Changes between two versions

What changed between the draft committee report and the plenary report

From · draft committee report· 13 Mar 2023

on the proposal for a directive of the European Parliament and of the Council amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2013/29/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU as regard emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency

To · plenary report· 25 Jul 2023

A-9-2023-0245

Changes to the text itself, in document order. Cover page, citations and punctuation-only edits are left out; they are under “Every difference”.

The changes · 83

Change 1

Changed:~~Title:~~Title 1: amending Directives 2000/14/EC, 2010/35/EU, 2013/29/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU as regard emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to an internal market emergency

Change 2

Removed:The machinery directive will likely be repealed by the new machinery regulation by next year. All references to the machinery regulation have been moved to the other proposal for a regulation accompanying the IMERA.

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.

Removed:Recital 6: (6) A number of EU 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 Directives 2000/14/EC41, 2010/35/EU43 , 2013/29/EU44 , 2014/28/EU45 , 2014/29/EU46 , 2014/30/EU47 , 2014/31/EU48 , 2014/32/EU49 , 2014/33/EU50 , 2014/34/EU51 , 2014/35/EU52 , 2014/53/EU53 and 2014/68/EU54 of the European Parliament and of the Council. Moreover, most of those legal acts are based on the principles of the new approach to technical harmonisation and are also aligned to the reference provisions laid down by Decision 768/2008/EC of the European Parliament and of the Council55 . / (deleted)

Added:Recital 2: (2) The framework established by [insert reference to IMERA Regulation] lays down measures, which should be deployed in a coherent, transparent, efficient, proportionate and timely manner, so as to prevent, mitigate and minimise the impact a crisis may cause on the functioning of the internal market.

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Removed:Recital 10: (10) To that end, emergency procedures should be laid down in Directives 2000/14/EC, 2010/35/EU, 2013/29/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU. Those procedures should be available only following the activation of the internal market emergency and only when a specific good covered by those Directives is designated as a crisis-relevant good in accordance with [insert reference to IMERA Regulation].

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.

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.

Added:Recital 5: (5) In order to complement, ensure consistency and 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 EU 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 Directives 2000/14/EC41 , 2010/35/EU43 , 2013/29/EU44 , 2014/28/EU45 , 2014/29/EU46 , 2014/30/EU47 , 2014/31/EU48 , 2014/32/EU49 , 2014/33/EU50 , 2014/34/EU51 , 2014/35/EU52 , 2014/53/EU53 and 2014/68/EU54 of the European Parliament and of the Council. Moreover, most of those legal acts are based on the principles of the new approach to technical harmonisation and are also aligned to the reference provisions laid down by Decision 768/2008/EC EC of the European Parliament and of the Council55 . / (deleted)

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 Directives, aimed at responding to impacts of crises affecting products that have been designated as crisis-relevant goods and covered by those Directives.

Added:Recital 8: (8) Experience from the past crises that have affected the internal market has shown that the procedures laid down in the sectoral legal acts are not designed to cater 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 Directives 2000/14/EC, 2010/35/EU, 2013/29/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and, 2014/68/EU. Those procedures should be available only following the activation of the internal market emergency and only when a specific good covered by those Directives is designated as a crisis-relevant good 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 authorisation 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 Directives 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 Directives, in those cases where the involvement of a notified body is mandatory and should be able to issue authorisations for those products, provided that they comply with 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 the 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…

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.

Change 3

Removed:Recital 17: (17) With respect to Directives 2013/29/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU, 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 internal market emergency.

Added:Recital 17: deleted

Change 4

Changed:Article 1 – paragraph 1 – point 1, Article 17a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 17b, 17c and 17d of this Directive only apply if Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

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Change 5

Added:Article 1 – paragraph 1 – point 1, Article 17a – paragraph 3 – subparagraph 1: 3. Member States shall ensure that measures taken to transpose in Articles 17b, 17c and 17d apply during the internal market emergency mode.

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17a – paragraph 3 – subparagraph 2: deleted

Added:Directive 2000/14/EC

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Added:Article 1 – paragraph 1 – point 1, Article 17a – paragraph 4: deleted

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of equipment designated as crisis-relevant goods as a matter of priority.

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17b – paragraph 4: 4. The prioritisation of applications for conformity assessment of equipment pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for equipment designated as crisis-relevant goods in respect of which they have been notified.

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17c – 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 specific equipment referred to in Article 12 and listed in the implementing act referred to Article 17a(1) and for which the conformity assessment procedures requiring 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 requirements of this Directive concerning the noise emission in the environment has been demonstrated.

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17c – paragraph 2 – subparagraph 2: deleted

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17c – 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 equipment may be placed on the market or put into service, including at least:

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17c – paragraph 3 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17c – paragraph 3 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the equipment was authorised under the internal market emergency mode.

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17c – paragraph 4: 4. By way of derogation from Article 17a(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.

Added:Directive 2000/14/EC

Change 6

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17c – 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 Directive with respect to such equipment. 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.

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17c – paragraph 8: 8. The application of Articles 17a to 17d 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.

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Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17c – paragraph 8 a (new): 8a. Equipment subject to derogation under paragraph 1 shall remain valid for six months after the end of 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 Directive.

Added:Directive 2000/14/EC

Added:Article 1 – paragraph 1 – point 1, Article 17d – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable 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 equipment, designated as crisis-relevant goods.

Change 7

Changed:Article 3 – paragraph 1 – ~~point~~subparagraph 1, Article 33a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 33b, 33c and 33d of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

Change 8

Removed:~~Article 3 – paragraph 1 – point 1, Article 33c – paragraph 5: deleted~~

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33a – paragraph 3: 3. Member States shall ensure that measures taken to transpose Articles 33b, 33c and 33d apply during the internal market emergency mode.

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33a – paragraph 4: deleted

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Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33a – paragraph 5: deleted

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of transportable pressure equipment designated as crisis-relevant goods as a matter of priority.

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33b – paragraph 4: 4. The prioritisation of applications for conformity assessment of transportable pressure equipment pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for transportable pressure equipment designated as crisis-relevant goods in respect of which they have been notified.

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33c – paragraph 1: 1. By way of derogation from Article 12, 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 transportable pressure equipment designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body referred to in Article 12 have not been carried out by a notified body but for which the compliance with all the applicable requirements set out in the Annexes to Directive 2008/68/EC and in this Directive has been demonstrated.

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33c – paragraph 2 – subparagraph 1: The manufacturer of a transportable pressure equipment subject to the authorisation procedure referred to in paragraph 1 of this Article shall declare on his sole responsibility that the transportable pressure equipment concerned complies with all the applicable requirements set out in the Annexes to Directive 2008/68/EC and in this Directive and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33c – paragraph 2 – subparagraph 2: deleted

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33c – 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 transportable pressure equipment may be placed on the market or put into service, including at least:

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33c – paragraph 3 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33c – paragraph 3 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the transportable pressure equipment was authorised under the internal market emergency mode.

