Sittings · Document

DRAFT REPORT (COM(2022)0461 – C90314/2022 – 2022/0279(COD)) 2023-03-10

On the proposal for a regulation of the European Parliament and of the Council 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

Committee on the Internal Market and Consumer Protection · Rapporteur: Andreas Schwab

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Amendments to a draft act

Amendments by Parliament set out in two columns

Deletions are indicated in bold italics in the left-hand column. Replacements are indicated in bold italics in both columns. New text is indicated in bold italics in the right-hand column.

The first and second lines of the header of each amendment identify the relevant part of the draft act under consideration. If an amendment pertains to an existing act that the draft act is seeking to amend, the amendment heading includes a third line identifying the existing act and a fourth line identifying the provision in that act that Parliament wishes to amend.

Amendments by Parliament in the form of a consolidated text

New text is highlighted in bold italics. Deletions are indicated using either the ▌symbol or strikeout. Replacements are indicated by highlighting the new text in bold italics and by deleting or striking out the text that has been replaced.

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DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council 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

(COM(2022)0461 – C90314/2022 – 2022/0279(COD))

(Ordinary legislative procedure: first reading)

– having regard to the Commission proposal to Parliament and the Council (COM(2022)0461),

– having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90314/2022),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 14 December 2022,

– having regard to the opinion of the Committee of the Regions of 8 February 2023,

– 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),

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

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment 1

Proposal for a regulation

Title

Text proposed by the Commission

Amendment

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

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/XXXX [Machinery Regulation] 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

Amendment 2

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(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 , (EU) 2023/XXX [Machinery Regulation] 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 and (EU) 2023/XXX [Machinery Regulation] are also aligned to the reference provisions laid down by Decision No 768/2008/EC of the European Parliament and of the Council45 .

__________________

40 OJ L 81, 31.3.2016, p. 1.

41 OJ L 81, 31.3.2016, p. 51.

42 OJ L 81, 31.3.2016, p. 99.

43 OJ L 170, 25.6.2019, p. 1.

44 OJ L 88, 4.4.2011, p. 5.

45 OJ L 218, 13.8.2008, p. 82.

Or. en

Amendment 3

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(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/XXX [Machinery Regulation] 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 4

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(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 provides for the possibility for a manufacturer to benefit from a presumption of conformity if their product complies with the European standard published in the Official Journal of the European Union, given that the standard covers all the risks associated with the product. 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.

Or. en

Amendment 5

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(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/XXX [Machinery Regulation], 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 6

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(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/XXX [Machinery Regulation] 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 7

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) With respect to Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011, in exceptional and duly justified circumstances, notably in order to ensure the interoperability among products or systems, the Commission should be able to adopt by means of implementing acts common specifications laying down mandatory technical specifications, with which the manufacturers will be required to comply. The implementing act laying down such common specifications should remain applicable for the duration of the Single Market emergency.

deleted

Or. en

Amendment 8

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

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

(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 9

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(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/XXX [Machinery Regulation] and (EU) No 305/2011 should therefore be amended accordingly,

Or. en

Amendment 10

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43a – paragraph 1

Text proposed by the Commission

Amendment

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 43f shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the IMERA Regulation] with respect to this Regulation.

Or. en

Amendment 11

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43c – paragraph 5

Text proposed by the Commission

Amendment

5. By way of derogation from Articles 7 and 20, subsystems or safety components, 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 12

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43c – paragraph 8

Text proposed by the Commission

Amendment

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.

Or. en

Amendment 13

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 No 1025/2012 were not adopted;

Or. en

Amendment 14

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 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 in the context of the emergency;

Or. en

Amendment 15

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43e – paragraph 2

Text proposed by the Commission

Amendment

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 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.

Or. en

Amendment 16

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43e – paragraph 2 a (new)

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.

Or. en

Amendment 17

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43e – 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 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, if appropriate, may amend the implementing act establishing the common specification in question.

Or. en

Amendment 18

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EU) 2016/424

Article 43f

Text proposed by the Commission

Amendment

Article 43f

deleted

Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential requirements set out in Annex II for subsystems or safety components, which have been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, 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 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.

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

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)

Text proposed by the Commission

Amendment

Article 1 a

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

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

‘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

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41c new –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 21

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41c new – 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.

Or. en

Amendment 22

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41e – paragraph 1 – point a

Text proposed by the Commission

Amendment

(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 No 1025/2012 were not adopted;

Or. en

Amendment 23

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

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

Text proposed by the Commission

Amendment

Or. en

Amendment 24

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41e – paragraph 2

Text proposed by the Commission

Amendment

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.

Or. en

Amendment 25

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41e – paragraph 2 a (new)

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.

Or. en

Amendment 26

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41e – 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 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, if appropriate, may amend the implementing act establishing the common specification in question.

Or. en

Amendment 27

Proposal for a regulation

Article 2 – paragraph 1

Regulation (EU) 2016/425

Article 41f

Text proposed by the Commission

Amendment

Article 41f

deleted

Adoption of mandatory common specifications

1. In duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential health and safety requirements set out in Annex II for PPE, which has been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, 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 apply 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.

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 28

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40c – paragraph 5

Text proposed by the Commission

Amendment

5. By way of derogation from Articles 6 and 17, appliances or fittings, 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 29

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40c – paragraph 8

Text proposed by the Commission

Amendment

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.

