Legal provisions of COM(2022)144 - Harmonised conditions for the marketing of construction products - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
dossier | COM(2022)144 - Harmonised conditions for the marketing of construction products. |
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document | COM(2022)144 ![]() |
date | November 27, 2024 |
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter and objectives
1. This Regulation lays down harmonised rules for the placing and making available on the market of construction products, regardless of whether undertaken in the framework of a service or not, by establishing:
(a) | harmonised rules on how to express the environmental and safety performance of construction products in relation to their essential characteristics, including on life cycle assessment; |
(b) | environmental, functional and safety product requirements for construction products. |
2. This Regulation also establishes:
(a) | rights and obligations for economic operators dealing with construction products or their components; and |
(b) | obligations for other actors providing services linked to the manufacturing and commercialisation of products covered by this Regulation. |
3. This Regulation aims to contribute to the efficient functioning of the internal market by ensuring the free movement of safe and sustainable construction products in the Union. It also aims to contribute to the objectives of a green and digital transition by preventing and reducing the impact that construction products have on the environment and on the health and safety of persons.
Article 2
Scope
1. This Regulation applies to construction products, including used products, and to the following items:
(a) | key parts of products; and |
(b) | parts or materials intended to be used for products covered by this Regulation, if the manufacturer of those parts or materials so requests. |
2. This Regulation does not apply to:
(a) | lifts subject to Directive 2014/33/EU of the European Parliament and of the Council (21), escalators or their components; |
(b) | requirements or performance assessment subject to Directive (EU) 2020/2184 of the European Parliament and of the Council (22) and covered by the delegated acts of the Commission referred to in Article 11(8) of that Directive. |
3. Member States may exempt from the application of this Regulation products falling within its scope that are placed on the market in the outermost regions of the Union within the meaning of Article 349 TFEU. Member States shall notify to the Commission and to the other Member States the national laws, regulations and administrative provisions providing such exemptions. They shall ensure that exempted products do not bear the CE marking referred to in Article 17. Products placed on the market on the basis of that exemption shall not be deemed to have been placed on the market in the Union within the meaning of this Regulation.
Article 3
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(1) | ‘construction product’ means any formed or formless physical item, including 3D-printed products, or a kit that is placed on the market, including by means of supply to the construction site, for incorporation in a permanent manner into construction works or parts thereof with the exception of items that need first to be integrated into a kit or another construction product prior to being incorporated in a permanent manner into construction works; |
(2) | ‘product’ means a construction product or other item falling within the scope of this Regulation as set out in Article 2; |
(3) | ‘permanent’ means intended to remain in the construction work, or in parts thereof, after the completion of the construction or renovation process; |
(4) | ‘making available on the market’ means any supply of a product for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge, regardless whether in the framework of providing a service or not; |
(5) | ‘placing on the market’ means the first making available of a product on the Union market, or the first making available on the Union market of a used product after a deinstallation of such a product; |
(6) | ‘performance’ means the degree to which a product has certain scalable essential characteristics; |
(7) | ‘essential characteristics’ means those characteristics of the product which relate to the basic requirements for construction works set out in Annex I, and those which are listed as predetermined environmental essential characteristics in Annex II; |
(8) | ‘product requirement’ means a characteristic, as set out in Annex III, which a product must have before it can be placed on the market; |
(9) | ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to this Regulation in relation to the manufacturing or remanufacturing of products, including products to be reused, or to making those products available on the market, in accordance with this Regulation; |
(10) | ‘manufacturer’ means a ‘manufacturer’ as defined in Article 3, point (8), of Regulation (EU) 2019/1020; |
(11) | ‘3D-dataset’ means a set of numerical data describing the shape of an object by its outer dimensions and its cavities; |
(12) | ‘construction works’ means buildings and civil engineering works whether over or in the ground or water, including but not limited to roads, bridges, tunnels, pylons and other facilities for transport of electricity, communication cables, pipelines, aqueducts, dams, airports, ports, waterways, and installations which are the bases for the rails of railways; |
(13) | ‘level’ means the result of the assessment of the performance of a product in relation to its essential characteristics, expressed as a numerical value; |
(14) | ‘class’ means a range of levels, delimited by a minimum and a maximum value, of performance of a product; |
(15) | ‘threshold level’ means a minimum or maximum performance level of a product with regard to a certain essential characteristic; |
(16) | ‘key part’ means a part which is used as a component or spare part for a product and which has been specified by a harmonised technical specification as essential for the characterisation, safety or performance of a product; |
(17) | ‘kit’ means a product placed on the market by a single economic operator as a set of at least two separate items, none of which needs to be a product itself, intended to be incorporated together into construction works; |
(18) | ‘European assessment document’ or ‘EAD’ means a document adopted by the organisation of technical assessment bodies for the purposes of issuing European technical assessments; |
(19) | ‘European technical assessment’ or ‘ETA’ means the documented assessment of the performance of a product, in relation to its essential characteristics, in accordance with the respective European assessment document; |
(20) | ‘used product’ means a product that is not waste or has ceased to be waste in accordance with Directive 2008/98/EC, and which has been installed at least once into a construction work, and that:
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(21) | ‘intended use’ means the purpose of a product as set out in the applicable harmonised technical specifications or European assessment documents; |
(22) | ‘declared use’ means the use intended by the manufacturer, including the conditions for usage, as set out in technical documentation, on labels, in general product information, in instructions for use, in safety information, or in publicity material; |
(23) | ‘repair’ means the process of fixing a faulty product or replacing its defective components, in order to return the product to a condition where it can fulfil its declared use; |
(24) | ‘maintenance’ means an action carried out to keep a product in a condition where it is able to function as specified; |
(25) | ‘remanufactured product’ means a product that is not waste, or has ceased to be waste in accordance with Directive 2008/98/EC, which has been installed at least once into a construction work, and that has been subject to a transformative process going beyond checking, cleaning and repairing recovery operations which, according to the applicable harmonised technical specification, are qualified as essential to the product’s performance; |
(26) | ‘risk’ means ‘risk’ as defined in Article 3, point (18), of Regulation (EU) 2019/1020; |
(27) | ‘product type’ means the abstract model of individual products, determined by the intended use and a set of characteristics which exclude any variation with regard to performance or to the fulfilment of product requirements set out in or in accordance with this Regulation, whilst identical products of different manufacturers belong to different product types; |
(28) | ‘state of the art’ means a way of achieving a certain goal which is either the most effective and advanced or close to it, or a way which is currently possible by applying common technologies, whether or not it is the most technologically advanced solution; |
(29) | ‘recycling’ means ‘recycling’ as defined in Article 3, point (17), of Directive 2008/98/EC; |
(30) | ‘fulfilment service provider’ means a ‘fulfilment service provider’ as defined in Article 3, point (11), of Regulation (EU) 2019/1020; |
(31) | ‘product family’ means all product types belonging to one of the families listed in Annex VII; |
(32) | ‘product category’ means a subset of the product types of a certain product family encompassing those product types which have in common a certain intended use as specified in harmonised technical specifications or European assessment documents; |
(33) | ‘factory production control’ means the documented, continuous and internal production control in a manufacturing plant with regard to certain parameters or quality aspects, reflecting the specificities of a respective product family or product category and manufacturing processes, and which aims at the constancy of performance or at the continuous fulfilment of product requirements, executed in accordance with Annex IX; |
(34) | ‘importer’ means an ‘importer’ as defined in Article 3, point (9), of Regulation (EU) 2019/1020; |
(35) | ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market, including by offering products for sale, hire or hire purchase, or displaying products to customers or installers in the course of a commercial activity, and including through distance selling, whether or not in return for payment; |
(36) | ‘authorised representative’ means any natural or legal person established in the Union who has received a written mandate from a manufacturer to act on that manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation; |
(37) | ‘individually manufactured’ means that, due to the specifications of the client, there is a need for readjustment of the production process for manufacture when compared with all other products produced for other clients by the economic operator in question; |
(38) | ‘micro-enterprise’ means a ‘micro-enterprise’ as defined in Article 2(3) of the Annex to Commission Recommendation 2003/361/EC (23); |
(39) | ‘custom-made’ means that, due to the specifications of the client, there is a variation in terms of size or material when compared with all other products produced for other clients by the economic operator in question; |
(40) | ‘permalink’ means an internet link to a website which is stable both for its content and the address (‘URL’); |
(41) | ‘data carrier’ means a linear bar code symbol, a two-dimensional symbol, or other automatic identification data capture medium that can be read by a device; |
(42) | ‘harmonised technical specifications’ means the performance harmonised standards which have been made mandatory for the purposes of the application of this Regulation in accordance with Article 5(8), the implementing acts referred to in Article 6(1) and the delegated acts referred to in Article 7(1), Article 9(3) and Article 10(2); |
(43) | ‘European standardisation organisation’ means a ‘European standardisation organisation’ as defined in Article 2, point (8) of Regulation (EU) No 1025/2012; |
(44) | ‘non-series process’ means a process that is neither predominantly automated or predominantly carried out using assembly-line techniques, nor repeated very often in relation to the volume of production by the economic operator concerned or the economic operators belonging to the same group of companies, determined by a common controlling natural or legal person, or the same organisational structure; |
(45) | ‘withdrawal’ means ‘withdrawal’ as defined in Article 3, point (23), of Regulation (EU) 2019/1020; |
(46) | ‘recall’ means ‘recall’ as defined in Article 3, point (22), of Regulation (EU) 2019/1020; |
(47) | ‘online marketplace’ means a provider of an intermediary service using an online interface which enables customers to conclude distance contracts with economic operators for the sale of products; |
(48) | ‘online interface’ means an ‘online interface’ as defined in Article 3, point (15), of Regulation (EU) 2019/1020; |
(49) | ‘supplier’ means any natural or legal person providing raw materials, intermediate products, or used products to manufacturers or to other persons providing raw materials, intermediate products, or used products to manufacturers; |
(50) | ‘service provider’ means any natural or legal person providing a service to a manufacturer or to a supplier of a key part, provided that the service is relevant for the manufacturing of products, including to their design, or to their deinstallation in the case of used products; |
(51) | ‘accreditation’ means ‘accreditation’ as defined in Article 2, point (10), of Regulation (EC) No 765/2008; |
(52) | ‘market surveillance authority’ means a ‘market surveillance authority’ as defined in Article 3, point (4), of Regulation (EU) 2019/1020; |
(53) | ‘life cycle’ means the consecutive and interlinked stages of a product’s life, from raw material acquisition or generation from natural resources, or in the case of products which have previously been incorporated into construction works, from the latest deinstallation from the construction work, to final disposal; |
(54) | ‘single liaison point’ means the authority designated as the focal point for contacts with the Commission and other Member States on construction product related issues; |
(55) | ‘notified body’ means a conformity assessment body authorised to carry out third-party assessment and verification tasks under this Regulation that has been duly notified; |
(56) | ‘notifying authority’ means the single public administration body, designated in accordance with this Regulation, in charge of the notification and monitoring of notified bodies; |
(57) | ‘technical assessment body’ or ‘TAB’ means a body, designated in accordance with this Regulation, that issues European technical assessments on the basis of European assessment documents; |
(58) | ‘designating authority’ means the single public administration body, designated in accordance with this Regulation, in charge of the designation and monitoring of TABs in a Member State; |
(59) | ‘product presenting a risk’ means a product that, whenever during its entire life cycle, has an inherent potential to affect adversely the health and safety of persons, the environment or the fulfilment of basic requirements for construction works when incorporated in those works, to a degree which, taking account of the state-of-the-art, goes beyond what is considered reasonable and acceptable in relation to its intended use and under normal or reasonably foreseeable conditions of use; |
(60) | ‘product presenting a serious risk’ means a ‘product presenting a serious risk’ as defined in Article 3, point (20), of Regulation (EU) 2019/1020; |
(61) | ‘by-product’ means a ‘by-product’ within the meaning of Article 5 of Directive 2008/98/EC; |
(62) | ‘recyclability’ means the capability of a material or product to be effectively and efficiently separated, collected, sorted and aggregated in specific waste streams for the purpose of being recycled into secondary raw materials while minimising the loss of quality or functionality compared to the relevant primary raw material; |
(63) | ‘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 (24); |
(64) | ‘internal market emergency mode’ means ‘internal market emergency mode’ as defined in Article 3, point (3), of Regulation (EU) 2024/2747. |
Article 4
Working plan and preparatory phase for the development of harmonised technical specifications
1. The Commission shall be supported by an expert group (‘the Construction Products Regulation Acquis Expert Group’ or ‘CPR Acquis Expert Group’). The CPR Acquis Expert Group shall be composed at least of experts designated by the Member States, representatives of European standardisation organisations and of relevant European stakeholder organisations receiving Union financing under Regulation (EU) No 1025/2012. The CPR Acquis Expert Group shall support the Commission in processing Member States’ requests for Union harmonisation through harmonised technical specifications. In particular, the CPR Acquis Expert Group shall assist the Commission in establishing and updating a working plan for the development of harmonised technical specifications, in preparing the technical content related to harmonised technical specifications, in deciding on the need to launch the procedures in relation to harmonised technical specifications that present deficiencies, are unavailable, or not able to cover immediate regulatory needs, and in determining the inclusion of used products in harmonised technical specifications.
2. After consulting the CPR Acquis Expert Group, the Commission shall establish a working plan for the development of harmonised technical specifications for product families listed in Annex VII, including product requirements as well as general product information, instructions for use and safety information, covering at least the following three-year period. The Commission shall set the priorities of the working plan using a transparent and balanced methodology, which shall be published together with the working plan. That methodology shall at least reflect the regulatory needs of the Member States, the safety issues related to construction works and products and the climate and circular economy goals of the Union.
The Commission shall publish the first working plan no later than 8 January 2026.
The Commission shall renew and update the working plan at least every three years. It shall publish the working plan for the following three-year period one year before the expiration of the working plan in force.
The Commission shall inform the European Parliament and the Member States annually about progress in implementing the working plan.
If the Commission considers that it cannot achieve the goals set out in the working plan, it shall amend it accordingly without undue delay, and shall inform the European Parliament and the Member States about the reasons thereof.
3. Following the working plan established under paragraph 2, Member States shall communicate to the Commission and the CPR Acquis Expert Group the essential characteristics they require for a product family or product category, and the assessment methods, threshold levels or classes of performance, as well as the product requirements, that they deem necessary.
When Member States communicate their regulatory needs to the Commission pursuant to the first subparagraph, the Commission shall integrate them or shall provide a statement of reasons why it is not possible to do so.
4. On the basis of the basic requirements for construction works set out in Annex I and taking into account the regulatory needs communicated by Member States in accordance with paragraph 3 of this Article, as well as the safety, environmental, circularity and climate objectives of the Union, the Commission, with the support of the CPR Acquis Expert Group, shall identify the technical aspects needed to prepare standardisation requests, including the relevant essential characteristics. Those essential characteristics and the list of predetermined environmental essential characteristics set out in Annex II shall constitute the basis for the preparation of the standardisation requests referred to in Article 5(2) and of the implementing acts referred to in Article 6(1).
5. The Commission shall ensure that essential characteristics are covered by harmonised technical specifications to the extent that the development of such specifications is technically and economically proportionate.
6. The Commission, with the support of the CPR Acquis Expert Group, shall identify the product requirements referred to in Article 7, as well as other harmonised technical specifications, and shall determine whether used products are to be covered by or excluded from a standardisation request or a harmonised technical specification. The CPR Acquis Expert Group shall, as a matter of urgency, be consulted on notifications from Member States made in accordance with Article 11(5).
7. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend:
(a) | the list of predetermined environmental essential characteristics set out in Annex II in order to adapt it to technical progress and new environmental risks and to comply with the priorities established pursuant to paragraph 2 of this Article based on the regulatory needs of the Member States; |
(b) | the product families listed in Annex VII, to adapt them to technical progress and to the regulatory needs of the Member States. |
Article 5
Harmonised standards laying down essential characteristics dealing with performance
1. The methods and the criteria for assessing the performance of a product in relation to its essential characteristics shall be laid down in harmonised standards made mandatory by means of the implementing acts referred to in paragraph 8 (‘performance harmonised standards’). Performance harmonised standards shall, where appropriate and without endangering the accuracy, reliability or stability of the results, provide methods for assessing the performance of the products in relation to their essential characteristics that are less onerous than testing.
2. The Commission shall, in accordance with Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards laying down essential characteristics and their assessment methods for one or more product families, or for one or more product categories within a family. The standardisation request shall set out the basic principles and reference points for the establishment of those essential characteristics and their assessment methods. The standardisation request shall explicitly state whether it covers or excludes used products from the scope of the request.
3. As part of the standardisation requests referred to in paragraph 2 of this Article, the Commission may also request the European standardisation organisations to provide the technical details necessary for the implementation of the assessment and verification system that is to be applied in accordance with the delegated acts referred to in Article 10(2).
4. The standardisation requests referred to in paragraph 2 may include a request to propose one or more of the following elements:
(a) | voluntary or mandatory threshold levels in relation to the essential characteristics; |
(b) | classes of performance in relation to the essential characteristics; |
(c) | those essential characteristics which always have to be declared by manufacturers. |
Such standardisation requests shall set out the basic principles and reference points for the establishment of the elements requested.
5. Where it has included with its standardisation request a request for a proposal in accordance with paragraph 4 of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation by determining, for the product families or product categories and for the elements covered by that request, the elements referred to in paragraph 4, first subparagraph of this Article.
After consulting the CPR Acquis Expert Group, the Commission may deviate from the proposals of the European standardisation organisation.
The Commission is empowered to adopt delegated acts, irrespective of any prior standardisation request but on the advice of the CPR Acquis Expert Group, in accordance with Article 89 to supplement this Regulation by determining the elements set out in paragraph 4, first subparagraph of this Article in relation to any of the groupings of essential characteristics of a horizontal nature listed in Annex X.
