NIS 2 Directive and Packaging Machinery upgrate

NIS 2 Directive and Packaging: Is it better to adapt an existing packaging line or invest in a new plant?

This is the question that many manufacturing companies are asking themselves with the entry into force of Legislative Decree 138/2024 (transposing the NIS 2 Directive) and in view of the application of the new Machinery Regulation (EU) 2023/1230.

Following this regulation, the choice between adapting or renewing the packaging line becomes as much a legal obligation as a strategic choice.

In this article we will cover the following topics:

• What is NIS 2 and who are the obligated entities
• The risks of non-compliance and the penalty framework
• Why the NIS 2 Directive affects the packaging sector
• Cyber Resilience Act and the risk of "Substantial Modification" in revamping
• Is it better to renew or replace the existing line? The 3 nodes of revamping
• The MF TECNO solution: a complete integrated "Security by Design" line
• Frequently Asked Questions (FAQ)

What is NIS 2 and who are the obligated entities

Created to increase cyber resilience in critical sectors and supply chains, it also directly impacts packaging departments.

Today, packaging lines are no longer isolated silos: they are hyper-connected plants equipped with PLCs, HMI interfaces, IoT sensors, and remote assistance modules, integrated into corporate networks or the cloud.

While this digitalization guarantees efficiency and productivity on the one hand, on the other hand it transforms machinery into potential gateways for cyberattacks and production stoppages (Operational Technology - OT).

Unlike previous legislation, NIS 2 significantly expands the scope of obligated entities, dividing companies into two macro-categories based on sector criticality and company size (normally medium and large enterprises with more than 50 employees or 10 million euros in turnover):

• Essential Entities: Strategic sectors at very high risk such as Energy, Transport, Banking, Healthcare, Water, and Digital Infrastructure.
• Important Entities: Critical sectors such as Food & Beverage (food production and processing), Chemical, Pharmaceutical, Waste Management, and Manufacturing.

The risks of non-compliance and the penalty framework

Underestimating the NIS 2 Directive and neglecting the adaptation of packaging lines exposes companies to direct consequences at the regulatory, economic, and reputational levels.

Legislative Decree 138/2024 establishes a particularly severe penalty framework:

• Essential Entities: Administrative fines up to 10 million euros or up to 2% of total annual worldwide turnover.
• Important Entities: Administrative fines up to 7 million euros or up to 1.4% of total annual worldwide turnover.

In addition to the financial burden of fines, the regulation introduces a substantial novelty: the direct liability of corporate management bodies, who may be held personally liable in the event of failure to adopt adequate security measures.

To this is added a further legal risk: installing unprotected components or software on the operational line can compromise the plant's compliance with the safety requirements of Machinery Regulation (EU) 2023/1230.

Why does the NIS 2 Directive affect the packaging sector?

Even if a manufacturing company or packaging machinery manufacturer does not fall directly among the obligated entities due to size or turnover, it is the logic of the Supply Chain that makes it indirectly subject to the rule.

Indeed, NIS 2 explicitly requires cited companies to guarantee the cybersecurity of their suppliers and supply chain.

Packaging machines are no longer isolated elements within the factory, but highly interconnected plants. There are 3 reasons to comply:

• Vulnerability of Operational Technology (OT) and remote access: Current packaging lines that are not adequately protected and updated represent potential entry points for ransomware or cyber attacks, thus compromising entire production.
• Supply Chain security and continuity: NIS 2 requires companies in critical sectors (such as Food & Beverage, Pharma, and Chemical) to ensure cyber resilience across the entire supply chain.
• Integration with the new Machinery Regulation (EU) 2023/1230: Cyber regulation is interwoven with the new regulatory framework for industrial machinery, which demands maximum attention to the integrity of data, software, and control systems. Mandatory as of January 20, 2027, it forces companies to evaluate whether it is more convenient to adapt the existing line or replace it with a new generation plant, in line with security by design principles.

Cyber Resilience Act and the risk of "Substantial Modification" in revamping

In addition to the NIS 2 Directive, the European regulatory landscape is enriched by two other fundamental pillars: Machinery Regulation (EU) 2023/1230 and the Cyber Resilience Act (EU) 2024/2847.

The Cyber Resilience Act (CRA) introduces the obligation to guarantee integrated cybersecurity requirements right from the design phase (security by design) and throughout the product lifecycle.

It is precisely at the intersection between cybersecurity and plant upgrades that the concept of "Substantial Modification" emerges, introduced strictly by the new Machinery Regulation:

• The risk of invasive revamping: When attempting to adapt a dated packaging line by replacing PLCs, redesigning OT network architecture, reprogramming safety logic, or adding new modules for remote control, the intervention risks no longer being simple maintenance or partial modernization.
• The shift in legal liability: If modifications impact the machine's safety performance or alter its original function, the intervention can be classified as a "substantial modification". In this case, whoever performs or commissions the revamping loses the original manufacturer's warranties and must assume the duties of a new manufacturer, including CE marking and drafting an updated technical file.

