Changes from plenary report to adopted text

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

RemovedRecital 4: (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.

RemovedRecital 5: (5) In order to complement, ensure consistency and to 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.

RemovedRecital 6: (6) A number of Union 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 Regulations (EU) 2016/42440 , (EU) 2016/42541 , (EU) 2016/42642 , (EU) 2019/100943, (EU) 2023/123043a and (EU) No 305/201144 of the European Parliament and of the Council. Those legal acts are based on the principles of the new approach to technical harmonisation. Moreover, Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/98844a, and (EU) 2023/1230 are also aligned to the reference provisions laid down by Decision No 768/2008/EC of the European Parliament and of the Council45 . In addition, Regulation (EU) 2023/988 lays down essential rules on the safety of consumer products placed or made available on the market. / 43a OJ L 165, 29.6.2023, p. 1. / 44a OJ L 135, 23.5.2023, p. 1.

RemovedRecital 7: (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 Regulations, aimed at preparing and responding to impacts of crises affecting products that have been designated as crisis-relevant goods and covered by those Regulations.

RemovedRecital 8: (8) Experience from the recent crises that have affected the internal market has shown that the procedures laid down in the sectoral legislation are not designed to cater for 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].

RemovedRecital 9: (9) In order to overcome the potential effects of disruptions to the internal market and in order to ensure that 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.

RemovedRecital 10: (10) To that end, emergency procedures should be laid down in Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/988, (EU) 2023/1230 and (EU) No 305/2011. Those procedures should be available only following the activation of the internal market emergency mode in accordance with [insert reference to IMERA Regulation].

RemovedRecital 11: (11) Furthermore, in cases 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 legislation. The authorisation for products granted exceptionally and temporarily should remain valid for six months after deactivation or expiration of the internal market emergency mode, where it does not does not affect in any way the health, safety and security of consumers. After this period, products should only be made available on the market after receiving an authorisation under the normal authorisation procedure provided for under the applicable rules. Products already granted authorisation exceptionally and temporarily may be re-authorised under the normal authorisation procedure. Nevertheless, products or components already purchased for use, or which are already in use, may continue to be used without new authorisation.

RemovedRecital 12: (12) As regards products falling within the scope of those Regulations 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 Regulations, where the involvement of a notified body is mandatory and should be able to issue authorisations for those products, provided that they comply with all the applicable essential safety requirements and that the safety of consumers and end-users is fully assured. 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. The principle of mutual recognition should apply to goods placed on the market under that derogation. The competent national authority should keep relevant technical documentation to ensure compliance with applicable rules. Products manufactured during the internal market emergency mode, where derogation from the conformity assessment procedures was authorised, should also be subject to the relevant obligations of traceability provided for in Regulation (EU) 2023/988, in part…

RemovedRecital 13: (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.

RemovedRecital 14: (14) A number of sectoral Union harmonisation legislation provide for the possibility for a manufacturer to benefit from a presumption of conformity if their product complies with a harmonised European standard. Furthermore, the general product safety framework laid down in Regulation (EU) 2023/988 provides for the possibility for a product to benefit from a presumption of conformity with the general product safety requirement if that product conforms with the European standard or parts thereof as far as the risks and risk categories covered by that standard are concerned, the references of which have been published in the Official Journal of the European Union. However, in cases where such standards do not exist or the compliance with such standards might be rendered excessively difficult as a result of the disruptions caused by the crisis, it is appropriate to provide for alternative mechanisms.

RemovedRecital 15: (15) With respect to Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/988, and (EU) 2023/1230, the competent national authorities should be able to presume that products manufactured in accordance with national or international standards within the meaning of Regulation (EU) No 1025/201246 ensuring an equivalent level of protection to that offered by the harmonised European standards comply with the relevant essential health and safety requirements.

RemovedRecital 16: (16) Furthermore, with respect to Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/988, (EU) 2023/1230 and (EU) No 305/2011, 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.

RemovedRecital 17: deleted

RemovedRecital 18: (18) In order to ensure that the level of safety provided by the harmonised products or by products under the general safety framework 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.

RemovedRecital 20: (20) Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/988, (EU) 2023/1230 and (EU) No 305/2011 should therefore be amended accordingly,

RemovedRecital 21: (21) In order for this Regulation to apply from the same date as [IMERA Regulation], its application should be deferred,

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43a – paragraph 1: 1. Articles 43b to 43g of this Regulation shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation].

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43a – paragraph 3 – subparagraph 1: Articles 43b to 43g, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43a – paragraph 3 – subparagraph 2: deleted

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43a – paragraph 4: deleted

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of subsystems and safety components designated as crisis-relevant goods as a matter of priority.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43b – paragraph 4: 4. The prioritisation of applications for conformity assessment of subsystems and safety components pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for subsystems and safety components designated as crisis-relevant goods in respect of which they have been notified.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 1: 1. By way of derogation from Article 18, the competent national authority, after carrying out a risk assessment, may authorise, on a duly justified request from an economic operator established in its Member State, 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 which has been designated as a crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body, referred to in Article 18 have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 2 – subparagraph 1: deleted

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 3 – introductory part: 3. Any authorisation issued by a national competent authority 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, including at least:

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 3 – point c: (c) an end date of validity of the authorisation, unless otherwise specified, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 3 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the subsystem or safety component was authorised under the internal market emergency mode.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 4: 4. By way of derogation from Article 43a(3), where appropriate, the national competent authority may also amend the conditions and requirements referred to in paragraph 3 of this Article after the deactivation or expiry of the internal market emergency mode.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 5: deleted

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 6: 6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Regulation with respect to such subsystems or safety components. The market surveillance authorities shall keep all records related to products authorised under a derogation for a period of 10 years. They shall make those records available to other market surveillance authorities upon request.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 7: 7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market or incorporation into a cableway installation of subsystems or safety components in accordance with paragraph 1.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 8: 8. The application of Articles 43a to 43g and the use of the authorisation procedure set out in paragraph 1 of this Article shall not affect the application of the relevant conformity assessment procedures laid down in Article 18.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43c – paragraph 8 a (new): 8a. Subsystems or safety components subject to derogation under paragraph 1 shall remain valid for six months after deactivation or expiration of the internal market emergency mode. After this period, they shall only be made available on the market after receiving an authorisation under the normal authorisation procedure provided for in this Regulation.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43d – paragraph 1 – point a: deleted

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43d – paragraph 1 – point b: (b) where severe disruptions in the functioning of the internal market, which were taken into consideration when activating 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 essential requirements set out in Annex II to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e– paragraph 1 – point a: (a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e– paragraph 1 – point a a (new): (aa) where a reference to harmonised standards covering the relevant essential requirements set out in Annex II is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and such reference is not expected to be published within a reasonable timeframe during the internal market emergency mode;

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e – paragraph 1 – point b: (b) where 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 essential requirements set out in Annex II to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e – paragraph 2: 2. 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 they shall apply to subsystems or safety components placed on the market until the last day of the period for which the internal market emergency mode remains active. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies and shall duly consult all relevant stakeholders.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e – paragraph 4: 4. By way of derogation from Article 43a(3), unless there is sufficient reason to believe that the subsystems or safety components covered by the 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 in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Regulation 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 in accordance with [the IMERA Regulation].

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential requirements which it aims to cover and which are set out in Annex II, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information, The Commission may amend, where appropriate, the implementing act establishing the common specification in question.

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43f: deleted / (deleted) / (deleted) / (deleted) / (deleted)

RemovedRegulation (EU) 2016/424

RemovedArticle 1 – paragraph 1, Article 43g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure best efforts are made to provide assistance to other market surveillance authorities during an 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 subsystems and safety components designated as crisis-relevant goods.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41a – paragraph 1: 1. Articles 41b to 43g of this Regulation shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation].

