Cyber Resilience Act, Preamble 61 to 71 (15.9.2022)
(61) Simultaneous coordinated control actions (‘sweeps’) are specific enforcement actions by market surveillance authorities that can further enhance product security. Sweeps should, in particular, be conducted where market trends, consumer complaints or other indications suggest that certain product categories are often found to present cybersecurity risks. ENISA should submit proposals for categories of products for which sweeps could be organised to the market surveillance authorities, based, among others, on the notifications of product vulnerabilities and incidents it receives.
(62) In order to ensure that the regulatory framework can be adapted where necessary, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of updates to the list of critical products in Annex III and specifying the definitions of the these product categories. Power to adopt acts in accordance with that Article should be delegated to the Commission to identify products with digital elements covered by other Union rules which achieve the same level of protection as this Regulation, specifying whether a limitation or exclusion from the scope of this Regulation would be necessary as well as the scope of that limitation, if applicable. Power to adopt acts in accordance with that Article should also be delegated to the Commission in respect of the potential mandating of certification of certain highly critical products with digital elements based on criticality crieria set out in this Regulation, as well as for specifying the minimum content of the EU declaration of conformity and supplementing the elements to be included in the technical documentation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making 33 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
(63) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to: specify the format and elements of the software bill of materials, specify further the type of information, format and procedure of the notifications on actively exploited vulnerabilities and incidents submitted to ENISA by the manufacturers, specify the European cybersecurity certification schemes adopted pursuant to Regulation (EU) 2019/881 that can be used to demonstrate conformity with the essential requirements or parts therefore as set out in Annex I of this Regulation, adopt common specifications in respect of the essential requirements set out in Annex I, lay down technical specifications for pictograms or any other marks related to the security of the products with digital elements, and mechanisms to promote their use, decide on corrective or restrictive measures at Union level in exceptional circumstances which justify an immediate intervention to preserve the good functioning of the internal market. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council 34 .
(64) In order to ensure trustful and constructive cooperation of market surveillance authorities at Union and national level, all parties involved in the application of this Regulation should respect the confidentiality of information and data obtained in carrying out their tasks.
(65) In order to ensure effective enforcement of the obligations laid down in this Regulation, each market surveillance authority should have the power to impose or request the imposition of administrative fines. Maximum levels for administrative fines to be provided for in national laws for non-compliance with the obligations laid down in this Regulation should therefore be established. When deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation should be taken into account and as a minimum those explicitly established in this Regulation, including whether administrative fines have been already applied by other market surveillance authorities to the same operator for similar infringements. Such circumstances can be either aggravating, in situations where the infringement by the same operator persists on the territory of other Member States than the one where an administrative fine has already been applied, or mitigating, in ensuring that any other administrative fine considered by another market surveillance authority for the same economic operator or the same type of breach should already take account, along with other relevant specific circumstances, of a penalty and the quantum thereof imposed in other Member States. In all such cases, the cumulative administrative fine that could be applied by market surveillance authorities of several Member States to the same economic operator for the same type of infringement should ensure the respect of the principle of proportionality.
(66) Where administrative fines are imposed on persons that are not an undertaking, the competent authority should take account of the general level of income in the Member State as well as the economic situation of the person when considering the appropriate amount of the fine. It should be for the Member States to determine whether and to what extent public authorities should be subject to administrative fines.
(67) In its relationships with third countries, the EU endeavours to promote international trade in regulated products. A broad variety of measures can be applied in order to facilitate trade, including several legal instruments such as bilateral (inter-governmental) Mutual Recognition Agreements (MRAs) for conformity assessment and marking of regulated products. MRAs are established between the Union and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment. These agreements are based on the mutual acceptance of certificates, marks of conformity and test reports issued by the conformity assessment bodies of either party in conformity with the legislation of the other party. Currently MRAs are in place for several countries. The agreements are concluded in a number of specific sectors, which might vary from one country to another. In order to further facilitate trade, and recognising that supply chains of products with digital elements are global, MRAs concerning conformity assessment may be concluded for products regulated under this Regulation by the Union in accordance with Article 218 TFEU. Cooperation with partner countries is also important, in order to strengthen cyber resilience globally, as in the long term this will contribute to a strengthened cybersecurity framework both within and outside of the EU.
(68) The Commission should periodically review this Regulation, in consultation with interested parties, in particular with a view to determining the need for modification in the light of changes to societal, political, technological or market conditions.
(69) Economic operators should be provided with a sufficient time to adapt to the requirements of this Regulation. This Regulation should apply [24 months] from its entry into force, with the exception of the reporting obligations concerning actively exploited vulnerabilities and incidents, which should apply [12 months] from the entry into force of this Regulation.
(70) Since the objective of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of the effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
(71) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council 35 and delivered its opinion on […],
Cyber Resilience Act Text 15.9.2022
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