Guide to the Machinery Directive for manufacturers

Guide to the Machinery Directive: The Purpose of Directive 2006/42/EC

Guide to the Machinery Directive: Directive 2006/42/EC, often referred to as the Machinery Directive, was introduced to establish common rules for machine safety across the European Union. Its main purpose is to protect machine users from hazards associated with their use and to ensure the free movement of machinery within the EU internal market through harmonized rules.

The Directive covers a broad range of machinery, including industrial machines, interchangeable equipment, safety components, lifting accessories, and machinery for lifting and moving persons. It sets out essential requirements for the design, manufacture, and use of machinery aimed at minimizing risks to users and third parties.

Background and context

The first directive on machinery, Directive 89/392/EEC, was introduced in 1989. It responded to the need to harmonize machine safety rules across different EU Member States. In 1998, it was replaced by Directive 98/37/EC, which introduced further improvements and simplifications. Finally, in 2006, Directive 2006/42/EC was adopted, introducing more detailed and stricter provisions intended to increase the level of health and safety protection for machine users.

Directive 2006/42/EC is the result of long-term consultation and cooperation between various stakeholders, including industry, standardization bodies, market surveillance authorities, and worker representatives. The introduction of this Directive was intended not only to improve safety, but also to simplify and harmonize procedures related to conformity assessment and the placing of machinery on the market.

Importance for machine manufacturers

For machine manufacturers, Directive 2006/42/EC is of key importance because it defines the detailed requirements their products must meet in order to be legally sold on the EU market. The manufacturer must ensure that every machine complies with the essential health and safety requirements set out in the Directive. In practice, this means manufacturers must carry out detailed risk analyses, apply appropriate protective measures, and document their products’ compliance with the Directive’s requirements.

Knowledge of and compliance with Directive 2006/42/EC is not only a legal obligation, but also a key part of building customer trust and reputation. Machines bearing the CE mark, which confirms compliance with the Directive, are regarded as safe and as meeting the highest quality standards. For manufacturers, this also means they can freely export their products throughout the European Union, opening up broad business opportunities.

Guide to the Machinery Directive: Essential Health and Safety Requirements

General safety principles

Directive 2006/42/EC sets out general safety principles intended to prevent hazards associated with the use of machinery. These principles cover a wide range of aspects, from machine design and construction to installation, maintenance, and operation under different conditions.

Guide to the Machinery Directive describes in detail the essential health and safety requirements that manufacturers must meet. Key aspects include:

• Ergonomics: Machines must be designed in accordance with ergonomic principles to minimize the risk of injury resulting from poor body posture, repetitive movements, or excessive physical effort.
• Stability: Machines must remain stable during use to prevent tipping or shifting that could cause accidents.
• Protection against noise and vibration: Machines must be designed to minimize users’ exposure to harmful noise and vibration, which may lead to long-term health problems.
• Protection against emissions: Machines must be equipped with systems that reduce emissions of substances harmful to health, such as dust, gases, fumes, or chemicals.

Risk analysis and assessment

One of the key elements of the Directive is the obligation for manufacturers to carry out risk analysis and assessment. This process includes identifying potential hazards associated with the use of the machine, assessing the likelihood of their occurrence, and estimating the possible consequences. Based on the results of the risk analysis, manufacturers must take appropriate preventive measures to reduce risk to an acceptable level.

Guide to the Machinery Directive places strong emphasis on risk analysis and assessment. This process includes:

1. Hazard identification: Identifying all possible hazards associated with the machine, such as mechanical, electrical, thermal, chemical, or ergonomic hazards.
2. Risk assessment: Estimating the likelihood of each hazard occurring and its potential consequences for the health and safety of users.
3. Risk reduction measures: Implementing appropriate protective measures to reduce risk to an acceptable level. These may include technical measures (e.g. guards, emergency stop devices), organizational measures (e.g. safety procedures), or training measures (e.g. operating instructions).

Protective measures and safeguards

Machines must be equipped with appropriate protective measures and safeguards to protect users from potential hazards. These measures include mechanical, electronic, and procedural safeguards.

Examples of protective measures and safeguards include:

• Guards and barriers: Physical guards and barriers that prevent access to moving machine parts that may pose a hazard to users.
• Emergency stop devices: Systems that enable the machine to be stopped quickly and safely in the event of a failure or hazard.
• Sensors and monitoring systems: Electronic sensors and monitoring systems that detect machine malfunctions and automatically shut it down or warn users.
• Operating procedures: Detailed instructions and procedures for the safe use, maintenance, and repair of machines that minimize the risk of accidents.

Guide to the Machinery Directive: Conformity Assessment Procedure

Self-assessment of conformity

For many simpler machines that do not present significant risk to users, the manufacturer may carry out the conformity assessment independently. In such cases, the manufacturer is responsible for ensuring that the machine meets all applicable requirements of the directive.

Guide to the Machinery Directive describes the conformity assessment procedures that manufacturers must follow for their machines to obtain CE marking. There are two main methods:

• Carrying out a risk analysis: Identifying and assessing hazards associated with the machine.
• Applying the relevant harmonized standards: These standards provide detailed guidance on how to meet the requirements of the directive.
• Drawing up a declaration of conformity: Documentation confirming that the machine meets all applicable requirements.
• Affixing the CE marking: Placing the CE marking on the machine as evidence of its compliance with EU regulations.

