Sittings · Document

PROVISIONAL AGREEMENT RESULTING FROM INTERINSTITUTIONAL NEGOTIATIONS 2024-02-16

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

Committee on the Internal Market and Consumer Protection

16.2.2024

PROVISIONAL AGREEMENT RESULTING FROM INTERINSTITUTIONAL NEGOTIATIONS

Subject: 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

(COM(2022)0462 – C90313(2022) – 2022/0280(COD))

The interinstitutional negotiations on the aforementioned proposal for a directive have led to a compromise. In accordance with Rule 74(4) of the Rules of Procedure, the provisional agreement, reproduced below, is submitted as a whole to the Committee on the Internal Market and Consumer Protection for decision by way of a single vote.

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▌ DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ▌

amending 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 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 Articles 91 and 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,

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) [insert reference to IMERA Regulation] aims to ensure the normal functioning of the internal market, including the free movement of goods, services and persons and ensure the availability of crisis-relevant goods and services and goods and services of strategic importance to citizens, businesses and public authorities during a crisis.

(2) The framework established by [insert reference to IMERA Regulation] lays down measures, which should be deployed in a coherent, transparent, efficient, proportionate and timely manner, so as to prevent, mitigate and minimise the impact on the functioning of the internal market that a crisis may cause.

(3) [insert reference to IMERA Regulation] lays down a multi-layered mechanism consisting of contingency planning, and internal market vigilance and emergency modes.

(4) [insert reference to IMERA Regulation] lays down rules with the objective of safeguarding the free movement of goods, services and persons in the internal market and to ensure the availability of goods and services that are particularly important also in times of crisis. [insert reference to IMERA Regulation] applies to both goods and services.

(5) In order to complement, ensure consistency and further enhance the effectiveness of such measures, it is appropriate to ensure that crisis-relevant goods referred to in [insert reference to IMERA Regulation] may be swiftly placed on the internal market in order to contribute to addressing and mitigating the disruptions.

(6) A number of EU sectoral legal acts lay down harmonised rules regarding the design, manufacture, conformity assessment and placing on the market of certain products. Such legal acts include Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, , 2014/29/EU, 2014/30/EU, 2014/33/EU11, 2014/34/EU12, ▌ 2014/35/EU13, 2014/53/EU14 and 2014/68/EU15 of the European Parliament and of the Council. Moreover, most of those legal acts are based on the principles of the new approach to technical harmonisation and are also aligned to the reference provisions laid down by Decision 768/2008/EC EC of the European Parliament and of the Council16.

(7) Neither the reference provisions laid down by Decision No 768/2008/EC, nor the specific provisions laid down by the sectoral Union harmonisation legislation provide for procedures designed to apply in crisis. It is appropriate to introduce targeted adjustments to those Directives, aimed at responding to impacts of crises affecting products that have been designated as crisis-relevant goods and covered by those Directives.

(8) Experience from the past crises that have affected the internal market has shown that the procedures laid down in the sectoral legal acts are not designed to cater 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 as a complement to the measures adopted under [insert reference to IMERA Regulation].

(9) In order to overcome the potential effects of disruptions on the internal market and in order to ensure that harmonised crisis-relevant goods are 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 products over any pending applications concerning products, which have not been designated as crisis-relevant. In the context of such prioritisation, no additional disproportionate costs may be charged by the conformity assessment body 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 limited to the period of application of the internal market emergency. The transfer of certain additional and proportionate costs by the conformity assessment bodies to the manufacturers should remain exceptional and should 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 conformity assessment should not become a barrier to the entry on the market of prospective new manufacturers, in particular SMEs and should not restrict the emergence of innovative products. Furthermore, the notified bodies are encouraged to increase their testing capacities for such products designated as crisis-relevant goods in respect to which they have been notified.

(10) To that end, 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 be available only following the activation of the internal market emergency mode and only when a specific good covered by those Directives is designated as a crisis-relevant good in accordance with [insert reference to IMERA Regulation▌].

(11) Furthermore, in cases, for example, where the disruptions might affect the conformity assessment bodies or in cases where the testing capacities for such crisis-relevant products 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 Union sectoral harmonisation legislation.

(12) As regards products falling within the scope of those harmonisation Directives that have been designated as crisis-relevant goods, 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 Directives, ▌ where the involvement of a notified body is mandatory and should be able to issue authorisations for those products, provided that they ensure the conformity with all the applicable essential safety requirements. Compliance with those substantive requirements may be demonstrated by various means, which may 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.

(12a) Since the essential safety requirements harmonised by the existing Directives remain applicable and the authorisation issued by a national competent authority without the CE marking may occur exceptionally, temporarily and additionally to the conformity assessment procedures laid down in those Directives, this amending Directive continues to improve the conditions for the functioning of the internal market. Therefore, this amending Directive takes into account both the context constituted by the fully harmonised rules stemming from the existing Directives and the complementary rules stemming from amendments that would be made to them which would not only allow national authorities to recognise authorisations issued in other Member States but would also 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 unless the requirements set in the authorisation do not ensure the conformity with the essential requirements laid down in these Directives. 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 health, life and safety. By not providing for an automatic mutual recognition of each national authorisation which is granted on a derogatory basis in times of crisis, this amending Regulation aims to avoid any circumvention or undermining of the CE marking procedure and thereby to maintain consumer confidence in the safety of products bearing the CE marking in the Union market. Therefore, these new derogatory rules, insofar as they prohibit the CE marking on the products which have been approved only at national level, should not affect the harmonised product legislation and consumer confidence in the 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 derogatory rules enable new manufacturers to swiftly place their products on the market without the need to wait for the finalisation of the normal conformity assessment procedures. Such an accelerated and exceptional placing on the market contributes to the swift increase in the supply of crisis-relevant goods and at the same time provides the manufacturers with a facilitation as it allows them to place initial batches or series of products on the market before the conclusion 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, derogatory set of rules alongside the existing rules thus makes it possible to transition towards the existing rules, enabling the manufacturers to continue placing their products on the market after the expiry or deactivation of the internal market emergency mode.

(12b) Where the Commission has extended the validity of an authorisation issued by a Member State by means of an implementing act, the conditions for the placing on the market of the concerned goods set out therein should apply only to those goods placed on the market after the date of entry into force of the said implementing act. That implementing act can provide that the benefit of the free movement is also granted to goods already placed on the market on the basis of pre-existing authorisation. All pre-existing authorisations adopted by Member States prior to the entry into force of the 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 are not to be withdrawn or recalled unless specific safety concerns have been identified with respect to such goods which result in corrective or restrictive actions to be taken by the Commission by means of another implementing act.

(12c) The validity of all authorisations for the placing on the market of goods designated as crisis-relevant in the context of an active internal market emergency mode, as referred to in the IMERA Regulation, 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 the authorisation has expired, no further placing of crisis-relevant goods on the market should occur 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 measures at their disposal in accordance with the provisions of those Directives. 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.

(12d) In order to ensure timely sharing of information and to allow all Member States to react, it should be ensured that the Commission and the other Member States are immediately informed of any decisions at national level to authorise crisis-relevant goods. The Information and Communication System for Market Surveillance (ICSMS) already provides the necessary functions to allow quick notification of administrative decisions and therefore can be used by Member States for this purpose. Moreover, information on all corrective or restrictive measures should also be shared. Pursuant to Regulation (EU) 2019/1020 such information is to be accessible in ICSMS irrespectively whether those measures have to be notified or not in Safety Gate due to the products presenting a serious risk. Double entry will be avoided by means of the data interface between Safety Gate and ICSMS maintained by the Commission in accordance with article 20(5) of Regulation (EU) 2019/1020.

(12e) All authorisations for the placing on the market of crisis-relevant goods issued by Member States should contain at least certain elements which substantiate the assessment of the compliance of the good in question with the applicable essential requirements and which allow to ensure traceability. The relevant elements concerning the traceability include specific requirements regarding the labelling, accompanying documents or any additional means of ensuring the identification of the goods concerned and allowing to trace them 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. These include the specific arrangements regarding the indication that the product concerned is a ‘crisis-relevant good’. On expiry of the internal market emergency mode, the Commission should be empowered to adopt via implementing acts any necessary adjustments to the traceability requirements for crisis-relevant products that have already been placed on the market on the basis of an authorisation issued by a Member State.