6. In cases where, on the basis of the nature or technical characteristics of a product, it is apparent that testing would be unnecessary or redundant, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation by laying down conditions under which a product is to be deemed to satisfy a certain level, threshold level or to qualify for a class of performance without testing, or without further testing.
7. The Commission shall assess the compliance of harmonised standards with the relevant standardisation requests, with this Regulation and with other Union law, including general principles of law. The Commission may assess whether harmonised standards comply with other harmonised standards under this Regulation or with other harmonised standards the references of which have been published in the Official Journal of the European Union.
The Commission shall carry out the assessment referred to in the first subparagraph of this paragraph and present its reasons in writing to the relevant European standardisation organisation and to the CPR Acquis Expert Group within six months after the relevant harmonised standard has been transmitted to it. Where the Commission considers that a standard, or a part thereof, is unsatisfactory, it shall specify the deficiencies. In order for the Commission to fulfil that obligation within that timeframe, the European standardisation organisations shall regularly inform the Commission of the progress and content of the European standardisation deliverable in accordance with Article 10(5) of Regulation (EU) No 1025/2012.
8. Where a harmonised standard is in conformity with applicable legal requirements and satisfies the requirements to be met in relation to the basic principles and reference points set out in the standardisation request, as well as in relation to the essential characteristics to be covered in view of the basic requirements for construction works, the Commission shall without delay adopt an implementing act making that standard mandatory. One year after such adoption the performance harmonised standard shall become mandatory for the purposes of this Regulation unless a later application date has been specified in the implementing act. A later application date shall be specified only in exceptional cases and its use shall be duly justified. A performance harmonised standard may be voluntarily applied from the date of the adoption of the implementing act.
Where the Commission considers a harmonised standard or a part thereof to be unsatisfactory, it may adopt an implementing act making that harmonised standard mandatory with restrictions.
The implementing acts referred to in the first and second subparagraph shall be adopted in accordance with the advisory procedure referred to in Article 90(2).
Where it is not possible to make a harmonised standard mandatory with restrictions, the Commission may adopt an implementing act in accordance with Article 6.
9. When a Member State, the European Parliament or the Commission, the last with the support of the CPR Acquis Expert Group, considers that a performance harmonised standard does not entirely fulfil the applicable legal requirements or satisfy the demands to be met in relation to the essential characteristics to be covered in view of the basic requirements for construction works, the procedure for formal objections to harmonised standards as set out in Article 11 of Regulation (EU) No 1025/2012 shall apply.
10. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend Annex X by adding additional groupings of essential characteristics of a horizontal nature.
Article 6
Other harmonised technical specifications laying down essential characteristics
1. While priority shall be given to the elaboration of standards, by way of derogation from Article 5(1) to (4) of this Regulation, in order to cover the regulatory needs of Member States and to pursue the goals of Article 114 TFEU, the Commission may adopt implementing acts laying down essential characteristics, their assessment methods and technical details pursuant to Article 5 of this Regulation for one or more product families or for one or more product categories within a family.
Those implementing acts shall be adopted only if the following conditions are fulfilled:
(a) | the Commission has requested, pursuant to Article 5(2), one or more European standardisation organisations to draft a harmonised standard and:
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(b) | no implementing act, as referred to in Article 5(8), first subparagraph, making mandatory a harmonised standard covering the essential characteristics, their assessment methods and technical details pursuant to Article 5 was adopted in the last 5 years, or such an implementing act was adopted within the last five years, but with restrictions, as referred to in Article 5(8), second subparagraph. |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
2. Before preparing a 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 are fulfilled.
3. When preparing the draft implementing act, the Commission shall take into account the views of relevant bodies and of the CPR Acquis Expert Group and shall duly consult all relevant stakeholder organisations receiving Union financing under Regulation (EU) No 1025/2012.
4. Where an implementing act referred to in paragraph 1 of this Article covers the same essential characteristics or assessment methods in relation to a specific product family or product category as a harmonised standard the reference of which has been published in the Official Journal of the European Union or in respect of which an implementing act referred to in Article 5(8) has been adopted, the Commission shall withdraw from the Official Journal of the European Union the reference of that harmonised standard or repeal that implementing act. Where the implementing act referred to in paragraph 1 of this Article only partially covers the harmonised standard, the Commission shall retain the implementing act laying down a harmonised standard that is subject to restrictions.
5. When a Member State or the European Parliament considers that an implementing act adopted in accordance with paragraph 1 does not entirely satisfy the requirements to be met in relation to the essential characteristics to be covered in view of the basic requirements for construction works, it shall inform the Commission thereof, by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act in question.
6. The Commission shall follow the procedure in Article 5 to request any revision or update of the essential characteristics or assessment methods in relation to the same product families or product categories as those covered by the implementing act referred to in paragraph 1 of this Article. Where the harmonised standard delivered by the European standardisation organisation is suitable to be adopted in accordance with Article 5(8), the Commission shall repeal the implementing act adopted in accordance with paragraph 1 of this Article, or the parts thereof which cover the same essential characteristics or assessment methods in relation to the same product families or product categories as those covered by the harmonised standard.
Article 7
Product requirements and harmonised standards conferring a presumption of conformity
1. Where a product family, or one or more product categories within a product family, is covered either by a performance harmonised standard or by an implementing act referred to in Article 6(1), the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by establishing product requirements in accordance with Annex III for that product family or product category, or for parts thereof.
2. Prior to their placing on the market, products covered by this Regulation shall satisfy the applicable product requirements.
3. The Commission may, in accordance with Article 10(1) of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards conferring the presumption of conformity (‘voluntary harmonised standards’) for the product requirements established by delegated acts referred to in paragraph 1 of this Article.
4. Where a voluntary harmonised standard requested in accordance with paragraph 3 is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the voluntary harmonised standard in accordance with Regulation (EU) No 1025/2012.
5. Where a voluntary harmonised standard is in conformity with the applicable legal requirements and satisfies the requirements in relation to the product requirements set out in the standardisation request, the Commission shall without delay publish the reference of that standard in the Official Journal of the European Union.
6. Where the reference of a voluntary harmonised standard cannot be published in the Official Journal of the European Union, the Commission may publish such a reference with restrictions. Where a reference of a voluntary harmonised standard cannot be published in the Official Journal of the European Union and cannot be published as a reference with restrictions, the Commission shall bring the issue to the attention of the committee referred to in Article 22 of Regulation (EU) No 1025/2012 and of the CPR Acquis Expert Group.
7. A product subject to product requirements which is in conformity with voluntary harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the product requirements covered by those standards or parts thereof.
8. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend Annex III in order to adapt it to technical progress and to cover new risks and environmental aspects and to comply with the priorities established in Article 4, based on the regulatory needs of the Member States.
Article 8
Common specifications conferring a presumption of conformity
1. The Commission may adopt implementing acts establishing common specifications that provide an alternative means to comply with the product requirements established in accordance with Article 7(1).
Those implementing acts shall be adopted only where the following conditions are fulfilled:
(a) | the Commission has requested, pursuant to Article 7(3), one or more European standardisation organisations to draft a voluntary harmonised standard for the product requirements and:
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(b) | no reference of voluntary harmonised standards covering the product requirements has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period. |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
2. Before preparing a 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.
3. When preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall take into account the views of the relevant bodies and of the CPR Acquis Expert Group and shall duly consult all relevant stakeholder organisations receiving Union financing under Regulation (EU) No 1025/2012.
4. A product which is in conformity with the common specifications established by implementing acts referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the product requirements established by delegated acts referred to in Article 7(1) covered by those common specifications or parts thereof.
5. The Commission shall repeal the implementing acts referred to in paragraph 1 of this Article, or parts thereof which cover the same product requirements as those covered by a voluntary harmonised standard the reference of which is published in the Official Journal of the European Union in accordance with Article 7(5) or (6).
6. When a Member State or the European Parliament considers that a common specification does not entirely satisfy the product requirements established by delegated acts referred to in Article 7(1), it shall inform the Commission thereof, by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.
Article 9
General product information, instructions for use and safety information
1. General product information, instructions for use and safety information shall be provided in relation to construction products covered by a harmonised technical specification or a European technical assessment. The content of the general product information, instructions for use and safety information is set out in Annex IV.
2. As part of the standardisation request referred to in Article 5(2), the Commission may also request the European standardisation organisation to issue guidelines, including technical details, necessary for drawing up general product information, instructions for use and safety information in accordance with Annex IV.
3. If the Commission considers that the guidelines issued by the European standardisation organisation pursuant to paragraph 2 of this Article for a specific product family or product category do not ensure adequate and homogeneous implementation of paragraph 1 of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation by establishing rules on the provision of general product information, instructions for use and safety information for the respective product family or product category.
4. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend Annex IV in order to adapt it to technical progress and new information needs.
Article 10
Assessment and verification systems
1. The assessment and verification of a product’s performance in relation to its essential characteristics, as set out in harmonised technical specifications adopted in accordance with Articles 5 and 6 or in European assessment documents referred to in Article 31, or of the product’s conformity with product requirements adopted in accordance with Article 7, shall be carried out in accordance with one or more of the systems set out in Annex IX.
2. The Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by determining, for each product family or product category, the applicable assessment and verification system among those referred to in Annex IX. Those delegated acts may determine different assessment and verification systems within the same product family or product category, differentiating by essential characteristic or product requirement. The assessment and verification systems shall be determined before the harmonised technical specifications or European assessment documents become applicable.
3. The delegated acts adopted in accordance with paragraph 2 shall take into account the intended uses, the potential damage resulting from product deficiencies, the product’s sensitivity to performance variations under production conditions, the likelihood of errors during its manufacturing and the possibility of easily detecting manufacturing errors. Those delegated acts shall be tailored to the respective product families or product categories and shall minimise the burden on manufacturers, whilst ensuring a high level of protection of health and safety of persons and of the environment.
4. The Commission is empowered to adopt delegated acts in accordance with Article 89 in order to amend Annex IX to:
(a) | introduce additional assessment and verification systems when necessary to adapt to technical progress; or |
(b) | amend the existing assessment and verification systems to counter systematic non-compliance by notified bodies or manufacturers and to harmonise the application of the requirements or obligations contained in them, without such amendments adding or removing any task defined in a system. |
When adopting delegated acts under point (a), the Commission may not introduce additional systems that set more demanding obligations for economic operators than those provided for in System 1+. In addition, the Commission may introduce such additional systems only when it is evident that guidance on the application of existing systems has proved to be insufficient.
Article 11
Harmonised zone and national measures
1. This Regulation, and the harmonised technical specifications adopted in accordance with it, together, establish a ‘harmonised zone’.
The harmonised zone covers all products subject to harmonised technical specifications.
Harmonised technical specifications shall be presumed to be comprehensive, in the following respects:
(a) | laying down all essential characteristics and their assessment methods; |
(b) | specifying all product requirements other than those covered by other Union law; and |
(c) | determining the applicable assessment and verification systems. |
Harmonised technical specifications for new products shall apply to used products from third countries unless the harmonised technical specification explicitly provides rules for used products.
2. Member States shall respect the harmonised zone in their national laws, regulations and administrative measures, and shall neither prohibit nor impede the making available on the market of products covered by it when those products are in compliance with this Regulation. Member States shall not lay down essential characteristics and their assessment methods or product requirements other than those set out in the harmonised technical specifications.
The harmonised zone does not affect the right of Member States to specify national requirements for the use of products that are subject to harmonised technical specifications. Any assessment methods and systems for assessment and verification set out in such national requirements shall be in accordance with the applicable harmonised technical specifications.
Member States shall ensure that the making available on the market of products within the harmonised zone which are in compliance with this Regulation shall not be impeded by rules or conditions imposed by public bodies or by private bodies acting as a public undertaking or private bodies acting as a public body on the basis of a monopoly position or under a public mandate.
3. When complying with the obligations provided for in paragraph 2, Member States shall in particular apply the following rules:
(a) | no requirements for information or registration related to the placing on the market of the product other than those laid down in the harmonised zone shall be established; |
(b) | no assessments of the product other than those set out in the harmonised zone shall be made mandatory; |
(c) | no markings attesting to conformity with requirements or declared performances in relation to essential characteristics covered by the harmonised zone shall be required other than the CE marking, and any existing provisions in national measures requiring such markings shall be withdrawn; |
(d) | national laws, regulations and administrative measures shall respect the threshold levels established in accordance with Article 5(5); |
(e) | national laws, regulations and administrative measures shall not be based on classes, sub-classes or additional classes other than those established in accordance with Article 5; |
(f) | national laws, regulations and administrative measures shall not require more assessments and verifications than those established in accordance with Article 10(1). |
4. Member States shall register in the Single Digital Gateway established by Regulation (EU) 2018/1724 of the European Parliament and of the Council (25) all their national laws, regulations and administrative measures related to construction products on their territory covered by the harmonised zone.
5. Where a Member State deems it necessary on imperative grounds of health and safety of persons or protection of the environment and in order to address immediate regulatory needs, to take measures applicable to products within the harmonised zone in relation to characteristics not laid down in harmonised technical specifications, it shall notify the Commission thereof, justifying the need for the measures taken and explaining the regulatory need it aims to address.
To that end, Member States shall use the procedure set up by Directive (EU) 2015/1535 of the European Parliament and of the Council (26). When doing so, Member States shall make reference to this paragraph and specify which elements are part of the measure.
The Commission shall reply to the notification within the time limits established in the procedure set up by Directive (EU) 2015/1535. The Commission shall within six months of the notification either put forward a proposal for authorisation in accordance with paragraph 6 of this Article or communicate its grounds for rejecting the national measure.
Upon receipt of a notification as referred to in the first subparagraph, the Commission shall, irrespective of whether it intends to authorise the measure, without delay submit the matter to the CPR Acquis Expert Group for consultations on whether updates to existing performance harmonised standards need to be requested as a priority.
6. The Commission shall adopt an implementing act, authorising the national measure notified under paragraph 5 where:
(a) | the notified measure appears duly justified in the light of imperative grounds of health and safety of persons or protection of the environment, including the climate; |
(b) | the regulatory need is not covered by harmonised technical specifications or by other Union law; |
(c) | the notified measure does not discriminate against economic operators of other Member States; |
(d) | the notified measure is able to cover the respective regulatory need; |
(e) | the notified measure does not constitute a serious obstacle to the functioning of the internal market; and |
(f) | the notified measure is not expected to be covered by a harmonised standard which is to be delivered within one year from the date of the notification referred to in paragraph 5 of this Article, following a standardisation request issued pursuant to Article 5(2), or, at the moment of that notification, no implementing act referred to in Article 6(1) has been presented to the committee referred to in Article 90(1). |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3). They shall be withdrawn once the regulatory need is covered by harmonised technical specifications or by other Union law.
On duly justified imperative grounds of urgency relating to health and safety of persons or the protection of the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 90(4).
7. This Regulation does not affect the possibility for Member States to introduce mandatory deposit-refund systems or to oblige manufacturers to accept to regain, directly or via their importers and distributors, ownership of their new, surplus or unsold non-custom-made products that are in a state equivalent to that in which they were placed on the market, provided that the measure does not directly or indirectly discriminate against economic operators in other Member States.
8. This Regulation does not affect the possibility for Member States to ban the destruction of surplus or unsold products, or to make their destruction conditional upon their previously having been made available on a national brokering platform for non-commercial use of products.
Article 12
Relationship with other Union law
1. To avoid double assessment of the same aspects of health and safety of persons or protection of the environment in respect of products, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation by laying down the conditions under which obligations relating to the assessment of a product’s performance or the fulfilment of certain product requirements, including the equivalence of assessment and verification systems required under this Regulation and obligations as regards general product information, instructions for use and safety information requirements, can be satisfied by the fulfilment of obligations provided for under other Union law.
The conditions referred to in the first subparagraph shall not allow for product safety levels which are less strict than those established in accordance with this Regulation.
2. Where conflicts arise between this Regulation and Regulation (EU) 2024/1781 as well as Regulation (EU) No 1025/2012, the relevant provisions of this Regulation shall prevail.
CHAPTER II
PROCEDURE, DECLARATIONS AND MARKINGS
Article 13
Declaration of performance and conformity
1. Where a product is covered by a harmonised technical specification adopted in accordance with Articles 5 or 6, the manufacturer shall undergo the applicable assessment and verification system set out in Annex IX and draw up a declaration of performance and conformity before such a product is placed on the market. Where a product is covered by a harmonised technical specification adopted in accordance with Article 7, the manufacturer shall also verify the product’s compliance with applicable product requirements that have been specified by delegated acts. The manufacturer of a product which is not covered by any harmonised technical specification may issue a declaration of performance and conformity in accordance with the relevant European assessment document and European technical assessment.
2. By drawing up the declaration of performance and conformity, the manufacturer assumes responsibility for the conformity of the product with its declared performance and any applicable product requirements, and becomes liable in accordance with Union and national laws on contractual and extra-contractual liability. In the absence of objective indications to the contrary, Member States shall presume the declaration of performance and conformity drawn up by the manufacturer to be accurate and reliable.
In the event of non-compliance, or in the absence of a declaration of performance and conformity when such a declaration is required, the product may not be made available on the market.