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33c – paragraph 4: 4. By way of derogation from Article 33a(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.

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33c – paragraph 5: deleted

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33c – 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 Directive with respect to such transportable pressure equipment. 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.

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33c – paragraph 8: 8. The application of Articles 33a to 33d 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 12.

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33c – paragraph 8 a (new): 8a. Transportable pressure equipment subject to derogation under paragraph 1 shall remain valid for six months after the end of 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.

Added:Directive 2010/35/EU

Added:Article 3 – paragraph 1 – subparagraph 1, Article 33d – paragraph 1 – subparagraph 2: The market surveillance authorities of the Member States shall ensure all reasonable 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 transportable pressure equipment designated as crisis-relevant goods.

Change 9

Changed:Article 4 – paragraph 1, Article 42a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 42b to 42g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

Change 10

Added:Article 4 – paragraph 1, Article 42a – paragraph 3: 3. Member States shall ensure that measures taken to transpose Articles 42b to 42g apply during the internal market emergency mode.

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42a – paragraph 4: deleted

Added:Directive 2013/29/EU

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Added:Article 4 – paragraph 1, Article 42b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of pyrotechnic articles designated as crisis-relevant goods as a matter of priority.

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42b – paragraph 4: 4. The prioritisation of applications for conformity assessment of pyrotechnic articles pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for pyrotechnic articles designated as crisis-relevant goods in respect of which they have been notified.

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42c – paragraph 1: 1. By way of derogation from Article 17, 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 pyrotechnic article which has been designated as crisis-relevant good and for which the conformity assessment procedures which require the mandatory involvement of a notified body referred to in Article 17 have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated.

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42c – paragraph 3: deleted

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42c – paragraph 4 – introductory part: 4. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the pyrotechnic article may be placed on the market, including at least:

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42c – paragraph 4 – point a: (a) a description of the procedures, by means of which the compliance with the applicable essential safety requirements of this Directive was successfully demonstrated;

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42c – paragraph 4 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42c – paragraph 4 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the pyrotechnic article was authorised under the internal market emergency mode.

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42c – paragraph 5: 5. By way of derogation from Article 42a(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.

Added:Directive 2013/29/EU

Change 11

Removed:Article 4 – paragraph 1, Article 42e – paragraph 1 – point -a (new): (-a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

Added:Article 4 – paragraph 1, Article 42c – paragraph 7: 7. 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 Directive with respect to such pyrotechnic articles. 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.

Change 12

Removed:Article 4 – paragraph 1, Article 42e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe in the context of the emergency;

Added:Article 4 – paragraph 1, Article 42c – paragraph 9: 9. The application of Articles 42a to 42g 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 17.

Change 13

Changed:Article 4 – paragraph 1, Article ~~42e – paragraph 2: 2. The implementing acts referred~~42 toc in– paragraph ~~1 of this Article shall be~~9 ~~adopted~~a ~~following~~(new): ~~the~~9a. ~~examination~~Pyrotechnic ~~procedure~~articles ~~referred~~subject to inderogation ~~Article~~under ~~44(3).~~paragraph ~~They~~1 shall ~~apply~~remain tovalid for ~~pyrotechnic articles placed on the~~six ~~market~~months ~~until~~after the ~~last day~~end of ~~the~~deactivation ~~period~~or ~~for~~expiration ~~which~~of the internal market emergency ~~mode remains active.~~mode. ~~When~~After ~~preparing~~this ~~the~~period, ~~draft~~they ~~implementing~~shall ~~act~~only ~~establishing~~be ~~the~~made ~~common~~available ~~specification,~~on the ~~Commission shall take into account the~~market ~~views~~after ofreceiving ~~relevant~~an ~~bodies~~authorisation orunder the ~~expert group~~normal ~~and~~authorisation ~~shall~~procedure ~~duly~~provided ~~consult~~for ~~all~~in ~~relevant~~this ~~stakeholders.~~Regulation.

Change 14

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42d – paragraph 1 – introductory part – 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 safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42e – 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;

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Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42e – paragraph 1 – point a: (a) where a reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive is not published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42e – 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 safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42e – 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 apply to for pyrotechnic articles 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 and shall duly consult all relevant stakeholders.

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42e – paragraph 4: 4. By way of derogation from Article 42a(3), unless there is sufficient reason to believe that the pyrotechnic articles covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the pyrotechnic articles in compliance with the said common specifications which has been placed on the market shall be deemed compliant with this Directive 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].

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential safety 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.

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42f: deleted / (deleted) / (deleted) / (deleted) / (deleted)

Added:Directive 2013/29/EU

Added:Article 4 – paragraph 1, Article 42g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable 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 pyrotechnic articles designated as crisis-relevant goods.

Change 15

Removed:~~Art. 45a – paragraph 1~~

Added:Article 5 – paragraph 1, Article 45a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 45b to 45g of this Directive shall only apply if the Commission has adopted an implementing act pursuant to Article 14(5) of [the IMERA Regulation].

Removed:Article 5 – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 45b to 45g of this Directive shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the IMERA Regulation] with respect to this Directive.

Change 16

Added:Article 5 – paragraph 1, Article 45a – paragraph 3 – subparagraph 1: Member States shall ensure that measures taken to transpose Articles 45b to 45g apply during the internal market emergency mode.

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45a – paragraph 3 – subparagraph 2: deleted

Added:Directive 2014/28/EU

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Added:Article 5 – paragraph 1, Article 45a – paragraph 4: deleted

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45b – paragraph 1: 1. This Article shall apply to explosives designated as crisis-relevant goods, which are subject to conformity assessment procedures, in accordance with Article 20 requiring the mandatory involvement of a notified body.

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of explosives designated as crisis-relevant goods as a matter of priority.

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45b – paragraph 4: 4. The prioritisation of applications for conformity assessment of explosives pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, which have lodged those applications.

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for explosives designated as crisis-relevant goods in respect of which they have been notified.

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45c – paragraph 1: 1. By way of derogation from Article 20, the competent national authority, after carrying out a risk assessment, may authorise, on a duly justified request, the placing on the market within the territory of that Member State, of a specific explosive 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 20 have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated.

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45c – paragraph 2 – subparagraph 2: deleted

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45c – 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 explosive may be placed on the market, including at least:

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45c – paragraph 3 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45c – paragraph 3 – point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the explosive was authorised under the internal market emergency mode.

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45c – paragraph 4: 4. By way of derogation from Article 45a(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.

Added:Directive 2014/28/EU

Change 17

Removed:Article 5 – paragraph 1, Article 45e – paragraph 1 – point -a (new): (-a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

Added:Article 5 – paragraph 1, Article 45c – 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 Directive with respect to such explosives. 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.

