Directive (EU) 2024/2749 of the European Parliament and of the Council of 9 October 2024 amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2014/29/EU, 2014/30/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU as regards emergency procedures for the conformity assessment, presumption of conformity, adoption of common specifications and market surveillance due to an internal market emergency (Text with EEA relevance)

• CELEX: Directive (EU) 2024/2749
• Articles: 13

Article 1 Amendments to Directive 2000/14/EC

Directive 2000/14/EC is amended as follows:

(1)

in Article 3, the following points are added:

‘(g)

“crisis-relevant goods” means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council  ( *1 ) ;

(h)

“internal market emergency mode” means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

( *1 )   Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) ( OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj ).’;"

(2)

the following articles are inserted:

‘Article 17a

Application of emergency procedures

1.   Member States shall ensure that measures taken to transpose Articles 17b, 17c and 17d of this Directive apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to equipment covered by this Directive.

2.   Member States shall ensure that measures taken to transpose Articles 17b, 17c and 17d of this Directive apply only to equipment referred to in Article 2(1) of this Directive which has been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.

3.   Member States shall ensure that measures taken to transpose Articles 17b, 17c and 17d of this Directive apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.

However, Article 17c(7) of this Directive shall apply during the internal market emergency mode and after its expiry or deactivation.

4.   The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to equipment referred to in Article 2(1) and placed on the market or put into service in accordance with Article 17c. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).

Article 17b

Prioritisation of the conformity assessment of equipment designated as crisis-relevant goods

1.   This Article applies to equipment listed in the implementing act referred to in Article 17a(1) that is subject to the conformity assessment procedures referred to in Article 14 that require the mandatory involvement of a notified body.

2.   The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of equipment referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 17a.

3.   The prioritisation of applications for a conformity assessment of equipment pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications.

4.   The notified bodies shall make reasonable efforts to increase their testing capacities for equipment referred to in paragraph 1 in respect of which they have been notified.

Article 17c

Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body

1.   By way of derogation from Article 14, a Member State may authorise, on a duly justified request from an economic operator, 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 in Article 17a(1) and for which the conformity assessment procedures referred to in Article 14 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable requirements laid down in this Directive concerning noise emission in the environment has been demonstrated in accordance with procedures referred to in that authorisation.

2.   The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable requirements laid down in this Directive concerning noise emission in the environment, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific equipment may be placed on the market or put into service. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 18(2).

The equipment subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

3.   On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 18(3).

4.   As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

5.   Manufacturers of equipment subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the equipment concerned complies with all the applicable requirements set out in this Directive concerning noise emission in the environment and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority.

6.   Any authorisation issued 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. Such authorisations shall set out at least the following:

(a)

a description of the procedures by means of which compliance with the applicable requirements of this Directive concerning noise emission in the environment was successfully demonstrated;

(b)

any specific requirements regarding the traceability of the equipment concerned;

(c)

an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 of Regulation (EU) 2024/2747;

(d)

any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the equipment concerned;

(e)

measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the equipment concerned that has been placed on the market or put into service.

7.   By way of derogation from Articles 6 and 11, equipment for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 6 shall not apply.

8.   The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such equipment, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council  ( *2 ) and under this Directive. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.

9.   The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 14.

Article 17d

Prioritisation of market surveillance activities and mutual assistance among authorities

1.   Member States shall prioritise the market surveillance activities for equipment listed in the implementing act referred to in Article 17a(1) of this Directive. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

2.   The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, 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 the reinforcement of the testing capacity for equipment listed in the implementing act referred to in Article 17a(1).

( *2 )   Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 ( OJ L 169, 25.6.2019, p. 1 ).’;"

(3)

Article 18 is replaced by the following:

‘Article 18

Committee procedure

1.   The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council  ( *3 ) .

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

3.   Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

( *3 )   Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers ( OJ L 55, 28.2.2011, p. 13 ).’."

Article 2 Amendments to Directive 2006/42/EC

Directive 2006/42/EC is amended as follows:

(1)

in Article 2, second paragraph, the following points are added:

‘(n)

“crisis-relevant goods” means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council  ( *4 ) ;

(o)

“internal market emergency mode” means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

( *4 )   Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) ( OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj ).’;"

(2)

the following articles are inserted:

‘Article 21b

Application of emergency procedures

1.   Member States shall ensure that measures taken to transpose Articles 21c to 21f of this Directive apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to machinery covered by this Directive.

2.   Member States shall ensure that measures taken to transpose Articles 21c to 21f of this Directive apply only to machinery which has been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.

3.   Member States shall ensure that measures taken to transpose Articles 21c to 21f of this Directive apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.

However, Article 21d(7) of this Directive shall apply during the internal market emergency mode and after its expiry or deactivation.

4.   The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to machinery placed on the market or put into service in accordance with Articles 21d and 21e. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(3).

Article 21c

Prioritisation of the conformity assessment of machinery designated as crisis-relevant goods

1.   This Article applies to machinery listed in the implementing act referred to in Article 21b(1) that is subject to the conformity assessment procedures referred to in Article 12 that require the mandatory involvement of a notified body.

2.   The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of machinery referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 21b.

3.   The prioritisation of applications for a conformity assessment of machinery pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications.