Article 14
Exemptions from drawing up a declaration of performance and conformity
By way of derogation from Article 13(1), a manufacturer may decide not to undergo the applicable assessment and verification of the product’s compliance with applicable product requirements and not to draw up a declaration of performance and conformity when any of the following applies:
(a) | the product is individually manufactured or custom-made and fulfils all of the following conditions:
|
(b) | the product is manufactured in a manner exclusively appropriate to heritage conservation and in a non-series process for adequately renovating construction works officially protected as part of a designated environment or because of their special architectural or historic merit, in compliance with the applicable national rules. |
Article 15
Content of the declaration of performance and conformity
1. The declaration of performance and conformity shall be drawn up using the model set out in Annex V. The declaration of performance and conformity shall express the performance of products in relation to the essential characteristics of those products in accordance with the relevant harmonised technical specifications or European assessment document.
Where product requirements specified in accordance with Article 7 are applicable, the declaration of performance and conformity shall state that the fulfilment of those requirements has been demonstrated.
2. The declaration of performance and conformity shall include the product’s environmental sustainability performance over its life cycle in respect of the predetermined environmental essential characteristics listed in Annex II for those characteristics that are declared. The performance shall include the packaging used or most likely to be used and shall be calculated using the latest version of software made available free of charge on the website of the Commission.
Updates of the software referred to in the first subparagraph shall become mandatory for the purposes of this Regulation one year after their publication. Such software updates may be voluntarily applied from their date of publication.
3. The declaration of performance and conformity shall cover at least a product’s performance over its life cycle with regard to the following essential characteristics:
(a) | essential characteristics listed in points (a) to (d) of Annex II, from 8 January 2026; |
(b) | essential characteristics listed in points (e) to (m), of Annex II, from 9 January 2030; |
(c) | essential characteristics listed in points (n) to (s), of Annex II, from 9 January 2032. |
The declaration of performance and conformity shall also cover those essential characteristics which always have to be declared, as determined in delegated acts adopted in accordance with Article 5(5).
4. No marking other than the CE marking may be placed on the declaration of performance and conformity.
5. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend the model set out in Annex V to adapt it to reflect technical progress as regards new information needs, to facilitate the fulfilment of digital product passport requirements set out in Articles 76 and 77, and to ensure interoperability and correct integration with the construction digital product passport system in accordance with Article 75.
6. The information referred to in Article 31 or, as the case may be, in Article 33 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (27) shall be provided together with the declaration of performance and conformity.
Article 16
Supply of the declaration of performance and conformity
1. The manufacturer shall supply by electronic means a copy of the declaration of performance and conformity of each product which is made available on the market, unless the declaration is included in a digital product passport that fulfils the conditions set out in Article 76 and is available through the construction digital product passport system established in accordance with Article 75.
However, where a batch of the same product is supplied to a single user, it may be accompanied by a single copy of the declaration of performance and conformity.
2. By way of derogation from paragraph 1 of this Article, a manufacturer may make the declaration of performance and conformity referred to in Article 13(1) available on a website, provided that the manufacturer complies with all of the following conditions:
(a) | ensures that the content of the declaration of performance and conformity is made available in an unamendable electronic format on the website; |
(b) | provides the declaration of performance and conformity in a human- and machine-readable format and offers the possibility to download a copy in a commonly readable format; |
(c) | ensures that the website where the declaration of performance and conformity has been made available is monitored and maintained so that the website and the declarations of performance and conformity are continuously available to recipients of the construction product; |
(d) | ensures that the recipients of construction products are able to access the declaration of performance and conformity free of charge; |
(e) | provides instructions to the recipients of construction products on how to access the website and the declarations of performance and conformity drawn up for such products available on that website; |
(f) | provides a link between the product and the declaration of performance and conformity related to it through the unique identification code of the product type; manufacturers may use a data carrier, including a permalink, to provide the link, provided that point (a) is complied with. |
3. As part of the standardisation request referred to in Article 5(2), the Commission may also request the European standardisation organisation to issue guidelines to ensure interoperability of the human- and machine readable formats referred to in paragraph 2, point (b) of this Article.
4. The manufacturer shall supply or make available in a digital product passport in accordance with paragraph 1, or on a website in accordance with paragraph 2, the declaration of performance and conformity in the language or languages required by each of the Member States in which the manufacturer intends to make the product available. Another economic operator who makes that manufacturer’s product available in any additional Member State shall make a translation or translations of the declaration of performance and conformity available in the languages required by the additional Member State, together with the respective original version.
Article 17
General principles and use of CE marking
1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
2. The CE marking shall be affixed only to those products for which the manufacturer has drawn up a declaration of performance and conformity in accordance with Articles 13 and 15. The CE marking shall be affixed to key parts.
3. By affixing the CE marking to the product, or having it affixed, the economic operator indicates that it has assumed responsibility for the conformity of the product with the declared performance and applicable product requirements laid down in accordance with this Regulation. By affixing the CE marking, the economic operator becomes liable for the declared performance and the fulfilment of those requirements in accordance with national law on contractual and extra-contractual liability.
4. The CE marking shall be the only marking attesting to the performance of the product with regard to assessed essential characteristics in accordance with this Regulation, as well as to the conformity of the product with this Regulation.
Article 18
Rules and conditions for the affixing of CE marking
1. The CE marking shall be affixed visibly, legibly and indelibly to the product. Where this is not possible or not warranted on account of the nature of the product, the CE marking shall be affixed to a label attached to the product or to the packaging or, where that is also not possible, to the accompanying documents.
2. The CE marking shall be followed by:
(a) | the last two digits of the year in which the CE marking was first affixed; or, in the case of used products, the last two digits of the year when the product was deinstalled followed by the last two digits of the year in which the CE marking was affixed to the used product; |
(b) | the name and the registered address, or the identifying mark allowing easy and unambiguous identification of the name and address, of the manufacturer; |
(c) | the name and the registered address of the authorised representative, or the identifying mark allowing easy and unambiguous identification of the name and address of the authorised representative where the manufacturer does not have a place of business in the Union or where the manufacturer chooses to have an authorised representative; |
(d) | the unique identification code of the product-type; |
(e) | the declaration code of the declaration of performance and conformity; |
(f) | the identification number of the notified body or bodies verifying the product type and assessing the factory production control, if applicable; and |
(g) | a data carrier connected to the digital product passport referred to in Article 76 if such a digital product passport is available through the construction digital product passport system established pursuant to Article 75. |
The information listed in points (d) and (e) of the first subparagraph of this paragraph may be replaced by a data carrier, including permalink connected to the declaration of performance and conformity pursuant to Article 16(2), point (e), if the declaration of performance and conformity is available on a website. The information listed in points (d) and (e) of the first subparagraph of this paragraph may be omitted if a data carrier referred to in point (g) of the first subparagraph of this paragraph is provided.
3. The CE marking shall be affixed before the product is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.
Article 19
Other markings and performance claims
1. Markings other than the CE marking, including private ones, may be affixed to a product only if they do not indicate that the product’s performance in relation to essential characteristics covered by applicable harmonised technical specifications had to be assessed in a way different from that laid down by this Regulation.
Officially recognised EN ISO 14024 type I ecolabels may be affixed to a product if they fulfil the requirement in the first subparagraph.
2. Markings allowed in accordance with paragraph 1 and other markings set out by Union legislation may be affixed to a product provided that they do not impair the visibility, legibility and meaning of the CE marking.
3. Where a product is covered by a harmonised technical specification, a claim made by an economic operator about the product’s performance, which concerns an essential characteristic covered by that harmonised technical specification, shall comply with the assessment method for that particular essential characteristic as laid down in the harmonised technical specifications.
4. Where a product is covered by harmonised technical specifications, claims about its performance in relation to the essential characteristics laid down in those harmonised technical specifications may be additionally provided in a place other than in the declaration of performance and conformity only if they are already provided in the declaration of performance and conformity.
The first subparagraph shall not apply to situations where, in accordance with Article 14, no declaration of performance and conformity has been drawn up.
CHAPTER III
OBLIGATIONS AND RIGHTS OF ECONOMIC OPERATORS
Article 20
Obligations of all economic operators
1. The obligations of economic operators under this Chapter are applicable only in relation to products covered by a harmonised technical specification, or to products that have been CE-marked on the basis of a European technical assessment.
2. An economic operator shall take all necessary measures to ensure continued compliance with this Regulation. Where non-compliance of the economic operator or of a product has been stated and corrective action has been requested by a market surveillance authority in accordance with Article 65(1), the economic operator shall submit progress reports to that authority until that authority decides that the corrective action can be closed.
3. An economic operator shall, on request of a competent national authority, identify to that authority any economic operator or other actor:
(a) | who has supplied that economic operator with a product, including components or spare parts of products, and the quantity of that supply, or who has supplied it with a service covered by this Regulation; |
(b) | to whom that economic operator has supplied a product, including components or spare parts of products, and the quantity of that supply, or to whom it has supplied a service covered by this Regulation. |
When identifying the economic operators or other actors referred to in the first subparagraph, an economic operator shall inform the competent national authority of, at least, the following:
(a) | the contact details, including addresses and email addresses of those economic operators or actors; |
(b) | the tax and company registration numbers of those economic operators or actors. |
4. An economic operator shall keep all documents and all information referred to in this Chapter at the disposal of competent national authorities for a period of 10 years after the economic operator supplied or was supplied with the product or service in question, unless the documents or the information have been made available through the digital product passport referred to in Article 76. An economic operator shall present the documentation and information within 10 days of receipt of a request by a competent national authority.
5. An economic operator may register itself in its respective national system established in accordance with Article 71(5).
An economic operator shall make available to consumers and users communication channels, including telephone numbers, email addresses or dedicated sections of its website, allowing them to communicate any accident, other incident or safety issue they have experienced with the product.
6. Where an economic operator considers that a non-conforming product presents a risk to health and safety of persons or to the environment, it shall immediately inform thereof the competent national authorities of the Member States in which it made the product available, giving details, in particular, of the non-compliance and of any corrective measures taken. An economic operator may inform the competent national authorities of any other likely infringement of this Regulation of which it becomes aware, of the non-compliance and of any corrective measures taken.
7. An economic operator shall be liable for infringements of this Article or of the Articles in this Chapter related to its activities, in accordance with national law on contractual and extra-contractual liability.
Article 21
Rights of manufacturers
1. A manufacturer shall have the right to request from its suppliers and service providers the information necessary in relation to their products to fulfil its obligations under this Regulation.
2. If the manufacturer is subject to third-party tasks carried out by a notified body, the manufacturer shall have the right to request from its suppliers or service providers that they permit that notified body to have access to their documentation and to their premises to the extent that the notified body requires such access in order to carry out its tasks.
3. The rights established in paragraph 1 also apply to a manufacturer placing a used or remanufactured product on the market in relation to the supplier of the used product, including the deinstaller where applicable. The information required may include, but is not limited to, information about the previous use of the product and about the process of deinstalling it.
4. A manufacturer shall have the right to request from its suppliers and service providers the data and calculations required under Article 15(2) in relation to the supplies or services provided, including the necessary validation reports issued by a notified body.
Article 22
Obligations of manufacturers
1. When placing a product on the market, the manufacturer shall determine the product type, respecting the boundaries set up therefor by the definition provided in Article 3, point (27). The manufacturer shall ensure that the product’s performance is assessed in relation to both mandatory essential characteristics and those essential characteristics intended to be declared. If the product is covered by product requirements established by delegated acts referred to in Article 7(1), the manufacturer shall ensure that the product has also been designed and constructed in accordance with those requirements.
A natural or legal person that manufactures a product using 3-D printing shall satisfy the obligations incumbent on manufacturers when placing it on the market. The obligations shall include, but are not limited to, the use of appropriate 3-D datasets, the use of materials compliant with the applicable procedures under this Regulation, and the verification of the compatibility of 3-D datasets, printing material and the printing technology used.
2. Where a product’s compliance with applicable requirements and its performance in relation to essential characteristics referred to in paragraph 1 of this Article have been demonstrated in accordance with the applicable assessment and verification system or systems set out in Annex IX, the manufacturer shall draw up a declaration of performance and conformity in accordance with Articles 13 to 15, affix the CE marking in accordance with Articles 17 and 18 and, when applicable, ensure the availability of spare parts not commonly available in the market, as referred to in paragraph 8 of this Article, and affix the labelling pursuant to paragraph 9 of this Article.
3. The manufacturer shall, as the basis for the declaration of performance and conformity, draw up a technical documentation in which he shall indicate:
(a) | the declared use, which shall fall within the scope of the applicable intended use; |
(b) | all the relevant elements necessary to demonstrate performance and conformity; |
(c) | information on the procedures in place referred to in paragraph 4 of this Article; |
(d) | information on the applicable system or systems set out in Annex IX; |
(e) | where relevant, information on the application of simplified procedures applied in accordance with Articles 59 to 61; and |
(f) | the calculation of the performance of environmental sustainability in respect of essential characteristics as referred to in Article 15(2). |
4. The manufacturer shall ensure that procedures are in place to ensure that products fulfil their declared performance and remain in conformity with this Regulation. Product design, including 3-D datasets, production processes and material used shall be appropriate. Where the product is manufactured in series production, the manufacturer shall ensure that procedures are in place to ensure that it maintains its declared performance and remains in conformity with this Regulation. Changes in the product design, including 3-D datasets, production process and material used shall be appropriate. Changes in the applicable harmonised technical specifications shall be adequately taken into account and, where the performance or conformity of the product is affected, shall trigger a re-assessment in accordance with the relevant assessment procedure.
The manufacturer shall, where deemed appropriate with regard to ensuring the accuracy, reliability and stability of the declared performance and of the conformity of a product, carry out sample testing of products placed or made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep importers and distributors informed thereof.
5. The manufacturer shall ensure that its products bear a manufacturer-specific unique identification code of the product type and, where available, a batch or serial number which is easily visible and legible for users. Where that is not possible on account of the nature of the product, the required information shall be provided on an affixed label, on the packaging or, where that is also not possible, in a document accompanying the product.
The manufacturer shall, in the same way as set out in the first subparagraph, label a product as ‘Only for professional use’ if expertise is needed in order to use it and shall display the label to customers before they are bound by a sales contract, including in the case of distance selling. Products not labelled ‘Only for professional use’ shall be deemed to also be intended for non-professional users and consumers within the meaning of this Regulation and of Regulation (EU) 2023/988.
The manufacturer shall display to customers, in a visible manner, before they are bound by a sales contract, including in the case of distance selling, the information which must be provided pursuant to this Regulation.
6. When making a product available on the market, the manufacturer shall ensure that it is accompanied by general product information, instructions for use and safety information, as set out in Annex IV in a language to be determined by the Member State concerned or, in absence of such determination, in a language which can be easily understood by users.
7. By 18 months after the entry into force of the delegated act referred to in Article 75(1) the manufacturer shall make available a digital product passport referred to in Article 76, through the construction digital product passport system referred to in Article 75, connected to a data carrier referred to in Article 18(2), point (g).
8. In order to ensure the availability of spare parts not commonly available on the market, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by imposing in respect of certain product families and product categories an obligation on manufacturers to make available on the market specific spare parts not commonly available for the products they place on the market.
The obligation established by the delegated acts referred to in the first subparagraph of this paragraph shall apply for a period of 10 years after the last product of the respective type has been placed on the market, unless the delegated act sets a different period.
Manufacturers subject to the obligation laid down in the first paragraph shall offer the spare parts within a reasonably short delivery period, at a reasonable and non-discriminatory price, and shall inform the public thereof.
9. In order to ensure transparency for users and to promote sustainable products, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by establishing specific environmental sustainability labelling requirements for particular product families and product categories when the following conditions are fulfilled:
(a) | the product is typically chosen or purchased by consumers; and |
(b) | the product does not have a significantly different overall environmental performance over its life cycle depending on its installation. |
The labelling shall be based on the performance of the product, as assessed in accordance with Article 5(1) or Article 6(1), and shall provide consumer-friendly information understandable by non-experts.
10. The delegated acts referred to in paragraph 9 shall determine the way in which the manufacturer is to affix the label, by specifying the following:
(a) | the content of the label; |
(b) | the layout of the label, taking into account its visibility and legibility; |
(c) | the manner in which the label is to be displayed to customers, including in the case of distance selling; |
(d) | where appropriate, the electronic means to be used for generating labels. |
11. A manufacturer who considers or has reason to believe that a product which it has placed on the market does not conform to its declared performance or does not comply with this Regulation shall immediately take the necessary corrective measures to bring that product into conformity or compliance, or, if appropriate, to withdraw or recall it. If the issue is linked to a supplied component or an externally provided service, the manufacturer shall inform the supplier or service provider and the manufacturer’s competent national authority.
12. Where the product presents a risk, the manufacturer shall, without undue delay and at the latest within three working days, inform all the authorised representatives, importers, distributors, fulfilment service providers, and online market places involved in its distribution, as well as the competent national authorities of the Member States in which the manufacturer or, to its knowledge, other economic operators made the product available. The manufacturer shall, to that effect, provide all useful details and, in particular, specify the type of the non-compliance, the frequency of accidents or incidents, and the corrective measures taken or recommended. In the case of risks caused by products which have already reached an end user or consumer who cannot be identified or contacted directly, the manufacturer shall, through the media and other appropriate channels, ensuring the widest possible reach, disseminate information about appropriate measures to eliminate or, if not possible, to reduce the risks. Where there is a serious risk the manufacturer shall withdraw and recall the product at its own cost.
Article 23
Obligations of authorised representatives
1. A manufacturer established in the Union may appoint, by a written mandate, any natural or legal person established within the Union as a single authorised representative. A manufacturer not established in the Union shall appoint a single authorised representative.
The drawing up of technical documentation shall not form part of the authorised representative’s mandate.
