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What is machinery safety?
Machinery safety means ensuring that you design, manufacture and operate machinery in compliance with safety standards. This is a vital concern in any industry as it ensures the safety of workers and assets and minimises production downtime and liability risks. Most manufacturing sites comprise an array of different machinery assemblies, adding complexity to the process.
The EU addresses machinery safety through comprehensive regulations that set machinery safety standards for manufacturers to follow. These directives outline requirements for design, manufacturing, and risk assessment of machinery to ensure compliance. In addition, the EU machinery regulations provide guidelines for assessment procedures to enforce compliance and enhance machine safety across member states.
In June 2023, the EU introduced the Machinery Regulation (EU) 2023/1230. The new regulation replaces the Machinery Directive (Directive 2006/42/EC) and is now in force throughout all EU Member States. It expands the scope and application of the current regulation with more specific machine safety provisions, giving you more legal clarity through well-defined requirements. From January 2027, the new Regulation becomes mandatory, and all economic operators must apply it.
TÜV SÜD is a trusted third party with vast experience in testing and certifying machinery. Our experts are up to date with the latest EU and worldwide regulations and can guide you with reliable risk assessment. You can rest assured that all your machinery will be safe, functional, efficient, and compliant with the latest regulations.
Why machinery safety is important
Compliance
Compliance with machinery safety standards reduces worker risks and safeguards your brand reputation, helping you gain customer trust and a competitive edge.
Market entry
Adhering to worldwide machinery safety standards is a vital step in entering new markets.
Efficiency
Machinery safety services also help you enhance machinery performance, helping it function more efficiently and last longer, translating into cost savings.
Product design
Better performing machinery can help you improve your product design. Fewer faulty products will mean fewer costly recalls and litigation.
How TÜV SÜD can help you with machinery safety
TÜV SÜD is an EU Notified Body, authorised to evaluate your machinery for compliance with the EU Machinery Directive. Our multidisciplinary team of experts will familiarise you with the regulation.
Our extensive modular range of in-house services for manufacturers will support you throughout the whole lifecycle of your machines. We can provide you a roadmap specifically tailored to your business, to gain access to the EU marketplace.
Our technical experts have experience in testing and certifying a wide range of machinery and mechanical products. By regularly participating in national and international standardisation committees, we stay up to date with all the latest regulations.
Our services ensure that your business will meet industry standards and regulatory requirements for safety and quality anywhere in the world.
What our machinery safety service includes
CE marking
- The CE marking indicates conformity with the applicable regulations and directives. Which means compliance with health, safety and environmental protection standards for products sold in the EU.
- TÜV SÜD supports you to achieve CE marking readiness. We conduct an initial audit to determine the status quo and then eliminate deviations or gaps step by step. In a final check, we validate CE marking readiness and assist you in issuing technical documentation, as basics for the CE marking.
Machine safety documentation review
We review documentation related to machinery regulations. In this, we assess various aspects such as the safety of critical components and flammability ratings for plastics and other materials used in the machine. Furthermore, we provide installation documentation and service instructions.
Machine safety testing services
TÜV SÜD offers a comprehensive array of testing services in our accredited labs. Our testing and documentation processes rigorously demonstrate compliance with safety requirements. We conduct thorough assessments to identify and mitigate potential safety hazards according to industry standards. These include tests for isolation barriers, creepage, and clearance distances to ensure protection against electric shocks.
Machinery Regulation (EU) 2023/1230 training
- Our customised training sessions offer more than just a general overview of the EU Machinery Regulation 2023/1230.
- We dive deep into product-specific requirements and interpret if and when the new regulations with their transition phase apply to your product. Besides, we provide technical advice and interpretation insights.
- We also offer a dedicated platform for addressing individual questions through our Q&A sessions. Here, you can engage directly with our experts, receiving clear and concise answers to your product-specific queries.
Product construction analysis
- TÜV SÜD offers analysis services for machine product construction. Our service evaluates the general construction and assembly methods and ensures that adequate protective earthing connections are in place.
- Furthermore, our machine construction analysis includes a compliance assessment with electrical, mechanical, and fire enclosure requirements. Through this analysis, we will ensure that the construction of the machine meets regulatory standards, promoting safety and compliance in its usage.
Frequently Asked Questions
What is the Machinery Regulation (EU) 2023/1230?
The Machinery Regulation (2023/1230) is a legal framework established by the European Parliament and the Council of European Union to ensure the safety and reliability of machinery placed on the market. It sets out requirements and standards for the design, manufacture, and operation of machinery to protect the health and safety of users and consumers.
Why has the Machinery Directive (2006/42/EC) been replaced by the new Machinery Regulation (EU) 2023/1230?
After more than 20 years, the Machinery Directive (2006/42/EC) has been replaced by the New Machinery Regulation (EU) 2023/1230. This is to address evolving technological advancements and to ensure a high level of safety for machinery and related products placed on the European Union market.
The earlier Directive provides some flexibility for application and has therefore allowed partly different interpretations by Member States (e.g. substantial modifications on machinery). This flexibility created legal uncertainties for machinery manufacturers and applicants of the Directive when exporting or placing them to different jurisdictions.
The New Machinery Regulation aims to harmonise safety requirements across member states. Furthermore, it should streamline compliance procedures and adapt to new market challenges and innovations in machinery design and production. By updating the regulatory framework, the EU seeks to enhance the protection of workers, consumers, and the environment while promoting innovation and competitiveness in the machinery sector.
The earlier Directive provides some flexibility for application and has therefore allowed partly different interpretations by Member States (e.g. substantial modifications on machinery). This flexibility created legal uncertainties for machinery manufacturers and applicants of the Directive when exporting or placing them to different jurisdictions.
The New Machinery Regulation aims to harmonise safety requirements across member states. Furthermore, it should streamline compliance procedures and adapt to new market challenges and innovations in machinery design and production. By updating the regulatory framework, the EU seeks to enhance the protection of workers, consumers, and the environment while promoting innovation and competitiveness in the machinery sector.
Why is machinery testing beneficial?
Machinery testing is beneficial for several reasons:
Safety Assurance
It ensures that machinery meets safety standards and regulations, reducing the risk of accidents and injuries.
Performance Verification
It helps validate the quality and reliability of machinery, ensuring it functions as intended.
Compliance with regulatory requirements and standards
This helps manufacturers avoid legal issues and penalties.
Risk Mitigation
Identifying and addressing potential safety hazards or quality issues early through testing helps mitigate risks and liabilities for manufacturers and users.
Customer Confidence
Machinery that has undergone testing and certification instills confidence in customers, enhancing reputation and market competitiveness.
How long can I continue to use the Machinery Directive (2006/42/EC)?
Placing products within the scope of the current machinery directive in conjunction with a Declaration of Conformity based on 2006/42/EG on the market is required until 2027-01-19 by the economic operator(s).
Making products available on the market after 2027-01-20 which were placed on the market in conformity with Directive 2006/42/EC before 2027-01-20 is possible.
Making products available on the market after 2027-01-20 which were placed on the market in conformity with Directive 2006/42/EC before 2027-01-20 is possible.
Are the standards still current, or do all standards have to be rewritten?
Placing products within the scope of the current Machinery Directive in conjunction with a Declaration of Conformity based on 2006/42/EG on the market is required until 2027-01-19 by the economic operator(s).
Making products available on the market also after 2027-01-20 which were placed on the market in conformity with Directive 2006/42/EC before 2027-01-20 is possible.
The CEN-/ CENELEC TC´s (Technical standardisation committees) have to carry out a “gap analysis” for their standards in scope.
In principle, there are three possible outcome scenarios for each gap analysis:
Making products available on the market also after 2027-01-20 which were placed on the market in conformity with Directive 2006/42/EC before 2027-01-20 is possible.
The CEN-/ CENELEC TC´s (Technical standardisation committees) have to carry out a “gap analysis” for their standards in scope.
In principle, there are three possible outcome scenarios for each gap analysis:
- hEn is not affected by the new/modified EHSRs – likely to be cited in the OJEU under MR as it is.
- hEn is affected by some of the new/modified EHSRs, but already covers them – likely to be cited in the OJEU under MR as it is.
- hEn is affected by some of the new/modified EHSRs, but is not (sufficiently) addressing them – citation in the OJEU possible, but with restriction(s).
The TC´s will decide how to proceed if the new/modified EHSRs will affect the standard.
TÜV SÜD is involved in several CEN- / CENELEC standardisation committees and therefore provides state-of-the-art testing and certification services.
To whom is the regulation (EU) 2023/1230 relevant?
Overall, the New Machinery Regulation is instrumental in promoting the safety and reliability of machinery within the EU market and is relevant for a wide group of stakeholders:
- Machinery manufacturers
- Authorised representatives
- Machinery importers
- Machinery distributors
- Natural/legal person who carries out substantial machinery modification
- Consumer protection organisations
Does a product that meets the Machinery Directive automatically meet the new regulation?
The manufacturer needs to analyse whether their product is impacted by new or changed Essential Health and Safety Requirements (EHSRs) and – if yes – by which of them (‘gap analysis’).
Based on the result of this gap analysis, the manufacturer will get the result of whether the product still complies with the EHSRs or not.
Independently from the EHSR, the economic operator (e.g. manufacturer) needs to fulfil the obligations laid down in Chapter II of MR (e.g. update marking requirements; CE-DoC; …).
Based on the result of this gap analysis, the manufacturer will get the result of whether the product still complies with the EHSRs or not.
Independently from the EHSR, the economic operator (e.g. manufacturer) needs to fulfil the obligations laid down in Chapter II of MR (e.g. update marking requirements; CE-DoC; …).
How can you make sure that the machines you develop are safe to use?
To ensure the safety of machines developed, adherence to the Machinery Regulation (2023/1230) is crucial.
- Following prescribed harmonised safety standards.
- Conducting thorough risk assessments during the development process.
- Utilising testing services and identifying potential safety issues.
- Combining regulatory compliance efforts with third-party testing services like TÜV SÜD.
Do the Directives and Regulations allow digital operating manuals for machinery?
According to the new Machinery Regulation (EU) 2023/1230, digital operating manuals are possible. The economic operator (e.g. manufacturer) accompanies a digital format of instructions for use / assembly instruction to the machinery.
This would be fully possible for machinery for sole professional use. In other cases, the economic operator needs to provide at least safety information in paper version. You need to consider several requirements for digital instructions by the economic operator(s) – please take care about this and do not underestimate this.
This would be fully possible for machinery for sole professional use. In other cases, the economic operator needs to provide at least safety information in paper version. You need to consider several requirements for digital instructions by the economic operator(s) – please take care about this and do not underestimate this.
