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EU Cybersecurity Law developments: June 2024

By
Paul Foley
Cyber-attacks, besides being among the fastest-growing form of crime worldwide, are also growing in scale, cost and sophistication. As a consequence, a raft of EU cyber security legislation impacting providers and users of digital services and digital equipment will have effect in 2024 and thereafter. This article provides a update (June 2024) to earlier published material.

© Copyright Paul Foley Law June 2024: All Rights Reserved. For advice and guidance as to how to comply with the EU Cybersecurity laws referred to below, please contact the firm at paul@paulfoleylaw.ie


The EU Cybersecurity laws framework comprises many pieces of legislation that cover cybersecurity from different angles (products, services, crisis management, and crimes).

In 2013, Directive 2013/40/EU (on attacks against information systems) which harmonised criminalisation and penalties for a number of offences directed against information systems, came into force.

In 2019, Regulation (EU) 2019/881 (EU Cybersecurity Act) entered into force. It aims to enhance the security of ICT products, ICT services and ICT processes by introducing a voluntary European cybersecurity certification framework.

Directive (EU) 2022/2555 (NIS2) is in force. Key provisions are described below. It is much wider in scope and more prescriptive than Directive (EU) 2016/1148 (NIS1) which is repealed as of 18.10.2024. Member States have until 17th of October 2024 to adopt and publish the measures necessary to comply with NIS2.

Regulation (EU) 2022/2554 (DORA)

DORA is in force. Member States have to publish the necessary implementing legislation by the 17th of January 2025. DORA is accompanied by Directive (EU) 2022/2556 (Dora Directive) which also applies from 17th of January 2025. As the Central Bank of Ireland, have stated, regulated financial entities should recognise similarities between a number of key DORA requirements and existing Central Bank guidance in relation to Outsourcing, Operational Resilience  and IT & Cybersecurity Risks as well as in existing sectoral guidelines.

EU Cyber Resilience Act (COM(2022) 454 final 2022/0272 (COD))

The EU Cyber Resilience Act (EU CRA) imposes substantial obligations on economic operators (primarily manufacturers, importers, distributors) in respect of products with digital elements whose intended and reasonably foreseeable use, includes a direct or indirect logical or physical data connection to a device or network (in-scope products) (Art 3(1) and Art 2(1) of the CRA).

The EU CRA is expected to be finalised, adopted and come into force in 2024 and to apply 24 or 36 months from the date of its entry into force. However the EU CRA, Art 11 reporting obligations, concerning actively exploited vulnerabilities and incidents, are expected to apply 12 months from the entry into force of the EU CRA.

Objectives of the EU CRA

Two main objectives are identified: (1) create conditions for the development of secure products with digital elements by ensuring that hardware and software products are placed on the market with fewer vulnerabilities and ensure that manufacturers take security seriously throughout a product’s life cycle; and (2) create conditions allowing users to take cybersecurity into account when selecting and using products with digital elements.

Out of Scope (Art 2 (part of))

The EU CRA as currently drafted will not apply to the following:

  • services, such as Software-as-a-Service (SaaS), except for remote data processing solutions (as defined) relating to a product with digital elements (recital 9);

  • free and open source software developed or supplied outside of the course of a commercial activity
  • (recital 10);

  • products with digital element to which the following Union acts apply (a) Regulation (EU) 2017/745 (Medical Devices Regulation); (b) Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation); (c) products to which (EU) 2019/2144 applies (on type-approval requirements for motor vehicles and their trailers and systems, components and separate technical units intended for such vehicles);

  • products with digital elements that have been certified in accordance with Regulation 2018/1139 (on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency);

  • products developed exclusively for national security or military purposes or specifically designed to process classified information.

Key Obligations of manufacturers (Art 10)

This article as regards the EU CRA,  focuses on manufacturers (Art 3(18)), on whom the most onerous obligations apply.

Amongst other obligations, manufacturers must when placing any in-scope product on the market:


  • ensure that it has been designed, developed and produced in accordance with the list of essential requirements (see section 1 of Annex 1 for the requirements for in-scope products and section 2 of Annex 1 for vulnerable handling requirements) (Art 10(1)); 

  • as part of the work referred to in Art 10(1), undertake an assessment of the cybersecurity risks associated with an in-scope product and take the outcome of that assessment into account during the planning, design, development, production, delivery and maintenance phases of the in–scope product (Art 10(2));

  • exercise due diligence when integrating components sourced from third parties in the in-scope product (Art 10(4));

  • systematically document, relevant cybersecurity aspects concerning the in-scope product including vulnerabilities they become aware of and any relevant information provided by third parties, and, where applicable, update the risk assessment of the in-scope product (Art 10(5));