Or. en

Amendment 30

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40e – 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 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 No 1025/2012 were not adopted;

Or. en

Amendment 31

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40e – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 32

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40e – paragraph 2

Text proposed by the Commission

Amendment

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.

Or. en

Amendment 33

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40e – paragraph 2 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 34

Proposal for a regulation

Article 3 – paragraph 1

Regulation (EU) 2016/426

Article 40f

Text proposed by the Commission

Amendment

Article 40f

deleted

Adoption of mandatory common specifications

1. In duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential requirements set out in Annex I for appliances or fittings, which have been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, 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) and they shall apply to appliances or fittings placed on the market at the latest until the last day of the period for which the Single Market emergency 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.

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 35

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41c – paragraph 5

Text proposed by the Commission

Amendment

5. By way of derogation from Articles 3 and 18, fertilising products, 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 36

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41c – paragraph 8

Text proposed by the Commission

Amendment

Or. en

Amendment 37

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41e – paragraph 2

Text proposed by the Commission

Amendment

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]. 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 38

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41e – 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 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, if appropriate, may amend the implementing act establishing the common specification in question.

Or. en

Amendment 39

Proposal for a regulation

Article 4 – paragraph 1

Regulation (EU) 2019/1009

Article 41f

Text proposed by the Commission

Amendment

Article 41f

deleted

Adoption of mandatory common specifications

1. In duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications for EU fertilising products to cover the requirements set out in Annexes I and II which have been designated as crisis-relevant goods.

2. The implementing acts referred to in paragraph 1 shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 45(3) and they shall apply to EU fertilising 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.

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 40

Proposal for a regulation

Article 4 a (new)

Text proposed by the Commission

Amendment

Article 4a

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

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

‘CHAPTER VIIa

Emergency procedures

Article 46a

Application of emergency procedures

1. Articles 46b to 46g of this Regulation 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 46b to 46g shall apply exclusively to machinery, which has been designated as a crisis-relevant good in the implementing act referred to in paragraph 1.

3. Articles 46b to 46g 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, which is subject to conformity assessment procedures in accordance with Article 21, which require the mandatory involvement of a notified body.

2. The notified bodies shall process, as a priority, all applications for a conformity assessment of machinery designated as a crisis-relevant good.

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

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

5. The notified bodies shall endeavour to increase their testing capacities for machinery designated as a crisis-relevant good in respect of which they have been notified.

Article 46c

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

1. By way of derogation from Article 21, 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 specific machinery which has been designated as a crisis-relevant good 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 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:

(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, 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.

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.

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.

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 does not affect the application of the relevant conformity assessment procedures laid down in Article 21.

Article 46d

Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market or putting into service, their competent authorities consider that the machinery which complies with the relevant international standards or any national standards in force in the Member State of manufacture, ensuring the safety level required by the essential health and safety requirements set out in Annex III to this Regulation, complies with those essential health and safety requirements in either of the following cases:

a) where a reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex III to this Regulation is not 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 the internal market emergency mode was activated 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 III to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 46e

Adoption of common specifications conferring a presumption of conformity

1. Where machinery has been designated as a crisis-relevant good, 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 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 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).They shall apply to machinery placed on the market 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. 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.

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].

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 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.

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 machinery designated as a crisis-relevant good.’

Or. en

Amendment 41

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) 305/2011

Article 59c – paragraph 5

Text proposed by the Commission

Amendment

5. Construction products, 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 42

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) 305/2011

Article 59c – paragraph 8

Text proposed by the Commission

Amendment

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.

Or. en

Amendment 43

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) 305/2011

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

Text proposed by the Commission

Amendment

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

Or. en

Amendment 44

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) 305/2011

Article 59d – paragraph 2

Text proposed by the Commission

Amendment

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 45

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) 305/2011

Article 59d – paragraph 5

Text proposed by the Commission

Amendment

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, if appropriate, may amend the implementing at establishing the common specification in question

Or. en

Amendment 46

Proposal for a regulation

Article 5 – paragraph 1 – point 1

Regulation (EU) 305/2011

Article 59e

Text proposed by the Commission

Amendment

Article 59e

deleted

Adoption of mandatory common specifications

1. In duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the methods and the criteria for assessing the performance of construction products which have been designated as crisis-relevant goods.

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 remains active. In the early preparation of the draft implementing acts establishing the common specifications, 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.

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

EXPLANATORY STATEMENT

1. Introduction

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

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

2. The Draft Report

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

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

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

2.1 Resilience during the contingency mode

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

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

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

2.2 Emergency Mode

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

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

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

2.3 Digital Tools and harmonisation of administrative procedures

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

2.4 Governance

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

3. Accompanying proposals

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

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

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

The following list is drawn up on a purely voluntary basis under the exclusive responsibility of the rapporteur. The rapporteur has received input from the following entities or persons in the preparation of the draft report:

Affordable Medicines Europe

APPLiA - Home Appliance Europe

BDA - Bundesvereinigung der Deutschen Arbeitgeberverbände e.V.

BDI - Bundesverband der Deutschen Industry e.V.

Business Europe

BWL - Bundesamt für wirtschaftliche Landesversorgung der Schweiz

Dutch Ministry of Economic Affairs

Eurochambres

Eurocommerce

France Industrie

Germany Ministry of Climate and Economics

Independent Retail Europe

Mission of the United Kingdom to the European Union

NESA - National Emergency Supply Agency of Finland

Orgalim

Prof. Dr. iur. Jan Bergmann

SME United