NIS 2 Directive and Packaging Machinery upgrate

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

This is the question 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 upgrading or renewing the packaging line becomes as much a legal obligation as a strategic decision.

In this article, we will cover the following topics:

• What NIS 2 is and who the obligated entities are
• 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 key issues of revamping
• The MF TECNO solution: a complete integrated "Security by Design" line
• Frequently Asked Questions (FAQ)

What NIS 2 is and who the obligated entities are

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

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

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

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

• Essential Entities: Highly critical strategic sectors 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 upgrade of packaging lines exposes companies to direct consequences on a regulatory, financial, and reputational level.

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 worldwide annual turnover.
• Important Entities: administrative fines up to 7 million euros or up to 1.4% of total worldwide annual turnover.

In addition to the financial burden of fines, the regulation introduces a fundamental new development: the direct personal liability of corporate management bodies, who can be held personally accountable for failing to adopt adequate security measures.

Added to this is 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 the NIS 2 Directive affects the packaging sector

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

NIS 2, in fact, explicitly requires the mentioned companies to ensure the cybersecurity of their suppliers and their supply chain.

Packaging machines are indeed no longer isolated elements within the plant, but highly interconnected systems. 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 gateways for ransomware or cyberattacks, thus compromising the entire production.
• Supply Chain security and continuity: NIS 2 requires companies in critical sectors (such as Food & Beverage, Pharma, and Chemical) to ensure the cybersecurity resilience of the entire supply chain.
• Integration with the new Machinery Regulation (EU) 2023/1230: Cyber regulations intersect with the new regulatory framework for industrial machinery, which requires maximum attention to data integrity, software, and control systems. Mandatory starting January 20, 2027, it forces companies to assess whether it is more cost-effective to upgrade the existing line or replace it with a new-generation plant, aligned with security-by-design logic.

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 Cyber Resilience Act (EU) 2024/2847.

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

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

• The risk of invasive revamping: When attempting to upgrade an outdated packaging line by replacing PLCs, redesigning OT network architecture, reprogramming safety logic, or adding new remote control modules, the intervention risks no longer being simple maintenance or partial modernization.
• The shift in legal responsibility: If modifications impact the safety performance of the machine or alter its original intended purpose, the intervention can be classified as a "substantial modification". In this case, whoever performs or commissions the revamping loses the original manufacturer's guarantees and must assume the burdens 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 key issues of revamping

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

Namely, considering whether to adapt existing lines to the regulations mentioned above or invest in new ones.

In other words, limiting oneself to protecting the existing equipment with perimeter solutions, performing a modernization intervention (revamping), or replacing the system with a new generation line.

Although revamping may seem at first glance like the most financially modest choice, it requires a careful technical-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 on older machinery lack sufficient memory or processing power to run modern security software and advanced passwords.
• Integration and segmentation costs: Securely connecting an outdated system 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 halts. Furthermore, modifying outdated machinery risks forfeiting the original manufacturer's warranty and assuming full legal responsibility and costs in the event 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 MF TECNO's value as the sole manufacturing and integrating partner of 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 turning a compliance obligation into a tangible 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. This eliminates at the root the incompatibility issues between PLCs, HMIs, communication protocols, and safety modules supplied by different manufacturers.
• "Security by Design" Engineering: MF TECNO packaging lines are built from the ground up to meet modern cybersecurity and operational continuity standards. OT/IT network segmentation, profiled user management, audit log tracking, and encrypted remote support protocols are natively integrated.
• Operational continuity and lifecycle management: Having a single interlocutor for hardware and software ensures continuous support over time. From the availability of original spare parts to software security updates and protected remote assistance, 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 unexpected downtime, speeding up format changeovers, and ensuring complete control over the plant, safeguarding production from cyber threats and technological obsolescence for decades to come.

Do you want to protect your production from cyber risks and ensure compliance with the latest regulations without fines or activity blocks?

Do not risk uncertain interventions or obsolete lines: contact MF TECNO experts today to request a personalized consultation and discover the integrated "Security by Design" solution perfect for your plant!

FAQ: Frequently Asked Questions

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

No, there is no NIS2 certification for individual industrial machines. The NIS 2 Directive (Legislative Decree 138/2024) applies to cybersecurity 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 machinery and packaging lines with automation architectures, remote access, and log tracking designed for secure data management.

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

The choice between revamping or replacing a machine depends on a complete technical-economic analysis. If the intervention requires replacing PLCs, rewriting safety software, redesigning the OT network architecture, or making substantial modifications to machine performance, it risks falling under the definition of "substantial modification" pursuant to Machinery Regulation (EU) 2023/1230. In this case, the company assumes the legal responsibility of a new manufacturer (including CE marking). Often, when evaluating integration costs and component obsolescence, replacement with a new integrated line proves to be more economically advantageous in the medium-to-long term.

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

In modern packaging, PLCs and HMI interfaces are no longer isolated but connected to corporate networks and the cloud for remote assistance and production monitoring. Outdated hardware or software architecture lacking OT network segmentation or secure authentication turns 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 implementation of a packaging line with a security-by-design approach?

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