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41a – paragraph 2: 2. Articles 41b to 43g shall apply exclusively to PPE which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41a – paragraph 3 – subparagraph 1: Articles 41b to 43g, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41a – paragraph 3 – subparagraph 2: deleted

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41a – paragraph 4: deleted

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of PPE designated as crisis-relevant goods as a matter of priority.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41b – paragraph 4: 4. The prioritisation of applications for conformity assessment of PPE pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for PPE designated as crisis-relevant goods in respect to which they have been notified.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41c – paragraph 1: 1. By way of derogation from Article 19, the competent national authority, after carrying out a risk assessment, may authorise, on a duly justified request from an economic operator established in its Member State, the placing on the market within the territory of that Member State, of a specific PPE which has been designated as crisis-relevant goods for which the conformity assessment procedures requiring 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.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41c – paragraph 2 – subparagraph 1: deleted

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41c – paragraph 3 – introductory part: 3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the PPE may be placed on the market, including at least:

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41c – paragraph 3 – point c: (c) an end date of validity, unless otherwise specified, of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41c – paragraph 3 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the PPE was authorised under the internal market emergency mode.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41c – paragraph 4: 4. By way of derogation from Article 41a(3), where appropriate, the national competent authority may also amend the conditions and requirements referred to in paragraph 3 of this Article also after the deactivation or expiry of the internal market emergency mode.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41c – paragraph 5: deleted

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41c – paragraph 6: 6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Regulation with respect to such PPE. The market surveillance authorities shall keep all records related to products authorised under a derogation for a period of 10 years. They shall make those records available to other market surveillance authorities upon request.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41c – paragraph 8: 8. The application of Articles 41a to 41g and the use of the authorisation procedure set out in paragraph 1 of this Article shall not affect the application of the relevant conformity assessment procedures laid down in Article 19.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41c – paragraph 8a (new): 8a. PPE subject to derogation under paragraph 1 shall remain valid for six months after deactivation or expiration of the internal market emergency mode. After this period, it shall only be made available on the market after receiving an authorisation under the normal authorisation procedure provided for in this Regulation.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41d – paragraph 1 – point b: (b) where severe disruptions in the functioning of the internal market, which were taken into consideration when activating 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 essential health and safety requirements set out in Annex II to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41e – paragraph 1 – point a: (a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41e – paragraph 1 – point a a (new): (aa) where a reference to harmonised standards covering the relevant essential requirements set out in Annex II is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and such reference is not expected to be published within a reasonable timeframe during the internal market emergency mode;

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41e – paragraph 1 – point b: (b) where severe disruptions in the functioning of the internal market, which led to the activation internal market emergency mode significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential health and safety requirements set out in Annex II to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41e – paragraph 2: 2. 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). They shall remain applicable to PPE placed on the market until the last day of the period for which the internal market emergency mode remains active. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies and shall duly consult all relevant stakeholders.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41e – paragraph 4: 4. By way of derogation from Article 41a(3), unless there is sufficient reason to believe that the PPE covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the PPE in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Regulation 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 in accordance with [the IMERA Regulation].

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential health and safety requirements which it aims to cover and which are set out in Annex II, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information. The Commission may amend, where appropriate, the implementing act establishing the common specification in question.

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41f: deleted / (deleted) / (deleted) / (deleted) / (deleted)

RemovedRegulation (EU) 2016/425

RemovedArticle 2 – paragraph 1, Article 41g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure best efforts are made to provide assistance to other market surveillance authorities during an 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 PPE designated as crisis-relevant goods.’

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40a – title: Application of emergency procedures

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40a – paragraph 1: 1. Articles 40b to 40g of this Regulation shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation] activating Article 26 of [the IMERA Regulation].

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40a – paragraph 2: 2. Articles 40b to 40g shall apply exclusively to appliances and fittings, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40a – paragraph 3 – subparagraph 1: Articles 40b to 40g, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode remains active.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40a – paragraph 3 – subparagraph 2: deleted

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40a – paragraph 4: deleted

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of appliances and fittings designated as crisis-relevant goods as a matter of priority.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40b – paragraph 4: 4. The prioritisation of applications for conformity assessment of appliances and fittings pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for appliances and fittings designated as crisis-relevant goods in respect to which they have been notified.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40c – title: Derogation from conformity assessment procedures requiring mandatory involvement of a notified body

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40c – paragraph 1: 1. By way of derogation from Article 14, the competent national authority, after carrying out a risk assessment, may authorise, on a duly justified request from an economic operator established in its Member State, the placing on the market or putting into service within the territory of that Member State, of a specific appliance or fitting 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 requirements has been demonstrated.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40c – paragraph 2 – subparagraph 1: deleted

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40c – paragraph 3 – introductory part: 3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the appliance or fitting may be placed on the market or put into service, including at least:

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40c – paragraph 3 – point c: (c) an end date of validity of the authorisation, unless otherwise specified, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40c – paragraph 3 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the appliance and fitting was authorised under the internal market emergency mode.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40c – paragraph 4: 4. By way of derogation from Article 40a(3), where appropriate, the national competent authority may also amend the conditions and requirements referred to in paragraph 3 of this Article after the deactivation or expiry of the internal market emergency mode.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40c – paragraph 5: deleted

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40c – paragraph 6: 6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1 shall be entitled to take all corrective and restrictive measures at national level provided for under this Regulation with respect to such appliances or fittings. The market surveillance authorities shall keep all records related to products authorised under a derogation for a period of 10 years. They shall make those records available to other market surveillance authorities upon request.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40c – paragraph 8: 8. The application of Articles 40a to 40g and the use of the authorisation procedure set out in paragraph 1 of this Article shall not affect the application of the relevant conformity assessment procedures laid down in Article 14.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40c – paragraph 8 a (new): 8a. Appliances and fittings subject to derogation under paragraph 1 shall remain valid for six months after deactivation or expiration of the internal market emergency mode. After this period, they shall only be made available on the market after receiving an authorisation under the normal authorisation procedure provided for in this Regulation.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40d – paragraph 1 – point b: (b) where severe disruptions in the functioning of the internal market, which were taken into consideration when activating 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 essential health and safety requirements set out in Annex I to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40e – paragraph 1 – point a: (a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40e – paragraph 1 – point a a (new): (aa) where a reference to harmonised standards covering the relevant essential requirements set out in Annex II is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and such reference is not expected to be published within a reasonable timeframe during the internal market emergency mode;

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40e – paragraph 1 – point b: (b) where 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 essential requirements set out in Annex I in this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40e – paragraph 2: 2. 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). They shall apply to appliances and fittings placed on the market no longer than until the last day of the period for which the internal market emergency mode remains active. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies and shall duly consult all relevant stakeholders.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40e – paragraph 4: 4. By way of derogation from Article 40a(3), unless there is sufficient reason to believe that the appliances or fittings covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the appliances or fittings in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Regulation 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 in accordance with [the IMERA Regulation].

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential requirements which it aims to cover and which are set out in Annex I, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information. The Commission may amend, where appropriate, the implementing act establishing the common specification in question.

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40f – title: deleted / (deleted) / (deleted) / (deleted) / (deleted)

RemovedRegulation (EU) 2016/426

RemovedArticle 3 – paragraph 1, Article 40g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure best efforts are made to provide assistance to other market surveillance authorities during an 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 appliances and fittings designated as crisis-relevant goods.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41a – paragraph 1: 1. Articles 41b to 41g of this Regulation shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation].

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41a – paragraph 2: 2. Articles 41b to 41g shall apply exclusively to fertilising products which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41a – paragraph 3 – subparagraph 1: 3. Articles 41b to 41g, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41a – paragraph 3 – subparagraph 2: deleted

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41a – paragraph 4: deleted

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of fertilising products designated as crisis-relevant goods as a matter of priority.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41b – paragraph 4: 4. The prioritisation of applications for conformity assessment of fertilising products pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for fertilising products designated as crisis-relevant goods in respect of which they have been notified.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41c – paragraph 1: 1. By way of derogation from Article 15, the competent national authority, after carrying out a risk assessment, may authorise, on a duly justified request from an economic operator established in its Member State, the placing on the market within the territory of that Member State, of a specific fertilising product which has been designated as a crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body referred to in Article 15 have not been carried out by a notified body but for which the compliance with the requirements set out in Annexes I and II has been demonstrated.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41c – paragraph 2 – subparagraph 2: deleted

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41c – paragraph 3 – introductory part: 3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the fertilising products may be placed on the market, including at least:

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41c – paragraph 3 – point c: (c) an end date of validity of the authorisation, unless otherwise specified, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41c – paragraph 3 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the fertilising product was authorised under the internal market emergency mode.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41c – paragraph 4: 4. By way of derogation from Article 41a(3), where appropriate, the national competent authority may also amend the conditions and requirements referred to in paragraph 3 of this Article also after the deactivation or expiry of the internal market emergency mode.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41c – paragraph 5: deleted

