What changed

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

– having regard to Rule 59 of its Rules of Procedure,

– having regard to the report of the Committee on the Internal Market and Consumer Protection (A90000/2023),(A9-0244/2023),

1. Adopts its position at first reading hereinafter set out;

amending Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011 as regards emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency

amending Regulations (EU) 2016/424, (EU) 2023/XXXX [General Product Safety Regulation (GPSR)], (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/XXXX2023/988, [Machinery(EU) Regulation]2023/1230 and (EU) No 305/2011 as regards emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to an internal market emergency

Or. en

(Text with EEA relevance)

(Text with EEA relevance)

Amendment 2

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

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

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

Amendment 3

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

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

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

Amendment 4

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) [insert reference to SMEI Regulation] lays down a multi-layered mechanism consisting of contingency planning, vigilance mode and Single Market emergency mode.

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

Amendment 5

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

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

(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.

Amendment 6

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

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

(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.

Amendment 7

Proposal for a regulation

Recital 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 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 and (EU) 2019/1009 are also aligned to the reference provisions laid down by Decision No 768/2008/EC of the European Parliament and of the Council45 .

(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) 2023/XXXX [GPSR], (EU) 2016/42541 , (EU) 2016/42642 , (EU) 2019/100943 ,2019/100943, (EU) 2023/XXX [Machinery Regulation]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 and2019/1009, (EU) 2023/XXX2023/98844a, [Machineryand Regulation](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.

__________________

43 OJ L 170, 25.6.2019, p. 1.

43a OJ L 165, 29.6.2023, p. 1.

44 OJ L 88, 4.4.2011, p. 5.

44 OJ L 88, 4.4.2011, p. 5.

44a OJ L 135, 23.5.2023, p. 1.

45 OJ L 218, 13.8.2008, p. 82.

45 OJ L 218, 13.8.2008, p. 82.

Or. en

Amendment 8

Amendment 3

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) Neither the reference provisions laid down by Decision No 768/2008/EC, nor the specific provisions laid down by the sectoral nionU 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.

(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.

Amendment 9

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) Experience from the recent crises that have affected the Single 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 SMEI Regulation].

(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].

Amendment 10

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) In order to overcome the potential effects of disruptions on the Single 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.

(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.

Amendment 11

Proposal for a regulation

Recital 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 and (EU) No 305/2011. Those procedures should be available only following the activation of the Single Market emergency mode in accordance with [insert reference to SMEI Regulation].

(10) To that end, emergency procedures should be laid down in Regulations (EU) 2016/424, (EU) No 2023/XXXX [GPSR], (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/XXX2023/988, [Machinery(EU) Regulation]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].

Or. en

Amendment 12

Amendment 4

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(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 EU sectoral legislation.

(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.

Amendment 13

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(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 Single Market emergency, to derogate from the obligation to carry out those conformity assessment procedures laid down in those Regulations, in those cases 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. 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.

(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 particular those set out in Article 15(5) thereof.

Amendment 14

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) Where a Single 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.

(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.

Amendment 15

Proposal for a regulation

Recital 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. However, in cases where such standards do not exist or the compliance with them might be rendered excessively difficult by the disruptions caused by the crisis, it is appropriate to provide for alternative mechanisms.

(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 manufacturerproduct to benefit from a presumption of conformity with the general product safety requirement if theirthat product compliesconforms with the European standard publishedor inparts thethereof Officialas Journalfar ofas the Europeanrisks Union,and givenrisk categories covered by that standard are concerned, the standardreferences coversof allwhich have been published in the risksOfficial associatedJournal withof the product.European Union. However, in cases where such standards do not exist or the compliance with themsuch standards might be rendered excessively difficult byas a result of the disruptions caused by the crisis, it is appropriate to provide for alternative mechanisms.

Or. en

Amendment 16

Amendment 5

Proposal for a regulation

(15) With respect to Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and, (EU) 2019/1009, 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.

(15) With respect to Regulations (EU) 2016/424, (EU) 2023/XXXX [GPSR], (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, and (EU) 2023/XXX2023/988, [Machineryand Regulation],(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.

__________________

46 OJ L 316, 14.11.2012, p. 12.

Or. en

Amendment 17

Amendment 6

Proposal for a regulation

(16) Furthermore, with respect to Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 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 Single Market emergency.

(16) Furthermore, with respect to Regulations (EU) 2016/424, (EU) No 2023/XXXX [GPSR], (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/XXX2023/988, [Machinery(EU) Regulation]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.

Or. en

Amendment 18

Amendment 7

Proposal for a regulation

deleted

Or. en

Amendment 19

Amendment 8

Proposal for a regulation

(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.

Or. en

Amendment 20

Amendment 9

Proposal for a regulation

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

(20) Regulations (EU) 2016/424, (EU) No 2023/XXX [GPSR], (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/XXX2023/988, [Machinery(EU) Regulation]2023/1230 and (EU) No 305/2011 should therefore be amended accordingly,

Or. en

Amendment 21

Amendment 10

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

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

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

Amendment 22

Proposal for a regulation

Article 1 – paragraph 1

1. Articles 43b to 43g shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Regulation.

1. Articles 43b to 43f43g of this Regulation shall only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA Regulation] with respect to this Regulation.Regulation].

