Understanding Machinery Directive 2006/42/EC: Manufacturer Obligations and Compliance

The Machinery Directive 2006/42/EC is a crucial legislative framework established by the European Parliament and the Council of the European Union to ensure the safety of machinery within the EU. Its primary objective is to guarantee that machinery placed on the market is safe for users, while manufacturers, importers, and distributors adhere to specific obligations. This article delves into the key aspects of the directive, including the definition of machinery, manufacturer obligations, employer responsibilities, and guidance for procurement and safety departments.

Introduction to Machinery Directive 2006/42/EC

Definition of the Directive

The Machinery Directive 2006/42/EC was adopted on May 17, 2006, by the European Parliament and the Council of the European Union. Its main goal is to harmonize the regulations of member states concerning the design, construction, and marketing of machinery, ensuring a high level of health and safety protection for users.

All machinery introduced to the EU market must bear the CE marking, confirming its compliance with the Machinery Directive 2006/42/EC.

Scope of Application

The directive covers a wide range of machinery, including:

• Machines, which are assemblies of parts, at least one of which moves, joined together for a specific function.
• Interchangeable equipment that modifies the function of a machine or tractor when mounted.
• Safety components marketed independently.
• Lifting accessories, chains, ropes, and straps designed for lifting as part of machinery or lifting equipment.
• Detachable mechanical transmission devices.
• Incomplete machinery requiring further assembly before use.

Excluded from the directive are special equipment used in amusement parks, machinery designed for nuclear purposes, weapons, certain transport means, and machinery designed for military and police applications.

The directive applies to all new machinery introduced to the EU market, including those imported from third countries.

Definition of Machinery According to the Directive

What is a Machine?

According to the Machinery Directive 2006/42/EC, a “machine” is defined as:

• An assembly equipped with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, joined together for a specific application.
• The above assembly, excluding components intended for connection at the place of use or to energy and drive sources.
• An assembly ready for installation and capable of functioning in its current state when mounted on a transport means or installed in a building or structure.
• Assemblies of machines that, to achieve a specific end result, are arranged and controlled to operate as an integrated whole.
• An assembly of linked parts or components, at least one of which moves, joined together for lifting loads, where the only power source is directly applied human muscle effort.

Types of Machinery Covered by the Directive

The directive encompasses various types of machinery, including:

• Metalworking, woodworking, and other material processing machines.
• Agricultural machinery, such as tractors and harvesters.
• Construction machinery, including cranes and excavators.
• Machines used in the food, pharmaceutical, and chemical industries.
• Material handling machines, such as conveyors and forklifts.

Each of these machine types must meet specific safety, design, and construction requirements to be legally marketed in the EU.

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Machinery Directive 2006/42/EC: Manufacturer Obligations

Ensuring Machinery Compliance with Essential Requirements

Manufacturers must ensure that their machinery complies with all essential health and safety requirements outlined in the Machinery Directive 2006/42/EC. This includes conducting a risk assessment associated with the use of the machine and implementing appropriate measures to eliminate or minimize hazards.

Conformity Assessment Procedures

Depending on the type of machinery, manufacturers must undertake appropriate conformity assessment procedures, which may include:

• Internal production control: The manufacturer independently assesses whether the machinery meets the directive’s requirements.
• EC type examination: A procedure where a notified body verifies the machinery’s compliance with harmonized standards.
• Full quality assurance: A quality management system that must be approved by a notified body.

Declaration of Conformity and CE Marking

Manufacturers must draft a Declaration of Conformity, confirming that the machinery meets all directive requirements. The declaration must include:

• Manufacturer’s identification details.
• Description of the machinery.
• List of harmonized standards applied.
• Signature of the person authorized to compile the declaration.

The CE marking must be affixed to the machinery in a visible location, confirming its compliance with EU regulations.

Technical Documentation

Manufacturers must also prepare technical documentation, which must be available upon request by market surveillance authorities. The documentation should include:

• General description of the machinery.
• Design and construction drawings and diagrams.
• List of standards and regulations applied to the machinery.
• Description of measures taken to ensure the machinery’s compliance with the directive’s essential requirements.
• Results of conducted tests and risk analyses.

Machinery Directive 2006/42/EC: Employer Responsibilities

Employer Obligations Related to Machinery Use

Employers are responsible for ensuring that all machinery used in the workplace is safe and compliant with the Machinery Directive 2006/42/EC. This includes several key obligations:

1. Risk Assessment: Employers must conduct regular risk assessments associated with machinery use to identify potential hazards and implement appropriate preventive measures.
2. Maintenance and Servicing: Machinery must be regularly inspected, maintained, and serviced according to the manufacturer’s instructions to ensure safe operation.
3. Employee Training: Employers must ensure that all employees operating machinery are adequately trained in its use, safety, and emergency procedures.
4. Instructions and Procedures: All instructions and procedures for the safe operation of machinery must be clearly defined and accessible to employees.
5. Personal Protective Equipment (PPE): Employers must provide employees with appropriate PPE and ensure it is used as recommended.