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41c – paragraph 6: 6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Regulation with respect to such fertilising products. The market surveillance authorities shall keep all records related to products authorised under a derogation for a period of 10 years. They shall make those records available to other market surveillance authorities upon request.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41c – paragraph 8: 8. The application of Articles 41a to 41g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 15.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41c – paragraph 8 a (new): 8a. Fertilising products subject to derogation under paragraph 1 shall remain valid for six months after deactivation or expiration of the internal market emergency mode. After this period, they shall only be made available on the market after receiving an authorisation under the normal authorisation procedure provided for in this Regulation.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41d – paragraph 1: Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market, their competent authorities consider as complying with requirements set out in Annex I, II or III of this Regulation fertilising products which comply with relevant international standards or any relevant national standards in force in the Member State of manufacture, ensuring a safety level equivalent to that required by the requirements set out in Annex I, II or III, comply with those essential requirements in either of the following cases:

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41d – paragraph 1 – point a (new): (a) where a reference to harmonised standards covering the relevant essential requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41d – paragraph 1 – point b (new): (b) where severe disruptions in the functioning of the internal market, which were taken into consideration when activating 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 requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41e – paragraph 1: 1. Where EU fertilising products have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such EU fertilising products for the requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation:

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41e – paragraph 1 – point a (new): (a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41e – paragraph 1 – point b (new): (b) where a reference to harmonised standards covering the relevant essential requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and such reference is not expected to be published within a reasonable timeframe during the internal market emergency mode;

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41e – paragraph 1 – point c (new): (c) where 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 requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41e – paragraph 2: 2. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 45(3). They shall apply to EU fertilising products placed on the market until the last day of the period for which the internal market emergency mode remains active. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies and shall duly consult all relevant stakeholders.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41e – paragraph 4: 4. By way of derogation from Article 41a(3), unless there is sufficient reason to believe that the fertilising products covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the fertilising products in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Regulation 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 in accordance with [the IMERA Regulation].

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the requirements set out in Annexes I and II, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information. The Commission may amend, where appropriate, the implementing act establishing the common specification in question.

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41f: deleted / (deleted) / (deleted) / (deleted) / (deleted)

RemovedRegulation (EU) 2019/1009

RemovedArticle 4 – paragraph 1, Article 41g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure best efforts are made to provide assistance to other market surveillance authorities during an 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 fertilising products designated as crisis-relevant goods.’

RemovedRegulation (EU) 2023/988

RemovedArticle 4 a (new) – paragraph 1 – point 1 (new), Article 2 – paragraph 1 – point b: Article 4 a / Amendments to Regulation (EU) 2023/988 / Regulation (EU) 2023/988 is amended as follows: / (1) In Article 2(1), point (b) is replaced by the following: / “(b) Chapter IIa, Chapter III, Section 1, Chapters V and VII and Chapters IX to XI do not apply.”

RemovedRegulation (EU) 2023/988

RemovedArticle 4 a (new) – paragraph 1 – point 2 (new), Chapter II a (new): (2) The following chapter is inserted: / ‘CHAPTER IIa / EMERGENCY PROCEDURES / Article 8a / Activation of the emergency procedures, relationship with other provisions of this Regulation and deactivation / 1. Articles 8b to 8d shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation]. / 2. Articles 8b to 8d shall only apply to products which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article. / 3. Articles 8b to 8d shall apply during the internal market emergency mode, except with respect to provisions concerning the powers of the Commission. / Article 8b / Presumption of safety based on national and international standards / Member States shall take all appropriate measures to ensure that, for the purpose of placing products on the market, their competent authorities consider that the products which comply with the relevant international standards or any national standards in force in the Member State of manufacture, and which ensure the safety level required by this Regulation, meet the general safety requirement laid down in this Regulation as far as the risks and risk categories covered by those standards are concerned in any of the following cases: / (a) where a reference to European standards is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012; / (b) where severe disruptions to the functionin…

