Cybersecurity Act (CSA)

ENISA should further develop and maintain its expertise on cybersecurity certification with a view to supporting the Union policy in that area. ENISA should build on existing best practices and should promote the uptake of cybersecurity certification within the Union, including by contributing to the establishment and maintenance of a cybersecurity certification framework at Union level (European cybersecurity certification framework) with a view to increasing the transparency of the cybersecurity assurance of ICT products, ICT services and ICT processes, thereby strengthening trust in the digital internal market and its competitiveness.

Cybersecurity certification plays an important role in increasing trust and security in ICT products, ICT services and ICT processes. The digital single market, and in particular the data economy and the IoT, can thrive only if there is general public trust that such products, services and processes provide a certain level of cybersecurity. Connected and automated cars, electronic medical devices, industrial automation control systems and smart grids are only some examples of sectors in which certification is already widely used or is likely to be used in the near future. The sectors regulated by Directive (EU) 2016/1148 are also sectors in which cybersecurity certification is critical.

In the 2016 Communication ‘Strengthening Europe’s Cyber Resilience System and Fostering a Competitive and Innovative Cybersecurity Industry’, the Commission outlined the need for high-quality, affordable and interoperable cybersecurity products and solutions. The supply of ICT products, ICT services and ICT processes within the single market remains very fragmented geographically. This is because the cybersecurity industry in Europe has developed largely on the basis of national governmental demand. In addition, the lack of interoperable solutions (technical standards), practices and Union-wide mechanisms of certification are among the other gaps affecting the single market in the field of cybersecurity. This makes it difficult for European businesses to compete at national, Union and global level. It also reduces the choice of viable and usable cybersecurity technologies that individuals and businesses have access to. Similarly, in the 2017 Communication on the Mid-Term Review on the implementation of the Digital Single Market Strategy – A Connected Digital Single Market for All, the Commission highlighted the need for safe connected products and systems, and indicated that the creation of a European ICT security framework setting rules on how to organise ICT security certification in the Union could both preserve trust in the internet and tackle the current fragmentation of the internal market.

Currently, the cybersecurity certification of ICT products, ICT services and ICT processes is used only to a limited extent. When it exists, it mostly occurs at Member State level or in the framework of industry driven schemes. In that context, a certificate issued by a national cybersecurity certification authority is not in principle recognised in other Member States. Companies thus may have to certify their ICT products, ICT services and ICT processes in several Member States where they operate, for example, with a view to participating in national procurement procedures, which thereby adds to their costs. Moreover, while new schemes are emerging, there seems to be no coherent and holistic approach to horizontal cybersecurity issues, for instance in the field of the IoT. Existing schemes present significant shortcomings and differences in terms of product coverage, levels of assurance, substantive criteria and actual use, impeding mutual recognition mechanisms within the Union.

Some efforts have been made in order to ensure the mutual recognition of certificates within the Union. However, they have been only partly successful. The most important example in this regard is the Senior Officials Group – Information Systems Security (SOG-IS) Mutual Recognition Agreement (MRA). While it represents the most important model for cooperation and mutual recognition in the field of security certification, SOG-IS includes only some of the Member States. That fact has limited the effectiveness of SOG-IS MRA from the point of view of the internal market.

Therefore, it is necessary to adopt a common approach and to establish a European cybersecurity certification framework that lays down the main horizontal requirements for European cybersecurity certification schemes to be developed and allows European cybersecurity certificates and EU statements of conformity for ICT products, ICT services or ICT processes to be recognised and used in all Member States. In doing so, it is essential to build on existing national and international schemes, as well as on mutual recognition systems, in particular SOG-IS, and to make possible a smooth transition from the existing schemes under such systems to schemes under the new European cybersecurity certification framework. The European cybersecurity certification framework should have a twofold purpose. First, it should help increase trust in ICT products, ICT services and ICT processes that have been certified under European cybersecurity certification schemes. Second, it should help avoid the multiplication of conflicting or overlapping national cybersecurity certification schemes and thus reduce costs for undertakings operating in the digital single market. The European cybersecurity certification schemes should be non-discriminatory and based on European or international standards, unless those standards are ineffective or inappropriate to fulfil the Union’s legitimate objectives in that regard.

The European cybersecurity certification framework should be established in a uniform manner in all Member States in order to prevent ‘certification shopping’ based on different levels of stringency in different Member States.

European cybersecurity certification schemes should be built on what already exists at international and national level and, if necessary, on technical specifications from forums and consortia, learning from current strong points and assessing and correcting weaknesses.

Flexible cybersecurity solutions are necessary for the industry to stay ahead of cyber threats, and therefore any certification scheme should be designed in a way that avoids the risk of being outdated quickly.