4.   The notified bodies shall make reasonable efforts to increase their testing capacities for machinery referred to in paragraph 1 in respect of which they have been notified.

Article 21d

Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body

1.   By way of derogation from Article 12, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market or putting into service within the territory of that Member State, of specific machinery listed in the implementing act referred to in Article 21b(1) and for which the conformity assessment procedures referred to in Article 12 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential health and safety requirements laid down in this Directive has been demonstrated in accordance with procedures referred to in that authorisation.

2.   The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure the conformity with the applicable essential health and safety requirements set out in Annex I, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific machinery may be placed on the market or put into service. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 22(3).

The machinery subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market or put into service as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

3.   On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 22(4).

4.   As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

5.   Manufacturers of machinery subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the machinery concerned complies with all the applicable essential health and safety requirements set out in Annex I and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority.

6.   Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the machinery may be placed on the market or put into service. Such authorisations shall set out at least the following:

(a)

a description of the procedures, by means of which compliance with the applicable essential health and safety requirements set out in Annex I to this Directive was successfully demonstrated;

(b)

any specific requirements regarding the traceability of the machinery concerned;

(c)

an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 of Regulation (EU) 2024/2747;

(d)

any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the machinery concerned;

(e)

measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the machinery concerned that has been placed on the market or put into service.

7.   By way of derogation from Articles 6 and 16, machinery for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 6 shall not apply.

8.   The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such machinery, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council  ( *5 ) and under this Directive. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.

9.   The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 12.

Article 21e

Presumption of conformity based on standards and common specifications

1.   Where machinery has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such machinery to cover the relevant essential health and safety requirements set out in Annex I to this Directive in the following cases:

(a)

where a reference to harmonised standards covering the relevant essential health and 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 of the European Parliament and of the Council  ( *6 ) and no such reference is expected to be published within a reasonable period; or

(b)

where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the relevant essential health and safety requirements set out in Annex I to this Directive and the references of which have already been 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 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts.

3.   The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 22(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article.

4.   Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Directive and shall duly consult all relevant stakeholders.

5.   Without prejudice to Article 7, machinery that is in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the relevant essential health and safety requirements set out in Annex I that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article.

6.   By way of derogation from Article 21b(3), first subparagraph, unless there is sufficient reason to believe that the machinery covered by the standards or common specifications referred to in paragraph 1 of this Article presents a risk to the health or safety of persons, the machinery that is in conformity with those standards or common specifications and which has been placed on the market or put into service shall be deemed to be in conformity with the relevant essential health and safety requirements set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.

7.   When a Member State considers that a standard or common specification as referred to in paragraph 1 does not entirely satisfy the relevant essential health and safety requirements set out in Annex I, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.

Article 21f

Prioritisation of market surveillance activities and mutual assistance among authorities

1.   Member States shall prioritise the market surveillance activities for machinery listed in the implementing act referred to in Article 21b(1) of this Directive. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

2.   The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, 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 the reinforcement of the testing capacity for machinery listed in the implementing act referred to in Article 21b(1).

( *5 )   Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 ( OJ L 169, 25.6.2019, p. 1 )."

( *6 )   Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council ( OJ L 316, 14.11.2012, p. 12 ).’;"

(3)

in Article 22, the following paragraph is added:

‘4.   Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.’.

Article 3 Amendments to Directive 2010/35/EU

Directive 2010/35/EU is amended as follows:

(1)

in Article 2, the following points are added:

‘(27)

“crisis-relevant goods” means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council  ( *7 ) ;

(28)

“internal market emergency mode” means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

( *7 )   Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) ( OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj ).’;"

(2)

the following chapter is inserted:

‘Chapter 5a

Emergency procedures

Article 33a

Application of emergency procedures

1.   Member States shall ensure that measures taken to transpose Articles 33b, 33c and 33d of this Directive apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to transportable pressure equipment covered by this Directive.

2.   Member States shall ensure that measures taken to transpose Articles 33b, 33c and 33d of this Directive apply only to transportable pressure equipment which has been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.

3.   Member States shall ensure that measures taken to transpose Articles 33b, 33c and 33d of this Directive apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.

However, Article 33c(7) of this Directive shall apply during the internal market emergency mode and after its expiry or deactivation.

4.   The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to transportable pressure equipment placed on the market in accordance with Article 33c. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 38a(2).

Article 33b

Prioritisation of the conformity assessment of transportable pressure equipment designated as crisis-relevant goods

1.   This Article applies to transportable pressure equipment listed in the implementing act referred to in Article 33a(1) that is subject to the conformity assessment procedures referred to in Article 12 that require the mandatory involvement of a notified body.

2.   The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of transportable pressure equipment referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 33a.

3.   The prioritisation of applications for a conformity assessment of transportable pressure equipment pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications.

4.   The notified bodies shall make reasonable efforts to increase their testing capacities for transportable pressure equipment referred to in paragraph 1 in respect of which they have been notified.

Article 33c

Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body

1.   By way of derogation from Article 12, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market within the territory of that Member State, of specific transportable pressure equipment listed in the implementing act referred to in Article 33a(1) and for which the conformity assessment procedures referred to in Article 12 that require the mandatory involvement of a notified body have not been carried out 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 in accordance with procedures referred to in that authorisation.