Change 18

Removed:Article 5 – paragraph 1, Article 45e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex II to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe in the context of the emergency;

Added:Article 5 – paragraph 1, Article 45c – paragraph 8: 8. The application of Articles 45a to 45g 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 20.

Change 19

Changed:Article 5 – paragraph 1, Article ~~45e~~45c – paragraph 2:8 2.a ~~The~~(new): ~~implementing~~8a. ~~acts~~Explosives ~~referred~~subject to inderogation under paragraph 1 ~~of this Article~~ shall ~~be adopted in accordance with the examination procedure referred to in Article 49(3). They shall apply to the explosives~~remain ~~placed~~valid onfor ~~the~~six ~~market~~months ~~until~~after ~~the~~deactivation ~~last~~or ~~day~~expiration of the ~~period for which the~~ internal market emergency ~~mode remains applicable in accordance with [the SMEI Regulation].~~mode. ~~When~~After ~~preparing~~this ~~the~~period, ~~draft~~they ~~implementing~~shall ~~act~~only ~~establishing~~be ~~the~~made ~~common~~available ~~specification,~~on the ~~Commission shall take into account the~~market ~~views~~after ofreceiving ~~relevant~~an ~~bodies~~authorisation orunder the ~~expert group~~normal ~~and~~authorisation ~~shall~~procedure ~~duly~~provided ~~consult~~for ~~all~~in ~~relevant~~this ~~stakeholders.~~Regulation.

Change 20

Changed:Article 5 – paragraph 1, Article ~~45e~~45d – paragraph 5:1 5.– ~~When~~introductory apart: Member ~~State considers~~States ~~that~~shall atake ~~common~~all ~~specification~~appropriate ~~referred~~measures to inensure ~~paragraph~~that, 1for ~~does~~the ~~not~~purposes ~~entirely~~of ~~satisfy~~placing on the ~~essential~~market, ~~safety~~their ~~requirements~~competent authorities consider that the explosives which itcomply ~~aims~~with tothe ~~cover~~relevant ~~and~~international ~~which~~standards ~~are~~or ~~set~~any ~~out~~national standards in ~~Annex~~force ~~II,~~in itthe ~~shall~~Member ~~inform~~State ~~the~~of ~~Commission~~manufacture, ~~thereof~~ensuring ~~with~~the asafety ~~detailed~~level ~~explanation~~required ~~and~~by the ~~Commission~~essential ~~shall~~safety ~~assess~~requirements ~~that~~set ~~information~~out ~~and,~~in ifAnnex ~~appropriate,~~II, ~~may~~complies ~~amend~~with ~~the~~those ~~implementing~~essential ~~act~~safety ~~establishing~~requirements ~~the~~in ~~common~~either ~~specification~~of inthe ~~question.~~following cases:

Change 21

Added:Article 5 – paragraph 1, Article 45d – paragraph 1 – introductory part – 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 Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45e – 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;

Added:Directive 2014/28/EU

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Added:Article 5 – paragraph 1, Article 45e – paragraph 1 – point a: (a) where a reference to harmonised standards covering the relevant essential safety requirements set out in Annex II to this Directive has not been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45e – 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 safety requirements set out in Annex II already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45e – 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 49(3). They shall apply to the explosives placed on the market until the last day of the period for which the internal market emergency mode remains applicable 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 relevant bodies and shall duly consult all groups established under relevant stakeholders.

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45e – paragraph 4: 4. By way of derogation from Article 45a(3), unless there is sufficient reason to believe that the explosives covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the explosives in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 and after the expiry or deactivation of the internal market emergency mode in accordance with [the IMERA Regulation].

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45a – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential 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. The Commission may amend, where appropriate, the implementing act establishing the common specification in question.

Added:Directive 2014/28/EU

Change 22

Added:Directive 2014/28/EU

Added:Article 5 – paragraph 1, Article 45g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable 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 explosives, designated as crisis-relevant goods.

Change 23

Changed:Article 6 – paragraph 1, Article 38a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 38b to 38g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

Change 24

Added:Article 6 – paragraph 1, Article 38a – paragraph 3 – subparagraph 1: Member States shall ensure that measures taken to transpose Articles 38b to 38g apply during the internal market emergency mode.

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38a – paragraph 2 – subparagraph 2: deleted

Added:Directive 2014/29/EU

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Added:Article 6 – paragraph 1, Article 38a – paragraph 4: deleted

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38 b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of vessels designated as crisis-relevant goods as a matter of priority.

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38b – paragraph 4: 4. The prioritisation of applications for conformity assessment of vessels pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for vessels designated as crisis-relevant goods in respect of which they have been notified.

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38c – paragraph 1: 1. By way of derogation from Article 13, 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 vessel 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 13 have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated.

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38c – paragraph 1 – subparagraph 2: deleted

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38c – 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 vessel may be placed on the market or put into service, including at least:

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38c – paragraph 2 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38c – paragraph 2 –point e a (new): (ea) labelling requirements, including radio frequency identification, indicating that the vessel was authorised under the internal market emergency mode.

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38 c – paragraph 4: 4. By way of derogation from Article 38a(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.

Added:Directive 2014/29/EU

Change 25

Removed:Article 6 – paragraph 1, Article 38e – paragraph 1 – point -a (new): (-a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

Added:Article 6 – paragraph 1, Article 38c – 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 Directive with respect to such vessels. 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.

Change 26

Removed:Article 6 – paragraph 1, Article 38e – paragraph 1 – point a (new): (a) where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe in the context of the emergency;

Added:Article 6 – paragraph 1, Article 38c – paragraph 8: 8. The application of Articles 38a to 38g 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 13.

Change 27

Removed:Article 6 – paragraph 1, Article 38e – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential safety 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 and, if appropriate, may amend the implementing act establishing the common specification in question.

Added:Article 6 – paragraph 1, Article 38c – paragraph 8 a (new): 8a. Vessels 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 Directive.

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38d – paragraph 1 – introductory part – 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 safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

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Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38e – 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;

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38e – paragraph 1 – point a: (a) where a reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive has not been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38e – 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 Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38e – 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 39(3) and they shall apply to vessels placed on the market until the last day of the period for which the internal market emergency mode remains active in accordance with Article 15(4) of [the IMERA Regulation]. When preparing the draft implementing act establishing the common specification, the Commission shall take into account the views of relevant bodies and shall duly consult all relevant stakeholders.

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38e – paragraph 4: 4. By way of derogation from Article 38a(3), unless there is sufficient reason to believe that the vessels covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the vessels in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive 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].

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38e – paragraph 2: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the essential safety 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.

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38f: deleted / (deleted) / (deleted) / (deleted) / (deleted)

Added:Directive 2014/29/EU

Added:Article 6 – paragraph 1, Article 38g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable 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 vessels, designated as crisis-relevant goods.’

