Regulation (EU) 2024/2748 of the European Parliament and of the Council of 9 October 2024 amending Regulations (EU) No 305/2011, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2023/988 and (EU) 2023/1230 as regards emergency procedures for the conformity assessment, presumption of conformity, adoption of common specifications and market surveillance due to an internal market emergency (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Having regard to the opinion of the Committee of the Regions (2),

Acting in accordance with the ordinary legislative procedure (3),

Whereas:

(1) Regulation (EU) 2024/2747 of the European Parliament and of the Council (4) lays down rules aiming to ensure, during a crisis, the normal functioning of the internal market, including the free movement of goods, services and persons, and the availability of crisis-relevant goods and services and of goods and services of critical importance to citizens, businesses and public authorities. That Regulation applies to both goods and services.

(2) Regulation (EU) 2024/2747 lays down measures which are to be deployed in a coherent, transparent, efficient, proportionate and timely manner, so as to prevent, mitigate and minimise the impact of a crisis on the functioning of the internal market.

(3) Regulation (EU) 2024/2747 lays down a multi-layered mechanism consisting of contingency planning and of internal market vigilance and emergency modes.

(4) In order to complement, ensure consistency and further enhance the effectiveness of the framework established by Regulation (EU) 2024/2747, it is appropriate to ensure that crisis-relevant goods referred to in that Regulation can be swiftly placed on the internal market in order to contribute to addressing and mitigating disruptions to that market.

(5) A number of sectorial Union legal acts lay down harmonised rules regarding the design, manufacture, placing on the market and, as applicable, conformity assessment of certain products. Such legal acts include Regulations (EU) No 305/2011 (5), (EU) 2016/424 (6), (EU) 2016/425 (7), (EU) 2016/426 (8) and (EU) 2023/1230 (9) of the European Parliament and of the Council (the ‘amended Regulations’). Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2023/1230 are based on the principles of the new approach to technical harmonisation. Moreover, those Regulations are also aligned to the reference provisions laid down by Decision No 768/2008/EC of the European Parliament and of the Council (10). Given the specificity of construction products and the particular focus of the system for their assessment, the procedures for the conformity assessment provided for in Decision No 768/2008/EC, and the modules set out therein, are not appropriate. Therefore, Regulation (EU) No 305/2011 lays down specific methods for the assessment and verification of constancy of performance in relation to the essential characteristics of construction products.

(6) Neither the reference provisions laid down by Decision No 768/2008/EC, nor the specific provisions laid down by the sectorial Union harmonisation legislation, provide for procedures designed to apply during a crisis. Therefore it is appropriate to introduce targeted adjustments to the amended Regulations, to allow a response to the impact of crises affecting products that have been designated as crisis-relevant goods in accordance with Regulation (EU) 2024/2747 and covered by the amended Regulations.

(7) Experience from previous crises that have affected the internal market has shown that the procedures laid down in the sectorial Union legal acts are not designed to cater to the needs of crisis-response scenarios and do not offer the necessary regulatory flexibility. It is therefore appropriate to provide for a legal basis for such crisis-response procedures in order to complement the measures adopted under Regulation (EU) 2024/2747.

(8) Non-harmonised products can also be designated as crisis-relevant goods. Therefore, some of the relevant mechanisms under this Regulation, in particular the presumption of conformity with the general safety requirement based on national requirements, or on national or international standards, could provide an additional way to demonstrate the presumption of safety of non-harmonised crisis-relevant goods during a crisis. This would facilitate the placing on the market of those goods during a crisis.

(9) In order to overcome the potential effects of disruptions to the functioning of the internal market in the event of a crisis and in order to ensure that during an internal market emergency mode crisis-relevant goods can be placed on the market swiftly, it is appropriate to provide for a requirement for the conformity assessment bodies to prioritise the conformity assessment applications for such goods over any pending applications concerning products which have not been designated as crisis-relevant goods. In the context of such prioritisation, the conformity assessment body should not be allowed to charge additional disproportionate costs to the manufacturer. All additional costs charged by a conformity assessment body to the manufacturer should be strictly proportionate to the actual additional efforts deployed by the conformity assessment body to implement the prioritisation and should be charged only during the internal market emergency mode. The transfer of certain additional and proportionate costs by the conformity assessment bodies to the manufacturers should remain exceptional and reflect a fair distribution of the costs among all the stakeholders involved in the efforts to contain the disruptions to the functioning of the internal market. The costs associated with a conformity assessment should not become a barrier to the entry on the market of prospective new manufacturers, in particular small and medium-sized enterprises, and should not restrict the emergence of innovative products. Furthermore, conformity assessment bodies notified under the amended Regulations should be encouraged to increase their testing capacities for products designated as crisis-relevant goods in respect of which they have been notified.

