Amendments to Directive 2014/34/EU
Article 7
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 ).’."