2.   The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable requirements set out in the Annexes to Directive 2008/68/EC and in this Directive, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific transportable pressure equipment may be placed on the market. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 38a(2) of this Directive.

The transportable pressure equipment subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

3.   On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 38a(3).

4.   As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

5.   Manufacturers and importers of transportable pressure equipment subject to the authorisation procedure referred to in paragraph 1 of this Article shall declare on their 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 competent national authority.

6.   Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the transportable pressure equipment may be placed on the market. Such authorisations shall set out at least the following:

(a)

a description of the procedures by means of which the compliance with the applicable requirements set out in the Annexes to Directive 2008/68/EC and in this Directive was successfully demonstrated;

(b)

any specific requirements regarding the traceability of the transportable pressure equipment concerned;

(c)

an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 of Regulation (EU) 2024/2747;

(d)

any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the transportable pressure equipment concerned;

(e)

measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the transportable pressure equipment concerned that has been placed on the market.

7.   By way of derogation from Articles 14 and 16, transportable pressure equipment for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the Pi marking and Article 16 shall not apply.

8.   The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such transportable pressure equipment, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council  ( *8 ) and under this Directive. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.

9.   The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 18.

Article 33d

Prioritisation of market surveillance activities and mutual assistance among authorities

1.   Member States shall prioritise the market surveillance activities for transportable pressure equipment listed in the implementing act referred to in Article 33a(1) of this Directive. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

2.   The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, 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 the reinforcement of the testing capacity for transportable pressure equipment listed in the implementing act referred to in Article 33a(1).

( *8 )   Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 ( OJ L 169, 25.6.2019, p. 1 ).’;"

(3)

the following article is inserted:

‘Article 38a

Committee procedure

1.   The Commission shall be assisted by the committee on the transport of dangerous goods established by Article 9 of Directive 2008/68/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council  ( *9 ) .

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

3.   Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

( *9 )   Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers ( OJ L 55, 28.2.2011, p. 13 ).’."

Article 4 Amendments to Directive 2014/29/EU

Directive 2014/29/EU is amended as follows:

(1)

in Article 2, the following points are added:

‘(18)

“crisis-relevant goods” means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council  ( *10 ) ;

(19)

“internal market emergency mode” means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

( *10 )   Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) ( OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj ).’;"

(2)

the following chapter is inserted:

‘Chapter 5a

Emergency procedures

Article 38a

Application of emergency procedures

1.   Member States shall ensure that measures taken to transpose Articles 38b to 38e of this Directive apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to vessels covered by this Directive.

2.   Member States shall ensure that measures taken to transpose Articles 38b to 38e of this Directive apply only to vessels which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.

3.   Member States shall ensure that measures taken to transpose Articles 38b to 38e of this Directive apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.

However, Article 38c(7) of this Directive shall apply during the internal market emergency mode and after its expiry or deactivation.

4.   The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to vessels placed on the market in accordance with Articles 38c and 38d. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 39(3).

Article 38b

Prioritisation of the conformity assessment of vessels designated as crisis-relevant goods

1.   This Article applies to vessels listed in the implementing act referred to in Article 38a(1) that are subject to the conformity assessment procedures referred to in Article 13 that require the mandatory involvement of a notified body.

2.   The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of vessels referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 38a.

3.   The prioritisation of applications for a conformity assessment of vessels pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications.

4.   The notified bodies shall make reasonable efforts to increase their testing capacities for vessels referred to in paragraph 1 in respect of which they have been notified.

Article 38c

Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body

1.   By way of derogation from Article 13, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market within the territory of that Member State, of specific vessels listed in the implementing act referred to in Article 38a(1) and for which the conformity assessment procedures referred to in Article 13 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential safety requirements of this Directive has been demonstrated in accordance with procedures referred to in that authorisation.

2.   The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable essential safety requirements of this Directive, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific vessel may be placed on the market. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 39(3).

The vessel subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

3.   On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 39(4).

4.   As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

5.   Manufacturers of vessels subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the vessels concerned comply with all the applicable essential safety requirements of this Directive and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority.

6.   Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the vessel may be placed on the market. Such authorisations shall set out at least the following:

(a)

a description of the procedures, by means of which the compliance with the applicable essential safety requirements of this Directive was successfully demonstrated;

(b)

any specific requirements regarding the traceability of the vessel concerned;

(c)

an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 of Regulation (EU) 2024/2747;

(d)

any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the vessel concerned;

(e)

measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the vessel concerned that has been placed on the market.

7.   By way of derogation from Articles 5, 15 and 16, vessels for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and the inscriptions provided for in point 1 of Annex III and Article 5 shall not apply.

8.   The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid, shall be entitled, with respect to such vessels, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council  ( *11 ) and under this Directive. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.

9.   The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 13.

Article 38d

Presumption of conformity based on standards and common specifications

1.   Where vessels have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such vessels to cover the essential safety requirements of this Directive in either of the following cases:

(a)

where a reference to harmonised standards covering the essential safety requirements of 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 period; or

(b)

where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the essential safety requirements of this Directive and the references of which have already been 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 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts.

3.   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 shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article.

4.   Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Directive and shall duly consult all relevant stakeholders.

