Legal provisions of COM(2023)208 - Amendment of Regulation (EU) 2019/881 as regards managed security services

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dossier COM(2023)208 - Amendment of Regulation (EU) 2019/881 as regards managed security services.
document COM(2023)208 EN
date April 18, 2023



Article 1

Amendments to Regulation (EU) 2019/881

Regulation (EU) 2019/881 is amended as follows:

(1) in Article 1(1), first subparagraph, point (b) is replaced by the following:

‘(b) a framework for the establishment of European cybersecurity certification schemes for the purpose of ensuring an adequate level of cybersecurity for ICT products, ICT services, ICT processes, and managed security services in the Union, as well as for the purpose of avoiding the fragmentation of the internal market with regard to cybersecurity certification schemes in the Union.’;

(2) Article 2 is amended as follows:

(a) points 9, 10 and 11 are replaced by the following:

‘(9) ‘European cybersecurity certification scheme’ means a comprehensive set of rules, technical requirements, standards and procedures that are established at Union level and that apply to the certification or conformity assessment of specific ICT products, ICT services, ICT processes, or managed security services;

’(10) ‘national cybersecurity certification scheme’ means a comprehensive set of rules, technical requirements, standards and procedures developed and adopted by a national public authority and that apply to the certification or conformity assessment of ICT products, ICT services, ICT processes and managed security services falling under the scope of the specific scheme;

(11) ‘European cybersecurity certificate’ means a document issued by a relevant body, attesting that a given ICT product, ICT service, ICT process or managed security service has been evaluated for compliance with specific security requirements laid down in a European cybersecurity certification scheme;’;

(b) the following point is inserted:

‘(14a) ‘managed security service’ means a service consisting of carrying out, or providing assistance for, activities relating to cybersecurity risk management, including incident response, penetration testing, security audits and consultancy’;

(c) points 20, 21 and 22 are replaced by the following:

‘(20) ‘technical specifications’ means a document that prescribes the technical requirements to be met by, or conformity assessment procedures relating to, an ICT product, ICT service, ICT process or managed security service;

(21) ‘assurance level’ means a basis for confidence that an ICT product, ICT service, ICT process or managed security service meets the security requirements of a specific European cybersecurity certification scheme, and indicates the level at which an ICT product, ICT service, ICT process or managed security service has been evaluated but as such does not measure the security of the ICT product, ICT service, ICT process or managed security service concerned;

(22) ‘conformity self-assessment’ means an action carried out by a manufacturer or provider of ICT products, ICT services, or ICT processes or managed security services, which evaluates whether those ICT products, ICT services, ICT processes or managed security services meet the requirements of a specific European cybersecurity certification scheme;’;

(3) in Article 4, paragraph 6 is replaced by the following

‘6. ENISA shall promote the use of European cybersecurity certification, with a view to avoiding the fragmentation of the internal market. ENISA shall contribute to the establishment and maintenance of a European cybersecurity certification framework in accordance with Title III of this Regulation, with a view to increasing the transparency of the cybersecurity of ICT products, ICT services, ICT processes, and managed security services, thereby strengthening trust in the digital internal market and its competitiveness.’;

(4) Article 8 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. ENISA shall support and promote the development and implementation of Union policy on cybersecurity certification of ICT products, ICT services, ICT processes and managed security services, as established in Title III of this Regulation, by:

(a) monitoring developments, on an ongoing basis, in related areas of standardisation and recommending appropriate technical specifications for use in the development of European cybersecurity certification schemes pursuant to Article 54(1), point (c), where standards are not available;

(b) preparing candidate European cybersecurity certification schemes (‘candidate schemes’) for ICT products, ICT services, ICT processes and managed security services in accordance with Article 49;

(c) evaluating adopted European cybersecurity certification schemes in accordance with Article 49(8);

(d) participating in peer reviews pursuant to Article 59(4);

(e) assisting the Commission in providing the secretariat of the ECCG pursuant to Article 62(5).’;

(b) paragraph 3 is replaced by the following:

‘3. ENISA shall compile and publish guidelines and develop good practices, concerning the cybersecurity requirements for ICT products, ICT services, ICT processes and managed security services, in cooperation with national cybersecurity certification authorities and industry in a formal, structured and transparent way.’;

(c) paragraph 5 is replaced by the following:

‘5. ENISA shall facilitate the establishment and take-up of European and international standards for risk management and for the security of ICT products, ICT services, ICT processes and managed security services.’;

(5) in Article 46, paragraphs 1 and 2 are replaced by the following:

‘1. The European cybersecurity certification framework shall be established in order to improve the conditions for the functioning of the internal market by increasing the level of cybersecurity within the Union and enabling a harmonised approach at Union level to European cybersecurity certification schemes, with a view to creating a digital single market for ICT products, ICT services, ICT processes and managed security services.’;