The provisions of this Regulation should be without prejudice to Union law providing specific rules on the certification of ICT products, ICT services and ICT processes. In particular, Regulation (EU) 2016/679 lays down provisions for the establishment of certification mechanisms and of data protection seals and marks, for the purpose of demonstrating the compliance of processing operations by controllers and processors with that Regulation. Such certification mechanisms and data protection seals and marks should allow data subjects to quickly assess the level of data protection of the relevant ICT products, ICT services and ICT processes. This Regulation is without prejudice to the certification of data processing operations under Regulation (EU) 2016/679, including when such operations are embedded in ICT products, ICT services and ICT processes.

European cybersecurity certification schemes are intended to help harmonise cybersecurity practices within the Union. They need to contribute to increasing the level of cybersecurity within the Union. The design of the European cybersecurity certification schemes should take into account and allow for the development of innovations in the field of cybersecurity.

The Commission should prepare, with the support of the European Cybersecurity Certification Group (the ‘ECCG’) and the Stakeholder Cybersecurity Certification Group and after an open and wide consultation, a Union rolling work programme for European cybersecurity certification schemes and should publish it in the form of a non-binding instrument. The Union rolling work programme should be a strategic document that allows industry, national authorities and standardisation bodies, in particular, to prepare in advance for future European cybersecurity certification schemes. The Union rolling work programme should include a multiannual overview of the requests for candidate schemes which the Commission intends to submit to ENISA for preparation on the basis of specific grounds. The Commission should take into account the Union rolling work programme while preparing its Rolling Plan for ICT Standardisation and standardisation requests to European standardisation organisations. In light of the rapid introduction and uptake of new technologies, the emergence of previously unknown cybersecurity risks, and legislative and market developments, the Commission or the ECCG should be entitled to request ENISA to prepare candidate schemes which have not been included in the Union rolling work programme. In such cases, the Commission and the ECCG should also assess the necessity of such a request, taking into account the overall aims and objectives of this Regulation and the need to ensure continuity as regards ENISA’s planning and use of resources.

Following such a request, ENISA should prepare the candidate schemes for specific ICT products, ICT services and ICT processes without undue delay. The Commission should evaluate the positive and negative impact of its request on the specific market in question, especially its impact on SMEs, on innovation, on barriers to entry to that market and on costs to end users. The Commission, on the basis of the candidate scheme prepared by ENISA, should be empowered to adopt the European cybersecurity certification scheme by means of implementing acts. Taking account of the general purpose and security objectives laid down in this Regulation, European cybersecurity certification schemes adopted by the Commission should specify a minimum set of elements concerning the subject matter, scope and functioning of the individual scheme. Those elements should include, among other things, the scope and object of the cybersecurity certification, including the categories of ICT products, ICT services and ICT processes covered, the detailed specification of the cybersecurity requirements, for example by reference to standards or technical specifications, the specific evaluation criteria and evaluation methods, as well as the intended assurance level (‘basic’, ‘substantial’ or ‘high’) and the evaluation levels where applicable. ENISA should be able to refuse a request by the ECCG. Such decisions should be taken by the Management Board and should be duly reasoned.

ENISA should further develop and maintain its expertise on cybersecurity certification with a view to supporting the Union policy in that area. ENISA should build on existing best practices and should promote the uptake of cybersecurity certification within the Union, including by contributing to the establishment and maintenance of a cybersecurity certification framework at Union level (European cybersecurity certification framework) with a view to increasing the transparency of the cybersecurity assurance of ICT products, ICT services and ICT processes, thereby strengthening trust in the digital internal market and its competitiveness.

The Commission should be empowered to adopt European cybersecurity certification schemes concerning specific groups of ICT products, ICT services and ICT processes. Those schemes should be implemented and supervised by national cybersecurity certification authorities, and certificates issued under those schemes should be valid and recognised throughout the Union. Certification schemes operated by the industry or by other private organisations should fall outside of the scope of this Regulation. However, the bodies operating such schemes should be able to propose that the Commission consider such schemes as a basis for approving them as a European cybersecurity certification scheme.

The governance of the European cybersecurity certification framework takes into account the involvement of Member States as well as the appropriate involvement of stakeholders, and establishes the role of the Commission during the planning and proposing, requesting, preparing, adopting and reviewing of European cybersecurity certification schemes.