  • for the expected in-scope product lifetime or for a period of five years from the placing of the in-scope product on the market, whichever is shorter, ensure that vulnerabilities of that in-scope product are handled effectively and in accordance with the essential requirements set out in section 2 of Annex I (Art 10(6) par 1);

  • have appropriate policies and procedures, including coordinated vulnerability disclosure policies, referred to in section 2, point (5), of Annex I, to process and remediate potential vulnerabilities in the in-scope product reported from internal or external sources (Art 10(6) par 2);

  • draw up the technical documentation referred to in Article 23 (technical documentation) and Annex V and include a cybersecurity risk assessment in that technical documentation (Arts 10(2) and 10(7) par 1);

  • carry out the chosen conformity assessment procedures referred to in Article 24 (conformity assessment procedures for products with digital elements) or have them carried out (Art 10(7) par 2);

  • where compliance of the in-scope product with the Annex 1 (sections 1 and 2 thereof) essential requirements have been demonstrated by the conformity assessment procedures, draw up the EU declaration of conformity in accordance with Article 20 (EU declaration of conformity) and affix the CE marking in accordance with Article 22 (Rules and conditions for affixing the CE marking); (Art 10(7) par 3);

  • ensure the in-scope product is accompanied by the information and instructions set out in Annex II (information and instructions to the user), in an electronic or physical form: which information must allow for a secure installation, operation and use of the in-scope product (Art 10(10)). Note Annex II par (6) requires: where applicable, where the software bill of materials can be accessed (Art 10(10));

  • either provide the EU declaration of conformity with the in-scope product or include it in the instructions and information set out in Annex II, or provide the internet address at which the EU declaration of conformity can be accessed (Art 10(11));

  • keep the technical documentation and the EU declaration of conformity, where relevant, at the disposal of the market surveillance authorities for ten years after the product with digital elements has been placed on the market (Art 10(8));

  • ensure that procedures are in place for in-scope products that are part of a series of production to remain in conformity (Art 10(9));

  • immediately take the corrective measures necessary to bring an in-scope product or the manufacturer’s processes into conformity, or to withdraw or to recall the in-scope product, as appropriate, where the manufacturer knows or has reason to believe that the in-scope product or the processes put in place by the manufacturer are not in conformity with the essential requirements (Art 10(12));

  • further to a reasoned request from a market surveillance authority, provide the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the in-scope products and of the processes put in place by the manufacturer with the essential requirements (Art 10(13));

  • where it ceases operations, inform, before the cease of operation takes effect, the relevant market surveillance authorities about this situation, as well as, by any means available and to the extent possible, the users of the concerned in-scope products placed on the market (Art 10(14));

  • within 24 hours of becoming aware of it, notify to ENISA:

  • - any actively exploited vulnerability contained in the in-scope product (Art 11(1)).

  • - any incident having impact on the security of the in-scope product (Art 11(2)).

  • - upon identifying a vulnerability in a component, including in an open source component, which is integrated in the in-scope product, report the vulnerability to the person or entity maintaining the component (Art 11(7)).

Software bill of materials

Within Annex I section 2(1) of the EU CRA, is the manufacturer requirement to identify and document vulnerabilities and components contained in the in-scope product, including by drawing up a software bill of materials in a commonly used and machine-readable format covering at the very least the top-level dependencies of the in-scope product.

A software bill of materials, the CRA states, can provide those who manufacture, purchase, and operate software, with information that enhances their understanding of the supply chain. This has multiple benefits: most notably it helps manufacturers and users to track known newly emerged vulnerabilities and risks. It is of particular importance for manufacturers to ensure that their products do not contain vulnerable components developed by third parties.

As a consequence, the Commission may, by means of implementing acts, specify the format and elements of the software bill of materials set out in section 2(1), of Annex I. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 51(2) (Art 10 (15)).

Conformity Assessment

Presumption of Conformity (Art 18)

In-scope products and processes put in place by the manufacturer:

  • which are in conformity with harmonised standards (as defined) will be presumed to be in conformity with the Annex 1 essential requirements (Art 18(1));

  • which are in conformity with the common specifications referred to in Article 19 (Common Specifications) will be presumed to be in conformity with the Annex 1 essential requirements, to the extent those common specifications cover those requirements (Art 18(2));

  • for which an EU statement of conformity or certificate has been issued under a European cybersecurity certification scheme adopted as per Regulation (EU) 2019/881 (EU Cyber Security Act) will be presumed to be in conformity with the Annex 1 essential requirements in so far as the EU statement of conformity or cybersecurity certificate, or parts thereof, cover those requirements (Art 18(3)).

Conformity assessment procedures for products with digital elements (Art 24)

The manufacturer must demonstrate conformity with essential requirements by using one of the following procedures:

  1. the internal control procedure (based on module A) set out in Annex VI; or

  2. the EU-type examination procedure (based on module B) set out in Annex VI followed by conformity to EU-type based on internal production control (based on module C) set out in Annex VI; or

  3. conformity assessment based on full quality assurance (based on module H) set out in Annex VI (Art 24(1)).

