Changes from report parliamentary committee draft to plenary report

AddedArticle 4 – paragraph 1, Article 41b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for fertilising products designated as crisis-relevant goods in respect of which they have been notified.

AddedRegulation (EU) 2019/1009

AddedArticle 4 – paragraph 1, Article 41c – paragraph 1: 1. By way of derogation from Article 15, the competent national authority, after carrying out a risk assessment, may authorise, on a duly justified request from an economic operator established in its Member State, the placing on the market within the territory of that Member State, of a specific fertilising product which has been designated as a crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body referred to in Article 15 have not been carried out by a notified body but for which the compliance with the requirements set out in Annexes I and II has been demonstrated.

AddedRegulation (EU) 2019/1009

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

AddedRegulation (EU) 2019/1009

AddedArticle 4 – paragraph 1, Article 41c – 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 fertilising products may be placed on the market, including at least:

AddedRegulation (EU) 2019/1009

AddedArticle 4 – paragraph 1, Article 41c – 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) 2019/1009

AddedArticle 4 – paragraph 1, Article 41c – paragraph 3 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the fertilising product was authorised under the internal market emergency mode.

AddedRegulation (EU) 2019/1009

AddedArticle 4 – paragraph 1, Article 41c – paragraph 4: 4. By way of derogation from Article 41a(3), where appropriate, the national competent authority may also amend the conditions and requirements referred to in paragraph 3 of this Article also after the deactivation or expiry of the internal market emergency mode.

AddedRegulation (EU) 2019/1009

Article 4 – paragraph 1, Article 41c – paragraph 5: deleted

Regulation (EU) 2019/1009

Change 34

AddedArticle 4 – paragraph 1, Article 41c – 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 fertilising products. The market surveillance authorities shall keep all records related to products authorised under a derogation for a period of 10 years. They shall make those records available to other market surveillance authorities upon request.

AddedRegulation (EU) 2019/1009

Article 4 – paragraph 1, Article 41c – paragraph 8: 8. The application of Articles 41a to 41g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 15.

Regulation (EU) 2019/1009

Change 35

ChangedArticle 4 – paragraph 1, Article 41e41c – paragraph 2: 2. The implementing acts referred to in paragraph 1 of this Article shall be adopted in8 accordancea with(new): the8a. examinationFertilising procedureproducts referredsubject to inderogation Articleunder 45(3).paragraph They1 shall apply to EU fertilising productsremain placedvalid onfor thesix marketmonths untilafter thedeactivation lastor dayexpiration of the period for which the internal market emergency mode remains active in accordance with [the IMERA Regulation]. When preparing the draft implementing actmode. establishingAfter thethis commonperiod, specification,they theshall Commissiononly shallbe takemade intoavailable accounton the viewsmarket ofafter thereceiving relevantan bodiesauthorisation orunder the expert groupnormal andauthorisation shallprocedure dulyprovided consultfor allin relevantthis stakeholders.Regulation.

Regulation (EU) 2019/1009

Change 36

RemovedArticle 4 – paragraph 1, Article 41e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the requirements set out in Annexes I and II, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, may amend the implementing act establishing the common specification in question.

AddedArticle 4 – paragraph 1, Article 41d – paragraph 1: Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market, their competent authorities consider as complying with requirements set out in Annex I, II or III of this Regulation fertilising products which comply with relevant international standards or any relevant national standards in force in the Member State of manufacture, ensuring a safety level equivalent to that required by the requirements set out in Annex I, II or III, comply with those essential requirements in either of the following cases:

Regulation (EU) 2019/1009

Change 37

AddedArticle 4 – paragraph 1, Article 41d – paragraph 1 – point a (new): (a) where a reference to harmonised standards covering the relevant essential requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

AddedRegulation (EU) 2019/1009

AddedArticle 4 – paragraph 1, Article 41d – paragraph 1 – point b (new): (b) where severe disruptions in the functioning of the internal market, which were taken into consideration when activating the internal market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

AddedRegulation (EU) 2019/1009

AddedArticle 4 – paragraph 1, Article 41e – paragraph 1: 1. Where EU fertilising products have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such EU fertilising products for the requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation:

AddedRegulation (EU) 2019/1009

AddedArticle 4 – paragraph 1, Article 41e – paragraph 1 – point a (new): (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) 2019/1009