The Commission should prepare, with the support of the European Cybersecurity Certification Group (the ‘ECCG’) and the Stakeholder Cybersecurity Certification Group and after an open and wide consultation, a Union rolling work programme for European cybersecurity certification schemes and should publish it in the form of a non-binding instrument. The Union rolling work programme should be a strategic document that allows industry, national authorities and standardisation bodies, in particular, to prepare in advance for future European cybersecurity certification schemes. The Union rolling work programme should include a multiannual overview of the requests for candidate schemes which the Commission intends to submit to ENISA for preparation on the basis of specific grounds. The Commission should take into account the Union rolling work programme while preparing its Rolling Plan for ICT Standardisation and standardisation requests to European standardisation organisations. In light of the rapid introduction and uptake of new technologies, the emergence of previously unknown cybersecurity risks, and legislative and market developments, the Commission or the ECCG should be entitled to request ENISA to prepare candidate schemes which have not been included in the Union rolling work programme. In such cases, the Commission and the ECCG should also assess the necessity of such a request, taking into account the overall aims and objectives of this Regulation and the need to ensure continuity as regards ENISA’s planning and use of resources.

Following such a request, ENISA should prepare the candidate schemes for specific ICT products, ICT services and ICT processes without undue delay. The Commission should evaluate the positive and negative impact of its request on the specific market in question, especially its impact on SMEs, on innovation, on barriers to entry to that market and on costs to end users. The Commission, on the basis of the candidate scheme prepared by ENISA, should be empowered to adopt the European cybersecurity certification scheme by means of implementing acts. Taking account of the general purpose and security objectives laid down in this Regulation, European cybersecurity certification schemes adopted by the Commission should specify a minimum set of elements concerning the subject matter, scope and functioning of the individual scheme. Those elements should include, among other things, the scope and object of the cybersecurity certification, including the categories of ICT products, ICT services and ICT processes covered, the detailed specification of the cybersecurity requirements, for example by reference to standards or technical specifications, the specific evaluation criteria and evaluation methods, as well as the intended assurance level (‘basic’, ‘substantial’ or ‘high’) and the evaluation levels where applicable. ENISA should be able to refuse a request by the ECCG. Such decisions should be taken by the Management Board and should be duly reasoned.

In order to raise awareness and to facilitate the acceptance of future European cybersecurity certification schemes, the Commission may issue general or sector-specific cybersecurity guidelines, for example on good cybersecurity practices or responsible cybersecurity behaviour highlighting the positive effect of the use of certified ICT products, ICT services and ICT processes.

The examination procedure should be used for the adoption of implementing acts on European cybersecurity certification schemes for ICT products, ICT services or ICT processes, for the adoption of implementing acts on arrangements for carrying out inquiries by ENISA, for the adoption of implementing acts on a plan for the peer review of national cybersecurity certification authorities, as well as for the adoption of implementing acts on the circumstances, formats and procedures of notifications of accredited conformity assessment bodies by the national cybersecurity certification authorities to the Commission.

ENISA should maintain a website providing information on and publicising European cybersecurity certification schemes, which should include, among other things, the requests for the preparation of a candidate scheme as well as the feedback received in the consultation process carried out by ENISA in the preparation phase. The website should also provide information about the European cybersecurity certificates and EU statements of conformity issued under this Regulation including information regarding the withdrawal and expiry of such European cybersecurity certificates and EU statements of conformity. The website should also indicate the national cybersecurity certification schemes that have been replaced by a European cybersecurity certification scheme.

Modern ICT products and systems often integrate and rely on one or more third-party technologies and components such as software modules, libraries or application programming interfaces. This reliance, which is referred to as a ‘dependency’, could pose additional cybersecurity risks as vulnerabilities found in third-party components could also affect the security of the ICT products, ICT services and ICT processes. In many cases, identifying and documenting such dependencies enables end users of ICT products, ICT services and ICT processes to improve their cybersecurity risk management activities by improving, for example, users’ cybersecurity vulnerability management and remediation procedures.

Organisations, manufacturers or providers involved in the design and development of ICT products, ICT services or ICT processes should be encouraged to implement measures at the earliest stages of design and development to protect the security of those products, services and processes to the highest possible degree, in such a way that the occurrence of cyberattacks is presumed and their impact is anticipated and minimised (‘security-by-design’). Security should be ensured throughout the lifetime of the ICT product, ICT service or ICT process by design and development processes that constantly evolve to reduce the risk of harm from malicious exploitation.

Undertakings, organisations and the public sector should configure the ICT products, ICT services or ICT processes designed by them in a way that ensures a higher level of security which should enable the first user to receive a default configuration with the most secure settings possible (‘security by default’), thereby reducing the burden on users of having to configure an ICT product, ICT service or ICT process appropriately. Security by default should not require extensive configuration or specific technical understanding or non-intuitive behaviour on the part of the user, and should work easily and reliably when implemented. If, on a case-by-case basis, a risk and usability analysis leads to the conclusion that such a setting by default is not feasible, users should be prompted to opt for the most secure setting.

ENISA should encourage Member States, manufacturers or providers of ICT products, ICT services or ICT processes to raise their general security standards so that all internet users can take the necessary steps to ensure their own personal cybersecurity and should give incentives to do so. In particular, manufacturers and providers of ICT products, ICT services or ICT processes should provide any necessary updates and should recall, withdraw or recycle ICT products, ICT services or ICT processes that do not meet cybersecurity standards, while importers and distributors should make sure that the ICT products, ICT services and ICT processes they place on the Union market comply with the applicable requirements and do not present a risk to Union consumers.

The purpose of European cybersecurity certification schemes should be to ensure that ICT products, ICT services and ICT processes certified under such schemes comply with specified requirements that aim to protect the availability, authenticity, integrity and confidentiality of stored, transmitted or processed data or of the related functions of or services offered by, or accessible via those products, services and processes throughout their life cycle. It is not possible to set out in detail the cybersecurity requirements relating to all ICT products, ICT services and ICT processes in this Regulation. ICT products, ICT services and ICT processes and the cybersecurity needs related to those products, services and processes are so diverse that it is very difficult to develop general cybersecurity requirements that are valid in all circumstances. It is therefore necessary to adopt a broad and general notion of cybersecurity for the purpose of certification, which should be complemented by a set of specific cybersecurity objectives that are to be taken into account when designing European cybersecurity certification schemes. The arrangements by which such objectives are to be achieved in specific ICT products, ICT services and ICT processes should then be further specified in detail at the level of the individual certification scheme adopted by the Commission, for example by reference to standards or technical specifications if no appropriate standards are available.

Therefore, it is necessary to adopt a common approach and to establish a European cybersecurity certification framework that lays down the main horizontal requirements for European cybersecurity certification schemes to be developed and allows European cybersecurity certificates and EU statements of conformity for ICT products, ICT services or ICT processes to be recognised and used in all Member States. In doing so, it is essential to build on existing national and international schemes, as well as on mutual recognition systems, in particular SOG-IS, and to make possible a smooth transition from the existing schemes under such systems to schemes under the new European cybersecurity certification framework. The European cybersecurity certification framework should have a twofold purpose. First, it should help increase trust in ICT products, ICT services and ICT processes that have been certified under European cybersecurity certification schemes. Second, it should help avoid the multiplication of conflicting or overlapping national cybersecurity certification schemes and thus reduce costs for undertakings operating in the digital single market. The European cybersecurity certification schemes should be non-discriminatory and based on European or international standards, unless those standards are ineffective or inappropriate to fulfil the Union’s legitimate objectives in that regard.

European cybersecurity certification schemes could provide for a conformity assessment to be carried out under the sole responsibility of the manufacturer or provider of ICT products, ICT services or ICT processes (‘conformity self-assessment’). In such cases, it should be sufficient that the manufacturer or provider of ICT products, ICT services or ICT processes itself carry out all of the checks to ensure that the ICT products, ICT services or ICT processes conform with the European cybersecurity certification scheme. Conformity self-assessment should be considered to be appropriate for low complexity ICT products, ICT services or ICT processes that present a low risk to the public, such as simple design and production mechanisms. Moreover, conformity self-assessment should be permitted for ICT products, ICT services or ICT processes only where they correspond to assurance level ‘basic’.

European cybersecurity certification schemes could allow for both conformity self-assessments and certifications of ICT products, ICT services or ICT processes. In such a case, the scheme should provide for clear and understandable means for consumers or other users to differentiate between ICT products, ICT services or ICT processes with regard to which the manufacturer or provider of ICT products, ICT services or ICT processes is responsible for the assessment, and ICT products, ICT services or ICT processes that are certified by a third party.

The manufacturer or provider of ICT products, ICT services or ICT processes who carry out a conformity self-assessment should be able to issue and sign the EU statement of conformity as part of the conformity assessment procedure. An EU statement of conformity is a document that states that a specific ICT product, ICT service or ICT process complies with the requirements of the European cybersecurity certification scheme. By issuing and signing the EU statement of conformity, the manufacturer or provider of ICT products, ICT services or ICT processes assumes responsibility for the compliance of the ICT product, ICT service or ICT process with the legal requirements of the European cybersecurity certification scheme. A copy of the EU statement of conformity should be submitted to the national cybersecurity certification authority and to ENISA.

Manufacturers or providers of ICT products, ICT services or ICT processes should make the EU statement of conformity, technical documentation, and all other relevant information relating to the conformity of the ICT products, ICT services or ICT processes with a European cybersecurity certification scheme available to the competent national cybersecurity certification authority for a period provided for in the relevant European cybersecurity certification scheme. The technical documentation should specify the requirements applicable under the scheme and should cover the design, manufacture and operation of the ICT product, ICT service or ICT process to the extent relevant to the conformity self-assessment. The technical documentation should be so compiled as to enable the assessment of whether an ICT product or ICT service complies with the requirements applicable under that scheme.

Recourse to European cybersecurity certification and to EU statements of conformity should remain voluntary, unless otherwise provided for in Union law, or in Member State law adopted in accordance with Union law. In the absence of harmonised Union law, Member States are able to adopt national technical regulations providing for mandatory certification under a European cybersecurity certification scheme in accordance with Directive (EU) 2015/1535 of the European Parliament and of the Council ⁽¹⁾. Member States also have recourse to European cybersecurity certification in the context of public procurement and of Directive 2014/24/EU of the European Parliament and of the Council ⁽²⁾.

^{(1) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).}

Once a European cybersecurity certification scheme is adopted, manufacturers or providers of ICT products, ICT services or ICT processes should be able to submit applications for certification of their ICT products or ICT services to the conformity assessment body of their choice anywhere in the Union. Conformity assessment bodies should be accredited by a national accreditation body if they comply with certain specified requirements set out in this Regulation. Accreditation should be issued for a maximum of five years and should be renewable on the same conditions provided that the conformity assessment body still meets the requirements. National accreditation bodies should restrict, suspend or revoke the accreditation of a conformity assessment body where the conditions for the accreditation have not been met or are no longer met, or where the conformity assessment body infringes this Regulation.

The provisions of this Regulation should be without prejudice to Union law providing specific rules on the certification of ICT products, ICT services and ICT processes. In particular, Regulation (EU) 2016/679 lays down provisions for the establishment of certification mechanisms and of data protection seals and marks, for the purpose of demonstrating the compliance of processing operations by controllers and processors with that Regulation. Such certification mechanisms and data protection seals and marks should allow data subjects to quickly assess the level of data protection of the relevant ICT products, ICT services and ICT processes. This Regulation is without prejudice to the certification of data processing operations under Regulation (EU) 2016/679, including when such operations are embedded in ICT products, ICT services and ICT processes.

The technical specifications to be used in European cybersecurity certification schemes should respect the requirements set out in Annex II to Regulation (EU) No 1025/2012 of the European Parliament and of the Council (19). Some deviations from those requirements could, however, be considered to be necessary in duly justified cases where those technical specifications are to be used in a European cybersecurity certification scheme referring to assurance level ‘high’. The reasons for such deviations should be made publicly available.

The Commission should prepare, with the support of the European Cybersecurity Certification Group (the ‘ECCG’) and the Stakeholder Cybersecurity Certification Group and after an open and wide consultation, a Union rolling work programme for European cybersecurity certification schemes and should publish it in the form of a non-binding instrument. The Union rolling work programme should be a strategic document that allows industry, national authorities and standardisation bodies, in particular, to prepare in advance for future European cybersecurity certification schemes. The Union rolling work programme should include a multiannual overview of the requests for candidate schemes which the Commission intends to submit to ENISA for preparation on the basis of specific grounds. The Commission should take into account the Union rolling work programme while preparing its Rolling Plan for ICT Standardisation and standardisation requests to European standardisation organisations. In light of the rapid introduction and uptake of new technologies, the emergence of previously unknown cybersecurity risks, and legislative and market developments, the Commission or the ECCG should be entitled to request ENISA to prepare candidate schemes which have not been included in the Union rolling work programme. In such cases, the Commission and the ECCG should also assess the necessity of such a request, taking into account the overall aims and objectives of this Regulation and the need to ensure continuity as regards ENISA’s planning and use of resources.

Following such a request, ENISA should prepare the candidate schemes for specific ICT products, ICT services and ICT processes without undue delay. The Commission should evaluate the positive and negative impact of its request on the specific market in question, especially its impact on SMEs, on innovation, on barriers to entry to that market and on costs to end users. The Commission, on the basis of the candidate scheme prepared by ENISA, should be empowered to adopt the European cybersecurity certification scheme by means of implementing acts. Taking account of the general purpose and security objectives laid down in this Regulation, European cybersecurity certification schemes adopted by the Commission should specify a minimum set of elements concerning the subject matter, scope and functioning of the individual scheme. Those elements should include, among other things, the scope and object of the cybersecurity certification, including the categories of ICT products, ICT services and ICT processes covered, the detailed specification of the cybersecurity requirements, for example by reference to standards or technical specifications, the specific evaluation criteria and evaluation methods, as well as the intended assurance level (‘basic’, ‘substantial’ or ‘high’) and the evaluation levels where applicable. ENISA should be able to refuse a request by the ECCG. Such decisions should be taken by the Management Board and should be duly reasoned.