Change 28

Changed:Article 7 – paragraph 1 – ~~point~~subparagraph 1, Article 40a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 40b to 40g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

Change 29

Removed:~~Article 7 – paragraph 1 – point 1, Article 40c – paragraph 5: deleted~~

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40a – paragraph 3: 3. Member States shall ensure that measures taken to transpose Articles 40b to 40g apply during the internal market emergency mode.

Change 30

Removed:Article 7 – paragraph 1 – point 1, Article 40e – paragraph 1 – point -a (new): (-a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40a – paragraph 4: deleted

Change 31

Removed:Article 7 – paragraph 1 – point 1, Article 40e – paragraph 1 – point a (new): (a) where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe in the context of the emergency;

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of apparatus designated as crisis-relevant goods as a matter of priority.

Change 32

Removed:Article 7 – paragraph 1 – point 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 41(2a). They shall apply to apparatus 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.

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40b – paragraph 4: 4. The prioritisation of applications for conformity assessment of apparatus pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

Change 33

Removed:Article 7 – paragraph 1 – point 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 safety 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 and, if appropriate, may amend the implementing act establishing the common specification in question.

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for apparatus designated as crisis-relevant goods in respect of which they have been notified.

Change 34

Removed:~~Article 7 – paragraph 1 – point 1, Article 40f: deleted / (deleted) / (deleted) / (deleted) / (deleted)~~

Added:Article 7 – paragraph 1 – subparagraph 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 apparatus 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 safety requirements has been demonstrated.

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 2 – subparagraph 2: deleted

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Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 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 apparatus may be placed on the market or put into service, including at least:

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 3 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 3 – point ea: (ea) labelling requirements, including radio frequency identification, indicating that the apparatus was authorised under the internal market emergency mode.

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 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 after the deactivation or expiry of the internal market emergency mode.

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 5: deleted

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 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 Directive with respect to such apparatus. 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.

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 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 shal not affect the application of the relevant conformity assessment procedures laid down in Article 14.

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40c – paragraph 8 a (new): 8a. Apparatus 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 Directive.

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40d – paragraph 1 – introductory part – 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 health and safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40e – 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;

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40e – paragraph 2 – point a: (a) where a reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive has not been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 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 to this Directive already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 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 41(2a). They shall apply to apparatus 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 and shall duly consult all relevant stakeholders.

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40e – paragraph 4: 4. By way of derogation from Article 40a(3), unless there is sufficient reason to believe that the apparatus covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the apparatus in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive 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].

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 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 safety 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.

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40f: deleted / (deleted) / (deleted) / (deleted) / (deleted)

Added:Directive 2014/30/EU

Added:Article 7 – paragraph 1 – subparagraph 1, Article 40g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable 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 apparatus, designated as crisis-relevant goods.’

Change 35

Changed:Article 8 – paragraph 1, Article 40a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 40b to 40g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

Change 36

Added:Article 8 – paragraph 1, Article 40a – paragraph 3 – subparagraph 1: Member States shall ensure that measures taken to transpose Articles 40b to 40g apply during the internal market emergency mode.

Added:Directive 2014/31/EU

Added:Article 8 – paragraph 1, Article 40a – paragraph 3 – subparagraph 2: deleted

Added:Directive 2014/31/EU

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Added:Article 8 – paragraph 1, Article 40a – paragraph 4: deleted

Added:Directive 2014/31/EU

Added:Article 8 – paragraph 1, Article 40b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of instruments designated as crisis-relevant goods as a matter of priority.

Added:Directive 2014/31/EU

Added:Article 8 – paragraph 1, Article 40b – paragraph 4: 4. The prioritisation of applications for conformity assessment of instruments pursuant to paragraph 2 and 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

Added:Directive 2014/31/EU

Added:Article 8 – paragraph 1, Article 40b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for instruments designated as crisis-relevant goods in respect of which they have been notified.

Added:Directive 2014/31/EU

Added:Article 8 – paragraph 1, Article 40c – paragraph 1: 1. By way of derogation from Article 13, 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 instrument 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 13 have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

Added:Directive 2014/31/EU

Added:Article 8 – paragraph 1, Article 40c – paragraph 2 – subparagraph 2: deleted

Added:Directive 2014/31/EU

Added:Article 8 – 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 instrument may be placed on the market or put into service, including at least:

Added:Directive 2014/31/EU

Added:Article 8 – paragraph 1, Article 40c – paragraph 3 – point c: (c) an end date of validity, unless otherwise specified, of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2014/31/EU

Added:Article 8 – paragraph 1, Article 40c – paragraph 3 – point e a: (ea) labelling requirements, including radio frequency identification, indicating that the instrument was authorised under the internal market emergency mode.

Added:Directive 2014/31/EU

Added:Article 8 – 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 also after the deactivation or expiry of the internal market emergency mode.

Added:Directive 2014/31/EU

Change 37

Removed:Article 8 – paragraph 1, Article 40e – paragraph 1 – point -a (new): (-a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

Added:Article 8 – 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 Directive with respect to such instruments. 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.

Change 38

Removed:Article 8 – paragraph 1, Article 40e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a raesonable timeframe in the context of the emergency;

Added:Article 8 – 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 13.

Change 39

Changed:Article 8 – paragraph 1, Article ~~40e~~40c – paragraph 2:8 2.a ~~The~~(new): ~~implementing~~8a. ~~acts~~Instruments ~~referred~~subject to inderogation under paragraph 1 ~~of this Article~~ shall ~~be adopted in accordance with the examination procedure referred to in Article 41(3). They shall apply to instruments~~remain ~~placed~~valid onfor ~~the~~six ~~market~~months ~~until~~after ~~the~~deactivation ~~last~~or ~~day~~expiration of the ~~period for which the~~ internal market emergency ~~mode remains active.~~mode. ~~When~~After ~~preparing~~this ~~the~~period, ~~draft~~they ~~implementing~~shall ~~act~~only ~~establishing~~be ~~the~~made ~~common~~available ~~specification,~~on the ~~Commission shall take into account the~~market ~~views~~after ofreceiving ~~relevant~~an ~~bodies~~authorisation orunder the ~~expert group~~normal ~~and~~authorisation ~~shall~~procedure ~~duly~~provided ~~consult~~for ~~all~~in ~~relevant~~this ~~stakeholders.~~Directive.

Change 40

Added:Article 8 – paragraph 1, Article 40d – 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 I to this Directive already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/31/EU

Added:Article 8 – 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;

Added:Directive 2014/31/EU

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Added:Article 8 – paragraph 1, Article 40e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

Added:Directive 2014/31/EU

Added:Article 8 – 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 of this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/31/EU

Added:Article 8 – 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 41(3). They shall apply to instruments 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 and shall duly consult all relevant stakeholders.

