Legal provisions of COM(2022)461 - Amending numerous regulations on emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency - Main contents
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| dossier | COM(2022)461 - Amending numerous regulations on emergency procedures for the conformity assessment, adoption of common specifications and ... |
|---|---|
| document | COM(2022)461  |
| date | October 9, 2024 |
Article 1
Amendments to Regulation (EU) No 305/2011
Regulation (EU) No 305/2011 is amended as follows:
| (1) | in Article 2, the following points are added:
(*1) Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).’;" |
| (2) | the following chapter is inserted: ‘Chapter VIa Emergency procedures Article 38a Application of emergency procedures 1. Articles 38b to 38d of this Regulation shall apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to construction products covered by this Regulation. 2. Articles 38b to 38d of this Regulation shall apply only to construction products which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747. 3. Articles 38b to 38d of this Regulation shall apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747. 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 construction products placed on the market in accordance with Articles 38b and 38c. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 64(2a). Article 38b Prioritisation of the assessment and verification of constancy of performance of construction products designated as crisis-relevant goods 1. This Article applies to construction products listed in the implementing act referred to in Article 38a(1) that are subject to third party tasks of notified bodies related to the assessment and verification of constancy of performance in accordance with Article 28(1). 2. The notified bodies shall make best efforts to process as a matter of priority requests for third party tasks related to the assessment and verification of constancy of performance of construction products referred to in paragraph 1, irrespective of whether those requests have been lodged before or after the activation of the emergency procedures pursuant to Article 38a. 3. The prioritisation of requests for third party tasks related to the assessment and verification of constancy of performance of construction products pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those requests. 4. The notified bodies shall make reasonable efforts to increase their respective assessment and verification capacities regarding construction products referred to in paragraph 1 in respect of which they have been notified. Article 38c Assessment and declaration of performance based on standards and common specifications 1. Where construction products have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications to cover the methods and the criteria for assessing the performance of those products in relation to their essential characteristics in the following cases:
2. The implementing acts referred to in paragraph 1 shall set out the most appropriate alternative technical solution for the purposes of providing assessment and declaration of performance in accordance with paragraph 5. To that end, the references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts. 3. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 64(2a) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article. 4. Before preparing the draft implementing act referred to in paragraph 1 of this Article, 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 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Regulation and shall duly consult all relevant stakeholders. 5. Without prejudice to Articles 4 and 6, the methods and the criteria provided in the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, may be used for assessing and declaring the performance of construction products covered by those standards or common specifications in relation to their essential characteristics. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible to draw up declarations of performance based on the standards or the common specifications referred to in the implementing act referred to in paragraph 1 of this Article. 6. By way of derogation from Article 38a(3), unless there is sufficient reason to believe that construction products covered by the standards or common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons or fail to achieve the declared performance, the declarations of performance of construction products which have been placed on the market in compliance with those standards or common specifications shall remain valid after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode. 7. When a Member State considers that a standard or common specification as referred to in paragraph 1 is incorrect in terms of methods and criteria for the assessment of performance in relation to essential characteristics, 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 38d Prioritisation of market surveillance activities and mutual assistance among authorities 1. Member States shall prioritise the market surveillance activities for construction products listed in the implementing act referred to in Article 38a(1) of this Regulation. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020 of the European Parliament and of the Council (*3). 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 an internal market emergency mode, 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 the reinforcement of the testing capacity for construction products listed in the implementing act referred to in Article 38a(1). (*2) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12)." (*3) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).’;" |
| (3) | in Article 64, the following paragraph is inserted: ‘2a. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 of the European Parliament and of the Council (*4) shall apply. (*4) 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 2
Amendments to Regulation (EU) 2016/424
Regulation (EU) 2016/424 is amended as follows:
| (1) | in Article 3, the following points are added:
(*5) Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).’;" |
| (2) | the following chapter is inserted: ‘Chapter Va Emergency procedures Article 43a Application of emergency procedures 1. Articles 43b to 43e of this Regulation shall apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to subsystems and safety components covered by this Regulation. 2. Articles 43b to 43e of this Regulation shall apply only to subsystems and safety components which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747. 3. Articles 43b to 43e of this Regulation shall apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747. However, Article 43c(7) of this Regulation shall apply during the internal market emergency mode and after its expiry or deactivation. 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 subsystems and safety components placed on the market or incorporated into a cableway installation in accordance with Articles 43c and 43d. 