Machinery Safety Risk Assessment & Certification

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.

SS 537 is the Singapore Standard Code of Practice for Safe Use of Machinery, which plays a pivotal role in ensuring that workplace machines comply with industry safety standards. In an era marked by increasingly sophisticated, intelligent, and high-speed machinery designed to handle today's industrial demands, safety remains as key to protect well-being of individuals, materials, and assets. 

This standard emphasizes the shared responsibility of workplace occupiers and machine owners in ensuring the safety of their machines throughout the operational lifecycles under the Workplace Safety and Health Act. By adhering to SS 537 standards, organizations can create a safer work environment while seamlessly integrating evolving machinery concepts in today's ever-changing industrial landscape.

From 2023, all Workplace occupiers and machine owners must verify the safety of their machines through an inspection company. TÜV SÜD is an authorised inspection body for SS 537 in Singapore.  

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.

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.

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.

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.

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.

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.

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

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.

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.

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

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; …).

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.

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!