(13) Where an internal market emergency entails 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 provide technical references, which may be used by the manufacturers to design and produce crisis-relevant goods ▌ which comply with the applicable essential health and safety requirements.

(14) A number of sectoral EU harmonised frameworks provide for the possibility for a manufacturer to benefit from a presumption of conformity if their product complies with a harmonised European standard. However, in cases where such standards do not exist or the 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.

(15) With respect to Directives 2006/42/EC, ▌ 2014/29/EU, 2014/30/EU, ▌ 2014/33/EU, 2014/34/EU, 2014/53/EU and 2014/68/EU, the competent national authorities should be able to presume that products manufactured in accordance with European or national standards of the Member States, or with relevant international standards developed by a recognised international standardisation body, identified by the Commission as suitable to reach conformity and ensuring an equivalent level of protection to that offered by the harmonised European standards comply with the relevant and applicable essential requirements. Products placed on the market on the basis of the presumption of conformity established via this emergency mechanism should not be withdrawn automatically simply as a result of the expiry or deactivation of the implementing act listing the European, relevant and applicable international or the national standards of the Member States. In cases where there are concerns regarding the compliance of a harmonised crisis-relevant product placed on the market during an internal market emergency on the basis of a presumption of conformity established via such an implementing act, the market surveillance authorities should be able to take all the necessary corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 and under the respective sectorial legislation. After the expiry or withdrawal of the implementing act, compliance with the European, relevant and applicable international or the national standards of the Member States should no longer provide a presumption of conformity with the relevant and applicable essential requirements.

(16) Furthermore, with respect to Directives 2006/42/EC, ▌ 2014/29/EU, 2014/30/EU, ▌ 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU, the Commission should have the possibility to adopt by means of implementing acts common specifications, on which the manufacturers may rely in order to benefit from a presumption of conformity with the applicable essential requirements. The implementing act laying down such common specifications should remain applicable for the duration of the internal market emergency. Products placed on the market on the basis of the presumption of conformity established via the demonstration of compliance with these common specifications should not be withdrawn automatically simply as a result of the expiry or withdrawal of the implementing act laying down the said common specifications. In cases where there are concerns regarding the compliance of a crisis-relevant product placed on the market during an internal market emergency on the basis of the presumption of conformity established via the demonstration of compliance with common specifications, the market surveillance authorities should be able to take all the necessary corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 and under the respective sectorial legislation. After the expiry or withdrawal of the implementing act laying down the common specifications a demonstration of compliance with the said common specifications should no longer provide a presumption of conformity with the relevant and applicable essential requirements.

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(18) In order to ensure that the level of safety provided by the harmonised products is not compromised, it is necessary to provide for rules for enhanced market surveillance, in particular with respect to goods designated as crisis-relevant and including by enabling closer cooperation and mutual support among the market surveillance authorities.

(18a) In accordance with the relevant provisions of the amended Directives, Member States should lay down rules on penalties applicable to infringements by economic operators and conformity assessment bodies of the provisions of those Directives including the new provisions introduced by this amending Directive and ensure that those rules are enforced by the competent national authorities, including the respective notifying authority.

(19) In accordance with its established practice, the Commission would systematically consult the relevant sectoral experts in the context of the early preparation of all draft implementing acts laying down common specifications.

(20) 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 should therefore be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Amendments to Directive 2000/14/EC

Directive 2000/14/EC is amended as follows:

(1) in Article 3 the following points are added:

‘(g) ‘crisis-relevant goods’ means ‘crisis-relevant goods’ within the meaning of Article 3, point (6) of Regulation (EU) …/…. [IMERA Regulation];

(h) ‘internal market emergency’ means ‘internal market emergency’ within the meaning of Article 3, point (3) of Regulation (EU) …/… [IMERA Regulation].;’

(2) the following articles are inserted:

‘Article 17a

▌ Application of emergency procedures

1. Member States shall ensure that measures taken to transpose Articles 17b , 17c, 17d shall only apply if the Commission has adopted an implementing act pursuant to Article 26 of the IMERA Regulation ▌ .

2. Member States shall ensure that measures taken to transpose in Articles 17b, 17 c and 17d apply exclusively to equipment, which has been designated as crisis-relevant goods pursuant to Article 14(3) of the IMERA Regulation.

3. Member States shall ensure that measures taken to transpose in Articles 17b, 17c and 17d shall apply only during the internal market emergency mode activated in accordance with Article 14 of the IMERA Regulation.

However, Article 17 ▌ c(5) shall apply during the internal market emergency mode and after its deactivation or expiry.

4. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to equipment placed on the market in accordance with Articles 17c to 17e. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).

Article 17b

▌ Prioritisation of the conformity assessment of crisis-relevant equipment

1. This Article shall apply to equipment listed in the implementing act referred to in Article 17a(1), which is subject to conformity assessment procedures in accordance with Article 14, which require the mandatory involvement of a notified body.

2. The notified bodies shall make best efforts to process all applications for conformity assessment of equipment designated as crisis-relevant goods as a matter of priority, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 43a.

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4. The prioritisation of applications for conformity assessment of ▌ equipment pursuant to paragraph 2 shall not give rise to additional disproportionate costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall make reasonable efforts to increase their testing capacities for ▌ equipment designated as crisis-relevant goods in respect of which they have been notified. ▌

Article 17c

▌ Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 14, the Member State may authorise, on a duly justified request from an economic operator, the placing on the market or putting into service within the territory of the Member State concerned, of specific equipment referred to in Article 12 and listed in the implementing act referred to in Article 17a(1)and for which the conformity assessment procedures requiring mandatory involvement of a notified body referred to in Article ▌ 14 have not been carried out ▌ but for which the compliance with all the applicable requirements concerning the noise emission in the environment of this Directive has been demonstrated in accordance with procedures referred to in that authorisation.

1a. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1. Unless the requirements set in the authorisation do not ensure the conformity with the applicable requirements concerning the noise emission in the environment , the Commission shall without delay adopt an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the specific equipment may be placed on the market. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 18(2).

The equipment subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the modalities of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

1b. On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 18 (3).

1c. As long as an implementing act referred to in paragraphs 1a or 1b is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of the issuing Member State, as well as on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of the said implementing act.

Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

2. The manufacturer of equipment subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the equipment concerned complies with all the applicable requirements concerning the noise emissions in the environment ▌ and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority.

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3. Any authorisation issued ▌ pursuant to paragraph 1 shall set out the conditions and requirements under which the equipment may be placed on the market or put into service. The authorisations shall at least set out the following:

(a) a description of the procedures, by means of which ▌ compliance with the applicable requirements concerning the noise emission in the environment ▌ was successfully demonstrated;

(b) any specific requirements regarding the traceability of the equipment concerned;

(c) an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 14 of [the IMERA Regulation];

(d) any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the equipment concerned;

(e) measures to be taken ▌ upon expiry of the internal market emergency with respect to the equipment concerned placed on the market.

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5. By way of derogation from Articles 6, and 11, equipment, for which an authorisation has been granted in accordance with paragraph 1 ▌ shall not bear the CE marking and Article 6 shall not apply.

5a The market surveillance authorities of a Member State, where an authorisation pursuant to paragraphs 1, 1a and 1c is valid , shall be entitled to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 and under this Directive with respect to such equipment.

They shall immediately inform the Commission and the market surveillance authorities of other Member States of these actions.

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8. ▌The use of the authorisation procedure set out in paragraphs 1 to 1c shall not affect the application of the relevant conformity assessment procedures laid down in Article 14 on the territory of the Member State concerned. ▌

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Article 17d

▌ Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for machinery, designated as crisis-relevant goods. The Commission shall facilitate coordination of these efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

(3) Article 18 is replaced by the following:

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‘Article 18

Committee procedure

1. The Commission shall be assisted by a Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council.

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2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.’

Article 2

Amendments to Directive 2006/42/EC

▌ Directive 2006/42/EC is amended as follows:▌

(1) In Article 2, second paragraph the following points are added:

‘n ‘crisis-relevant goods’ means ‘crisis-relevant goods’ within the meaning of Article 3, point (6) of Regulation (EU) …/…. IMERA Regulation;

o 'internal market emergency’ means ‘internal market emergency’ within the meaning of Article 3, point (3) of Regulation (EU) …/… IMERA Regulation].;’

(2) the following Articles are inserted:

‘Article 21b

▌ Application of emergency procedures ▌

1. Member States shall ensure that measures taken to transpose Articles 21c to 21h of this directive only apply if the Commission has adopted an implementing act pursuant to Article ▌ 26 of [the IMERA Regulation] ▌ .

2. Member States shall ensure that measures taken to transpose Articles 21c to 21h ▌ apply exclusively to machinery, which has been designated as crisis-relevant goods pursuant to Article 14 of [the IMERA Regulation].

3. Member States shall ensure that measures taken to transpose Articles 21c to 21h shall apply only during the internal market emergency mode activated in accordance with Article 14 of [the IMERA Regulation].

However, Article 21 ▌ d(5) shall apply during the internal market emergency mode and after its deactivation or expiry ▌

4. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to machinery placed on the market in accordance with Articles 21d to 21g. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(3).

Article 21c

▌ Prioritisation of the conformity assessment of crisis-relevant machinery

1. This Article shall apply to machinery designated as crisis-relevant goods, which is subject to conformity assessment procedures in accordance with Article 12, which require the mandatory involvement of a notified body.

2. The notified bodies shall make the best efforts to process all applications for conformity assessment of machinery designated as crisis-relevant goods as a matter of priority, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 21b.▌

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4. The prioritisation of applications for conformity assessment of machinery pursuant to paragraph 2 ▌ shall not give rise to ▌ additional disproportionate costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall make reasonable efforts to increase their testing capacities for machinery designated as crisis-relevant goods in respect of which they have been notified. ▌

Article 21d

▌ Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 12, the Member State may authorise, on a duly justified request from an economic operator, the placing on the market or putting into service within the territory of the Member State concerned, of a specific machinery which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body, referred to in Article 12 have not been carried out by a notified body but for which the compliance with all the applicable essential ▌ requirements has been demonstrated in accordance with procedures referred to in that authorisation.

1a. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1. Unless the requirements set in the authorisation do not ensure the conformity with the applicable essential health and safety requirements laid down in this Directive, the Commission shall without delay adopt an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the specific machinery may be placed on the market or put into service. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 22(3).

The machinery subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market or put into service as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the modalities of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

2. The manufacturer of machinery subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the machinery concerned complies with all the applicable essential health and safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national ▌ authority.

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3. Any authorisation issued ▌ pursuant to paragraph 1 shall set out the conditions and requirements under which the machinery may be placed on the market or put into service. The authorisations shall at least set out the following:

(a) a description of the procedures, by means of which the compliance with the applicable essential health and safety requirements of this Directive was successfully demonstrated;

(b) any specific requirements regarding the traceability of the machinery concerned;

(d) any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the machinery concerned;

(e) measures to be taken ▌ upon expiry of the internal market emergency with respect to the machinery placed on the market or put into service

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5. By way of derogation from Articles 6 and 16, machinery, for which an authorisation has been granted in accordance with paragraph 1 ▌ shall not bear the CE marking and Article 6 shall not apply.▌

They shall immediately inform the Commission and the market surveillance authorities of other Member States of these actions.

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8. The ▌ use of the authorisation procedure set out in paragraphs 1 to 1c does not affect the application of the relevant conformity assessment procedures laid down in Article 12 on the territory of the Member State concerned.

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Article 21f

Presumption of conformity based on standards and common specifications

1. Where machinery has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such machinery to cover the applicable essential health and safety requirements set out in Annex I, in either of the following cases:

(a) ▌ no reference to harmonised standards covering the relevant essential ▌ requirements set out in Annex II is published in the Official Journal of the European Union▌ in accordance with Regulation (EU) No 1025/2012and no such reference is expected to be published within a reasonable period; or

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(b) ▌ severe disruptions in the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant applicable essential health and safety requirements set out in Annex I ▌ and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

1a. The implementing acts referred to in paragraph 1 shall deploy the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 3. To this end, the implementing act may publish the references to European standards, to relevant applicable international or national standards or, if there is no relevant applicable European, international or national standard, may establish common specifications.

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2. The implementing acts referred to in paragraph 1 ▌ shall be adopted ▌ in accordance with the examination procedure referred to in Article 22(3) and they shall apply ▌ until the last day of the period for which the internal market emergency mode remains active, unless amended or repealed in accordance with paragraph 5.

2a. Before preparing the draft implementing act referred to in paragraph 1, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 have been fulfilled. When preparing the draft implementing act referred to in paragraph 1, the Commission shall take into account the views of relevant bodies or expert groups established under this Directive and shall duly consult all relevant stakeholders.

3. Without prejudice to Article 7, machinery which is in conformity with the standards or common specifications referred to in paragraph 1 , or parts thereof, shall be presumed to be in conformity with the applicable essential health and safety requirements set out in Annex I covered by those standards or common specifications or parts thereof. The presumption of conformity provided by the standards or the common specifications referred to in the implementing act referred to in paragraph 1 shall automatically cease to apply on the day the internal Market Emergency mode expires or is deactivated.

4. By way of derogation from Article 21b(3), first subparagraph, unless there is sufficient reason to believe that the machinery covered by the standards or common specifications referred to in paragraph 1 ▌ presents a risk to the health or safety of persons, the machinery which is in conformity with the standards or common specifications and which has been placed on the market or put into service shall be deemed compliant with the applicable essential health and safety requirements set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 ▌ and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

5. When a Member State considers that a standard or common specification referred to in paragraph 1 does not entirely satisfy the applicable essential health and safety requirements ▌ set out in Annex I, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question. ▌

▌

Article 21h

▌ Prioritisation of market surveillance activities and mutual assistance among authorities

(3) In Article 22 the following paragraph is added:

‘ Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.’

Article 3

Amendments to Directive 2010/35/EU

Directive 2010/35/EU is amended as follows:

(1) in Article 2 the following points are added:

‘(27) ‘crisis-relevant goods’ means ‘crisis-relevant goods’ within the meaning of Article 3, point (6) of Regulation (EU) …/…. IMERA Regulation;

(28) ‘internal market emergency’ means ‘internal market emergency’ within the meaning of Article 3, point (3) of Regulation (EU) …/… IMERA Regulation.;’

(2) the following chapter is inserted:

‘Chapter 5a ▌ EMERGENCY PROCEDURES

Article 33a

▌ Application of emergency procedures ▌

1. Member States shall ensure that measures taken to transpose Articles 33b, 33c and 33d of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 26 of the IMERA Regulation with respect to transportable pressure equipment covered by this Directive.

2. Member States shall ensure that measures taken to transpose Articles 33b, 33c and 33d apply exclusively to transportable pressure equipment, which has been designated as crisis-relevant goods pursuant to Article 14 of [the IMERA Regulation].▌

3. Member States shall ensure that measures taken to transpose Articles 33b, 33c and 33d shall apply only during the internal market emergency mode activated in accordance with Article 14 of [the IMERA Regulation].▌

4. However, ▌ Article 33c(5) shall apply during the internal market emergency mode and after its deactivation or expiry.

5. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to transportable pressure equipment placed on the market in accordance with Article 33c. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 38a(2). ▌

Article 33b

▌ Prioritisation of the conformity assessment of crisis-relevant transportable pressure equipment

1. This Article shall apply to transportable pressure equipment designated as crisis-relevant goods, which is subject to conformity assessment procedures in accordance with Article 12, which require the mandatory involvement of a notified body.

2. The notified bodies shall make best efforts to process all applications for conformity assessment of transportable pressure equipment designated as crisis-relevant goods as a matter of priority, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 33a.

