Regulation (EU) 2016/426

In force

This text since 29 May 2026law://eu/reg/2016/426/art_40c@2026-11-14

Contents

Article 40cDerogation 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 a specific appliance or fitting listed in the implementing act referred to in Article 40a(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 requirements laid down 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 requirements laid down 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 appliance or fitting 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 42(3).The appliance or fitting 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 42(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 appliances or fittings subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the appliance or the fitting concerned complies with all the applicable essential requirements set out in Annex I and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority.

6.Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the appliance or fitting 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 requirements set out in Annex I to this Regulation was successfully demonstrated;

(b)any specific requirements regarding the traceability of the appliance or fitting 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 appliance or fitting concerned;

(e)measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the appliance or fitting concerned that has been placed on the market or used for the manufacturer’s own purposes.

7.By way of derogation from Articles 6, 16 and 17, appliances or fittings 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 appliances or fittings, 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^note and under this Regulation. 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.

Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.

Key facts

Type: Regulation · (EU) 2016/426 · EEA relevant
Adopted: 9 Mar 2016
In force: 20 Apr 2016
Applies from: 21 Oct 2016
Applies from: 21 Mar 2018
Applies from: 21 Apr 2018
Text current to: 29 May 2026
Made by: Council of the European Union, European Parliament
Official: EUR-Lex 32016R0426 · ELI

Topics

EC conformity marking European standard gas appliance harmonisation of standards market approval marketing standard market supervision safety standard technical standard Gas appliances Internal market - Principles Technical barriers

History · 1 version

29 May 2026Reading
changed by Regulation (EU) 2024/2748

Connections

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Cited by 9: Regulation (EU) 2019/10202 provisions; Regulation (EU) 2024/1689 (Artificial Intelligence Act)2 provisions; Commission Implementing Decision (EU) 2026/17506 provisions; this act2 provisions; Commission Implementing Decision (EU) 2024/2944; Commission Implementing Decision (EU) 2025/17934 provisions; Regulation (EU) 2024/2748; Directive (EU) 2020/2184; Commission Implementing Decision (EU) 2019/1729

Defined terms · 32

Show every defined term

accreditation
means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
appliance category
means the identification of gas families and/or gas groups that an appliance is designed to burn safely and at the desired performance level, as indicated by the appliance category marking;
appliances
means appliances burning gaseous fuels used for cooking, refrigeration, air-conditioning, space heating, hot water production, lighting or washing, and also forced draught burners and heating bodies to be equipped with such burners;
authorised representative
means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
burning
means a process in which gaseous fuel reacts with oxygen producing heat or light;
conformity assessment
means the process demonstrating whether the essential requirements of this Regulation relating to an appliance or a fitting have been fulfilled;
conformity assessment body
means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
cooking
means the art or practice of preparing or warming food for consumption with the use of heat and employing a wide range of methods;
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;
distributor
means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an appliance or a fitting available on the market;
economic operators
means the manufacturer, the authorised representative, the importer and the distributor;
energy efficiency
means the ratio of output of performance of an appliance to input of energy;
fittings
means safety devices, controlling devices or regulating devices and sub-assemblies thereof, designed to be incorporated into an appliance or to be assembled to constitute an appliance;
gas family
means a group of gaseous fuels with similar burning behaviour linked together by a range of Wobbe indices;
gas group
means a specified range of Wobbe indices within that of the gas family concerned;
gaseous fuel
means any fuel which is in a gaseous state at a temperature of 15 °C under an absolute pressure of 1 bar;
harmonised standard
means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;
importer
means any natural or legal person established within the Union who places an appliance or a fitting from a third country on the Union market;
industrial premises
means any place where the main activity carried out is an industrial process that would be subject to specific national health and safety regulations;
industrial process
means the extraction, growth, refining, processing, production, manufacture or preparation of materials, plants, livestock, animal products, food or other products with a view to their commercial use;
internal market emergency mode
means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.
making available on the market
means any supply of an appliance or a fitting for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
manufacturer
means any natural or legal person who manufactures an appliance or a fitting or who has an appliance or a fitting designed or manufactured, and markets that appliance or fitting under his name or trademark or uses the appliance for his own purposes;
national accreditation body
means a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
placing on the market
means the first making available of an appliance or a fitting on the Union market;
putting into service
means the first use of an appliance in the Union by its end-user;
recall
means any measure aimed at achieving the return of an appliance that has already been made available to the end-user or of a fitting that has already been made available to an appliance manufacturer;
technical specification
means a document that prescribes technical requirements to be fulfilled by an appliance or a fitting;
Union harmonisation legislation
means any Union legislation harmonising the conditions for the marketing of products;
washing
means the entire washing process, including drying and ironing;
withdrawal
means any measure aimed at preventing an appliance or a fitting in the supply chain from being made available on the market;
Wobbe index
means an indicator of the interchangeability of fuel gases used to compare the combustion energy output of different composition fuel gases in an appliance;