New EU machinery regulation.

Manufacturers and operators should prepare early for the implementation of the machinery regulation shifting safety responsibilities to machine operatives.

The implementation of the new Machinery Regulation (EU) 2023/1230, effective from 20 January 2027, marks one of the most significant changes to European machinery safety legislation in recent years. While manufacturers remain responsible for compliance when machinery is first placed on the market, the regulation introduces expanded responsibilities for operators throughout the machine's operational lifecycle.

The updated regulation introduces new requirements covering cybersecurity, artificial intelligence, and substantial machine modifications. Under the new rules, operators making significant changes to existing machinery may themselves be considered manufacturers, requiring them to perform risk assessments, maintain technical documentation, and complete conformity assessments before placing modified equipment back into service.

Growing need for early preparation.
Although the regulation will soon become mandatory, many organisations continue to face uncertainty due to the absence of official implementation guidance. This leaves manufacturers, machine builders, and plant operators making important compliance decisions without detailed interpretation from regulators.

Markus Erdorf

"As companies prepare for the transition, understanding how the new regulation applies to existing machinery is becoming increasingly important," said Markus Erdorf, Senior Safety Consultant at Leuze.

"Organisations should begin reviewing their machinery, documentation, cybersecurity strategies, and modification procedures now rather than waiting for the implementation deadline."

Cybersecurity becomes part of machine safety.
One of the most notable developments within the new Machinery Regulation is the integration of cybersecurity into machinery safety requirements. Organisations will need to protect machinery against unauthorised access, data manipulation, and other cyber risks while demonstrating compliance through appropriate documentation and risk assessments.

For many operators, this represents a significant shift from traditional machine safety practices and requires closer collaboration between safety engineers, automation specialists, and IT security teams.

Practical steps for machine operators.
To reduce future compliance risks, Leuze recommends that operators:

• Review the new Machinery Regulation requirements early.
• Work closely with machinery manufacturers and system integrators.
• Document all safety-related modifications and inspections.
• Evaluate whether planned machine changes qualify as substantial modifications.
• Monitor evolving standards related to machinery safety, cybersecurity, and AI.

Supporting safe machinery throughout its lifecycle.
As machinery safety requirements continue to evolve, Leuze supports manufacturers and operators with machine safety consulting, risk assessments, training, and engineering services designed to help organisations achieve regulatory compliance while maintaining operational efficiency.

"The responsibility for machine safety no longer ends when equipment is commissioned," added Erdorf. "Preparing today will help manufacturers and operators reduce compliance risks and ensure safe machine operation throughout the entire lifecycle."

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@EU_Commission @LeuzeUK @LeuzeUSA @mepaxIntPR #PAuto

Simplifying regulatory complience

Thermo Fisher Scientific has announced that Nova Biologicals, one of America's largest providers of laboratory testing and consultancy services to the water, environmental, medical device and pharmaceutical industries, has implemented an integrated Thermo Scientific LIMS (laboratory information management system) and NextDocs DMS (document management system) solution. The solution automates time-consuming, paper-based laboratory data management processes, ensures compliance with stringent industry regulations and enables it to deliver premier customer service. The comprehensive solution demonstrates Thermo Fisher’s ability to provide customers with the most comprehensive Informatics offerings that solve the industries ever-growing and expanding needs.

(The detailed Nova Biologicals case study.)

“Our mission is to deliver value to our customers by minimizing risk, increasing efficiencies and validating and improving their products through Good Laboratory Practices (GLP), regulatory compliance and laboratory data management,” said Dr. Pearce, CEO and founder of Nova.

In the wake of more stringent regulations for environmental testing introduced by the US National Environmental Laboratory Accreditation Conference (NELAC) and the US Environmental Protection Agency (EPA) in recent years, Nova required stronger compliance through record keeping, demonstration of capability (DOC), document control, reagent and standard traceability and reporting. Because its manual, paper-based system could no longer support this, Nova selected Thermo Scientific SampleManager LIMS integrated with the NextDocs DMS. In addition to more efficiently meeting industry regulations, the company can now serve their customers more effectively.

Nova offers comprehensive diagnostic testing for the presence of infectious disease organisms, processing around 10,000 water samples each month to ensure compliance with the federal Safe Drinking Water Act (SDWA). In addition to helping Nova comply with regulatory requirements, Thermo Scientific SampleManager LIMS has also improved laboratory efficiencies and sample throughput, delivering significant cost and time savings in Nova’s laboratory by automating previously lengthy, manual document management processes. Dr. Pearce comments, “We are delighted with the tangible benefits that the new solution has delivered, including significant cost and time savings. Since its introduction into our laboratory, the SampleManager and NextDocs DMS solution has been instrumental in helping Nova maintain its NELAC accreditation in the state of Texas. The solution has also refined work processes and improved reporting to customers in terms of both quality and speed.”

Thermo Scientific SampleManager LIMS is offered in combination with NextDocs DMS, creating a fully-integrated and highly configurable solution. Thermo Fisher Scientific is well-positioned, via Thermo Scientific CONNECTS, to offer the most comprehensive Informatics solutions for laboratories consisting of a combination of Thermo Scientific instruments, LIMS and chromatography data management (CDS) software and services. The company also partners with technology leaders to extend its Informatics capabilities, working with well-known companies such as Microsoft and SAP and with leading solutions such as NextDocs’s Document Management System and Accelerys’s Electronic Laboratory Notebook (ELN).


“By integrating Thermo Scientific SampleManager LIMS with NextDocs DMS, we are able to create a more comprehensive, personalized, seamless solution that works better together, offering greater benefit to our customers,” said Dave Champagne, vice president and general manager, Informatics at Thermo Fisher Scientific.

Biofuel plants urged to monitor discharge levels to avoid fines

Instrumentation company Quantitech is urging biodiesel producers in the UK to take necessary environmental monitoring precautions to avoid fines resulting from inadvertent discharges into streams and waterways.

The warning comes following a clampdown by the US Environmental Protection Agency which saw many biofuel plants come under close scrutiny and in some instances fined for monitoring lapses.

In order to improve monitoring, biofuel producers are being urged to monitor their waste by-products more closely prior to discharging and to measure oil and grease concentration levels to ensure compliance.

The InfraCal TOG/TPH (Total Oil and Grease/Total Petroleum Hydrocarbons) from Quantitech offers on-site results in 10-15 minutes, is easy-to-use, lightweight and is ideal for monitoring fuel, oil and grease discharge levels both before and after treatment.

Quantitech’s Keith Golding believes that portable instrumentation is ideal for regular effluent checks to ensure that UK biofuel producers meet the necessary monitoring requirements. He said: “One of the main advantages of the InfraCal TOG/TPH is that it provides users with virtually instant readings and removes the inconvenience of having to wait for off-site lab results.

“By undertaking routine portable monitoring, biofuel producers in the UK should be able to avoid the pitfalls experienced by their counterparts in the USA.”