▌

4. The prioritisation of applications for conformity assessment of transportable pressure equipment pursuant to paragraph 2 shall not give rise to additional disproportionate costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall make reasonable efforts to increase their testing capacities for ▌ transportable pressure equipment designated as crisis-relevant goods in respect of which they have been notified. ▌

Article 33c

▌ Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 12, the Member State may authorise, on a duly justified request from an economic operator, the placing on the market within the territory of the Member State concerned, of a specific transportable pressure equipment designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body referred to in Article 12 have not been carried out by a notified body but for which the compliance with all the applicable requirements set out in the Annexes to Directive 2008/68/EC and in this Directive has been demonstrated in accordance with procedures referred to in that authorisation.

1a. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1. Unless the requirements set in the authorisation do not ensure conformity with the applicable requirements set out in the Annexes to Directive 2008/68/EC and in this Directive, the Commission shall without delay adopt an implementing act extending for a limited period of time the validity of the authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the specific transportable pressure equipment may be placed on the market. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 38a(2).

The transportable pressure equipment subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the modalities of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

2. The manufacturer, the importer, the distributor and the user of a transportable pressure equipment subject to the authorisation procedure referred to in paragraph 1 of this Article shall declare on his sole responsibility that the transportable pressure equipment concerned complies with all the applicable requirements set out in the Annexes to Directive 2008/68/EC and in this Directive and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national ▌ authority.

▌

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the transportable pressure equipment may be placed on the market or put into service. The authorisations shall at least set out the following:▌

(a) a description of the procedures, by means of which the compliance with the applicable requirements set out in the Annexes to Directive 2008/68/EC and in this Directive was successfully demonstrated;

(b) any specific requirements regarding the traceability of the transportable pressure equipment concerned;

(d) any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the transportable pressure equipment concerned;

(e) measures to be taken ▌ upon expiry of the internal market emergency with respect to the transportable pressure equipment placed on the market.

▌

5. By way of derogation from Articles 14 and 16, transportable pressure equipment , for which an authorisation has been granted in accordance with paragraph 1 ▌ shall not bear the Pi marking and Article 16 shall not apply.

5a. The market surveillance authorities of a Member State, where an authorisation pursuant to paragraphs 1, 1a and 1c is valid , shall be entitled to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 and under this Regulation with respect to such transportable pressure equipment. The market surveillance authorities of a Member State, where an authorisation pursuant to paragraphs 1, 1a and 1c is valid , shall be entitled to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 and under this Directive with respect to such transportable pressure equipment.

They shall immediately inform the Commission and the market surveillance authorities of other Member States of these actions.

▌

8. ▌The use of the authorisation procedure set out in paragraphs 1 to 1c shall not affect the application of the relevant conformity assessment procedures laid down in Article 18 on the territory of the Member State concerned.

▌

Article 33d

▌ Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for transportable pressure equipment, designated as crisis-relevant goods. The Commission shall facilitate coordination of these efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

2. The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during a internal market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for designated as crisis-relevant goods. The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during a internal market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for transportable pressure equipment ▌ designated as crisis-relevant goods. ’

(3) the following Article is inserted:

‘Article 38a

Committee procedure

1. The Commission shall be assisted by the committee on the transport of dangerous goods established by Article 9 of Directive 2008/68/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council*.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

(*) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).’

▌

Article 6

Amendments to Directive 2014/29/EU

Directive 2014/29/EU is amended as follows:

(1) in Article 2 the following points are added:

‘ (18) ‘crisis-relevant goods’ means ‘crisis-relevant goods’ within the meaning of Article 3, point (6) of Regulation (EU) …/…. IMERA Regulation;

(19) ‘internal market emergency’ means ‘internal market emergency’ within the meaning of Article 3, point (3) of Regulation (EU) …/… [IMERA Regulation].;’

(2) ▌ the following chapter▌ is inserted:

‘Chapter 5a ▌ EMERGENCY PROCEDURES

Article 38a

▌ Application of emergency procedures ▌

1. Member States shall ensure that measures taken to transpose Articles 38b to 38g of this Directive only apply if the Commission has adopted an implementing act pursuant to ▌ Article 26 of [the IMERA Regulation].

2. Member States shall ensure that measures taken to transpose Articles 38b to 38g apply exclusively to vessels, which have been designated as crisis-relevant goods pursuant to Article 14 of [the IMERA Regulation].

3. Member States shall ensure that measures taken to transpose Articles 38b to 38g shall apply only during the internal market emergency mode activated in accordance with Article 14 of [the IMERA Regulation].▌

However, Article 38 ▌ c(5) shall apply during the internal market emergency mode and after its deactivation or expiry ▌

4. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to vessels placed on the market in accordance with Articles 38c to 38f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 39(3). ▌

Article 38b

▌ Prioritisation of the conformity assessment of crisis-relevant vessels

1. This Article shall apply to vessels designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 13 requiring the mandatory involvement of a notified body.

2. The notified bodies shall make best efforts to process all applications for conformity assessment of vessels designated as crisis-relevant goods as a matter of priority, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 38a.▌

▌

4. The prioritisation of applications for conformity assessment of vessels components pursuant to paragraph 2 shall not give rise to additional disproportionate costs for the manufacturers, who have lodged those applications. The prioritisation of applications for conformity assessment of vessels pursuant to paragraph 2 shall not give rise to additional disproportionate costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall make reasonable efforts to increase their testing capacities for vessels designated as crisis-relevant goods in respect of which they have been notified. ▌

Article 38c

▌ Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 13, the Member State may authorise, on a duly justified request from an economic operator, the placing on the market or putting into service within the territory of the Member State concerned, of ▌ a specific vessel which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body, referred to in Article 13 have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated in accordance with procedures referred to in that authorisation.

1a. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1. Unless the requirements set in the authorisation do not ensure conformity with the applicable essential safety requirements laid down in this Directive, the Commission shall without delay adopt an implementing act extending for a limited period of time the validity of the authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the specific vessel may be placed on the market or put into service. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 39(3).

The vessel subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the modalities of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

2. The manufacturer of a vessel subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the vessel concerned complies with all the applicable essential safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national ▌ authority.

▌

3. Any authorisation issued ▌ pursuant to paragraph 1 shall set out the conditions and requirements under which the vessel may be placed on the market or put into service. The authorisations shall at least set out the following:▌

(a) a description of the procedures, by means of which the compliance with the applicable essential safety requirements of this Directive was successfully demonstrated;

(b) any specific requirements regarding the traceability of the vessel concerned;

(d) any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the vessel concerned;

(e) measures to be taken ▌ upon expiry of the internal market emergency with respect to the vessel placed on the market.

▌

5. By way of derogation from Articles 5, 15 and 16, vessels, for which an authorisation has been granted in accordance with paragraph 1 ▌ shall not bear the CE marking and inscriptions and Article 5 shall not apply.

They shall immediately inform the Commission and the market surveillance authorities of other Member States of these actions.

▌

8. ▌The use of the authorisation procedure set out in paragraphs 1 to 1c shall not affect the application of the relevant conformity assessment procedures laid down in Article 13 on the territory of the Member State concerned. ▌

▌

Article 38e

Presumption of conformity based on standards and common specifications

1. Where vessels ▌ have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such vessels to cover the applicable essential safety requirements set out in Annex I, in either of the following cases:

▌

(b) ▌ severe disruptions in the functioning of the internal Market, which led to the activation of the internal Market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant applicable essential safety requirements set out in Annex I and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

▌

2. The implementing acts referred to in paragraph 1 shall be adopted ▌ in accordance with the examination procedure referred to in Article 39(3) and they shall apply ▌ until the last day of the period for which the internal market emergency mode remains active, unless amended or repealed in accordance with paragraph 5.