AddedArticle 4 – paragraph 1, Article 41e – paragraph 1 – point b (new): (b) where a reference to harmonised standards covering the relevant essential requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and such reference is not expected to be published within a reasonable timeframe during the internal market emergency mode;

AddedRegulation (EU) 2019/1009

AddedArticle 4 – paragraph 1, Article 41e – paragraph 1 – point c (new): (c) where severe disruptions in the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 14 of [the IMERA Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

AddedRegulation (EU) 2019/1009

AddedArticle 4 – 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 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. 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) 2019/1009

AddedArticle 4 – paragraph 1, Article 41e – paragraph 4: 4. By way of derogation from Article 41a(3), unless there is sufficient reason to believe that the fertilising products covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the fertilising products in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Regulation after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

AddedRegulation (EU) 2019/1009

AddedArticle 4 – paragraph 1, Article 41e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the requirements set out in Annexes I and II, it shall inform the Commission thereof with a detailed 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) 2019/1009

Article 4 – paragraph 1, Article 41f: deleted / (deleted) / (deleted) / (deleted) / (deleted)

Change 38

RemovedArticle 4 a (new): 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 …

AddedRegulation (EU) 2019/1009

RemovedRegulation (EU) 305/2011

AddedArticle 4 – paragraph 1, Article 41g – 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 fertilising products designated as crisis-relevant goods.’

AddedRegulation (EU) 2023/988

AddedArticle 4 a (new) – paragraph 1 – point 1 (new), Article 2 – paragraph 1 – point b: Article 4 a / Amendments to Regulation (EU) 2023/988 / Regulation (EU) 2023/988 is amended as follows: / (1) In Article 2(1), point (b) is replaced by the following: / “(b) Chapter IIa, Chapter III, Section 1, Chapters V and VII and Chapters IX to XI do not apply.”

AddedRegulation (EU) 2023/988

AddedArticle 4 a (new) – paragraph 1 – point 2 (new), Chapter II a (new): (2) The following chapter is inserted: / ‘CHAPTER IIa / EMERGENCY PROCEDURES / Article 8a / Activation of the emergency procedures, relationship with other provisions of this Regulation and deactivation / 1. Articles 8b to 8d shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation]. / 2. Articles 8b to 8d shall only apply to products which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article. / 3. Articles 8b to 8d shall apply during the internal market emergency mode, except with respect to provisions concerning the powers of the Commission. / Article 8b / Presumption of safety based on national and international standards / Member States shall take all appropriate measures to ensure that, for the purpose of placing products on the market, their competent authorities consider that the products which comply with the relevant international standards or any national standards in force in the Member State of manufacture, and which ensure the safety level required by this Regulation, meet the general safety requirement laid down in this Regulation as far as the risks and risk categories covered by those standards are concerned in any of the following cases: / (a) where a reference to European standards is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012; / (b) where severe disruptions to the functionin…

AddedRegulation (EU) 2023/1230

AddedArticle 4 b (new), Chapter VI a (new): Article 4b / Amendments to Regulation (EU) 2023/1230 / In Regulation (EU)2023/1230, the following chapter is inserted: / ‘CHAPTER VIa EMERGENCY PROCEDURES / Article 46a / Application of emergency procedures / 1. Articles 46b to 46f of this Regulation shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation]. / 2. Articles 46b to 46f shall apply exclusively to machinery which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article. / 3. Articles 46b to 46f shall apply during the internal market emergency mode, except with respect to provisions concerning the powers of the Commission. / Article 46b / Prioritisation of the conformity assessment of crisis-relevant machinery / 1. This Article shall apply to machinery designated as crisis-relevant goods, which is subject to conformity assessment procedures in accordance with Article 21, requiring mandatory involvement of a notified body. / 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for a conformity assessment of machinery designated as crisis-relevant goods, as a matter of priority. / 3. All pending applications for a conformity assessment of machinery designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for conformity assessment of machinery which has not been designated as crisis-relevant goods. This prio…

AddedRegulation (EU) No 305/2011

AddedArticle 5 – paragraph 1 – point 1, Article 59a – paragraph 1: 1. Articles 59b to 59f of this Article shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation].

AddedRegulation (EU) No 305/2011

AddedRegulation (EU) No 305/2011

AddedArticle 5 – paragraph 1 – point 1, Article 59a – paragraph 3 – subparagraph 1: 3. Articles 59b to 59f, except as regards provisions concerning the powers of the Commission, shall apply during the internal market emergency mode.

AddedRegulation (EU) No 305/2011