2. The European cybersecurity certification framework shall provide for a mechanism to establish European cybersecurity certification schemes. It shall attest that the ICT products, ICT services and ICT processes that have been evaluated in accordance with such schemes comply with specified security requirements for the purpose of protecting the availability, authenticity, integrity or confidentiality of stored or transmitted or processed data or the functions or services offered by, or accessible via, those products, services and processes throughout their life cycle. In addition, it shall attest that managed security services that have been evaluated in accordance with such schemes comply with specified security requirements for the purpose of protecting the availability, authenticity, integrity and confidentiality of data, which are accessed, processed, stored or transmitted in relation to the provision of those services, and that those services are provided continuously with the requisite competence, expertise and experience by staff with a very high level of relevant technical knowledge and professional integrity.’;

(6) in Article 47, paragraphs 2 and 3 are replaced by the following:

‘2. The Union rolling work programme shall in particular include a list of ICT products, ICT services and ICT processes or categories thereof, and managed security services, that are capable of benefiting from being included in the scope of a European cybersecurity certification scheme.

3. Inclusion of specific ICT products, ICT services and ICT processes or categories thereof, or of managed security services, in the Union rolling work programme shall be justified on the basis of one or more of the following grounds:

(a) the availability and the development of national cybersecurity certification schemes covering a specific category of ICT products, ICT services, or ICT processes or managed security services and, in particular, as regards the risk of fragmentation;

(b) relevant Union or Member State law or policy;

(c) market demand;

(d) developments in the cyber threat landscape;

(e) request for the preparation of a specific candidate scheme by the ECCG.’;

(7) in Article 49, paragraph 7 is replaced by the following:

‘7. The Commission, based on the candidate scheme prepared by ENISA, may adopt implementing acts providing for a European cybersecurity certification scheme for ICT products, ICT services, ICT processes and managed security services which meets the requirements set out in Articles 51, 52 and 54. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 66(2).’;

(8) Article 51 is amended as follows:

(a) the title is replaced by the following:

Security objectives of European cybersecurity certification schemes for ICT products, ICT services and ICT processes


(b) the introductory sentence is replaced by the following:

‘A European cybersecurity certification scheme for ICT products, ICT services or ICT processes shall be designed to achieve, as applicable, at least the following security objectives:’

(9) The following Article is inserted:

‘Article 51a

Security objectives of European cybersecurity certification schemes for managed security services


‘A European cybersecurity certification scheme for managed security services shall be designed to achieve, as applicable, at least the following security objectives:

(a) ensure that the managed security services are provided with the requisite competence, expertise and experience, including that the staff in charge of providing these services has a very high level of technical knowledge and competence in the specific field, sufficient and appropriate experience, and the highest degree of professional integrity;

(b) ensure that the provider has appropriate internal procedures in place to ensure that the managed security services are provided at a very high level of quality at all times ;

(c) protect data accessed, stored, transmitted or otherwise processed in relation to the provision of managed security services against accidental or unauthorised access, storage, disclosure, destruction, other processing, or loss or alteration or lack of availability;

(d) ensure that the availability and access to data, services and functions is restored in a timely manner in the event of a physical or technical incident;

(e) ensure that authorised persons, programs or machines are able only to access the data, services or functions to which their access rights refer;

(f) record, and enable to assess, which data, services or functions have been accessed, used or otherwise processed, at what times and by whom;

(g) ensure that the ICT products, ICT services and ICT processes [and the hardware] deployed in the provision of the managed security services are secure by default and by design, do not contain known vulnerabilities and include the latest security updates;’;

(10) Article 52 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. A European cybersecurity certification scheme may specify one or more of the following assurance levels for ICT products, ICT services, ICT processes and managed security services: ‘basic’, ‘substantial’ or ‘high’. The assurance level shall be commensurate with the level of the risk associated with the intended use of the ICT product, ICT service, ICT process or managed security service, in terms of the probability and impact of an incident.’;

(b) paragraph 3 is replaced by the following:

‘3. The security requirements corresponding to each assurance level shall be provided in the relevant European cybersecurity certification scheme, including the corresponding security functionalities and the corresponding rigour and depth of the evaluation that the ICT product, ICT service, ICT process or managed security service is to undergo.’;

(c) paragraphs 5, 6 and 7 are replaced by the following:

‘5. A European cybersecurity certificate or EU statement of conformity that refers to assurance level ‘basic’ shall provide assurance that the ICT products, ICT services, ICT processes and managed security services for which that certificate or that EU statement of conformity is issued meet the corresponding security requirements, including security functionalities, and that they have been evaluated at a level intended to minimise the known basic risks of incidents and cyberattacks. The evaluation activities to be undertaken shall include at least a review of technical documentation. Where such a review is not appropriate, substitute evaluation activities with equivalent effect shall be undertaken.

6. A European cybersecurity certificate that refers to assurance level ‘substantial’ shall provide assurance that the ICT products, ICT services, ICT processes and managed security services for which that certificate is issued meet the corresponding security requirements, including security functionalities, and that they have been evaluated at a level intended to minimise the known cybersecurity risks, and the risk of incidents and cyberattacks carried out by actors with limited skills and resources. The evaluation activities to be undertaken shall include at least the following: a review to demonstrate the absence of publicly known vulnerabilities and testing to demonstrate that the ICT products, ICT services, ICT processes or managed security services correctly implement the necessary security functionalities. Where any such evaluation activities are not appropriate, substitute evaluation activities with equivalent effect shall be undertaken.

7. A European cybersecurity certificate that refers to assurance level ‘high’ shall provide assurance that the ICT products, ICT services, ICT processes and managed security services for which that certificate is issued meet the corresponding security requirements, including security functionalities, and that they have been evaluated at a level intended to minimise the risk of state-of-the-art cyberattacks carried out by actors with significant skills and resources. The evaluation activities to be undertaken shall include at least the following: a review to demonstrate the absence of publicly known vulnerabilities; testing to demonstrate that the ICT products, ICT services, ICT processes or managed security services correctly implement the necessary security functionalities at the state of the art; and an assessment of their resistance to skilled attackers, using penetration testing. Where any such evaluation activities are not appropriate, substitute activities with equivalent effect shall be undertaken.’;

(11) in Article 53, paragraphs 1, 2 and 3 are replaced by the following:

‘1.   A European cybersecurity certification scheme may allow for the conformity self-assessment under the sole responsibility of the manufacturer or provider of ICT products, ICT services, ICT processes or managed security services. Conformity self-assessment shall be permitted only in relation to ICT products, ICT services, ICT processes and managed security services that present a low risk corresponding to assurance level ‘basic’.

2. The manufacturer or provider of ICT products, ICT services, ICT processes or managed security services may issue an EU statement of conformity stating that the fulfilment of the requirements set out in the scheme has been demonstrated. By issuing such a statement, the manufacturer or provider of ICT products, ICT services, ICT processes or managed security services shall assume responsibility for the compliance of the ICT product, ICT service, ICT process or managed security service with the requirements set out in that scheme.

3. The manufacturer or provider of ICT products, ICT services, ICT processes or managed security services shall make the EU statement of conformity, technical documentation, and all other relevant information relating to the conformity of the ICT products, ICT services or managed security services with the scheme available to the national cybersecurity certification authority referred to in Article 58 for the period provided for in the corresponding European cybersecurity certification scheme. A copy of the EU statement of conformity shall be submitted to the national cybersecurity certification authority and to ENISA.’;

(12) in Article 54, paragraph 1 is amended as follows:

(a) point (a) is replaced by the following:

‘(a) the subject matter and scope of the certification scheme, including the type or categories of ICT products, ICT services, ICT processes and managed security services covered;’;

(b) point (j) is replaced by the following:

‘(j) rules for monitoring compliance of ICT products, ICT services, ICT processes and managed security services with the requirements of the European cybersecurity certificates or the EU statements of conformity, including mechanisms to demonstrate continued compliance with the specified cybersecurity requirements;’;

(c) point (l) is replaced by the following:

‘(l) rules concerning the consequences for ICT products, ICT services, ICT processes and managed security services that have been certified or for which an EU statement of conformity has been issued, but which do not comply with the requirements of the scheme;’;

(d) point (o) is replaced by the following:

‘(o) the identification of national or international cybersecurity certification schemes covering the same type or categories of ICT products, ICT services, ICT processes and managed security services, security requirements, evaluation criteria and methods, and assurance levels;’;

(e) point (q) is replaced by the following:

‘(q) the period of the availability of the EU statement of conformity, technical documentation, and all other relevant information to be made available by the manufacturer or provider of ICT products, ICT services, ICT or managed security services processes;’;


(13) Article 56 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. ICT products, ICT services, ICT processes and managed security services that have been certified under a European cybersecurity certification scheme adopted pursuant to Article 49 shall be presumed to comply with the requirements of such scheme’;.