3. Without prejudice to Article 12, vessels which are in conformity with the standards or common specifications referred to in paragraph 1, or parts thereof, shall be presumed to be in conformity with the applicable essential safety requirements set out in Annex I covered by those standards, common specifications or parts thereof. The presumption of conformity provided by the standards, parts thereof or the common specifications referred to in the implementing act referred to in paragraph 1 can no longer be relied upon from the day the internal market emergency mode expires or is deactivated.

4. By way of derogation from Article 38a(3), ▌ unless there is sufficient reason to believe that the vessels covered by the standards or common specifications referred to in paragraph 1 ▌ present a risk to the health or safety of persons, the vessels which are in conformity with those standards or common specifications and which have been placed on the market shall be deemed compliant with the applicable essential safety requirements set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 ▌ and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

5. When a Member State considers that a standard or common specification referred to in paragraph 1 does not entirely satisfy the applicable essential safety requirements ▌ set out in Annex I, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and, may, where appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question. ▌

▌

Article 38g

▌ Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for vessels, designated as crisis-relevant goods. The Commission shall facilitate coordination of these efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

Article 7

Amendments to Directive 2014/30/EU

Directive 2014/30/EU is amended as follows:

(1) in Article 3 (1) the following points are added:

‘ (26) ‘crisis-relevant goods’ means ‘crisis-relevant goods’ within the meaning of Article 3, point (6) of Regulation (EU) …/…. [IMERA Regulation];

(27)‘internal market emergency’ means ‘internal market emergency’ within the meaning of Article 3, point (3) of Regulation (EU) …/… [IMERA Regulation].’

(2) the following chapter ▌ is inserted:

‘Chapter 5a ▌ EMERGENCY PROCEDURES

Article 40a

▌ Application of emergency procedures ▌

1. Member States shall ensure that measures taken to transpose Articles 40b to 40g of this Directive only apply if the Commission has adopted an implementing act pursuant to ▌ Article 26 of [the IMERA Regulation] with respect to apparatus covered by this Directive.

2. Member States shall ensure that measures taken to transpose Articles 40b to 40g apply exclusively to apparatus, which have been designated as crisis-relevant goods pursuant to Article 14 of [the IMERA Regulation].▌

3. Member States shall ensure that measures taken to transpose Articles 40b to 40g shall apply only during the internal market emergency mode activated in accordance with Article 14 of [the IMERA Regulation].▌

4. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to apparatus placed on the market in accordance with Articles 40c to 40f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 41(2a). ▌

Article 40b

▌ Prioritisation of the conformity assessment of crisis-relevant apparatus

1. This Article shall apply to apparatus designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 14 requiring the mandatory involvement of a notified body.

2. The notified bodies shall make best efforts to process all applications for conformity assessment of ▌ apparatus designated as crisis-relevant goods as a matter of priority, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 40a.

▌

4. The prioritisation of applications for conformity assessment of apparatus pursuant to paragraph 2 shall not give rise to additional disproportionate costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall make reasonable efforts to increase their testing capacities for apparatus designated as crisis-relevant goods in respect of which they have been notified. ▌

▌

▌ ▌

▌

▌ ▌

▌

Article 40e

Presumption of conformity based on standards and common specifications

1. Where apparatus ▌ has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications for such apparatus to cover the applicable essential requirements set out in Annex I ▌ in either of the following cases:

▌

(b) ▌ severe disruptions in the functioning of the internal Market, which led to the activation of the internal Market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant applicable essential requirements set out in Annex I and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

▌

2. The implementing acts referred to in paragraph 1 ▌ shall be adopted ▌ in accordance with the examination procedure referred to in Article 41(2) and they shall apply ▌ until the last day of the period for which the internal market emergency mode remains active, unless amended or repealed in accordance with paragraph 5.

3. Without prejudice to Article 13, apparatus which are in conformity with the standards or common specifications referred to in paragraph 1, or parts thereof, shall be presumed to be in conformity with the applicable essential requirements set out in Annex I covered by those standards, common specifications or parts thereof. The presumption of conformity provided by the standards, parts thereof or the common specifications referred to in the implementing act referred to in paragraph 1 can no longer be relied upon from the day the internal market emergency mode expires or is deactivated.

4. By way of derogation from Article 40a(3), ▌ unless there is sufficient reason to believe that the apparatus covered by the standards or common specifications referred to in paragraph 1 ▌ present a risk to the health or safety of persons, the apparatus which are in conformity with those standards or common specifications and which have been placed on the market shall be deemed compliant with the applicable essential requirements set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 ▌ and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

5. When a Member State considers that a standard or common specification referred to in paragraph 1 does not entirely satisfy the applicable essential ▌ requirements ▌ set out in Annex I, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and, may, where appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question. ▌

▌

Article 40g

▌ Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for apparatus, designated as crisis-relevant goods. The Commission shall facilitate coordination of these efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

(3) in Article 41, the following paragraph ▌ is inserted:

‘2a. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. ’

▌

Article 10

Amendments to Directive 2014/33/EU

▌ Directive 2014/33/EU is amended as follows:

(1) in Article 2 the following points are added:

‘ (22) ‘crisis-relevant goods’ means ‘crisis-relevant goods’ within the meaning of Article 3, point (6) of Regulation (EU) …/…. [IMERA Regulation];

(23) ‘internal market emergency’ means ‘internal market emergency’ within the meaning of Article 3, point (3) of Regulation (EU) …/… [IMERA Regulation]. ’

(2) the following chapter is inserted:

‘Chapter Va ▌ EMERGENCY PROCEDURES

Article 41a

Application of emergency procedures ▌

1. Member States shall ensure that measures taken to transpose Articles 41b to 41g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 26 of [the IMERA Regulation] with respect to lifts and safety components for lifts covered by this Directive.

2. Member States shall ensure that measures taken to transpose Articles 41b to 41g apply exclusively to lifts and safety components for lifts, which have been designated as crisis-relevant goods pursuant to Article 14 of [the IMERA Regulation].▌

3. Member States shall ensure that measures taken to transpose Articles 41b to 41g shall apply only during the internal market emergency mode activated in accordance with Article 14 of [the IMERA Regulation].▌

However, ▌ Article 41c(6) shall apply during the internal market emergency mode and after its deactivation or expiry.

4. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to lifts and safety components for lifts placed on the market in accordance with Articles 41c to 41f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3). ▌

Article 41b

▌ Prioritisation of the conformity assessment of crisis-relevant lifts and safety components for lifts

1. This Article shall apply to all lifts and safety components for lifts designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Articles 15 and 16 requiring mandatory involvement of a notified body.

2. The notified bodies shall make the best efforts to process all applications for conformity assessment of lifts and safety components for lifts designated as crisis-relevant goods as a matter of priority, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 41a.▌

▌

4. The prioritisation of applications for conformity assessment of lifts and safety components for lifts ▌ pursuant to paragraph 2 shall not give rise to ▌ additional disproportionate costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall make reasonable efforts to increase their testing capacities for lifts and safety components for lifts designated as crisis-relevant goods in respect of which they have been notified. ▌

Article 41c

▌ Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 15, the Member State may authorise, on a duly justified request from an economic operator, the placing on the market within the territory of the Member State concerned, of a specific safety component for lifts which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body, referred to in that Article have not been carried out by a notified body but for which the compliance with all the applicable essential health and safety requirements has been demonstrated in accordance with procedures referred to in that authorisation.

2. By way of derogation from Article 16, the Member State may authorise, on a duly justified request from an economic operator, the placing on the market ▌ within the territory of the Member State concerned, of a specific lift which has been designated as crisis-relevant good and for which the ▌ conformity assessment procedures requiring the mandatory involvement of a notified body, referred to in that Article have not been carried out by a notified body but for which the compliance with all the applicable essential health and safety requirements has been demonstrated in accordance with procedures referred to in that authorisation.

2a. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraphs 1 or 2. Unless the requirements set in the authorisation do not ensure conformity with the applicable essential health and safety requirements laid down in this Directive, the Commission shall without delay adopt an implementing act extending for a limited period of time the validity of the authorisation granted by a Member State in accordance with paragraph 2 to the territory of the Union and set the conditions under which the specific lift or the safety component for lifts may be placed on the market. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 42(3).