European cybersecurity certification schemes should take into account current software and hardware development methods and, in particular, the impact of frequent software or firmware updates on individual European cybersecurity certificates. European cybersecurity certification schemes should specify the conditions under which an update may require that an ICT product, ICT service or ICT process be recertified or that the scope of a specific European cybersecurity certificate be reduced, taking into account any possible adverse effects of the update on compliance with the security requirements of that certificate.

In order to further facilitate trade, and recognising that ICT supply chains are global, mutual recognition agreements concerning European cybersecurity certificates may be concluded by the Union in accordance with Article 218 of the Treaty on the Functioning of the European Union (TFEU). The Commission, taking into account the advice from ENISA and the European Cybersecurity Certification Group, may recommend the opening of relevant negotiations. Each European cybersecurity certification scheme should provide specific conditions for such mutual recognition agreements with third countries.

European cybersecurity certificates and EU statements of conformity should help end users to make informed choices. Therefore, ICT products, ICT services and ICT processes that have been certified or for which an EU statement of conformity has been issued should be accompanied by structured information that is adapted to the expected technical level of the intended end user. All such information should be available online, and, where appropriate, in physical form. The end user should have access to information regarding the reference number of the certification scheme, the assurance level, the description of the cybersecurity risks associated with the ICT product, ICT service or ICT process, and the issuing authority or body, or should be able to obtain a copy of the European cybersecurity certificate. In addition, the end user should be informed of the cybersecurity support policy, namely for how long the end user can expect to receive cybersecurity updates or patches, of the manufacturer or provider of ICT products, ICT services or ICT processes. Where applicable, guidance on actions or settings that the end user can implement to maintain or increase the cybersecurity of the ICT product or of the ICT service and contact information of a single point of contact to report and receive support in the case of cyberattacks (in addition to automatic reporting) should be provided. That information should be regularly updated and made available on a website providing information on European cybersecurity certification schemes.

A conformity assessment is a procedure for evaluating whether specified requirements relating to an ICT product, ICT service or ICT process have been fulfilled. That procedure is carried out by an independent third party that is not the manufacturer or provider of the ICT products, ICT services or ICT processes that are being assessed. A European cybersecurity certificate should be issued following the successful evaluation of an ICT product, ICT service or ICT process. A European cybersecurity certificate should be considered to be a confirmation that the evaluation has been properly carried out. Depending on the assurance level, the European cybersecurity certification scheme should indicate whether the European cybersecurity certificate is to be issued by a private or public body. Conformity assessment and certification cannot guarantee per se that certified ICT products, ICT services and ICT processes are cyber secure. They are instead procedures and technical methodologies for attesting that ICT products, ICT services and ICT processes have been tested and that they comply with certain cybersecurity requirements laid down elsewhere, for example in technical standards.

Recourse to European cybersecurity certification and to EU statements of conformity should remain voluntary, unless otherwise provided for in Union law, or in Member State law adopted in accordance with Union law. In the absence of harmonised Union law, Member States are able to adopt national technical regulations providing for mandatory certification under a European cybersecurity certification scheme in accordance with Directive (EU) 2015/1535 of the European Parliament and of the Council ⁽¹⁾. Member States also have recourse to European cybersecurity certification in the context of public procurement and of Directive 2014/24/EU of the European Parliament and of the Council ⁽²⁾.

^{(1) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).}

In some areas, it could be necessary in the future to impose specific cybersecurity requirements and make the certification thereof mandatory for certain ICT products, ICT services or ICT processes, in order to improve the level of cybersecurity in the Union. The Commission should regularly monitor the impact of adopted European cybersecurity certification schemes on the availability of secure ICT products, ICT services and ICT processes in the internal market and should regularly assess the level of use of the certification schemes by the manufacturers or providers of ICT products, ICT services or ICT processes in the Union. The efficiency of the European cybersecurity certification schemes, and whether specific schemes should be made mandatory, should be assessed in light of the cybersecurity-related legislation of the Union, in particular Directive (EU) 2016/1148, taking into consideration the security of the network and information systems used by operators of essential services.

With a view to achieving the objectives of this Regulation and avoiding the fragmentation of the internal market, national cybersecurity certification schemes or procedures for ICT products, ICT services or ICT processes covered by a European cybersecurity certification scheme should cease to be effective from a date established by the Commission by means of implementing acts. Moreover, Member States should not introduce new national cybersecurity certification schemes for ICT products, ICT services or ICT processes already covered by an existing European cybersecurity certification scheme. However, Member States should not be prevented from adopting or maintaining national cybersecurity certification schemes for national security purposes. Member States should inform the Commission and the ECCG of any intention to draw up new national cybersecurity certification schemes. The Commission and the ECCG should evaluate the impact of the new national cybersecurity certification schemes on the proper functioning of the internal market and in light of any strategic interest in requesting a European cybersecurity certification scheme instead.