(10) Emergency procedures should be laid down in Regulations (EU) No 305/2011, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2023/988 of the European Parliament and of the Council (11) and Regulation (EU) 2023/1230. Those procedures should become applicable only following the activation of the internal market emergency mode and only when a specific good covered by those Regulations is designated as a crisis-relevant good in accordance with Regulation (EU) 2024/2747 and the Commission has adopted an implementing act activating those procedures in accordance with that Regulation.

(11) Furthermore, in cases where, for example, the disruptions to the functioning of the internal market could affect the conformity assessment bodies or in cases where the testing capacities for products designated as crisis-relevant goods would not be sufficient, it is appropriate to provide for the possibility for the national competent authorities to exceptionally and temporarily authorise the placing on the market of products which have not undergone the usual conformity assessment procedures required by the respective sectorial Union harmonisation legislation.

(12) As regards products falling within the scope of the amended Regulations that have been designated as crisis-relevant goods, in the context of an ongoing internal market emergency the national competent authorities should be able to derogate from the obligation to carry out the conformity assessment procedures laid down in the amended Regulations, where the involvement of a notified body is mandatory. In such cases those authorities should be able to issue authorisations for placing on the market, and, as applicable, for putting into service, those products, provided that conformity with all the applicable essential safety requirements is ensured. It should be possible to demonstrate compliance with those requirements by various means, which could include testing performed by the national authorities of samples provided by the manufacturer having applied for an authorisation. The specific procedures which were followed to demonstrate the compliance and their results should be clearly described in the authorisation issued by the national competent authority.

(13) Given that the essential safety requirements harmonised by the amended Regulations will remain applicable and that it should be possible for a national competent authority to issue the authorisation for placing products on the market without the CE marking exceptionally, temporarily and in addition to the conformity assessment procedures laid down in those Regulations, this Regulation continues to improve the conditions for the functioning of the internal market. This Regulation takes into account both the context constituted by the fully harmonised rules stemming from the existing Regulations and the complementary rules stemming from amendments that this Regulation makes to them. Those amendments would allow national authorities to recognise authorisations issued in other Member States and require the Commission to extend the validity of such national authorisations from the territory of a single Member State to the territory of the Union, by means of implementing acts, provided that the requirements set out in the authorisation ensure conformity with the essential requirements laid down in those amended Regulations. Such a parallel national authorisation scheme in exceptional times of crisis, in addition to the Union conformity assessment procedure, is justified and proportionate for the achievement of the legitimate objective of protecting the health, life and safety of persons. By not providing for an automatic mutual recognition of each national authorisation that derogates from conformity assessment procedures in times of crisis, this Regulation aims to avoid any circumvention or undermining of the CE marking procedure and thereby aims to maintain consumer confidence in the safety of products in the Union market bearing the CE marking. Therefore, those new derogating rules, insofar as they prohibit affixing the CE marking to products which have been approved only at national level, should not affect the harmonised product legislation and consumer confidence in CE marking, which can only be affixed where all the harmonised substantive and procedural rules have been respected. By providing an additional, parallel avenue for exceptionally placing crisis-relevant goods on the market in the context of an internal market emergency, the derogating rules enable new manufacturers to swiftly place their products on the market without waiting for the finalisation of the normal conformity assessment procedures. Such an accelerated and exceptional placing on the market would contribute to the swift increase in the supply of crisis-relevant goods, and at the same time facilitate manufacturers as it would allow them to place initial batches or series of products on the market before the completion of the conformity assessment procedures. Once the conformity assessment procedures have been successfully completed, subsequent batches or series of products should be fully compliant with the relevant applicable rules and thus benefit from free movement. The co-existence, during an internal market emergency, of an exceptional, derogating set of rules alongside the ordinarily applicable rules makes it possible to transition to the ordinarily applicable rules, enabling the manufacturers to continue placing their products on the market after the expiry or deactivation of the internal market emergency mode.

(14) Where the Commission has extended the validity of an authorisation issued by a Member State to the territory of the whole Union by means of an implementing act, the conditions for the placing on the market of the goods concerned set out therein should apply only to those goods placed on the market after the date of entry into force of that implementing act. That implementing act could provide that the benefit of the free movement is also granted to goods already placed on the market on the basis of pre-existing authorisations. All pre-existing authorisations issued by Member States prior to the entry into force of a Commission implementing act should cease to provide a legal basis for the placing of the goods on the market after the entry into force of the Commission implementing act concerning the same goods, and Member States should take the necessary actions to that effect. Goods already placed on the market on the basis of an authorisation adopted by a Member State prior to the adoption of the Commission implementing act should not need to be withdrawn or recalled unless specific safety concerns have been identified with respect to such goods which result in the need for corrective or restrictive actions to be taken by the Commission by means of another implementing act.

(15) The validity of all authorisations, issued during an active internal market emergency mode in accordance with the emergency procedures established by this Regulation, for the placing on the market of products designated as crisis-relevant goods, should automatically expire on the date of expiry or deactivation of the internal market emergency mode. However, it should also be possible to issue authorisations with a shorter validity. Once an authorisation has expired, crisis-relevant goods should no longer be placed on the market on the basis of that authorisation. However, the expiry of an authorisation should not automatically trigger an obligation to withdraw or recall goods which have already been placed on the market on the basis of that authorisation. In cases where the placing on the market has occurred in breach of the conditions laid down in the authorisation or where there are sufficient reasons to believe that the goods covered by such authorisation present a risk to the health or safety of persons, the national market surveillance authorities should be entitled to take all the corrective and restrictive actions at their disposal in accordance with the amended Regulations and Regulation (EU) 2019/1020 of the European Parliament and of the Council (12). In order to ensure uniform conditions for the implementation of the sectorial emergency procedures, the Commission should be empowered to lay down rules regarding the follow-up actions to be taken and the procedures to be followed with respect to the goods placed on the market in accordance with the relevant sectorial emergency procedures.

(16) In order to ensure the timely sharing of information and to allow all Member States to react, the Commission and the other Member States should be informed immediately of any decisions taken at national level to authorise crisis-relevant goods. The Information and Communication System for Market Surveillance (ICSMS) provided for in Regulation (EU) 2019/1020 already provides the necessary functions to allow quick notification of administrative decisions and therefore Member States should be able to use it for that purpose. Moreover, information on all corrective or restrictive actions should also be shared. Pursuant to Regulation (EU) 2019/1020, such information is to be accessible in the ICSMS irrespective of whether those actions have to be notified in the Safety Gate due to the products presenting a serious risk. Double entry will be avoided by means of the data interface between the Safety Gate and the ICSMS, which will be maintained by the Commission in accordance with Regulation (EU) 2019/1020.

(17) All authorisations for the placing on the market of crisis-relevant goods issued by Member States should contain at least certain information supporting the assessment that the goods concerned are compliant with the applicable essential requirements and should contain certain elements ensuring traceability. The elements concerning traceability should include specific requirements regarding the labelling, accompanying documents or any additional means of ensuring the identification of the goods concerned and allowing them to be traced along the supply chain. In order to ensure uniform and coherent implementation of the traceability requirements across the Union, Commission implementing acts extending the validity of authorisations issued by a Member State should also specify the common traceability requirements. Those requirements should include the specific arrangements regarding the indication that the product concerned is a ‘crisis-relevant good’. The Commission should be empowered to adopt via implementing acts, on expiry or deactivation of the internal market emergency mode, any necessary adjustments to the traceability requirements for crisis-relevant goods that have already been placed on the market on the basis of an authorisation issued by a Member State.

(18) Where an internal market emergency causes an exponential increase in the demand for certain products and in order to support the efforts of economic operators to meet such demand, it is appropriate to establish a mechanism for the provision of technical references which manufacturers should be able to use to design and produce crisis-relevant goods that comply with the applicable essential health and safety requirements.

(19) A number of sectorial Union harmonised acts provide for the possibility for a manufacturer to benefit from a presumption of conformity if its product complies with a harmonised standard. In addition, the Union general product safety framework established by Regulation (EU) 2023/988 establishes, under certain conditions, a mechanism of presumption of conformity with the general safety requirement where a product complies with relevant European standards, the references of which have been published in the Official Journal of the European Union. However, in cases where such standards do not exist or compliance with them might be rendered excessively difficult by the disruptions caused by the crisis, it is appropriate to provide for alternative crisis-response mechanisms.