The lifts or the safety components for lifts subject to the extension of validity referred to in the first subparagraph shall bear the information that they are placed on the market as “crisis-relevant goods”. The implementing act referred to in the first subparagraph shall specify the modalities of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

2b. On duly justified imperative grounds of urgency, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 42(4).

2c. As long as the implementing act referred to in paragraph 2a is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of the issuing Member State, as well as on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of the said implementing act.

Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

3. The manufacturer of a lift or ▌ safety component for lifts subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the lifts or safety component for lifts concerned complies with all the applicable essential health and safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the ▌ competent national authority.

▌

4. Any authorisation issued ▌ pursuant to paragraph 1or 2 shall set out the conditions and requirements under which the lift or ▌ safety component for lifts may be placed on the market. The authorisations shall at least set out the following:

(a) a description of the procedures, by means of which the compliance with the applicable essential health and safety requirements of this Directive was successfully demonstrated;

(b) any specific requirements regarding the traceability of the lift or safety component for lifts concerned;

(d) any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the lifts or safety component for lifts concerned;

(e) measures to be taken with respect to the lift or safety component for lifts placed on the market upon expiry of the internal market emergency.

▌

6. By way of derogation from Articles 3, 18 and 19, lifts or safety components for lifts, for which an authorisation has been granted in accordance with paragraphs 1 or 2 ▌ shall not bear the CE marking and Article 3 shall not apply. parked

6a. The market surveillance authorities of a Member State, where an authorisation pursuant to paragraphs 1, 2, 2a and 2c is valid , shall be entitled to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 and under this Directive with respect to such lifts or safety components for lifts.

They shall immediately inform the Commission and the market surveillance authorities of other Member States of these actions.

▌

9. ▌The use of the authorisation procedure set out in paragraphs 1 to 1c shall not affect the application of the relevant conformity assessment procedures laid down in Article 15 and 16 on the territory of the Member State concerned ▌

▌

Article 41e

Presumption of conformity based on standards and common specifications

1. Where lifts and safety components for lifts ▌ have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such lifts and safety components for lifts to cover the applicable essential health and safety requirements set out in Annex I in either of the following cases:

▌

(b) ▌ severe disruptions in the functioning of the internal Market, which led to the activation of the internal Market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant applicable essential health and safety requirements set out in Annex I ▌ and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

▌

2. The implementing acts referred to in paragraph 1 ▌ shall be adopted ▌ in accordance with the examination procedure referred to in Article 42(3). They shall apply ▌ until the last day of the period for which the internal Market emergency mode remains active, unless amended or repealed in accordance with paragraph 5.

3. Without prejudice to Article 14, lifts and safety components for lifts which are in conformity with the standards or common specifications referred to in paragraph 1 , or parts thereof, shall be presumed to be in conformity with the essential health and safety requirements set out in Annex I covered by those standards or common specifications or parts thereof. The presumption of conformity provided by the standards or the common specifications referred to in the implementing act referred to in paragraph 1 shall automatically cease to apply on the day the internal Market Emergency mode expires or is deactivated.

4. By way of derogation from Article 41a(3), first subparagraph, unless there is sufficient reason to believe that the lifts and safety components for lifts covered by the standards or common specifications referred to in paragraph 1 ▌ present a risk to the health or safety of persons, the lifts and safety components for lifts which are in conformity with the standards or common specifications and which have been placed on the market shall be deemed compliant with the applicable essential health and safety requirements set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 ▌ and after the expiry or deactivation of the internal Market Emergency mode in accordance with [the IMERA Regulation].

▌

Article 41g

▌ Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for lifts and safety components for lifts designated as crisis-relevant goods. The Commission shall facilitate coordination of these efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

Article 11

Amendments to Directive 2014/34/EU

▌ Directive 2014/34/EU is amended as follows:

(1) in Article 2 the following points are added:

‘ (27) ‘crisis-relevant goods’ means ‘crisis-relevant goods’ within the meaning of Article 3, point (6) of Regulation (EU) …/…. [IMERA Regulation];

(28) ‘internal market emergency’ means ‘internal market emergency’ within the meaning of Article 3, point (3) of Regulation (EU) …/… [IMERA Regulation]. ’

(2) the following chapter is inserted:

‘Chapter 5a ▌ EMERGENCY PROCEDURES

Article 38a

▌ Application of emergency procedures ▌

1. Member States shall ensure that measures taken to transpose Articles 38b to 38g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article ▌ 26 of [the IMERA Regulation] ▌ .

2. Member States shall ensure that measures taken to transpose Articles 38b to 38g apply exclusively to products, which have been designated as crisis-relevant goods pursuant to Article 14 (5) of [the IMERA Regulation].

However, Article 38 ▌ c(5) shall apply during the internal market emergency mode and after its deactivation or expiry.

4. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to products placed on the market in accordance with Articles 38c to 38e. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 39(3). ▌

Article 38b

▌ Prioritisation of the conformity assessment of crisis-relevant products

1. This Article shall apply to all products designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 13 requiring mandatory involvement of a notified body.

2. The notified bodies shall make best efforts to process all applications for conformity assessment of products designated as crisis-relevant goods as a matter of priority, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 38a.

▌

4. The prioritisation of applications for conformity assessment of products pursuant to paragraph 2 shall not give rise to additional disproportionate costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall make reasonable efforts to increase their testing capacities for ▌ products designated as crisis-relevant goods in respect of which they have been notified. ▌

Article 38c

▌ Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 13, the Member State may authorise, on a duly justified request from an economic operator, the placing on the market or putting into service within the territory of the Member State concerned, of a specific product which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring mandatory involvement of a notified body, referred to in that Article have not been carried out ▌ but for which the compliance with all the applicable essential health and safety requirements has been demonstrated in accordance with procedures referred to in that authorisation.

1a. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1. Unless the requirements set in the authorisation do not ensure conformity with the applicable essential health and safety requirements laid down in this Directive, the Commission shall without delay adopt an implementing act extending for a limited period of time the validity of the authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the specific product may be placed on the market or put into service. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 39(3).

The product subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market as a 'crisis-relevant good'. The implementing act referred to in the first subparagraph shall specify the modalities of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

2. The manufacturer of a product subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the product concerned complies with all the applicable essential health and safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the ▌ competent national authority.

▌

3. Any authorisation issued ▌ pursuant to paragraph 1 shall set out the conditions and requirements under which the product may be placed on the market or put into service. The authorisations shall at least set out the following:

(a) a description of the procedures, by means of which the compliance with the applicable essential health and safety requirements ▌ was successfully demonstrated;

(b) any specific requirements regarding the traceability of the product concerned;

(d) any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the product concerned;

(e) measures to be taken ▌ upon expiry of the internal market emergency with respect to the product placed on the market.

▌

5. By way of derogation from Articles 5, 15 and 16, products, for which an authorisation has been granted in accordance with paragraph 1 ▌ shall not bear the CE marking and Article 5 shall not apply.

They shall immediately inform the Commission and the market surveillance authorities of other Member States of these actions.

▌

8. ▌The use of the authorisation procedure set out in paragraphs 1 to 1c does not affect the application of the relevant conformity assessment procedures laid down in Article 13 on the territory of the Member State concerned. ▌

▌

Article 38e

Presumption of conformity based on standards and common specifications

1. Where products ▌ have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such products to cover the applicable essential health and safety requirements set out in Annex II in either of the following cases:

▌

(b) ▌ severe disruptions in the functioning of the internal Market, which led to the activation of the internal Market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant applicable essential health and safety requirements set out in Annex II and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

▌

2. The implementing acts referred to in paragraph 1 ▌ shall be adopted ▌ in accordance with the examination procedure referred to in Article 39(3) and they shall apply ▌ until the last day of the period for which the internal market emergency mode remains active, unless amended or repealed in accordance with paragraph 5.