For class 1 critical in-scope products (see under class 1 of Annex III for the listing), where broadly Article 18 or Article 19, cannot be applied, the in-scope product concerned and the processes put in place by the manufacturer, must be submitted by the manufacturer with regard to those essential requirements to either of the following procedures:

  1. EU-type examination procedure (based on module B) provided for in Annex VI followed by conformity to EU-type based on internal production control (based on module C) set out in Annex VI; or

  2. conformity assessment based on full quality assurance (based on module H) set out in Annex VI
  3. (Art 24(2)).

For class 2 critical in-scope products (see under class 2 of Annex III for the listing) the manufacturer must, demonstrate conformity with the essential requirements, by using one of the following procedures:

  1. EU-type examination procedure (based on module B) set out in Annex VI followed by conformity to EU-type based on internal production control (based on module C) set out in Annex VI; or

  2. conformity assessment based on full quality assurance (based on module H) set out in Annex VI (Art 24(3)).

The Commission argue that the EU CRA will minimise the regulatory burden put on manufacturers by several product safety acts. The Commission also argue that compliance with the CRA requirements will facilitate compliance with the requirement of security of processing of personal data under Regulation (EU) 2016/679 (General Data Protection Regulation).

Directive (EU) 2022/2555 (NIS2)

The review of NIS1 (Directive (EU) 2016/1148) evidenced a wide divergence in its implementation (it was implemented in significantly different ways) and there are also divergences in its supervision and enforcement. Hence the need for and adoption of NIS2.

This article focuses on private sector aspects of NIS2NIS2 is in force and is much wider in scope and more prescriptive than NIS1 which is repealed as of 18.10.2024). Art 20 and Art 21 (referred to below), are particularly onerous. Member States have until 17th of October 2024 to adopt and publish the measures necessary to comply with NIS2.

In-scope entities

Entities subject to NIS2 are classified as essential entities and important entities (see Art 3 and Annex 1 (sectors of highly criticality ) and Annex II (other critical sectors) of NIS2). All entities of the type listed in Annexes I and II that do not qualify as essential entities will be considered important entities (Article 3(2)).

essential and important entities have the same cybersecurity management and reporting requirements, but different enforcement and fines regimes apply to each.

Examples of in-scope entities

Digital Infrastructure, ICT Service Management and Digital providers

DNS service providers, TLD name registries, entities providing domain name registration services, cloud computing service providers, data centre service providers, content delivery network providers, managed service providers, managed security service providers are all in scope. Additionally providers of online marketplaces, of online search engines or of social networking services platforms are also in scope.

Manufacture, production and distribution of chemicals

Undertakings carrying out the manufacture of substances and the distribution of substances or mixtures, as referred to in Article 3(9) and (14), of Regulation (EC) No 1907/2006 (REACH Regulation) and undertakings carrying out the production of articles, as defined in Article 3(3), of that Regulation, from substances or mixtures, are in scope.

Health

Entities manufacturing medical devices considered to be critical during a public health emergency (public health emergency critical devices list) within the meaning of Article 22 of Regulation (EU) 2022/123 are in scope.

Transport: Air transport

Air carriers as defined in Article 3(4) of Regulation (EC) No 300/2008 (on common rules in the field of civil aviation security) used for commercial purposes are in scope.

Art 3 entities in scope

qualified trust service providers regardless of their size.

providers of public electronic communications networks or of publicly available electronic communications services which qualify as medium-sized enterprises.

Governance

Management bodies of essential and important entities must approve their Art 21 cybersecurity risk-management measures and oversee their implementation. Management bodies can be held liable for infringements by the entities of the Art 21 obligations (Art 20(1)).

Members of the management bodies of essential and important entities are required to follow training, and must offer similar training to their employees on a regular basis. The reason is so they gain sufficient knowledge and skills to identify risks and assess cybersecurity risk-management practices and their impact on the services provided by the entity (Art 20(2)).

Cybersecurity risk-management measures

Art 21 measures (just below) (as regards compliance with) will require detailed legal review.

essential and important entities must take technical, operational and organisational measures to manage the risks posed to the security of network and information systems which they use for their operations or for the provision of their services (Art 21(1)).

The measures must include at least the following:

  1. policies on risk analysis and information system security;

  2. incident handling;

  3. business continuity;

  4. supply chain security;

  5. security in network and information systems acquisition, development and maintenance, including vulnerability handling and disclosure;

  6. policies and procedures to assess the effectiveness of cybersecurity risk-management measures;

  7. basic cyber hygiene practices and cybersecurity training;

  8. policies and procedures regarding the use of cryptography and, where appropriate, encryption;

  9. human resources security, access control policies and asset management;

  10. the use of multi-factor authentication or continuous authentication solutions, secured voice, video and text communications and secured emergency communication systems within the entity, where appropriate (Art 21(2)).