Guide to the Machinery Directive: EC Type-Examination

More complex machines that may pose a greater risk to users require EC type-examination by a notified body. EC type-examination is a process in which the notified body assesses whether the machine meets all requirements of the directive.

The stages of EC type-examination include:

• Review of technical documentation: Assessment of the technical documentation prepared by the manufacturer, including technical drawings, test results, and risk analyses.
• Inspections and tests: Carrying out inspections and tests on the machine to verify its conformity with the requirements of the directive.
• Issuing a certificate of conformity: If the machine meets all requirements, the notified body issues an EC type-examination certificate, which is necessary to obtain CE marking.

Guide to the Machinery Directive: Quality assurance systems

Manufacturers must implement appropriate quality assurance systems to ensure that every machine produced meets the specified safety standards. These systems include procedures for design, production, quality control, and the monitoring and improvement of production processes.

Elements of the quality assurance system include:

• Quality system documentation: Detailed procedures and instructions covering all stages of machine production.
• Control of production processes: Regular audits and inspections to ensure production processes comply with the directive’s requirements.
• Monitoring and improvement: Ongoing monitoring of production performance and implementation of improvements to increase machine quality and safety.

Guide to the Machinery Directive: CE Marking

The importance of CE marking

CE marking is a key element confirming that a machine meets all health, safety, and environmental protection requirements set out in EU directives. It is essential for legally placing a machine on the European Union market.

CE marking is not a quality certificate, but evidence of compliance with the EU’s minimum legal requirements. It gives consumers confidence that the product has been assessed for safety and complies with the relevant regulations.

CE marking is evidence that a machine meets all health, safety, and environmental protection requirements set out in EU directives, which is essential for legally placing the machine on the European Union market.

The marking process

To apply the CE mark, the manufacturer must complete several stages of the conformity assessment process:

1. Identification of applicable directives: Determining which EU directives apply to the product in question.
2. Carrying out a conformity assessment: Depending on the type of machine, this may include self-assessment, EC type-examination by a notified body, or implementation of a quality assurance system. For more on conformity assessment procedures, see the relevant guidance.
3. Preparation of technical documentation: This contains all information necessary to confirm the machine’s compliance with the directive’s requirements.
4. Drawing up the EC Declaration of Conformity: Documentation in which the manufacturer declares that the machine complies with the relevant directives.
5. Affixing the CE marking: The CE marking must be placed on the machine in a visible, legible, and indelible location.

Examples of correct marking

CE marking should be affixed in accordance with the guidelines set out in the EU directives. Here are several rules for correct marking:

• The CE marking must be placed on the machine in a visible, legible, and indelible location.
• The size of the CE marking must not be less than 5 mm, unless the regulations for the specific product provide otherwise.
• The CE marking must be placed next to the name of the manufacturer or its authorized representative, together with the address and identification number.
• If the machine is subject to EC type-examination by a notified body, the identification number of that body must appear next to the CE marking.

Guide to the Machinery Directive: Technical Documentation

Scope and content of the documentation

Technical documentation is a key element in demonstrating that a machine complies with the directive’s requirements. It must be sufficiently detailed to allow an assessment of the machine’s compliance with the regulations.

The guide to the Machinery Directive indicates that technical documentation is a key element in demonstrating that a machine complies with the directive’s requirements. It must include:

• A general description of the machine, its intended use, and its functions.
• Technical drawings and design diagrams.
• A description of the protective measures applied in the machine.
• The results of the risk analyses carried out.
• Technical specifications of the materials and components used.
• Operating and maintenance instructions.
• Test results and quality control records.
• The EC Declaration of Conformity.

Retention and availability of documentation

Technical documentation must be retained by the manufacturer or its authorized representative for at least 10 years from the date the machine is placed on the market. The documentation should be made available to the relevant supervisory authorities on request so they can verify the machine’s compliance with the directive’s requirements.

Examples of technical documents

Examples of technical documents that should be included in the documentation include:

• Technical drawings showing the machine design.
• Electrical and hydraulic diagrams.
• A description of how the safety systems operate.
• Results of tests, strength calculations, and other examinations.
• Risk analyses and the preventive measures applied.
• Operating and maintenance instructions, including emergency procedures.
• Declarations of conformity and certificates issued by notified bodies.

Guide to the Machinery Directive: Operating Instructions and Information for Users

Requirements for operating instructions

Operating instructions are an essential part of every machine and must be supplied in the official language of the country where the machine is sold. They must be clear, understandable, and comprehensive to ensure safe and efficient use of the machine.

Operating instructions should include:

• Information on the safe use of the machine.
• A description of all machine functions and how the machine operates.
• Procedures for starting, operating, and stopping the machine.
• Instructions for maintenance and repairs.
• Warnings about potential hazards and the precautions to be taken.
• Instructions on what to do in emergency situations.