3. Without prejudice to Article 17, products which are in conformity with the standards or common specifications referred to in paragraph 1, or parts thereof, shall be presumed to be in conformity with the applicable essential health and safety requirements set out in Annex II covered by those standards, common specifications or parts thereof. The presumption of conformity provided by the standards, parts thereof or the common specifications referred to in the implementing act referred to in paragraph 1 can no longer be relied upon from the day the internal market emergency mode expires or is deactivated.

4. By way of derogation from Article 38a(3), ▌ unless there is sufficient reason to believe that the ▌ products ▌ covered by the standards or common specifications referred to in paragraph 1 ▌ present a risk to the health or safety of persons, the products which are in conformity with those standards or common specifications and which have been placed on the market shall be deemed compliant with the applicable essential health and safety requirements set out in Annex II after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 ▌ and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

5. When a Member State considers that a standard or common specification referred to in paragraph 1 does not entirely satisfy the applicable essential health and safety ▌ requirements ▌ set out in Annex II, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and, may, where appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question. ▌

▌

Article 38g

▌ Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for products designated as crisis-relevant goods. The Commission shall facilitate coordination of these efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

Article 12

Amendments to Directive 2014/35/EU

▌ Directive 2014/35/EU is amended as follows:

(1) in Article 2 the following points are added:

‘ (15) ‘crisis-relevant goods’ means ‘crisis-relevant goods’ within the meaning of Article 3, point (6) of Regulation (EU) …/…. [IMERA Regulation];

(16) ‘internal market emergency’ means ‘internal market emergency’ within the meaning of Article 3, point (3) of Regulation (EU) …/… [IMERA Regulation].;’

(2) the following chapter is inserted:

‘Chapter 4a ▌ EMERGENCY PROCEDURES

Article 22a

▌ Application of emergency procedures ▌

1. Member States shall ensure that measures taken to transpose Articles 22b to 22c and 22d of this Directive ▌ only apply if the Commission has adopted an implementing act pursuant to Article ▌ 26 of [the IMERA Regulation] ▌ .

2. Member States shall ensure that measures taken to transpose Articles 22b, 22c and 22d apply exclusively to electrical equipment, which has been designated as crisis-relevant goods pursuant to Article 14 of [the IMERA Regulation].

3. Member States shall ensure that measures taken to transpose Articles 22b, 22c and 22d shall apply only during the internal market emergency mode activated in accordance with Article 14 of [the IMERA Regulation].

4. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to electrical equipment placed on the market in accordance with Articles 22c to 22e. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(3). ▌

Article 22b

Presumption of conformity based on standards and common specifications

1. Where electrical equipment, has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such electrical equipment to cover the safety objectives referred to in Article 3 and set out in Annex I in either of the following cases:

▌

(a) ▌ no reference to harmonised standards covering the relevant essential requirements set out in Annex II is published in the Official Journal of the European Union▌ in accordance with Regulation (EU) No 1025/2012and no such reference is expected to be published within a reasonable period; or

▌

(b) ▌ severe disruptions in the functioning of the internal Market, which led to the activation of the internal Market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the safety objectives referred to in Article 3 and set out in Annex I ▌ and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

▌

2. The implementing acts referred to in paragraph 1 ▌ shall be adopted ▌ in accordance with the examination procedure referred to in Article 23(2). They shall apply ▌ until the last day of the period for which the internal Market emergency mode remains active, unless amended or repealed in accordance with paragraph 5.

3. Without prejudice to Articles 12, 13 and 14, electrical equipment which is in conformity with the standards or common specifications referred to in paragraph 1, or parts thereof, shall be presumed to be in conformity with the safety objectives referred to in Article 3 and set out in Annex I covered by those standards or common specifications or parts thereof. The presumption of conformity provided by the standards or the common specifications referred to in the implementing act referred to in paragraph 1 shall automatically cease to apply on the day the internal Market Emergency mode expires or is deactivated.

4. By way of derogation from Article 22a(3), unless there is sufficient reason to believe that ▌ electrical equipment components covered by the standards or common specifications referred to in paragraph 1 ▌ present a risk to the health or safety of persons, the electrical equipment which are in conformity with those standards or common specifications and which have been placed on the market ▌ shall be deemed compliant with the safety objectives referred to in Article 3 and set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 ▌ and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

5. When a Member State considers that a standard or common specification referred to in paragraph 1 does not entirely satisfy the safety objectives referred to in Article 3 and set out in Annex I, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question. ▌

▌

Article 22d

▌ Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for electrical equipment designated as crisis-relevant goods. The Commission shall facilitate coordination of these efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

Article 13

Amendments to Directive 2014/53/EU

▌ Directive 2014/53/EU is amended as follows:

(1) in Article 2 (1) the following points are added:

‘ (27) ‘crisis-relevant goods’ means ‘crisis-relevant goods’ within the meaning of Article 3, point (6) of Regulation (EU) …/…. [IMERA Regulation];

(28) ‘internal market emergency’ means ‘internal market emergency’ within the meaning of Article 3, point (3) of Regulation (EU) …/… [IMERA Regulation].; ’

(2) the following chapter is inserted:

‘Chapter Va ▌ EMERGENCY PROCEDURES

Article 43a

▌ Application of emergency procedures ▌

1. Member States shall ensure that measures taken to transpose Articles 43b to 43g shall apply only if the Commission has adopted an implementing act pursuant to Article ▌ 26 of [the IMERA Regulation] ▌ .

2. Member States shall ensure that measures taken to transpose Articles 43b to 43g shall apply exclusively to radio equipment, which has been designated as crisis-relevant goods pursuant to Article 14(3) of the IMERA Regulation.

3. Member States shall ensure that measures taken to transpose Articles 43b to 43g shall apply only during the internal market emergency mode activated in accordance with Article 14 of [the IMERA Regulation].

However, Article 43 ▌ c(5) shall apply during the internal Market emergency mode and after its deactivation or expiry.

4. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to radio equipment placed on the market in accordance with Articles 43c to 43e. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3). ▌

Article 43b

▌ Prioritisation of the conformity assessment of crisis-relevant radio equipment

1. This Article shall apply to all radio equipment designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 17 requiring mandatory involvement of a notified body.

2. The notified bodies shall make best efforts to process all applications for conformity assessment ▌ radio equipment designated as crisis-relevant goods as a matter of priority, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 43a.

▌

4. The prioritisation of applications for conformity assessment of radio equipment pursuant to paragraph 2 shall not give rise to additional disproportionate costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall make reasonable efforts to increase their testing capacities for radio equipment designated as crisis-relevant goods in respect of which they have been notified. ▌

Article 43c

▌ Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 17, the Member State may authorise, on a duly justified request from an economic operator, the placing on the market within the territory of the Member State concerned, of a specific radio equipment which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body, referred to in Article 17 have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated in accordance with procedures referred to in that authorisation.

1a. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1. Unless the requirements set in the authorisation do not ensure the conformity with the applicable essential requirements laid down in this Directive, the Commission shall without delay adopt an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the specific radio equipment may be placed on the market. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 44(3).

The specific radio equipment subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market as a "crisis-relevant good". The implementing act referred to in the first subparagraph shall specify the modalities of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

2. The manufacturer of radio equipment subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the radio equipment concerned complies with all the applicable essential requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national ▌ authority.

▌

3. Any authorisation issued ▌ pursuant to paragraph 1 shall set out the conditions and requirements under which the radio equipment may be placed on the market. The authorisations shall at least set out the following:

(a) a description of the procedures, by means of which ▌ compliance with the applicable essential requirements ▌ was successfully demonstrated;

(b) any specific requirements regarding the traceability of the radio equipment concerned;

(d) any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the radio equipment concerned;

(e) measures to be taken ▌ upon expiry of the internal market emergency with respect to the radio equipment placed on the market.

▌

4. By way of derogation from Articles 9, 19 and 20, radio equipment, for which an authorisation has been granted in accordance with paragraph 1 ▌ shall not bear the CE marking and Article 9 shall not apply.

5. The market surveillance authorities of a Member State, where an authorisation pursuant to paragraphs 1, 1a and 1c is valid, shall be entitled to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 and under this Directive with respect to such radio equipment.