Added:Directive 2014/31/EU

Added:Article 8 – paragraph 1, Article 40e – paragraph 4: 4. By way of derogation from Article 40a(3), unless there is sufficient reason to believe that the instruments covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the instruments in compliance with the said common specifications which has been placed on the market shall be deemed compliant with this Directive 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].

Added:Directive 2014/31/EU

Added:Article 8 – 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.

Added:Directive 2014/31/EU

Change 41

Added:Directive 2014/31/EU

Added:Article 8 – paragraph 1, Article 40g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable 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 instruments, designated as crisis-relevant goods.’

Change 42

Changed:Article 9 – paragraph 1, Article 45a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 45b to 45g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

Change 43

Added:Article 9 – paragraph 1, Article 45a – paragraph 3 – subparagraph 1: Member States shall ensure that measures taken to transpose Articles 45b to 45g apply during the internal market emergency mode.

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45a – paragraph 3 – subparagraph 2: deleted

Added:Directive 2014/32/EU

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Added:Article 9 – paragraph 1, Article 45a – paragraph 4: deleted

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of measuring instruments designated as crisis-relevant goods as a matter of priority.

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45b – paragraph 4: 4. The prioritisation of applications for conformity assessment of measuring instruments pursuant to paragraph 2 and 3 shall not give rise to any extraordinary additional costs for the manufacturers who have lodged those applications.

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for measuring instruments designated as crisis-relevant goods in respect of which they have been notified.

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45c – paragraph 1: 1. By way of derogation from Article 17, 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 use within the territory of that Member State, of a specific measuring instrument which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring mandatory involvement of a notified body, referred to in Article 17 have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45c – paragraph 2 – subparagraph 2: deleted

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45c – 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 measuring instrument may be placed on the market or put into use, including at least:

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45c – paragraph 3 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45c – paragraph 3 – point e a: (ea) labelling requirements, including radio frequency identification, indicating that the measuring instrument was authorised under the internal market emergency mode.

Added:Directive 2014/32/EU

Change 44

Removed:Article 9 – paragraph 1, Article 45e – paragraph 1 – point -a (new): (-a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

Added:Article 9 – paragraph 1, Article 45c – paragraph 5: 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 Directive with respect to such measuring instruments. 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.

Change 45

Removed:Article 9 – paragraph 1, Article 45e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential requirements set out in Annex I and in the relevant instrument-specific Annexes has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe in the context of the emergency.;

Added:Article 9 – paragraph 1, Article 45c – paragraph 7: 7. The application of Articles 45a to 45g 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 17.

Change 46

Changed:Article 9 – paragraph 1, Article ~~45e~~45c – paragraph ~~2: 2. The implementing acts referred to in paragraph 1 of this Article shall be adopted in~~7 ~~accordance~~a ~~with~~(new): ~~the~~7a. ~~examination~~Measuring ~~procedure~~instruments ~~referred~~subject to inderogation ~~Article~~under ~~46(3).~~paragraph ~~They~~1 shall remain ~~apply to measuring instruments placed~~valid onfor ~~the~~six ~~market~~months ~~until~~after the ~~last day~~end of ~~the~~deactivation ~~period~~or ~~for~~expiration ~~which~~of the internal market emergency ~~mode remains active.~~mode. ~~When~~After ~~preparing~~this ~~the~~period, ~~draft~~they ~~implementing~~shall ~~act~~only ~~establishing~~be ~~the~~made ~~common~~available ~~specification,~~on the ~~Commission shall take into account the~~market ~~views~~after ofreceiving ~~relevant~~an ~~bodies~~authorisation orunder the ~~expert group~~normal ~~and~~authorisation ~~shall~~procedure ~~duly~~provided ~~consult~~for ~~all~~in ~~relevant~~this ~~stakeholders.~~Directive.

Change 47

Added:Article 9 – paragraph 1, Article 45d – introductory part: deleted

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45d – paragraph 1 – introductory part – 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 I and in the relevant instrument-specific Annexes to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/32/EU

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Added:Article 9 – paragraph 1, Article 45e – 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;

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45e – paragraph 1 – point a: (a) where a reference to harmonised standards covering the relevant essential safety requirements set out in Annex II to this Directive has not been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45e – paragraph 1 – point b: (b) the 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 and in the relevant instrument-specific Annexes to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45e – 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 46(3). They shall apply to measuring instruments 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 and shall duly consult all relevant stakeholders.

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45e – paragraph 4: 4. By way of derogation from Article 45a(3), unless there is sufficient reason to believe that the measuring instruments covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the measuring instruments in compliance with the said common specifications which have been placed on the market shall be deemed compliant with this Directive 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].

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45e – 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 and in the relevant instrument-specific Annexes, 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.

Added:Directive 2014/32/EU

Change 48

Added:Directive 2014/32/EU

Added:Article 9 – paragraph 1, Article 45g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable 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 measuring instruments, designated as crisis-relevant goods.

Change 49

Changed:Article 10 – paragraph 1, Article 41a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 41b to 41g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

Change 50

Added:Article 10 – paragraph 1, Article 41a – paragraph 3 – subparagraph 1: 3. Member States shall ensure that measures taken to transpose Articles 41b to 41g apply during the internal market emergency mode.

Added:Directive 2014/33/EU

Added:Article 10 – paragraph 1, Article 41a – paragraph 3 – subparagraph 2: deleted

Added:Directive 2014/33/EU

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Added:Article 10 – paragraph 1, Article 41a – paragraph 4: deleted

Added:Directive 2014/33/EU

Added:Article 10 – 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 lifts and safety components for lifts designated as crisis-relevant goods as a matter of priority.

Added:Directive 2014/33/EU

Added:Article 10 – paragraph 1, Article 41b – paragraph 4: 4. The prioritisation of applications for conformity assessment of lifts and safety components for lifts pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

Added:Directive 2014/33/EU

Added:Article 10 – paragraph 1, Article 41b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made increase their testing capacities for lifts and safety components for lifts designated as crisis-relevant goods in respect of which they have been notified.

Added:Directive 2014/33/EU

Added:Article 10 – 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 making available or putting into service within the territory of that Member State, of a specific safety component for lifts which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring mandatory involvement of a notified body referred to in that Article 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.

Added:Directive 2014/33/EU

Added:Article 10 – paragraph 1, Article 41c – paragraph 3 – subparagraph 2: deleted

Added:Directive 2014/33/EU

Added:Article 10 – paragraph 1, Article 41c – paragraph 4 – introductory part: 4. Any authorisation issued by a national competent authority pursuant to paragraphs 1 or 2 shall set out the conditions and requirements under which the lift or a the safety component for lifts may be placed on the market, made available or put into service respectively, including at least:

Added:Directive 2014/33/EU

Added:Article 10 – paragraph 1, Article 41c – paragraph 4 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2014/33/EU

Added:Article 10 – paragraph 1, Article 41c – paragraph 4 – point e a: (ea) labelling requirements, including radio frequency identification, indicating that the lifts and safety components for lifts were authorised under the internal market emergency mode.