Or. en

Amendment 23

Amendment 11

Proposal for a regulation

Regulation (EU) 2016/424

Article 43a – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Articles 43b to 43g, except as regards provisions concerning the powers of the Commission, shall apply during the Single Market emergency mode.

Articles 43b to 43g, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode.

Amendment 24

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43a – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

However, Article 43c(2), second subparagraph, and Article 43c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

deleted

Amendment 25

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43a – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to subsystems and safety components placed on the market in accordance with Articles 43c to 43f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3).

deleted

Amendment 26

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43b – paragraph 2

Text proposed by the Commission

Amendment

2. The notified bodies shall process all applications for conformity assessment of subsystems and safety components designated as crisis-relevant goods as a matter of priority.

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.

Amendment 27

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43b – paragraph 4

Text proposed by the Commission

Amendment

4. The prioritisation of applications for conformity assessment of subsystems and safety components pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

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.

Amendment 28

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43b – paragraph 5

Text proposed by the Commission

Amendment

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

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.

Amendment 29

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43c – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 18, any competent national authority may authorise, on a duly justified request, the placing on the market or the incorporation into a cableway installation within the territory of the Member State concerned, of a specific subsystem or safety component 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 18 have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

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.

Amendment 30

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43c – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The manufacturer shall also deploy all reasonable measures to ensure that the subsystem or safety component, which has been granted an authorisation pursuant to paragraph 1, does not leave the territory of the Member State, which issued the authorisation.

deleted

Amendment 31

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43c – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

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:

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:

Amendment 32

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43c – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c) an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(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;

Amendment 33

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43c – paragraph 3 – point e a (new)

Text proposed by the Commission

Amendment

(ea) labelling requirements, including radio frequency identification, indicating that the subsystem or safety component was authorised under the internal market emergency mode.

Amendment 34

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43c – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from Article 43a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3also after the deactivation or expiry of the Single Market Emergency mode.

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.

Amendment 35

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43c – paragraph 5

deleted

Or. en

Amendment 36

Amendment 12

Proposal for a regulation

Regulation (EU) 2016/424

Article 43c – paragraph 6

Text proposed by the Commission

Amendment

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.

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.

Amendment 37

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43c – paragraph 7

Text proposed by the Commission

Amendment

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market of subsystems or safety components in accordance with paragraph 1.

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.

Amendment 38

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

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 does not affect the application of the relevant conformity assessment procedures laid down in Article 18 on the territory of the Member State concerned.

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

Or. en

Amendment 39

Amendment 13

Proposal for a regulation

Regulation (EU) 2016/424

Article 43e43c – paragraph 1 – point8 a (new)

Text proposed by the Commission

Amendment

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.

Amendment 40

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43d – paragraph 1 – point a

Text proposed by the Commission

Amendment

Where

deleted

Amendment 41

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43d – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI 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.

(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.

Amendment 42

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43e– paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) where no reference to harmonised standards covering the relevant essential requirements set out in Annex II is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

Or. en

Amendment 43

Amendment 14

Proposal for a regulation

Regulation (EU) 2016/424

Article 43e –43e– paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(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 induring the contextinternal ofmarket theemergency emergency;mode;

Or. en

Amendment 44

Amendment 15

Proposal for a regulation

Regulation (EU) 2016/424

Article 43e – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 14 of [the SMEI 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.

(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.

Amendment 45

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43e – paragraph 2

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and 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 Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

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. In the early preparationWhen ofpreparing the draft implementing act establishing the common specification, the Commission shall gathertake into account the views of relevant bodies or expert groups established underthe relevant sectoral Union legislation. Based on that consultation, thebodies Commissionand shall prepareduly theconsult draftall implementingrelevant act.stakeholders.

Or. en

Amendment 46

Amendment 16

Proposal for a regulation

Regulation (EU) 2016/424

Article 43e – paragraph 2 a (new)4

Text proposed by the Commission

Amendment

2a. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies or the expert group and shall duly consult all relevant stakeholders.

4. 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 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 the said 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 Single Market Emergency mode in accordance with [the SMEI Regulation].

Or. en

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].

Amendment 1747

Proposal for a regulation

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 and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

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 and,information, ifThe appropriate,Commission may amendamend, where appropriate, the implementing act establishing the common specification in question.

Or. en

Amendment 48

Amendment 18

Proposal for a regulation

3. 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 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 Single Market Emergency mode in accordance with [the SMEI Regulation].

Or. en

Amendment 49

Justification

Mandatory common specifications are a novel concept and the added value of mandatory common specifications within a crisis framework over common specifications is unclear.

Amendment 19

Proposal for a regulation

Article 1 a– (new)paragraph 1

Regulation (EU) 2016/424

Article 43g – paragraph 2

Text proposed by the Commission

Amendment

Article 1 a

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single 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.

Amendments to Regulation (EU) 2023/XXXX [[General Product Safety Regulation (‘GPSR’)]

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.

In Regulation (EU) 2023/XXXX [GPSR], the following Chapter IIa is inserted:

Amendment 50

‘CHAPTER IIa

EMERGENCY PROCEDURES

Article 8a

Activation of the crisis procedures, relationship with other provisions of this Regulation and deactivation

1. The provisions laid down in this Chapter shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the IMERA Regulation] with respect to this Regulation.