5.   Without prejudice to Article 12, vessels that are in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the essential safety requirements of this Directive that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article.

6.   By way of derogation from Article 38a(3), first subparagraph, unless there is sufficient reason to believe that the vessels covered by the standards or common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the vessels that are in conformity with those standards or common specifications and which have been placed on the market shall be deemed to be in conformity with the essential safety requirements of this Directive after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.

7.   When a Member State considers that a standard or common specification as referred to in paragraph 1 does not entirely satisfy the essential safety requirements of this Directive, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.

Article 38e

Prioritisation of market surveillance activities and mutual assistance among authorities

1.   Member States shall prioritise the market surveillance activities for vessels listed in the implementing act referred to in Article 38a(1) of this Directive. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

2.   The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, 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 the reinforcement of the testing capacity for vessels listed in the implementing act referred to in Article 38a(1).

( *11 )   Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 ( OJ L 169, 25.6.2019, p. 1 ).’."

Article 5 Amendments to Directive 2014/30/EU

Directive 2014/30/EU is amended as follows:

(1)

in Article 3(1), the following points are added:

‘(26)

“crisis-relevant goods” means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council  ( *12 ) ;

(27)

“internal market emergency mode” means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

( *12 )   Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) ( OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj ).’;"

(2)

the following chapter is inserted:

‘Chapter 5a

Emergency procedures

Article 40a

Application of emergency procedures

1.   Member States shall ensure that measures taken to transpose Articles 40b and 40c of this Directive apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to apparatus covered by this Directive.

2.   Member States shall ensure that measures taken to transpose Articles 40b and 40c of this Directive apply only to apparatus which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.

3.   Member States shall ensure that measures taken to transpose Articles 40b and 40c of this Directive apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.

4.   The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to apparatus placed on the market in accordance with Article 40b. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 41(2a).

Article 40b

Presumption of conformity based on standards and common specifications

1.   Where apparatus has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such apparatus to cover the essential requirements set out in Annex I to this Directive in the following cases:

(a)

where a reference to harmonised standards covering the essential 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 period; or

(b)

where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the essential requirements set out in Annex I to this Directive and the references of which have already been 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 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European or relevant applicable national or international standard, common specifications may be established by those implementing acts.

3.   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) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article.

4.   Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Directive and shall duly consult all relevant stakeholders.

5.   Without prejudice to Article 13, apparatus that are in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the essential requirements set out in Annex I that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article.

6.   By way of derogation from Article 40a(3), unless there is sufficient reason to believe that the apparatus covered by the standards or common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the apparatus that are in conformity with those standards or common specifications and which have been placed on the market shall be deemed to be in conformity with the essential requirements set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.

7.   When a Member State considers that a standard or common specification referred to in paragraph 1 does not entirely satisfy the essential requirements set out in Annex I, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.

Article 40c

Prioritisation of market surveillance activities and mutual assistance among authorities

1.   Member States shall prioritise the market surveillance activities for apparatus listed in the implementing act referred to in Article 40a(1) of this Directive. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020 of the European Parliament and of the Council  ( *13 ) .

2.   The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, 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 the reinforcement of the testing capacity for apparatus listed in the implementing act referred to in Article 40a(1).

( *13 )   Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 ( OJ L 169, 25.6.2019, p. 1 ).’;"

(3)

in Article 41, the following paragraph is inserted:

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

Article 6 Amendments to Directive 2014/33/EU

Directive 2014/33/EU is amended as follows:

(1)

in Article 2, the following points are added:

‘(22)

“crisis-relevant goods” means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council  ( *14 ) ;

(23)

“internal market emergency mode” means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

( *14 )   Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) ( OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj ).’;"

(2)

the following chapter is inserted:

‘Chapter Va

Emergency procedures

Article 41a

Application of emergency procedures

1.   Member States shall ensure that measures taken to transpose Articles 41b to 41e of this Directive apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to lifts and safety components for lifts covered by this Directive.

2.   Member States shall ensure that measures taken to transpose Articles 41b to 41e of this Directive apply only to lifts and safety components for lifts which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.

3.   Member States shall ensure that measures taken to transpose Articles 41b to 41e of this Directive apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.

However, Article 41c(8) of this Directive shall apply during the internal market emergency mode and after its expiry or deactivation.

4.   The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to lifts and safety components for lifts placed on the market in accordance with Articles 41c and 41d. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 42(3).

Article 41b

Prioritisation of the conformity assessment of lifts and safety components for lifts designated as crisis-relevant goods

1.   This Article applies to all lifts and safety components for lifts listed in the implementing act referred to in Article 41a(1) that are subject to the conformity assessment procedures referred to in Articles 15 and 16 that require the mandatory involvement of a notified body.

2.   The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of lifts and safety components for lifts referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 41a.

3.   The prioritisation of applications for a conformity assessment of lifts and safety components for lifts pursuant to paragraph 2 shall not result in additional disproportionate costs for the installers and manufacturers who have lodged those applications.

4.   The notified bodies shall make reasonable efforts to increase their testing capacities for lifts and safety components for lifts referred to in paragraph 1 in respect of which they have been notified.

