What changed between the draft committee report and the plenary report

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

10 unchanged paragraphs

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)

The European Parliament,

– 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,

Changed:– 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;

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.

Change 1

Changed:Title: 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

Change 2

Removed: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) 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 .

Added:Recital 1: (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.

Change 3

Changed:Recital 10:2: (10)(2) ToThe thatframework end,established emergencyby procedures[insert shouldreference beto laidIMERA downRegulation] inlays Regulationsdown (EU)measures, 2016/424,which (EU)should Nobe 2023/XXXXdeployed [GPSR],in (EU)a 2016/425,coherent, (EU)transparent, 2016/426,efficient, (EU)proportionate 2019/1009,and (EU)timely 2023/XXXmanner, [Machineryso Regulation]as andto (EU)prevent, Nomitigate 305/2011.and Thoseminimise proceduresthe shouldimpact bea availablecrisis onlymay followingcause on the activationfunctioning of the internal market emergency mode in accordance with [insert reference to IMERA Regulation]..

Change 4

Removed: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. 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.

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

Removed:Recital 15: (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.

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

Removed:Recital 16: (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.

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

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

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

Added:Recital 8: (8) Experience from the recent crises that have affected the internal market has shown that the procedures laid down in the sectoral legislation are not designed to cater for the needs of crisis-response scenarios and do not offer the necessary regulatory flexibility. It is therefore appropriate to provide for a legal basis for such crisis-response procedures as a complement to the measures adopted under [insert reference to IMERA Regulation].

Added:Recital 9: (9) In order to overcome the potential effects of disruptions to the internal market and in order to ensure that crisis-relevant goods are placed on the market swiftly, it is appropriate to provide for a requirement for the conformity assessment bodies to prioritise the conformity assessment applications of such products over any pending applications concerning products which have not been designated as crisis-relevant.

Added: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, (EU) 2023/988, (EU) 2023/1230 and (EU) No 305/2011. Those procedures should be available only following the activation of the internal market emergency mode in accordance with [insert reference to IMERA Regulation].

Added:Recital 11: (11) Furthermore, in cases where the disruptions might affect the conformity assessment bodies or in cases where the testing capacities for such crisis-relevant products would not be sufficient, it is appropriate to provide for the possibility for the national competent authorities to exceptionally and temporarily authorise the placing on the market of products, which have not undergone the usual conformity assessment procedures required by the respective Union sectoral legislation. The authorisation for products granted exceptionally and temporarily should remain valid for six months after deactivation or expiration of the internal market emergency mode, where it does not does not affect in any way the health, safety and security of consumers. After this period, products should only be made available on the market after receiving an authorisation under the normal authorisation procedure provided for under the applicable rules. Products already granted authorisation exceptionally and temporarily may be re-authorised under the normal authorisation procedure. Nevertheless, products or components already purchased for use, or which are already in use, may continue to be used without new authorisation.

Added:Recital 12: (12) As regards products falling within the scope of those Regulations that have been designated as crisis-relevant goods, the national competent authorities should be able, in the context of an ongoing internal market emergency, to derogate from the obligation to carry out those conformity assessment procedures laid down in those Regulations, where the involvement of a notified body is mandatory and should be able to issue authorisations for those products, provided that they comply with all the applicable essential safety requirements and that the safety of consumers and end-users is fully assured. Compliance with those substantive requirements may be demonstrated by various means, which may include testing performed by the national authorities of samples provided by the manufacturer having applied for an authorisation. The specific procedures, which were followed to demonstrate the compliance and their results should be clearly described in the authorisation issued by the national competent authority. The principle of mutual recognition should apply to goods placed on the market under that derogation. The competent national authority should keep relevant technical documentation to ensure compliance with applicable rules. Products manufactured during the internal market emergency mode, where derogation from the conformity assessment procedures was authorised, should also be subject to the relevant obligations of traceability provided for in Regulation (EU) 2023/988, in part…

Added:Recital 13: (13) Where an internal market emergency entails an exponential increase in the demand for certain products and in order to support the efforts of economic operators to meet such demand, it is appropriate to provide technical references, which may be used by the manufacturers to design and produce crisis-relevant goods which comply with the applicable essential health and safety requirements.

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

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

Added:Recital 16: (16) Furthermore, with respect to Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/988, (EU) 2023/1230 and (EU) No 305/2011, the Commission should have the possibility to adopt by means of implementing acts common specifications, on which the manufacturers may rely in order to benefit from a presumption of conformity with the applicable essential requirements. The implementing act laying down such common specifications should remain applicable for the duration of the internal market emergency.

Recital 17: deleted

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

Change 5

Changed:Recital 20: (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,

Change 6

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

Regulation (EU) 2016/424

Change 7

Changed:Article 1 – paragraph 1, Article 43a – paragraph 1: 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].

Regulation (EU) 2016/424

Change 8

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

Added:Regulation (EU) 2016/424

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

Added:Regulation (EU) 2016/424

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

Added:Regulation (EU) 2016/424

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

Added:Regulation (EU) 2016/424

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

Added:Regulation (EU) 2016/424

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

Added:Regulation (EU) 2016/424

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

Added:Regulation (EU) 2016/424

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

Added:Regulation (EU) 2016/424

Added:Article 1 – paragraph 1, Article 43c – paragraph 3 – introductory part: 3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the subsystem or safety component may be placed on the market or incorporated into a cableway installation, including at least: