Source: OJ L 2024/2847, 20.11.2024Current language: EN
- Cyber resilience for products with digital elements
Basic legislative acts
- CRA regulation
Annex I ESSENTIAL CYBERSECURITY REQUIREMENTS
Part I Cybersecurity requirements relating to the properties of products with digital elements
Products with digital elements shall be designed, developed and produced in such a way that they ensure an appropriate level of cybersecurity based on the risks.
On the basis of the cybersecurity risk assessment referred to in Article 13(2) and where applicable, products with digital elements shall:
be made available on the market without known exploitable vulnerabilities;
be made available on the market with a secure by default configuration, unless otherwise agreed between manufacturer and business user in relation to a tailor-made product with digital elements, including the possibility to reset the product to its original state;
ensure that vulnerabilities can be addressed through security updates, including, where applicable, through automatic security updates that are installed within an appropriate timeframe enabled as a default setting, with a clear and easy-to-use opt-out mechanism, through the notification of available updates to users, and the option to temporarily postpone them;
ensure protection from unauthorised access by appropriate control mechanisms, including but not limited to authentication, identity or access management systems, and report on possible unauthorised access;
protect the confidentiality of stored, transmitted or otherwise processed data, personal or other, such as by encrypting relevant data at rest or in transit by state of the art mechanisms, and by using other technical means;
protect the integrity of stored, transmitted or otherwise processed data, personal or other, commands, programs and configuration against any manipulation or modification not authorised by the user, and report on corruptions;
process only data, personal or other, that are adequate, relevant and limited to what is necessary in relation to the intended purpose of the product with digital elements (data minimisation);
protect the availability of essential and basic functions, also after an incident, including through resilience and mitigation measures against denial-of-service attacks;
minimise the negative impact by the products themselves or connected devices on the availability of services provided by other devices or networks;
be designed, developed and produced to limit attack surfaces, including external interfaces;
be designed, developed and produced to reduce the impact of an incident using appropriate exploitation mitigation mechanisms and techniques;
provide security related information by recording and monitoring relevant internal activity, including the access to or modification of data, services or functions, with an opt-out mechanism for the user;
provide the possibility for users to securely and easily remove on a permanent basis all data and settings and, where such data can be transferred to other products or systems, ensure that this is done in a secure manner.
Part II Vulnerability handling requirements
Manufacturers of products with digital elements shall:
identify and document vulnerabilities and components contained in products with digital elements, 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 products;
in relation to the risks posed to products with digital elements, address and remediate vulnerabilities without delay, including by providing security updates; where technically feasible, new security updates shall be provided separately from functionality updates;
apply effective and regular tests and reviews of the security of the product with digital elements;
once a security update has been made available, share and publicly disclose information about fixed vulnerabilities, including a description of the vulnerabilities, information allowing users to identify the product with digital elements affected, the impacts of the vulnerabilities, their severity and clear and accessible information helping users to remediate the vulnerabilities; in duly justified cases, where manufacturers consider the security risks of publication to outweigh the security benefits, they may delay making public information regarding a fixed vulnerability until after users have been given the possibility to apply the relevant patch;
put in place and enforce a policy on coordinated vulnerability disclosure;
take measures to facilitate the sharing of information about potential vulnerabilities in their product with digital elements as well as in third-party components contained in that product, including by providing a contact address for the reporting of the vulnerabilities discovered in the product with digital elements;
provide for mechanisms to securely distribute updates for products with digital elements to ensure that vulnerabilities are fixed or mitigated in a timely manner and, where applicable for security updates, in an automatic manner;
ensure that, where security updates are available to address identified security issues, they are disseminated without delay and, unless otherwise agreed between a manufacturer and a business user in relation to a tailor-made product with digital elements, free of charge, accompanied by advisory messages providing users with the relevant information, including on potential action to be taken.
Relevant recitals
Recital 40 Support period and security updates
Taking into account the iterative nature of software development, manufacturers that have placed subsequent versions of a software product on the market as a result of a subsequent substantial modification of that product should be able to provide security updates for the support period only for the version of the software product that they have last placed on the market. They should be able to do so only if the users of the relevant previous product versions have access to the product version last placed on the market free of charge and do not incur additional costs to adjust the hardware or software environment in which they operate the product. This could, for instance, be the case where a desktop operating system upgrade does not require new hardware, such as a faster central processing unit or more memory. Nonetheless, the manufacturer should continue to comply, for the support period, with other vulnerability-handling requirements, such as having a policy on coordinated vulnerability disclosure or measures in place to facilitate the sharing of information about potential vulnerabilities for all subsequent substantially modified versions of the software product placed on the market. Manufacturers should be able to provide minor security or functionality updates that do not constitute a substantial modification only for the latest version or sub-version of a software product that has not been substantially modified. At the same time, where a hardware product, such as a smartphone, is not compatible with the latest version of the operating system it was originally delivered with, the manufacturer should continue to provide security updates at least for the latest compatible version of the operating system for the support period.
