Key takeaways:
This article discusses the role and content of the EC Declaration of Conformity and the related technical documentation in the process of assessing machinery compliance with the Machinery Directive 2006/42/EC.
- The EC Declaration of Conformity confirms compliance with the requirements of the Machinery Directive 2006/42/EC and is required when placing machinery on the EU market
- Without a declaration, machines cannot be legally sold or used; the manufacturer or authorised representative is responsible.
- Required elements of the declaration: machine identification, manufacturer details, reference to 2006/42/EC, harmonised standards, declaration of conformity, signature
- If a notified body is involved, its details must be provided; the declaration must be drawn up in accordance with Annex II of the Directive
- Technical documentation (including the description, drawings, diagrams, finite element analysis calculations, and the list of standards) must be retained for at least 10 years and made available to the supervisory authorities.
In today’s rapidly evolving machinery industry, ensuring safety and compliance with applicable legal requirements is essential. The EC Declaration of Conformity plays a central role here, as it confirms that a machine meets all the requirements of the Machinery Directive 2006/42/EC. This article explains the process of issuing this declaration, its importance, and the detailed requirements it must satisfy.
EC Declaration of Conformity: What the Machinery Directive Says
The importance of the EC Declaration of Conformity
The EC Declaration of Conformity (often incorrectly referred to as a CE declaration) is a key document in the machinery industry because it confirms that a machine complies with the applicable safety requirements. Issuing this declaration is mandatory for every machine manufacturer that intends to place products on the European Union market. Without it, machines cannot be legally sold or used. This process helps ensure that all machines are safe for users and for the environment, and it is closely linked to the broader process of CE certification of machinery.
EC Declaration of Conformity: Requirements
The EC Declaration of Conformity must contain several key elements for it to be valid and effective. These include:
- Document title: The document must be titled “EC Declaration of Conformity”.
- Date of issue: The date on which the declaration was issued must be included.
- Product description: It should contain precise information identifying the machine, such as its name, type, and model.
- Contact details: The full details of the manufacturer and, where applicable, its authorised representative must be provided.
- Reference to essential requirements: It should refer to the relevant directives, in this case the Machinery Directive 2006/42/EC.
- Harmonised standards: The document should include a list of the harmonised standards used for the conformity assessment.
- Statement of conformity: It must clearly state that the product complies with the specified requirements.
- Notified bodies: If a notified body was involved in the certification process, this must be indicated together with its details.
- Signature of the authorised person: The declaration must be signed by a person representing the company, in accordance with the entry in the National Court Register (KRS).
The manufacturer or its authorised representative is responsible for issuing the declaration before the machine is placed on the market. This process includes assessing the machine’s conformity with the requirements of the Machinery Directive and preparing and retaining the technical documentation.
Technical documentation
Technical documentation is an integral part of the certification process. It contains all the information needed to assess whether the machine complies with the requirements. This documentation includes:
- General description of the machine
- Design drawings and diagrams
- Descriptions and explanations necessary to understand those drawings and diagrams and the operation of the machine
- Results of strength calculations (finite element analysis)
- List of harmonised standards and other technical documents
Declaration of Incorporation for partly completed machinery
The Declaration of Incorporation is used for partly completed machinery. Partly completed machinery is an assembly which, by itself, cannot perform a specific application and is intended to be incorporated into another machine. The Declaration of Incorporation must include:
- Name and address of the manufacturer
- Description of the partly completed machinery
- A statement that the partly completed machinery is to be incorporated into another machine in order to form a complete machine compliant with the Machinery Directive
- Signature of the person authorised to represent the manufacturer
EC Declaration of Conformity: Detailed requirements
The EC Declaration of Conformity must be drawn up in accordance with Annex II of the Machinery Directive 2006/42/EC. The detailed requirements are as follows:
- Document title:
- The document must clearly indicate that it is an EC Declaration of Conformity.