2. Articles 8b to 8e shall only apply to products which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1.

3. Articles 8b to 8e shall apply during the internal market emergency mode, except with respect to provisions concerning the powers of the Commission.

4. The Commission shall be empowered to lay down, by means of implementing acts, rules regarding the follow-up actions to be taken by economic operators or market surveillance authorities with respect to products placed on the market in accordance with this Chapter. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(3).

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 the this Regulation, comply with the general safety requirement laid down in this Regulation in either 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 functioning of the internal market, which were taken into consideration when the internal market emergency mode was activated in accordance with Article XX of [the IMERA Regulation], significantly restrict the possibility for manufacturers to make use of the European standards covering the relevant essential safety requirements already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 8c

Adoption of common specifications enabling a presumption of safety

1. With respect to products covered by this Regulation that have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common technical specifications in either of the following cases:

(a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

(b) 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 in the context of the emergency;

(c) where severe disruptions in the functioning of the internal market, which were taken into consideration when the internal market emergency mode was activated in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibility for manufacturers to make use of the European standards covering the relevant essential safety requirements already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article XX and they shall remain applicable at the latest until the last day of the period for which the internal market emergency mode has been activated in accordance with Article 14 of [the IMERA Regulation].

3. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies or the expert group and shall duly consult all relevant stakeholders.

4. Products covered by this Regulation which are in conformity with common specifications adopted pursuant to paragraph 1 of this Article shall be presumed to be in conformity with the general safety requirement laid down in Article 5 for the aspects covered by those common specifications or parts thereof.

5. Products covered by this Regulation, which comply with the said common specifications referred to in paragraph 1 and have been placed on the market, shall not be affected by the subsequent expiry or withdrawal of an implementing act adopted pursuant to paragraph 2, which has laid down those common specifications, unless there is sufficient reason to believe that goods covered by those common specifications present a risk to the health or safety of persons.

6. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the general safety requirement laid down in Article 5, it shall inform the Commission thereof with a detailed explanation and the Commission shall consider that information and, if appropriate, may amend or withdraw the implementing act establishing the common specification in question.

Article 8e

Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise market surveillance activities for products covered by this Regulation, which have been designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall endeavour 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 products covered by this Regulation which have been designated as crisis-relevant goods.

Or. en

Amendment 20

Proposal for a regulation

Regulation (EU) 2016/425

Article 41c new –paragraph 5

Article 41a – paragraph 1

Text proposed by the Commission

Amendment

1. Articles 41b to 41g shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Regulation.

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].

Amendment 51

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41a – paragraph 2

Text proposed by the Commission

Amendment

2. Articles 41b to 41g shall apply exclusively to PPE, which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1.

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.

Amendment 52

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41a – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Articles 41b to 41g, except as regards provisions concerning the powers of the Commission, shall apply during the Single Market emergency mode.

Articles 41b to 43g, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode.

Amendment 53

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41a – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

However, Article 41c(2), second subparagraph, and Article 41c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

deleted

Amendment 54

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41a – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to PPE placed on the market in accordance with Articles 41c to 41f. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3).

deleted

Amendment 55

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41b – paragraph 2

Text proposed by the Commission

Amendment

2. The notified bodies shall process all applications for conformity assessment of PPE designated as crisis-relevant goods as a matter of priority.

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.

Amendment 56

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41b – paragraph 4

Text proposed by the Commission

Amendment

4. The prioritisation of applications for conformity assessment of PPE pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

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.

Amendment 57

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41b – paragraph 5

Text proposed by the Commission

Amendment

5. The notified bodies shall deploy their best efforts to increase their testing capacities for PPE designated as crisis-relevant goods in respect to which they have been notified.

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.

Amendment 58

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41c – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 19, any competent national authority may authorise, on a duly justified request, the placing on the market within the territory of the Member State concerned, of a specific PPE which has been designated as crisis-relevant good 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.

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.

Amendment 59

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41c – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The manufacturer shall also deploy all reasonable measures to ensure that the PPE, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which issued the authorisation.

deleted

Amendment 60

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41c – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

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:

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:

Amendment 61

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41c – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c) an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(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;

Amendment 62

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41c – paragraph 3 – point e a (new)

Text proposed by the Commission

Amendment

(ea) labelling requirements, including radio frequency identification, indicating that the PPE was authorised under the internal market emergency mode.

Amendment 63

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41c – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from Article 41a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 of this Article also after the deactivation or expiry of the Single Market Emergency mode.

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.

Amendment 64

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41c – paragraph 5

Text proposed by the Commission

Amendment

5. By way of derogation from Articles 7 and 17, PPE, for which an authorisation has been granted in accordance with paragraph 1 of this Article, shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

deleted

Or. en

Amendment 65

Amendment 21

Proposal for a regulation

Regulation (EU) 2016/425

Article 41c new – paragraph 86

Text proposed by the Commission

Amendment

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.

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.

Amendment 66

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41c – paragraph 8

Text proposed by the Commission

Amendment

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 19 on the territory of the Member State concerned.

8. The application of Articles 41a to 41g and the use of the authorisation procedure set out in paragraph 1 of this Article doesshall not affect the application of the relevant conformity assessment procedures laid down in Article 19.

Or. en

Amendment 67

Amendment 22

Proposal for a regulation

Regulation (EU) 2016/425

Article 41c – paragraph 8a (new)

Text proposed by the Commission

Amendment

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.

Amendment 68

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41d – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI 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.

(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.

Amendment 69

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41e – paragraph 1 – point a

(a) where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex II is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

Or. en

Amendment 70

Amendment 23

Proposal for a regulation

Amendment

(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 induring the contextinternal ofmarket theemergency emergency;mode;

Or. en

Amendment 71

Amendment 24

Proposal for a regulation

Regulation (EU) 2016/425

Article 41e – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) where severe disruptions in the functioning of the Single Market, which led to the activation Single 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.

(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.

Amendment 72

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41e – paragraph 2

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and 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 Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

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.

Or. en

Amendment 73

Amendment 25

Proposal for a regulation

Regulation (EU) 2016/425

Article 41e – paragraph 2 a (new)4

Text proposed by the Commission

Amendment

2a. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies or expert group and shall duly consult all relevant stakeholders.

4. By way of derogation from Article 41a(3), first subparagraph, 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 Single Market Emergency mode in accordance with [the SMEI Regulation].

Or. en

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].

Amendment 2674

Proposal for a regulation

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 and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

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 and,information. ifThe appropriate,Commission may amendamend, where appropriate, the implementing act establishing the common specification in question.

Or. en

Amendment 75

Amendment 27

Proposal for a regulation

3. By way of derogation from Article 41a(3), first subparagraph, unless there is sufficient reason to believe that the PPE covered by the mandatory 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 Single Market Emergency mode in accordance with [the SMEI Regulation].

Or. en

Amendment 76

Amendment 28

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41g – paragraph 2

Text proposed by the Commission

Amendment

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single 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.

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.’

Amendment 77

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40a – title

Text proposed by the Commission

Amendment

Applicationof emergency procedures

Application of emergency procedures

Amendment 78

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40a – paragraph 1

Text proposed by the Commission

Amendment

1. Articles 40b to 40g shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Regulation.

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].

Amendment 79

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40a – paragraph 2

Text proposed by the Commission

Amendment

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

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.

Amendment 80

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40a – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Articles 40b to 40g, except as regards provisions concerning the powers of the Commission, shall apply during the Single Market emergency mode remains active.

Articles 40b to 40g, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode remains active.

Amendment 81

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40a – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

However, Article 40c(2), second subparagraph, and Article 40c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

deleted

Amendment 82

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40a – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to appliances and fittings placed on the market in accordance with Articles 40c to 40f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3).

deleted

Amendment 83

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40b – paragraph 2

Text proposed by the Commission

Amendment

2. The notified bodies shall process all applications for conformity assessment of appliances and fittings designated as crisis-relevant goods as a matter of priority.

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.

Amendment 84

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40b – paragraph 4

Text proposed by the Commission

Amendment

4. The prioritisation of applications for conformity assessment of appliances and fittings pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

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.

Amendment 85

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40b – paragraph 5

Text proposed by the Commission

Amendment

5. The notified bodies shall deploy their best efforts to increase their testing capacities for appliances and fittings designated as crisis-relevant goods in respect to which they have been notified.

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.

Amendment 86

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40c – title

Text proposed by the Commission

Amendment

Derogation from conformity assessment procedures requiring mandatory involvement of a notified bod

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

Amendment 87

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40c – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 14, any competent national authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, 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.

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.

Amendment 88

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40c – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The manufacturer shall also deploy all reasonable measures to ensure that the appliance or fitting, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which issued the authorisation.

deleted

Amendment 89

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40c – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

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, including:

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:

Amendment 90

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40c – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c) an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(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;

Amendment 91

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40c – paragraph 3 – point e a (new)

Text proposed by the Commission

Amendment

(ea) labelling requirements, including radio frequency identification, indicating that the appliance and fitting was authorised under the internal market emergency mode.

Amendment 92

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40c – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from Article 40a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 also after the deactivation or expiry of the Single Market Emergency mode.

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.

Amendment 93

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40c – paragraph 5

deleted

Or. en

Amendment 94

Amendment 29

Proposal for a regulation

Regulation (EU) 2016/426

Article 40c – paragraph 6

Text proposed by the Commission

Amendment

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.

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.

Amendment 95

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

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 does not affect the application of the relevant conformity assessment procedures laid down in Article 14 on the territory of the Member State concerned.

8. The application of Articles 40a to 40g and the use of the authorisation procedure set out in paragraph 1 of this Article doesshall not affect the application of the relevant conformity assessment procedures laid down in Article 14.

Or. en

Amendment 96

Amendment 30

Proposal for a regulation

Regulation (EU) 2016/426

Article 40c – paragraph 8 a (new)

Text proposed by the Commission

Amendment

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.

Amendment 97

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40d – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI 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.

(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.

Amendment 98

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40e – paragraph 1 – point a

(a) where no reference to harmonised standards covering the relevant essential requirements set out in Annex I is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

Or. en

Amendment 99

Amendment 31

Proposal for a regulation

Amendment

(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 induring the contextinternal ofmarket theemergency emergency;mode;

Or. en

Amendment 100

Amendment 32

Proposal for a regulation

Regulation (EU) 2016/426

Article 40e – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 15(4) of [the SMEI 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.

(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.

Amendment 101

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40e – paragraph 2

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and 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 Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

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.

Or. en

Amendment 102

Amendment 33

Proposal for a regulation

Regulation (EU) 2016/426

Article 40e – paragraph 2 a (new)4

Text proposed by the Commission

Amendment

2a. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies or the expert group and shall duly consult all relevant stakeholders.

4. 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 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 Single Market Emergency mode in accordance with [the SMEI Regulation].

Or. en

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].

Amendment 34103

Proposal for a regulation

Regulation (EU) 2016/426

Article 40f

Article 40e – paragraph 5

Text proposed by the Commission

Amendment

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 and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

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.

Amendment 104

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40f – title

Text proposed by the Commission

Amendment

Article 40f

3. 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 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 Single Market Emergency mode in accordance with [the SMEI Regulation].

Or. en

Amendment 105

Amendment 35

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40g – paragraph 2

Text proposed by the Commission

Amendment

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single 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.

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.

Amendment 106

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41a – paragraph 1

Text proposed by the Commission

Amendment

1. Articles 41b to 41g shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Regulation.

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].

Amendment 107

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41a – paragraph 2

Text proposed by the Commission

Amendment

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

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.

Amendment 108

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41a – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

3. Articles 41b to 41g, except as regards provisions concerning the powers of the Commission, shall apply during the Single Market emergency mode.

3. Articles 41b to 41g, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode.

Amendment 109

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41a – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

However, Article 41c(2), second subparagraph, and Article 41c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

deleted

Amendment 110

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41a – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to fertilising products placed on the market in accordance with Articles 41c to 41f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).

deleted

Amendment 111

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41b – paragraph 2

Text proposed by the Commission

Amendment

2. The notified bodies shall process all applications for conformity assessment of fertilising products designated as crisis-relevant goods as a matter of priority.

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.

Amendment 112

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41b – paragraph 4

Text proposed by the Commission

Amendment

4. The prioritisation of applications for conformity assessment of fertilising products pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

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.

Amendment 113

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41b – paragraph 5

Text proposed by the Commission

Amendment

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

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.

Amendment 114

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41c – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 15, any competent national authority may authorise, on a duly justified request, the placing on the market within the territory of the Member State concerned, of a specific fertilising product 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 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.

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.

Amendment 115

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41c – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The manufacturer shall also deploy all reasonable measures to ensure that the fertilising product, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which issued the authorisation.

deleted

Amendment 116

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41c – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

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:

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:

Amendment 117

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41c – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c) an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(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;

Amendment 118

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41c – paragraph 3 – point e a (new)

Text proposed by the Commission

Amendment

(ea) labelling requirements, including radio frequency identification, indicating that the fertilising product was authorised under the internal market emergency mode.

Amendment 119

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41c – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from Article 41a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3of this Articcle also after the deactivation or expiry of the Single Market Emergency mode.

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.

Amendment 120

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41c – paragraph 5

deleted

Or. en

Amendment 121

Amendment 36

Proposal for a regulation

Regulation (EU) 2019/1009

Article 41c – paragraph 6

Text proposed by the Commission

Amendment

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.

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.

Amendment 122

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

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.

Or. en

Amendment 123

Amendment 37

Proposal for a regulation

Regulation (EU) 2019/1009

Article 41c – paragraph 8 a (new)

Text proposed by the Commission

Amendment

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.

Amendment 124

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41d – paragraph 1

Text proposed by the Commission

Amendment

Where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI 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, the 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.

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:

Amendment 125

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41d – paragraph 1 – point a (new)

Text proposed by the Commission

Amendment

(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;

Amendment 126

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41d – paragraph 1 – point b (new)

Text proposed by the Commission

Amendment

(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.

Amendment 127

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41e – paragraph 1

Text proposed by the Commission

Amendment

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) where severe disruptions in the functioning of the Single Market, which led to the activation of [were taken into consideration when] the Single Market emergency mode 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.

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:

Amendment 128

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41e – paragraph 1 – point a (new)

Text proposed by the Commission

Amendment

(a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

Amendment 129

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41e – paragraph 1 – point b (new)

Text proposed by the Commission

Amendment

(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;

Amendment 130

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41e – paragraph 1 – point c (new)

Text proposed by the Commission

Amendment

(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.

Amendment 131

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41e – paragraph 2

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 45(3). They shall apply to EUfertilising products placed on the market until the last day of the period for which the Single Market emergency mode remains active in accordance with [the SMEI Regulation]. In the early preparation of the draft implementing acts establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

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 in accordance with [the IMERA Regulation].active. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies or the expert group and shall duly consult all relevant stakeholders.

Or. en

Amendment 132

Amendment 38

Proposal for a regulation

Regulation (EU) 2019/1009

Article 41e – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from Article 41a(3), first subparagraph, 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 Single Market Emergency mode in accordance with [the SMEI Regulation].