2. The authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
(a) | keep the declaration of performance and conformity and the technical documentation at the disposal of competent national authorities; |
(b) | further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product with its declared performance and its compliance with other applicable requirements in this Regulation; |
(c) | terminate the contract if the manufacturer has acted contrary to its obligations under this Regulation and inform the manufacturer, the competent national authorities of the Member States where the product is placed on the market and the competent national authority of his own place of business thereof; |
(d) | when there is reason to believe that a product is non-compliant or presents a risk, inform the manufacturer and the competent national authorities of the Member States where the product is placed on the market and the competent national authority of the authorised representative thereof; and |
(e) | cooperate with the competent national authorities, at their request, in any action taken to eliminate risks posed by, and to remedy non-conformities of, products covered by the mandate of the authorised representative. |
3. The authorised representative shall verify at documentary level that:
(a) | the product bears the CE marking, and the labelling in accordance with Article 22(9); |
(b) | the product is accompanied by a declaration of performance and conformity, or that declaration is available in accordance with Article 16(1) or (2); and |
(c) | the manufacturer has complied with the requirements set out in Article 22(5), (6) and (7). |
4. Where an authorised representative identifies a case of non-compliance mentioned in paragraph 3 of this Article, it shall ask the manufacturer to act in accordance with Article 22(11) and (12).
Article 24
Obligations of importers
1. Importers shall place on the market only products which are compliant with this Regulation.
2. Before placing a product on the market, the importer shall ensure that the product’s compliance with applicable requirements and its performance in relation to relevant essential characteristics have been demonstrated by the manufacturer in accordance with Article 22(1) and (2).
The importer shall ensure that:
(a) | the manufacturer has drawn up the technical documentation referred to in Article 22(3); |
(b) | the product bears the CE marking, and the labelling in accordance with Article 22(9); |
(c) | the product is accompanied by the declaration of performance and conformity or that the declaration is available in accordance with Article 16(1) or (2); and |
(d) | the manufacturer has complied with the requirements set out in Article 22(5), (6) and (7). |
3. The importer shall verify that the use of the product has been declared by the manufacturer, and shall ensure that the product is accompanied by general product information, instructions for use and safety information as set out in Annex IV in a language determined by the Member State concerned or, in absence of such determination, in a language which can be easily understood by users. The importer shall display to customers, in a visible manner, before they are bound by a sales contract, including in the case of distance selling, the information which must be provided pursuant to this Regulation or harmonised technical specifications.
4. The importer shall ensure that, while a product is under its responsibility, the conditions of its storage or transport do not jeopardise its conformity with the declaration of performance and conformity, or its compliance with other applicable requirements in this Regulation.
5. Where an importer considers, or has reason to believe, that a product is not in conformity with the declaration of performance and conformity, or not in compliance with other applicable requirements in this Regulation, the importer shall not place the product on the market until it conforms to the accompanying declaration of performance and conformity and it complies with the other applicable requirements of this Regulation, or until the declaration of performance and conformity is corrected. Furthermore, where the product presents a risk, the importer shall inform the manufacturer and the responsible competent national authority thereof.
6. The importer shall indicate its name, registered trade name or registered trade mark, its place of business, its contact address and, where available, electronic means of communication, either on the product or, where that is not possible, on its packaging, or in a document accompanying the product.
7. The importer shall investigate complaints, and, if necessary, keep a register of complaints, of non-conforming products and of product withdrawals or recalls, and shall keep manufacturers and distributors informed of any such monitoring.
8. Importers who consider or have reason to believe that a product, which they have placed on the market, is not in conformity with its declared performance or not in compliance with other applicable requirements in this Regulation, shall immediately take the necessary corrective measures to bring that product into conformity, or, if appropriate, to withdraw or recall it. Furthermore, where the product poses a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
9. Importers selling to end users shall also fulfil the obligations incumbent on distributors.
Article 25
Obligations of distributors
1. When making products available on the market, distributors shall act with due care in relation to the obligations of this Regulation.
2. Before making a product available on the market, the distributor shall verify that:
(a) | the product bears the CE marking, and the labelling in accordance with Article 22(9), where required; |
(b) | the product is accompanied, where required, by a declaration of performance and conformity, or that the declaration is available in accordance with Article 16(2); |
(c) | the product is accompanied by general product information, instructions for use and safety information in accordance with Article 22(6), in a language which can be easily understood by end users in the Member State in which the product is to be made available on the market; |
(d) | the manufacturer and the importer have complied with the requirements set out in Article 22(5) and (7) and Article 24(6) respectively. |
3. The distributor shall display to customers, in a visible manner, before they are bound by a sales contract, including in the case of distance selling, the information which must be provided pursuant to this Regulation.
4. Where a distributor considers or has reason to believe that a product is not in conformity with its declared performance or not in compliance with other applicable requirements in this Regulation, the distributor shall not make the product available on the market until it conforms to its accompanying declaration of performance and conformity and it complies with the other applicable requirements in this Regulation. Furthermore, where the product presents a risk, the distributor shall inform the manufacturer and the responsible competent national authorities thereof.
5. The distributor shall ensure that, while a product is under its responsibility, storage or transport conditions do not jeopardise the product’s conformity with its declared performance or its compliance with other applicable requirements in this Regulation.
6. A distributor who considers or has reason to believe that a product, which it has made available on the market, is not in conformity with its declared performance or not in compliance with other applicable requirements in this Regulation shall make sure that the necessary corrective measures to bring that product into conformity or, if appropriate, to withdraw or to recall it, are taken. Furthermore, where the product poses a risk, the distributor shall immediately inform the competent national authorities of the Member States in which it has made the product available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
Article 26
Cases in which obligations of manufacturers apply to importers and distributors
1. An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of a manufacturer pursuant to Article 22, where:
(a) | it places a product on the market under its own name or trademark; |
(b) | it modifies a product intentionally or the product is unintentionally modified in such a way that compliance with the declaration of performance and conformity, or with the requirements set out in or adopted in accordance with this Regulation may be affected; |
(c) | it makes a product available on the market with a declared use that is different from the declared use attributed by the manufacturer in the process of assessment and verification; |
(d) | it claims for the product characteristics deviating from the characteristics declared by the manufacturer; or |
(e) | it opts to assume the role of the manufacturer. |
2. Paragraph 1 shall also apply to an economic operator who places on the market:
(a) | a used product covered by a harmonised technical specification laying down provisions for used products; |
(b) | a used product not covered by a harmonised technical specification with provisions for used products and not placed on the Union market before; |
(c) | a remanufactured product. |
3. Paragraph 1 shall not apply where the economic operator only:
(a) | adds translations of information supplied by the manufacturer; |
(b) | replaces the outer packaging of a product already placed on the market, including when changing the packaging size, if the repackaging is carried out in such a way that the original condition of the product cannot be affected by it, and that any information required by this Regulation is still correctly provided. |
4. An economic operator providing the activities listed in paragraph 3 shall inform thereof the manufacturer or its authorised representative, regardless of whether that economic operator owns the products or provides services. It shall carry out the repackaging in such a way that neither the original condition of the product nor its compliance with this Regulation is affected by the repackaging, and such that any information required by this Regulation is still correctly provided. The economic operator shall act with due care in relation to the obligations of this Regulation.
Article 27
Obligations of fulfilment service providers
1. When contributing to the making available on the market of a product, fulfilment service providers shall act with due care in relation to the obligations of this Regulation.
2. A fulfilment service provider shall make sure that the labelling and documents provided by the manufacturer or importer are available or accompany the product, and in particular:
(a) | the CE marking and the labelling referred to in Article 22(9); |
(b) | the declaration of performance and conformity; |
(c) | the general product information and the instructions for use and safety information referred to in Article 22(6). |
3. A fulfilment service provider shall ensure that the conditions during warehousing, packaging, addressing or dispatching do not jeopardise a product’s conformity with its declared performance or its compliance with other applicable requirements in this Regulation. Manufacturers or importers of construction products shall provide their fulfilment service providers with the detailed information necessary for ensuring the safe storage, packaging, addressing or dispatch, and the further functioning of the product.
4. Fulfilment service providers shall support product withdrawals or recalls, regardless of whether initiated by market surveillance authorities, manufacturers, authorised representatives or importers.
5. Where a fulfilment service provider considers or has reason to believe that a product is not in conformity with the declaration of performance and conformity or not in compliance with other applicable requirements in this Regulation, it shall not support the making available of the product on the market until the product conforms to the relevant declaration of performance and conformity, and it complies with the other applicable requirements in this Regulation, or until the declaration of performance and conformity is corrected. Furthermore, where the product presents a risk, the fulfilment service provider shall inform the manufacturer and the responsible competent national authority thereof.
Article 28
Obligations of online marketplaces
1. An online marketplace shall:
(a) | for the purpose of complying with Article 31(1) of Regulation (EU) 2022/2065 of the European Parliament and of the Council (28), design and organise its online interface in such a way that allows economic operators to fulfil their obligations under Article 29(2) of this Regulation; |
(b) | establish a single contact point for direct communication with Member States’ competent national authorities in relation to compliance with this Regulation, which can be the same as the contact point referred to in Article 22(1) of Regulation (EU) 2023/988 or Article 11(1) of Regulation (EU) 2022/2065; |
(c) | give an appropriate answer to notices related to the notification of accidents and other incidents involving products received in accordance with Article 16 of Regulation (EU) 2022/2065; |
(d) | cooperate to ensure effective market surveillance measures, including by abstaining from putting in place obstacles to such measures; |
(e) | inform the competent national authorities of any action taken with regard to the non-compliance or suspected non-compliance of products covered by this Regulation; |
(f) | establish a regular and structured exchange of information regarding content that has been removed by online marketplaces at the request of competent national authorities; |
2. As far as powers conferred by Member States in accordance to Article 14 of Regulation (EU) 2019/1020 are concerned, Member States shall confer on their market surveillance authorities the power, in respect of all products covered by this Regulation, to order an online marketplace to remove from its online interface specific illegal content referring to a non-compliant product, to disable access to it, or to display an explicit warning to end users when they access it. Such orders shall comply with Article 9 of Regulation (EU) 2022/2065.
3. An online marketplace shall take the necessary measures to receive and process in accordance with Article 9 of Regulation (EU) 2022/2065 the orders referred to in paragraph 2 of this Article.
4. This Article shall also apply to manufacturers, importers, or distributors offering products online without the involvement of an online marketplace.
Article 29
Online and other distance sales
1. Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at customers in the Union. An offer for sale shall be considered to be targeted at customers in the Union if the relevant economic operator directs, by any means, its activities to a Member State. An offer shall, inter alia, be considered to be targeted at customers in the Union where:
(a) | the economic operator uses the currency of a Member State; |
(b) | the economic operator has used an internet domain name registered in one of the Member States, or uses an internet domain that refers to the Union or to one of the Member States; or |
(c) | the geographical areas to which dispatch is available include a Member State. |
The conditions listed in the first subparagraph shall not apply if the economic operator explicitly and effectively excludes the Union market.
2. Where an economic operator makes a product available on the market online or through other means of distance selling, the offer of that product shall, where required, clearly and visibly indicate the CE marking, the information listed in Article 18(2), the label pursuant to Article 22(9) and a data carrier connected to a digital product passport in accordance with Article 22(7).
3. Any natural or legal person providing an intermediary service for the placing on the market of products shall fulfil the obligations of an economic operator pursuant to paragraph 2 in relation to the services provided.
Article 30
Implementing acts regarding the obligations and rights of economic operators
Where it is necessary, to ensure the harmonised application of this Regulation, and only to the extent necessary to prevent diverging practices fragmenting the internal market for economic operators, the Commission may adopt implementing acts providing details on how economic operators are to fulfil the obligations and exercise the rights set out in this Chapter.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
CHAPTER IV
EUROPEAN ASSESSMENT DOCUMENTS
Article 31
European assessment documents
1. The methods and criteria for assessing the performance of products, including used products, in relation to their essential characteristics may be laid down in European assessment documents provided that the products are not covered by:
(a) | a harmonised standard made mandatory by an implementing act referred to in Article 5(8); |
(b) | an implementing act referred to in Article 6(1); or |
(c) | a harmonised standard to be delivered in a period shorter than one year, in accordance with a standardisation request referred to in Article 5(2). |
2. A product shall not be considered to be covered by harmonised standards or implementing acts referred to in paragraph 1 where:
(a) | the declared use of the product falls outside of the scope of the intended use set out in the harmonised standard or implementing act; |
(b) | the materials used are not identical to the materials to be used in accordance with the harmonised standard or implementing act; or |
(c) | the assessment method set out in the harmonised standard or implementing act is not appropriate for that product. |
3. Following a request for a European technical assessment by a manufacturer, a group of manufacturers or a manufacturers’ association, or on the initiative of the Commission, the organisation of TABs may, in agreement with the Commission, draw up and adopt a European assessment document.
The basic requirements for construction works set out in Annex I and the list of predetermined environmental essential characteristics set out in Annex II shall constitute the basis for the preparation of European assessment documents. The development and adoption of a European assessment document shall follow the principles and the procedure set out in Article 32.
4. European assessment documents shall not be drawn up in relation to an essential characteristic of, or assessment method for, a product when there is another European assessment document covering the same essential characteristic or assessment method in relation to that specific product, the reference of which has either already been published in the Official Journal of the European Union, or which has been submitted to the Commission for assessment in accordance with Article 34(1).
5. The organisation of TABs and the Commission may merge or reject requests for the development of a European assessment document in accordance with point 5 of Annex VI.
6. From the date of mandatory application of a harmonised technical specification adopted in accordance with Article 5(8) or Article 6(1), covering the same product and the same intended use as a European assessment document, the European assessment document shall no longer be used for the purposes of this Regulation. In that case the Commission shall withdraw the reference of the European assessment document from the Official Journal of the European Union.
7. European assessment documents shall constitute the basis for European technical assessments set out in Article 37.
Article 32
Principles and procedure for the development and adoption of European assessment documents
1. When developing and adopting European assessment documents, individual TABs and the organisation of TABs shall follow the procedure set out in Annex VI.
2. When developing and adopting European assessment documents, individual TABs and the organisation of TABs shall:
(a) | be transparent to Member States, the manufacturer concerned and to other manufacturers or stakeholders that request to be informed; |
(b) | disclose confidential information to the Commission only when necessary to assess the compliance of a European assessment document with regulatory provisions and protect commercial secrecy and confidentiality; |
(c) | specify appropriate mandatory time limits in order to avoid unjustified delay; |
(d) | allow for adequate participation by the Member States and the Commission; |
(e) | be cost-effective for the manufacturer; and |
(f) | ensure sufficient collegiality and coordination amongst TABs designated for the product in question. |
The balancing of requirements laid down in points (a) and (b) of the first subparagraph shall allow at least for the disclosure of the name of the product at the stage of the approval and the communication of the work programme, as set out in point 3 of Annex VI, and for the disclosure of the detailed contents of the draft European assessment document set out in point 8 of Annex VI.
3. The TABs shall, together with the organisation of TABs, bear the full costs of the development and adoption of European assessment documents, unless such development is initiated by the Commission.
4. TABs and the organisation of TABs shall avoid the proliferation of European assessment documents where there is no technical justification for differentiating between products. They shall, in particular, give preference to extending the scope of existing European assessment documents over creating new European assessment documents.
5. The Commission is empowered to adopt, after consultations with the organisation of TABs, delegated acts in accordance with Article 89 to amend Annex VI in order to add additional procedural rules for the development and adoption of European assessment documents, where it is necessary to ensure the good functioning of the system of European assessment documents.
Article 33
Obligations of the TAB receiving a request for a European technical assessment
1. When receiving a request for a European technical assessment from a manufacturer, a group of manufacturers or a manufacturers’ association, the TAB shall comply with the following requirements:
(a) | where the product is covered by a harmonised technical specification or a European assessment document cannot be drawn up in accordance with Article 31, the TAB shall inform the applicant that a European technical assessment cannot be issued; |
(b) | where the product is fully covered by a European assessment document the reference of which has been published in the Official Journal of the European Union, the TAB shall inform the applicant that the referenced European assessment document will be used as the basis for the European technical assessment to be issued; |
(c) | where the product is eligible for a European assessment document referred to in Article 31, and no such document is in the process of being developed, the TAB shall inform the applicant that the procedures set out in Annex VI will be initiated. |
In the cases referred to in point (c) of the first subparagraph of this Article, but where a harmonised standard covering the same product is expected to be delivered in a period longer than one year as established in a standardisation request referred to in Article 5(2), the TAB shall inform the applicant about the possibility of a European assessment document no longer being used pursuant to Article 31(6).
2. In the cases referred to in paragraph 1, first subparagraph, points (b) and (c) of this Article, the TAB shall inform the organisation of TABs and the Commission of the content of the request and of the reference to a relevant delegated act determining the assessment and verification system referred to in Article 10(2), which the TAB intends to apply for that product, or of the lack of such delegated act.
3. If the Commission considers that an appropriate delegated act determining the assessment and verification system does not exist for the product, it may adopt a delegated act in accordance with Article 10(2).
Article 34
Publication of references
1. The Commission shall, in accordance with point 9 of Annex VI, assess the compliance of European assessment documents with harmonised technical specifications, with this Regulation and with other Union law. Where a European assessment document is in conformity with applicable legal requirements, the Commission shall without delay publish a reference of that document in the Official Journal of the European Union. Where a reference to a European assessment documents cannot be published in the Official Journal of the European Union, the Commission may publish such a reference with restrictions.
2. Following publication in accordance with paragraph 1 of this Article, a European assessment document may, in accordance with Article 37, be used as a basis for a European technical assessment for a period of 10 years, unless the reference of the European assessment document has been withdrawn from the Official Journal of the European Union or that European assessment document is no longer used pursuant to Article 31(6). The organisation of TABs may in the last year of that period decide to submit the European assessment document for renewal. The Commission shall in that case reassess the European assessment document in accordance with paragraph 1 of this Article.