Added:Directive 2014/33/EU

Added:Article 10 – paragraph 1, Article 41c – paragraph 5: 5. 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 4 of this Article after the deactivation or expiry of the internal market emergency mode.

Added:Directive 2014/33/EU

Change 51

Removed:Article 10 – 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 No 1025/2012 were not adopted;

Added:Article 10 – paragraph 1, Article 41c – paragraph 7: 7. 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 Directive with respect to such lifts or safety components for lifts. 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.

Change 52

Removed:Article 10 – paragraph 1, Article 41e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe in the context of the emergency;

Added:Article 10 – paragraph 1, Article 41c – paragraph 9: 9. The application of Articles 41a to 41g 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 15 or 16.

Change 53

Changed:Article 10 – paragraph 1, Article ~~41e~~41c – paragraph ~~2: 2. The implementing acts referred to in paragraph 1 of this Article~~9 ~~shall~~a be(new): ~~adopted~~9a. inLifts ~~accordance~~and ~~with~~safety ~~the~~components ~~examination~~for ~~procedure~~lifts ~~referred~~subject to inderogation ~~Article~~under ~~42(3).~~paragraph ~~They~~1 shall ~~apply to lifts and safety~~remain ~~components~~valid for ~~lifts placed on the~~six ~~market~~months ~~until~~after ~~the~~deactivation ~~last~~or ~~day~~expiration of the ~~period for which the~~ internal market emergency ~~mode remains active.~~mode. ~~When~~After ~~preparing~~this ~~the~~period, ~~draft~~they ~~implementing~~shall ~~act~~only ~~establishing~~be ~~the~~made ~~common~~available ~~specification,~~on the ~~Commission shall take into account the~~market ~~views~~after ofreceiving ~~relevant~~an ~~bodies~~authorisation orunder the ~~expert group~~normal ~~and~~authorisation ~~shall~~procedure ~~duly~~provided ~~consult~~for ~~all~~in ~~relevant~~this ~~stakeholders.~~Directive.

Change 54

Added:Article 10 – paragraph 1, Article 41d – paragraph 1 – introductory part – point b: (b) where the 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 health and safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/33/EU

Added:Article 10 – 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;

Added:Directive 2014/33/EU

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Added:Article 10 – paragraph 1, Article 41e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

Added:Directive 2014/33/EU

Added:Article 10 – paragraph 1, Article 41e – 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 health and safety requirements set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/33/EU

Added:Article 10 – 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 42(3). They shall apply to lifts and safety components for lifts 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 and shall duly consult all relevant stakeholders.

Added:Directive 2014/33/EU

Added:Article 10 – paragraph 1, Article 41e – paragraph 4: 4. By way of derogation from Article 41a(3), unless there is sufficient reason to believe that the lifts and safety components for lifts covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the lifts and safety components for lifts in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Directive 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].

Added:Directive 2014/33/EU

Added:Article 10 – 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 essential health and safety 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.

Added:Directive 2014/33/EU

Change 55

Added:Directive 2014/33/EU

Added:Article 10 – paragraph 1, Article 41g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable 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 lifts and safety components for lifts designated as crisis-relevant goods.’

Change 56

Changed:Article 11 – paragraph 1, Article 38a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 38b to 38g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

Change 57

Added:Article 11 – paragraph 1, Article 38a – paragraph 3 – subparagraph 1: 3. Member States shall ensure that measures taken to transpose Articles 38b to 38g apply during the internal market emergency mode.

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38a – paragraph 1 – subparagraph 2: deleted

Added:Directive 2014/34/EU

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Added:Article 11 – paragraph 1, Article 38a – paragraph 4: deleted

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38b – paragraph 2: 2. The notified bodies shall ensure all reasonable efforts are made to process all applications for conformity assessment of products designated as crisis-relevant goods as a matter of priority.

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38b – paragraph 4: 4. The prioritisation of applications for conformity assessment of products pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for products designated as crisis-relevant goods in respect of which they have been notified.

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38c – paragraph 1: 1. By way of derogation from Article 13, 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 product which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring mandatory involvement of a notified body, referred to in that Article 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.

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38c – paragraph 2 – subparagraph 2: deleted

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38c – 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 product may be placed on the market or put into service, including at least:

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38c – paragraph 1 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38c – paragraph 3 – point e a: (ea) labelling requirements, including radio frequency identification, indicating that the product was authorised under the internal market emergency mode.

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38c – paragraph 4: 4. By way of derogation from Article 38a(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.

Added:Directive 2014/34/EU

Change 58

Removed:Article 11 – paragraph 1, Article 38e – paragraph 1 – point -a (new): (-a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

Added:Article 11 – paragraph 1, Article 38c – 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 Directive with respect to such 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.

Change 59

Removed:Article 11 – paragraph 1, Article 38e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex II to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe in the context of the emergency;

Added:Article 11 – paragraph 1, Article 38c – paragraph 8: 8. The application of Articles 38a to 38g 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 13.

Change 60

Changed:Article 11 – paragraph 1, Article ~~38e~~38c – paragraph 2:8 2.a ~~The~~(new): ~~implementing~~8a. ~~acts~~Products ~~referred~~subject to inderogation under paragraph 1 ~~of this Article~~ shall ~~be adopted in accordance with the examination procedure referred to in Article 39(3). They shall apply to products~~remain ~~placed~~valid onfor ~~the~~six ~~market~~months ~~until~~after ~~the~~deactivation ~~last~~or ~~day~~expiration of the ~~period for which the~~ internal market emergency ~~mode remains active.~~mode. ~~When~~After ~~preparing~~this ~~the~~period, ~~draft~~they ~~implementing~~shall ~~act~~only ~~establishing~~be ~~the~~made ~~common~~available ~~specification,~~on the ~~Commission shall take into account the~~market ~~views~~after ofreceiving ~~relevant~~an ~~bodies~~authorisation orunder the ~~expert group~~normal ~~and~~authorisation ~~shall~~procedure ~~duly~~provided ~~consult~~for ~~all~~in ~~relevant~~this ~~stakeholders.~~Directive.

Change 61

Added:Article 11 – paragraph 1, Article 38d – paragraph 1 – introductory part – 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 health and safety requirements set out in Annex II to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38e – 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;

Added:Directive 2014/34/EU

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Added:Article 11 – paragraph 1, Article 38e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex II to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38e – 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 health and safety requirements set out in Annex II to this Directive already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38e – 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 39(3). They shall apply to 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 and shall duly consult all relevant stakeholders.

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38e – paragraph 4: 4. By way of derogation from Article 38a(3), unless there is sufficient reason to believe that the 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 products in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive 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].

Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38e – paragraph 5: 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. The Commission may amend, where appropriate, the implementing act establishing the common specification in question.

Added:Directive 2014/34/EU

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Added:Directive 2014/34/EU

Added:Article 11 – paragraph 1, Article 38g – paragraph 1: 1. The market surveillance authorities of the Member States shall ensure all reasonable 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 products designated as crisis-relevant goods.’

Change 63

Changed:Article 12 – paragraph 1, Article 22a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles ~~22b to 22c~~22 and 22d of this Directive l only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

Change 64

Removed:Article 12 – paragraph 1, Article 22b – paragraph 1 point -a (new): (-a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

Added:Article 12 – paragraph 1, Article 22a – paragraph 2 – subparagraph 1: 2. Member States shall ensure that measures taken to transpose Articles 22b and 22d apply exclusively to electrical equipment, which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

Change 65

Removed:Article 12 – paragraph 1, Article 22b – paragraph 1 – point a: (a) where no reference to harmonised standards covering the safety objective set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe in the context of the emergency;

Added:Article 12 – paragraph 1, Article 22a – paragraph 3: 3. Member States shall ensure that measures taken to transpose Articles 22b and 22d apply during the internal market emergency mode.

Change 66

Removed:Article 12 – paragraph 1, Article 22b – 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 23(2). They shall apply to electrical equipment 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.

Added:Article 12 – paragraph 1, Article 22a – paragraph 4: deleted

Change 67

Added:Article 12 – paragraph 1, Article 22b – 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;

Added:Directive 2014/35/EU

Added:Article 12 – paragraph 1, Article 22b – paragraph 1 – point a: (a) where no reference to harmonised standards covering the safety objective set out in Annex I to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

Added:Directive 2014/35/EU

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Added:Article 12 – paragraph 1, Article 22b – 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 safety objectives referred to in Article 3 and set out in Annex I to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/35/EU

Added:Article 12 – paragraph 1, Article 22b – 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 23(2). They shall apply to electrical equipment 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 and shall duly consult all relevant stakeholders.

Added:Directive 2014/35/EU

Added:Article 12 – paragraph 1, Article 22b – paragraph 4: 4. By way of derogation from Article 22a(3), unless there is sufficient reason to believe that the electrical equipment covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the electrical equipment in compliance with those common specifications which has been placed on the market, shall be deemed compliant with this Directive 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].

Added:Directive 2014/35/EU

Added:Article 12 – paragraph 1, Article 22b – paragraph 5: 5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the safety objectives referred to in Article 3 and 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.

Added:Directive 2014/35/EU

Change 68

Added:Directive 2014/35/EU

Added:Article 12 – paragraph 1, Article 22d – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable 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 electrical equipment designated as crisis-relevant goods.

Change 69

Changed:Article 13 – paragraph 1, Article 43a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 43b to 43g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

Change 70

Added:Article 13 – paragraph 1, Article 43a – paragraph 3 – subparagraph 1: Member States shall ensure that measures taken to transpose Articles 43b to 43g apply during the internal market emergency mode.

Added:Directive 2014/53/EU

Added:Article 13 – paragraph 1, Article 43a – paragraph 3 – subparagraph 2: deleted

Added:Directive 2014/53/EU

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Added:Article 13 – paragraph 1, Article 43a – paragraph 4: deleted

Added:Directive 2014/53/EU

Added:Article 13 – 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 radio equipment designated as crisis-relevant goods as a matter of priority.

Added:Directive 2014/53/EU

Added:Article 13 – paragraph 1, Article 43b – paragraph 4: 4. The prioritisation of applications for conformity assessment of radio equipment pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

Added:Directive 2014/53/EU

Added:Article 13 – paragraph 1, Article 43b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for radio equipment designated as crisis-relevant goods in respect of which they have been notified.

Added:Directive 2014/53/EU

Added:Article 13 – paragraph 1, Article 43c – paragraph 1: 1. By way of derogation from Article 17, 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 specific radio equipment which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring mandatory involvement of a notified body, referred to in that Article have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

Added:Directive 2014/53/EU

Added:Article 13 – paragraph 1, Article 43c – paragraph 2 – subparagraph 2: deleted

Added:Directive 2014/53/EU

Added:Article 13 – 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 radio equipment may be placed on the market, including at least:

Added:Directive 2014/53/EU

Added:Article 13 – paragraph 1, Article 43c – paragraph 3 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2014/53/EU

Added:Article 13 – paragraph 1, Article 43c – paragraph 3 – point e a: (ea) labelling requirements, including radio frequency identification, indicating that the radio equipment, was authorised under the internal market emergency mode.

Added:Directive 2014/53/EU

Change 71

Removed:Article 13 – paragraph 1, Article 43e – paragraph 1 – point -a (new): (-a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

Added:Article 13 – paragraph 1, Article 43c – paragraph 5: 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 Directive with respect to such radio equipment. 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.

Change 72

Removed:Article 13 – paragraph 1, Article 43e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential requirements set out in Article 3 has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe in the context of the emergency;

Added:Article 13 – paragraph 1, Article 43c – paragraph 7: 7. 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 17.

Change 73

Changed:Article 13 – paragraph 1, Article ~~43e~~43c – paragraph ~~2: 2. The implementing acts referred to in paragraph 1 of this Article shall be adopted in~~7 ~~accordance~~a ~~with~~(new): ~~the~~7a. ~~examination~~Radio ~~procedure~~equipment ~~referred~~subject to inderogation ~~Article~~under ~~45(3).~~paragraph ~~They~~1 shall ~~apply to radio equipment~~remain ~~placed~~valid onfor ~~the~~six ~~market~~months ~~until~~after ~~the~~deactivation ~~last~~or ~~day~~expiration of the ~~period for which the~~ internal market emergency ~~remains active.~~mode. ~~When~~After ~~preparing~~this ~~the~~period, ~~draft~~they ~~implementing~~shall ~~act~~only ~~establishing~~be ~~the~~made ~~common~~available ~~specification,~~on the ~~Commission shall take into account the~~market ~~views~~after ofreceiving ~~relevant~~an ~~bodies~~authorisation orunder the ~~expert group~~normal ~~and~~authorisation ~~shall~~procedure ~~duly~~provided ~~consult~~for ~~all~~in ~~relevant~~this ~~stakeholders.~~Directive.

Change 74

Added:Article 13 – paragraph 1, Article 43d – paragraph 1 – introductory part – 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 Article 3 of this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/53/EU

Added:Article 13 – 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;

Added:Directive 2014/53/EU

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Added:Article 13 – paragraph 1, Article 43e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential requirements set out in Article 3 has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

Added:Directive 2014/53/EU

Added:Article 13 – 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 Article 3 of this Article and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/53/EU

Added:Article 13 – 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 45(3). They shall apply to radio equipment 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 and shall duly consult all relevant stakeholders.