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].

Amendment 133

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

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 explanationand the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

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 and,information. ifThe appropriate,Commission may amendamend, where appropriate, the implementing act establishing the common specification in question.

Or. en

Amendment 134

Amendment 39

Proposal for a regulation

3. By way of derogation from Article 41a(3), first subparagraph, unless there is sufficient reason to believe that the EU fertilising products covered by the mandatory 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 Single Market Emergency mode in accordance with [the SMEI Regulation].

Or. en

Amendment 135

Amendment 40

Proposal for a regulation

Article 4 a– (new)paragraph 1

Regulation (EU) 2019/1009

Article 41g – paragraph 2

Text proposed by the Commission

Amendment

Article 4a

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single 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.

Amendments to Regulation (EU) 2023/XXXX [Machinery Regulation]

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.’

In Regulation (EU)2023/XXXX, the following Chapter VIIa is inserted:

Amendment 136

‘CHAPTER VIIa

Proposal for a regulation

Emergency procedures

Article 4 a (new) – paragraph 1 – point 1 (new)

Regulation (EU) 2023/988

Article 2 – paragraph 1 – point b

Present text

Amendment

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 III, Section 1, Chapters V and VII and Chapters IX to XI do not apply.

“(b) Chapter IIa, Chapter III, Section 1, Chapters V and VII and Chapters IX to XI do not apply.”

Amendment 137

Proposal for a regulation

Article 4 a (new) – paragraph 1 – point 2 (new)

Regulation (EU) 2023/988

Chapter II a (new)

Text proposed by the Commission

Amendment

(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 functioning of the internal market, which were taken into consideration when the internal market emergency mode was activated in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibility for manufacturers to make use of the European standards already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 8c

Adoption of common specifications enabling a presumption of safety for the risks and aspects covered by common specifications

1. With respect to products covered by this Regulation that have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common technical specifications in either of the following cases:

(a) where no specific safety requirements in accordance with Article 7 paragraph 2 have been adopted;

(b) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

(c) 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 and such reference is not expected to be published within a reasonable timeframe during the internal market emergency mode;

(d) where severe disruptions in the functioning of the internal market, which were taken into consideration when the internal market emergency mode was activated in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibility for manufacturers to make use of the European standards covering the relevant essential safety requirements already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 46(3) and they shall remain applicable at the latest until the last day of the period for which the internal market emergency mode has been activated in accordance with Article 14 of [the IMERA Regulation].

3. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the Consumer Safety Network, referred to in Article 30 and shall duly consult relevant stakeholders.

4. Products covered by this Regulation which are in conformity with common specifications adopted pursuant to paragraph 1 of this Article shall be presumed to be in conformity with the general safety requirement laid down in Article 5 for the risks and risk categories covered by those common specifications or parts thereof.

5. Products covered by this Regulation, which comply with the common specifications adopted pursuant to paragraph 1 and have been placed on the market, shall not be affected by the subsequent expiry or withdrawal of an implementing act adopted pursuant to paragraph 2, which has laid down those common specifications, unless there is sufficient reason to believe that goods covered by those common specifications present a risk to the health or safety of persons.

6. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the general safety requirement laid down in Article 5, it shall inform the Commission thereof with a detailed explanation and the Commission shall consider that information. The Commission may amend, where appropriate, amend the implementing act establishing the common specification in question.

Article 8d

Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise market surveillance activities for products covered by this Regulation, which have been designated as crisis-relevant goods.

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 products covered by this Regulation which have been designated as crisis-relevant goods.

Amendment 138

Proposal for a regulation

Article 4 b (new)

Regulation (EU) 2023/1230

Chapter VI a (new)

Text proposed by the Commission

Amendment

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 46g46f of this Regulation shall only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA Regulation] with respect to this Regulation.Regulation].

2. Articles 46b to 46g46f shall apply exclusively to machinery,machinery which has been designated as a crisis-relevant goodgoods in the implementing act referred to in paragraph 1.1 of this Article.

3. Articles 46b to 46g46f shall apply during the internal market emergency mode, except with respect to provisions concerning the powers of the Commission. However, 46c(2), second subparagraph, and Article 46c(5), shall apply during the internal market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down, by means of implementing acts, rules regarding the follow-up actions to be taken with respect to machinery placed on the market in accordance with this Chapter. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(3).

Article 46b

Prioritisation of the conformity assessment of crisis-relevant machinery

1. This Article shall apply to machinery designated as a crisis-relevant good,goods, which is subject to conformity assessment procedures in accordance with Article 21, which require therequiring mandatory involvement of a notified body.

2. The notified bodies shall process,ensure asall areasonable priority,efforts are made to process all applications for a conformity assessment of machinery designated as crisis-relevant goods, as a crisis-relevantmatter good.of priority.

3. All pending applications for a conformity assessment of machinery designated as a crisis-relevant goodgoods shall be required to be processed as a matter of priority, overahead of any other applications for conformity assessment of machinery which has not been designated as a crisis-relevant good.goods. This priority requirement appliesshall apply to all applications for conformity assessments of machinery designated as a crisis-relevant good,goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 46a.