Article 41c

Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body

1.   By way of derogation from Article 15, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market within the territory of that Member State, of a specific safety component for lifts listed in the implementing act referred to in Article 41a(1) and for which the conformity assessment procedures referred to in Article 15 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential health and safety requirements laid down in this Directive has been demonstrated in accordance with procedures referred to in that authorisation.

2.   By way of derogation from Article 16, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market within the territory of that Member State, of a specific lift listed in the implementing act referred to in Article 41a(1) and for which the conformity assessment procedures referred to in Article 16 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential health and safety requirements laid down in this Directive has been demonstrated in accordance with procedures referred to in that authorisation.

3.   The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 or 2 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable essential health and safety requirements set out in Annex I, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 or 2 of this Article to the territory of the whole Union and shall set out the conditions under which the specific lift or safety component for lifts may be placed on the market. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1 or 2 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 42(3).

The lifts or the safety components for lifts subject to the extension of validity referred to in the first subparagraph shall bear the information that they are placed on the market as “crisis-relevant goods”. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

4.   On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 42(4).

5.   As long as an implementing act as referred to in paragraph 3 or 4 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

6.   Installers of lifts or manufacturers of safety components for lifts subject to the authorisation procedure referred to in paragraph 1 or 2 shall declare on their sole responsibility that the lifts or safety components for lifts concerned comply 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 competent national authority.

7.   Any authorisation issued pursuant to paragraph 1 or 2 shall set out the conditions and requirements under which the lift or safety component for lifts may be placed on the market. Such authorisations shall set out at least the following:

(a)

a description of the procedures, by means of which the compliance with the applicable essential health and safety requirements set out in Annex I to this Directive was successfully demonstrated;

(b)

any specific requirements regarding the traceability of the lift or safety component for lifts concerned;

(c)

an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 of Regulation (EU) 2024/2747;

(d)

any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the lifts or safety components for lifts concerned;

(e)

measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the lifts or safety components for lifts concerned that have been placed on the market.

8.   By way of derogation from Articles 3, 18 and 19, lifts or safety components for lifts for which an authorisation has been granted in accordance with paragraph 1 or 2 of this Article shall not bear the CE marking and Article 3 shall not apply.

9.   The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2, 3 and 5 of this Article is valid shall be entitled, with respect to such lifts or safety components for lifts, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council  ( *15 ) and under this Directive. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.

10.   The use of the authorisation procedure set out in paragraphs 1 to 5 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Articles 15 and 16.

Article 41d

Presumption of conformity based on standards and common specifications

1.   Where lifts and safety components for lifts have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such lifts and safety components for lifts to cover the applicable essential health and safety requirements set out in Annex I to this Directive in the following cases:

(a)

where a reference to harmonised standards covering the applicable essential health and 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 period; or

(b)

where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of installers or manufacturers to make use of the harmonised standards that cover the applicable essential health and safety requirements set out in Annex I to this Directive and the references of which have already been 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 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts.

3.   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) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article.

4.   Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Directive and shall duly consult all relevant stakeholders.

5.   Without prejudice to Article 14, lifts and safety components for lifts that are in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the applicable essential health and safety requirements set out in Annex I that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for installers and manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article.

6.   By way of derogation from Article 41a(3), first subparagraph, unless there is sufficient reason to believe that the lifts and safety components for lifts covered by the standards or 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 that are in conformity with those standards or common specifications and which have been placed on the market shall be deemed to be in conformity with the applicable essential health and safety requirements set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.

7.   When a Member State considers that a standard or common specification referred to in paragraph 1 does not entirely satisfy the applicable essential health and safety requirements set out in Annex I, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.

Article 41e

Prioritisation of market surveillance activities and mutual assistance among authorities

1.   Member States shall prioritise the market surveillance activities for lifts and safety components for lifts listed in the implementing act referred to in Article 41a(1) of this Directive. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

2.   The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, 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 the reinforcement of the testing capacity for lifts and safety components for lifts listed in the implementing act referred to in Article 41a(1).

( *15 )   Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 ( OJ L 169, 25.6.2019, p. 1 ).’."

Article 7 Amendments to Directive 2014/34/EU

Directive 2014/34/EU is amended as follows:

(1)

in Article 2, the following points are added:

‘(27)

“crisis-relevant goods” means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council  ( *16 ) ;

(28)

“internal market emergency mode” means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

( *16 )   Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) ( OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj ).’;"

(2)

the following chapter is inserted:

‘Chapter 5a

Emergency procedures

Article 38a

Application of emergency procedures

1.   Member States shall ensure that measures taken to transpose Articles 38b to 38e of this Directive apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to products covered by this Directive.

2.   Member States shall ensure that measures taken to transpose Articles 38b to 38e of this Directive apply only to products which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.

3.   Member States shall ensure that measures taken to transpose Articles 38b to 38e of this Directive apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.

However, Article 38c(7) of this Directive shall apply during the internal market emergency mode and after its expiry or deactivation.

4.   The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to products placed on the market or used for the manufacturer’s own purposes in accordance with Articles 38c and 38d. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 39(3).

Article 38b

Prioritisation of the conformity assessment of products designated as crisis-relevant goods

1.   This Article applies to all products listed in the implementing act referred to in Article 38a(1) that are subject to the conformity assessment procedures referred to in Article 13 that require mandatory involvement of a notified body.