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 subsystems and safety components designated as crisis-relevant goods 1. This Article applies to subsystems and safety components listed in the implementing act referred to in Article 43a(1) that are subject to the conformity assessment procedures referred to in Article 18 that require the mandatory involvement of a notified body. 2. The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of subsystems and safety components referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 43a. 3. The prioritisation of applications for a conformity assessment of subsystems and safety components pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications. 4. The notified bodies shall make reasonable efforts to increase their testing capacities for subsystems and safety components referred to in paragraph 1 in respect of which they have been notified. Article 43c Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body 1. By way of derogation from Article 18, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market or the incorporation into a cableway installation within the territory of that Member State, of a specific subsystem or safety component listed in the implementing act referred to in Article 43a(1) and for which the conformity assessment procedures referred to in Article 18 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential requirements laid down in Annex II has been demonstrated in accordance with procedures referred to in that authorisation. 2. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable essential requirements laid down in Annex II, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific subsystem or safety component may be placed on the market or incorporated into a cableway installation. 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 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 44(3). The subsystem or safety component 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 content and presentation 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. 3. 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 44(4). 4. As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation. 5. Manufacturers of subsystems or safety components subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the subsystem or safety component concerned complies with all the applicable essential requirements set out in Annex II and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority. 6. Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the subsystem or safety component may be placed on the market or incorporated into a cableway installation. Such authorisations shall set out at least the following:
7. By way of derogation from Articles 7, 20 and 21, subsystems or safety components for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 7 shall not apply. 8. The market surveillance authorities of a Member State, where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such subsystems or safety components, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council (*6) and under this Regulation. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions. 9. The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 18. Article 43d Presumption of conformity based on standards and common specifications 1. Where subsystems and safety components have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications for such subsystems and safety components to cover the applicable essential requirements set out in Annex II to this Regulation in the following cases:
2. The implementing acts referred to in paragraph 1 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts. 3. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 44(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article. 4. Before preparing the draft implementing act referred to in paragraph 1 of this Article, 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 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Regulation and shall duly consult all relevant stakeholders. 5. Without prejudice to Article 17, subsystems and safety components that are in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the applicable essential requirements set out in Annex II that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article. 6. By way of derogation from Article 43a(3), first subparagraph, unless there is sufficient reason to believe that the subsystems or safety components, covered by the standards or common specifications referred to in paragraph 1 of this Article, present a risk to the health or safety of persons, the subsystems or safety components that are in conformity with those standards or common specifications and which have been placed on the market, shall be deemed to be in conformity with the applicable essential requirements set out in Annex II after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the internal market emergency mode. 7. 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 II, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question. Article 43e Prioritisation of market surveillance activities and mutual assistance among authorities 1. Member States shall prioritise the market surveillance activities for subsystems and safety components listed in the implementing act referred to in Article 43a(1) of this Regulation. The Commission shall facilitate coordination of such prioritisation 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 an internal market emergency mode, 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 the reinforcement of the testing capacity for subsystems and safety components listed in the implementing act referred to in Article 43a(1). (*6) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).’." |
Article 3
Amendments to Regulation (EU) 2016/425
Regulation (EU) 2016/425 is amended as follows:
| (1) | in Article 3, the following points are added:
(*7) Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).’;" |
| (2) | the following chapter is inserted: ‘Chapter VIa Emergency procedures Article 41a Application of emergency procedures 1. Articles 41b to 41e of this Regulation shall apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to PPE covered by this Regulation. 2. Articles 41b to 41e of this Regulation shall apply only to PPE which has been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747. 3. Articles 41b to 41e of this Regulation shall apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747. However, Article 41d(7) of this Regulation shall apply during the internal market emergency mode and after its expiry or deactivation. 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 PPE placed on the market in accordance with Articles 41c and 41d. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3). Article 41b Prioritisation of the conformity assessment of PPE designated as crisis-relevant goods 1. This Article applies to PPE listed in the implementing act referred to in Article 41a(1) that is subject to the conformity assessment procedures referred to in Article 19 that require the mandatory involvement of a notified body. 2. The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of PPE referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 41a. 3. The prioritisation of applications for a conformity assessment of PPE pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications. 