- Date of issue:
- The declaration must include the date on which it was issued.
- Product description:
- The name, type, model, and serial number of the machine, enabling it to be identified unambiguously.
- Manufacturer’s and authorised representative’s address:
- Full contact details of the manufacturer and, where applicable, its authorised representative.
- Reference to essential requirements:
- Identification of the relevant provisions of the Machinery Directive 2006/42/EC.
- Reference to detailed provisions:
- A list of the harmonised standards applied in the machine’s conformity assessment.
- Statement of conformity:
- A clear statement that the machine complies with all relevant requirements of the directive.
- Notified bodies:
- If a notified body was involved in the certification process, this must be stated together with its details.
- Signature of the company representative:
- The declaration must be signed by a person authorised to represent the manufacturer, in accordance with the entry in the National Court Register (KRS).
| Element | Content |
|---|---|
| Document title | EC DECLARATION OF CONFORMITY |
| Date of issue | [Date of issue] |
| Product description | Name: [Product name], Type: [Type], Model: [Model], Serial number: [Serial number] |
| Manufacturer’s address | [Manufacturer name], [Manufacturer address] |
| Authorised representative’s address | [Representative name], [Representative address] (if applicable) |
| Reference to essential requirements | Machinery Directive 2006/42/EC |
| Reference to detailed provisions | Harmonised standards: [List of harmonised standards] |
| Statement of conformity | We hereby declare that the above product complies with the requirements of the Machinery Directive 2006/42/EC |
| Notified body | [Name of notified body], [Identification number] (if applicable) |
| Signature | [Name of authorised person], [Position], [Signature] |
The manufacturer is required to retain this documentation for at least 10 years from the date of manufacture of the last machine produced. This documentation must be made available to the relevant market surveillance authorities at any time.
EC Declaration of Conformity: The role of technical documentation
Technical documentation is an integral part of the machinery certification process and must be made available on request to the relevant market surveillance authorities. Under the Machinery Directive 2006/42/EC, the technical documentation should include:
- General description of the machine: presenting the machine’s purpose and intended use.
- Design drawings, schematics and diagrams: showing the machine’s construction in detail.
- Descriptions and explanations: enabling the drawings, schematics and operation of the machine to be understood.
- Structural strength calculation results (FEM): relating to the safety of the design.
- List of applied harmonised standards: and other relevant technical documents.
- Operating instructions: containing guidance on the safe use, maintenance and servicing of the machine.
- Risk analysis according to EN ISO 12100: identification and assessment of risks associated with use of the machine, together with the safety measures applied.
Declaration of Incorporation for partly completed machinery
Under the Machinery Directive 2006/42/EC, partly completed machinery must be accompanied by a Declaration of Incorporation before being placed on the market. This declaration confirms that the partly completed machinery is intended to be incorporated into another machine or system in order to become a complete and safe machine compliant with the directive. The key elements of the Declaration of Incorporation include:
- Identification of the partly completed machinery: as with the EC Declaration of Conformity, this includes the manufacturer’s name and address, a description of the machine, and its serial number.
- Description of the integration conditions: a detailed description of how and under what conditions the partly completed machinery is to be integrated into another machine.
- Statement of conformity: confirmation that the partly completed machinery meets all applicable health and safety requirements when integrated as described.
The Declaration of Incorporation must be kept with the partly completed machinery until it has been fully integrated and put into service as a complete machine.
EC Declaration of Conformity: Practical application in the machinery industry
EC Declaration of Conformity: application
The EC Declaration of Conformity is widely used across various areas of industrial automation. In the machinery industry, CE certification of machinery is a key element in ensuring safety and quality. The process of adapting machines to minimum requirements is essential to ensure that each machine presents minimal risk during use.
Industrial automation relies on the EC Declaration of Conformity to ensure that all machines and equipment in use meet the requirements of the Machinery Directive. Companies involved in machine design must take these requirements into account at the concept stage to avoid costly modifications later in production, and practical support from a design office can help embed compliance from the outset.