They shall immediately inform the Commission and the market surveillance authorities of other Member States of these actions.

▌

7. ▌The use of the authorisation procedure set out in paragraphs 1 to 1c shall not affect the application of the relevant conformity assessment procedures laid down in Article 17 on the territory of the Member State concerned. ▌

▌

Article 43e

Presumption of conformity based on standards and common specifications

1. Where radio equipment ▌ has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications for such radio equipment to cover the applicable essential requirements set out in Article 3 in either of the following cases:

▌

(b) ▌ severe disruptions in the functioning of the internal Market, which led to the activation of the internal Market emergency mode in accordance with Article 14 of [the IMERA Regulation], ▌ significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant applicable essential requirements set out in Article 3 ▌ and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

▌

2. The implementing acts referred to in paragraph 1 ▌ shall be adopted ▌ in accordance with the examination procedure referred to in Article 45(3) and they shall apply ▌ until the last day of the period for which the internal market emergency mode remains active, unless amended or repealed in accordance with paragraph 5.

3. Without prejudice to Article 16, radio equipment which is in conformity with the standards or common specifications referred to in paragraph 1, or parts thereof, shall be presumed to be in conformity with the applicable essential requirements set out in Article 3 covered by those standards, common specifications or parts thereof. The presumption of conformity provided by the standards, parts thereof or the common specifications referred to in the implementing act referred to in paragraph 1 can no longer be relied upon from the day the internal market emergency mode expires or is deactivated.

4. By way of derogation from Article 43a(3), unless there is sufficient reason to believe that the radio equipment covered by the standards or common specifications referred to in paragraph 1 ▌ presents a risk to the health or safety of persons, the radio equipment which is in conformity with those standards or common specifications and which has been placed on the market shall be deemed compliant with the applicable essential requirements set out in Article 3 after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 ▌ and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

5. When a Member State considers that a standard or common specification referred to in paragraph 1 does not entirely satisfy the applicable essential requirements ▌ set out in Article 3, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and, may, where appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question. ▌

▌

Article 43g

▌ Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for radio equipment designated as crisis-relevant goods. The Commission shall facilitate coordination of these efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

Article 14

Amendments to Directive 2014/68/EU

▌ Directive 2014/68/EU is amended as follows:

(1) in Article 2 the following points are added:

‘ (33) ‘crisis-relevant goods’ means ‘crisis-relevant goods’ within the meaning of Article 3, point (6) of Regulation (EU) …/…. [IMERA Regulation];

(34) ‘internal market emergency’ means ‘internal market emergency’ within the meaning of Article 3, point (3) of Regulation (EU) …/… [IMERA Regulation].;’

(2) the following chapter is inserted:

‘Chapter 5a ▌ EMERGENCY PROCEDURES

Article 43a

▌ Application of emergency procedures ▌

1. Member States shall ensure that measures taken to transpose Articles 43b to 43g of this Directive shall only apply if the Commission has adopted an implementing act pursuant to Article ▌ 26 of [the IMERA Regulation] ▌ .

2. Member States shall ensure that measures taken to transpose Articles 43b to 43g shall apply exclusively to pressure equipment and assemblies, which have been designated as crisis-relevant goods pursuant to Article [14(3) of the IMERA Regulation].

However, Article 43 ▌ c(5) shall apply during the internal Market emergency mode and after its deactivation or expiry.

4. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to pressure equipment and assemblies placed on the market in accordance with Articles 43c to 43e. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3). ▌

Article 43b

▌ Prioritisation of the conformity assessment of crisis-relevant pressure equipment and assemblies

1. This Article shall apply to pressure equipment or assemblies designated as crisis-relevant goods, which are subject to conformity assessment procedures, which require the mandatory involvement of a notified body, in accordance with Article 14.

2. The notified bodies shall make best efforts to process all applications for conformity assessment of pressure equipment and assemblies designated as crisis-relevant goods as a matter of priority, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 43a.

▌

4. The prioritisation of applications for conformity assessment of pressure equipment and assemblies pursuant to paragraph 2 shall not give rise to additional disproportionate costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall make reasonable efforts to increase their testing capacities for pressure equipment and assemblies designated as crisis-relevant goods in respect of which they have been notified. ▌

Article 43c

▌ Derogation from the ▌ conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 14, the Member State may authorise, on a duly justified request from an economic operator, the placing on the market or putting into service within the territory of the Member State concerned, of a specific pressure equipment or assembly which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body, referred to in ▌ Article 14 have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated in accordance with procedures referred to in that authorisation.

1a. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1. Unless the requirements set in the authorisation do not ensure the conformity with the applicable essential safety requirements laid down in this Directive, the Commission shall without delay adopt an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the specific pressure equipment or assemblies may be placed on the market. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 44(3).

The pressure equipment or assemblies subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market as a "crisis-relevant good". The implementing act referred to in the first subparagraph shall specify the modalities of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

2. The manufacturer of pressure equipment or assembly subject to the authorisation procedure referred to in paragraph 1 ▌ shall declare on his sole responsibility that the pressure equipment or assembly concerned complies with all the applicable essential safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national ▌ authority.

▌

3. Any authorisation issued ▌ pursuant to paragraph 1 shall set out the conditions and requirements under which the pressure equipment or assembly may be placed on the market or put into service. The authorisations shall at least set out the following:

(a) a description of the procedures, by means of which ▌ compliance with the applicable essential health and safety requirements ▌ was successfully demonstrated;

(b) any specific requirements regarding the traceability of the pressure equipment or assembly concerned;

(d) any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the pressure equipment or assembly concerned;

(e) measures to be taken ▌ upon expiry of the internal market emergency with respect to the pressure equipment or assembly placed on the market.

▌

5. By way of derogation from Articles 5, 18 and 19, pressure equipment or assemblies, for which an authorisation has been granted in accordance with paragraph 1 ▌ shall not bear the CE marking and Article 5 shall not apply.

They shall immediately inform the Commission and the market surveillance authorities of other Member States of these actions.

▌

Article 43e

Presumption of conformity based on standards and common specifications

1. Where pressure equipment and assemblies have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications for such pressure equipment and assemblies ▌ to cover the applicable essential safety requirements set out in Annex I in either of the following cases:

▌

2. The implementing acts referred to in paragraph 1 ▌ shall be adopted ▌ in accordance with the examination procedure referred to in Article 44(3) and they shall apply ▌ until the last day of the period for which the internal market emergency mode remains active, unless amended or repealed in accordance with paragraph 5.

3. Without prejudice to Article 12, pressure equipment or assemblies which are in conformity with the standards or common specifications referred to in paragraph 1, or parts thereof, shall be presumed to be in conformity with the applicable essential safety requirements set out in Annex I covered by those standards, common specifications or parts thereof. The presumption of conformity provided by the standards, parts thereof or the common specifications referred to in the implementing act referred to in paragraph 1 can no longer be relied upon from the day the internal market emergency mode expires or is deactivated.

4. By way of derogation from Article 43a(3), unless there is sufficient reason to believe that the pressure equipment and assemblies covered by the standards or common specifications referred to in paragraph 1 present a risk to the health or safety of persons, the pressure equipment and assemblies which are in conformity with those standards or common specifications and which have been placed on the market shall be deemed compliant with the applicable essential safety requirements set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 ▌ and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

▌

Article 43g

▌ Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for pressure equipment and assemblies designated as crisis-relevant goods. The Commission shall facilitate coordination of these efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

Article 15

Transposition

1. By … [OP: Please insert the date identical to that of the entry into application of the IMERA Regulation] Member States shall adopt and publish the measures necessary to comply with this Directive. They shall immediately inform the Commission thereof.

2. They shall apply those measures from […] [OP: please insert the date of the entry into application of the IMERA Regulation + 1 day].

When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such ▌ reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

3. As soon as this Directive has entered into force, Member States shall ensure that the Commission is informed, in sufficient time for it to submit its comments, of any draft laws, regulations or administrative provisions which they intend to adopt in the field covered by this Directive.

Article 16

Entry into force

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

Article 17

Addressees

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President