4. The notified bodies shall make reasonable efforts to increase their testing capacities for PPE referred to in paragraph 1 in respect of which they have been notified. Article 41c Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body 1. By way of derogation from Article 19, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market within the territory of that Member State, of specific PPE listed in the implementing act referred to in Article 41a(1) and for which the conformity assessment procedures referred to in Article 19 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential health and safety requirements laid down in Annex II has been demonstrated in accordance with procedures referred to in that authorisation. 2. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable essential health and safety requirements laid down in Annex II, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific PPE 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 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 44(3). The PPE 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 content and presentation 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. 3. 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 44(4). 4. As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation. 5. Manufacturers of PPE subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the PPE concerned complies with all the applicable essential health and safety requirements set out in Annex II and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority. 6. Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the PPE may be placed on the market. Such authorisations shall set out at least the following:
7. By way of derogation from Articles 7, 16 and 17, PPE for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 7 shall not apply. 8. The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such PPE, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council (*8) and under this Regulation. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions. 9. The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 19. Article 41d Presumption of conformity based on standards and common specifications 1. Where PPE has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications for such PPE to cover the applicable essential health and safety requirements set out in Annex II to this Regulation in the following cases:
2. The implementing acts referred to in paragraph 1 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts. 3. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 44(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article. 4. Before preparing the draft implementing act referred to in paragraph 1 of this Article, 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 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Regulation and shall duly consult all relevant stakeholders. 5. Without prejudice to Article 14, PPE that is in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the applicable essential health and safety requirements set out in Annex II that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article. 6. By way of derogation from Article 41a(3), first subparagraph, unless there is sufficient reason to believe that the PPE covered by the standards or common specifications referred to in paragraph 1 of this Article presents a risk to the health or safety of persons, the PPE that is in conformity with those standards or common specifications and which has been placed on the market shall be deemed to be in conformity 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 3 of this Article and after the expiry or deactivation of the internal market emergency mode. 7. When a Member State considers that a standard or common specification as 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, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question. Article 41e Prioritisation of market surveillance activities and mutual assistance among authorities 1. Member States shall prioritise the market surveillance activities for PPE listed in the implementing act referred to in Article 41a(1) of this Regulation. The Commission shall facilitate coordination of such prioritisation 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 an internal market emergency mode, 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 the reinforcement of the testing capacity for PPE listed in the implementing act referred to in Article 41a(1). (*8) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).’." |
Article 4
Amendments to Regulation (EU) 2016/426
Regulation (EU) 2016/426 is amended as follows:
| (1) | in Article 2, the following points are added:
(*9) Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).’;" |
| (2) | the following chapter is inserted: ‘Chapter Va Emergency procedures Article 40a Application of emergency procedures 1. Articles 40b to 40e of this Regulation shall apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to appliances and fittings covered by this Regulation. 2. Articles 40b to 40e of this Regulation shall apply only to appliances and fittings which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747. 3. Articles 40b to 40e of this Regulation shall apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747. However, Article 40c(7) of this Regulation shall apply during the internal market emergency mode and after its expiry or deactivation. 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 appliances and fittings placed on the market or used for the manufacturer’s own purposes in accordance with Articles 40c and 40d. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3). Article 40b Prioritisation of the conformity assessment of appliances and fittings designated as crisis-relevant goods 1. This Article applies to all appliances and fittings listed in the implementing act referred to in Article 40a(1) that are subject to the conformity assessment procedures referred to in Article 14 that require the mandatory involvement of a notified body. 2. The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of appliances and fittings referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 40a. 3. The prioritisation of applications for a conformity assessment of appliances and fittings pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications. 4. The notified bodies shall make reasonable efforts to increase their testing capacities for appliances and fittings referred to in paragraph 1 in respect of which they have been notified. Article 40c Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body 1. By way of derogation from Article 14, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market or use for the manufacturer’s own purposes within the territory of that Member State, of a specific appliance or fitting listed in the implementing act referred to in Article 40a(1) and for which the conformity assessment procedures referred to in Article 14 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential requirements laid down in Annex I has been demonstrated in accordance with procedures referred to in that authorisation. 2. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable essential requirements laid down in Annex I, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific appliance or fitting may be placed on the market or used for the manufacturer’s own purposes. 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 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 42(3). The appliance or fitting subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market or used for the manufacturer’s own purposes as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the content and presentation 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. 3. 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 42(4). 4. As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation. 5. Manufacturers of appliances or fittings subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the appliance or the fitting concerned complies with all the applicable essential requirements set out in Annex I and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority. 6. Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the appliance or fitting may be placed on the market or used for the manufacturer’s own purposes. Such authorisations shall set out at least the following:
7. By way of derogation from Articles 6, 16 and 17, appliances or fittings for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 6 shall not apply. 8. The market surveillance authorities of a Member State, where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such appliances or fittings, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council (*10) and under this Regulation. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions. 9. The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 14. Article 40d Presumption of conformity based on standards and common specifications 1. Where appliances or fittings have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications for such appliances or fittings to cover the applicable essential requirements set out in Annex I to this Regulation in the following cases:
2. The implementing acts referred to in paragraph 1 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts. 3. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 42(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article. 4. Before preparing the draft implementing act referred to in paragraph 1 of this Article, 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 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Regulation and shall duly consult all relevant stakeholders. 5. Without prejudice to Article 13, appliances or fittings that are in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the applicable essential requirements set out in Annex I that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article. 6. By way of derogation from Article 40a(3), first subparagraph, unless there is sufficient reason to believe that the appliances or fittings covered by the standards or common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the appliances or fittings that are in conformity with those standards or common specifications and which have been placed on the market or used for the manufacturer’s own purposes shall be deemed to be in conformity with the applicable essential requirements set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode. 7. When a Member State considers that a standard or common specification as 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, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question. Article 40e Prioritisation of market surveillance activities and mutual assistance among authorities 1. Member States shall prioritise the market surveillance activities for appliances and fittings listed in the implementing act referred to in Article 40a(1) of this Regulation. The Commission shall facilitate coordination of such prioritisation 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 an internal market emergency mode, 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 the reinforcement of the testing capacity for appliances and fittings listed in the implementing act referred to in Article 40a(1). (*10) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).’." |
Article 5
Amendments to Regulation (EU) 2023/988
Regulation (EU) 2023/988 is amended as follows:
| (1) | in Article 2(1), third subparagraph, point (b) is replaced by the following:
; |
| (2) | in Article 3, the following points are added:
(*11) Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).’;" |
| (3) | the following chapter is inserted: ‘Chapter IIa Emergency procedures Article 8a Application of emergency procedures 1. Articles 8b and 8c of this Regulation shall apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to products covered by this Regulation. 2. Articles 8b and 8c of this Regulation shall apply only to products covered by this Regulation which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747. 3. Articles 8b and 8c of this Regulation shall apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747. Article 8b Presumption of conformity with the general safety requirement in the context of an internal market emergency 1. In addition to the presumption of conformity laid down in Article 7 of this Regulation, where severe disruptions to the functioning of the internal market, which were taken into consideration when the internal market emergency mode was activated in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities for manufacturers to make use of relevant European standards the references of which have already been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, the presumption of conformity with the general safety requirement laid down in Article 5 may also be established for the purpose of placing products on the market if the product conforms to national requirements as regards the risks and risk categories covered by health and safety requirements laid down in the national law of the Member State in which the product is made available on the market, provided that such law is in compliance with Union law. 2. In addition to the cases where the presumption of conformity with the general safety requirement laid down in Article 5 of this Regulation applies under paragraph 1 of this Article and Article 7(1) of this Regulation, Member States shall take all appropriate measures to ensure that, for the purpose of placing or making available of products on the market, their competent authorities consider that products which comply with relevant European standards other than those the references of which have been published in the Official Journal of the European Union in accordance with Article 10(7) of Regulation (EU) No 1025/2012, with relevant international standards developed by a recognised international standardisation body as defined in Article 2(9) of Regulation (EU) No 1025/2012, or with relevant national standards developed by a national standardisation body as defined in Article 2(10) of Regulation (EU) No 1025/2012, are presumed to meet the general safety requirement laid down in this Regulation as far as the risks and risk categories covered by those standards are concerned, unless such standards are not adequate in view of the other elements of Articles 6 and 8 of this Regulation. 3. Article 7(3) applies to the presumption of conformity established in accordance with this Article. Article 8c Prioritisation of market surveillance activities and mutual assistance among authorities 1. Member States shall prioritise market surveillance activities for products covered by this Regulation that are listed in the implementing act referred to in Article 8a(1). 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 an internal market emergency mode.’. |