Article 35
Content of the European assessment document
1. A European assessment document shall contain the following elements:
(a) | a description of the product or product category covered and its intended use; and |
(b) | the list of essential characteristics, relevant for the intended use of the product or product category as agreed between the manufacturer and the organisation of TABs as well as predetermined environmental essential characteristics as set out in Annex II, and the methods and criteria for assessing the performance of the product or product category in relation to the essential characteristics listed. |
2. The European assessment document shall set out:
(a) | the technical details necessary for the implementation of the assessment and verification systems that are to be applied in accordance with the delegated acts adopted under Article 10(2); |
(b) | the guidelines, including technical details necessary for drawing up general product information, instructions for use and safety information as referred to in Annex IV; |
(c) | the guidelines to ensure interoperability of the human and machine readable formats for the declaration of performance and conformity in accordance with paragraph 16(2), point (b). |
3. Where the performance of the product can appropriately be assessed by reference to its essential characteristics, including assessment methods and criteria, already established for them in harmonised technical specifications or other European assessment documents, those existing essential characteristics and their methods and criteria shall be incorporated as parts of the European assessment document, unless it is technically necessary to deviate from that rule.
Where applicable, these principles shall also apply for threshold levels and classes of performance adopted in accordance with Article 5(5).
Article 36
Formal objections against European assessment documents
1. A Member State shall inform the Commission of all of the following:
(a) | where it considers that a European assessment document does not entirely conform with applicable legal requirements or satisfy the demands to be met in relation to the essential characteristics to be covered in view of the basic requirements for construction works set out in Annex I and the predetermined environmental essential characteristics set out in Annex II; |
(b) | where it considers that a European assessment document raises a major concern for health and safety of persons, the protection of the environment or consumer protection; |
(c) | where it considers that a European assessment document does not fulfil the requirements set out in Article 31(1). |
The Member State concerned shall substantiate its viewpoints. The Commission shall consult the other Member States on the issues raised by the Member State concerned.
2. In the light of the views of all the Member States, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the European assessment documents concerned in the Official Journal of the European Union.
3. The Commission shall inform the Member States and the organisation of TABs of its decision referred to in paragraph 2 and, where necessary, request the revision of the European assessment document concerned.
Article 37
European technical assessment
1. A European technical assessment shall be issued by a TAB, at the request of a manufacturer on the basis of a European assessment document the reference of which has been published in the Official Journal of the European Union in accordance with Article 34.
Provided that there is a European assessment document the reference of which has been published in the Official Journal of the European Union in accordance with Article 34, a European technical assessment may be issued even in the case where a standardisation request has been issued. Such issuing shall be possible until the European assessment document is no longer used pursuant to Article 31(6).
2. When a request for a European technical assessment is made, the procedure laid down in Annex VI shall apply.
3. The European technical assessment shall include the performance to be declared, by levels or classes, or in a description, of those essential characteristics that are agreed by the manufacturer and the TAB receiving the request for the European technical assessment for the declared use, and the technical details necessary for the implementation of the assessment and verification system.
The European technical assessment shall also include the assessment of the performance for the predetermined environmental essential characteristics listed in Article 15(3).
4. The Commission may adopt implementing acts to establish the format of the European technical assessment.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
5. European technical assessments issued on the basis of a European assessment document remain valid for either five years after the end of the period set out in Article 34(2) or five years after the reference of the European assessment document is withdrawn from the Official Journal of the European Union.
When the relevant European assessment document for a product is no longer used pursuant to Article 31(6), that product may no longer be placed on the market on the basis of a European technical assessment.
6. Products covered by a European assessment document for which a European technical assessment has been issued may be CE marked and thereby obtain the same status as products CE marked on the basis of harmonised technical specifications, where the manufacturer satisfies the obligations set out in this Regulation. Where these obligations refer to harmonised technical specifications, the manufacturer shall refer to the European assessment document instead or, where the harmonised technical specifications are also relevant, in addition.
CHAPTER V
TECHNICAL ASSESSMENT BODIES
Article 38
Designating authorities
1. Member States wishing to designate TABs shall designate a single designating authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and designation of TABs. Designating authorities shall satisfy the requirements for notifying authorities set out in Articles 43(1) and Article 44. Member States may designate the notifying authority referred to in Article 43, as the designating authority. The designating authority shall not be eligible for designation in accordance with Article 39(1).
2. Unless otherwise specified in this Chapter, the provisions applicable to notifying authorities and to notification procedures apply also to designating authorities and to the designation procedures.
Article 39
Designation, monitoring and evaluation of TABs
1. Member States may, through their designating authorities, designate TABs within their territories for one or several product families listed in Annex VII. Member States may also designate TABs within their territories as competent for emerging or innovative products that do not fall into already existing product families listed in Annex VII.
Member States shall communicate the name of the TAB, its address and the product family or families it is competent for to the Commission.
2. The Commission shall assign an identification number to each TAB.
The Commission shall make publicly available the list of TABs designated under this Regulation by electronic means and indicate their identifications numbers, the product families for which they are designated and any limitations in the most precise possible way.
The Commission shall ensure that that list is kept up-to-date.
3. The designating authority shall monitor the activities and competence of the TABs designated in their respective Member State, and where necessary their subsidiaries and subcontractors, and evaluate them in relation to the respective requirements set out in this Chapter. The designating authority shall impose corrective measures on TABs wherever there is an infringement of this Regulation.
Member States shall inform the Commission of their national procedures for the designation of TABs, of the monitoring of their activity and competence, and of any changes to that information.
4. TABs shall, without delay, and at the latest within 15 days, inform the designating authority of any changes which may affect their compliance with the requirements set out in this Chapter or their ability to satisfy their obligations under this Regulation.
5. TABs shall, at the request of the relevant designating authority, supply all relevant information and documents, required to enable that authority, the Commission and the Member States to verify their compliance with the requirements under this Regulation.
6. Where a TAB no longer complies with the requirements of this Regulation, the designating authority shall restrict, suspend or withdraw the designation of that TAB for the relevant product family as appropriate, depending on the seriousness of the failure to meet those requirements. Where a TAB has repeatedly not complied with corrective measures imposed in accordance with paragraph 3 of this Article, the designating authority may restrict, suspend or withdraw the designation of that TAB. The designating authority shall inform the Commission and the other Member States of any restriction, suspension or withdrawal of a designation. Articles 53(2) and 54 shall apply.
Article 40
Requirements for TABs
1. A TAB shall be competent, and equipped, to carry out the assessment in relation to the product families for which it has been designated. The decision-making staff and at least half of the technical competent staff shall be employed by the TAB under the national law of the designating Member State.
2. The TAB shall satisfy the requirements set out in Annex VIII, within the scope of its designation. Article 46(2) to (5), Article 46(6), points (a) and (b), Article 46(7), (8), (9) and (11) and Article 47 shall apply.
3. A TAB shall have made publicly available its organigram and the names of the members of its internal decision-making bodies.
4. A TAB shall participate in the activities of the organisation of TABs or ensure that their assessment personnel is informed about those activities.
Article 41
Coordination of TABs
1. The TABs shall establish an organisation for technical assessment (‘organisation of TABs’) under this Regulation.
2. The organisation of TABs shall at least carry out the following tasks:
(a) | supply the Commission with relevant technical content relating to European assessment documents when the development of harmonised technical specifications based on the same product families is due to take place in accordance with the working plan referred to in Article 4(2). That information shall be based on close collaboration with the relevant European standardisation organisations; |
(b) | organise the coordination of the TABs and, if necessary, ensure cooperation and consultation with other stakeholders; |
(c) | ensure that examples of best practice are shared between TABs to promote greater efficiency and provide a better service to industry; |
(d) | develop and adopt European assessment documents; |
(e) | coordinate the application of the procedures set out in Article 59(2), Article 60(2) and in Article 61(2), as well as provide the support needed to that end; |
(f) | inform the Commission of any question related to the preparation of European assessment documents and of any aspects related to the interpretation of the procedures set out in Article 60(2) and in Article 61(2) and suggest improvements to the Commission based on experience gained; |
(g) | communicate any observations concerning a TAB not satisfying its tasks in accordance with the procedures set out in Article 60(2) and in Article 61(2) to the Commission and the Member State which designated the TAB; |
(h) | report annually to the Commission on:
|
(i) | ensure that adopted European assessment documents and references to European technical assessments are kept publicly available. |
The organisation of TABs shall set up a secretariat in order to carry out these tasks.
3. Member States shall ensure that the TABs contribute adequately with financial and human resources to the organisation of TABs. Organisation of TABs shall establish the contribution of each TAB which shall be proportionate taking into account the annual budget or turnover of each TAB related to its activities as TAB.
4. The weight in the decision-making process of the organisation of TABs shall not depend on the TABs’ financial contribution, the number of European assessment documents developed or the number of European technical assessments issued by them.
5. The Commission shall be invited to participate in all meetings of the organisation of TABs.
6. Union financing may be granted to the organisation of TABs for the implementation of the tasks referred to in paragraph 2. The Commission may make the financing of the organisation of TABs, whether by way of grants or public tenders, subject to the fulfilment of certain organisational and performance requirements set out in those tasks.
CHAPTER VI
NOTIFYING AUTHORITIES AND NOTIFIED BODIES
Article 42
Notification
1. Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party tasks in the assessment and verification of performance, assessment of conformity and of the verification of environmental sustainability calculations for the purposes of this Regulation.
2. Member States shall inform the Commission of their procedures for the assessment and notification of bodies to be authorised to carry out these tasks and the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available.
Article 43
Notifying authorities
1. Member States shall designate a notifying authority responsible for setting up and carrying out the necessary procedures for the assessment and notification of the bodies to be authorised to carry out third-party tasks in the assessment and verification process for the purposes of this Regulation, and the monitoring of notified bodies, including their compliance with requirements laid down in Articles 46 and 48.
2. Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by their national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body which is not a governmental entity that body shall be a legal person and shall comply mutatis mutandis with the requirements laid down in Article 44. In addition, it shall have arrangements to cover liabilities arising out of its activities.
4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraphs 2 and 3.
Article 44
Requirements relating to notifying authorities
1. The notifying authority shall be established in such a way that no conflicts of interest with notified bodies occur.
2. The notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
3. The notifying authority shall be organised in such a way that each decision relating to notification of a body to be authorised to carry out third-party tasks in the assessment and verification process is taken by competent persons different from those who carried out the assessment.
4. The notifying authority shall not offer or provide any activities that notified bodies perform, or consultancy services on a commercial or competitive basis.
5. The notifying authority shall safeguard the confidentiality of the information obtained. However, it shall, upon request, exchange information on notified bodies with the Commission, with notifying authorities of other Member States and with other competent national authorities which shall safeguard the confidentiality of the information received.
6. The notifying authority, including in the cases in which the notifying authority is the national accreditation body, shall assess only the specific conformity assessment body applying for notification and not take account of the capacities or personnel of parent or sister companies. The notifying authority shall assess that body in relation to all relevant requirements and third-party assessment and verification tasks.
7. The notifying authority shall have a sufficient number of competent personnel and sufficient funding at its disposal for the proper performance of its tasks.
Article 45
Coordination of notifying and designating authorities
1. The Commission shall ensure that appropriate coordination and cooperation between the Member States’ national authorities responsible for notification policy and the notifying and designating authorities is put in place and operated in the form of a coordination group of notifying and designating authorities in the field of construction products. That group shall meet on a regular basis and at least annually.
Member States’ national authorities responsible for notification policy and the notifying and designating authorities under this Regulation shall participate in the activities of that group.
2. The Commission may establish the specific arrangements for the functioning of the coordination group of the notifying and designating authorities.
3. The Commission shall provide for the organisation of regular exchanges of experience between the Member States’ national authorities responsible for notification policy and the notifying and designating authorities.
Article 46
Requirements relating to notified bodies
1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 12.
2. A conformity assessment body shall be established under the national law of a Member State and have legal personality.
3. A conformity assessment body shall be a third-party body independent of the organisation or the product it assesses.
It shall not have any business ties with organisations that have an interest in the products it assesses, in particular with manufacturers, their trade partners and their shareholding investors.
However, a body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body. This shall not preclude the body from carrying out assessment and verification activities for competing manufacturers.
4. A conformity assessment body, its top-level management and the personnel responsible for carrying out the third-party tasks in the assessment and verification process shall not be the designer, manufacturer, supplier, importer, distributor, installer, purchaser, owner, user or maintainer of the products which it assesses, or the representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of products for personal purposes.
A conformity assessment body, its top-level management and the personnel responsible for carrying out the third-party tasks in the assessment and verification process shall not be directly involved in the design, manufacture or construction, or marketing, installation, use or maintenance of those products, nor represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement and integrity related to the activities for which they have been notified. This shall apply in particular to consultancy services in relation to product families for which they have been notified.
Conformity assessment bodies shall ensure that activities of their parent or sister companies, their subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of their assessment or verification activities.
A conformity assessment body shall not delegate to a subcontractor or a subsidiary the establishment and the supervision of internal procedures, general policies, codes of conduct or other internal rules, the assignment of its personnel to specific tasks and the conformity assessment decisions.
5. Conformity assessment bodies and their personnel shall carry out the third-party tasks in the assessment and verification process with the highest degree of professional integrity and requisite technical competence in the specific field. They shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their assessment or verification activities, especially from persons or groups of persons with an interest in the results of those activities.
6. A conformity assessment body shall be capable of carrying out all the third-party tasks in the assessment and verification process assigned to it in accordance with Annex IX in relation to which it has been notified, irrespective of whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.
At all times and for each assessment and verification system and for each kind or category of products, essential characteristics and tasks in relation to which it has been notified, the conformity assessment body shall have the following at its disposal:
(a) | the necessary competent personnel with technical knowledge and sufficient and appropriate experience to perform the third-party tasks in the assessment and verification process; |
(b) | the necessary description of the procedures in accordance with which the assessment process is carried out, ensuring the transparency and the ability of reproduction of those procedures, including a description of competence showing how relevant personnel, their status and tasks correspond to the conformity assessment tasks in relation to which the body intends to be notified; |
(c) | appropriate policies and procedures to distinguish between the tasks it carries out as a conformity assessment body and its other activities; |
(d) | procedures for the performance of activities, which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process. |
The conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the activities for which it intends to be notified in an appropriate manner and shall have access to all necessary equipment or facilities.
7. The personnel responsible for carrying out the activities in relation to which the body intends to be notified, shall have the following:
(a) | sound technical and vocational training covering all the third-party tasks in the assessment and verification process within the relevant scope for which the body has been notified; |
(b) | satisfactory knowledge of the requirements of the assessments and verifications it carries out and adequate authority to carry out such operations, including appropriate knowledge and understanding of the applicable harmonised technical specifications, European assessment documents and of the relevant provisions of the Regulation; |
(c) | the ability required to draw up the certificates, records and reports to demonstrate that the assessments and the verifications have been carried out. |
8. Personnel responsible for taking assessment decisions shall:
(a) | be employed by the conformity assessment body under the national law of the notifying Member State; |
(b) | not have any potential conflict of interest, |
(c) | be competent to verify the assessments made by other staff, external experts or subcontractors; |
(d) | be sufficient in number to ensure business continuity and a consistent approach to conformity assessments. |
9. The impartiality of the body and its top-level management and of the assessment personnel shall be guaranteed.
The remuneration of the top-level management and assessment personnel of a body shall not depend on the number of assessments carried out or their results.
10. A conformity assessment body shall take out liability insurance, unless liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible for the assessment or the verification performed.
11. The personnel of the conformity assessment body shall observe professional secrecy regarding all information obtained in carrying out its tasks under Annex IX, except in relation to the notifying authorities and other competent national authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.
12. Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed about the relevant standardisation activities and the activities of the notified body coordination group established under this Regulation and shall apply as general guidance the administrative decisions and documents produced as a work result of that group.
Article 47
Presumption of conformity of notified bodies
Where a conformity assessment body to be authorised to carry out third-party tasks in the assessment and verification process demonstrates its conformity with the criteria laid down in the relevant harmonised standards the references of which have been published in the Official Journal of the European Union, harmonised technical specifications referred to in Article 5, European assessment documents, voluntary harmonised standards for product requirements the references of which have been published in the Official Journal of the European Union in accordance with Article 7(5) or (6) or the common specifications referred to in Article 8(1) or parts thereof, it shall be presumed to comply with the requirements set out in Article 46 in so far as the applicable documents cover those requirements.
Article 48
Subsidiaries and subcontractors of notified bodies
1. Where a notified body subcontracts specific tasks connected with the third-party tasks in the assessment and verification process or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 46, and shall inform the notifying authority accordingly.
2. The notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established and monitor their competence in relation to its own as described in Article 46(6), point (b).
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.
4. The notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment and monitoring of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex IX.
Article 49
Use of facilities outside the testing laboratory of the notified body
1. At the request of the manufacturer and where justified by technical, economic or logistic reasons related to the nature of the product or the test equipment, notified bodies may decide to carry out the tests referred to in Annex IX, for the assessment and verification systems 1+, 1 and 3 or have such tests carried out under their supervision, either in the manufacturing plants using the test equipment of the internal laboratory of the manufacturer or, with the prior consent of the manufacturer, in an external laboratory, using the test equipment of that laboratory.
Notified bodies carrying out such tests shall be specifically designated as competent to work away from their own test facilities and shall also in that regard comply with the requirements laid down in Article 46.
2. Before carrying out the tests referred to in paragraph 1, notified bodies shall verify whether the requirements of the test method are satisfied and shall evaluate whether:
(a) | test equipment has an appropriate calibration system and the traceability of the measurements is guaranteed; and |
(b) | the quality of the test results is ensured. |
Notified bodies shall assume full responsibility for the tests in their entirety, including the accuracy and traceability of calibration and measurements, and for the reliability of the test results.
Article 50
Application for notification
1. A body to be authorised to carry out third-party tasks in the assessment and verification systems shall submit an application for notification to the notifying authority of the Member State in which it is established.
2. The application shall be accompanied by a description of the activities to be performed, the assessment and verification processes for which the body claims to be competent, the description of competence referred to in Article 46(6), point (b), as well as an accreditation certificate, where one exists, issued by the national accreditation body, attesting that the body fulfils the requirements laid down in Article 46. The accreditation certificate shall relate only to the precise legal body applying for notification and shall be based, in addition to relevant harmonised standards, on the specific requirements and tasks provided for in this Regulation.
3. Where the body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 46.
Article 51
Notification procedure
1. Notifying authorities may notify only bodies which have satisfied the requirements laid down in Article 46.
2. Notifying authorities shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.
Exceptionally, for cases regarding groupings of essential characteristics set out in Annex X, for which the appropriate electronic tool is not available, a notification in other electronic form shall be accepted.
3. The notification shall include full details of the functions to be performed, reference to the relevant harmonised technical specification or to the relevant European assessment document and, for the purposes of the system set out in Annex IX, the essential characteristics for which the body is competent and the relevant attestation of that competence.
However, reference to the relevant harmonised technical specification or to the relevant European assessment document is not required in the cases regarding groupings of essential characteristics set out in Annex X.
4. Where a notification is not based on an accreditation certificate as referred to in Article 50(2), the notifying authority shall provide the Commission and the other Member States with all documentary evidence which attests to the body’s competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 46.
5. The body concerned may perform the activities of a notified body if the Commission or the other Member States do not raise any objections within two weeks of a notification, where an accreditation certificate is used, or within two months of notification, where an accreditation certificate is not used.
Only such a body shall be considered a notified body for the purpose of this Regulation.
6. Valid notifications shall be included by the Commission in the list of notified bodies referred to in Article 52(2).
7. The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification.
Article 52
Identification numbers and lists of notified bodies
1. The Commission shall assign an identification number to a notified body.
It shall assign a single such number even where the body is notified under several Union acts.
2. The Commission shall make publicly available the list of bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified.
The Commission shall ensure that that list is kept up-to-date.
Article 53
Changes to the notification
1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 46, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the notification as appropriate, depending on the seriousness of the failure to meet those requirements or to fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.
2. In the event of a restriction, suspension or withdrawal of a notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that that body’s files are either processed by another notified body or kept available for the responsible notifying and competent national authorities at their request.
Article 54
Challenge of the competence of notified bodies
1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.
2. The notifying Member State shall provide the Commission, on request, with all information related to the basis for notification or the maintenance of the competence of the body concerned.
3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.
4. Where the Commission ascertains that a notified body does not meet, or no longer meets, the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including withdrawal of notification if necessary.
Article 55
Operational obligations of notified bodies
1. Notified bodies shall, in accordance with Annex IX carry out the following assessments and verifications:
(a) | assess the performance and the conformity of products; |
(b) | verify the conformity of products; |
(c) | verify the constancy of performance of products; |
(d) | validate the environmental sustainability calculations undertaken by the manufacturer; |
(e) | verify the compliance of the manufacturer with the obligations of this Regulation. |
Those tasks are hereinafter referred to as ‘assessments and verifications’.
2. Assessments and verifications shall be carried out with transparency as regards the manufacturer, and in a proportionate manner, avoiding an unnecessary burden for economic operators. The notified bodies shall perform their activities taking due account of the size of the undertaking, the sector in which the undertaking operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
In so doing, the notified bodies shall nevertheless respect the degree of rigour required for the product by this Regulation and the part played by the product for the fulfilment of all basic requirements for construction works.
3. Where, in the course of the initial inspection of the manufacturing plant and of factory production control, a notified body finds that the manufacturer has not ensured the constancy of performance and conformity of the manufactured product, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate or a validation report.
4. Where, in the course of the monitoring activity aiming at the verification of conformity and of the constancy of performance of the manufactured product, a notified body finds that a product no longer has the same performance to that of the product-type, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the validation report if necessary.
5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates or validation reports, as appropriate.
6. When taking assessment decisions, including when deciding on the need to suspend or withdraw a certificate or validation report in light of possible instances of non-compliance, notified bodies shall apply clear and pre-determined criteria.
7. When requested by a manufacturer or provider to do so, notified bodies shall cooperate and share all relevant information with notified bodies that have recognised its assessments and verifications in accordance with Article 62. Notified bodies shall establish an agreement for that purpose.
Article 56
Information obligations of notified bodies
1. Notified bodies shall inform the notifying authority of the following:
(a) | any refusal, restriction, suspension or withdrawal of certificates, validation reports or test reports; |
(b) | any circumstances affecting the scope of, and conditions for, notification; |
(c) | any request for information on assessment or verification activities carried out which they have received from competent national authorities; and |
(d) | on request, third-party tasks in accordance with the assessment and verification systems carried out within the scope of their notification and any other activity performed, including cross-border activities and subcontracting. |
2. Notified bodies shall provide the other bodies notified under this Regulation which carry out similar third-party tasks in accordance with the assessment and verification systems and for products covered by the same harmonised technical specification or the same European assessment document with relevant information on issues relating to negative results from these assessments and verifications, in particular, any refusal, restriction, suspension, or withdrawal of certificates, validation reports or of test reports, and, upon request, positive results from those assessments.
A notified body shall, upon request from another notified body, a competent national authority or the Commission inform the requesting party whether certificates, validation reports or test reports issued by it are valid, restricted, suspended or withdrawn.
3. Where the Commission or a competent national authority of a Member State submits a request to a notified body established on the territory of another Member State relating to an assessment carried out by that notified body, it shall send a copy of that request to the notifying authority of that other Member State. The notified body concerned shall respond without delay and within 15 days at the latest to the request. The notifying authority shall ensure that such requests are resolved by the notified body unless there is a legitimate reason for not doing so.
4. Where notified bodies have or receive evidence that:
(a) | another notified body does not comply with the requirements laid down in Article 46 or its obligations; |
(b) | a product placed on the market does not comply with this Regulation; |
(c) | a product placed on the market, due to its physical condition, is likely to cause a serious risk, |
they shall alert and share such evidence with the relevant market surveillance authority or notifying authority, as appropriate.
Article 57
Implementing acts on notified bodies’ obligations
Where this is necessary to ensure a harmonised application of this Regulation and where the coordination group of notifying and designating authorities have not been able to resolve a dispute concerning their diverging practices, in accordance with Article 45, and only to the extent necessary to prevent diverging practices fragmenting the internal market for economic operators, the Commission may adopt implementing acts providing details on how to execute the obligations of notified bodies contained in Articles 55 and 56.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
Article 58
Coordination of notified bodies
1. The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put into place and properly operated in the form of a group of notified bodies.
Notified bodies shall participate in the work of that group, directly or by means of designated representatives. Notifying authorities shall ensure that notified bodies participate in the work of that group.
2. Notified bodies shall apply as general guidance any relevant documents produced as a result of the work of the group referred to in paragraph 1.
3. Coordination and cooperation in the group referred to in paragraph 1 shall aim to ensure the harmonised application of this Regulation.
CHAPTER VII
SIMPLIFIED PROCEDURES
Article 59
Replacement of type-testing and type-calculation
1. A manufacturer may replace type-testing or type-calculation with a specific section in the technical documentation referred to in Article 22(3) demonstrating that:
(a) | for one or several essential characteristics of the product, which the manufacturer places on the market, that product is deemed to achieve a certain level or class of performance without testing or calculation, or without further testing or calculation, in accordance with the conditions set out in the delegated acts referred to in Article 5(6); or |
(b) | the product, covered by a harmonised technical specification or a European assessment document, which the manufacturer places on the market is a system made of components, which the manufacturer duly assembles following precise instructions, including compatibility criteria in the case of individual components, given by the provider of such a system or of a component thereof, who has already tested that system or that component for one or several of its essential characteristics in accordance with the relevant harmonised technical specification or European assessment document. When these conditions are satisfied and when the manufacturer has notably verified that the precise compatibility criteria of the provider are met, the manufacturer is entitled to declare performance corresponding to all or part of the test results provided to it for the system or the component; |
(c) | the product, covered by a harmonised technical specification or by a European technical assessment, which the manufacturer places on the market, corresponds to a product-type of a product manufactured by another manufacturer and is already subject to type-testing or type-calculation. |
When the conditions in point (c) are satisfied, the manufacturer may declare the performance corresponding to all or part of the results of this other product. The manufacturer shall only apply this simplification after having obtained an authorisation of the other manufacturer, who remains responsible for the accuracy, reliability and stability of those test results.
2. If the assessment and verification system applicable includes a performance assessment by a notified body as set out in Annex IX, a notified body or TAB shall, in place of the assessment of the performance of the product set out in Annex IX, assess and certify the correct fulfilment of the obligations referred to in paragraph 1 of this Article.
Article 60
Use of simplified procedures by micro-enterprises
1. A micro-enterprise may replace type-testing or type-calculation for an essential characteristic under assessment and verification system 3 set out in point 5 of Annex IX with a specific section in the technical documentation referred to in Article 22(3) providing data equivalent to the assessment required for this essential characteristic in accordance with the applicable harmonised technical specifications or European assessment document.
2. A notified body or TAB shall, instead of the assessment of the performance of the product set out in Annex IX, assess and certify the correct fulfilment of the obligations referred to in paragraph 1 of this Article.
Article 61
Custom-made non-series products
1. As an alternative to the exemption in Article 14, point (a), a manufacturer of a product that fulfils the conditions in Article 14, point (a), may replace the performance assessment of the product with a specific section in the technical documentation referred to in Article 22(3) demonstrating the compliance of that product with the applicable requirements and providing data equivalent to the data required by this Regulation and the applicable harmonised technical specifications or European assessment document.
2. If the assessment and verification system applicable includes a performance assessment by a notified body as set out in Annex IX, a notified body or TAB shall, in place of the assessment of the performance of the product set out in Annex IX, assess and certify the correct fulfilment of the obligations referred to in paragraph 1 of this Article.
Article 62
Recognition of assessment and verification by another notified body
1. When a notified body is to assess and verify a certain product in accordance with Annex IX, it may refrain from the assessment and verification and recognise the assessment and verification undertaken by another notified body for the same economic operator where all of the following conditions apply:
(a) | the product has been correctly assessed and verified by the other notified body; |
(b) | the assessed or verified economic operator agrees to share all relevant data and documents with the recognising notified body; and |
(c) | the validity of the certificate is limited to the validity of the certificate issued by the other notified body. |
This paragraph shall also apply to validation reports and to assessments of calculation of the environmental sustainability undertaken under Regulation (EU) 2024/1781.
2. When a notified body is to assess and verify a certain product in accordance with Annex IX, it may refrain from the assessment and verification of its parts or materials and recognise the results of the assessment and verification by another notified body, if the provider of those parts or materials applied the required assessment and verification system to them and there is an agreement between the manufacturer of the product and the provider that ensures the free flow of all information between them and the notified bodies in view of ensuring compliance with this Regulation.
This paragraph shall also apply to assessments of the calculation of the environmental sustainability undertaken under Regulation (EU) 2024/1781.
CHAPTER VIII
MARKET SURVEILLANCE AND SAFEGUARD PROCEDURES
Article 63
Complaint portal
1. Without prejudice to the obligations of economic operators under this Regulation and the activities of market surveillance authorities under Regulation (EU) 2019/1020, the Commission shall set up a system allowing any natural or legal person to share complaints or reports related to possible non-compliance with this Regulation.
2. Where the Commission considers a complaint or report relevant and substantiated based on clearly defined criteria, it shall without undue delay transmit that complaint or report to the single liaison point of the Member State concerned for that single liaison point to follow-up with the relevant natural or legal person in accordance with Article 11(7), point (a) of Regulation (EU) 2019/1020.
Article 64
Market surveillance authorities and single liaison point
1. Member States shall designate, amongst their market surveillance authorities, one or more authorities that dispose of the particular knowledge needed to assess products both technically and legally.
2. Member States shall designate a single liaison point to act as the focal point for contacts with the Commission and single liaison points of other Member States which are competent under this Regulation, including for requests pursuant to Articles 22, 23 and 24 of Regulation (EU) 2019/1020.
3. Market surveillance authorities designated in accordance with paragraph 1 of this Article shall have all the powers listed in Article 14 of Regulation (EU) 2019/1020. For the purposes of this Regulation those powers shall also apply to all economic operators covered by this Regulation.
4. For the purpose of market surveillance, investigation and enforcement, market surveillance authorities shall have the power to request from other authorities or bodies relevant information in their possession.
Article 65
Procedure to deal with non-compliance
1. Where a market surveillance authority of one Member State has sufficient reason to believe that certain products covered by a harmonised technical specification or for which a European technical assessment has been issued, or their manufacturer, are non-compliant, it shall carry out an evaluation in relation to those products and the manufacturer concerned covering the respective requirements laid down by this Regulation. The relevant economic operators shall, as necessary, cooperate with the market surveillance authorities.
Where, in the course of that evaluation, the market surveillance authority finds that the products or their manufacturer do not comply with the requirements and obligations laid down in this Regulation, it shall without delay require the relevant economic operator to take appropriate and proportionate corrective actions, as provided for in Article 16(3) of Regulation (EU) 2019/1020, to bring the non-compliance to an end or, if that is not possible, to withdraw the products from the market, or to recall them, all within a reasonable period which is commensurate with the nature of the non-compliance.
The market surveillance authority shall inform the notified bodies accordingly, if notified bodies are involved.
2. Where the market surveillance authority considers that the non-compliance is not limited to its national territory, it shall, via the single liaison point, inform the Commission and the other Member States of the results of the evaluation and of the actions which it has required the economic operator to take.
3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union.
4. Where the relevant economic operator, within the period referred to in the second subparagraph of paragraph 1, does not take the corrective action referred to in paragraph 1, second subparagraph, or where the non-compliance persists, the market surveillance authority shall ensure that the product concerned is withdrawn or recalled, or that making it available on the market is prohibited or restricted.
The market surveillance authority shall inform the public, and via the single liaison point the Commission and the other Member States, without delay, of those measures.
5. The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant products, the origin of those products, the nature of the non-compliance alleged and the risk involved, the nature and duration of national measures taken as well as the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:
(a) | failure of the products to achieve the declared performance; |
(b) | failure of the products to meet product requirements established by delegated acts referred to in Article 7(1); |
(c) | failure of the manufacturer to meet obligations; |
(d) | shortcomings in the harmonised technical specifications, in a European assessment document, in the voluntary harmonised standards for product requirements the references of which have been published in the Official Journal of the European Union in accordance with Article 7(5) or (6) or in the common specifications established by implementing acts referred to in Article 8(1). |
6. Member States other than the Member State initiating the procedure shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the products concerned, and, in the event of disagreement with the notified national measure, of their objections.
7. Where, within two months of receipt of the information referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State in relation to the product concerned, that measure shall be deemed justified.
8. Member States shall ensure that appropriate restrictive measures are taken without delay in respect of the product or manufacturer concerned, such as withdrawal of the products from their market.
Article 66
Union safeguard procedure
1. Where, on completion of the procedure set out in Article 65(4), (6) and (7), objections are raised against a measure taken by a Member State or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator and shall evaluate the national measure. The consultation period shall not exceed two months. On the basis of the results of that evaluation, the Commission shall endeavour to adopt implementing acts, within two additional months, after the end of consultation period, setting out its decision as to whether the measure is justified or not.
Those implementing acts shall be adopted in accordance with the advisory procedure referred in Article 90(2).
The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator.
2. If the national measure is considered to be justified, all Member States shall, without delay, ensure that appropriate restrictive measures, such as withdrawal, are taken in respect of the non-compliant product and shall inform the Commission accordingly. If the national measure is considered to be unjustified, the Member State concerned shall withdraw the measure.
3. Where the national measure is considered to be justified and the non-compliance of the product or its manufacturer is attributed to shortcomings in the harmonised technical specifications, European assessment documents, voluntary harmonised standards or common specifications established by implementing acts as referred to in Article 65(5), point (d), the Commission shall apply the procedure provided for in Article 5(9), Article 6(5), Article 7(6) or Article 36 of this Regulation or in Article 11 of Regulation (EU) No 1025/2012, as appropriate.
Article 67
Compliant products which nevertheless present a risk
1. Where, having performed an evaluation pursuant to Article 65(1), a market surveillance authority finds that, although a product is in compliance with this Regulation, it presents a risk to the health or safety of persons or, where applicable, to the environment or to other aspects of public interest protection, it shall require the relevant economic operator to take all appropriate measures to ensure that the products concerned, when placed on the market, no longer present that risk, to withdraw the products from the market or to recall them within a reasonable period, commensurate with the nature of the risk, which it may prescribe.
2. The economic operator shall ensure that any corrective action is taken in respect of all the products concerned which that economic operator has made available on the market throughout the Union.
3. The market surveillance authority shall, via the single liaison point, immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.
4. The Commission shall without delay consult the Member States and the relevant economic operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act setting out its decision whether the measure is justified or not and, where necessary, ordering appropriate measures.
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 90(2).
5. The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator.
Article 68
Market surveillance coordination and support
1. For the purposes of this Regulation, the administrative cooperation group set up pursuant to Article 30(2) of Regulation (EU) 2019/1020 (‘ADCO’) shall meet at regular intervals and, where necessary, at the reasoned request of the Commission or of two or more participating market surveillance authorities.
In the context of performing its tasks set out in Article 32 of Regulation (EU) 2019/1020, the ADCO shall support the implementation of this Regulation, namely by identifying common priorities for market surveillance.
2. Based on priorities identified in consultation with the ADCO, the Commission shall:
(a) | organise joint market surveillance and testing projects in areas of common interest; |
(b) | organise joint investment in market surveillance capacities, including equipment and IT tools; |
(c) | organise common trainings for the staff of market surveillance authorities, notifying authorities and notified bodies, including on the correct interpretation and application of this Regulation and on methods and techniques relevant for applying or verifying compliance with it; |
(d) | draw up guidelines for the application and enforcement of this Regulation, including requirements and obligations set out in harmonised technical specifications adopted pursuant to this Regulation, as well as common practices and methodologies for effective market surveillance. |
The Union shall, where appropriate, finance the actions referred to in points (a), (b) and (c).
3. The Commission shall provide technical and logistic support to ensure that the ADCO fulfils its tasks set out in this Article and in Article 32 of Regulation (EU) 2019/1020.
Article 69
Recovery of costs
Where a product has been found to be non-compliant, market surveillance authorities shall have the right to recover from the economic operators who placed or made the product available on the market the costs of document inspection and physical product testing, provided that those costs are accompanied by a justification.
Article 70
Reporting and benchmarking
1. Market surveillance authorities shall enter into the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 information on the nature and severity of any penalty imposed in relation to non-compliance with this Regulation.
2. Every four years, by 30 June, the Commission shall, draw up a report based on the information entered by market surveillance authorities into the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. The first of those reports shall be published by 9 January 2030.
The report shall include:
(a) | information on the nature and number of checks performed by market surveillance authorities during the four previous calendar years pursuant to Article 34(4) and (5) of Regulation (EU) 2019/1020; |
(b) | information on the levels of non-compliance identified and on the nature and severity of penalties imposed for the four previous calendar years in relation to products covered by harmonised technical specifications or CE marked based on a European technical assessment; |
(c) | indicative benchmarks for market surveillance authorities in relation to the frequency of checks and the nature and severity of penalties imposed. |
3. The Commission shall publish the report referred to in paragraph 2 of this Article in the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and shall make public a summary of the report.
CHAPTER IX
INFORMATION AND ADMINISTRATIVE COOPERATION
Article 71
Information systems for harmonised decision-making
1. The Commission shall establish and maintain an information and communication system for the collection, processing and storage of information, in a structured form, on issues relating to the interpretation or application of the rules laid down in or pursuant to this Regulation, with the aim of ensuring the harmonised application of those rules.
In addition to the Commission and Member States, market surveillance authorities, the single liaison offices appointed under Article 10(3) of Regulation (EU) 2019/1020, the authorities designated under Article 25(1) of Regulation (EU) 2019/1020, notifying authorities, representatives of the group of notified bodies and of the organisation of TABs, and product contact points for construction shall be able to access the information and communication system.
2. The bodies listed in paragraph 1 may use the information and communication system to raise any question or issue related to the interpretation or application of the rules laid down in or pursuant to this Regulation, including their relationship to other provisions of Union law.
3. For the purposes of paragraph 2, the bodies listed in paragraph 1 may raise questions or issues related to the following topics:
(a) | the application or interpretation by any other body of the rules laid down in, or pursuant to, this Regulation in a way that diverges from their own practice; |
(b) | questions or issues raised through the information and communication system related to the situation they are confronted with or to their own practice; |
(c) | situations not foreseen by the rules laid down in or pursuant to this Regulation when first published or referred to in the Official Journal of the European Union, especially but not limited to situations brought about by the emergence of new products or business models; |
(d) | whether the rules laid down in or pursuant to this Regulation apply to a situation to which other provisions of Union law also apply and the resulting question of which rules are to prevail. |
4. When raising a question or issue, the relevant body shall enter into the information and communication system information concerning:
(a) | any decision taken in relation to the question or issue raised; |
(b) | the rationale behind the approach taken; |
(c) | any alternative approach it has identified and its rationale. |
5. Member States shall establish a national information system or email distribution service to inform their competent national authorities, the economic operators active on their territory, TABs and notified bodies with place of business on their territory and, on request, also other TABs and notified bodies, on all matters relevant for the correct interpretation or application of the rules laid down in or pursuant to this Regulation. In doing so, they shall take into account the information available in the information and communications system referred to in paragraph 1.
6. Competent national authorities, TABs and notified bodies with a place of business in the respective Member State shall register themselves in the system or for the email distribution service and take account of all information transmitted via them. Economic operators may register themselves in the system or for the email distribution service. Member States shall take appropriate measures to bring the system or email distribution service to the attention of economic operators.
7. The national information system or email distribution service shall be able to receive complaints from any natural or legal person, including TABs and notified bodies, on the uneven application of the rules laid down in or pursuant to this Regulation. If deemed appropriate, the single liaison point shall forward such complaints to their peers in other Member States and to the Commission.
Article 72
Product contact points for construction
1. Member States shall support economic operators by product contact points for construction. Member States shall designate and maintain at least one product contact point for construction on their territory and shall ensure that their product contact points for construction have sufficient powers and adequate resources for the proper performance of their tasks. They shall ensure that product contact points for construction deliver their services in accordance with Regulation (EU) 2018/1724 and that they coordinate with the product contact points for mutual recognition established pursuant to Article 9(1) of Regulation (EU) 2019/515 of the European Parliament and of the Council (29).
2. Product contact points for construction shall provide, at the request of an economic operator or a competent national authority of another Member State, any useful product related information, such as:
(a) | electronic copies of, or online access to, the national technical rules and national administrative procedures applicable to products in the territory in which the product contact points for construction is established; |
(b) | information on whether those products are subject to prior authorisation under national law; |
(c) | rules applicable to the incorporation, assembling or installation of products. |
Product contact points for construction shall also provide information on product related provisions of this Regulation and of acts adopted in accordance with it.
3. Product contact points for construction shall provide information free of charge within 15 working days of receiving any request under paragraph 2.
4. Product contact points for construction shall be able to carry out their functions in a manner that avoids conflicts of interest, particularly in respect of the procedures for obtaining the CE marking.
5. Paragraphs 1 to 4 apply also to products which have not yet been covered by harmonised technical specifications.
6. The Commission shall publish and keep up-to-date a list of the national product contact points for construction.
Article 73
Training and exchange of staff
1. Market surveillance authorities, product contact points for construction, designating authorities, TABs, notifying authorities, and notified bodies shall ensure that their staff:
(a) | keep up-to-date in their area of competence and receive periodic additional training to that end; and |
(b) | receive periodically training on the harmonised interpretation and application of the rules laid down in or pursuant to this Regulation. |
2. The Commission shall, periodically and at least once a year, organise training events jointly for the staff of market surveillance authorities, product contact points for construction, designating authorities, notifying authorities, and notified bodies. The Commission shall organise these training events in cooperation with the Member States.
The training events shall be open to the participation of the staff of the authorities designated under Article 25(1) of Regulation (EU) 2019/1020, the single liaison offices appointed under Article 10(3) of Regulation (EU) 2019/1020 and, where appropriate, of other authorities of the Member States involved in the implementation or enforcement of this Regulation.
3. The Commission may organise, in cooperation with the Member States, programmes for the exchange of staff between the market surveillance authorities, notifying authorities, and notified bodies of two or more Member States.
Article 74
Shared roles and joint decision-making
1. In order to fulfil their obligations under this Regulation with regard to market surveillance, designation and supervision of TABs, notified bodies, and product contact points for construction, Member States may designate:
(a) | a body or authority set up in cooperation with another Member State or other Member States for the purpose of joint designation; |
(b) | a body or authority already designated by another Member State for the same purpose, in cooperation with that Member State. |
The Member States concerned shall jointly ensure that the shared bodies or authorities meet all relevant requirements. They shall be jointly responsible for them, whilst decisions taken towards natural or legal persons on a certain Member State shall be legally attributable only to that Member State.
2. The authorities of different Member States may, without prejudice to their individual obligations under this Regulation or other legislative acts, share resources and responsibilities in order to ensure the harmonised application or effective enforcement of this Regulation.
To that end, they may also:
(a) | take joint decisions, especially in relation to joint cross-border activities or in relation to economic operators active on the territory of the relevant Member States; |
(b) | establish common projects, such as joint market surveillance or testing projects; |
(c) | pool resources for specific purposes, such as building up testing capacity or for internet surveillance; |
(d) | delegate the execution of tasks to a peer authority of another Member State, whilst staying formally responsible for the decisions taken by that authority; |
(e) | transfer a task from one Member State to the other, provided that such transfer is clearly communicated to all concerned. |
The relevant Member States shall be jointly responsible for the actions taken in accordance with this paragraph.
CHAPTER X
DIGITAL PRODUCT PASSPORT
Article 75
Construction digital product passport system
1. The Commission shall adopt delegated acts in accordance with Article 89 to supplement this Regulation by setting up a construction digital product passport system, in accordance with the conditions set out in this Chapter.
2. The construction digital product passport system shall:
(a) | be compatible with, interoperable with and based upon the digital product passport established by Regulation (EU) 2024/1781, without compromising interoperability with Building Information Modelling (BIM), and taking into account the specific characteristics and requirements related to construction products; |
(b) | have the functionalities required to implement and manage digital product passports referred to in Article 76; |
(c) | determine the actors, including economic operators, clients, deinstallers, users and competent national authorities, which are to have access to information in the digital product passport and to what information they are to have access, taking into account the need to protect intellectual property rights, and sensitive commercial information, and to ensure the safety of construction works; |
(d) | determine the actors, including manufacturers, authorised representatives, importers, distributors and digital product passport service providers, which are allowed to introduce or update the information in the digital product passport, including where necessary the creation of a new digital product passport, and what information they may introduce or update; |
(e) | lay down detailed arrangements for updating the information in the digital product passport of an existing product; |
(f) | establish procedures to ensure the availability of digital product passports after an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the digital product passport or, if necessary, after the obligations of manufacturers to ensure its availability have expired, including the establishment of a back-up system by digital product passport service providers; |
(g) | establish requirements for digital product passport service providers, including, if required, a certification scheme to verify such requirements, to be based upon developments under Regulation (EU) 2024/1781 for the same purpose, as far as possible; |
(h) | when required, lay down more detailed or alternative rules and procedures related to the life cycle of identifiers, data carriers, digital credentials and the digital product passport registry to those established by Regulation (EU) 2024/1781 for the same purpose; |
(i) | ensure that the system is accessible for period of 25 years after the last product corresponding to its product type has been placed on the market and that the economic operator makes available the digital product passport for at least 10 years, without„ in the case of a longer period, creating a disproportionate cost and burden for the economic operators; |
(j) | take into account the need to ensure the availability of information for the reuse and remanufacturing of products. |
Article 76
Digital product passport
1. The information in the digital product passport shall be accurate, complete, and up-to-date.
2. A digital product passport for a product under this Regulation shall:
(a) | include the following information:
|
(b) | be connected to one or more data carriers; |
(c) | be accessible by electronic means through the data carrier displayed, in accordance with Article 18(2), point (g); |
(d) | correspond to the product type and its unique identification code referred to in Article 22(5); |
(e) | be accessible free of charge to all economic operators, clients, users and authorities through the data carrier; |
(f) | give different levels of access to the construction digital product passport system; |
(g) | allow actors specified in the construction digital product passport system to introduce or to update the information in the digital product passport; |
(h) | be accessible for an established period after the last product corresponding to its product type has been placed on the market. |
3. The requirements referred to in paragraph 2 shall:
(a) | ensure that actors along the value chain can easily access and understand product information relevant to them; |
(b) | facilitate the verification of product compliance by competent national authorities; and |
(c) | improve traceability of products along the value chain. |
4. Products in respect of which the exemption established in Article 14 is applied are also exempt from the obligation to provide a digital product passport.
Article 77
General requirements for the digital product passport
1. A digital product passport shall meet the following conditions:
(a) | it shall be connected through one or more data carriers to a persistent unique identification code of the product type; |
(b) | the data carrier shall be affixed in accordance with Article 18(2), point (g); |
(c) | the data carrier shall comply with Article 79(1); |
(d) | all information included in the digital product passport shall be based on open standards, developed with an interoperable format and shall, as appropriate, be machine-readable, structured, searchable and transferable through an open interoperable data exchange network, without ‘vendor lock-in’, in accordance with the essential requirements set out in Article 78; documents provided together with the declaration of performance and conformity referred to in Article 76(2)(a)(i) and technical documentation referred to in Article 76(2)(a)(iii) shall be exempted from this obligation when justified for technical reasons; |
(e) | personal data related to the end-user of the product shall not be stored in the digital product passport without the explicit consent of the end-user in compliance with Article 6 of Regulation (EU) 2016/679 of the European Parliament and of the Council (30); |
(f) | the information in the digital product passport shall include a reference to the product type referred to in Article 76(2), point (d); |
(g) | the access to information included in the digital product passport shall be regulated in accordance with the essential requirements set out in Article 78 and the specific access rights shall be identified in accordance with construction digital product passport system levels of access; |
(h) | the declaration of performance and conformity referred to in Article 76(2), point (a)(i), shall follow the guidelines issued in accordance with Article 16(3). |
2. Where other Union legislation requires or allows the inclusion of specific information in the digital product passport, that information may be included in the digital product passport in accordance with the delegated act referred to in Article 75(1).
3. The manufacturer placing the product on the market shall provide actors making the products available on the market online or through other means of distance sales with a digital copy of the data carrier and the product identifier to allow them to make it accessible to customers where they cannot physically access the product. The economic operator shall provide that digital copy or a webpage link free of charge and within 5 working days of receiving the request.
Article 78
Technical design and operation of the digital product passport
The technical design and operation of the digital product passport shall comply with the following essential requirements:
(a) | digital product passports shall be fully interoperable with other digital product passports as regards the technical, semantic and organisational aspects of end-to-end communication and data transfer; |
(b) | a recipient of the digital product passport shall have easy access, free of charge, to it based on the recipient’s respective access rights in the construction digital product passport system; |
(c) | the data included in the digital product passport shall be stored as specified in the construction digital product passport system referred to in Article 75; |
(d) | if the data included in the digital product passport is stored or otherwise processed by authorised operators or digital product passport service providers, they shall not be allowed to sell, reuse or process such data, in whole or in part, beyond what is necessary for the provision of the relevant storing or processing services, unless this is specifically agreed with the economic operator placing the product on the market; |
(e) | the digital product passport shall remain available for the period specified in Article 76(2), point (h), including after an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the digital product passport, and shall fulfil the conditions established in accordance with Article 75(2), point (f), as regards the obligation to establish a back-up system; |
(f) | the right to access and to introduce, modify or update information in the digital product passport shall be restricted to the access rights specified in the construction digital product passport system; |
(g) | protection of information that constitutes trade secrets within the meaning of Article 2(1) Directive (EU) 2016/943 of the European Parliament and of the Council (31) or intellectual property rights shall be ensured; |
(h) | data authentication, reliability and integrity shall be ensured; |
(i) | digital product passports shall be designed and operated so that a high level of security and privacy is ensured and fraud is avoided. |
Article 79
Unique identifiers and digital product passport registry
1. Article 12 of Regulation (EU) 2024/1781 shall apply for the purposes of the implementation of this Regulation as regards unique identifiers and data carriers unless the delegated act referred to in Article 75(1) of this Regulation lays down more detailed or alternative rules related to those unique identifiers and data carriers, as referred to in Article 75(2)(h) of this Regulation.
2. Article 13 of Regulation (EU) 2024/1781 shall apply for the purposes of the implementation of this Regulation as regards the digital product passport registry unless the delegated act referred to in Article 75(1) of this Regulation lays down more detailed or alternative rules related to that registry, as referred to in Article 75(2)(h) of this Regulation.
3. Article 14 of Regulation (EU) 2024/1781 shall apply for the purposes of implementation of this Regulations as regards the web portal for information in the digital product passport.
Article 80
Mandatory use and technical adaptation
1. Six months after the entry into force of the delegated act referred to in Article 75(1), the system shall be fully operational and shall be fulfilling its intended objectives, including the functionalities provided for in Article 76. 18 months after the entry into force of the delegated act referred to in Article 75(1) the obligations established pursuant to Article 22(7) shall apply. The system may be used by manufacturers voluntarily in the interim period.
2. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend this Regulation to:
(a) | further specify, add and remove functionalities referred to in Article 75(2) in order to adapt it to technical progress or to adapt it to the once-only principle in relation to information requirements in other Union law; |
(b) | revise Articles 77(1) and 78 of this Regulation to ensure compatibility and interoperability with Regulation (EU) 2024/1781. |
CHAPTER XI
INTERNATIONAL COOPERATION
Article 81
International cooperation
1. For the purposes of the protection of health and safety of persons or of the environment, the Commission may, cooperate with authorities of third countries or international organisations in the field of application of this Regulation. Such cooperation may include:
(a) | the exchange of information on enforcement activities and measures related to safety and protection of the environment, including market surveillance; |
(b) | the exchange of data of economic operators; |
(c) | the exchange of information on assessment methods and product testing; |
(d) | the exchange of information on product recalls, requests for corrective actions and other similar actions; |
(e) | cooperation on scientific, technical, and regulatory matters, aiming to improve product safety or the protection of the environment and consumers; |
(f) | the exchange of information on emerging issues of significant environmental, health and safety relevance; |
(g) | the exchange of information on standardisation-related activities; |
(h) | the exchange of officials. |
The exchange of information pursuant to this paragraph shall respect confidentiality rules and comply with applicable Union law.
2. The information exchange referred to in paragraph 1 may take the form of:
(a) | a non-systematic exchange, in duly justified and specific cases; or |
(b) | a systematic exchange, based on an administrative arrangement specifying the type of information to be exchanged and the modalities for the exchange. |
The Commission shall regularly inform Member States about the cooperation activities with third countries or international organisations that it undertakes pursuant to the first subparagraph.
3. The Commission may adopt implementing acts, giving authorities of selected third countries that voluntarily apply this Regulation, or that have regulatory systems for construction products similar to this Regulation, access to or the right to fully participate in one or more of the following:
(a) | the information and communication system established in accordance with Article 71(1); |
(b) | the construction digital product passport system set up in accordance with Article 75; |
(c) | the training events organised in accordance with Article 73(2). |
Access to the systems and events referred to in the first subparagraph shall be granted on condition that the third country concerned commits to act against economic operators that infringe this Regulation from their territory, and to ensure confidentiality.
Full participation in the systems referred to in Articles 71 and 75 may only be granted where agreements between the European Union and third countries so provide. Such participation may be offered to third countries provided that the third country’s legislation is aligned with this Regulation and third country competent national authorities recognise certificates issued by notified bodies or European technical assessments in accordance with this Regulation. Such participation shall be subject to the fulfilment of the same obligations as those which apply to Member States under this Regulation, including notification and follow-up obligations.
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the advisory procedure referred to in Article 90(2).
4. Any information exchange under this Article, to the extent it involves personal data, shall be carried out in accordance with Union data protection rules. If no adequacy decision pursuant to Article 45 of Regulation (EU) 2016/679 has been adopted by the Commission in respect of the third country or international organisation concerned, the information exchange shall exclude personal data. If an adequacy decision for the third country or international organisation has been adopted, the information exchange with that third country or international organisation may contain personal data falling within the scope of the adequacy decision but only to the extent that such exchange is necessary for the sole purpose of the protection of health and safety of persons or of the environment.
CHAPTER XII
INCENTIVES AND PUBLIC PROCUREMENT
Article 82
Member State incentives for construction products
Where Member States provide incentives for a product category for which the performance is expressed as a class of performance referred to in Article 5(5) or as a class included in environmental sustainability labelling referred to in Article 22(9), those incentives shall be targeted at the highest two classes of performance.
Where classes of performance are defined in relation to more than one sustainability parameter, it shall be indicated in relation to which parameter this Article should be implemented.
When doing so, the Commission shall take into account the following criteria:
(a) | the number of products in each class of performance; and |
(b) | the need to ensure the affordability of the products meeting those requirements, in order to avoid significant negative impacts on consumers. |
Article 83
Green public procurement
1. The Commission shall adopt delegated acts in accordance with Article 89 to supplement this Regulation by specifying mandatory minimum environmental sustainability requirements for construction products.
2. For procurement procedures falling within the scope of Directives 2014/24/EU (32) or 2014/25/EU (33) of the European Parliament and of the Council, where contracts require minimum environmental sustainability performance for construction products as regards their essential characteristics covered by harmonised technical specifications, contracting authorities and contracting entities shall apply the mandatory minimum environmental sustainability requirements laid down in the delegated acts referred to in paragraph 1.
This shall not prevent contracting authorities and contracting entities from establishing:
(a) | more ambitious environmental sustainability requirements related to essential characteristics referred in the first subparagraph; or |
(b) | additional environmental sustainability requirements related to other essential characteristics than those referred in the first subparagraph. |
3. Member States and the Commission shall provide technical assistance and advice to contracting authorities and contracting entities in charge of public procurement on how to comply with mandatory minimum environmental sustainability requirements laid down in the delegated acts referred to in paragraph 1.
4. Mandatory minimum environmental sustainability requirements laid down in the delegated acts referred to in paragraph 1 for public contracts awarded by contracting authorities or contracting entities may, as appropriate to the product family or product category concerned, take the form of:
(a) | ‘technical specifications’ within the meaning of Article 42 of Directive 2014/24/EU and Article 60 of Directive 2014/25/EU; |
(b) | ‘selection criteria’ within the meaning of Article 58 of Directive 2014/24/EU and Article 80 of Directive 2014/25/EU; |
(c) | ‘conditions for performance of contracts’ within the meaning of Article 70 of Directive 2014/24/EU and Article 87 of Directive 2014/25/EU; |
(d) | ‘contract award criteria’ within the meaning of Article 67 of Directive 2014/24/EU and of Article 82 of Directive 2014/25/EU. |
5. When establishing mandatory minimum environmental sustainability requirements pursuant to paragraph 1 for public contracts, the Commission shall, in line with paragraphs 13 and 28 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, consult experts designated by each Member State and relevant stakeholders, carry out an impact assessment and take into account at least the following criteria:
(a) | the value and volume of public contracts awarded for the product family or product category concerned; |
(b) | the environmental benefits resulting from the uptake of products in the highest two classes of performance; |
(c) | the need to ensure sufficient demand for more environmentally sustainable products; |
(d) | the economic feasibility, for contracting authorities or contracting entities, of buying more environmentally sustainable products, without entailing disproportionate costs, and the availability of those products on the market; |
(e) | the market situation at Union level of the relevant product family or product category; |
(f) | the effects of the requirements on competition; |
(g) | the impact on, and needs of, SMEs; |
(h) | the Members States’ regulatory needs and different climate conditions. |
The first impact assessment shall be launched by the Commission by 31 December 2026.
6. Contracting authorities and contracting entities may on an exceptional basis decide not to apply paragraph 2 of this Article where, after preliminary market consultation in line with Article 40 of Directive 2014/24/EU and Article 58 of Directive 2014/25/EU, it was found that:
(a) | the required construction product can only be supplied by a specific economic operator, and no reasonable alternative or substitute exists; |
(b) | no suitable tenders or no suitable requests to participate have been submitted in response to a previous public procurement procedure; or |
(c) | the application of paragraph 1 or the incorporation of the required construction product in construction works would oblige that contracting authority or contracting entity to incur disproportionate costs, or would result in incompatibility or technical difficulties. |
Contracting authorities and contracting entities may presume that estimated contract value differences above 10 %, based on objective and transparent data, are disproportionate.
When contracting authorities and contracting entities use the derogation in this paragraph, the procurement procedure cannot be considered to be environmentally sustainable in relation to the construction products to which the exceptions have been applied.
Every three years, Member States shall report to the Commission about the use of this paragraph, in accordance with Article 83 of Directive 2014/24/EU.
This paragraph shall be without prejudice to the possibility of excluding abnormally low tenders under Article 69 of Directive 2014/24/EU and Article 84 of Directive 2014/25/EU.
7. The EU Ecolabel and other national or regional EN ISO 14024 type I ecolabelling schemes officially recognised in accordance with Article 11 of Regulation (EC) No 66/2010 of the European Parliament and of the Council (34) may be used to demonstrate compliance with the minimum environmental sustainability requirements where such label complies with the requirements set out in Article 19 of this Regulation.
CHAPTER XIII
REGULATORY STATUS OF PRODUCTS
Article 84
Regulatory status of products
Upon a duly substantiated request of a Member State or on its own initiative, the Commission may adopt implementing acts, determining whether or not a specific item, or category of items is a product within the meaning of this Regulation.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
CHAPTER XIV
EMERGENCY PROCEDURES
Article 85
Application of emergency procedures
1. Articles 86 to 88 of this Regulation shall apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to construction products covered by this Regulation.
2. Articles 86 to 88 of this Regulation shall apply only to construction products, which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.
3. This Chapter, except as regards the power of the Commission referred to in Article 87(7) of this Regulation, shall 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 construction products placed on the market in accordance with Articles 86 and 87. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 90(3).
Article 86
Prioritisation of the assessment and verification of crisis-relevant construction products
1. This Article applies to construction products listed in the implementing act referred to in Article 85(1), that are subject to third-party tasks of notified bodies related to the assessment and verification of construction products, in accordance with Article 10(1).
2. The notified bodies shall make best efforts to process as a matter of priority requests for third-party tasks related to the assessment and verification of construction products referred to in paragraph 1, irrespective of whether those requests have been lodged before or after the activation of the emergency procedures pursuant to Article 85.
3. The prioritisation of requests for third-party tasks related to the assessment and verification of construction products pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those requests.
4. The notified bodies shall make reasonable efforts to increase their respective assessment and verification capacities regarding construction products referred to in paragraph 1 in respect of which they have been notified.
Article 87
Assessment and declaration of performance based on standards and common specifications
1. Where construction products have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications to cover the methods and the criteria for assessing the performance of those products in relation to their essential characteristics in the following cases:
(a) | where there are no performance harmonised standards and no implementing acts adopted in accordance with Article 6(1) that cover the relevant methods and criteria for assessing the performance of those products in relation to their essential characteristics and no such standards or acts are expected to be adopted 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 performance harmonised standards or implementing acts adopted in accordance with Article 6(1) of this Regulation that provide the relevant methods and criteria for assessing the performance of those products in relation to their essential characteristics. |
2. The implementing acts referred to in paragraph 1 shall set out the most appropriate alternative technical solution for the purposes of providing assessment and declaration of performance in accordance with paragraph 5. To that end, the references of European standards or references of relevant applicable international or national standards may be published in those implementing acts or, if there is no European standard or no relevant applicable international or national 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 90(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless those 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 the CPR Acquis Expert Group and shall duly consult all relevant stakeholders.
5. Without prejudice to Articles 13 and 15, the methods and the criteria provided in the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, may be used for assessing and declaring the performance of construction products covered by those standards or common specifications in relation to their essential characteristics. From the day following the expiry or deactivation of the internal market emergency mode it shall no longer be possible to draw up declarations of performance and conformity based on the standards or the common specifications referred to in the implementing act referred to in paragraph 1 of this Article.
6. By way of derogation from Article 85(3), unless there is sufficient reason to believe that construction 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 or fail to achieve the declared performance, the declarations of performance and conformity of construction products which have been placed on the market in compliance with those standards or common specifications shall remain valid 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. Where a Member State considers that a standard or common specification as referred to in paragraph 1 is incorrect in terms of methods and criteria for the assessment of performance in relation to essential characteristics, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and, may, where appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.
Article 88
Prioritisation of market surveillance activities and mutual assistance among authorities
1. Member States shall prioritise the market surveillance activities for construction products listed in the implementing act referred to in Article 85(1) of this Regulation. 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 construction products listed in the implementing act referred to in Article 85(1).
CHAPTER XV
FINAL PROVISIONS
Article 89
Delegated acts
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 4(7), Article 5(5), (6) and (10), Article 7(1), and (8), Article 9(3) and (4), Article 10(2),and (4), Article 12, Article 15(5), Article 22(8) and (9), Article 32(5), Article 75(1), Article 80(2) and Article 83(1)shall be conferred on the Commission for a period of five years from 7 January 2025. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. The delegation of powers referred to in Article 4(7), Article 5(5), (6) and (10), Article 7(1) and (8), Article 9(3) and (4), Article 10(2) and (4), Article 12, Article 15(5), Article 22(8) and (9), Article 32(5), Article 75(1), Article 80(2) and Article 83(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 4(7), Article 5(5), (6) or (10), Article 7(1) or (8), Article 9(3) or (4), Article 10(2) or (4), Article 12, Article 15(5), Article 22(8) or (9), Article 32(5), Article 75(1), Article 80(2) or Article 83(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 90
Committee procedure
1. The Commission shall be assisted by the Committee on Construction Products. This committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
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 91
Electronic applications, decisions, documentation and information
1. All applications from or to notified bodies or TABs and decisions made by these bodies made in accordance with this Regulation can be provided on paper or in a commonly used electronic format provided that the signature complies with the requirements of Regulation (EU) No 910/2014 and the signing person has been entrusted with the task of representing the body or economic operator, in accordance with the law of the Member States or Union law respectively.
2. All information obligations under this Regulation may, unless otherwise stated, be satisfied by electronic means. Where the information is provided by electronic means, the information shall be issued in a commonly readable electronic format that enables the recipient to download and print that information.
When the obligation is established in accordance with Article 22(7), economic operators shall fulfil information obligations related to documents referred to in Article 76(2) by providing the digital product passport.
Declaration of performance and conformity as well as general product information, instructions for use and safety information shall be provided in paper format, free of charge, if requested by the end-user at the time of purchase.
Article 92
Penalties
Member States shall lay down the rules on penalties applicable to instances of non-compliance with this Regulation and shall take all measures necessary to ensure that these rules are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 8 December 2026, notify the Commission of those rules and of those measures and thereafter shall notify it, without delay, of any subsequent amendment affecting them.
Article 93
Evaluation
No later than 9 January 2033 and at least every six years thereafter, the Commission shall carry out an evaluation of this Regulation and of its contribution to the functioning of the internal market and the improvement of the environmental sustainability of products and construction works and built environment. That evaluation shall, inter alia, assess the correlation of this Regulation with Regulation (EU) 2024/1781 and the potential environmental and economic benefits and the impact of extended producer responsibility of manufacturers of certain construction products and of the regain of ownership of surplus and unsold products at Union level. The Commission shall also evaluate the effect of the application of this Regulation on the state of the market for different categories of used products. The Commission shall evaluate whether the penalties applied by the Member States are effective and whether they create fragmentation in the internal market. The Commission shall, if necessary, suggest how to harmonise those penalties.
The Commission shall present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. Member States shall provide the Commission with the information necessary for the preparation of that report.
Where appropriate, the report shall be accompanied by a legislative proposal for the amendment of the relevant provisions of this Regulation.
Article 94
Repeal
Regulation (EU) No 305/2011 is repealed with effect from 8 January 2026, with the exception of Article 2, Articles 4 to 9, Articles 11 to 18, Articles 27 and 28, Articles 36 to 40, Articles 47 to 49, Articles 52 and 53, Article 55, Articles 60 to 64 of that Regulation and Annexes III and V thereto which are repealed with effect from 8 January 2040.
References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XI to this Regulation.
Article 95
Derogations and transitional provisions
1. Product contact points for construction designated under Regulation (EU) No 305/2011 shall be deemed to have been designated under this Regulation as well.
2. TABs and notified bodies that are designated or notified under Regulation (EU) No 305/2011 shall be deemed to have been designated or notified under this Regulation as well. However, they shall be assessed and designated anew by the designating Member States in accordance with their periodic re-assessment cycle and at the latest by 8 January 2030. The objection procedure set out in Article 51(5) of this Regulation shall apply.
3. Harmonised standards the references of which are included in the list published in accordance with Article 17(5) of Regulation (EU) No 305/2011 that are in force on 8 January 2026 shall remain valid under Regulation (EU) No 305/2011 until they are withdrawn by the Commission or otherwise repealed.
4. European assessment documents, the references of which are included in the list published in accordance with Article 22 of Regulation (EU) No 305/2011 by 8 January 2026, shall remain valid until 9 January 2031, unless they have expired for other reasons. Products shall not be placed on the market on the basis of European technical assessments issued in accordance with these European assessment documents after 9 January 2036.
5. When a harmonised technical specification adopted in accordance with Article 5(8) or Article 6(1) of this Regulation covers the same product and the same intended use as a European assessment document, the reference of which is included in the list published in accordance with Article 22 of Regulation (EU) No 305/2011, the European assessment document shall no longer be used for the purposes of this Regulation and products shall not be placed on the market on the basis of European technical assessments issued in accordance with this European assessment document.
6. European technical assessments issued pursuant to European assessment documents the references of which are not included in the list published in accordance with Article 22 of Regulation (EU) No 305/2011 by 8 January 2026 shall be treated as European technical assessment requests under this Regulation. The administrative transfer shall be done at no cost for the manufacturer.
7. Certificates, test reports and European technical assessments issued under Regulation (EU) No 305/2011 may be used as the technical basis to demonstrate a product’s compliance with this Regulation in cases where the product type corresponds to a product type under this Regulation and the requirements and assessment methods are valid in the light of the applicable harmonised technical specification or European assessment document. The recognition of such documents shall be possible under the conditions set out in Article 62 of this Regulation, applied mutatis mutandis.
8. Article 2, Articles 4 to 9, Articles 11 to 18, Articles 27 and 28, Articles 36 to 40, Articles 47 to 49, Articles 52 and 53, Article 55 and Articles 60 to 64 of Regulation (EU) No 305/2011 shall only apply to products covered by standards referred to in paragraph 3 of this Article or to products covered by European assessment documents referred to in paragraph 4 of this Article.
For the purposes of Article 5(7), Article 6(1), and Article 31(2) of this Regulation, harmonised standards the references of which are included in the list published in accordance with Article 17(5) of Regulation (EU) No 305/2011 and which have not been withdrawn shall be treated as performance harmonised standards.
9. The requirements and obligations of economic operators set out in Chapters I, II and III shall only be applicable to a certain product family or product category within such a family from one year after the date of adoption of an implementing act referred to in Article 5(8) making a harmonised standard mandatory or an implementing act referred to in Article 6(1), covering that product family or product category, unless a later application date has been specified in the implementing act. However, economic operators may choose to apply those harmonised technical specifications as from their entry into force by undergoing the procedure leading to a declaration of performance and conformity.
10. Within one year following the date of application of requirements and obligations in relation to a certain product family or product category as set out in paragraph 9 of this Article, the Commission shall withdraw from the Official Journal of the European Union references of harmonised standards and European assessment documents or parts thereof published there in accordance with Articles 17(5) and 22 of Regulation (EU) No 305/2011 when they cover the same respective product family or product category.
Article 96
Entry into force
This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.
It shall apply as from 8 January 2026, with the exception of Articles 1 to 4, Article 5(1) to (7), Article 7(1), Article 9, Article 10, Article 12(1) first subparagraph, Article 16(3), Article 37(4), Article 63, Article 89 and Article 90 and Annexes I, II, III, IV, VII, IX and X, which shall apply from 7 January 2025, and of Article 92, which shall apply from 8 January 2027.
This Regulation shall be binding in its entirety and directly applicable in all Member States.