4. The prioritisation of applications for a conformity assessment of machinery pursuant to paragraphs 2 and 3 shall not give rise to any extraordinary additional costs for the manufacturers who have lodged those applications.

5. The notified bodies shall endeavourensure all reasonable efforts are made to increase their testing capacities for machinery designated as a crisis-relevant goodgoods in respect of which they have been notified.

Article 46c

Derogation from third party conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 21, anythe competent national authorityauthority, after carrying out a risk assessment, may authorise, on a duly justified request,request from an economic operator established in its Member State, the placing on the market or putting into service within the territory of thethat Member State concerned,State, of specific machinery which has been designated as a crisis-relevant goodgoods and for which the conformity assessment procedures requiring mandatory involvement of a notified body referred to in Article 21 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.

2. The manufacturer of machinery, subject to the authorisation procedure referred to in paragraph 1, shall declare on his sole responsibility that the machinery concerned complies with all the applicable essential health and safety requirements set out in Annex III and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority. The manufacturer shall also deploy all reasonable measures to ensure that the machinery, which has been granted an authorisation pursuant to paragraph 1, does not leave the territory of the Member State which has granted the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the machinery may be placed on the market or put into service, including:including at least:

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

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

(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;

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

(e) measures to be taken with respect to the machinery concerned upon expiry of the authorisation in order to ensure that the machinery concerned is brought back in compliance with all the requirements of this Regulation.Regulation;

4. By way of derogation from Article 21d and paragraph (3), first subparagraph of this Article, the national competent authority may, where appropriate, amend the conditions of the authorisation referred to in paragraph 3 of this Article, also after the deactivation or expiry of the internal market emergency mode.

(f) labelling requirements, including radio frequency identification, indicating that the machinery was authorised under the internal market emergency mode.

5. 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 machinery.

4. By way of derogation from Article 46(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.

5. 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 machinery. 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.

6. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of machinery in accordance with paragraph 1.

7. The application of Articles 46a to 46g and the use of the authorisation procedure set out in paragraph 1 of this Article doesshall not affect the application of the relevant conformity assessment procedures laid down in Article 21.

8. Machinery 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.

Article 46d

Adoption of common specifications conferring a presumption of conformity

1. Where machinery has been designated as a crisis-relevant good,goods, the Commission is empowered to adopt implementing acts establishing common specifications for such machinery to cover the essential health and safety requirements set out in Annex III to this Regulation, in either of the following cases:

a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

b) where a reference to harmonised standards covering the relevant essential requirements set out in Annex IIIII 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 induring the contextinternal ofmarket theemergency emergency;mode;

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

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 46(3).They48(3). They shall apply to machinery placed on the market until the last day of the period for which the internal market emergency mode hasremains beenactive. activatedWhen inpreparing accordancethe withdraft-implementing Articleact 14establishing the common specification, the Commission shall take into account the views of [thethe IMERArelevant Regulation].bodies and shall duly consult all relevant stakeholders.

3. When preparing the draft-implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies or the expert group and shall duly consult all relevant stakeholders.

3. Without prejudice to Article 17, machinery which is in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III covered by those common specifications or parts thereof.

4. WithoutBy prejudiceway toof derogation from Article 17,46a(3), machineryunless whichthere is insufficient conformityreason withto believe that the machinery covered by the common specifications adopted pursuantreferred to in paragraph 21 of this Article shallpresents bea presumedrisk to bethe health or safety of persons, the machinery in conformitycompliance with those common specifications which has been placed on the essentialmarket healthshall andbe safetydeemed requirementscompliant setwith outthis inRegulation Annexafter IIIthe coveredexpiry byor thoserepeal commonof specificationsan implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or partsdeactivation thereof.of the internal market emergency mode in accordance with [the IMERA Regulation].

5. By way of derogation from Article 46a(3), first subparagraph, unless there is sufficient reason to believe that the machinery covered by the common specifications referred to in paragraph 1 of this Article presents a risk to the health or safety of persons, the machinery 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].

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 III, 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.

6. 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 III, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, may amend the implementing act establishing the common specification in question.

Article 46f

Article 46g

Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for machinery, designated as a crisis-relevant good.goods.

2. The market surveillance authorities of the Member States shall endeavourensure 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 machinery designated as a crisis-relevant good.’goods.’

Or. en

Amendment 139

Amendment 41

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59a – paragraph 1

Text proposed by the Commission

Amendment

1. Articles 59b to 59f shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Regulation.

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].

Amendment 140

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59a – paragraph 2

Text proposed by the Commission

Amendment

2. Articles 59b to 59f shall apply exclusively to construction products, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

2. Articles 59b to 59f shall apply exclusively to construction products, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

Amendment 141

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59a – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

3. Articles 59b to 59f, except as regards provisions concerning the powers of the Commission, shall apply during the Single Market emergency mode.

3. Articles 59b to 59f, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode.

Amendment 142

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59a – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

However, Article 59c(2), second subparagraph, and Article 59c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

deleted

Amendment 143

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59a – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to construction products placed on the market in accordance with Articles 59b to 59f. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 64(2a)

deleted

Amendment 144

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59b – paragraph 2

Text proposed by the Commission

Amendment

2. The notified bodies shall 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.

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.