References in national legislation to national standards which have ceased to be effective due to the entry into force of a European cybersecurity certification scheme can be a source of confusion. Therefore, Member States should reflect the adoption of a European cybersecurity certification scheme in their national legislation.

Member States should designate one or more national cybersecurity certification authorities to supervise compliance with obligations arising from this Regulation. A national cybersecurity certification authority may be an existing or new authority. A Member State should also be able to designate, after agreeing with another Member State, one or more national cybersecurity certification authorities in the territory of that other Member State.

National cybersecurity certification authorities should in particular monitor and enforce the obligations of manufacturers or providers of ICT products, ICT services or ICT processes established in its respective territory in relation to the EU statement of conformity, should assist the national accreditation bodies in the monitoring and supervision of the activities of conformity assessment bodies by providing them with expertise and relevant information, should authorise conformity assessment bodies to carry out their tasks where such bodies meet additional requirements set out in a European cybersecurity certification scheme, and should monitor relevant developments in the field of cybersecurity certification. National cybersecurity certification authorities should also handle complaints lodged by natural or legal persons in relation to European cybersecurity certificates issued by those authorities or in relation to European cybersecurity certificates issued by conformity assessment bodies, where such certificates indicate assurance level ‘high’, should investigate, to the extent appropriate, the subject matter of the complaint and should inform the complainant of the progress and the outcome of the investigation within a reasonable period. Moreover, national cybersecurity certification authorities should cooperate with other national cybersecurity certification authorities or other public authorities, including by the sharing of information on the possible non-compliance of ICT products, ICT services and ICT processes with the requirements of this Regulation or with specific European cybersecurity certification schemes. The Commission should facilitate that sharing of information by making available a general electronic information support system, for example the Information and Communication System on Market Surveillance (ICSMS) and the Rapid Alert System for dangerous non-food products (RAPEX), already used by market surveillance authorities pursuant to Regulation (EC) No 765/2008.

In order to achieve equivalent standards throughout the Union, to facilitate mutual recognition and to promote the overall acceptance of European cybersecurity certificates and EU statements of conformity, it is necessary to put in place a system of peer review between national cybersecurity certification authorities. Peer review should cover procedures for supervising the compliance of ICT products, ICT services and ICT processes with European cybersecurity certificates, for monitoring the obligations of manufacturers or providers of ICT products, ICT services or ICT processes who carry out the conformity self-assessment, for monitoring conformity assessment bodies, as well as the appropriateness of the expertise of the staff of bodies issuing certificates for assurance level ‘high’. The Commission should be able, by means of implementing acts, to establish at least a five-year plan for peer reviews, as well as lay down criteria and methodologies for the operation of the peer review system.

Once a European cybersecurity certification scheme is adopted, manufacturers or providers of ICT products, ICT services or ICT processes should be able to submit applications for certification of their ICT products or ICT services to the conformity assessment body of their choice anywhere in the Union. Conformity assessment bodies should be accredited by a national accreditation body if they comply with certain specified requirements set out in this Regulation. Accreditation should be issued for a maximum of five years and should be renewable on the same conditions provided that the conformity assessment body still meets the requirements. National accreditation bodies should restrict, suspend or revoke the accreditation of a conformity assessment body where the conditions for the accreditation have not been met or are no longer met, or where the conformity assessment body infringes this Regulation.

The Commission should prepare, with the support of the European Cybersecurity Certification Group (the ‘ECCG’) and the Stakeholder Cybersecurity Certification Group and after an open and wide consultation, a Union rolling work programme for European cybersecurity certification schemes and should publish it in the form of a non-binding instrument. The Union rolling work programme should be a strategic document that allows industry, national authorities and standardisation bodies, in particular, to prepare in advance for future European cybersecurity certification schemes. The Union rolling work programme should include a multiannual overview of the requests for candidate schemes which the Commission intends to submit to ENISA for preparation on the basis of specific grounds. The Commission should take into account the Union rolling work programme while preparing its Rolling Plan for ICT Standardisation and standardisation requests to European standardisation organisations. In light of the rapid introduction and uptake of new technologies, the emergence of previously unknown cybersecurity risks, and legislative and market developments, the Commission or the ECCG should be entitled to request ENISA to prepare candidate schemes which have not been included in the Union rolling work programme. In such cases, the Commission and the ECCG should also assess the necessity of such a request, taking into account the overall aims and objectives of this Regulation and the need to ensure continuity as regards ENISA’s planning and use of resources.

