Legal provisions of COM(2022)461 - Amending numerous regulations on emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency

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dossier COM(2022)461 - Amending numerous regulations on emergency procedures for the conformity assessment, adoption of common specifications and ...
document COM(2022)461 EN
date September 19, 2022

Contents

Article 1 - Amendments to Regulation (EU) 2016/424

In Regulation (EU) 2016/424, the following Chapter VIa is inserted:

‘CHAPTER Via
EMERGENCY PROCEDURES

Article 43 - a Application of emergency procedures

1. Articles 43b to 43g shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Regulation.

2. Articles 43b to 43g shall apply exclusively to subsystems and safety components, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Articles 43b to 43g, except as regards provisions concerning the powers of the Commission, shall apply during the Single Market emergency mode. 

However, Article 43c(2), second subparagraph, and Article 43c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to subsystems and safety components placed on the market in accordance with Articles 43c to 43f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3).

Article 43 - b Prioritisation of the conformity assessment of crisis-relevant subsystems and safety components

1. This Article shall apply to all subsystems and safety components designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 18 requiring mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of subsystems and safety components designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of subsystems and safety components designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for conformity assessment of subsystems and safety components, which have not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of subsystems and safety components designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 43a.

4. The prioritisation of applications for conformity assessment of subsystems and safety components pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for subsystems and safety components designated as crisis-relevant goods in respect of which they have been notified.

Article 43 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 18, any competent national authority may authorise, on a duly justified request, the placing on the market or the incorporation into a cableway installation within the territory of the Member State concerned, of a specific subsystem or safety component 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 18 have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

2. The manufacturer of a subsystem or safety component subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the subsystem or safety component concerned complies with all the applicable essential requirements set out in Annex II and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the subsystem or safety component, which has been granted an authorisation pursuant to paragraph 1, does not leave the territory of the Member State, which issued the authorisation.

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

(a)a description of the procedures, by means of which compliance with the applicable essential requirements was successfully demonstrated;

(b)specific requirements regarding the traceability of the subsystem or safety component concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the subsystem or safety component concerned;

(e)measures to be taken with respect to the subsystem or safety component concerned upon expiry of the authorisation in order to ensure that the subsystem or safety component concerned is brought back in compliance with all the requirements of this Regulation.

4. By way of derogation from Article 43a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 7 and 20, subsystems or safety components, for which an authorisation has been granted in accordance with paragraph 1 of this Article, shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Regulation with respect to such subsystems or safety components.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market of subsystems or safety components in accordance with paragraph 1.

8. The application of Articles 43a to 43g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 18 on the territory of the Member State concerned.

Article 43 - d Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market, their competent authorities consider that subsystems and safety components, which comply with the relevant international standards or any national standards in force in the Member State of manufacture, ensuring the safety level required by the essential requirements set out in Annex II, comply with those essential requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential requirements set out in Annex II is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

Where

(b)severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex II to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 43 - e Adoption of common specifications conferring a presumption of conformity

1. Where subsystems and safety components, have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such subsystems and safety components to cover the essential requirements set out in Annex II in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential requirements set out in Annex II is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 14 of [the SMEI Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex II to this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 44(3) and they shall apply to subsystems or safety components placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 17, subsystems and safety components which are in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those common specifications or parts thereof.

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

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

Article 43 - f Adoption of mandatory common specifications

1. In exceptional and duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential requirements set out in Annex II for subsystems or safety components, which have been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 44(3). They shall apply to subsystems or safety components placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

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

Article 43 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for subsystems and safety components designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for subsystems and safety components designated as crisis-relevant goods.

Article 2 - Amendments to Regulation (EU) 2016/425

In Regulation (EU) 2016/425, the following Chapter VIa is inserted:

‘CHAPTER VIa
EMERGENCY PROCEDURES

Article 41 - a Application of emergency procedures

1. Articles 41b to 41g shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Regulation.

2. rticles 41b to 41g shall apply exclusively to PPE, which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1.

3. Articles 41b to 41g, except as regards provisions concerning the powers of the Commission, shall apply during the Single Market emergency mode.