2.   The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of products referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 38a.

3.   The prioritisation of applications for a conformity assessment of products pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications.

4.   The notified bodies shall make reasonable efforts to increase their testing capacities for products referred to in paragraph 1 in respect of which they have been notified.

Article 38c

Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body

1.   By way of derogation from Article 13, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market or use for the manufacturer’s own purposes within the territory of that Member State, of a specific product which has been listed in the implementing act referred to in Article 38a(1) and for which the conformity assessment procedures referred to in Article 13 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential health and safety requirements set out in Annex II has been demonstrated in accordance with procedures referred to in that authorisation.

2.   The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable essential health and safety requirements set out in Annex II, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific product may be placed on the market or used for the manufacturer’s own purposes. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 39(3).

The product subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market or used for the manufacturer’s own purposes as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

3.   On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 39(4).

4.   As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

5.   Manufacturers of products subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the product concerned complies with all the applicable essential health and safety requirements set out in Annex II and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority.

6.   Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the product may be placed on the market or used for the manufacturer’s own purposes. Such authorisations shall set out at least the following:

(a)

a description of the procedures by means of which compliance with the applicable essential health and safety requirements set out in Annex II to this Directive was successfully demonstrated;

(b)

any specific requirements regarding the traceability of the product concerned;

(c)

an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 of Regulation (EU) 2024/2747;

(d)

any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the product concerned;

(e)

measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the products concerned that have been placed on the market or used for the manufacturer’s own purposes.

7.   By way of derogation from Articles 5, 15 and 16, products for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 5 shall not apply.

8.   The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such products, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council  ( *17 ) and under this Directive. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.

9.   The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 13.

Article 38d

Presumption of conformity based on standards and common specifications

1.   Where products have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such products to cover the applicable essential health and safety requirements set out in Annex II to this Directive in the following cases:

(a)

where a reference to harmonised standards covering the applicable essential health and 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 period; or

(b)

where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the applicable essential health and safety requirements set out in Annex II to this Directive and the references of which have already been 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 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts.

3.   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 shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article.

4.   Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Directive and shall duly consult all relevant stakeholders.

5.   Without prejudice to Article 17, products that are in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the applicable essential health and safety requirements set out in Annex II that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article.

6.   By way of derogation from Article 38a(3), first subparagraph, unless there is sufficient reason to believe that the products covered by the standards or common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the products that are in conformity with those standards or common specifications and which have been placed on the market shall be deemed to be in conformity with the applicable essential health and safety requirements set out in Annex II after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.

7.   When a Member State considers that a standard or common specification as referred to in paragraph 1 does not entirely satisfy the applicable essential health and safety requirements set out in Annex II, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.

Article 38e

Prioritisation of market surveillance activities and mutual assistance among authorities

1.   Member States shall prioritise the market surveillance activities for products listed in the implementing act referred to in Article 38a(1) of this Directive. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

2.   The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, 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 the reinforcement of the testing capacity for products listed in the implementing act referred to in Article 38a(1).

( *17 )   Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 ( OJ L 169, 25.6.2019, p. 1 ).’."

Article 8 Amendments to Directive 2014/35/EU

Directive 2014/35/EU is amended as follows:

(1)

in Article 2, the following points are added:

‘(15)

“crisis-relevant goods” means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council  ( *18 ) ;

(16)

“internal market emergency mode” means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

( *18 )   Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) ( OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj ).’;"

(2)

the following chapter is inserted:

‘Chapter 4a

Emergency procedures

Article 22a

Application of emergency procedures

1.   Member States shall ensure that measures taken to transpose Articles 22b and 22c of this Directive apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to electrical equipment covered by this Directive.

2.   Member States shall ensure that measures taken to transpose Articles 22b and 22c of this Directive apply only to electrical equipment which has been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.

3.   Member States shall ensure that measures taken to transpose Articles 22b and 22c of this Directive apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.

4.   The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to electrical equipment placed on the market in accordance with Article 22c. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2).

Article 22b

Presumption of conformity based on standards and common specifications

1.   Where electrical equipment has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such electrical equipment to cover the safety objectives referred to in Article 3 of this Directive and set out in Annex I to this Directive in the following cases:

(a)

where a reference to harmonised standards covering the safety objectives referred to in Article 3 of this Directive and 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 period; or

(b)

where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the safety objectives referred to in Article 3 of this Directive and set out in Annex I to this Directive and the references of which have already been 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 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts.

3.   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) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article.

4.   Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Directive and shall duly consult all relevant stakeholders.

5.   Without prejudice to Articles 12, 13 and 14, electrical equipment that is in conformity with the standards or common specifications referred to in paragraph 1 this Article, or parts thereof, shall be presumed to be in conformity with the safety objectives referred to in Article 3 and set out in Annex I that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article.

6.   By way of derogation from Article 22a(3), unless there is sufficient reason to believe that electrical equipment covered by the standards or common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the electrical equipment that is in conformity with those standards or common specifications and which has been placed on the market shall be deemed to be in conformity with the safety objectives referred to in Article 3 and set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.

7.   When a Member State considers that a standard or 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 by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.