Project management and certification
Design offices play a key role in preparing the EC Declaration of Conformity. Project management includes integrating certification processes and carrying out safety audits, which are an integral part of certification. A safety audit makes it possible to identify potential hazards early and implement appropriate corrective measures, including hazard identification in accordance with ISO 12100.
Project management in machine certification requires careful planning and coordination. Design offices must work closely with production, quality control, and external auditors to ensure that every machine meets the requirements of the Machinery Directive. Effective project management helps minimise risk and optimise certification costs, especially when supported by a structured approach to risk assessment according to ISO 12100.
EC Declaration of Conformity: Engineering outsourcing and certification
Engineering outsourcing can significantly speed up the machine certification process. Companies specializing in certification and engineering services provide support in preparing technical documentation and carrying out the necessary conformity tests. Engineering outsourcing allows companies to focus on their core business while external specialists handle complex certification processes.
Examples of companies offering certification services include:
- Companies specializing in CE certification of machinery, offering comprehensive services that include conformity assessment, preparation of technical documentation, and testing and audits.
- Design offices that specialize in designing and adapting machines to meet the requirements of the Machinery Directive.
- Industrial automation integrators, responsible for integrating automation systems with machines and ensuring that all system components comply with the requirements.
Modern technologies and the EC Declaration of Conformity
In the era of Industry 4.0, automation of production processes is becoming increasingly common. The industrial automation integrator plays a key role in the certification process, ensuring that all system components comply with the requirements of the EC Declaration of Conformity. Industry 4.0 brings new challenges and opportunities in machine certification, including:
- Production automation, which requires all automated systems to be safe and compliant with applicable standards.
- PLC programming, which is a key element of industrial automation systems and must comply with safety requirements.
- SCADA, meaning supervisory control and data acquisition systems, which must comply with the requirements of the Machinery Directive and ensure safe operation.
The EC Declaration of Conformity is an essential part of the machine certification process in the machinery industry. It confirms compliance with standards and legal requirements, which is crucial for user safety and environmental protection. Although demanding, the certification process brings many benefits, including improved safety, higher quality, and greater trust in products. Modern technologies and innovations such as Industry 4.0 further support this process, making it more efficient and transparent. It is also worth following the upcoming legal framework described in the Regulation on Machinery 2023/1230/EU.
The EC Declaration of Conformity and the Declaration of Incorporation for partly completed machinery are the foundation of a safe and legally compliant machinery market in the European Union. Every manufacturer and industrial automation integrator must understand the requirements and processes associated with these documents to ensure the highest level of safety and quality in their products. These issues are particularly important in sectors such as the automotive industry, the FMCG industry, heavy industry, and the electronics industry & semiconductors, where machine safety and compliance are critical.
EC Declaration of Conformity: Safety, Standards and Certification
This document confirms that the machine complies with the requirements of the Machinery Directive 2006/42/EC. It is required to place the machine legally on the European Union market.
The manufacturer or its authorized representative is responsible. The declaration must be drawn up before the machine is placed on the market.
It must include, among other things, the title “EC Declaration of Conformity”, the date of issue, machine identification (name, type, model, serial number), the manufacturer’s details, a reference to the Machinery Directive 2006/42/EC, a list of harmonized standards, and the signature of a person authorized in accordance with the National Court Register. If a notified body was involved, its details must also be provided.
It is an integral part of the conformity assessment, allowing confirmation that the directive’s requirements have been met. It includes, among other things, a description of the machine, drawings and diagrams, descriptions of its operation, the results of strength calculations (FEA), and a list of the standards applied.
This document is used for partly completed machinery that cannot in itself perform a specific application and is intended to be incorporated into other machinery. It includes, among other things, the manufacturer’s details, a description of the partly completed machinery, a statement that it is intended for incorporation, and the signature of the authorized person.