RemovedRegulation (EU) 2023/1230

RemovedArticle 4 b (new), Chapter VI a (new): Article 4b / Amendments to Regulation (EU) 2023/1230 / In Regulation (EU)2023/1230, the following chapter is inserted: / ‘CHAPTER VIa EMERGENCY PROCEDURES / Article 46a / Application of emergency procedures / 1. Articles 46b to 46f of this Regulation shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation]. / 2. Articles 46b to 46f shall apply exclusively to machinery which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article. / 3. Articles 46b to 46f shall apply during the internal market emergency mode, except with respect to provisions concerning the powers of the Commission. / Article 46b / 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 21, requiring mandatory involvement of a notified body. / 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for a conformity assessment of machinery designated as crisis-relevant goods, as a matter of priority. / 3. All pending applications for a conformity assessment of machinery designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for conformity assessment of machinery which has not been designated as crisis-relevant goods. This prio…

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59a – paragraph 1: 1. Articles 59b to 59f of this Article shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation].

RemovedRegulation (EU) No 305/2011

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59a – paragraph 3 – subparagraph 1: 3. Articles 59b to 59f, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59a – paragraph 3 – subparagraph 2: deleted

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59a – paragraph 4: deleted

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process requests for third party tasks related to the assessment and verification of constancy of performance of construction products designated as crisis-relevant goods as a matter of priority.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59b – paragraph 4: 4. The prioritisation of applications for third party tasks related to the assessment and verification of constancy of performance of construction products pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their respective assessment and verification capacities regarding construction products designated as crisis-relevant goods.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59c – paragraph 1: 1. By way of derogation from Article 28(1), the competent national authority, after carrying out a risk assessment, may exceptionally authorise, on a duly justified request from an economic operator established in its Member State, the placing on the market within the territory of that Member State, of a specific construction product which has been designated as crisis-relevant good for which the required third-party assessment and verification of constancy of performance procedures referred to in Article 28(1) have not been carried out by a notified body.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59c – paragraph 2 – subparagraph 2: deleted

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59c – paragraph 3 – introductory part: 3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the construction products may be placed on the market, including at least:

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59c – paragraph 3 – point c: (c) an end date of validity, unless otherwise specified, of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59c – paragraph 3 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the construction product was authorised under the internal market emergency mode.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59c – paragraph 4: 4. By way of derogation from Article 54a(3), where appropriate, the national competent authority may also amend the conditions and requirements referred to in paragraph 3 of this Article after the deactivation or expiry of the internal market emergency mode.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59c – paragraph 5: deleted

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59c – paragraph 6: 6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Regulation with respect to such construction products. The market surveillance authorities shall keep all records related to products authorised under a derogation for a period of 10 years. They shall make those records available to other market surveillance authorities upon request.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59c – paragraph 8: 8. The application of Articles 59a to 59f and the use of the authorisation procedure set out in paragraph 1 of this Article shall not affect the application of the relevant procedures for the assessment and verification of constancy of performance required by Article 28.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59c – paragraph 8 a (new): 8a. Construction products subject to derogation under paragraph 1 shall remain valid for six months after deactivation or expiration of the internal market emergency mode. After this period, they shall only be made available on the market after receiving an authorisation under the normal authorisation procedure provided for in this Regulation.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59d – paragraph 1 – point a: (a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59d – paragraph 1 – point a a (new): (aa) where a reference to harmonised standards covering the relevant essential requirements set out in Annex II is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and such reference is not expected to be published within a reasonable timeframe during the internal market emergency mode;

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59d – paragraph 1 – point b: (b) where the 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, providing the relevant methods and criteria for assessing the performance of those product in relation to their essential characteristics, and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59d – paragraph 2: 2. 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). They shall apply to construction products placed on the market until the last day of the period for which the internal market emergency mode remains active. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of relevant bodies and shall duly consult all relevant stakeholders.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59d – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 is incorrect in terms of criteria and methods for the assessment of performance in relation to essential characteristics, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information. The Commission may amend, where appropriate, the implementing at establishing the common specification in question.

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59e: deleted / (deleted) / (deleted) / (deleted) / (deleted)

RemovedRegulation (EU) No 305/2011

RemovedArticle 5 – paragraph 1 – point 1, Article 59f – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure best efforts are made to provide assistance to other market surveillance authorities during an 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 construction products designated as crisis-relevant goods.’