Information on safe use

Operating instructions must describe in detail how to use the machine safely, including:

• What personal protective equipment (PPE) is required when working with the machine.
• How to operate the machine correctly under different working conditions.
• How to avoid potential hazards associated with operating the machine.
• What safety procedures must be followed during maintenance and repairs.

Guide to the Machinery Directive: Special Machines and Exceptions

Machines for underground work

Machines intended for underground use, such as powered hydraulic supports, must meet specific safety requirements. These requirements include:

• Increased structural strength to withstand extreme underground conditions.
• Ventilation and fire protection systems to ensure safety in potentially explosive atmospheres.
• Special monitoring and control systems that enable safe operation of the machine in difficult underground conditions.

Machines on drilling platforms

Machines installed on drilling platforms, such as well-servicing equipment, must meet stringent safety standards. These requirements include:

• Explosion protection and gas detection systems to protect against gas leaks and other hazards.
• Emergency evacuation systems and rescue procedures to ensure the platform can be left quickly and safely in the event of a failure.
• Reinforced structures that can withstand extreme offshore environmental conditions, such as strong winds and waves.

Machines used in amusement parks

Equipment designed for use in amusement parks, such as roller coasters and carousels, is excluded from the Machinery Directive, but must comply with national safety regulations. These requirements include:

• Regular inspections and safety tests to ensure the equipment is in good technical condition and safe for users.
• Safety systems such as seat belts and guardrails to prevent passengers from falling out of the ride.
• Emergency procedures and staff training to ensure a quick and effective response to any failures or emergency situations.

Guide to the Machinery Directive: Harmonised Standards and Other EU Legislation

The importance of harmonised standards

Harmonised standards are developed by European standardisation organisations such as CEN and CENELEC and are recognised by the European Commission as meeting the requirements of EU directives. Applying harmonised standards gives manufacturers a presumption of conformity with the directive’s requirements, which simplifies conformity assessment procedures and obtaining CE marking.

Examples of relevant standards

Examples of harmonised standards that may be applied to different types of machinery include:

• EN ISO 12100: Safety of machinery – General principles for design – Risk assessment and risk reduction.
• EN 60204-1: Safety of machinery – Electrical equipment of machines – Part 1: General requirements.
• EN 13849-1: Safety of machinery – Safety-related parts of control systems – Part 1: General principles for design.

Interaction with other EU legislation

Machinery covered by the Machinery Directive may also be subject to other EU legislation, depending on its specifications and intended use. Examples include:

• Directive 2014/30/EU on electromagnetic compatibility, which requires machinery not to interfere with other electrical equipment and to be immune to electromagnetic disturbance.
• Directive 2014/35/EU on low-voltage equipment, which sets electrical safety requirements for equipment operating at voltages from 50 V to 1000 V for alternating current and from 75 V to 1500 V for direct current.
• Directive 2011/65/EU (RoHS), which restricts the use of certain hazardous substances in electrical and electronic equipment.

• Equipment for lifting persons, such as mobile elevating work platforms, that presents a risk of falling from a height greater than 3 metres must meet stringent safety requirements to ensure user protection.

Summary of key points

Directive 2006/42/EC introduces comprehensive machinery safety requirements that manufacturers must meet to ensure user protection and compliance with EU law. Compliance with these requirements is essential for legally placing machinery on the EU market and ensuring its safe use.

The manufacturer must ensure that each machine meets the essential health and safety requirements set out in the Directive. This includes carrying out a detailed risk analysis, applying appropriate protective measures, and documenting compliance with the Directive’s requirements.

The importance of continuous improvement

Manufacturers should continuously improve their production processes and quality management systems to keep pace with changing requirements and safety standards. Continuous improvement is essential to maintaining regulatory compliance and ensuring the highest level of product safety and quality.

The role of manufacturers in ensuring safety

Manufacturers play a key role in ensuring that their machines are safe for users. This requires not only regulatory compliance, but also a commitment to continuous improvement and innovation. The manufacturer must ensure that each machine meets the Directive’s requirements by carrying out appropriate risk analyses, applying protective measures, and documenting compliance. Protecting users is not only a legal obligation, but also an ethical and business responsibility.

Industrial Automation and Production Automation

In the context of modern manufacturing, the guide to the Machinery Directive also addresses the role of industrial automation and production automation. An industrial automation integrator plays a key role in implementing automation systems that improve the efficiency and safety of production processes. Automation of production processes helps reduce the risk of human error and improve the quality of finished products. Automation systems such as PLCs (Programmable Logic Controllers) and SCADA (Supervisory Control and Data Acquisition) systems are an integral part of modern production lines, providing real-time control and monitoring of manufacturing processes.

Guide to the Machinery Directive: Key Elements

The guide to the Machinery Directive discusses in detail various aspects of machinery safety, including a safety audit. Regular safety audits are essential to ensure that machines comply with applicable standards and regulations. A design office is often involved in machine design, ensuring compliance with the Directive’s requirements and other industry standards.

Engineering outsourcing is another aspect covered in the guide. Many companies choose to outsource design and technical analysis to external specialists, allowing them to focus on their core business while gaining access to expert knowledge and experience.