Recital 53 Overlap with the machinery regulation
Manufacturers of products falling within the scope of Regulation (EU) 2023/1230 of the European Parliament and of the Council(24)Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (OJ L 165, 29.6.2023, p. 1). which are also products with digital elements as defined in this Regulation should comply with both the essential cybersecurity requirements set out in this Regulation and the essential health and safety requirements set out in Regulation (EU) 2023/1230. The essential cybersecurity requirements set out in this Regulation and certain essential requirements set out in Regulation (EU) 2023/1230 might address similar cybersecurity risks. Therefore, the compliance with the essential cybersecurity requirements set out in this Regulation could facilitate the compliance with the essential requirements that also cover certain cybersecurity risks as set out in Regulation (EU) 2023/1230, and in particular those regarding the protection against corruption and safety and reliability of control systems set out in sections 1.1.9 and 1.2.1 of Annex III to that Regulation. Such synergies have to be demonstrated by the manufacturer, for instance by applying, where available, harmonised standards or other technical specifications covering relevant essential cybersecurity requirements following a risk assessment covering those cybersecurity risks. The manufacturer should also follow the applicable conformity assessment procedures set out in this Regulation and in Regulation (EU) 2023/1230. The Commission and the European standardisation organisations, in the preparatory work supporting the implementation of this Regulation and of Regulation (EU) 2023/1230 and the related standardisation processes, should promote consistency in how the cybersecurity risks are to be assessed and in how those risks are to be covered by harmonised standards with regard to the relevant essential requirements. In particular, the Commission and the European standardisation organisations should take into account this Regulation in the preparation and development of harmonised standards to facilitate the implementation of Regulation (EU) 2023/1230 as regards in particular the cybersecurity aspects related to the protection against corruption and safety and reliability of control systems set out in sections 1.1.9 and 1.2.1 of Annex III to that Regulation. The Commission should provide guidance to support manufacturers subject to this Regulation that are also subject to Regulation (EU) 2023/1230, in particular to facilitate the demonstration of compliance with relevant essential requirements set out in this Regulation and in Regulation (EU) 2023/1230.
Recital 54 Assessment of cybersecurity risks
In order to ensure that products with digital elements are secure both at the time of their placing on the market as well as during the time the product with digital elements is expected to be in use, it is necessary to lay down essential cybersecurity requirements for vulnerability handling and essential cybersecurity requirements relating to the properties of products with digital elements. While manufacturers should comply with all essential cybersecurity requirements related to vulnerability handling throughout the support period, they should determine which other essential cybersecurity requirements related to the product properties are relevant for the type of product with digital elements concerned. For that purpose, manufacturers should undertake an assessment of the cybersecurity risks associated with a product with digital elements to identify relevant risks and relevant essential cybersecurity requirements in order to make available their products with digital elements without known exploitable vulnerabilities that might have an impact on the security of those products and to appropriately apply suitable harmonised standards, common specifications or European or international standards.
Recital 56 Automatic security updates
One of the most important measures for users to take in order to protect their products with digital elements from cyberattacks is to install the latest available security updates as soon as possible. Manufacturers should therefore design their products and put in place processes to ensure that products with digital elements include functions that enable the notification, distribution, download and installation of security updates automatically, in particular in the case of consumer products. They should also provide the possibility to approve the download and installation of the security updates as a final step. Users should retain the ability to deactivate automatic updates, with a clear and easy-to-use mechanism, supported by clear instructions on how users can opt out. The requirements relating to automatic updates as set out in an annex to this Regulation are not applicable to products with digital elements primarily intended to be integrated as components into other products. They also do not apply to products with digital elements for which users would not reasonably expect automatic updates, including products with digital elements intended to be used in professional ICT networks, and especially in critical and industrial environments where an automatic update could cause interference with operations. Irrespective of whether a product with digital elements is designed to receive automatic updates or not, its manufacturer should inform users about vulnerabilities and make security updates available without delay. Where a product with digital elements has a user interface or similar technical means allowing direct interaction with its users, the manufacturer should make use of such features to inform users that their product with digital elements has reached the end of the support period. Notifications should be limited to what is necessary in order to ensure the effective reception of this information and should not have a negative impact on the user experience of the product with digital elements.
Recital 57 Separation of security and functionality updates
To improve the transparency of vulnerability handling processes and to ensure that users are not required to install new functionality updates for the sole purpose of receiving the latest security updates, manufacturers should ensure, where technically feasible, that new security updates are provided separately from functionality updates.
Recital 64 Secure by default and free security updates
Manufacturers should make their products with digital elements available on the market with a secure by default configuration and provide security updates to users free of charge. Manufacturers should only be able to deviate from the essential cybersecurity requirements in relation to tailor-made products that are fitted to a particular purpose for a particular business user and where both the manufacturer and the user have explicitly agreed to a different set of contractual terms.
Recital 77 Software bill of materials
In order to facilitate vulnerability analysis, manufacturers should identify and document components contained in the products with digital elements, including by drawing up an SBOM. An SBOM can provide those who manufacture, purchase, and operate software with information that enhances their understanding of the supply chain, which has multiple benefits, in particular it helps manufacturers and users to track known newly emerged vulnerabilities and cybersecurity risks. It is of particular importance that manufacturers ensure that their products with digital elements do not contain vulnerable components developed by third parties. Manufacturers should not be obliged to make the SBOM public.
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