Amendment 145

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59b – paragraph 4

Text proposed by the Commission

Amendment

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 additional costs for the manufacturerswho have lodged those applications.

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.

Amendment 146

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59b – paragraph 5

Text proposed by the Commission

Amendment

5. The notified bodies shall deploy their best efforts to increase their respective assessment and verification capacities regarding construction products designated as crisis-relevant goods.

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.

Amendment 147

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59c – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 28(1), the competent national authority may exceptionally authorise, on a duly justified request, the placing on the market within the territory of the Member State concerned, 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 that Article have not been carried out by a notified body.

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.

Amendment 148

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59c – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The manufacturer shall also deploy all reasonable measures to ensure that the construction product, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which issued the authorisation.

deleted

Amendment 149

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59c – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

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:

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:

Amendment 150

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59c – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c) an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(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;

Amendment 151

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59c – paragraph 3 – point e a (new)

Text proposed by the Commission

Amendment

(ea) labelling requirements, including radio frequency identification, indicating that the construction product was authorised under the internal market emergency mode.

Amendment 152

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59c – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from Article 54a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation issued referred to in paragraph 3 of this Article, also after the deactivation or expiry of the Single Market Emergency mode.

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.

Amendment 153

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59c – paragraph 5

deleted

Or. en

Amendment 154

Amendment 42

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59c – paragraph 6

Text proposed by the Commission

Amendment

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.

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.

Amendment 155

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

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 does not affect the application of the relevant procedures for the assessment and verification of constancy of performance required by Article 28 on the territory of the Member State concerned.

8. The application of Articles 59a to 59f and the use of the authorisation procedure set out in paragraph 1 of this Article doesshall not affect the application of the relevant procedures for the assessment and verification of constancy of performance required by Article 28.

Or. en

Amendment 156

Amendment 43

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59c – paragraph 8 a (new)

Text proposed by the Commission

Amendment

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.

Amendment 157

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59d – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) where no reference to harmonised standards covering the relevant methods and criteria for assessing the performance of those products in relation to their essential characteristics is published in the Official Journal of the European Union in accordance with Article 17(5);

(a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation (EU) No 1025/2012 were not adopted;

Amendment 158

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59d – paragraph 1 – point a a (new)

Amendment

(aa) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

(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;

Or. en

Amendment 159

Amendment 44

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59d – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) where the severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode 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 Article 17(5).

(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.

Amendment 160

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59d – paragraph 2

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the Standing Committee on Construction and 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 Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the Standing Committee on Construction and 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 or the expert group and shall duly consult all relevant stakeholders.

Or. en

Amendment 161

Amendment 45

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

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 and, if appropriate, amend or withdraw the implementing at establishing the common specification in question

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 and,information. ifThe appropriate,Commission may amendamend, where appropriate, the implementing at establishing the common specification in questionquestion.

Or. en

Amendment 162

Amendment 46

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59e

3. By way of derogation from Article 59a(3), first subparagraph, unless there is sufficient reason to believe that the construction products covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the construction 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 Single Market Emergency mode in accordance with [the SMEI Regulation].

Or. en

Amendment 163

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) No 305/2011

Article 59f – paragraph 2

Text proposed by the Commission

Amendment

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single 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.

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.’

Amendment 164

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the Commission

Amendment

It shall apply from [OP- please insert the date identical to that of the entry into application of the SMEI Regulation].

It shall apply from [OP- please insert the date identical to the date of application of the IMERA Regulation].

EXPLANATORY STATEMENT

ANNEX: LIST OF ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

SME United

PROCEDURE – COMMITTEE RESPONSIBLE

Title

Amending Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011 as regards emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency

References

COM(2022)0461 – C9-0314/2022 – 2022/0279(COD)

Date submitted to Parliament

19.9.2022

Committee responsible

Date announced in plenary

IMCO

21.11.2022

Rapporteurs

Date appointed

Andreas Schwab

16.12.2022

Discussed in committee

28.3.2023

25.4.2023

28.6.2023

Date adopted

18.7.2023

Result of final vote

+:

–:

0:

35

3

2

Members present for the final vote

Andrus Ansip, Pablo Arias Echeverría, Alessandra Basso, Brando Benifei, Adam Bielan, Biljana Borzan, Vlad-Marius Botoş, Markus Buchheit, Anna Cavazzini, Deirdre Clune, David Cormand, Alexandra Geese, Sandro Gozi, Maria Grapini, Svenja Hahn, Krzysztof Hetman, Virginie Joron, Eugen Jurzyca, Kateřina Konečná, Maria-Manuel Leitão-Marques, Antonius Manders, Leszek Miller, Anne-Sophie Pelletier, René Repasi, Christel Schaldemose, Andreas Schwab, Tomislav Sokol, Ivan Štefanec, Róża Thun und Hohenstein, Tom Vandenkendelaere, Kim Van Sparrentak, Marion Walsmann

Substitutes present for the final vote

Claude Gruffat, Ivars Ijabs, Karen Melchior, Tsvetelina Penkova, Kosma Złotowski

Substitutes under Rule 209(7) present for the final vote

Eric Minardi, Paulo Rangel, Grzegorz Tobiszowski

Date tabled

24.7.2023

FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE

Key to symbols: