What is the Machinery Regulation (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Why will the Machinery Directive (2006/42/EC) be repealed by the New Machinery Regulation (EU) 2023/1230?

After more than 20 years, the Machinery Directive (2006/42/EC) is being replaced by the New Machinery Regulation (EU) 2023/1230 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 current 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 to validate the quality and reliability of machinery, ensuring it functions as intended Compliance with regulatory requirements and standards, helping 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?

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.

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 standardization committees) have to carry out a “gap analysis” for their standards in scope. In principle 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 – revision of standards or issuing of new standards will have to be started. TÜV SÜD is involved in several CEN- / CENELEC standardization committees and is therefore at the front end base and applicable to apply state of the art within our testing and certification services.

To whom is this new 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 manufacturer Authorised representatives Machinery importers Machinery Distributor Natural/legal person who carries out substantial machinery modification Consumer Protection Organisations such as Stiftung Warentest

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 if the product still complies with the EHSRs or not. Independently from the EHSR, the economic operator (e.g. manufacturer) needs to fulfill 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 in 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 enhances machine safety for end-users.

Is there already a digital operating manual possible?

According to the new Machinery Regulation (EU) 2023/1230 it would be 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, at least safety information needs to be provided by the economic operator in paper version. There are several requirements to be considered for digital instructions by the economic operator(s) – please take care about this and do not underestimate this!

Machinery Safety & EU Machinery Directive Compliance - ISO 12100

MACHINERY SAFETY REQUIREMENTS

Machine safety is a paramount concern in any industry as it ensures the safety of workers and assets and minimizes production downtime and liability risks. Most manufacturing sites comprise an array of different machinery assemblies, adding complexity to the process.

The EU addresses machine safety through comprehensive directives and regulations that set standards for manufacturers to follow. These directives outline requirements for design, manufacturing, and risk assessment of machinery to ensure compliance with safety standards. Additionally, the EU provides guidelines for conformity assessment procedures to enforce compliance and enhance machine safety across member states.

In June 2023 the Machinery Regulation (EU) 2023/1230 was introduced. The new regulation replaces the Machinery Directive (Directive 2006/42/EC) and has entered into force throughout all EU Member States. From January 2027 its application becomes mandatory, and the new requirements must be applied by all economic operators.

HOW TÜV SÜD CAN SUPPORT YOUR MACHINERY BUSINESS

TÜV SÜD is an EU Notified Body, authorised to evaluate Annex IV-Products for compliance with the EU Machinery Directive. Our multidisciplinary team of experts familiarises you with the new regulation for machine safety.

Our extensive modular range of in-house services for manufacturers provides end-to-end advisory services and a roadmap specifically tailored to your business, to gain access to the EU marketplace.

What is the EU Machinery Directive?

The EU Machinery Directive (2006/42/EC) specifies a number of essential health and safety requirements (EHSR), which are designed to guarantee that any piece of industrial machinery will be safe to use. The requirements cover a wide range of machines and machinery.

To view a list of Annex IV equipment and requirements, download the full EU Machinery Directive document.

Download here

EN ISO 12100 – Hazard & risk analysis

For all products which fall under the scope of the Machinery Directive, a hazard analysis/risk assessment must be carried out.

A risk assessment follows a series of logical steps to identify and examine any potential hazards associated with machinery. This provides information for a risk evaluation, in which a decision is made on the safety of machinery for risks to be reduced where necessary.

The European Norm standard, EN ISO 12100, outlines the hazard analysis/risk assessment procedure as follows:

Determination of the limits of the machinery
Hazard identification
Risk estimation and risk evaluation

EN ISO 12100 also provides guidance on the safety of machinery and the type of documentation required in verifying a risk assessment.

The Machinery Directive is one of several EU regulations which must be complied with in order to achieve the CE mark. CE Marking is a legal requirement for all products sold within the European Union and demonstrates that the minimum requirements of all applicable directives have been met.

TÜV SÜDs service options according to legal requirements:

CE Marking

The CE marking indicates conformity with the applicable regulations and directives and subsequently, corresponding health, safety and environmental protection standards for products sold within the EU.

TÜV SÜD supports customers on their way to CE marking readiness. Therefore, 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 offer a service for reviewing documentation related to the new machine regulation. This service involves assessing 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. By conducting this review, TÜV Süd aims to ensure compliance with regulatory requirements and enhance overall safety standards for the machine.
Machine Safety Testing Services

In our commitment to ensuring the safety and reliability of, TÜV SÜD offers a comprehensive array of testing services in our accredited labs.

Our accredited testing and documentation processes are designed to rigorously demonstrate compliance with safety requirements. We conduct thorough assessments to identify and mitigate potential safety hazards according to industry standards. Examples of this testing scheme are 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 Machinery Regulation (EU) 2023/1230.

We dive deep into product-specific requirements and interpret if and when the new Machinery Directive and the new Machinery Regulation with their transition phase apply to your product. Besides, we provide technical advice and interpretation insights. Furthermore, we 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, the machine construction analysis includes a compliance assessment with electrical, mechanical, and fire enclosure requirements. Through this analysis, TÜV Süd aims to ensure that the construction of the machine meets regulatory standards, promoting safety and compliance in its usage.

Machinery Regulation – new and old

The new Machinery Regulation (EU) 2023/1230 was introduced in 2023 and replaces the Machinery Directive (Directive 2006/42/EC). From January 2027 its application becomes mandatory, and the new requirements must be applied by all economic operators.

It expands the scope and application of the current Machinery Directive, introducing more specific machine safety provisions that are legal requirements for economic operators, such as manufacturers or distributors for example.

This gives machinery end-users more legal certainty through defined and binding requirements imposed on the design, construction and placing into operation of machinery and related products.

Your benefits from working with TÜV SÜD

TÜV SÜD is your independent third-party service provider regarding machine safety. We support you throughout the whole lifecycle of machines. Our technical experts have experience in testing and certifying a wide range of machinery and mechanical products to ensure they comply with the European Machinery Regulation. Due to our continuous work and participation in national and international standardization committees, we stay up to date with all the latest regulations.

Your benefits at a glance:

Building customer trust
Improved product design
Mitigation of risks
Compliance Assurance
Special market acceptance of your product
Gaining a competitive edge

Our service ensures that your business will meet industry standards, as well as market and regulatory requirements for safety and quality – anywhere in the world.

Frequently Asked Questions (FAQs) on Machine Safety

What is the Machinery Regulation (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 will the Machinery Directive (2006/42/EC) be repealed by the New Machinery Regulation (EU) 2023/1230?

After more than 20 years, the Machinery Directive (2006/42/EC) is being replaced by the New Machinery Regulation (EU) 2023/1230 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 current 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 to validate the quality and reliability of machinery, ensuring it functions as intended
- Compliance with regulatory requirements and standards, helping 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?

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.
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 standardization committees) have to carry out a “gap analysis” for their standards in scope.

In principle 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 – revision of standards or issuing of new standards will have to be started.

TÜV SÜD is involved in several CEN- / CENELEC standardization committees and is therefore at the front end base and applicable to apply state of the art within our testing and certification services.
To whom is this new 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 manufacturer
- Authorised representatives
- Machinery importers
- Machinery Distributor
- Natural/legal person who carries out substantial machinery modification
- Consumer Protection Organisations such as Stiftung Warentest
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 if the product still complies with the EHSRs or not. Independently from the EHSR, the economic operator (e.g. manufacturer) needs to fulfill 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 in 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 enhances machine safety for end-users.
Is there already a digital operating manual possible?

According to the new Machinery Regulation (EU) 2023/1230 it would be 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, at least safety information needs to be provided by the economic operator in paper version. There are several requirements to be considered for digital instructions by the economic operator(s) – please take care about this and do not underestimate this!