Employers are required to provide regular training for employees on safe machinery operation and ensure appropriate personal protective equipment (PPE) is available.

Ensuring Workplace Safety and Hygiene

Workplace safety and hygiene (OSH) are critical aspects of employer responsibility. Employers must ensure that:

• All machinery is equipped with appropriate guards and safety devices to protect workers from injuries.
• Collective protective measures, such as ventilation or dust extraction systems, are installed and functioning correctly.
• Employees are aware of the hazards associated with machinery use and know how to respond in emergency situations.
• Regular OSH audits and inspections are conducted to ensure all safety procedures are followed.

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Machinery Directive 2006/42/EC: Guidance for Procurement Departments

Criteria for Machine Selection

The procurement department plays a crucial role in ensuring that purchased machinery complies with the Machinery Directive 2006/42/EC. When selecting machinery, the procurement department should consider the following criteria:

1. Compliance with Standards: Verify that the machinery has CE marking and a Declaration of Conformity, confirming its compliance with EU regulations.
2. Technical Documentation: Ensure the manufacturer provides complete technical documentation, including operating, maintenance, and assembly instructions.
3. Risk Assessment: Choose machinery that has undergone risk assessment and is designed to minimize hazards.
4. Service Support: Ensure that the manufacturer offers after-sales support, including servicing and access to spare parts.
5. References and Reviews: Seek feedback from other users and check the manufacturer’s references to assess the reliability and quality of the machinery.

Verification of Documentation and CE Marking

The procurement department should thoroughly verify the documentation provided by the manufacturer. Key elements to focus on include:

• Declaration of Conformity: Ensure the declaration contains all required information, such as manufacturer details, machine description, applied harmonized standards, and the signature of the authorized person.
• Operating Instructions: Confirm that instructions are clear, detailed, and available in the user’s language.
• CE Marking: Verify that the CE mark is affixed to the machinery in a visible, legible, and durable manner.

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Machinery Directive 2006/42/EC: Guidance for Safety Departments

Control and Supervision of Machinery Use

Safety departments have key responsibilities related to controlling and supervising the safe use of machinery in the workplace. Here are some basic guidelines:

1. Regular Inspections: Conduct regular inspections of machinery to check their technical condition and compliance with OSH requirements.
2. Safety Audits: Organize regular safety audits, including risk assessment, documentation review, and adherence to safety procedures.
3. Compliance Monitoring: Ensure all machinery is used according to the manufacturer’s instructions and legal regulations.
4. Reporting and Documentation: Maintain accurate records of all inspections, audits, and incidents related to machinery use.

Training and Instruction for Employees

Education and training are key elements of OSH strategy. Safety departments should ensure:

• Initial Training: Every employee who will use machinery should undergo initial training covering safe operation, maintenance, and emergency response.
• Periodic Training: Regular periodic training helps maintain a high level of employee awareness about hazards and safety procedures.
• Operating Instructions: Employees should have easy access to operating instructions and emergency procedures, which should be placed in visible locations near machinery.

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Machinery Directive 2006/42/EC: Importing Machinery

Import Procedures

Importing machinery into the European Union involves specific procedures that must be followed to ensure compliance with the Machinery Directive 2006/42/EC:

1. Compliance Verification: The importer must ensure that the machinery complies with the directive’s requirements and bears the CE marking.
2. Documentation Verification: The importer should thoroughly check the technical documentation, including the Declaration of Conformity and operating instructions.
3. Safety Inspection: Before introducing the machinery to the EU market, the importer must conduct a safety inspection to ensure compliance with all directive requirements.
4. Registration and Notification: In some cases, it may be necessary to notify the relevant market surveillance authorities about the import.

Compliance Requirements for Imports

Imported machinery must meet the same requirements as machinery produced within the EU. This means importers must ensure:

• CE Marking: The machinery must bear the CE mark, confirming its compliance with EU regulations.
• Technical Documentation: Complete technical documentation, including the Declaration of Conformity, must be available upon request.
• Operating Instructions: Operating and maintenance instructions must be provided in the language of the country where the machinery will be used.
• Conformity Assessment Procedures: Depending on the type of machinery, additional conformity assessment procedures, such as EC type examination or full quality assurance, may be required.

Importers of machinery into the EU must ensure that each machine has complete technical documentation and complies with the directive’s requirements before it is marketed.

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Machinery Directive 2006/42/EC: Declaration of Conformity

What Should the Declaration of Conformity Include?