Article 22c

Prioritisation of market surveillance activities and mutual assistance among authorities

1.   Member States shall prioritise the market surveillance activities for electrical equipment listed in the implementing act referred to in Article 22a(1) of this Directive. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020 of the European Parliament and of the Council  ( *19 ) .

2.   The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, 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 the reinforcement of the testing capacity for electrical equipment listed in the implementing act referred to in Article 22a(1).

( *19 )   Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 ( OJ L 169, 25.6.2019, p. 1 ).’."

Article 9 Amendments to Directive 2014/53/EU

Directive 2014/53/EU is amended as follows:

(1)

in Article 2(1), the following points are added:

‘(27)

“crisis-relevant goods” means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747. of the European Parliament and of the Council  ( *20 ) ;

(28)

“internal market emergency mode” means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

( *20 )   Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) ( OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj ).’;"

(2)

the following chapter is inserted:

‘Chapter Va

Emergency procedures

Article 43a

Application of emergency procedures

1.   Member States shall ensure that measures taken to transpose Articles 43b to 43e of this Directive apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to radio equipment covered by this Directive.

2.   Member States shall ensure that measures taken to transpose Articles 43b to 43e of this Directive apply only to radio equipment which has been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.

3.   Member States shall ensure that measures taken to transpose Articles 43b to 43e of this Directive apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.

However, Article 43c(7) of this Directive shall apply during the internal market emergency mode and after its expiry or deactivation.

4.   The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to radio equipment placed on the market in accordance with Articles 43c and 43d. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).

Article 43b

Prioritisation of the conformity assessment of radio equipment designated as crisis-relevant goods

1.   This Article applies to radio equipment listed in the implementing act referred to in Article 43a(1) that is subject to the conformity assessment procedures referred to in Article 17 that require the mandatory involvement of a notified body.

2.   The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of radio equipment referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 43a.

3.   The prioritisation of applications for a conformity assessment of radio equipment pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications.

4.   The notified bodies shall make reasonable efforts to increase their testing capacities for radio equipment referred to in paragraph 1 in respect of which they have been notified.

Article 43c

Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body

1.   By way of derogation from Article 17, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market within the territory of that Member State, of specific radio equipment listed in the implementing act referred to in Article 43a(1) and for which the conformity assessment procedures referred to in Article 17 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the relevant essential requirements set out in Article 3 has been demonstrated in accordance with procedures referred to in that authorisation.

2.   The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the relevant essential requirements set out in Article 3, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific radio equipment may be placed on the market. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 45(3).

The radio equipment subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

3.   On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 45(4).

4.   As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

5.   Manufacturers of radio equipment subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the radio equipment concerned complies with all the relevant essential requirements set out in Article 3 and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority.

6.   Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the radio equipment may be placed on the market. Such authorisations shall set out at least the following:

(a)

a description of the procedures, by means of which compliance with the relevant essential requirements set out in Article 3 of this Directive was successfully demonstrated;

(b)

any specific requirements regarding the traceability of the radio equipment concerned;

(c)

an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 Regulation (EU) 2024/2747;

(d)

any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the radio equipment concerned;

(e)

measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the radio equipment concerned that has been placed on the market.

7.   By way of derogation from Articles 9, 19 and 20, radio equipment for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 9 shall not apply.

8.   The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such radio equipment, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council  ( *21 ) and under this Directive. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.

9.   The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 17.

Article 43d

Presumption of conformity based on standards and common specifications

1.   Where radio equipment has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such radio equipment to cover the relevant essential requirements set out in Article 3 of this Directive in the following cases:

(a)

where a reference to harmonised standards covering the relevant essential requirements set out in Article 3 of 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 period; or

(b)

where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the relevant essential requirements set out in Article 3 of this Directive and the references of which have already been 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 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts.

3.   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) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article.

4.   Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Directive and shall duly consult all relevant stakeholders.

5.   Without prejudice to Article 16, radio equipment that is in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the relevant essential requirements set out in Article 3 that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article.

6.   By way of derogation from Article 43a(3), first subparagraph, unless there is sufficient reason to believe that the radio equipment covered by the standards or common specifications referred to in paragraph 1 of this Article presents a risk to the health or safety of persons, the radio equipment that is in conformity with those standards or common specifications and which has been placed on the market shall be deemed to be in conformity with the relevant essential requirements set out in Article 3 after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.

7.   When a Member State considers that a standard or common specification as referred to in paragraph 1 of this Article does not entirely satisfy the relevant essential requirements set out in Article 3, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.

Article 43e

Prioritisation of market surveillance activities and mutual assistance among authorities

1.   Member States shall prioritise the market surveillance activities for radio equipment listed in the implementing act referred to in Article 43a(1) of this Directive. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

2.   The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, 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 the reinforcement of the testing capacity for radio equipment listed in the implementing act referred to in Article 43a(1).

( *21 )   Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 ( OJ L 169, 25.6.2019, p. 1 ).’."

Article 10 Amendments to Directive 2014/68/EU

Directive 2014/68/EU is amended as follows:

(1)

in Article 2, the following points are added:

‘(33)

“crisis-relevant goods” means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the Council  ( *22 ) ;

(34)

“internal market emergency mode” means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

( *22 )   Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) ( OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj ).’;"

(2)

the following chapter is inserted:

‘Chapter 5a

Emergency procedures

Article 43a

Application of emergency procedures

1.   Member States shall ensure that measures taken to transpose Articles 43b to 43e of this Directive apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to pressure equipment and assemblies covered by this Directive.