However, Article 41c(2), second subparagraph, and Article 41c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to PPE placed on the market in accordance with Articles 41c to 41f. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3).

Article 41 - b Prioritisation of the conformity assessment of crisis-relevant PPE

1. This Article shall apply to PPE designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 19 requiring mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of PPE designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of such PPE shall be processed as a matter of priority, ahead of any other applications for conformity assessment of PPE, which has not been designated as crisis-relevant goods. This requirement applie with respect to all applications for conformity assessment of PPE designated as crisis-relevant good, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 41a.

4. The prioritisation of applications for conformity assessment of PPE pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for PPE designated as crisis-relevant goods in respect to which they have been notified.

Article 41 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 19, any competent national authority may authorise, on a duly justified request, the placing on the market within the territory of the Member State concerned, of a specific PPE which has been designated as crisis-relevant good 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.

2. The manufacturer of a PPE subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the PPE concerned complies with all the applicable essential health and safety requirements and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the PPE, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which issued the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the PPE may be placed on the market, including:

(a)a description of the procedures, by means of which the compliance with the applicable essential health and safety requirements was successfully demonstrated;

(b)specific requirements regarding the traceability of the PPE concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the PPE concerned;

(e)measures to be taken with respect to the PPE concerned upon expiry of the authorisation in order to ensure that the PPE concerned is brought back in compliance with all the requirements of this Regulation.

4. By way of derogation from Article 41a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 of this Article also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 7 and 17, PPE, for which an authorisation has been granted in accordance with paragraph 1 of this Article, shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Regulation with respect to such PPE.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market of PPE in accordance with paragraph 1.

8. The application of Articles 41a to 41g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 19 on the territory of the Member State concerned.

Article 41 - d Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market, their competent authorities consider that the PPE, which complies with the relevant international standards or any national standards in force in the Member State of manufacture, ensuring the safety level required by the essential health and safety requirements set out in Annex II, complies with those essential health and safety requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex II is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI 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 Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 41 - e Adoption of common specifications conferring a presumption of conformity

1. Where PPE, have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such PPE to cover the essential health and safety requirements set out in Annex II in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex II is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation Single Market emergency mode 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 Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 44(3). They shall remain applicable to PPE placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 14, PPE which are in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by those common specifications or parts thereof.

4. By way of derogation from Article 41a(3), first subparagraph, unless there is sufficient reason to believe that the PPE covered by the common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the PPE in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Regulation after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

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 and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 41 - f Adoption of mandatory common specifications

1. In duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential health and safety requirements set out in Annex II for PPE, which has been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, referred to in paragraph 1 of this Article, shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 44(3). They shall apply to PPE placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 41a(3), first subparagraph, unless there is sufficient reason to believe that the PPE covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the PPE in compliance with those common specifications which has been placed on the market shall be deemed compliant with this Regulation after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 41 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for PPE designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single 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 PPE designated as crisis-relevant goods.’

Article 3 - Amendments to Regulation (EU) 2016/426

In Regulation (EU) 2016/426, the following Chapter VIa is inserted after Chapter VI:

‘CHAPTER VIa
EMERGENCY PROCEDURES

Article 40 - a Applicationof emergency procedures

1. Articles 40b to 40g shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Regulation.

2. Articles 40b to 40g shall apply exclusively to appliances and fittings, which has been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Articles 40b to 40g, except as regards provisions concerning the powers of the Commission, shall apply during the Single Market emergency mode remains active.

However, Article 40c(2), second subparagraph, and Article 40c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to appliances and fittings placed on the market in accordance with Articles 40c to 40f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3).

Article 40 - b Prioritisation of the conformity assessment of crisis-relevant appliances and fittings

1. This Article shall apply to all appliances and fittings designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 14 requiring mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of appliances and fittings designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of appliances and fittings designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for appliances and fittings, which have not been designated as crisis-relevant goods. This requirement applies with respect to all applications for conformity assessment of appliances and fittings designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 41a.

4. The prioritisation of applications for conformity assessment of appliances and fittings pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for appliances and fittings designated as crisis-relevant goods in respect to which they have been notified.