(b) paragraph 3 is amended as follows:

(i) the first subparagraph is replaced by the following:

‘The Commission shall regularly assess the efficiency and use of the adopted European cybersecurity certification schemes and whether a specific European cybersecurity certification scheme is to be made mandatory through relevant Union law to ensure an adequate level of cybersecurity of ICT products, ICT services, ICT processes and managed security services in the Union and improve the functioning of the internal market. The first such assessment shall be carried out by 31 December 2023, and subsequent assessments shall be carried out at least every two years thereafter. Based on the outcome of those assessments, the Commission shall identify the ICT products, ICT services, ICT processes and managed security services covered by an existing certification scheme which are to be covered by a mandatory certification scheme.’;

(ii) the third subparagraph is amended as follows:

(aa) point (a) is replaced by the following:

‘(a) take into account the impact of the measures on the manufacturers or providers of such ICT products, ICT services, ICT processes or managed security services and on the users in terms of the cost of those measures and the societal or economic benefits stemming from the anticipated enhanced level of security for the targeted ICT products, ICT services, ICT processes or managed security services;’;

(bb) point (d) is replaced by the following:

‘(d) take into account any implementation deadlines, transitional measures and periods, in particular with regard to the possible impact of the measure on the manufacturers or providers of ICT products, ICT services, ICT processes or managed security services, including SMEs;’;

(c) paragraphs 7 and 8 are replaced by the following:

‘7. The natural or legal person who submits ICT products, ICT services, ICT processes or managed security services for certification shall make available to the national cybersecurity certification authority referred to in Article 58, where that authority is the body issuing the European cybersecurity certificate, or to the conformity assessment body referred to in Article 60 all information necessary to conduct the certification.

8. The holder of a European cybersecurity certificate shall inform the authority or body referred to in paragraph 7 of any subsequently detected vulnerabilities or irregularities concerning the security of the certified ICT product, ICT service, ICT process or managed security services that may have an impact on its compliance with the requirements related to the certification. That authority or body shall forward that information without undue delay to the national cybersecurity certification authority concerned.’

(14) in Article 57, paragraphs 1 and 2 are replaced by the following:

‘1. Without prejudice to paragraph 3 of this Article, national cybersecurity certification schemes, and the related procedures for the ICT products, ICT services, ICT processes and managed security services that are covered by a European cybersecurity certification scheme shall cease to produce effects from the date established in the implementing act adopted pursuant to Article 49(7). National cybersecurity certification schemes and the related procedures for the ICT products, ICT services, ICT processes and managed security services that are not covered by a European cybersecurity certification scheme shall continue to exist.

2. Member States shall not introduce new national cybersecurity certification schemes for ICT products, ICT services, ICT processes and managed security services already covered by a European cybersecurity certification scheme that is in force.’;

(15) Article 58 is amended as follows:

(a) paragraph 7 is amended as follows:

(i) points (a) and (b) are replaced by the following:

‘(a) supervise and enforce rules included in European cybersecurity certification schemes pursuant to point (j) of Article 54(1) for the monitoring of the compliance of ICT products, ICT services, ICT processes and managed security services with the requirements of the European cybersecurity certificates that have been issued in their respective territories, in cooperation with other relevant market surveillance authorities;

(b) monitor compliance with and enforce the obligations of the manufacturers or providers of ICT products, ICT services, ICT processes or managed security services that are established in their respective territories and that carry out conformity self-assessment, and shall, in particular, monitor compliance with and enforce the obligations of such manufacturers or providers set out in Article 53(2) and (3) and in the corresponding European cybersecurity certification scheme;’;

(ii) point (h) is replaced by the following:

‘(h) cooperate with other national cybersecurity certification authorities or other public authorities, including by sharing information on the possible non-compliance of ICT products, ICT services, ICT processes and managed security services with the requirements of this Regulation or with the requirements of specific European cybersecurity certification schemes; and’;

(b) paragraph 9 is replaced by the following:

‘9. National cybersecurity certification authorities shall cooperate with each other and with the Commission, in particular, by exchanging information, experience and good practices as regards cybersecurity certification and technical issues concerning the cybersecurity of ICT products, ICT services, ICT and managed security services processes.’;

(16) in Article 59 (3), points (b) and (c) are replaced by the following:

‘(b) the procedures for supervising and enforcing the rules for monitoring the compliance of ICT products, ICT services, ICT processes and managed security services with European cybersecurity certificates pursuant to Article 58(7), point (a);

(c) the procedures for monitoring and enforcing the obligations of manufacturers or providers of ICT products, ICT services, ICT processes or managed security services pursuant to Article 58(7), point (b);’;

(17) in Article 67, paragraphs 2 and 3 are replaced by the following:

‘2. The evaluation shall also assess the impact, effectiveness and efficiency of the provisions of Title III of this Regulation with regard to the objectives of ensuring an adequate level of cybersecurity of ICT products, ICT services, ICT processes and managed security services in the Union and improving the functioning of the internal market.

3. The evaluation shall assess whether essential cybersecurity requirements for access to the internal market are necessary in order to prevent ICT products, ICT services, ICT processes and managed security services which do not meet basic cybersecurity requirements from entering the Union market.’.


Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.