In today’s rapidly evolving machinery industry, ensuring the safety and compliance of machines with prevailing legal standards is crucial. The EC Declaration of Conformity: Safety, Standards, and Certification plays a vital role as a document confirming that a machine meets all requirements of the Machinery Directive 2006/42/EC. This article aims to elucidate the issuance process of this declaration, its significance, and the specific requirements it must fulfill.
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EC Declaration of Conformity: Insights from the Machinery Directive
The Importance of the EC Declaration of Conformity
The EC Declaration of Conformity (often mistakenly referred to as the CE Declaration) is a pivotal document in the machinery industry, certifying compliance with safety standards. Issuing this declaration is mandatory for any machine manufacturer aiming to introduce their products to the European Union market. Without this declaration, machines cannot be legally sold or used. This process ensures that all machines are safe for users and the environment.
Requirements for the EC Declaration of Conformity
The EC Declaration of Conformity must include several key elements essential for its validity and effectiveness, such as:
- Document Title: The document must be titled “EC Declaration of Conformity”.
- Date of Issue: The date when the declaration was issued must be included.
- Product Description: It should contain precise information identifying the machine, such as name, type, model.
- Contact Addresses: Full details of the manufacturer and, if applicable, their authorized representative must be provided.
- Reference to Essential Requirements: It should refer to the relevant directives, in this case, the Machinery Directive 2006/42/EC.
- Harmonized Standards: The document should list the harmonized standards used for conformity assessment.
- Statement of Conformity: It must clearly state that the product complies with specified requirements.
- Notified Bodies: If a notified body participated in the certification process, this must be noted along with its details.
- Authorized Person’s Signature: The declaration must be signed by a person representing the company, in accordance with the National Court Register (KRS).
The manufacturer or their authorized representative is responsible for issuing the declaration before the machine is placed on the market. This process includes assessing the machine’s compliance with the Machinery Directive requirements and preparing and maintaining the technical documentation.
Technical Documentation
Technical documentation is an integral part of the certification process. It contains all necessary information to enable the assessment of the machine’s compliance with requirements. This documentation includes:
- General description of the machine
- Design drawings and diagrams
- Descriptions and explanations necessary to understand these drawings and diagrams and the machine’s operation
- Results of strength calculations (FEM)
- List of harmonized standards and other technical documents
Declaration of Incorporation for Incomplete Machines
A Declaration of Incorporation is used for incomplete machines. An incomplete machine is a component that cannot fulfill a specific application on its own and is intended to be incorporated into another machine. The Declaration of Incorporation must include:
- Name and address of the manufacturer
- Description of the incomplete machine
- Statement that the incomplete machine is to be incorporated into another machine to form a complete machine compliant with the Machinery Directive
- Signature of the person authorized to represent the manufacturer
Detailed Requirements for the EC Declaration of Conformity
The EC Declaration of Conformity must be prepared in accordance with Annex II of the Machinery Directive 2006/42/EC. Here are the detailed requirements:
- Document Title:
- The document must clearly indicate that it is an EC Declaration of Conformity.
- Date of Issue:
- The declaration must include the date it was issued.
- Product Description:
- Name, type, model, and serial number of the machine, allowing for its unambiguous identification.
- Manufacturer’s and Authorized Representative’s Address:
- Full contact details of the manufacturer and, if applicable, their authorized representative.
- Reference to Essential Requirements:
- Indication of the relevant provisions of the Machinery Directive 2006/42/EC.
- Reference to Specific Provisions:
- List of harmonized standards applied for the conformity assessment of the machine.
- Statement of Conformity:
- Clear statement that the machine complies with all relevant directive requirements.
- Notified Bodies:
- If a notified body participated in the certification process, this must be noted along with its details.
- Signature of the Company Representative:
- The declaration must be signed by a person authorized to represent the manufacturer, in accordance with 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] |
| Authorized Representative’s Address | [Representative Name], [Representative Address] (if applicable) |
| Reference to Essential Requirements | Machinery Directive 2006/42/EC |
| Reference to Specific Provisions | Harmonized Standards: [List of Harmonized Standards] |
| Statement of Conformity | We hereby declare that the above product complies with the requirements of the Machinery Directive 2006/42/EC |
| Notified Body | [Notified Body Name], [Identification Number] (if applicable) |
| Signature | [Authorized Person’s Name], [Position], [Signature] |
The manufacturer is obliged to retain this documentation for at least 10 years from the date of production of the last machine unit. This documentation must be available to the relevant market surveillance authorities at any time.
EC Declaration of Conformity: The Role of Technical Documentation
Technical documentation is an indispensable part of the machinery certification process and must be available upon request by the relevant market surveillance authorities. According to the Machinery Directive 2006/42/EC, technical documentation should include:
- General description of the machine: outlining the purpose and application of the machine.
- Design drawings, diagrams, and schematics: detailing the construction of the machine.
- Descriptions and explanations: enabling the understanding of drawings, diagrams, and the machine’s operation.
- Results of strength calculations (FEM): concerning the safety of the structure.
- List of applied harmonized standards: and other relevant technical documents.
- Operating instructions: containing guidelines for safe use, maintenance, and servicing of the machine.
- Risk assessment according to EN ISO 12100:2012: identifying and assessing risks associated with machine use and implemented safety measures.