RemovedArticle 6 – paragraph 2: It shall apply from [OP- please insert the date identical to the date of application of the IMERA Regulation].

Removed1. Introduction

RemovedOn 19 September 2022, the European Commission published the proposal for the “Single Market Emergency Instrument” (SMEI) and two legislative proposals with targeted amendments to sectoral legislation. SMEI provides a general framework for EU crisis response in the internal market and complements other sector-specific crisis response mechanisms such as the Union Civil Protection Mechanism and sector-specific crisis frameworks in the areas of health, semiconductors or food security.

RemovedSMEI was drawn up in response to the fragmentation of the internal market during the Covid-19 pandemic where ad-hoc, unilateral border closures impinged on the freedom of movement of goods, services and workers, and exacerbated supply chain disruptions. The unprecedented crisis led to a chaotic initial response by the Member States, marked by a lack of coordination and solidarity, and the introduction of unjustified restrictions, without fully taking into consideration their devastating effect on the proper functioning of the internal market. The new instrument provides for a horizontal crisis governance framework to make sure that the internal market remains open and that supply chains are more resilient.

Removed2. The Draft Report

RemovedThe Rapporteur fully supports the objective of the Regulation of safeguarding free movement of goods, workers and services. At the same time, the Rapporteur believes that resilience is key to ensuring that the internal market delivers on its ultimate goal of supporting the EU’s economy. The Rapporteur therefore proposes to change the title to “Internal Market Emergency and Resilience Act” (IMERA) and to introduce additional changes to strengthen the Union’s resilience. The Rapporteur welcomes IMERA’s approach to preserving the free movement of goods, services and workers. During the Covid-19 pandemic, the rights of workers and companies as enshrined in the Treaties were disproportionately limited. The Rapporteur would like to highlight that the Treaty freedoms are not suspended in times of crises: unilateral limitations to free movement often even hampered the crisis response, such as limiting the mobility of health workers, hospital machinery maintenance service providers or the availability of food supplies. Therefore, the Rapporteur emphasizes the important role that “Fast lanes” played during the pandemic and highlights that the new instrument should further develop such measures.

RemovedDuring the Covid 19 pandemic and the EU’s response to Russia’s illegal war in Ukraine, the government-led crisis responses were complemented by the rapid adjustments companies made to their supply chains and production lines. The Rapporteur believes that market interventions must remain instruments of last resort, while market-based mechanisms such as procurement and cooperation between the government and the industry are better, faster and more efficient crisis responses.

RemovedIn view of these considerations, the Rapporteur strengthens some elements, in particular pertaining to resilience and the free movement of workers, goods and services. At the same time, he wants to ensure that during a crisis, the spirit of cooperation and solidarity governs the relationship between governments and companies willing to help.

Removed2.1 Resilience during the contingency mode

RemovedThe Rapporteur believes that IMERA must increase the resilience of supply chains by fostering cooperation between businesses, the Commission and Member States on a voluntary basis. The Rapporteur therefore proposes to ensure the crisis-preparedness of all actors through biennial stress tests, trainings and crisis protocols involving not only all relevant national authorities, but also stakeholders such as businesses, social partners and experts.

RemovedCompanies possess critical knowledge and resources for crisis responses, as highlighted by the Covid pandemic. In the Rapporteur’s opinion, the inclusion of companies must be an integral part of any crisis response mechanism. The Rapporteur wants to foster greater involvement of companies by allowing them to provide advice on crisis-measures through an online platform. Moreover, to address common sector-specific vulnerabilities at a European level, the Commission should conduct supply chain stress tests on a voluntary basis, thereby giving both the Commission and businesses the opportunity to develop best practices on supply chain resilience.

RemovedThe Rapporteur believes that strategic reserves must become a more permanent consideration in increasing the Union’s resilience, and increased cooperation and exchange of best practices between the Commission and the Member States is needed. At the same time, the Rapporteur notes that the pro-cyclical creation of reserves during the “Vigilance Mode” or “Emergency Mode” risks increased scarcity, rising prices, affecting competition and the level playing field, and an exacerbation of the situation. Moreover, strategic reserves require established relationships between economic operators and administrative arrangements specific to each sector. Member States are better placed to accomplish that as they already have well-established mechanisms to administer strategic reserves. Therefore, the Rapporteur suggests giving the Commission a permanent role in ensuring coordination, information exchange and promoting solidarity between Member States in the administration of strategic reserves, while removing the empowerment to prescribe mandatory stockpiles during the “Vigilance Mode”.

