The European Parliament adopted by 412 votes to 52, with 161 abstentions, a legislative resolution on the proposal for a directive of the European Parliament and of the Council amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2013/29/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU as regard emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency.

The European Parliament adopted its position at first reading under the ordinary legislative procedure.

The proposed directive is part of a package of texts establishing the single market instrument for emergency situations . It amends the harmonised rules established by a number of EU sectoral frameworks. It amends a number of EU sectoral directives that lay down harmonised rules governing the design, manufacture, conformity assessment and placing on the market of certain goods.

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 establishing a single market instrument for emergency situations.

In order to overcome the potential effects of disruptions to the internal market in the event of a crisis and to ensure that during an internal market emergency mode harmonised 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 of 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.

Emergency procedures should be laid down in Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2014/29/EU, 2014/30/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU. Those procedures should become applicable only following the activation of the internal market emergency mode, only when a specific good covered by those Directives is designated as a crisis-relevant good and the Commission has adopted an implementing act activating those procedures in accordance with that Regulation.

As regards products, falling within the scope of the amended Directives, 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 Directives, 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.

Therefore, this Directive takes into account both the context constituted by the fully harmonised rules stemming from the amended Directives and the complementary rules stemming from amendments made 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 Directives

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.

The validity of all authorisations, issued during an active internal market emergency mode in accordance with the emergency procedures established by this Directive, 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 the market on the basis of that authorisation.

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 Committee on the Internal Market and Consumer Protection adopted the report by Andreas SCHWAB (EPP, DE) on the proposal for a directive of the European Parliament and of the Council amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2013/29/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU as regards emergency procedures for conformity assessment, the adoption of common specifications and market surveillance on grounds of a single market emergency.

The proposal aims to address two distinct but interrelated problems: obstacles to the free movement of goods, services and persons in times of crisis, and shortages of crisis-relevant goods and services. It is part of a package of texts establishing the single market instrument for emergencies, which Members propose to rename the Internal Market Emergency and Resilience Act (IMERA regulation).

The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows.

The proposal aims to amend the harmonised rules established by a number of EU sectoral frameworks. These frameworks do not provide for the possibility for Member States to adopt crisis response measures by way of derogation from the harmonised rules.

The Commission proposes to amend 13 sectoral directives. The EU sectoral frameworks that are considered in the context of the proposal are those that form part of the ‘harmonised products’. These sectoral frameworks establish harmonised rules for the design, manufacture, conformity assessment and placing on the market of the products concerned.

The proposal provides for the possibility for competent national authorities to exceptionally and temporarily authorise the placing on the market of products that have not been subject to the usual conformity assessment procedures required by the Union. Members specified that the authorisation granted for products on an exceptional and temporary basis should remain valid for six months after the deactivation or expiration of the internal market emergency mode, where it does not affect the health and safety of consumers. After this period, products should only be made available on the market after having received authorisation under the normal authorisation procedure provided for under the applicable rules.

In addition, the national competent authorities should be able, in the context of an ongoing internal market emergency, to derogate from the obligation to carry out those conformity assessment procedures laid down in those Regulations, where the involvement of a notified body is mandatory and should be able to issue authorisations for those products, provided that they comply with all the applicable essential safety requirements and that the safety of consumers and end-users is fully assured. The principle of mutual recognition should apply to goods placed on the market under that derogation.

Products manufactured during the internal market emergency mode, where derogation from the conformity assessment procedures was authorised, should also be subject to the relevant obligations of traceability provided for in Regulation (EU) 2023/988 on general product safety.

Regarding the directives concerned by the proposal, Members deleted the possibility for the Commission to adopt, in exceptional and duly justified circumstances, by means of implementing acts, common specifications laying down mandatory technical specifications with which manufacturers will be required to comply, in particular in order to ensure interoperability between products or systems.

PURPOSE: to make targeted amendments to certain Directives regarding emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency.