Article 40 - c Derogation from conformity assessment procedures requiring mandatory involvement of a notified bod

1. By way of derogation from Article 14, any competent national authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific appliance or fitting which has been designated as crisis-relevant good and for which the conformity assessment procedures requiring the mandatory involvement of a notified body, referred to in Article 14, have not been carried out by a notified body but for which the compliance with all the applicable essential requirements has been demonstrated.

2. The manufacturer of an appliance or a fitting subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the appliance or the fitting concerned complies with all the applicable essential requirements set out in Annex I and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the appliance or fitting, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which issued the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the appliance or fitting may be placed on the market, including:

(a)a description of the procedures, by means of which compliance with the applicable essential requirements was successfully demonstrated;

(b)specific requirements regarding the traceability of the subsystem or safety component concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the subsystem or safety component concerned;

(e)measures to be taken with respect to the appliance or fitting concerned upon expiry of the authorisation in order to ensure that the appliance or fitting concerned is brought back in compliance with all the requirements of this Regulation.

4. By way of derogation from Article 40a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3 also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 6 and 17, appliances or fittings, for which an authorisation has been granted in accordance with paragraph 1 of this Article, shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1 shall be entitled to take all corrective and restrictive measures at national level provided for under this Regulation with respect to such appliances or fittings.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market of appliances or fittings in accordance with paragraph 1.

8. The application of Articles 40a to 40g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 14 on the territory of the Member State concerned.

Article 40 - d Presumption of conformity based on national and international standards

Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market or putting into service, their competent authorities consider that appliances and fittings, which comply with relevant international standards or any national standards in force in the Member State of manufacture, ensuring the safety level required by the essential requirements set out in Annex I, comply with those essential requirements in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential safety requirements set out in Annex I is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI 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 Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

Article 40 - e Adoption of common specifications conferring a presumption of conformity

1. Where appliances or fittings have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such appliances or fittings to cover the essential requirements set out in Annex I in either of the following cases:

(a)where no reference to harmonised standards covering the relevant essential requirements set out in Annex I is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b)where severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation], significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant essential requirements set out in Annex I in this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 42(3). They shall apply to appliances and fittings placed on the market no longer than until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 13, appliances or fittings which are in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the essential requirements set out in Annex I covered by those common specifications or parts thereof.

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

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 and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 40 - f Adoption of mandatory common specifications

1. In duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the essential requirements set out in Annex I for appliances or fittings, which have been designated as crisis-relevant goods.

2. The implementing acts establishing mandatory common specifications, referred to in paragraph 1 of this Article, shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 42(3) and they shall apply to appliances or fittings placed on the market at the latest until the last day of the period for which the Single Market emergency remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

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

Article 40 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. The Member States shall prioritise the market surveillance activities for appliances and fittings designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for appliances and fittings designated as crisis-relevant goods.

Article 4 - Amendments to Regulation (EU) 2019/1009

In Regulation (EU) 2019/1009, the following Chapter Va is inserted:

CHAPTER V - a

EMERGENCY PROCEDURES

Article 41 - a Applicationof emergency procedures

1. Articles 41b to 41g shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Regulation.

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

3. Articles 41b to 41g, except as regards provisions concerning the powers of the Commission, shall apply during the Single Market emergency mode.

However, Article 41c(2), second subparagraph, and Article 41c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to fertilising products placed on the market in accordance with Articles 41c to 41f. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).

Article 41 - b Prioritisation of the conformity assessment of crisis-relevant fertilising products

1. This Article shall apply to fertilising products designated as crisis-relevant goods, which are subject to conformity assessment procedures in accordance with Article 15 requiring mandatory involvement of a notified body.

2. The notified bodies shall process all applications for conformity assessment of fertilising products designated as crisis-relevant goods as a matter of priority.

3. All pending applications for conformity assessment of fertilising products designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications for conformity assessment of fertilising products, which have not been designated as crisis-relevant goods. This requirement is applicable with respect to all applications for conformity assessment of fertilising products designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 41a.