Removed2.2 Emergency Mode

RemovedThe Rapporteur believes that the focus of IMERA during a crisis must be to safeguard the free movement of goods, services and workers as enshrined in the treaties, especially in case of emergencies. The Rapporteur proposes to strengthen the elements of the first chapter of the emergency mode and align it with the treaties and with case law. Moreover, the Rapporteur wants to draw more attention to the situation of border regions as they are the most affected by limitations to free movement. Hence, he would like to aim for a unified definition of “working from home”.

RemovedTo the Rapporteur, companies and market forces are central to any crisis response in the Internal Market. While he sees the necessity for priority rated orders, he suggests improvements to provide further leeway to companies and ensure more legal certainty. Since businesses delivered despite uncoordinated actions by public authorities during the pandemic, the Rapporteur suggests more limited and voluntary requests for information. Moreover, to provide legal certainty, the Rapporteur improves the rules governing the use of data and the protection of trade and business secrets, and of intellectual property. Furthermore, the Rapporteur proposes procedural elements to ensure that priority rated orders remain an instrument of last resort and will not endanger the economic viability of companies. Recalling that companies during the Covid pandemic were under a heavy strain, the Rapporteur suggests adjustments to the sanctions regimes to reflect the lower revenues likely generated during a crisis.

RemovedThe Rapporteur considers solidarity to be the key for the mutual trust and, ultimately, for the smooth free movement of goods, services and workers. Therefore, he suggests a mechanism whereby Member States may launch a call for solidarity in case of shortages of crisis-relevant goods and services. During Covid, export restrictions and joint procurement pitted EU-members against like-minded neighbours that were equally in need of crisis-relevant goods. To avoid such situations in the future and to strengthen European solidarity, the rapporteur proposes to open up the joint procurement to Andorra, Monaco and San Marino, accession candidate countries and countries of the European Free Trade Area.

Removed2.3 Digital Tools and harmonisation of administrative procedures

RemovedDuring the Covid pandemic, nationally divergent requirements and administrative procedures for entering another Member State created great confusion and frustration for citizens, especially workers and service providers, in particular in border regions. The Rapporteur therefore foresees that the Commission must immediately develop digital tools similar to the successful interoperable Covid-19 certificate to guarantee the functioning of “fast lanes” for critical goods and services. The Commission must provide a digital portal, covering all registration or authorisation forms for cross-border activities, especially for crisis-relevant declarations similar to Covid Certificates, and for crisis-relevant professional services to accelerate authorisation, registration or declaration procedures.

Removed2.4 Governance

RemovedCovid highlighted the importance of good cooperation between all governments in the EU’s internal market, but also the importance of parliamentary scrutiny. Therefore, the Rapporteur proposes to model the advisory group after an expert group within the well-known and established rules for such groups, thereby giving the European Parliament and EEA/EFTA countries a more permanent seat at the table as observers. Given the general nature of IMERA, the Rapporteur also suggests improvement to key definitions, thereby increasing legal certainty and predictability.

Removed3. Accompanying proposals

RemovedThe Rapporteur suggests targeted changes to the two accompanying proposals to make sure that free movement of harmonised and non-harmonised goods is facilitated across the EU. As regards the crisis instruments at the Commission’s disposal, the Rapporteur suggests providing a mechanism also for the rapid placing on the market for non-harmonized products, which would have increased the availability of safe personal protection equipment during the Covid pandemic. Furthermore, to incentivize companies to ramp up production during a crisis, the Rapporteur proposes to permit the continued sale of goods that were put on the market under emergency procedures for a limited period of time after the end of the single market emergency, without compromising on the safety of the products.

RemovedIt is the Rapporteur’s belief that IMERA should primarily improve the resilience of the internal market, ensuring constant coordination between Member States and ensuring readiness for the event of sudden shocks at all times. Thereby, in times of crisis, the Internal Market must stay open and functional and protect consumers, workers and businesses alike from emergencies.