Following such a request, ENISA should prepare the candidate schemes for specific ICT products, ICT services and ICT processes without undue delay. The Commission should evaluate the positive and negative impact of its request on the specific market in question, especially its impact on SMEs, on innovation, on barriers to entry to that market and on costs to end users. The Commission, on the basis of the candidate scheme prepared by ENISA, should be empowered to adopt the European cybersecurity certification scheme by means of implementing acts. Taking account of the general purpose and security objectives laid down in this Regulation, European cybersecurity certification schemes adopted by the Commission should specify a minimum set of elements concerning the subject matter, scope and functioning of the individual scheme. Those elements should include, among other things, the scope and object of the cybersecurity certification, including the categories of ICT products, ICT services and ICT processes covered, the detailed specification of the cybersecurity requirements, for example by reference to standards or technical specifications, the specific evaluation criteria and evaluation methods, as well as the intended assurance level (‘basic’, ‘substantial’ or ‘high’) and the evaluation levels where applicable. ENISA should be able to refuse a request by the ECCG. Such decisions should be taken by the Management Board and should be duly reasoned.

With a view to achieving the objectives of this Regulation and avoiding the fragmentation of the internal market, national cybersecurity certification schemes or procedures for ICT products, ICT services or ICT processes covered by a European cybersecurity certification scheme should cease to be effective from a date established by the Commission by means of implementing acts. Moreover, Member States should not introduce new national cybersecurity certification schemes for ICT products, ICT services or ICT processes already covered by an existing European cybersecurity certification scheme. However, Member States should not be prevented from adopting or maintaining national cybersecurity certification schemes for national security purposes. Member States should inform the Commission and the ECCG of any intention to draw up new national cybersecurity certification schemes. The Commission and the ECCG should evaluate the impact of the new national cybersecurity certification schemes on the proper functioning of the internal market and in light of any strategic interest in requesting a European cybersecurity certification scheme instead.

Without prejudice to the general peer review system to be put in place across all national cybersecurity certification authorities within the European cybersecurity certification framework, certain European cybersecurity certification schemes may include a peer-assessment mechanism for the bodies that issue European cybersecurity certificates for ICT products, ICT services and ICT processes with an assurance level ‘high’ under such schemes. The ECCG should support the implementation of such peer-assessment mechanisms. The peer assessments should assess in particular whether the bodies concerned carry out their tasks in a harmonised way, and may include appeal mechanisms. The results of the peer assessments should be made publicly available. The bodies concerned may adopt appropriate measures to adapt their practices and expertise accordingly.

With a view to ensuring the consistent application of the European cybersecurity certification framework, an ECCG that consists of representatives of national cybersecurity certification authorities or other relevant national authorities should be established. The main tasks of the ECCG should be to advise and assist the Commission in its work towards ensuring the consistent implementation and application of the European cybersecurity certification framework, to assist and closely cooperate with ENISA in the preparation of candidate cybersecurity certification schemes, in duly justified cases to request ENISA to prepare a candidate scheme, to adopt opinions addressed to ENISA on candidate schemes and to adopt opinions addressed to the Commission on the maintenance and review of existing European cybersecurity certifications schemes. The ECCG should facilitate the exchange of good practices and expertise between the various national cybersecurity certification authorities that are responsible for the authorisation of conformity assessment bodies and the issuance of European cybersecurity certificates.

In order to further facilitate trade, and recognising that ICT supply chains are global, mutual recognition agreements concerning European cybersecurity certificates may be concluded by the Union in accordance with Article 218 of the Treaty on the Functioning of the European Union (TFEU). The Commission, taking into account the advice from ENISA and the European Cybersecurity Certification Group, may recommend the opening of relevant negotiations. Each European cybersecurity certification scheme should provide specific conditions for such mutual recognition agreements with third countries.

With a view to ensuring the consistent application of the European cybersecurity certification framework, an ECCG that consists of representatives of national cybersecurity certification authorities or other relevant national authorities should be established. The main tasks of the ECCG should be to advise and assist the Commission in its work towards ensuring the consistent implementation and application of the European cybersecurity certification framework, to assist and closely cooperate with ENISA in the preparation of candidate cybersecurity certification schemes, in duly justified cases to request ENISA to prepare a candidate scheme, to adopt opinions addressed to ENISA on candidate schemes and to adopt opinions addressed to the Commission on the maintenance and review of existing European cybersecurity certifications schemes. The ECCG should facilitate the exchange of good practices and expertise between the various national cybersecurity certification authorities that are responsible for the authorisation of conformity assessment bodies and the issuance of European cybersecurity certificates.