Declaration of Incorporation for Incomplete Machines
Incomplete machines, under the Machinery Directive 2006/42/EC, must be accompanied by a Declaration of Incorporation before being placed on the market. This declaration confirms that the incomplete machine is intended to be integrated with another machine or system to become a complete and safe machine compliant with the directive. Key elements of the Declaration of Incorporation include:
- Identification of the incomplete machine: similar to the EC Declaration of Conformity, it includes the name and address of the manufacturer, description of the machine, and its serial number.
- Description of integration conditions: a detailed description of how and under what conditions the incomplete machine is to be integrated with another machine.
- Statement of compliance: confirmation that the incomplete machine meets all applicable safety and health requirements when integrated as described.
The Declaration of Incorporation must be retained with the incomplete machine until its full integration and commissioning as a complete machine.
EC Declaration of Conformity: Practical Application in the Machinery Industry
EC Declaration of Conformity: Application
The EC Declaration of Conformity finds broad application across various fields of industrial automation. In the machinery industry, CE certification of machines is a key element in ensuring safety and quality. The process of adapting machines to minimum requirements is essential to ensure that each machine poses minimal risk during use.
Industrial automation relies on the EC Declaration of Conformity to ensure that all machines and devices used comply with the Machinery Directive’s requirements. Companies involved in machine design must consider these requirements at the concept stage to avoid costly modifications at later production stages.
Project Management and Certification
Design offices play a crucial role in preparing the EC Declaration of Conformity. Project management involves integrating certification processes and conducting safety audits, which are integral to the certification process. Safety audits allow for early detection of potential hazards and the implementation of appropriate corrective measures.
Project management in machine certification requires careful planning and coordination. Design offices must closely collaborate with production, quality control departments, and external auditors to ensure that each machine meets the Machinery Directive’s requirements. Proper project management minimizes risk and optimizes certification-related costs.
EC Declaration of Conformity: Engineering Outsourcing and Certification
Engineering outsourcing can significantly expedite the machine certification process. Companies specializing in certification and engineering services offer support in preparing technical documentation and conducting necessary compliance tests. Engineering outsourcing allows companies to focus on their core activities while external specialists handle complex certification processes.
Examples of companies offering certification services include:
- Companies specializing in CE machine certification, offering comprehensive services including conformity assessment, technical documentation preparation, and conducting tests and audits.
- Design offices specializing in designing and adapting machines to the Machinery Directive’s requirements.
- Industrial automation integrators, who integrate automation systems with machines and ensure that all system components comply with requirements.
Modern Technologies and the EC Declaration of Conformity
In the era of Industry 4.0, the 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 EC Declaration of Conformity requirements. Industry 4.0 introduces new challenges and opportunities in machine certification, including:
- Production automation, which requires all automated systems to be safe and compliant with standards.
- PLC programming, a key element of industrial automation systems that must comply with safety requirements.
- SCADA, or supervisory control and data acquisition systems, which must comply with the Machinery Directive requirements and ensure safe operations.
The EC Declaration of Conformity is an indispensable element of the machine certification process in the machinery industry. It ensures compliance with standards and legal regulations, which is crucial for user safety and environmental protection. Although demanding, the certification process brings numerous benefits, including increased safety, quality, and trust in products. Modern technologies and innovations, such as Industry 4.0, further support this process, making it more efficient and transparent.
The EC Declaration of Conformity and the Declaration of Incorporation for incomplete machines are the foundation of a safe and legally compliant machinery market in the European Union. Every manufacturer and industrial automation integrator must be aware of the requirements and processes associated with these documents to ensure the highest level of safety and quality of their products.
FAQ: EC Declaration of Conformity
The EC Declaration of Conformity is an official document in which the manufacturer declares that their machine meets all the requirements of the relevant EU directives, including the Machinery Directive 2006/42/EC.
The EC Declaration of Conformity must be issued by the machine manufacturer or their authorized representative in the European Union.
The EC Declaration of Conformity must include:Title: “EC DECLARATION OF CONFORMITY”Date of issueProduct description allowing for unambiguous identification: name, type, modelAddress of the manufacturer and, if applicable, the authorized representativeReference to essential requirements (New Approach Directives)Reference to specific provisions (harmonized standards)Statement of compliance with directive requirementsReference to the actions of the notified body, if involved in the certification processSignature of the person representing the company (owner or authorized person)
The statement of conformity means that the product meets all the requirements specified in the relevant EU directives, as confirmed by the manufacturer.
Failure to issue the EC Declaration of Conformity prevents the legal introduction of the machine to the EU market, which can result in legal sanctions, including a ban on the sale and use of the machine and financial penalties.
The EC Declaration of Conformity must be signed by a person authorized to represent the manufacturer, in accordance with the National Court Register (KRS) or the appropriate register.
Yes, the EC Declaration of Conformity should include a list of harmonized standards applied for the conformity assessment of the machine with the directive’s requirements.
A notified body is an organization approved by an EU member state to assess product conformity. Its involvement is required in the certification process if the directive mandates it, especially for more complex or potentially hazardous machines.
The manufacturer must retain the EC Declaration of Conformity for at least 10 years from the date of production of the last machine unit.
The EC Declaration of Conformity is issued for a complete machine that meets all the directive’s requirements. The Declaration of Incorporation is used for incomplete machines that must be integrated with another machine to meet the directive’s requirements. The Declaration of Incorporation states that the incomplete machine meets the relevant safety requirements when properly integrated.