4. The prioritisation of applications for conformity assessment of fertilising products pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturers, who have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their testing capacities for fertilising products designated as crisis-relevant goods in respect of which they have been notified.

Article 41 - c Derogation from the conformity assessment procedures requiring mandatory involvement of a notified body

1. By way of derogation from Article 15, any competent national authority may authorise, on a duly justified request, the placing on the market within the territory of the Member State concerned, of a specific fertilising product 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 15 have not been carried out by a notified body but for which the compliance with the requirements set out in Annexes I and II has been demonstrated.

2. The manufacturer of a fertilising product subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the fertilising product concerned complies with the requirements set out in Annexes I and II and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the fertilising product, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which issued the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the fertilising products may be placed on the market, including:

(a)a description of the procedures, by means of which compliance with the applicable essential requirements was successfully demonstrated;

(b)specific requirements regarding the traceability of the fertilising product concerned;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the need to ensure the continuous conformity assessment with respect to the fertilising product;

(e)measures to be taken with respect to the fertilising product concerned upon expiry of the authorisation in order to ensure that the fertilising product concerned is brought back in compliance with all the requirements of this Regulation.

4. By way of derogation from Article 41a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation referred to in paragraph 3of this Articcle also after the deactivation or expiry of the Single Market Emergency mode.

5. By way of derogation from Articles 3 and 18, fertilising products, for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Regulation with respect to such fertilising products.

7. Member States shall inform the Commission and the other Member States of any decision to authorise the placing on the market of fertilising products in accordance with paragraph 1.

8. The application of Articles 41a to 41g and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant conformity assessment procedures laid down in Article 15 on the territory of the Member State concerned.

Article 41 - d Presumption of conformity based on national and international standards

Where severe disruptions in the functioning of the Single Market, which were taken into consideration when activating the Single Market emergency mode in accordance with Article 15(4) of [the SMEI Regulation] significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, the Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market, their competent authorities consider as complying with requirements set out in Annex I, II or III of this Regulation fertilising products which comply with relevant international standards or any relevant national standards in force in the Member State of manufacture, ensuring a safety level equivalent to that required by the requirements set out in Annex I, II or III.

Article 41 - e Adoption of common specifications conferring a presumption of conformity

1. Where EU fertilising products, have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications for such EU fertilising products for the requirements set out in Annex I, II or III or tests referred to in Article 13(2) where severe disruptions in the functioning of the Single Market, which led to the activation of [were taken into consideration when] the Single Market emergency mode significantly restrict the possibilities of manufacturers to make use of the harmonised standards covering the relevant requirements set out in Annex I, II or III or tests referred to in Article 13(2) of this Regulation and already published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 45(3). They shall apply to EUfertilising products placed on the market until the last day of the period for which the Single Market emergency mode remains active in accordance with [the SMEI Regulation]. In the early preparation of the draft implementing acts establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Article 13, EU fertilising products which are in conformity with common specifications adopted pursuant to paragraph 2 of this Article shall be presumed to be in conformity with the requirements set out in Annex I, II or III [or tests referred to in Article 13(2)] covered by those common specifications or parts thereof.

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

5. When a Member State considers that a common specification referred to in paragraph 1 does not entirely satisfy the requirements set out in Annexes I and II, it shall inform the Commission thereof with a detailed explanationand the Commission shall assess that information and, if appropriate, amend or withdraw the implementing act establishing the common specification in question.

Article 41 - f Adoption of mandatory common specifications

1. In duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications for EU fertilising products to cover the requirements set out in Annexes I and II which have been designated as crisis-relevant goods.

2. The implementing acts referred to in paragraph 1 shall be adopted following a consultation of the sectoral experts and in accordance with the examination procedure referred to in Article 45(3) and they shall apply to EU fertilising products placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

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

Article 41 - g Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for fertilising products designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single Market emergency, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support such as reinforcement of the testing capacity for fertilising products designated as crisis-relevant goods.’

