Packaging industry faces new digitalization compliance standards with EU Machinery Regulation

The EU Machinery Regulation was adopted in 2023 and will become mandatory on January 20, 2027. It introduces revisions to the Machinery Directive, which is currently in place, while aiming to continue the free movement of machinery in the single market and the protection of EU workers and citizens. 

“For packaging equipment manufacturers, the most significant change lies in the shift from a directive to a regulation, which removes national interpretation differences and creates a more uniform compliance framework across the EU,” Marcel Veenstra, Marketing and Communications manager at Sealpac International, tells Packaging Insights. 

According to the European Commission (EC), the regulation also sets out to integrate provisions for machinery with safety functions that are AI-powered, cybersafety for compliance-relevant software data, and safety control systems. It also aims to address the conformity assessment of machinery with higher risk factors.

The EC adds that the regulation updates certain product category-specific provisions and clarifies conditions under which the instructions for use and the declaration of conformity can be provided in a digital format.

“From Sealpac’s perspective, the new Machinery Regulation is a substantial but logical evolution rather than a disruptive overhaul,” says Veenstra. “In practice, this brings clearer expectations around topics that are already highly relevant to modern packaging machinery, such as safety, digital controls, and cybersecurity aspects.”

“While the core safety principles remain familiar, the regulation better reflects today’s connected, automated, and data-driven production environments.”

Industry preparedness 

Veenstra says that, overall, the packaging machinery industry is reasonably well prepared, particularly manufacturers that already design machines according to the latest standards of the International Organisation for Standardisation and European Norm.

Marcel Veenstra, Marketing and Communications manager at Sealpac International.“For companies that have already invested in high safety standards and structured compliance processes, like us at Sealpac, the transition should be manageable. All our product lines are manufactured in Germany according to the latest machine regulations.”

At IFFA 2025 in Germany, Sealpac launched its F-series thermoformer. Recently, the company also introduced its FlatSkin packaging concept, and its Amax and M-Flex traysealers.

Many of the forthcoming harmonized standards are updates or refinements of existing ones, rather than entirely new concepts, Veenstra points out.

“At Sealpac, we have always designed equipment to the highest safety standards. In fact, next to the mandatory EU CE marking, our traysealers are additionally tested according to the strict German Geprüfte Sicherheit (GS) quality mark. This guarantees maximum safety for operators.”

The scope of the GS, or “Tested Safely,” mark includes essential product characteristics, such as electrical safety, ergonomics, and noise, but also covers an evaluation of Sealpac’s factory production. 

“Initially designed for the German market, it is now a worldwide recognized mark of quality and safety, which ensures that our packaging machines adhere to the highest possible standards,” he adds. 

“As far as other companies are concerned, the pace at which the updated standards will be referenced and applied will be critical. There will likely be a transition period in which old and new standards coexist, requiring manufacturers to carefully document their choices.”

Manufacturers should prepare 

Sealpac expects an initial increase in the administrative and technical workloads for packaging and packaging machinery producers, especially during the transition phase. 

“Manufacturers will need to revisit risk assessments, particularly for software-related and digital safety aspects, as well as update technical documentation and declarations of conformity. They should review internal procedures for software changes and lifecycle management,” Veenstra suggests.

Once these processes are embedded, however, he expects the ongoing workload to stabilize. 

“Smaller suppliers may feel the impact more strongly, as they often have fewer dedicated compliance and engineering resources. The new emphasis on documentation, software safety, and traceability can pose challenges if processes are not yet formalized.”

“However, smaller manufacturers that collaborate with suppliers, integrators, and external experts, and that start preparing early, can remain fully competitive.”

Veenstra further says that the Machinery Regulation should be seen not only as a compliance exercise, but as an opportunity, as it supports safer interaction between people and increasingly automated machines.

It is also said to support greater transparency across the supply chain and a level playing field within the EU internal market.

“Manufacturers that embrace the regulation proactively can turn compliance into a competitive advantage, rather than viewing it as an administrative burden,” concludes Veenstra. 

At the Aicomp Summit, held last month in Austria, efficiency and regulatory compliance emerged as key benefits of the packaging industry’s accelerating digitalization.