark.
Machine upgrades: Practical advice
When carrying out a machine upgrade and the recertification process, it is worth avoiding the most common mistakes, such as an incomplete risk assessment, missing technical documentation, or incorrect placement of the CE mark.
Most common mistakes and how to avoid them:
- Incomplete risk assessment: Carry out a detailed risk analysis to identify all potential hazards.
- Incomplete technical documentation: Keep the technical documentation up to date and complete, covering all aspects of the machine.
- Incorrect placement of the CE mark: Ensure that the CE mark is placed on the machine in a visible and durable location.
Machine upgrades and the related CE recertification are essential to ensure safety and regulatory compliance. Following the principles of the Machinery Directive and carrying out the conformity assessment process thoroughly helps avoid legal and technical issues while ensuring the safe use of machinery. For machine manufacturers and users, understanding and implementing these principles is not only a legal requirement, but also a responsible approach to safety and quality. It is also worth tracking how the legal framework is evolving, for example in the Regulation on Machinery 2023/1230/EU.
Industrial machine building and machine design
Industrial machine building and machine design are integral parts of the machine upgrade process. Working with a design office makes it possible to develop new components and systems that improve machine performance and safety. Strength calculations and risk analysis are essential to ensure that machines meet all technical requirements and safety standards. Depending on the project scope, companies also use engineering outsourcing to support redesign and implementation work.
Automation of production processes and production lines
Production process automation and the modernization of production lines are key to improving efficiency and reducing production costs. An automation systems integrator plays an important role in the upgrade process, ensuring that all systems are integrated and operate smoothly. Production automation increases efficiency and reduces errors and failures, which is essential for maintaining competitiveness in the market. These needs are especially visible in sectors such as the automotive industry, pharmaceutical industry, and FMCG industry.
Machine modernization and the CE mark
The CE marking is the manufacturer’s declaration that the product complies with EU requirements on health, safety, and environmental protection. It is mandatory for products covered by EU directives and allows them to be freely marketed within the European market.
The CE marking may be affixed only by the manufacturer or its authorized representative. This requires carrying out a conformity assessment and having technical documentation confirming compliance with the requirements.
When the modification is substantial and may affect operational safety and compliance with the Machinery Directive 2006/42/EC. Examples include changes to control systems, the addition of new functions, or structural modifications.
These are minor changes that do not affect the machine’s safety requirements or compliance. Examples include changing the color or replacing worn components with identical new ones.
In some cases, yes—when the modification is independent of the original design, but it requires a conformity assessment against current regulations. This applies to modifications that have a significant impact on functionality or safety.