Article 5 - Amendments to Regulation (EU) No 305/2011

In Regulation (EU) 305/2011 is amended as follows:

the following Chapter VIIIa is inserted:

‘‘CHAPTER VIIIa
EMERGENCY PROCEDURES

Article 59 - a Application of emergency procedures

1. Articles 59b to 59f shall only apply if the Commission has adopted an implementing act pursuant to Article 23 of [the SMEI Regulation] activating Article 26 of [the SMEI Regulation] with respect to this Regulation.

2. Articles 59b to 59f shall apply exclusively to construction products, which have been designated as crisis-relevant goods in the implementing act referred to in paragraph 1 of this Article.

3. Articles 59b to 59f, except as regards provisions concerning the powers of the Commission, shall apply during the Single Market emergency mode.

However, Article 59c(2), second subparagraph, and Article 59c(5) shall apply during the Single Market emergency mode and after its deactivation or expiry.

4. The Commission shall be empowered to lay down by means of implementing acts rules regarding the follow-up actions to be taken with respect to construction products placed on the market in accordance with Articles 59b to 59f. These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 64(2a)

Article 59 - b Prioritisation of the assessment and verification of constancy of performance of crisis-relevant construction products

1. This Article shall apply to construction products designated as crisis-relevant goods, which are subject to third party tasks of notified bodies related to the assessment and verification of constancy of performance, in accordance with Article 28(1).

2. The notified bodies shall process requests for third party tasks related to the assessment and verification of constancy of performance of construction products designated as crisis-relevant goods as a matter of priority.

3. All pending applications for the performance of third party tasks related to the assessment and verification of constancy of performance of construction products designated as crisis-relevant goods shall be processed as a matter of priority, ahead of any other applications regarding construction products, which have not been designated as crisis-relevant goods. This requirement applies with respect to all applications for third party tasks related to the assessment and verification of constancy of performance of construction products designated as crisis-relevant goods, irrespective of whether they have been lodged before or after the activation of the emergency procedures pursuant to Article 59a.

4. The prioritisation of applications for third party tasks related to the assessment and verification of constancy of performance of construction products pursuant to paragraph 3 shall not give rise to any additional costs for the manufacturerswho have lodged those applications.

5. The notified bodies shall deploy their best efforts to increase their respective assessment and verification capacities regarding construction products designated as crisis-relevant goods.

Article 59 - c Derogation from the third party assessment procedures for assessment and verification of constancy of performance

1. By way of derogation from Article 28(1), the competent national authority may exceptionally authorise, on a duly justified request, the placing on the market within the territory of the Member State concerned, of a specific construction product which has been designated as crisis-relevant good for which the required third-party assessment and verification of constancy of performance procedures referred to in that Article have not been carried out by a notified body.

2. The manufacturer of a construction product subject to the authorisation procedure referred to in paragraph 1 shall declare on his sole responsibility that the construction product concerned achieves the declared performance and shall be responsible for the fulfilment of all the procedures for the assessment and verification of constancy of performance indicated by the national competent authority.

The manufacturer shall also deploy all reasonable measures to ensure that the construction product, which has been granted an authorisation pursuant to paragraph 1 does not leave the territory of the Member State, which issued the authorisation.

3. Any authorisation issued by a national competent authority pursuant to paragraph 1 shall set out the conditions and requirements under which the construction products may be placed on the market, including:

(a)a description of the procedures, to be followed in order to demonstrate that the construction product achieves the declared performance and complies with this Regulation, as applicable;

(b)the specific requirements regarding the safety as well as the traceability, including labelling, of the concerned construction product;

(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the Single Market emergency mode has been activated;

(d)any specific requirements regarding the continuous performance of third party tasks related to the assessment and verification of constancy of performance with respect to the concerned construction product;

(e)measures to be taken with respect to the construction product concerned upon expiry of the authorisation in order to ensure that the construction product concerned is brought back in compliance with all the requirements of this Regulation.

4. By way of derogation from Article 54a(3), first subparagraph, where appropriate, the national competent authority may amend the conditions of the authorisation issued referred to in paragraph 3 of this Article, also after the deactivation or expiry of the Single Market Emergency mode.

5. Construction products, for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not leave the territory of the Member State which has issued the authorisation and shall not bear the CE marking.

6. The market surveillance authorities of the Member State, whose competent authority has granted an authorisation pursuant to paragraph 1, shall be entitled to take all corrective and restrictive measures at national level provided for under this Regulation with respect to such construction products.

7. Member States shall inform the Commission s of any decision to authorise the placing on the market of construction products in accordance with paragraph 1.

8. The application of Articles 59a to 59f and the use of the authorisation procedure set out in paragraph 1 of this Article does not affect the application of the relevant procedures for the assessment and verification of constancy of performance required by Article 28 on the territory of the Member State concerned.

Article 59 - d Adoption of common specifications enabling performance assessment

1. Where construction products, have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts establishing common specifications to cover the methods and the criteria for assessing the performance of those products in relation to their essential characteristics in either of the following cases:

(a)where no reference to harmonised standards covering the relevant methods and criteria for assessing the performance of those products in relation to their essential characteristics is published in the Official Journal of the European Union in accordance with Article 17(5);

(b)where the severe disruptions in the functioning of the Single Market, which led to the activation of the Single Market emergency mode significantly restrict the possibilities of manufacturers to make use of the harmonised standards, providing the relevant methods and criteria for assessing the performance of those product in relation to their essential characteristics, and already published in the Official Journal of the European Union in accordance with Article 17(5).

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the Standing Committee on Construction and in accordance with the examination procedure referred to in Article 64(2a). They shall apply to construction products placed on the market until the last day of the period for which the Single Market emergency mode remains active. In the early preparation of the draft implementing act establishing the common specification, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. Without prejudice to Articles 4 and 6, the methods and the criteria provided in the common specifications adopted pursuant to paragraph 1 of this Article, may be used for assessing and declaring the performance of construction products covered by those common specifications in relation to their essential characteristics.

4. By way of derogation from Article 59a(3), first subparagraph, declaration of performance in compliance with the common specifications referred to in paragraph 1 of this Article regarding construction products which have been placed on the market shall not be affected by the subsequent expiry or repeal of the implementing act, which has laid down those common specifications, unless there is sufficient reason to believe that construction products covered by those common specifications present a risk or do not achieve the declared performance.

5. When a Member State considers that a common specification referred to in paragraph 1 is incorrect in terms of criteria and methods for the assessment of performance in relation to essential characteristics, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend or withdraw the implementing at establishing the common specification in question

Article 59 - e Adoption of mandatory common specifications

1. In duly justified cases, the Commission is empowered to adopt implementing acts establishing mandatory common specifications to cover the methods and the criteria for assessing the performance of construction products which have been designated as crisis-relevant goods.

2. The implementing acts referred to in paragraph 1 of this Article shall be adopted following a consultation of the Standing Committee on Construction and in accordance with the examination procedure referred to in Article 64(2a). They shall apply to construction products placed on the market until the last day of the period for which the Single Market emergency remains active. In the early preparation of the draft implementing acts establishing the common specifications, the Commission shall gather the views of relevant bodies or expert groups established under relevant sectoral Union legislation. Based on that consultation, the Commission shall prepare the draft implementing act.

3. By way of derogation from Article 59a(3), first subparagraph, unless there is sufficient reason to believe that the construction products covered by the mandatory common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the construction products in compliance with those common specifications which have been placed on the market shall be deemed compliant with this Regulation after the expiry or repeal of an implementing act adopted pursuant to paragraph 2 of this Article and after the expiry or deactivation of the Single Market Emergency mode in accordance with [the SMEI Regulation].

Article 59 - f Prioritisation of market surveillance activities and mutual assistance among authorities

1. Member States shall prioritise the market surveillance activities for construction products designated as crisis-relevant goods.

2. The market surveillance authorities of the Member States shall deploy their best efforts to provide assistance to other market surveillance authorities during a Single 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 construction products designated as crisis-relevant goods.’

(2) In Article 64, the following paragraph 2a is inserted:

‘2a. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.’

Article 6 - Entry into force Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from [OP- please insert the date identical to that of the entry into application of the SMEI Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.