Changes from report parliamentary committee draft to plenary report

AddedRegulation (EU) 2016/424

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

AddedRegulation (EU) 2016/424

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

AddedRegulation (EU) 2016/424

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

AddedRegulation (EU) 2016/424

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

Regulation (EU) 2016/424

Change 9

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

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

Regulation (EU) 2016/424

Change 10

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

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

Regulation (EU) 2016/424

Change 11

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

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

Regulation (EU) 2016/424

Change 12

ChangedArticle 1 – paragraph 1, Article 43e43c – paragraph 2: 2. The implementing acts referred to in paragraph 1 of this Article shall be8 adopteda in(new): accordance8a. withSubsystems theor examinationsafety procedurecomponents referredsubject to in Articlederogation 44(3)under andparagraph they1 shall apply to subsystems or safety componentsremain placedvalid onfor thesix marketmonths untilafter thedeactivation lastor dayexpiration of the period for which the internal market emergency mode remains active. In the early preparation of the draftmode. implementingAfter actthis establishingperiod, thethey commonshall specification,only thebe Commissionmade shallavailable gatheron the views of relevant bodiesmarket orafter expertreceiving groupsan establishedauthorisation under relevant sectoral Union legislation. Based on that consultation, the Commissionnormal shallauthorisation prepareprocedure theprovided draftfor implementingin act.this Regulation.

Regulation (EU) 2016/424

Change 13

RemovedArticle 1 – paragraph 1, Article 43e – paragraph 2 a (new): 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.

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

Regulation (EU) 2016/424

Change 14

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

AddedArticle 1 – paragraph 1, Article 43d – paragraph 1 – point b: (b) where severe disruptions in the functioning of the internal market, which were taken into consideration when activating the internal market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex II to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Regulation (EU) 2016/424

Change 15

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

AddedRegulation (EU) 2016/424

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

AddedRegulation (EU) 2016/424

AddedArticle 1 – paragraph 1, Article 43e – paragraph 1 – point b: (b) where severe disruptions in the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex II to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

AddedRegulation (EU) 2016/424

AddedArticle 1 – paragraph 1, Article 43e – paragraph 2: 2. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 44(3) and they shall apply to subsystems or safety components placed on the market until the last day of the period for which the internal market emergency mode remains active. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies and shall duly consult all relevant stakeholders.

AddedRegulation (EU) 2016/424

AddedArticle 1 – paragraph 1, Article 43e – paragraph 4: 4. By way of derogation from Article 43a(3), unless there is sufficient reason to believe that the subsystems or safety components covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the subsystems or safety components in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Regulation after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

AddedRegulation (EU) 2016/424

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

AddedRegulation (EU) 2016/424

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

Change 16

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

AddedRegulation (EU) 2016/424

RemovedArticle 1 a (new): 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 wi…

AddedArticle 1 – paragraph 1, Article 43g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for subsystems and safety components designated as crisis-relevant goods.

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Change 17

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

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

Regulation (EU) 2016/425

Change 18

ChangedArticle 2 – paragraph 1, Article 41c new41a – paragraph 8: 8. The application2: of2. Articles 41a41b to 41g and the use of the43g authorisationshall procedureapply setexclusively outto inPPE paragraphwhich 1has ofbeen thisdesignated Articleas doescrisis-relevant notgoods affectin the application of theimplementing relevantact conformityreferred assessmentto proceduresin laidparagraph down1 inof Articlethis 19.Article.

Regulation (EU) 2016/425

Change 19

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

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

Regulation (EU) 2016/425

Change 20

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

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

Regulation (EU) 2016/425

Change 21

RemovedArticle 2 – paragraph 1, Article 41e – paragraph 2: 2. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 44(3). They shall remain applicable to PPE placed on the market until the last day of the period for which the internal market emergency mode remains active.

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

Regulation (EU) 2016/425

Change 22

ChangedArticle 2 – paragraph 1, Article 41e41b – paragraph 2 a (new): 2a.2: When2. preparingThe thenotified draftbodies implementingshall actensure establishingall thereasonable commonefforts specification,are themade Commissionto shallprocess takeall intoapplications accountfor theconformity viewsassessment of the relevant bodies orPPE expertdesignated groupas andcrisis-relevant shallgoods dulyas consulta allmatter relevantof stakeholders.priority.

Regulation (EU) 2016/425