2.   Member States shall ensure that measures taken to transpose Articles 43b to 43e of this Directive apply only to pressure equipment and assemblies which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.

3.   Member States shall ensure that measures taken to transpose Articles 43b to 43e of this Directive apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.

However, Article 43c(7) of this Directive shall apply during the internal market emergency mode and after its expiry or deactivation.

4.   The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to pressure equipment and assemblies placed on the market or used for the manufacturer’s own purposes in accordance with Articles 43c and 43d. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 44(3).

Article 43b

Prioritisation of the conformity assessment of pressure equipment and assemblies designated as crisis-relevant goods

1.   This Article applies to pressure equipment or assemblies listed in the implementing act referred to in Article 43a(1) that are subject to the conformity assessment procedures referred to in Article 14 that require the mandatory involvement of a notified body.

2.   The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of pressure equipment and assemblies referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 43a.

3.   The prioritisation of applications for conformity assessment of pressure equipment and assemblies pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications.

4.   The notified bodies shall make reasonable efforts to increase their testing capacities for pressure equipment and assemblies referred to in paragraph 1 in respect of which they have been notified.

Article 43c

Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body

1.   By way of derogation from Article 14, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market or use for the manufacturer’s own purposes within the territory of that Member State, of specific pressure equipment or assembly listed in the implementing act referred to in Article 43a(1) and for which the conformity assessment procedures referred to in Article 14 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential safety requirements set out in Annex I has been demonstrated in accordance with procedures referred to in that authorisation.

2.   The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable essential safety requirements set out in Annex I, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific pressure equipment or assemblies may be placed on the market or used for the manufacturer’s own purposes. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 44(3).

The pressure equipment or assemblies subject to the extension of validity referred to in the first subparagraph shall bear the information that they are placed on the market or used for the manufacturer’s own purposes as a “crisis-relevant good”. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

3.   On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 44(4).

4.   As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

5.   Manufacturers of pressure equipment or assemblies subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the pressure equipment or assembly concerned complies with all the applicable essential safety requirements set out in Annex I and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority.

6.   Any authorisation issued 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 used for the manufacturer’s own purposes. Such authorisations shall set out at least the following:

(a)

a description of the procedures by means of which compliance with the applicable essential safety requirements set out in Annex I to this Directive was successfully demonstrated;

(b)

any specific requirements regarding the traceability of the pressure equipment or assembly concerned;

(c)

an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 of Regulation (EU) 2024/2747;

(d)

any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the pressure equipment or assembly concerned;

(e)

measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the pressure equipment or assembly concerned that has been placed on the market or used for the manufacturer’s own purposes.

7.   By way of derogation from Articles 5, 18 and 19, pressure equipment or assemblies for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 5 shall not apply.

8.   The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such pressure equipment or assemblies, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council  ( *23 ) and under this Directive. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.

9.   The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 14.

Article 43d

Presumption of conformity based on standards and common specifications

1.   Where pressure equipment and assemblies have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such pressure equipment and assemblies to cover the applicable essential safety requirements set out in Annex I to this Directive in the following cases:

(a)

where a reference to harmonised standards covering the applicable 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 period; or

(b)

where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the applicable essential safety requirements set out in Annex I to this Directive and the references of which have already been 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 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts.

3.   The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 44(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article.

4.   Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Directive and shall duly consult all relevant stakeholders.

5.   Without prejudice to Article 12, pressure equipment or assemblies that are in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the applicable essential safety requirements set out in Annex I that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article.

6.   By way of derogation from Article 43a(3), first subparagraph, unless there is sufficient reason to believe that the pressure equipment and assemblies covered by the standards or 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 that are in conformity with those standards or common specifications and which have been placed on the market or used for the manufacturer’s own purposes shall be deemed to be in conformity with the applicable essential safety requirements set out in Annex I after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.

7.   When a Member State considers that a standard or common specification as referred to in paragraph 1 does not entirely satisfy the applicable essential safety requirements set out in Annex I, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.

Article 43e

Prioritisation of market surveillance activities and mutual assistance among authorities

1.   Member States shall prioritise the market surveillance activities for pressure equipment and assemblies listed in the implementing act referred to in Article 43a(1) of this Directive. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

2.   The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, 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 the reinforcement of the testing capacity for pressure equipment and assemblies listed in the implementing act referred to in Article 43a(1).

( *23 )   Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 ( OJ L 169, 25.6.2019, p. 1 ).’."

Article 11 Transposition

1.   By 29 May 2026 Member States shall adopt and publish the measures necessary to comply with this Directive. They shall immediately inform the Commission thereof.

2.   They shall apply those measures from 30 May 2026.

When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

3.   As soon as this Directive has entered into force, Member States shall ensure that the Commission is informed, in sufficient time for it to submit its comments, of any draft laws, regulations or administrative provisions which they intend to adopt in the field covered by this Directive.

Article 12 Entry into force

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

Article 13 Addressees

This Directive is addressed to the Member States.