Reporting requirements

essential and or important entities must submit to the CSIRT (as defined) or, where applicable, the competent authority:

early warning

without undue delay and in any event within 24 hours of becoming aware of the significant incident, an early warning, which, where applicable, must indicate whether the significant incident is suspected of being caused by: (a) unlawful or malicious acts; or (b) could have a cross-border impact;

incident notification

without undue delay and in any event within 72 hours of becoming aware of the significant incident, an incident notification, which, where applicable, must update the information referred to just above ( ie the early warning)  and indicate:

  • an initial assessment of the significant incident, including its severity and impact,
  • as well as, where available, the indicators of compromise;

Intermediate report

on the request of the CSIRT or, where relevant, the competent authority, an intermediate report on relevant status updates;

Final report

final report not later than one month after the submission of the incident notification referred to just above including the following:

  • a detailed description of the incident, including its severity and impact; and
  • the type of threat or root cause that is likely to have triggered the incident;
  • applied and ongoing mitigation measures;
  • where applicable, the cross-border impact of the incident (Art 23(4)).

Trust service provider exception

By way of derogation, a trust service provider must, with regard to significant incidents that have an impact on the provision of its trust services, notify the CSIRT or, where applicable, the competent authority, without undue delay and in any event within 24 hours of becoming aware of the significant incident (Art 23(4) last paragraph).

Non-EU established providers

DNS service providers, TLD name registries, entities providing domain name registration services, cloud computing service providers, data centre service providers, content delivery network providers, managed service providers, managed security service providers, as well as providers of online marketplaces, of online search engines or of social networking services platforms, not established in the Union, but which offer services within the Union, must designate a representative in the Union (Art 26(3)).

The representative must be established in one of those Member States where the services are offered (Art 26(3)).

Registry of entities

ENISA must create and maintain a registry of digital infrastructure, ICT service management and digital providers (Art 27(1)).

The Art 27(1) entities will be required to submit the following information to the competent authorities by 17 January 2025:

  1. the name of the entity;

  2. the relevant sector, subsector and type of entity referred to in Annex I or II, where applicable;

  3. the address of the entity’s main establishment and its other legal establishments in the Union or, if not established in the Union, of its representative designated pursuant to Article 26(3);

  4. up-to-date contact details, including email addresses and telephone numbers of the entity and, where applicable, its representative designated pursuant to Article 26(3);

  5. the Member States where the entity provides services; and

  6. the entity’s IP ranges (Art 27(2)).

The Article 27(1) entities will be required to notify the competent authority about any changes to the information they submitted under Art 27(2) without delay and in any event within three months of the date of the change (Art 27(3)).

Supervision and enforcement powers in relation to essential entities and important entities

The supervision and enforcement powers under NIS2 for competent authorities differ between essential entities ( set out in Art 32) and important entities (set out in Art 33). 

For example under Art 32(5), Member States must ensure that their competent authorities have the power to:

  1. suspend temporarily, or request suspension temporarily of a certification or authorisation concerning part or all of the relevant services provided or activities carried out by the essential entity;

  2. request in accordance with national law, to prohibit temporarily any natural person who is responsible for discharging managerial responsibilities at chief executive officer or legal representative level in the essential entity from exercising managerial functions in that entity (Art 32(5) extract).   This requirement is not included in Art 33.

Another example is provided by Art 34(4), which requires that infringements by essential entities of the obligations in Articles 21 or 23 are subject to administrative fines of a maximum of at least €10 million or 2% of the total worldwide annual turnover in the preceding financial year of the undertaking to which the entity belongs, whichever is higher.

Under Art 34(5), in relation to fines, member states must ensure that infringements by important entities of the obligations laid down in Art 21 or Art 23 are subject to administrative fines of a maximum of at least EUR 7 million or 1.4% of the total worldwide annual turnover in the preceding financial year of the undertaking to which the important entity belongs, whichever is higher.

There are additional obligations imposed on TLD name registries and entities providing domain name registration services in Art 28 (not reproduced here).

EU Cybersecurity Act 2019 (Regulation (EU) 2019/881)

In 2019, as stated above, the EU Cybersecurity Act (Act) entered into force. Amongst other things, it aims to enhance the security of ICT products, ICT services and ICT processes by introducing a voluntary European cybersecurity certification framework.

Finally, on 18 April 2023, the European Commission adopted a proposal for a Regulation amending the Act as regards managed security services. The proposal aims to avoid fragmentation of the internal market, by enabling the adoption of European cybersecurity certification schemes for managed security services. There is a concrete risk the Commission argue, of fragmentation of the internal market for these services, which the present proposal aims to address.


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