The Declaration of Conformity is a document in which the manufacturer confirms that the machinery meets all the requirements of the Machinery Directive 2006/42/EC. It should include the following elements:

• Manufacturer’s Identification: Name, address, and contact details of the manufacturer.
• Description of the Machinery: A brief but detailed description of the machinery, including its trade name, model, and serial number.
• List of Applied Harmonized Standards: A list of standards applied to ensure the machinery’s compliance with the directive’s requirements.
• Authorized Person’s Signature: The declaration must be signed by a person authorized to represent the manufacturer, along with the date and place of the document’s issuance.

Importance of the Declaration of Conformity

The Declaration of Conformity is a key document in the process of placing machinery on the EU market. Its importance includes:

• Confirmation of Compliance: The declaration serves as formal confirmation that the machinery meets all the requirements of the Machinery Directive 2006/42/EC.
• Basis for CE Marking: Only based on the Declaration of Conformity can the manufacturer affix the CE marking to the machinery.
• Compliance Documentation: The declaration is part of the technical documentation that the manufacturer must maintain and provide upon request by market surveillance authorities.
• User Confidence: Having a Declaration of Conformity increases user confidence in the machinery, confirming its safety and compliance with regulations.

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Machinery Directive 2006/42/EC: Machine Documentation

Components of Technical Documentation

Technical documentation is a key element in ensuring machinery compliance with the Machinery Directive 2006/42/EC. It should include:

1. General Description of the Machinery: A detailed description of the machinery, its purpose, and main functions.
2. Design and Construction Drawings and Diagrams: Comprehensive drawings and diagrams illustrating the construction and operation of the machinery.
3. List of Standards and Regulations: A list of all harmonized standards and regulations applied to the design and construction of the machinery.
4. Description of Safety Measures: A description of safety measures implemented to protect users from hazards.
5. Results of Tests and Risk Analyses: Documentation of test results and risk assessments related to the use of the machinery.
6. Operating and Maintenance Instructions: Detailed instructions for operating, maintaining, and repairing the machinery.

Importance and Storage of Documentation

Technical documentation serves several key functions:

• Basis for Conformity Assessment: It serves as the basis for assessing the machinery’s compliance with the Machinery Directive 2006/42/EC requirements.
• Verification by Authorities: Market surveillance authorities may request access to the documentation to verify the machinery’s compliance.
• Technical Assistance: The documentation is an invaluable source of information for service personnel and users, helping to resolve technical issues.
• Storage: The manufacturer is required to store the technical documentation for at least 10 years from the date the machinery is placed on the market. The documentation can be stored in paper or electronic form, provided it is easily accessible upon request.

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Machinery Directive 2006/42/EC: Stakeholder Obligations

The Machinery Directive 2006/42/EC imposes a range of obligations on manufacturers, employers, importers, and other stakeholders to ensure the safety of machinery placed on the EU market. Key obligations include:

• Manufacturer: Ensure machinery compliance with safety requirements, conduct conformity assessment procedures, draft the Declaration of Conformity, and prepare technical documentation.
• Employer: Ensure safe machinery use, regular maintenance, and employee training.
• Procurement Department: Verify machinery compliance with the directive before purchase, check documentation and CE marking.
• Safety Departments: Supervise workplace safety, conduct regular inspections, and provide training.

Stakeholder	Main Obligations
Manufacturer	Ensure machinery compliance with safety requirements Draft the EC Declaration of Conformity Prepare and store technical documentation Affix the CE marking to the machinery
Employer	Ensure safe machinery use Regular maintenance and inspections Train employees in machinery operation Provide appropriate personal protective equipment (PPE)
Procurement Department	Verify machinery compliance with the directive before purchase Check technical documentation and CE marking
Safety Departments	Control and supervise machinery use Conduct regular safety inspections and audits Organize OSH training for employees
Importer	Verify compliance of imported machinery with the directive Check and store technical documentation Ensure CE marking before market introduction

Machinery Directive 2006/42/EC: Importance of the Directive for Workplace Safety

The Machinery Directive 2006/42/EC plays a crucial role in improving workplace safety across the European Union. Its provisions aim to:

• Minimize Risk: By setting design and construction requirements, the directive reduces risks associated with machinery use to a minimum.
• Ensure High Protection Levels: The directive’s provisions ensure a high level of health and safety protection for machinery users.
• Standardize Regulations: The directive harmonizes machinery regulations across the EU, facilitating trade and market introduction.
• Increase User Confidence: Machinery compliant with the directive and bearing the CE marking is perceived as safe and reliable, enhancing user confidence.

External Links

Full text of the Machinery Directive 2006/42/EC: [Link to the official document]

Machinery Directive 2006/42/EC: FAQ