Article 6
Amendments to Regulation (EU) 2023/1230
Regulation (EU) 2023/1230 is amended as follows:
| (1) | in Article 3, the following points are added:
(*12) Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).’;" |
| (2) | the following chapter is inserted: ‘Chapter IVa Emergency procedures Article 25a Application of emergency procedures 1. Articles 25b to 25e of this Regulation shall apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to machinery and related products covered by this Regulation. 2. Articles 25b to 25e of this Regulation shall apply only to machinery and related products which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747. 3. Articles 25b to 25e of this Regulation shall apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747. However, Article 25c(7) of this Regulation shall apply during the internal market emergency mode and after its expiry or deactivation. 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 and related products placed on the market or put into service in accordance with Articles 25c and 25d. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3). Article 25b Prioritisation of the conformity assessment of machinery and related products designated as crisis-relevant goods 1. This Article applies to all types of machinery and related products listed in the implementing act referred to in Article 25a(1) that are subject to the conformity assessment procedures referred to in Article 25 that require the mandatory involvement of a notified body. 2. The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of machinery and related products referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 25a. 3. The prioritisation of applications for a conformity assessment of machinery and related products pursuant to paragraph 2 shall not result in additional disproportionate additional costs for the manufacturers, who have lodged those applications. 4. The notified bodies shall make reasonable efforts to increase their testing capacities for machinery and related products referred to in paragraph 1 in respect of which they have been notified. Article 25c Derogation from conformity assessment procedures requiring the mandatory involvement of a notified body 1. By way of derogation from Article 25, a 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 that Member State, of specific machinery or related products listed in the implementing act referred to in Article 25a(1) and for which the conformity assessment procedures referred to in Article 25 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential health and safety requirements set out in Annex III has been demonstrated in accordance with procedures referred to in that authorisation. 2. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable essential health and safety requirements laid down in Annex III, the Commission shall adopt, without delay, 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 of this Article to the territory of the whole Union and shall set out the conditions under which the specific machinery or related products 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 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 48(3). The machinery or related products subject to the extension of validity referred to in the first subparagraph shall bear the information that they are 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 content and presentation 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. 3. 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 48(4). 4. As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation. 5. Manufacturers of machinery or of related products subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the machinery or the related products concerned comply with all the applicable essential health and safety requirements set out in Annex III and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority. 6. Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the machinery or the related products may be placed on the market or put into service. Such authorisations shall set out at least the following:
7. By way of derogation from Articles 4, 23 and 24, machinery or related products for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 4 shall not apply. 8. The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such machinery and related products, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 and under this Regulation. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions. 9. The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 25. Article 25d Presumption of conformity based on standards and common specifications 1. Where machinery or related 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 machinery or related products to cover the applicable essential health and safety requirements set out in Annex III to this Regulation in the following cases:
2. The implementing acts referred to in paragraph 1 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts. 3. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 48(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article. 4. Before preparing the draft implementing act referred to in paragraph 1 of this Article, 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 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Regulation and shall duly consult all relevant stakeholders. 5. Without prejudice to Article 20, machinery and related products that are in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the applicable essential health and safety requirements set out in Annex III that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article. 6. By way of derogation from Article 25a(3), first subparagraph, unless there is sufficient reason to believe that the machinery and the related products covered by the standards or common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the machinery and the related products that are in conformity with those standards or common specifications and which have been placed on the market or put into service shall be deemed to be in conformity with the applicable essential health and safety requirements set out in Annex III after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode. 7. 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 III, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question. Article 25e Prioritisation of market surveillance activities and mutual assistance among authorities 1. The Member States shall prioritise the market surveillance activities for machinery and related products listed in the implementing act referred to in Article 25a(1) of this Regulation. The Commission shall facilitate coordination of such prioritisation 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 an internal market emergency mode, 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 the reinforcement of the testing capacity for machinery and the related products listed in the implementing act referred to in Article 25a(1).’. |
Article 7
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 29 May 2026.
This Regulation shall be binding in its entirety and directly applicable in all Member States.