Added:Directive 2014/53/EU

Added:Article 13 – paragraph 1, Article 43e – paragraph 4: 4. By way of derogation from Article 43a(3), nnless there is sufficient reason to believe that the radio equipment covered by the common specifications referred to in paragraph 1 of this Article presents a risk to the health or safety of persons, the radio equipment in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Directive 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]

Added:Directive 2014/53/EU

Added:Article 13 – 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 Article 3, 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.

Added:Directive 2014/53/EU

Change 75

Added:Directive 2014/53/EU

Added:Article 13 – paragraph 1, Article 43g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable 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 radio equipment designated as crisis-relevant goods.

Change 76

Changed:Article 14 – paragraph 1, Article 43a – paragraph 1: 1. Member States shall ensure that measures taken to transpose Articles 43b to 43g of this Directive only apply if the Commission has adopted an implementing act pursuant to Article 2314(5) of [the IMERA ~~Regulation] with respect to this Directive.~~Regulation].

Change 77

Added:Article 14 – paragraph 1, Article 43a – paragraph 3 – subparagraph 1: 3. Member States shall ensure that measures taken to transpose Articles 43b to 43g apply during the internal market emergency mode.

Added:Directive 2014/68/EU

Added:Article 14 – paragraph 1, Article 43a – paragraph 1 – subparagraph 2: deleted

Added:Directive 2014/68/EU

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Added:Article 14 – paragraph 1, Article 43a – paragraph 4: deleted

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Added:Article 14 – 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 pressure equipment and assemblies designated as crisis-relevant goods as a matter of priority.

Added:Directive 2014/68/EU

Added:Article 14 – paragraph 1, Article 43b – paragraph 4: 4. The prioritisation of applications for conformity assessment of pressure equipment and assemblies pursuant to paragraph 3 shall not give rise to any extraordinary additional costs for the manufacturers, who have lodged those applications.

Added:Directive 2014/68/EU

Added:Article 14 – paragraph 1, Article 43b – paragraph 5: 5. The notified bodies shall ensure all reasonable efforts are made to increase their testing capacities for pressure equipment and assemblies designated as crisis-relevant goods in respect of which they have been notified.

Added:Directive 2014/68/EU

Added:Article 14 – paragraph 1, Article 43c – 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 specific pressure equipment or assembly designated as crisis-relevant good and for which the conformity assessment procedures referred to in that Article have not been carried out by a notified body but for which the compliance with all the applicable essential safety requirements has been demonstrated.

Added:Directive 2014/68/EU

Added:Article 14 – paragraph 1, Article 43c – paragraph 1 – subparagraph 2: deleted

Added:Directive 2014/68/EU

Added:Article 14 – 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 pressure equipment or assembly may be placed on the market or put into service, including at least:

Added:Directive 2014/68/EU

Added:Article 14 – paragraph 1, Article 43c – paragraph 3 – point c: (c) an end date of validity of the authorisation, which, unless otherwise specified, cannot go beyond the last day of the period for which the internal market emergency mode has been activated;

Added:Directive 2014/68/EU

Added:Article 14 – paragraph 1, Article 43c – paragraph 3 – point e a: (ea) labelling requirements, including radio frequency identification, indicating that the pressure equipment and assembly was authorised under the internal market emergency mode.

Added:Directive 2014/68/EU

Added:Article 14 – 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.

Added:Directive 2014/68/EU

Change 78

Removed:Article 14 – paragraph 1, Article 43e – paragraph 1 – point -a (new): (-a) where the European standardisation deliverables addressing a request pursuant to Article 10(1) of Regulation No 1025/2012 were not adopted;

Added:Article 14 – 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 Directive with respect to such pressure equipment or assemblies. 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.

Change 79

Removed:Article 14 – paragraph 1, Article 43e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex II to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe in the context of the emergency;

Added:Article 14 – 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 14.

Change 80

Changed:Article 14 – paragraph 1, Article ~~43e~~43c – paragraph ~~2: 2. The implementing acts referred to in paragraph 1 of this Directive shall be~~8 ~~adopted~~a in(new): ~~accordance~~8a. ~~with~~Pressure ~~the~~equipment ~~examination~~and ~~procedure~~assemblies ~~referred~~subject to inderogation ~~Article~~under ~~44(3).~~paragraph ~~They~~1 shall ~~apply to the pressure equipment and assemblies~~remain ~~placed~~valid onfor ~~the~~six ~~market~~months ~~until~~after ~~the~~deactivation ~~last~~or ~~day~~expiration of the ~~period for which the~~ internal market emergency ~~mode remains active.~~mode. ~~When~~After ~~preparing~~this ~~the~~period, ~~draft~~they ~~implementing~~shall ~~act~~only ~~establishing~~be ~~the~~made ~~common~~available ~~specification,~~on the ~~Commission shall take into account the~~market ~~views~~after ofreceiving ~~relevant~~an ~~bodies~~authorisation orunder the ~~expert group~~normal ~~and~~authorisation ~~shall~~procedure ~~duly~~provided ~~consult~~for ~~all~~in ~~relevant~~this ~~stakeholders.~~Directive.

Change 81

Removed:Article 14 – 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 safety 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 and, if appropriate, may amend the implementing act establishing the common specification in question.

Added:Article 14 – paragraph 1, Article 43d – paragraph 1 – introductory part – 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 safety requirements set out in Annex II to this Directive and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Change 82

Added:Article 14 – 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;

Added:Directive 2014/68/EU

Added:Article 14 – paragraph 1, Article 43e – paragraph 1 – point a: (a) where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex II to this Directive has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable timeframe during the internal market emergency mode;

Added:Directive 2014/68/EU

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Added:Article 14 – 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 safety requirements set out in Annex II to this Directive already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Added:Directive 2014/68/EU

Added:Article 14 – paragraph 1, Article 43e – paragraph 2: 2. The implementing acts referred to in paragraph 1 of this Directive shall be adopted in accordance with the examination procedure referred to in Article 44(3). They shall apply to the pressure equipment and assemblies 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 and shall duly consult all relevant stakeholders.

Added:Directive 2014/68/EU

Added:Article 14 – paragraph 1, Article 43e – paragraph 4: 4. By way of derogation from Article 43a(3), nnless there is sufficient reason to believe that the pressure equipment and assemblies covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the pressure equipment and assemblies in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Directive 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].

Added:Directive 2014/68/EU

Added:Article 14 – 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 safety 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.

Added:Directive 2014/68/EU

Change 83

Added:Directive 2014/68/EU

Added:Article 14 – paragraph 1, Article 43g – paragraph 2: 2. The market surveillance authorities of the Member States shall ensure all reasonable 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 pressure equipment and assemblies designated as crisis-relevant goods.’