PROPOSED ACT: Directive of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: recent crises, such as the COVID-19 pandemic or Russia’s invasion of Ukraine, have demonstrated some vulnerability of the Single Market and its supply chains in case of unforeseen disruptions and, at the same time, how much the European economy and all its stakeholders rely on a well-functioning Single Market. In the future, in addition to geopolitical instability, climate change and resulting natural disasters, biodiversity loss, and global economic instability may lead to other, new emergency situations. For this reason, the functioning of the Single Market needs to be guaranteed in times of emergency .

The impact of a crisis on the Single Market can be two-fold. On the one hand, a crisis can lead to the appearance of obstacles to free movement within the Single Market, thus disrupting its functioning. On the other hand, a crisis can amplify the shortages of crisis-relevant goods and services if the Single Market is fragmented and is not functioning.

The proposal therefore aims to address two separate but interrelated problems: obstacles to free movement of goods, services and persons in times of crisis and shortages of crisis-relevant goods and services.

It is part of a package of proposal establishing the single market instrument for emergencies (SMEI) and responds to the request, expressed by the European Council in its conclusions of 1-2 October 2020, to draw lessons from the COVID-19 crisis and to address the fragmentation, barriers and weaknesses of the Single Market in facing emergency situations.

CONTENT: the proposal aims to amend the harmonised rules established by a number of EU sectoral frameworks . These frameworks do not provide for the possibility for Member States to adopt crisis response measures by derogation from the harmonised rules.

The proposal is based on Articles 91 and 114 TFEU, with Article 91 being the original legal basis for the adoption of Directive 2010/35/EU on transportable pressure equipment and Article 114 being the original legal basis for the remaining 13 sectoral frameworks.

These 13 sectoral frameworks are:

- Directive 2000/14/EC on noise emissions in the environment by equipment for use outdoors;

- Directive 2006/42/EU on machinery; Directive 2013/29/EU on pyrotechnic articles; Directive 2014/28/EU on civil explosives;

- Directive 2014/29/EU on simple pressure vessels;

- Directive 2014/30/EU on electromagnetic compatibility;

- Directive 2014/31/EU on non-automatic weighing instruments;

- Directive 2014/32/EU on measuring instruments;

- Directive 2014/33/EU on lifts;

- Directive 2014/34/EU on equipment for potentially explosive atmospheres (ATEX);

- Directive 2014/35/EU on low voltage equipment;

- Directive 2014/53/EU on radio equipment;

- Directive 2014/68/EU pressure equipment.

The EU sectoral frameworks, which are considered in the context of this proposal are the ones, which are among the so-called ‘harmonised products’. These sectoral frameworks lay down harmonised rules regarding the design, manufacture, conformity assessment and placing on the market of such products. Essentially, these sectoral frameworks introduce for each respective sector/product category the essential safety requirements which the products should meet and the procedures how to assess the compliance with these requirements. These rules lay down full harmonisation and therefore the Member States cannot derogate from these rules, even in a case of emergency, unless the respective framework provides for such a possibility.

Another common feature of these frameworks is that they are more or less closely aligned to the general principles laid down in Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products , which lays down reference provisions for the drawing up of Community legislation harmonising the conditions for the marketing of products.

The changes that this proposal aims to introduce cover the following aspects:

(1) prioritisation by the notified bodies of the conformity assessment of products designated as crisis-relevant;

(2) possibility for the national competent authorities to issue temporary authorisations for crisis relevant products, which have not undergone the standard conformity assessment procedures, provided that the products comply with all the applicable essential requirements and provided that the authorisation is limited to the duration of the Single Market emergency and to the territory of the issuing Member State;

(3) possibility for the manufacturers to rely on relevant international and national standards during an emergency if no harmonised standards are available and if the alternative standards ensure an equivalent level of safety;

(4) possibility for the Commission to adopt via delegated acts voluntary or mandatory common technical specifications for crisis-relevant products;

(5) prioritisation of the market surveillance activities for crisis-relevant goods.

The general objective of the initiative is to lay down the mechanisms and procedures, which would allow to prepare for and to address potential crises and disruptions to the proper functioning of the Single Market. Such measures are also aimed to minimise the intra-EU obstacles to the free movement in times of crisis.