Is it better to renew or replace the existing line? The 3 nodes of revamping

Faced with new requirements, manufacturing companies need to make strategic choices.

That is to say, consider whether to adapt existing lines to the above regulations or invest in new ones.

In other words, limit themselves to protecting the existing system with perimeter solutions, perform a modernization intervention (revamping), or replace the plant with a new generation line.

Although revamping may seem at first sight to be the most financially contained choice, it requires careful technical and economic evaluation.

Adapting to regulations often turns out to be an illusion of savings due to a series of hidden costs and structural constraints:

• Outdated and incompatible hardware: Computers and control boards in older machinery lack sufficient memory or processing power to run modern security programs and advanced passwords.
• Integration and segmentation burdens: Securely connecting an old plant to the corporate network requires continuous work from specialized technicians to install protective barriers and reprogram software. In the end, labor hours and modifications end up canceling out initial savings.
• Impact on efficiency and warranties: Adding "layers" of security on an old machine can slow it down or cause unexpected stoppages. Furthermore, modifying dated machinery risks losing the original manufacturer's warranties and assuming all legal liability and costs in case of breakdowns.

The MF TECNO solution: a complete integrated "Security by Design" line

Faced with growing technological and regulatory complexity, the real strategic turning point lies in moving from a fragmented approach to an integrated and natively secure architecture.

This is where the value of MF TECNO as a single manufacturer and integrator partner for the entire packaging line comes into play.

Replacing an obsolete or non-adaptable plant with a new MF TECNO line does not just mean complying with regulations, but transforming a compliance obligation into a concrete competitive advantage:

• Single point of contact for the entire line: MF TECNO designs, engineers, and manufactures the entire packaging cycle in-house: from raw material handling to weighing, bagging, palletizing, and end-of-line packaging. This eliminates root causes of incompatibility between PLCs, HMIs, communication protocols, and safety modules from different manufacturers.
• "Security by Design" architecture: MF TECNO packaging lines are built from the ground up to meet modern standards for cybersecurity and operational continuity. OT/IT network segmentation, profiled user management, audit log tracking, and encrypted remote assistance protocols are integrated natively.
• Operational continuity and lifecycle oversight: Having a single partner for hardware and software ensures continuous long-term support. From original spare parts availability to software security updates and protected remote technical support, risks related to unsupported components or outdated operating systems are avoided.
• An investment in productivity for the next 10-15 years: Choosing a new MF TECNO line allows for drastically reducing unplanned downtime, speeding up format changeovers, and ensuring complete plant governability, securing production against cyber attacks and technological obsolescence for decades to come.

FAQ: Frequently Asked Questions

1) Is there a "NIS2 certified machine" or "NIS2 compliant machine"?

No, there is no NIS2 certification for individual industrial machines. The NIS 2 Directive (D.Lgs. 138/2024) applies to cyber risk management and operational continuity across the entire corporate organization. However, to comply with NIS2 requirements regarding supply chain and OT network security, companies must adopt machines and packaging lines with automation architectures, remote access, and log tracking prepared for secure data management.

2) In view of NIS2 and Machinery Regulation 2023/1230, when is revamping convenient and when machine replacement?

The choice between revamping or machine replacement depends on a complete technical-economic analysis. If the intervention requires PLC replacement, safety software rewriting, OT network architecture redesign, or substantial changes to machine performance, there is a risk of falling under the definition of "substantial modification" according to Machinery Regulation (EU) 2023/1230. In this case, the company assumes legal liability as a new manufacturer (including CE marking). Often, evaluating integration costs and component obsolescence, replacement with a new integrated line turns out to be more economically advantageous in the medium-long term.

3) How does cybersecurity for PLC and HMI affect the packaging packaging line?

In modern packaging, PLCs and HMI interfaces are no longer isolated but connected to the corporate network and cloud for remote assistance and production monitoring. Dated hardware or software architecture lacking OT network segmentation or secure authentication transforms the packaging line into a vulnerable entry point for ransomware attacks. Protecting automation means ensuring production continuity and avoiding delivery blocks.

4) How does MF TECNO guarantee the realization of a packaging line with a security by design approach?

MF TECNO designs its packaging lines applying security by design principles to both automation hardware and software. Natively integrating access management, network segmentation, encrypted remote assistance, and component oversight, MF TECNO guarantees maximum operational continuity from feeding to end-of-line. This unified approach reduces management complexity and secures productive investment for the next 10-15 years.