Changes from report parliamentary committee draft to plenary report

AddedRegulation (EU) 2016/426

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

AddedRegulation (EU) 2016/426

AddedArticle 3 – paragraph 1, Article 40c – paragraph 1: 1. By way of derogation from Article 14, the competent national authority, after carrying out a risk assessment, may authorise, on a duly justified request from an economic operator established in its Member State, the placing on the market or putting into service within the territory of that Member State, of a specific appliance or fitting which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body, referred to in Article 14, have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

AddedRegulation (EU) 2016/426

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

AddedRegulation (EU) 2016/426

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

AddedRegulation (EU) 2016/426

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

AddedRegulation (EU) 2016/426

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

AddedRegulation (EU) 2016/426

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

AddedRegulation (EU) 2016/426

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

Regulation (EU) 2016/426

Change 27

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

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

Regulation (EU) 2016/426

Change 28

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

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

Regulation (EU) 2016/426

Change 29

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

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

Regulation (EU) 2016/426

Change 30

ChangedArticle 3 – paragraph 1, Article 40e40d – paragraph 2:1 2.– Thepoint implementingb: acts(b) referredwhere tosevere disruptions in paragraphthe 1functioning of thisthe Articleinternal shallmarket, bewhich adoptedwere taken into consideration when activating the internal market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the examinationpossibilities procedureof referredmanufacturers to inmake Articleuse 42(3).of Theythe shallharmonised applystandards tocovering appliancesthe relevant essential health and fittingssafety placedrequirements onset theout marketin noAnnex longerI thanto untilthis theRegulation lastand dayalready ofpublished in the periodOfficial forJournal whichof the internalEuropean marketUnion emergencyin modeaccordance remainswith active.Regulation (EU) No 1025/2012.

Regulation (EU) 2016/426

Change 31

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

Regulation (EU) 2016/426

Change 32

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

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

AddedRegulation (EU) 2016/426

AddedArticle 3 – paragraph 1, Article 40e – paragraph 1 – point b: (b) where severe disruptions in the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex I in this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

AddedRegulation (EU) 2016/426

AddedArticle 3 – paragraph 1, Article 40e – paragraph 2: 2. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 42(3). They shall apply to appliances and fittings placed on the market no longer than until the last day of the period for which the internal market emergency mode remains active. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of the relevant bodies and shall duly consult all relevant stakeholders.

AddedRegulation (EU) 2016/426

AddedArticle 3 – paragraph 1, Article 40e – paragraph 4: 4. By way of derogation from Article 40a(3), unless there is sufficient reason to believe that the appliances or fittings covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the appliances or fittings in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Regulation after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

AddedRegulation (EU) 2016/426

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

AddedRegulation (EU) 2016/426

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

AddedRegulation (EU) 2016/426

AddedArticle 3 – paragraph 1, Article 40g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for appliances and fittings designated as crisis-relevant goods.

Regulation (EU) 2019/1009

Change 33

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

AddedRegulation (EU) 2019/1009

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

AddedRegulation (EU) 2019/1009

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

AddedRegulation (EU) 2019/1009

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

AddedRegulation (EU) 2019/1009

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

AddedRegulation (EU) 2019/1009

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

AddedRegulation (EU) 2019/1009

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

AddedRegulation (EU) 2019/1009