Legal provisions of COM(2022)144 - Harmonised conditions for the marketing of construction products

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dossier COM(2022)144 - Harmonised conditions for the marketing of construction products.
document COM(2022)144 EN
date March 30, 2022


CHAPTER I

GENERAL PROVISIONS

Contents

Article 1 - Subject matter

This Regulation establishes harmonised rules for the making available on the market and direct installation of construction products, regardless of whether undertaken in the framework of a service or not, by establishing:

(a)rules on how to express the environmental, including climate, and safety performance of construction products in relation to their essential characteristics;

(b)environmental, including climate, functional and safety product requirements for construction products.

This Regulation also establishes obligations incumbent on economic operators dealing with construction products or their components or with products that could be regarded as construction products whilst not being intended by their manufacturer to be construction products.

Article 2 - Scope

1. This Regulation shall apply to construction products and to the following items:

(a)3D-datasets placed on the market to permit the 3D-printing of construction products covered by this Regulation and 3D-printed construction products and moulds;

(b)materials intended to be used for the 3D-printing of construction products on or close to the construction site or for the manufacturing using moulds on or close to the construction site;

(c)construction products manufactured on the construction site for immediate incorporation into construction works, without separate commercial action for the placing on the market;

(d)key parts of products covered by this Regulation;

(e)parts or materials intended to be used for products covered by this Regulation, if the manufacturer of those parts or materials so requests;

(f)kits or assemblies, where their composition is specified in and covered by harmonised technical specifications or European assessment documents (EADs);

(g)prefabricated one-family-houses of less than 180 m2 surface floor space with one floor or of less than 100 m2 surface floor space on two floors.

Member States may decide not to apply this Regulation for the houses referred to in point (g) by notification to the Commission.

2. This Regulation shall also apply to used construction products and to used items referred to in paragraph 1 in any of the following cases:

(a)those used construction products or items are imported from third countries without having been placed on the Union market before;

(b)the economic operator has changed the intended use of those used construction products or items from the intended use assigned to those construction products or items by the initial manufacturer in another way than by a reduction in terms of performance or intended uses or to mere decoration” purposes, those purposes being defined by the absence of any structural function for the construction works;

(c)the economic operator making the used construction products or items available on the market claims for them characteristics or the fulfilment of product requirements set out in Annex I, additional to or different from the characteristics and requirements declared pursuant to this Regulation or Regulation (EU) 305/2011 when the used construction product or item was first placed on the market;

(d)the used construction products or items have been subject to a transformative process going beyond repair, cleaning and regular maintenance (‘remanufactured product’);

(e)the economic operator making the used construction products or item available on the market opts for the application of this Regulation.

3. This Regulation shall not apply to:

(a)lifts subject to Directive 2014/33/EU of the European Parliament and of the Council 43 , escalators and their components;

(b)boilers, pipes, tanks and ancillaries and other products intended to be in contact with water for human consumption;

(c)systems treating waste water;

(d)sanitary appliances;

(e)traffic signalling products.

4. This Regulation also shall also apply to 3D-printing services of construction products and of items covered by this Regulation. 3D-printing services include renting out of 3D-printing machines that could be used for construction products and items covered by this Regulation.

This Regulation shall also apply to services linked to:

–the manufacturing and commercialisation of construction products and or items covered by this Regulation, and

–to the de-installing, preparation for re-use, remanufacturing and dealing with used construction products or items covered by this Regulation.

5. Member States may exempt from the application of this Regulation construction products and items covered by this Regulation that are placed on the market or directly installed in the outermost regions of the European Union in the meaning of Article 349 of the Treaty on the Functioning of the European Union. Member States shall notify to the European Commission and to the other Member States the regulations providing such exemptions. They shall ensure that exempted construction products or items do not bear the CE marking in accordance with Article 16. Construction products or items placed on the market or directly installed on the basis of such exemption shall not be deemed to be placed on the market or directly installed in the Union in 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 its packaging and instructions for use, or a kit or assembly combining such items, that is placed on the market or produced for incorporation in a permanent manner in construction works or parts thereof within the Union, with the exception of items that are necessarily first integrated into an assembly, kit or other construction product prior to being incorporated in a permanent manner in construction works;

(2) ‘permanent’ means for a duration of two years or longer;

(3) ‘product’ means a construction product or other item covered by this Regulation in accordance with Article 2(1) to (3);

(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) ‘direct installation’ means the installation of a product into a construction work of a client without prior making available on the market or the installation of a one-family house covered by this Regulation, regardless whether in the framework of providing a service or not;

(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 as set out in Annex I Part A Point 1 or which have been listed in Annex I Part A Point 2;

(8) ‘product requirements’ means a threshold level or another characteristic with which a product has to comply before it can be placed on the market or installed directly, including those requirements relating to labelling and instructions for use or other information to be provided;

(9) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider, the 3D-printing service provider, manufacturer, importer or distributor of materials intended for 3D-printing of products, online seller, the broker, the supplier, the service provider, the own-brand-labeller or any other natural or legal person, other than authorities, notified bodies, technical assessment bodies and product contact points for construction who is subject to this Regulation in relation to the manufacturing, de-installation for re-use, re-manufacturing or repackaging of products, or making those products available on the market or installing those products directly in accordance with this Regulation, and economic operators as defined in Article 3, point (13) of Regulation (EU) 2019/1020 of the European Parliament and of the Council 44 ;

(10) ‘3D-printing service provider’ means any natural or legal person offering, in the course of a commercial activity, one of the following services: renting or leasing out 3D-printers, printing out 3D-printing datasets, or brokering one of these services, regardless of whether the printing material is provided by that person or not;

(11) ‘materials intended for 3D-printing of products’ means any material intended or the 3D-printing of products for which the respective economic operators have not explicitly and consistently excluded the use as materials for 3D-printing;

(12) ‘manufacturer’ means a manufacturer as defined in Article 3, point (8), of Regulation (EU) 2019/1020;

(13) ‘3D-datasets’ means a set of numerical data describing the shape of an object by its outer dimensions and its cavities in view of permitting the 3D-printing of that object;

(14) ‘construction works’ means buildings and civil engineering works that may both be over or in the ground or water, including bridges, tunnels, pylons and other facilities for transport of electricity, communication cables, pipelines, aqueducts, dams, airports, ports, water ways, and installations which are the basis for rails of railways, but excluding wind mills, oil platforms or chemical plants, industry manufacturing installations, agricultural installations, electricity generation installations, military installations, whilst their shelters may be buildings;

(15) ‘buildings’ means facilities, other than containers, giving shelter to humans, animals or objects, which either are permanently fixed to the ground or can only be transported by the help of special equipment whilst having a surface floor space of at least 20m2 on one or several levels;

(16) ‘level’ means the result of the assessment of the performance of a product in relation to its essential characteristics, expressed as a numerical value;

(17) ‘class’ means a range of levels, delimited by a minimum and a maximum value, of performance of a product;

(18) ‘threshold level’ means a mandatory minimum or maximum performance level of a product with regard to a certain essential characteristic;

(19) ‘placing on the market’ means the first making available of a product on the Union market or the first making available of a used product where any of the conditions of Article 2(2) are fulfilled or of a remanufactured product;

(20) ‘key part’ means a part which is intended by the manufacturer of a product or another economic operator to be used as component or spare part for a product and that has been specified by harmonised technical specifications as essential for the characterisation, safety or performance of a product;

(21) ‘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 in construction works;

(22) ‘assembly’ means a set of at least two separate items, one of which is a product;

(23) ‘European assessment document’ means a document adopted by the organisation of technical assessment bodies for the purposes of issuing European technical assessments;

(24) ‘used product’ means a product that is not waste as defined in Article 3, point (1), of Directive 2008/98/EC of the European Parliament and of the Council , and which has been installed at least once into a construction work, and that:

(a)has not been subject to a process going beyond repair, cleaning or regular maintenance, as specified by the original manufacturer in its instructions for use or acknowledged to be necessary according to common civil engineering knowledge;

(b)has not undergone a process going beyond repair, cleaning and regular maintenance or ‘preparing for re-use’ in the meaning of Article 3, point (16) of Directive 2008/98/EC after being de-installed;

(25) ‘intended use’ means the use intended by the manufacturer, including the conditions for usage, as laid out in technical documentation, on labels, in instructions for use, or in publicity material, whilst usages mentioned only in one of these are already part of the ‘intended use’;

(26) ‘repair’ means the process of returning a faulty product to a condition where it can fulfil its intended use;

(27) ‘maintenance’ means an action carried out to retain a product in a condition where it is able to function as required;

(28) ‘remanufactured product’ means a product that is not waste as defined in Article 3, point (1), of Directive 2008/98/EC, but that has been installed at least once into a construction work, and that has been subject to a transformative process going beyond repair, cleaning and regular maintenance;

(29) ‘risk’ means risk as defined in Article 3, point (18), of Regulation (EU) 2019/1020;

(30) ‘preparing for re-use’ means checking, cleaning or repairing retrieval operations, by which products or components of products are prepared so that they can be re-used without any other pre-processing;

(31) ‘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, produced in a specific production process using a given combination of raw materials or components, whilst identical items of different manufacturers also belong to different product types;

(32) ‘state of the art’ means a way to achieve a certain goal which is either the most effective and advanced or close to it and thus above the average of ways which can be chosen; 

(33) ‘recycling’ means recycling as defined in Article 3, point (17), of Directive 2008/98/EC;

(34) ‘fulfilment service provider’ means a fulfilment service provider as defined in Article 3, point (11), of Regulation (EU) 2019/1020;

(35) ‘product family’ means all product types belonging to the product areas listed in Annex IV, Table 1;

(36) ‘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;

(37) ‘factory production control’ means the documented, permanent and internal production control in a factory with regard to certain parameters or quality aspects, reflecting the specificities of a respective product family or a group and manufacturing processes, and which aim at the constancy of performance or of continuous fulfilment of product requirements, executed in accordance with Annex V;

(38) ‘harmonised zone’ means the sphere jointly covered by this Regulation, the harmonised technical specifications, and the Commission acts of general applicability adopted pursuant this Regulation;

(39) ‘Union law’ means the TEU, the TFEU, general principles of law, acts of general applicability referred to in the second, third and fourth paragraph of Article 288 TFEU and any international agreements to which the Union is party or the Union and its Member States are parties; 

(40) ‘importer’ means an importer as defined in Article 3, point (9), of Regulation (EU) 2019/1020;

(41) ‘distributor’ means a distributor as defined in Article 3, point (10), of Regulation (EU) 2019/1020;

(42) ‘individually manufactured’ means that, due to the specifications of the client, there is a variation in terms of manufacturing method when compared with all other products produced for other clients by the economic operator in question;

(43) ‘micro-enterprise’ means a micro-enterprise as referred to in the Annex to Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises ;

(44) ‘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.

(45) ‘permalink’ means an internet link to a website which is stable both for its content and the address (“URL”);

(46) ‘harmonised technical specifications’ means construction products standards established in accordance with Article 4(2) the reference of which has been published in the Official Journal in accordance with Article 34 and thereby were rendered mandatory for purposes of application of this Regulation, and delegated acts adopted in accordance with Article 4(3) and (4), Article 5(2), or Article 22(4) that contain technical prescriptions;

(47) ‘Construction products standard’ means a standard adopted by a European standardisation organisation on the basis of a request made by the Commission for the application of this Regulation the reference of which has been published in the Official Journal in accordance with Article 34, regardless of whether the use of such standard is rendered mandatory for purposes of application under this Regulation in accordance with Article 4(2) and Article 34(2) or whether they stay voluntary in accordance with Article 5(2), Article 22(4) and Article 34(3);

(48) ‘double use product’ means a product that is, by its manufacturer, intended to be used as product and as an item with another intended use that would fall outside of the scope of this Regulation if it had only that other intended use;

(49) ‘European standardisation organisation’ means a European standardisation organisation as defined in Article 2(8), of Regulation (EU) 1025/2012;

(50) ‘European technical assessment’ (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;

(51) ‘full-time equivalence’ means the work-power of one person employed full-time as defined by the Member State concerned or the work-power of several persons employed part-time working together the same number of hours per day or week;

(52) ‘non-series process’ means a process that is neither prevailingly automated or produced using assembly-line techniques, nor repeated more than 100 times per year by the economic operator in question or the economic operators belonging to the same group of companies, defined by a common controlling natural or legal person, or the same organisational structure;

(53) ‘withdrawal’ means withdrawal as defined in Article 3, point (23), of Regulation (EU) No 2019/1020;

(54) ‘recall’ means withdrawal as defined in Article 3, point (22), of Regulation (EU) No 2019/1020;

(55) ‘online marketplace’ means a provider of an intermediary service using software, including a website, part of a website or an application, that allows customers to conclude distance contracts with economic operators for the sale of products;

(56) ‘online interface’ means online interface as defined in Article 3, point (15), of Regulation (EU) 2019/1020;

(57) ‘broker’ means any natural or legal person providing an intermediation service for the placing on the market or direct installation of products;

(58) ‘own-brand-labeller’ means any natural or legal person other than the manufacturer who wishes to sell a product as his own and therefore affixes his name, trade-mark or label in addition to the mandatory inscriptions of other economic operators;

(59) ‘supplier’ means any natural or legal person providing raw materials or interim products to manufacturers or to other persons providing raw materials or interim products to manufacturers;

(60) ‘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 their design;

(61) ‘accreditation’ means ‘accreditation’ as defined in Article 2(10), of Regulation (EC) No 765/2008;

(62) ‘market surveillance authority’ means an authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020;

(63) ‘life cycle’ means the consecutive and interlinked stages of a product’s life, from raw material acquisition or generation from natural resources over manufacturing, de-installation, possibly reuse with or without prior remanufacturing to final disposal;

(64) ‘reuse’ means any operation by which a product or its components, having reached the end of their first use, are used for the same purpose for which they were conceived;

(65) ‘competent authority’ means the market surveillance authority designated in accordance with Article 69(1);

(66) ‘national competent authority’ means the market surveillance authority designated in accordance with Article 69(2);

(67) ‘notifying authority’ means the single public administration in charge of the designation and supervision of notified bodies, designated in accordance with Article 48, unless specified otherwise in the respective provision: only in the Member State where the respective notified body is located;

(68) ‘designating authority’ means the single public administration in charge of the designation and supervision of Technical Assessment Bodies, designated in accordance with Article 43, unless specified otherwise in the respective provision: only in the Member State where the respective technical assessment body is located;

(69) ‘authority’ means the European Commission, its agencies, and any notifying authority, designating authority or market surveillance authority, unless specified otherwise in the respective provision: regardless of in which Member State it is located;

(70) ‘product presenting a risk’ means a product that, whenever during its entire life-cycle and even when created indirectly, 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;

(71) ‘product presenting a serious risk’ means a product presenting a serious risk as defined in Article 3, point (20), of Regulation (EU) 2019/1020.

Article 4 - Essential characteristics of products

1. The basic requirements for construction works, set out in Annex I Part A Point 1 shall constitute the basis for the preparation of standardisation requests and harmonised technical specifications.

2. The essential characteristics specified in accordance with paragraph 1 or listed in Annex I Part A Point 2 and the methods for their assessment shall be laid down in standards which are rendered mandatory for purposes of application of this Regulation. The essential characteristics of products shall be identified in view of the basic requirements for construction works, taking account of the regulatory needs of Member States.

The Commission may issue standardisation requests in accordance with Article 10 of Regulation (EU) 1025/2012 laying down the basic principles and corner stones for the establishment of these essential characteristics and their assessment methods.

The respective standardisation requests may also include a request that the European standardisation organisation determine in the standards referred to in the first subparagraph the voluntary or mandatory threshold levels and classes of performance in relation to the essential characteristics and which of the essential characteristics may or shall be declared by manufacturers. In that case, the Commission shall lay down the basic principles and corner stones for the establishment of the threshold levels, classes and mandatory characteristics in the standardisation request.

The Commission shall verify that the basic principles and corner stones, and the Union law are respected in the standards prior to publishing the reference thereof in the Official Journal in accordance with Article 34.

3. By way of derogation from paragraph 2 and in order to cover the regulatory needs of Member States and to pursue the goals of Article 114 of the Treaty on the Functioning of the European Union, the Commission is empowered to supplement this Regulation by means of delegated acts in accordance with Article 87, by establishing, for particular product families and categories, voluntary or mandatory essential characteristics and their assessment methods in any of the following cases:

(a)there are undue delays in the adoption of certain standards referred to in the first subparagraph of Article 4(2)by the European standardisation organisations, whilst an undue delay is given where the European standardisation organisation does not submit a standard within the time-frame set out in the standardisation request;

(b)there is an urgency for the adoption of more harmonised technical specifications that cannot be matched with standards referred to in the first subparagraph of Article 4(2) alone;

(c)one or more essential characteristics referring to basic work requirements set out in Annex I Part A, Point 1 or included in Annex I Part A, Point 2 are not covered by the standards referred to in the first subparagraph of Article 4(2) the references of which are already published in the Official Journal;

(d)the standards referred to in the first subparagraph of Article 4(2) are for other reasons considered not sufficient to cover regulatory needs of Member States or the needs of economic operators;

(e)the standards referred to in the first subparagraph of Article 4(2) are not in line with EU climate and environmental legislation and ambition; 

(f)references to standards referred to in the first subparagraph of Article 4(2) cannot be published in the Official Journal for the reasons set out in Article 34(4) or other legal reasons;

(g)references to standards referred to in the first subparagraph of Article 4(2) have been withdrawn from the Official Journal or were published with a restriction.

4. In order to cover the regulatory needs of Member States and to pursue the environmental, safety and harmonisation goals of Article 114 of the Treaty on the Functioning of the European Union, the Commission is empowered to supplement this Regulation, by means of delegated acts in accordance with Article 87, by determining, for particular product families and categories, the following:

(a)threshold levels and classes of performance in relation to the essential characteristics and which of the essential characteristics may or shall be declared by manufacturers;

(b)conditions under which a product shall be deemed to satisfy a certain threshold level or to qualify for a class of performance without testing or without further testing.

5. The Commission is empowered to amend Annex I Part A by means of delegated acts in accordance with Article 87 in order to adapt it to technical progress and to cover new risks and environmental aspects.

Article 5 - Product requirements

1. All products covered by this Regulation shall, prior to their placing on the market or direct installation, satisfy the generic, directly applicable product requirements set out in Annex I Part D and the product requirements laid down in Annex I Part B and C as specified for the respective product family or category in accordance with paragraph 2. The product requirements laid down in Annex I Part B and C are only applicable where they have been specified in accordance with paragraph 2.

2. In order to specify the product requirements set out in Annex I Part B, C and D, the Commission is empowered to supplement this Regulation, by means of delegated acts in accordance with Article 87, by specifying, for particular product families and categories, these product requirements and by laying down the corresponding assessment methods. Once the Commission has specified these product requirements by delegated acts, it may issue standardisation requests which aim at the elaboration of voluntary harmonised standards providing presumption of conformity with these mandatory product requirements as specified by these delegated acts.

3. The Commission is empowered to amend Annex I Part B, C and D by means of delegated acts in accordance with Article 87 in order to adapt it to technical progress and in particular to cover new risks and environmental aspects.

Article 6 - Assessment and verification systems and their product specific modalities

1. In order to apply a tailor-made approach and to minimise the potential burden on manufacturers whilst ensuring a high level of protection of health, safety and the environment, the Commission is empowered to supplement this Regulation by means of delegated acts in accordance with Article 87, by determining for each product family or category the applicable assessment and verification system among those set out in Annex V. It may also determine different assessment and verification systems to the same product family or category when differentiating by essential characteristic or product requirement.

2. In order to facilitate and to harmonise the application of the requirements or obligations contained in Annex V, the Commission is empowered to supplement this Regulation, by means of delegated acts in accordance with Article 87, by specifying these requirements and obligations for a given product family or category

3. In order to counter systematic non-compliances of notified bodies or manufacturers or in view of adaptation to technical progress, the Commission is empowered to amend this Regulation, by means of delegated acts in accordance with Article 87, by introducing additional assessment or verification steps in the systems of Annex V.

Article 7 - Harmonised zone and national measures

1. The harmonised zone shall be presumed to be comprehensive, covering all potential requirements for products other than those covered by other Union law.

2. Member States shall respect the harmonised zone in their national law, other rules or administrative action and shall not set additional requirements for products covered by it. They shall in particular apply the following:

(a)no information, registration or other requirements other than those laid down in the harmonised zone shall be established;

(b)no assessments other than those set out in the harmonised zone shall be made mandatory;

(c)unless otherwise specified in accordance with Article 5(3), national law, other rules or administrative action shall not duplicate or go beyond product requirements specified in accordance with Article 5 or the threshold levels established in accordance with Article 4(4);

(d)national law, other rules or administrative action shall not require more assessments and verifications than those set out in Annex V and shall not extend the scope of the assessments and verifications of Annex V;

(e)national law, other rules or administrative action shall replicate and not request more or less than what has been required by threshold levels established in accordance with Article 4(4);

(f)national law, other rules or administrative action shall not be based on classes, sub-classes or additional classes other than those established in accordance with Article 4(4);

(g)where assessment methods have been established in accordance with Article 4(2) or in Article 5(2), national law, other rules or administrative action shall, both for construction works and in relation to the characteristics of or requirements for products, not refer to other assessment methods or modify or complement these assessment methods or select just a part thereof.

This paragraph shall also apply to public tenders or direct attributions of contracts where those public tenders or direct attributions are executed under direct or indirect control of public entities or are executed with reference to public provisions on public tenders or direct attribution of contracts. This paragraph shall also apply to grants or other positive incentives with the exception of fiscal incentives. However, harmonised technical specifications may permit or recommend Member States to link the decisions on the attribution of public tenders, of contracts or of grants or other positive incentives to sub-classes or additional classes other than those established in accordance with Article 4(4) where these still relate to environmental performances assessed in accordance with these harmonised technical specifications.

3. Member States shall communicate to the other Member States and to the Commission the essential characteristics they require for each product family or category, the respective product requirements and the assessment methods they apply. They shall refer to these essential characteristics, requirements and assessment methods proactively in all fora and on all occasions relevant for the elaboration of harmonised technical specifications. Fora elaborating harmonised technical specifications shall take note of these essential characteristics, requirements and assessment methods. The essential characteristics shall be covered by harmonised technical specifications to the extent possible.

4. Where a Member State deems it necessary, on imperative grounds of health, safety or protection of the environment, including climate, to establish requirements by regulation or to take administrative measures in derogation of paragraph 2, it shall notify the Commission thereof, justifying the need for the procedural obligations established and explain the regulatory need it aims to address and provide evidence both for the existence of the regulatory need and the lack of coverage by the harmonised zone and other Union law. Member States shall to that end use the notification procedure under Directive (EU) 2015/1535, where applicable.

5. The Commission shall, by means of implementing acts, authorise the national measure notified under paragraph 4 where:

(a)it ascertains that the regulation or administrative measure appears duly justified in the light of imperative grounds of health, safety or protection of the environment referred to in paragraph 4;

(b)the regulatory need is not covered by the harmonised zone or by other Union law;

(c)the notified regulation or administrative measure does not discriminate against economic operators of other Member States;

(d)the notified regulation or administrative measure is able to cover the respective regulatory need;

(e)the notified regulation or administrative measure does not constitute a disproportionally large obstacle to the functioning of the Union market; and

(f)the Commission does not indicate by a letter of intent addressed to the Member States its intention to publish or cite, within one year as from the date of notification in accordance with paragraph 4, in the Official Journal the harmonised technical specification or to adopt an act of general applicability covering the respective need.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(2).

On duly justified imperative grounds of urgency relating to human health and safety or the protection of the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 88(3).

6. Member States shall register all their national regulation, and administrative measures directly or indirectly influencing the usability of products on their territory, into the Single Digital Gateway.

7. This Regulation does not hinder Member States to introduce mandatory deposit-refund systems, to oblige manufacturers to take back used or not used products directly or via their importers and distributors and to establish obligations regarding the collection and the treatment of products for waste, provided that all of the following is complied with:

(a)the owner of the product, whilst having a choice amongst the manufacturer, the importer or the distributor as addressee, is in charge of the transport back to the distributor, importer or manufacturer;

(b)economic operators in other Member States are not otherwise directly or indirectly discriminated.

8. Member States may ban the destruction of products taken back in accordance with Article 22(2), point (j) and Article 26 or make the destruction of these products dependent on their prior making available on a national brokering platform for non-commercial use of products.

Article 8 - Relationship with other Union law

To avoid double assessment of products, the Commission is empowered to supplement this Regulation by delegated acts adopted in accordance with Article 87 by determining the conditions under which the fulfilment of obligations under other Union law also fulfils certain obligations under this Regulation, where otherwise the same aspect of health, safety or protection of the environment would be assessed in parallel under this Regulation and other Union law.

CHAPTER II

PROCEDURE, DECLARATIONS AND MARKINGS

Article 9 - Declaration of performance

1. Where a product is covered by a harmonised technical specification adopted in accordance with Article 4(2) or (3), the manufacturer shall undergo the applicable assessment and verification system set out in Annex V and draw up a declaration of performance before such a product is placed on the market. A manufacturer of a product which is not covered by any harmonised technical specification may issue a declaration of performance in accordance with the relevant European assessment document and European technical assessment.

2. Where a product is covered by a harmonised technical specification, information about its performance in relation to the essential characteristics laid down in the applicable harmonised technical specification may be provided elsewhere than in the declaration of performance only if in parallel provided in the declaration of performance. This obligation shall not apply to situations where, in accordance with Article 10, no declaration of performance has been drawn up.

3. By drawing up the declaration of performance, the manufacturer assumes responsibility for the conformity of the product with such declared performance and becomes liable in accordance with Union and national laws on contractual and extra-contractual liability, and this even where it did not act negligently. In the absence of objective indications to the contrary, Member States shall presume the declaration of performance drawn up by the manufacturer to be accurate and reliable.

Article 10 - Exemptions from drawing up a declaration of performance

1. By way of derogation from Article 9(1), a manufacturer may refrain from drawing up a declaration of performance when placing a product covered by a harmonised technical specification on the market where any of the following applies:

(a)the product is, otherwise than by 3D-printing or already existing moulds, individually manufactured or custom-made in a non-series process in response to a specific order, and installed in a single identified construction work, by a manufacturer who is also responsible for the safe incorporation of the product into the construction work in compliance with the applicable national rules, and under the supervision of those responsible for the safe execution of the construction works designated under the applicable national rules;

(b)the product is otherwise than by 3D-printing or already existing moulds manufactured on the construction site, in a non-series process for its incorporation in the respective construction work in compliance with the applicable national rules and under the supervision of those responsible for the safe execution of the construction works designated under the applicable national rules; or

(c)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.

2. A Member State may exempt from Article 9(1) remanufactured products based on products which remain safe after remanufacturing provided that it ensures that the product does not to circulate outside the territory of that Member State.

3. A Member State may exempt from Article 9(1) parts of construction works other than products that are prepared for re-use or remanufactured provided that the part does not to circulate outside the territory of that Member State.

4. A Member State may exempt from Article 9(1) products where all of the following applies:

(a)the manufacturer is a micro-enterprise without belonging to a family of companies or other commercial organisation, including networks, able to determine or organise the manufacturer’s activities;

(b)the manufacturer uses exclusively or in essence components or materials with commonly known stable characteristics or products which have been voluntarily subject to this Regulation and, in all instances, the characteristics of the product depend in essence on the characteristics of these components or materials;

(c)the product does not to circulate outside the territory of that Member State.

Article 11 - Content of the declaration of performance

1. The declaration of performance 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.

2. The declaration of performance shall be drawn up using the model set out in Annex II without the section relating to conformity. The declaration of performance shall at least cover the performance with regard to the mandatory essential characteristics listed in Annex I Part A Point 2, the essential characteristics mandatory by virtue of harmonised technical specifications or delegated acts adopted in accordance with Article 4(3), and the assessment of environmental sustainability referred to in Article 22(1).

3. The Commission is empowered to amend the model set out in Annex II by delegated acts adopted in accordance with Article 87 to permit the inclusion of further information in order to allow economic operators to cover new information needs.

4. 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 45 shall be provided together with the declaration of performance.

Article 12 - Modified declaration of performance for used, remanufactured and surplus products

1. Where a declaration of performance, issued by the initial manufacturer or another economic operator pursuant to this Regulation or Regulation (EU) 305/2011, is available for a used product, the new declaration of performance may, in derogation from Article 11(1), refer to the initial declaration of performance in relation to the characteristics declared therein if:

(a)the intended use is not changed otherwise than by reduction in terms of performance or intended uses or to merely decorative purposes;

(b)the lifespan of the initial product or the relevant durability performance has been specified in the initial declaration of performance, the harmonised technical specification on which the initial declaration of performance was based, or is generally known on the basis of common civil engineering knowledge;

(c)the time that expired after the first integration of the product into a construction work does not exceed the lifespan of the product or the relevant durability performance, whatever is shorter.

The economic operator shall attach the initial declaration of performance to the declaration of performance issued by him, whilst the latter shall be labelled “declaration of performance for used product”.

2. Where there is no declaration of performance available for a used product issued by the initial manufacturer or another economic operator pursuant to this Regulation or Regulation (EU) 305/2011, an economic operator may issue a new declaration of performance without undergoing a full procedure in accordance with this Regulation where it limits the intended use to “decoration”. Where the economic operator has used this derogation, the declaration of performance shall be labelled “declaration of performance for used product”.

3. Paragraphs 1 and 2 shall not apply where:

(a)the mechanical and chemical properties of the used product cannot be assumed to be stable enough anymore for the new intended use;

(b)health and safety of persons would be at risk due to the properties of the product;

(c)the product has been subject to stresses that makes it unsuitable for the new intended use; or

(d)such stress is not very unlikely according to the protocol established by the de-installer in accordance with Article 29 and the documentation on the conditions of a certain building (“building log-book”).

Member States shall set-up requirements for de-installers and the certification to be provided in accordance with the last sentence, including on the definition of stresses that render the product unsuitable.

4. Paragraphs 1 to 3 shall also apply to remanufactured products, if the transformative process, whilst going beyond repair, cleaning or regular maintenance or preparing for re-use as defined in Article 3, point (16), of Directive 2008/98/EC after being de-installed, does not jeopardise the compliance with this Regulation or the performance of the product in relation to the relevant characteristics because, by their design, the transformative process cannot negatively influence the performance and the compliance or because the used replacement part has been assessed as equivalently performing and compliant. Where the economic operator has used this derogation, the declaration of performance shall be labelled “declaration of performance for re-manufactured product”.

5. Paragraphs 1 to 4 shall apply to all of the following:

(a)products which have reached the user or have left the distribution chain, but were never installed and for which the initial manufacturer no longer assumes any responsibility as new product (“surplus products”);

(b)for which the initial manufacturer refused to confirm its responsibility within one month after receiving the respective request of the economic operator wishing to make available on the market the surplus product.

Where the economic operator has used this derogation, the declaration of performance shall be labelled “declaration of performance for surplus product”.

6. Article 21(3) and Article 22(1) shall only apply to products falling under the derogations of paragraphs 1 to 5 where the economic operator making them available on the market requests their application.

Article 21(2) shall not apply to products falling under the derogations of paragraphs 1 to 5. However, the economic operators shall provide the information set out in Annex I Part D.

7. Unless the economic operator opts for the application of harmonised technical specifications, the products falling under the derogations of paragraphs 1 to 5 shall be exempted from threshold levels, product requirements and applicable harmonised technical specifications.

8. By issuing the declaration of performance, the economic operator assumes responsibility for the conformity of the product with such declared performance and becomes liable in accordance with EU 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 to be accurate and reliable.

9. This article shall not apply to used, remanufactured or surplus products which have never been placed on the Union market or which have never been installed in the Union.

Article 13 - Declaration of conformity

1. Before placing a product on the market, the manufacturer who is not exempted from the obligation to produce a declaration of performance shall:

(a)verify the product’s compliance with the product requirements of Annex I Part B and C to the extent that they have been specified by delegated acts in accordance with Article 5(2), and with the product requirements of Annex I Part D;

(b)undergo the respective assessment and verification system set out in Annex V; and

(c)draw up a declaration of conformity.

2. The manufacturer may decide to issue a declaration of conformity in accordance with paragraph 1 even where exempted from the obligation to produce a declaration of performance.

3. By the declaration of conformity, the manufacturer assumes responsibility for the conformity of the product with the product requirements and becomes liable in accordance with national laws on contractual and extra-contractual liability, and this even where it did not act negligently. In case of non-compliance or absence of a declaration of conformity, the product may not be made available on the market. In the absence of objective indications to the contrary, Member States shall presume the declaration of conformity drawn up by the manufacturer to be accurate and reliable.

Article 14 - Content of the declaration of conformity

1. The declaration of conformity shall express conformity of a product with product requirements referred to in Article 5(1) and (2).

2. The manufacturer shall combine the declaration of conformity with the declaration of performance into a single declaration, to be labelled “Declaration of performance and conformity” as set out in Annex II.

3. Article 11(2) to (4) and Article 12 shall apply with regard to the declaration of conformity.

4. The manufacturer shall fulfil the obligations of this Article as from the first revision of the declaration of performance undertaken by the manufacturer after the date of application of harmonised technical specification, for the respective product family or category, but at the latest 3 years after that date.

Article 15 - Supply of the declaration of performance and of the declaration of conformity

1. The manufacturer shall supply by electronic means a copy of the declaration of performance and of the declaration of conformity of each product which is made available on the market.

However, where a batch of the same product is supplied to a single user, it may be accompanied by a single copy of the declarations.

2. Where the declaration is provided by electronic means, the manufacturer shall issue that declaration in a commonly readable, but unamendable electronic format. Alternatively, the manufacturer may use a permalink provided that the permalink and the document accessible via the permalink are unamendable. Commission Delegated Regulation (EU) No 157/2014 46 shall apply under this Regulation.

The manufacturer shall supply a paper copy of the declarations if the recipient requests for such paper copy.

3. Declarations may contain permalinks to unamendable environmental product declarations or other unamendable documents containing the requested information if those documents follow the order and structure of the declarations or if a correlation table linking the order of the declarations to the order of these documents is provided together with the permalink.

4. The manufacturer shall supply the declaration of performance and the declaration of conformity in the language or the languages required by the Member States where the manufacturer intends to make the product available. Another economic operator who makes a product available in another Member State shall make available a translation of the declaration of performance and the declaration of conformity in the languages required by that Member State together with the original, and shall comply with paragraphs 1 and 2.

Article 16 - 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 to those products for which the manufacturer has drawn up a declaration of performance or conformity in accordance with Articles 9 and 11 to 14. The CE marking shall be affixed to key parts. The CE marking may not be affixed to parts which are not key parts.

3. If neither a declaration of performance nor a declaration of conformity has been drawn up by the manufacturer, the CE marking shall not be affixed.

4. By affixing or having affixed the CE marking, the economic operator indicates that it takes responsibility for the conformity of the product with the declared performance and applicable product requirements of this Regulation or 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 these requirements in accordance with national law on contractual and extra-contractual liability.

5. The CE marking shall be the only marking which attests the performance of the product with regard to assessed essential characteristics and the conformity of the product with this Regulation.

Member States shall not introduce any references or shall withdraw any references in national measures to a marking attesting conformity with requirements or the declared performance in relation to the essential characteristics covered by the harmonised zone.

6. A Member State shall not prohibit or impede, within its territory or under its responsibility, the making available on the market or the use of products bearing the CE marking, when the declared performances correspond to the requirements for such use in that Member State.

A Member State shall not prohibit or impede, within its territory or under its responsibility, the making available on the market or the use of products bearing the CE marking, when the product conforms with product requirements set-up in or by means of this Regulation, unless it is specified in the respective harmonised technical specification that the respective requirements constitute only minimum requirements.

7. A Member State shall ensure that the use of products bearing the CE marking shall not be impeded by rules or conditions imposed by public bodies or private bodies acting as a public undertaking, or acting as a public body on the basis of a monopoly position or under a public mandate.

Article 17 - Rules and conditions for the affixing of CE marking

1. The CE marking shall be affixed visibly, legibly and indelibly to the product or to a label attached to it. Where this is not possible or not warranted on account of the nature of the product, it shall be affixed to the packaging or to the accompanying documents.

2. The CE marking shall be followed by:

(a)the two last digits of the year in which it was first affixed;

(b)the name and the registered address of the manufacturer, or the identifying mark allowing identification of the name and address of the manufacturer easily and without any ambiguity;

(c)the name and the registered address of the authorised representative, or the identifying mark allowing identification of the name and address of the authorised representative easily and without any ambiguity 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, the permalink to the manufacturer’s products registration(s) in Union databases and the precise location therein where the product can be found; 

(e)the permalink to the manufacturer’s own product presentation website, if any there is any;

(f)the reference number of the declaration of performance; and

(g)the identification number of the notified body, if applicable.

The items listed in points d) to f) may be replaced by a permalink to the combined declaration of performance and of conformity (electronic CE marking).

3. The CE marking shall be affixed before the product is placed on the market or directly installed into a construction work. It may be subsequently followed by a pictogram or any other mark indicating a special risk or use.

Article 18 - Other markings

Markings other than the CE marking, including private ones, may be affixed on a product only if they do not cover or refer to harmonised technical specifications or to product requirements or essential characteristics or assessment methods included in the harmonised zone.

No other marking than marking set out by Union legislation may be affixed on a product in a distance smaller than the double length of the CE marking measured from any point of the CE and the other marking set out by Union law.

No other marking than the CE marking may be placed on the declaration of performance or the declaration of conformity.


CHAPTER III

OBLIGATIONS AND RIGHTS OF ECONOMIC OPERATORS

Article 19 - Obligations of all economic operators

1. An economic operator shall take all necessary measures to ensure continued compliance, including of products, 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 70(1), the economic operator shall submit progress reports to that authority until that authority decides that the corrective action can be closed.

2. Where diverging statements of non-compliance of an economic operator or of a product and requests for corrective action emanate from authorities of different Member States, an economic operator shall take differentiated measures, subject to where the products are intended to be made available on the market or directly installed. Where this is not possible or where a more severe measure imposed by one Member State encompasses the less severe measure imposed by another, the more severe measure shall be taken. Where these rules do not lead to a clear result, the Member States concerned and the Commission, and, on their request, other Member States shall try to find a common solution and, if need is, adopt an implementing act in accordance with Article 33.

3. An economic operator shall, on request of an authority, communicate any economic operator or other actor to that authority:

(a)who has supplied it with a product, including components or replacement parts of products, or services, with relevance for a product, and the quantity of that supply;

(b)to who it has supplied a product, including components or replacement parts of products, or services, with relevance for a product, and the quantity of that supply;

(c)who is involved in financial and other collateral services linked to the making available or direct installation of products.

When identifying the operators referred to in first subparagraph, an economic operator shall inform the authority about to all connected data, including:

(i)addresses of the operators referred to in the first subparagraph;

(ii)contact details of these operators;

(iii)email addresses, websites and social media profiles of these operators;

(iv)    tax and company registration numbers of these operators;

(v)bank accounts of these operators; and

(vi)    names, addresses, contact details of natural or legal persons acting for those operators.

4. An economic operator shall be able to present all documentation and information referred to in this Chapter to authorities for a period of ten years after they have last been in possession or dealing with the product in question, unless they are permanently available via the product registration database or system established in accordance with Article 78. It shall present the documentation and information within 10 days of receipt of a request by the respective authority.

5. An economic operator shall provide all the requested data into the database or system established in accordance with Article 78 within two months after the availability of that database or system has been stated in a publication of the Official Journal and bear the fees of registration linked thereto. It shall at least bi-annually verify the correctness of the provided data.

An economic operator shall register into its respective national system established in accordance with Article 77(5).

An economic operator shall make available to consumers and users communication channels, including telephone numbers, e-mail or dedicated sections of its website and social media page, allowing it to communicate any accident, other incident or safety issue it has experienced with the product.

6. An economic operator may inform authorities of any likely infringement of this Regulation it becomes aware of. Where this economic operator considers that non-conforming products present a risk to human safety or to the environment, it shall immediately inform the competent authorities of the Member States in which it made the product available thereof, giving details, in particular, of the non-compliance and of any corrective measures taken.

7. An economic operator subject to certification by a notified body or supplying services or parts to manufacturers shall permit notified bodies to have access to its documentation and to its premises to the extent that this is needed for the activities of the notified bodies. It shall produce correct information for notified bodies and shall correct any incorrect information. Moreover, this economic operator shall inform the notified body within one month of all changes that might affect the compliance with this Regulation.

Article 20 - Procedural rights of economic operators

1. Any definitive or interim measure, decision or order taken or made by authorities pursuant to this Regulation against an economic operator and the natural or legal persons acting on their behalf shall state the exact grounds on which it is based.

2. Any such measure, decision or order shall be communicated without delay to the relevant economic operator and the natural or legal persons acting on their behalf, who shall at the same time be informed of the remedies available to them under the law of the Member State concerned and of the time limits to which those remedies are subject.

3. Before a measure, decision or order referred to in paragraph 1 is taken or made, the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 working days, unless there is urgency of the measure, decision or order, based on health or safety requirements or other grounds relating to the public interests covered by this Regulation.

4. If the measure, decision or order is taken or made without the economic operator being given the opportunity to be heard, the economic operator shall be given that opportunity as soon as possible thereafter and that measure, decision or order can be reviewed promptly by the market surveillance authority.

5. Member States shall ensure that any measure covered by this Article can be appealed, with or without prior administrative appeal procedure, before a competent court. That court shall also be competent for deciding on the suspensive effect of the appeal or interim measures to be imposed by the court in view of both the public interest and the interests of the economic operator.

Article 21 - Obligations of manufacturers

1. The manufacturer shall determine the product type, respecting the boundaries set up therefore by the definition provided in Article 3 point (31). The product type shall be processed in accordance with the applicable assessment and verification system set out in Annex V. The manufacturer shall draw up a declaration of performance and a declaration of conformity in accordance with Articles 9 and Articles 11 to 15 and affix the CE marking in accordance with Articles 16 and 17.

2. The manufacturer shall refrain from any claim about the characteristics of a product that is not based on:

(a)the assessment method contained in a harmonised technical specification where the relevant characteristic is covered by such; or

(b)where no such assessment method exists, an assessment method which represents the most effective and advanced method to achieve an accurate assessment.

3. The manufacturer shall, as the basis for the declarations referred to in paragraph 1, draw up a technical documentation describing the intended use including the precise conditions for use and all the elements necessary to demonstrate performance and conformity.

That technical documentation shall contain the mandatory or facultative calculation of environmental, including climate sustainability assessed in accordance with harmonised technical specifications adopted under this Regulation or with Commission acts adopted under this Regulation.

The second subparagraph shall not apply in case of used, remanufactured or surplus products, unless the economic operator, subject to the obligations of this Article by virtue of Article 26, opts for the application of this Regulation for new products.

4. The manufacturer shall ensure that procedures are in place to ensure that series production maintains the declared performance and conformity. Changes in the production process, in product design or in characteristics, and changes in the harmonised technical specifications by reference to which performance or conformity of a product is declared or by application of which its performance or conformity is verified, shall be adequately taken into account and, in case the product’s performance or conformity 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, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep importers and distributors informed of any such monitoring.

The procedures referred to in the first subparagraph, the sample tests referred to in the second subparagraph and the application of the applicable system of Annex V shall be described in the technical documentation referred to in paragraph 3.

5. The manufacturer shall ensure that its product bear a manufacturer-specific type number and a batch or serial number. If this is impossible, the required information shall be provided on the packaging, on an affixed tag or, as last resort, 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 it is not intended for consumers or other non-professional users. Products not labelled “Only for professional use” shall be deemed to be also intended for non-professional users and consumers in the meaning of this Regulation and the Regulation (EU) … [Regulation on General Product Safety].

The manufacturer shall, in a visible manner, display to customers before it is bound by a sales contract, including in case of distance selling, the information which shall be labelled pursuant to this Regulation or harmonised technical specifications.

6. When making a product available on the market in a certain Member State, the manufacturer shall ensure that the product is accompanied by the information set out in harmonised technical specifications and in Annex I Part D 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 Commission may, by means of implementing acts determine the format and the way of transmission of information to be provided by the manufacturer in accordance with the first subparagraph.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(2).

7. The manufacturer shall upload the data of the declaration of performance, of the declaration of conformity, the information referred to in paragraph 6 and the technical documentation in the EU product database or system established in accordance with Article 78.

8. The manufacturer who has reason to believe that a product which it has placed on the market is not in conformity with requirements of this Regulation or adopted in accordance with this Regulation, shall immediately take the necessary corrective measures to bring that product into conformity, 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 national competent authority thereof; the latter shall transmit the respective information to the national competent authority responsible for the supplier or service provider and suggest appropriate measures.

9. Where the product presents a risk or is likely to present a risk, the manufacturer shall within two working days thereof inform the authorised representative, importers, distributors, fulfilment service providers, and online market places involved in the 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 case of risks caused by products which have already reached the final user or consumer, the manufacturer shall also alert the media and inform them about appropriate measures to eliminate or, if not possible, to reduce the risks. In case of a “serious risk” in the meaning of Article 3, point (71) the manufacturer shall withdraw and recall the product at their own cost.

10. The manufacturer shall be liable for infringement of this Article and of Article 19 in accordance with national law on contractual and extra-contractual liability.

Article 22 - Additional environmental obligations of manufacturers

1. For the product characteristics specified in Annex I Part A Point 2, the manufacturer shall assess the environmental characteristics of the product in accordance with harmonised technical specifications or with Commission acts adopted under this Regulation and use, once available, the latest version of the software made freely available on the website of the European Commission. However, this shall not apply in case of used, remanufactured or surplus products, unless the economic operator, subject to the obligations of this Article by virtue of Article 26, opts for the application of this Regulation as for new products.

2. Unless product safety or the safety of construction works is thereby negatively impacted, the manufacturer has the following obligations:

(a)design and manufacture products and their packaging in such a way that their overall environmental, including climate sustainability reaches the state of the art level, unless a lower level:

(i)is proportionate when compared to the environmental sustainability improvement triggered by them at the level of the construction works; and

(ii)is either necessary to improve the environmental sustainability at the level of the construction works.

(b)under the conditions set out in point (a)(i) and (ii) give preference to recyclable materials and materials gained from recycling;

(c)respect the minimum recycled content obligations and other limit values regarding aspects of environmental, including climate sustainability contained in harmonised technical specifications;

(d)prevent premature obsolescence of products, use reliable parts and design products in such a way that their durability does not fall beyond the average durability of products of the respective category;

(e)design products in such a way that they can be easily repaired, refurbished and upgraded, unless such design triggers non-compliance with other requirements of this Regulation, or other Union law, or repairing, refurbishing or upgrading is risky for human safety or the environment, in which case the manufacturer shall refrain from repairable, refurbishable or upgradable design and warn against repairing in accordance with point (f);

(f)make available, in product databases, instructions for use and on permalinks of their own websites, information on how to repair the products and any additional information necessary for repairing, including relevant warnings;

(g)make available on the market itself or by specially designated distributors or by manufacturers of spare parts, with reasonably short delivery time, spare parts for their products for 10 years after the last product of the respective type has been placed on the market or directly installed and inform proactively about this availability;

(h)design products in such a way that re-use, remanufacturing and recycling are facilitated, namely by facilitating the separation of components and materials at the later stage of recycling and avoiding mixed, blended or intricate materials, unless remanufacturing and recycling are risky for human safety or the environment. In this case the manufacturer shall refrain from such design and warn against remanufacturing and recycling in accordance with the following point;

(i)make available, in product databases, instructions for use and on their own websites, information on how to remanufacture or recycle the products and any additional information necessary for re-use, remanufacturing or recycling, including relevant warnings;

(j)accept to regain, directly or via their importers and distributors, ownership of surplus and unsold products that are in a state equivalent to the one in which they were placed on the market.

Where obligations of this paragraph cannot be cumulatively fulfilled due to a conflict arising between different obligations, the manufacturer shall choose a trade-off solution that brings the highest and most cost-effective benefits in terms of environmental sustainability for the products and construction works combined. However, the “safety first” principle, applicable both for the construction product and the construction works, shall in all instances be respected, and shall encompass protection of health.

3. Paragraph 2, points (a) to (c) and paragraph 2 point (j), shall not apply in case of used, remanufactured or surplus products, unless the economic operator, subject to the obligations of this Article by virtue of Article 26, opts for the application of this Regulation as for new products.

4. In order to specify the obligations set out in paragraph 2, the Commission is empowered to supplement this Regulation, by means of delegated acts in accordance with Article 87, by specifying, for particular product families and categories, these obligations. Alternatively, the Commission may issue standardisation requests which aim at the elaboration of harmonised standards providing presumption of conformity with the obligations of paragraph 2 for a specific product family or category. The obligations contained in paragraph 2 shall not apply before such a delegated act or a harmonised standard has become applicable.

5. In order to ensure transparency for the users and to promote sustainable products, the Commission is empowered to supplement this Regulation by delegated acts adopted in accordance with Article 87 to establish specific environmental sustainability labelling requirements including “traffic-light-labelling” in relation to environmental obligations set out in paragraph 1, product inherent environmental requirements set out in Annex I Part C Point 2, and environmental performance classes established in accordance with of Article 4(4), point (a).

6. The manufacturer shall affix the traffic light label in the way set out in the delegated acts adopted in accordance with paragraph 5.

Article 23 - Obligations of authorised representatives

1. A manufacturer 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.

2. Authorised representatives shall act with due care in relation to the obligations of this Regulation. They shall be liable for gross negligence or conscious infringement of this Article and of Article 19 in accordance with national law on contractual and extra-contractual liability.

3. The authorised representative shall perform the tasks specified in the mandate. The mandate shall allow the authorised representative to carry out at least the following tasks and shall give the authorised representative the following rights:

(a)keep the declaration of performance and the technical documentation at the disposal of national market surveillance authorities;

(b)provide the market surveillance authorities with all the information and documentation necessary to demonstrate the conformity of the product with the declaration of performance and compliance with other applicable requirements in this Regulation at their reasoned request;

(c)terminate the contract where the manufacturer infringes this Regulation and inform thereof the competent national authorities of the Member States where the product is placed on the market and the national competent authority of his own place of business;

(d)when having reason to believe that a product in question is non-compliant or presents a risk, inform the national competent authorities of the Member States where the product is placed on the market and the national competent authority of his own place of business thereof; and

(e)cooperate with the market surveillance authorities, at their request, on any action taken

–to eliminate risks posed by products covered by the mandate of the authorised representative; or

–to remedy non-conformities.

The drawing up of technical documentation shall not form part of the authorised representative’s mandate, but may become subject to a separate contract between the manufacturer and the authorised representative.

4. The authorised representative shall verify the compliance of the product with requirements regarding marking, labelling, instructions for use, declaration of performance and conformity. The authorised representative shall also verify at a documentary level that the manufacturer satisfies his obligations set out in Article 19(4) to (6), Article 21(1) to (3) and (5) to (7), Article 22(1) and Article 22(2) points (f) and (i), and Article 27(6).

5. Where an authorised representative considers that there is a non-compliance mentioned in the paragraph 4, the authorised representative shall ask the manufacturer to remedy the non-compliances. The manufacturer shall thereon stop the placing on the market and ask other economic operators involved in the distribution to stop their commercial activities, until the authorised representative regards the infringements as remedied. Where the non-compliances are not remedied within one month whilst products possibly continue to be made available on the market, the authorised representative shall be allowed to terminate his contract with the manufacturer and thereof inform the national competent authorities of the Member States where the products are placed on the market and the national competent authority of his own place of business. The latter shall coordinate joint actions of all competent authorities, unless the national competent authorities agree on another national competent authority to coordinate.

Article 24 - Obligations of importers

1. The importer shall place on the Union market only products which are compliant with this Regulation. Before placing a product on the market, the importer shall verify at a documentary level that the manufacturer has complied with the obligations set out in Article 21(1), (3) and (5) to (7) and in Article 22(2), points (f) and (i). It shall be liable for infringement of this Article and of Article 19 in accordance with national law on contractual and extra-contractual liability.

2. The importer shall verify that the intended use of the product has been precisely and correctly determined by the manufacturer and shall ensure that the product is accompanied by a clear indication of the information set out in harmonised technical specifications and in Annex I Part D in a language determined by the Member State concerned which can be easily understood by users. The importer shall, in a visible manner, display to customers before they are bound by a sales contract, including in case of distance selling, the information which shall be labelled pursuant to this Regulation or harmonised technical specifications. 

3. The importer shall ensure that, while a product is under its responsibility, storage or transport conditions do not jeopardise its conformity with the declaration of performance and compliance with other applicable requirements in this Regulation.

4. After having assembled all available product information from the manufacturer and the de-installer, the importer shall in particular scrutinise used and remanufactured products, namely with regard to damages or indications for loss of performance or non-compliance and changed mechanical or chemical properties, and assess all risks; when necessary to ensure safety or the protection of the environment, the importer shall reduce the intended use or refrain from selling. This obligation shall also apply to used and remanufactured products for which no declaration of performance is mandatory.

5. Where an importer considers or has reason to believe that the product is not in conformity with the declaration of performance 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 it complies with the other applicable requirements in this Regulation or until the declaration of performance is corrected. Furthermore, where the product presents a risk, the importer shall inform the manufacturer and the geographically responsible national competent 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 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. The importer selling to final users shall also fulfil the obligations incumbent on distributors.

Article 25 - Obligations of distributors

1. When making a product available on the market, the distributor shall act with due care in relation to the obligations of this Regulation. It shall be liable for infringement of this Article and of Article 19 in accordance with national law on contractual and extra-contractual liability.

2. When making a product available on the market, the distributor shall fulfil the obligations incumbent on importers in accordance with Article 24(1) to (5) whilst references to “placing on the market” shall be understood as “further making available on the market”.

3. The distributor shall ensure that no products are sold to consumers or other non-professional users which are labelled “for professional use only”. These products shall, in their premises, online and on paper publicity material, be presented as products for professional use only.

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 Articles 21 and 22, where:

(a)there is no manufacturer in the meaning of this Regulation;

(b)it places a product on the market as manufacturer under its name or trademark;

(c)it modifies a product in such a way that compliance with the declaration of performance and of conformity or with the requirements set out in and in accordance with this Regulation may be affected;

(d)it treats a product in a way that changes the hazards or increases the level of risk caused by it during its life-cycle;

(e)it makes a product available on the market with an intended use that is different from the intended use attributed by the manufacturer in the performance and conformity assessment procedure; or

(f)it claims for it characteristics deviating from the characteristics claimed by the manufacturer.

2. Paragraph 1 shall also apply to:

(a)an importer of used or remanufactured products, unless the used or remanufactured product have been placed on the Union market before being used;

(b)an importer or distributor of used products who does either of the following:

(i)subjects those used products to a transformative process going beyond repair, cleaning and regular maintenance after being de-installed;

(ii)opts for assuming the role of the manufacturer.

3. Paragraph 1 shall not apply where the economic operator only:

(a)adds translations of the information supplied by the manufacturer;

(b)replaces the outer packaging of a product already placed on the market, including when changing the pack 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 the information to be provided in accordance with 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 they own the products or whether they provide services. It shall carry out the repackaging in such a way that the original condition of the product cannot be affected by the repackaging and that the information to be provided in accordance with this Regulation is still correctly provided. The economic operator shall act with due care in relation to the obligations of this Regulation. It shall be liable for infringement of this Regulation.

Article 27 - Obligation of fulfilment service providers, brokers, online market places, online sellers, online shops and online search engines

1. When contributing to the making available on the market or direct installation of a product, fulfilment service provider or broker shall act with due care in relation to the obligations of this Regulation. It shall be liable for infringement of this Article and of Article 19 in accordance with national law on contractual and extra-contractual liability.

2. A fulfilment service provider, online seller or broker shall:

(a)display, in a visible manner, to customers before they are bound by a sales contract, including in case of distance selling, the information which shall be labelled pursuant to this Regulation or harmonised technical specifications;

(b)verify that the manufacturer has complied with the obligations set out in Article 21(1), (3) and (5) to (7) and Article 22(2), points (f) and (i);

(c)fulfil the obligations laid down in Article 24(5), whilst references to “placing on the market” shall be understood as “supporting the making available on the market”;

(d)eliminate all offers for products which are non-compliant or likely to be risky in the meaning of Article 21(9) last sentence on their own initiative or, within two working days, on request of the market surveillance authorities;

(e)inform concerned authorities on the measures taken in accordance with points (b), (c) and (d);

(f)support product withdrawals or recalls, regardless of whether initiated by authorities, the manufacturer, the authorised representative or the importer. In cooperation with the economic operator concerned, the fulfilment service provider or broker shall inform consumers directly of product withdrawals or recalls. It shall keep the concerned authorities informed of any action taken.

3. An online marketplace shall:

(a)design and organise its online interface in such a way that it allows third party traders to provide to the customers of these traders any information referred to in paragraph 2, point (a);

(b)establish a single contact point for direct communication with Member States’ authorities in relation to non-compliant, under-performing or unsafe product. This contact point may be the same as the one referred to in [Article 20(1)] of Regulation (EU) …/… [the General Product Safety Regulation] or [Article 10(1)] of Regulation (EU) …/… [the Digital Services Act];

(c)give an appropriate answer without undue delay, and in any event within five working days, in the Member State where the online marketplace operates, to notices related to notification of accidents and other incidents with products received in accordance with [Article 14] of Regulation (EU) […/…] on a Single Market for Digital Services (Digital Service Act) and amending Directive 2000/31/EC;

(d)cooperate to ensure effective market surveillance measures, including by abstaining from putting in place obstacles to such measures;

(e)inform the market surveillance authorities of any action taken;

(f)establish a regular and structured exchange of information on offers that have been removed on the basis of this Article by online marketplaces;

(g)allow online tools operated by market surveillance authorities to access their interfaces in order to identify non-compliant products;

(h)upon request of the market surveillance authorities, when the online marketplace or its online sellers have put in place technical obstacles to the extraction of data from their online interfaces, allow those authorities to scrape such data for product compliance purposes based on the identification parameters provided by the requesting market surveillance authorities.

4. 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, for all products covered by this Regulation, to order an online marketplace to remove specific illegal content referring to a non-compliant product from its online interface, to disable access to it or to display an explicit warning to end users when they access it. Such orders shall comply with [Article 8(1)] of Regulation (EU) …/… [the Digital Services Act].

5. An online marketplace shall take the necessary measures to receive and process in accordance with [Article 8] of Regulation (EU) …/…[the Digital Services Act] the orders referred to in paragraph 4.

6. The paragraphs 1 and 2, paragraph 3, points (b) to (i) and paragraphs 4 and 5 shall also apply to manufacturers, importers, distributors or other economic operators offering products online without involvement of an online marketplace (“online shops”).

7. The paragraph 3, points (d) to (h) shall also apply to online search engines.

8. A fulfilment service provider shall ensure that the conditions during warehousing, packaging, addressing or dispatching, do not jeopardise the products’ compliance with the requirements set out in this Regulation.

Article 28 - Obligations of 3D-printing service providers and of providers of moulds, of 3D-printing datasets, and of 3D-printing materials

1. A 3D-printing service provider shall:

(a)refrain from placing on the market or directly installing products for clients without satisfying the obligations incumbent on manufacturers;

(b)inform its clients that they may use 3D-printing services only for the fabrication of products for their own use, unless satisfying the obligations incumbent on manufacturers;

(c)inform its clients that the 3D-datasets and the materials to be used shall have undergone the procedures applicable to products under this Regulation; and

(d)inform its clients that both the information provided by the manufacturer of the 3D-dataset and the information provided by the manufacturer of the printing material shall coincide and confirm the usability of the material for that type of 3D-dataset and the given 3D-printing technology.

2. Providers of moulds and of 3D-datasets intended to produce items covered by this Regulation shall produce 10 such items and shall make them available to the notified body, technical assessment body and to authorities on request. Providers of moulds and of 3D-datasets intended to produce items covered by this Regulation shall assess and document the fulfilment of requirements of this Regulation with regard to the produced items.

3. Providers of materials intended to be used for the 3D-printing of items covered by this Regulation on or close to the construction site shall produce 10 such items for each intended use and shall make them available to the notified body, technical assessment body and to authorities on request. Providers of materials intended to be used for the 3D-printing of items covered by this Regulation on or close to the construction site shall assess and document the fulfilment of requirements of this Regulation with regard to the produced items.

Article 29 - Obligations of economic operators de-installing or dealing with used products for re-use or remanufacturing

1. An economic operator de-installing used products for re-use or re-manufacturing shall establish protocols on the place, conditions and presumed length of use of the de-installed product and make them available together with the products, regardless whether it exert its activity on its own behalf or for somebody else. The economic operator shall also make the protocols available on request to authorities, to later users of these products and to owners of the construction works in which they were re-installed.

2. Where an economic operator brokers, sells or otherwise makes available de-installed used products on its own behalf or for somebody else, it shall also fulfil the obligations of importers or distributors with regard to used products.

Article 30 - Obligations of suppliers and service providers involved in the manufacturing of products

1. A supplier or service provider involved in the manufacturing of products shall:

(a)provide to manufacturers, notified bodies and authorities all available information on the environmental sustainability of their supplied component or service;

(b)ensure the correctness of such information namely by respecting this Regulation and correct any errors made by communication to all their clients and, if potentially useful, to notified bodies and authorities;

(c)permit, in absence of such information, their customers to assess that environmental sustainability on their own expense and support that assessment, namely by giving access to all documents, including those of commercial character, relevant for that assessment;

(d)permit notified bodies to verify the correctness of any calculation of the environmental sustainability and support that verification;

(e)permit notified bodies to verify the performance and compliance of the supplied component or service and support that verification.

2. Where a supplier or service provider has been informed in accordance with the last sentence of Article 21(8), it shall forward that information to his other clients who have, in the last 5 years, received components or services which are identical with regard to the issue in question. In case of a serious risk as defined in Article 3, point (71) or a risk falling under the last sentence of Article 21(9), the supplier or service provider shall also inform the national competent authorities of the Member States where products with that component or manufacturing service have been made available on the market or directly installed; where it cannot identify these Member States, it shall inform all national competent authorities.

Article 31 - Double use and pseudo products

1. A manufacturer of double use products shall satisfy the obligations of this Regulation for all the items of the respective type, unless they are specifically marked as “not for construction”.

2. Other economic operators dealing with double use products shall fulfil the obligations incumbent on them in accordance with this Regulation. In their commercial contracts, they shall establish an obligation of their clients to do the same and not to sell or to use items for construction which are marked as “not for construction”.

3. For items suitable for construction for which the manufacturer has never intended such use and which, therefore, have not been CE-marked (“pseudo products”), other economic operators shall:

(a)not acquire or sell them as items being intended for construction without undergoing the procedures set out in this Regulation to be undergone by manufacturers;

(b)ensure by presentation that they cannot be understood as being intended for construction; and

(c)establish a contractual obligation of their clients to do the same and not to use these items for construction.

Article 32 - 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 clients in the Union. An offer for sale shall be considered to be targeted at clients in the Union if the relevant economic operator directs, by any means, its activities to a Member State. Inter alia, an offer shall be considered to be targeted at clients in the Union where:

(a)the economic operator uses an official language of a Member State, unless selling to the Union is explicitly excluded by effective means;

(b)the economic operator uses the currency of the Member States or a crypto-currency covered by Regulation (EU) […] 47 unless, in the latter case, selling to the Union is explicitly excluded by effective means;

(c)the economic operator has the used internet domain name registered in one of the Member States or uses an internet domain that refers to the Union or one of the Member States; or

(d)the geographical areas to which dispatch is available includes a Member State.

2. Member States shall designate a single centralised market surveillance authority responsible for detecting products offered from economic operators outside the Union to clients on their territory online and via other distance sales methods.

Article 33 - Implementing acts on economic operators’ obligations and rights

Where this is necessary to ensure a harmonised application of this Regulation and only to the extent necessary to prevent diverging practices creating an uneven playing field for economic operators, the Commission may adopt implementing acts providing details on how to execute the obligations and rights of economic operators contained in this Chapter.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(2).

CHAPTER IV

CONSTRUCTION PRODUCTS STANDARDS AND EUROPEAN ASSESSMENT DOCUMENTS

Article 34 - Construction products standards

1. Construction products standards shall be established by the European standardisation organisations on the basis of a standardisation request issued by the Commission.

2. Construction products standards developed pursuant to Article 4(2) shall be of mandatory application for purposes of this Regulation as of six months after the publication of their reference in the Official Journal in accordance with paragraph 4, but may be voluntarily applied on request of the manufacturer as from the date of that publication. They shall provide the methods and the criteria for assessing the performance of the products in relation to their essential characteristics. These standards shall, where appropriate and without endangering the accuracy, reliability or stability of the results, provide methods less onerous than testing for assessing the performance of the products in relation to their essential characteristics, classes, threshold levels or product requirements.

3. Construction products standards developed pursuant to the second sentence of Article 5(2) or the third sentence of Article 22(4) shall be voluntary. Products which are in conformity with voluntary standards adopted in accordance with Article 5(2), 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 requirements laid down in Annex I Part B and C, as specified for the respective product family or category by harmonised technical specifications adopted in accordance with the second sentence of Article 5(2), to the extent that those requirements are covered by such voluntary standards and that this coverage has been precisely stated in the respective harmonised standard. Manufacturers who comply with voluntary standards adopted in accordance with Article 22(2), 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 obligations set out in Article 22(2), to the extent that those obligations are covered by such standards and that this coverage has been precisely stated in the respective standard.

4. The Commission shall assess the conformity of construction products standards established by the European standardisation organisations with the relevant standardisation requests, with this Regulation and with other Union law. The Commission shall publish or publish with restrictions in the Official Journal of the European Union the list of references of accepted conforming construction products standards that have been made available at an affordable price. Where a reference to a standard cannot be published otherwise in the Official Journal, the Commission is empowered to supplement this Regulation by delegated acts adopted in accordance with Article 86 to modify the respective standards for purposes of legal effects under this Regulation.

Article 35 - European assessment document

1. Article 4(1) and (4), Article 6, Article 9 and Articles 11 to 17 shall apply to European assessment documents. Where the CE marking is issued on the basis of a European assessment document and European technical assessment, the European assessment document shall be referred to in the declaration of performance and the declaration of conformity.

2. Following a request for a European technical assessment by a manufacturer or a group of manufacturers or on initiative of the Commission, a European assessment document may be drawn up and adopted by the organisation of technical assessment bodies (‘TABs’) in agreement with the Commission for any product not covered by:

(a)a harmonised technical specification;

(b)a harmonised technical specification intended to be adopted in the next 2 years as from the date of verification with the Commission;

(c)another European assessment document already cited in the Official Journal or submitted to the Commission for citation therein.

The product shall not be considered as covered by the harmonised technical specification where:

(i)the intended use of the product is different than the intended use supposed in the document,

(ii)the materials used are not identical to the materials intended to be used under the document, or

(iii)the assessment method of the document is not appropriate for that product.

3. The organisation of TABs and the Commission may bundle or reject requests for the development of a European assessment document. The procedure for adopting the European assessment document shall respect Article 36 and shall comply with Article 37 and Annex III.

4. The Commission is empowered to amend Annex III by delegated act adopted in accordance with Article 87 to establish supplementary procedural rules for the development and adoption of a European assessment document, where this is necessary to ensure the good functioning of the European assessment documents system.

Article 36 - Principles for the development and adoption of European assessment documents

1. The procedure for developing and adopting European assessment documents shall respect the following principles:

(a)be transparent to Member States, the manufacturer concerned and to other manufacturers or stakeholders that request to be informed;

(b)disclose as little as possible information protected by intellectual property rights, and protect commercial secrecy and confidentiality;

(c)specify appropriate mandatory time limits in order to avoid unjustified delay;

(d)allow at any stage 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 principles laid down in points (a) and (b) shall at least allow 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 Annex III, point 3., and the detailed contents of the draft European assessment document set out in Annex III, point 7.

2. The TABs shall, together with the organisation of TABs, bear the full costs of the development and adoption of European assessment documents, unless it is started on initiative of the Commission.

3. TABs and the organisation of TABs shall avoid any proliferation of European assessment documents where there is no technical justification for differentiating between products and therefore in particular give preference to the extension of a scope of an existing European assessment document.

4. TABs and the organisation of TABs shall refrain from developing European assessment documents where there is a high likelihood of duplication with harmonised technical specifications or pre-existing European assessment documents and shall withdraw duplicating European assessment documents.

Article 37 - Obligations of the TAB receiving a request for a European technical assessment

1. The TAB receiving a request for a European technical assessment from a manufacturer, a group of manufacturers or the manufacturers’ association shall inform the applicant if the product is covered, fully or partially, by a harmonised technical specification or European assessment document as follows:

(a)where the product is fully covered by a harmonised technical specification, the TAB shall inform the manufacturer, the group of manufacturers or the manufacturers’ association that, in accordance with Article 35(2), 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 cited in the Official Journal, the TAB shall inform the manufacturer, the group of manufacturers or the manufacturers’ association that such a document will be used as the basis for the European technical assessment to be issued;

(c)where the product is not covered by any harmonised technical specification or European assessment document and where no such harmonised technical specification is intended to be adopted in the next two years, or no such or European assessment document is already in the procedure of developing pursuant to Annex III, the TAB shall apply the procedures set out in Annex III or those established in accordance with Article 35(4).

2. In the cases referred to in paragraph 1, points (b) and (c), the TAB shall inform the organisation of TABs and the Commission of the content of the request and of the reference to a relevant Commission act determining the assessment and verification system, which the TAB intends to apply for that product, or of the lack of such a Commission decision.

3. If the Commission considers that an appropriate Commission act determining the assessment and verification system does not exist for the product, it may adopt such act in accordance with Article 6(1).

Article 38 - Publication of references

1. The Commission shall assess the conformity of European assessment documents with harmonised technical specifications, with this Regulation and with other Union law. The Commission shall publish or publish with restriction in the Official Journal of the European Union the list of references of accepted conforming European assessment documents. The Commission shall publish any updates to that list.

2. Only European assessment documents referred to in that list and published in at least one language of the Union by either the Commission or by the organisation of TABs shall authorise the issuing of European technical assessments in accordance with Article 42 and trigger legal effects in accordance with Article 42(5), including with regard to the manufacturer who requested the development of the European assessment document. This legal effect of European assessment documents shall expire ten years after their first citation in the Official Journal of the European Union unless they have been renewed in the last year prior to expiry and the Commission decides to maintain the listing.

Article 39 - Dispute resolution in cases of disagreement between TABs

If the TABs do not agree upon the European assessment document within the time limits provided for, the organisation of TABs shall submit this matter to the Commission for appropriate resolution, including instructions to this organisation how to complete its work.

Article 40 - Content of the European assessment document

1. A European assessment document shall contain the following elements:

(a)a description of the product covered; and

(b)the list of essential characteristics, relevant for the intended use of the product as set out by the manufacturer and agreed between the manufacturer and the organisation of TABs, and the methods and criteria for assessing the performance of the product in relation to those essential characteristics.

2. Principles for the applicable factory production control to be applied shall be set out in the European assessment document, taking into account the conditions of the manufacturing process of the product concerned.

3. Where the performance of some of certain essential characteristics of the product can appropriately be assessed with methods and criteria established in harmonised technical specifications or European assessment documents, those existing methods and criteria shall be incorporated as parts of the European assessment document, unless there are good reasons to deviate from this rule.

Article 41 - 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 satisfy applicable legal requirements or the demands to be met in relation to the basic requirements for construction works or product requirements set out in Annex I; 

(b)where it considers that a European assessment document raises a major concern for human health and safety, 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 35(2),

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 organisation of TABs of its decision referred to in paragraph 2 and, where necessary, request the revision of the European assessment document concerned.

Article 42 - European technical assessment

1. The European technical assessment shall be issued by a TAB, at the request of a manufacturer on the basis of a European assessment document established in accordance with the procedures set out in Article 37 and Annex III the reference of which has been cited in the Official Journal of the European Union in accordance with Article 38.

Provided that there is a European assessment document, 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 citation of the construction products standard in the Official Journal of the Union.

2. The European technical assessment shall include the performance to be declared, by levels or classes, or in a description, of those essential characteristics agreed by the manufacturer and the TAB receiving the request for the European technical assessment for the declared intended use, and technical details necessary for the implementation of the assessment and verification system.

3. 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 88(2).

4. European technical assessments issued on the basis of a European assessment document remain valid for five years after the expiry date of the European assessment document in accordance with Article 38(2).

5. 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 43 - Designating authorities

1. Member States wishing to designate technical assessment bodies shall designate a single authority in charge of technical assessment bodies (hereafter: the “designating authority”). Designating authorities shall satisfy the requirements for notifying authorities set out in Articles 48(1) and Article 49. The designating authority shall not be eligible for designation in accordance with Article 44(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. However, Member States may not use accreditation.

Article 44 - Designation, monitoring and evaluation of TABs

1. Member States may designate Technical Assessment Bodies (TABs) within their territories for one or several product areas listed in of Annex IV, Table 1. The Commission is empowered to amend this table by delegated acts adopted in accordance with Article 87 to adapt it to technical progress.

Member States shall communicate the name of the technical assessment body, its address and the product areas referred to in the first sentence to the Commission.

2. The Commission shall publish the list of those TABs that satisfy applicable legal requirements referred to Article 45(1) and (2) by electronic means and indicate the product areas for which they are designated and any limitations in the most precise possible way.

The Commission shall publish any updates to that list.

3. The designating authority designated in accordance with Article 43 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 instruct the TABs wherever there is an infringement of law or common practice agreed between the Member States and the Commission. In case of repeated infringement of the law, it may revoke the designation of the TAB.

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 relevant Member State and notified 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. The Commission may investigate the compliance of TABs with the requirements set out in this chapter, as well as the fulfilment by the responsible designating authorities of their monitoring obligations.

6. TABs shall, upon request by the relevant designating authority, supply all relevant information and documents, required to enable the authority, the Commission and the Member States to verify compliance.

7. Where a TAB no longer complies with the requirements of this Regulation, the Member State shall withdraw the designation of that TAB for the relevant product area and inform the Commission and the other Member States thereof. Articles 58 and 59 apply.

Article 45 - Requirements for TABs

1. A TAB shall be competent and equipped to carry out the assessment in the product area for which it has been designated. The decision making staff and at least half of the technical competent staff of the TAB shall be located in the designating Member State.

2. The TAB shall satisfy the requirements set out in Annex IV, Table 2 within the scope of its designation. Article 50(1) to (5), Article 50(6) points (a) and (b), Article 50(7), (8) and (10) and Article 51 shall apply.

3. A TAB shall have made publicly available its organigram and the names of the members of its internal decision-making bodies.

Where a TAB no longer complies with the requirements referred to in paragraphs 1 and 2, the Member State shall withdraw the designation of that TAB for the relevant product area and inform the Commission and the other Member States thereof.

Article 46 - 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)investigate the potential for new harmonised technical specifications and inform the Commission of such potential;

(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 65(2) and in Article 66(1), 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 65(2) and in Article 66(1) 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 65(2) and in Article 66(1) to the Commission and the Member State which designated the TAB;

(h)report annually to the Commission on the fulfilment of the tasks referred to above, and in particular on the geographical distribution of the TABs, the allocation of European assessment document development tasks to the TABs and the performance and the independence of TABs; and

(i)ensure that adopted European assessment documents and references to European technical assessments are kept publicly available in all EU languages.

The organisation of TABs shall asset up a secretariat in order to carry out these tasks.

3. Member States shall ensure that the TABs contribute with financial and human resources to the organisation of TABs. The value of the contribution of each TAB shall not be less than 2% of its annual budget or turn-over.

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. The Commission may make the financing of the organisation of TABs, regardless of via grants or public tenders, subject to the fulfilment of certain organisational and performance requirements, including with regard to a fair geographic distribution of TABs.

CHAPTER VI

NOTIFYING AUTHORITIES AND NOTIFIED BODIES

Article 47 - Notification

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 (hereinafter referred to as ‘notified bodies’).

Member States shall inform the Commission of their national procedures for the assessment and notification of bodies to be authorised to carry out these tasks. The Commission shall make that information publicly available.

Article 48 - 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 for the monitoring of notified bodies, including their compliance with requirements laid out in Article 50.

2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by their national accreditation bodies in accordance with Chapter II of Regulation (EC) No 765/2008. Member States shall instruct their national accreditation body to take as a basis for accreditation only the precise legal body applying for accreditation and to assess that body against the relevant requirements and tasks laid down in this Regulation.

3. Where the notifying authority delegates the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity that body shall be a legal person and shall comply with the requirements laid down in Article 49. In addition, it shall have arrangements to cover liabilities arising from its activities.

4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraphs 2 and 3.

5. The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for policy on notification and notifying authorities.

Article 49 - 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 activities performed by notified bodies, 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 relevant national authorities.

6. The notifying authority shall have a sufficient number of competent personnel and sufficient funding at its disposal for the proper performance of its tasks. The Commission may adopt implementing acts laying down a minimum number of full-time equivalences considered sufficient for the proper monitoring of notified bodies, where appropriate in relation to specific conformity assessment tasks. Where monitoring is carried out by a national accreditation body or a body referred to in Article 48(3), this minimum number shall apply to that body.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(2).

Article 50 - Requirements for notified bodies

1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

2. A conformity assessment body shall be established under national law and have legal personality.

3. A conformity assessment body shall be independent of the organisation or the product it assesses.

It shall be independent of any and all business ties with organisations having an interest in the products it assesses, manufacturers, their trade partners or their shareholding investors, as well as with other notified bodies and their business associations, parent companies or subsidiaries. This does not preclude the notified body from carrying out assessment and verification activities for competing manufacturers.

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 an independent body.

4. A notified 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, nor the representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the notified body or the use of products for personal purposes.

A notified body, its top-level management and the personnel responsible for carrying out the third party tasks in the assessment and verification process shall not become directly involved in the design, manufacture or construction, 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 nor provide consultancy services.

A notified body shall ensure that activities of its parent or sister companies, its subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of its assessment and/or verification activities.

The establishment and the supervision of internal procedures, general policies, codes of conduct or other internal rules, the assignment of personnel to specific tasks and the conformity assessment decisions may not be delegated to a subcontractor or a subsidiary.

5. A notified body and its 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 and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their assessment and/or verification activities, especially from persons or groups of persons with an interest in the results of those activities.

6. A notified 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 V in relation to which it has been notified, whether those tasks are carried out by the notified 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 notified body shall have the following at its disposal:

(a)the necessary personnel with technical knowledge and sufficient and appropriate experience to perform the third party tasks in the assessment and verification process. Personnel responsible for taking assessment decisions shall be employed by the notified body under the national law of the notifying Member State, shall not have any other potentially conflicting loyalty obligation or potential conflict of interest, shall be competent to verify the assessments made by other staff, external experts or subcontractors. Its number shall be sufficient to ensure business continuity and a consistent approach to conformity assessments;

(b)the necessary description of procedures according to which the assessment process is carried out, ensuring the transparency and the ability of reproduction of these procedures. This shall include a qualification matrix matching relevant personnel, their respective status and tasks within the conformity assessment body with the conformity assessment tasks in relation to which the body intends to be notified;

(c)appropriate policies and procedures in place that distinguish between the tasks it carries out as a notified body and other activities;

(d)the necessary procedures to perform its 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.

A notified 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;

(c)appropriate knowledge and understanding of the applicable harmonised technical specifications and of the relevant provisions of the Regulation;

(d)the ability required to draw up the certificates, records and reports to demonstrate that the assessments and the verifications have been carried out.

8. The impartiality of the body, its top-level management and assessment personnel shall be guaranteed.

The remuneration of the body’s top-level management and assessment personnel shall not depend on the number of assessments carried out or on the results of such assessments.

9. A notified 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 and/or the verification performed.

10. The personnel of the notified body shall be bound to observe professional secrecy with regard to all information gained in carrying out its tasks under Annex V, except in relation to the competent administrative authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

11. A notified body shall ensure that its assessment personnel is informed of the relevant standardisation activities and shall participate in, and ensure that its assessment personnel is informed of, 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 51 - Presumption of conformity

A conformity assessment body to be authorised to carry out third party tasks in the assessment and verification process which demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to comply with the requirements set out in Article 50 in so far as the applicable harmonised standards cover those requirements.

Article 52 - Formal objection

Where a Member State or the Commission has a formal objection to the harmonised standards referred to in Article 51, the provisions of Article 11 of Regulation (EU) 1025/2012 shall apply.

Article 53 - 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 50, 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. The relevant notified bodies shall establish procedures for the on-going monitoring of the competence, activities and performance of its subcontractors or subsidiaries, taking into account the qualification matrix referred to in Article 50(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 any subcontractor or the subsidiary and the tasks carried out by such parties under Annex V.

Article 54 - Use of facilities outside the testing laboratory of the notified body

1. On request of the manufacturer and where justified by technical, economic or logistic reasons, notified bodies may decide to carry out the tests referred to in Annex V, 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 in that regard comply with the requirements laid down in Article 50.

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 55 - Application for notification

1. A body to be authorised to carry out third party tasks in the assessment and verification process 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/or verification processes for which the body claims to be competent, the qualification matrix referred to in Article 50(6), point (b), an accreditation certificate, where one exists, issued by the national accreditation body within the meaning of Regulation (EC) No 765/2008, attesting that the body meets the requirements laid down in Article 50. The accreditation certificate shall relate only to the specific conformity assessment body applying for notification and not take account of the capacities or personnel of parent or sister companies. It shall be based, in addition to relevant harmonised standards, on the specific requirements and assessment tasks.

3. Where the body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 50.

Article 56 - Notification procedure

1. Notifying authorities may notify only bodies which have satisfied the requirements laid down in Article 50.

2. They shall notify the Commission and the other Member States, notably using the electronic notification tool developed and managed by the Commission.

Exceptionally, for cases set out in Annex VI, for which the appropriate electronic tool is not available, a hard copy of the notification shall be accepted.

3. The notification shall include full details of the functions to be performed, reference to the relevant harmonised technical specification and, for the purposes of the system set out in Annex V, the essential characteristics for which the body is competent.

However, reference to the relevant harmonised technical specification is not required in the cases set out in Annex VI.

4. Where a notification is not based on an accreditation certificate as referred to in Article 55(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 50.

5. A notification may become valid only where no objections are raised by the Commission or the other Member States within 2 weeks of notification, where an accreditation certificate is used, or within 2 months of notification, where an accreditation certificate is not used.

The notification shall become valid the day after the body is included in the list of notified bodies referred to in Article 57(2) by the Commission. The Commission shall not list a body if it is aware or becomes aware that the relevant body does not meet the requirements laid down in Article 50.

6. The body concerned may perform the activities of a notified body only after the notification has become valid. Only such a body shall be considered as a notified body for the purpose of this Regulation.

7. The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification.

Article 57 - Identification numbers and lists of notified bodies

1. The Commission shall assign an identification number to each 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 allocated to them and the activities for which they have been notified, notably using the electronic notification tool developed and managed by the Commission.

The Commission shall ensure that this list is kept up-to-date.

Article 58 - 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 50, 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.

2. In the event of withdrawal, restriction or suspension of notification or where the notified body has ceased its activity, the notifying Member State concerned shall take the appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.

Article 59 - 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.

Article 60 - Operational obligations for notified bodies

1. Notified bodies shall, in accordance with Annex V:

(a)assess the performance and the conformity of products;

(b)verify the conformity of products and of the manufacturer;

(c)verify the constancy of performance of products;

(d)verify the calculation of environmental sustainability calculations undertaken by the manufacturer.

These tasks are hereafter 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.

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 its certificate 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, as appropriate.

6. When taking assessment decisions, including when deciding on the need to suspend or withdraw a certificate or approval decisions in light of possible non-compliances, notified bodies shall apply clear and pre-determined criteria.

7. Notified bodies shall ensure rotation between the personnel carrying out different assessment tasks.

Article 61 - Information obligations for notified bodies

1. Notified bodies shall inform the notifying authority of the following:

(a)any refusal, restriction, suspension or withdrawal of certificates;

(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 market surveillance authorities; and

(d)on request, third party tasks in accordance with the systems of assessment and verification 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 carrying out similar third party tasks in accordance with the assessment and verification systems and for products covered by the same harmonised technical specification with relevant information on issues relating to negative and, on request, positive results from these assessments verifications, and therein in particular any refusal, restriction, suspension, or withdrawal of certificates or test reports. On request from other notified bodies or an authority, a notified body shall confirm the status of certificates or test reports issued by it.

3. Where the Commission or the market surveillance 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 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. 4.Notified bodies shall share with the market surveillance or notifying authority concerned, as appropriate, evidence on all of the following:

(a)another notified body does not comply with the requirements laid down in Article 50 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.

Article 62 - Implementing acts on notified bodies’ obligations and rights

Where this is necessary to ensure a harmonised application of this Regulation and only to the extent necessary to prevent diverging practices leading to unequal treatment of and creating an uneven playing field for economic operators, the Commission may, adopt implementing acts providing details on how to execute the obligations of notified bodies contained in Articles 60 and 61.

Those implementing acts shall be adopted in accordance with examination procedure referred to in Article 88(2).

Article 63 - Coordination of notified bodies

The Commission shall ensure that appropriate coordination and cooperation between bodies notified pursuant to Article 47 are put into place and properly operated in the form of a group of notified bodies. Coordination and cooperation in the groups referred to in paragraph 1 shall aim at ensuring the harmonised application of this Regulation.

Notified bodies shall participate in the work of that group, directly or by means of designated representatives.

Notified bodies shall apply as general guidance the administrative decisions and documents produced by that group.

CHAPTER VII

SIMPLIFIED PROCEDURES

Article 64 - Use of appropriate technical documentation

1. A manufacturer may replace type testing by appropriate technical documentation 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 to that end in the relevant harmonised technical specification or a Commission act; or

(b)the product, covered by a harmonised technical specification, which the manufacturer places on the market is a system made of items, which the manufacturer assembles duly following precise instructions, including compatibility criteria in case of individual items, given by the provider of such a system or of a component thereof, who has already tested that system or that item for one or several of its essential characteristics in accordance with the relevant harmonised technical specification. 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 for the system or the item provided to him.

2. If the product referred to in paragraph 1 belongs to a family or category of products for which the applicable assessment and verification system is system 1 + or 1, as set out in Annex V, a notified body or TAB shall, in addition to the tasks set out in Annex V, assess and certify the correct fulfilment of the obligations referred to in paragraph 1.

Article 65 - Use of simplified procedures by micro-enterprises

1. Micro-enterprises manufacturing products covered by a harmonised technical specification may treat products to which system 3 applies in accordance with provisions for system 4. When a manufacturer uses this simplified procedure, the manufacturer shall demonstrate compliance of the product with the applicable requirements by means of a Specific Technical Documentation.

2. The fulfilment of the requirements of this Article shall be assessed and confirmed by a TAB or a notified body.

Article 66 - Custom-made non-series products

1. In relation to products covered by a harmonised technical specification and which are individually manufactured or custom-made in a non-series process in response to a specific order, and which are installed in a single identified construction work by manufacturers who are also responsible for the safe incorporation of those products into construction works, the performance assessment part of the applicable system, as set out in Annex V, may be replaced by the manufacturer by Specific Technical Documentation demonstrating compliance of that product with the applicable requirements and providing data equivalent to those required by this Regulation and the applicable harmonised technical specifications. Equivalence is given where all the data needed and requirements applicable to the particular construction work and its future dismantling, including reuse, remanufacturing and recycling of its installed products, are provided or fulfilled on the basis of state-of-the-art methods.

2. A notified body or TAB shall, in addition to the tasks set out in Annex V, assess and certify the correct fulfilment of the obligations referred to in paragraph 1.

Article 67 - Recognition of assessment and verification by another notified body

1. A notified body (hereafter: recognising notified body) may refrain from the assessment and verification of a certain item to be assessed or verified in accordance with this Regulation and recognise the assessment and verification undertaken by another notified body for the same economic operator where:

(a)the item has been correctly assessed and verified by the other notified body which is - whilst being rebuttable - to be assumed where the respective report does not contain any information suggesting an error;

(b)there is an agreement in place between the two notified bodies obliging them to share all information regarding the assessment and verification and their respective certificates and reports;

(c)the assessed or verified economic operator agrees to share all relevant data and documents with the recognising notified body;

(d)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 test reports that are not followed by a certification and to assessments of calculation of the environmental sustainability undertaken under Regulation (EU) ... [Regulation on ecodesign for sustainable products].

2. Where the notified body wishes to recognise an assessment or verification undertaken by another notified body in relation to an economic operator for which only the other notified body is in charge (“other economic operator”), and provided that there is additionally an agreement in place between the two economic operators that ensures the free flow of all information between them and the notified bodies in view of ensuring compliance with this Regulation, the recognition shall only be possible with regard to the following:

(a)with regard to the verification of the environmental sustainability calculation of the other economic operator, namely supplier or service provider, and their respective supplied goods or services, or

(b)with regard to components where these components do not constitute the entire product.

This paragraph shall also apply to assessments of calculation of the environmental sustainability undertaken under Regulation (EU) ... [Regulation on ecodesign for sustainable products].

CHAPTER VIII

MARKET SURVEILLANCE AND SAFEGUARD PROCEDURES

Article 68 - Complaint Portal

1. The Commission shall set up a system allowing any natural or legal person to share complaints or reports related to possible non-compliances with this Regulation.

2. Where the Commission consider a complaint or report relevant and substantiated, it shall assign it to a market surveillance authority for it to follow-up with the relevant natural or legal person in accordance with Article 11(7), point (a) of Regulation (EU) 2019/1020.

Article 69 - Competent authorities

1. Member States shall designate, amongst their market surveillance authorities, one or more ‘competent authorities’ that dispose of the particular knowledge needed to assess products both technically and legally.

2. Member States shall designate, amongst their competent authorities, the ‘national competent authority’ which is the focal point for contacts with other Member States.

Article 70 - Procedure to deal with non-compliances

1. Where a market surveillance authority of one Member State has sufficient reason to believe that certain products covered by a construction products standard or for which a European technical assessment has been issued, or its manufacturer, is non-compliant, it shall carry out an evaluation in relation to the products and the manufacturer concerned covering the respective requirements laid down by this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities.

Where, in the course of that evaluation, the market surveillance authority finds that the products or its manufacturer does not comply with the requirements and obligations laid down in this Regulation, it shall without delay require the relevant economic operators to take all appropriate and proportionate corrective actions to bring the products or himself into compliance with those requirements and obligations or to withdraw the products from the market, or to recall them, all within a reasonable period and commensurate with the nature and degree of the non-compliance. The corrective action required to be taken by the economic operators may include the actions listed in Article 16(3) of Regulation (EU) 2019/1020.

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 national competent authority, inform the Commission and the other Member States of the results of the evaluation and of the actions which it has required the economic operators to take.

3. The economic operators shall take all appropriate corrective action in respect of all the products that that economic operators has made available on the market throughout the Union.

4. Where the relevant economic operators, within the period referred to in the second subparagraph of paragraph 1, do not take adequate corrective action or where the non-compliance persists, the market surveillance authority shall take all appropriate provisional or definitive measures to prohibit or restrict the making available on the market of the products, to withdraw these product from the market or to recall them.

The market surveillance authority shall inform the public, and via the national competent authority the Commission and the other Member States, without delay, of those measures.

5. The information referred to in the last sentence of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant products, the origin of the 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 either of the following:

(a)failure of the products to achieve the declared performance and/or to meet the requirements related to the fulfilment of basic requirements for construction works laid down in this Regulation;

(b)failure of the manufacturer to meet obligations;

(c)shortcomings in the harmonised technical specifications or a European assessment document.

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. The other 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 71 - Union safeguard procedure

1. Where, on completion of the procedure set out in Article 70(4), 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 operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide by means of implementing act adopted whether the measure is justified or not.

Those implementing acts shall be adopted in accordance with advisory procedure referred in Article 88(1).

The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operators.

2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant product is withdrawn from their markets and shall inform the Commission accordingly. If the national measure is considered 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 construction products standards as referred to in Article 70(5), point (c), the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

Article 72 - Complying products which nevertheless present a risk

1. Where, having performed an evaluation pursuant to Article 70(1), a market surveillance authority Member State finds that, although certain products are in compliance with this Regulation, they present a risk for the fulfilment of the basic requirements for construction works, to the health or safety of persons, to the environment or to other aspects of public interest protection, it shall require the relevant economic operators 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 national competent authority, 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 enter into consultation with 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 decide by implementing act whether the measure is justified or not and, where necessary, propose appropriate measures.

5. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(1).

6. The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operators.

Article 73 - Minimum checks and minimum human resources

1. The Commission is empowered to adopt delegated acts in accordance with Article 87 supplementing this Regulation by laying down the minimum number of checks to be performed by the market surveillance authorities of each Member State on specific products covered by harmonised technical specifications or in relation to specific requirements set out in such measures in order to ensure checks are performed on a scale adequate to safeguard the effective enforcement of this Regulation. The delegated acts may, where relevant, specify the nature of the checks required and methods to be used.

2. The Commission is also empowered to adopt delegated acts in accordance with Article 87 supplementing this Regulation by laying down the minimum human resources to be deployed by Member States for purposes of market surveillance with regard to products covered by this Regulation.

Article 74 - Market surveillance coordination and support

1. For the purposes of this Regulation, the administrative cooperation group (‘ADCO’) set up pursuant to Article 30(2) of Regulation (EU) 2019/1020 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)elaborate guidelines for the application and enforcement of requirements and obligations set out in delegated acts referred to in Article 4(3) and (4) and Article 5(2) and (3) and the delegated acts referred to in Article 22(4), including 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 the ADCO fulfils its tasks set out in Article 32 of Regulation (EU) 2019/1020 and this Article.

Article 75 - Retrieval of costs

Market surveillance authorities shall have the right to recover from economic operators in possession of a non-compliant product or from the manufacturer the costs of document inspection and physical product testing.

Article 76 - 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. The Commission shall, every 2 years, draw up a report by 30 June 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 these reports shall be published by [OP: Please add date: two years after date of application of this Regulation].

The report shall include:

(a)information on the nature and number of checks performed by market surveillance authorities during the two 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 two previous calendar years in relation to products covered by delegated acts adopted pursuant to Articles 4, 5, 6 and 22 of this Regulation;

(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 77 - 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, notified bodies, and product contact points for Construction shall be able to access the information and communication system. The Commission may, by implementing decision give access to authorities of third countries that apply voluntarily this Regulation or that have regulatory systems for construction products similar to this Regulation.

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(1).

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. They shall raise such questions or issues where reasonable doubt exists about how to apply or interpret those rules in a given situation.

3. For purposes of paragraph 2, reasonable doubt shall be assumed to exist where the bodies listed in paragraph 1:

(a)are aware or made aware of the application or interpretation of the rules laid down in or pursuant to this Regulation by any other body in a way that diverges from their own practise;

(b)are aware or made aware of questions or issues raised through the information and communication system related to the situation they are confronted with or to their own practice;

(c)are confronted with a situation 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)have to apply the rules laid down in or pursuant to this Regulation to a situation to which other provisions of Union law also apply and the resulting question.

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 presumable reasoning/rationale behind the approach taken;

(c)any alternative approach it has identified and its respective reasoning/rationale;

5. Member States shall establish a national information system or email list service to inform their 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. Authorities, economic operators, TABs and notified bodies with place of business in the respective Member State shall register into that system or email list service and take account of all information transmitted via them.

7. The national information system or email list service shall be able to receive complaints on behalf of the national competent authority 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 national competent authority shall forward such complaints to their peers in other Member States and to the Commission.

8. Member States and the Commission may use artificial intelligence to detect diverging decision making practices.

Article 78 - EU construction products database or system

1. The Commission is empowered to supplement this Regulation by means of delegated act according to Article 87, by setting up a Union construction products database or system that builds to the extent possible on the Digital Product Passport established by Regulation (EU) ... [Regulation on ecodesign for sustainable products].

2. Economic operators may access all information stored in that database or system which regards them specifically. They may request that incorrect information is corrected.

3. The Commission may, by implementing acts give access to this database or system to certain authorities of third countries that apply voluntarily this Regulation or that have regulatory systems for construction products similar to this Regulation provided that these countries:

(a)ensure confidentiality,

(b)are partners of a mechanism for lawful transfers of personal data compliant with the Regulation (EU) 2016/679 48 ,

(c)commit to engage actively by notifying facts that might trigger the need for action of market surveillance authorities, and

(d)commit to engage against economic operators infringing this Regulation from their territory.

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(1).

Article 79 - 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 and at any rate at least one full-time equivalence per Member State and one additional full-time equivalence per each ten millions of inhabitants. They shall ensure that product contact points for construction deliver their services in accordance with Regulation (EU) 2018/1724 49 and that they coordinate with the contact points for mutual recognition established by Article 9(1) of Regulation (EU) No 2019/515 50 .

2. Product contact points for construction shall provide, at the request of an economic operator or a market surveillance 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 respond within 15 working days of receiving any request under paragraph 3.

4. Product contact points for construction shall not charge any fee for the provision of the information under paragraph 3.

5. 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.

6. Paragraphs 1 to 6 apply also to products which have not yet been covered by harmonised technical specifications.

7. The Commission shall publish update a list of the national product contact points for construction.

Article 80 - Trainings 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, 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. The Commission may, by implementing decision adopted in accordance give access to third countries that apply voluntarily this Regulation or that have regulatory systems for construction products similar to this Regulation.

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(1).

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 81 - 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

INTERNATIONAL COOPERATION

Article 82 - International cooperation

1. The Commission may cooperate, including through the exchange of information, with third countries or international organisations in the field of application of this Regulation, such as:

(a)enforcement activities and measures related to safety and protection of the environment, including market surveillance;

(b)exchange of data of economic operators;

(c)assessment methods and product testing;

(d)coordinated product recalls, requests for corrective actions and other similar actions;

(e)scientific, technical, and regulatory matters, aiming to improve product safety or the protection of the environment;

(f)emerging issues of significant environmental, health and safety relevance;

(g)standardisation-related activities;

(h)exchange of officials.

2. The Commission may provide third countries or international organisations with selected information from the product database or system referred to in Article 78, to the system referred to in Article 77 and to the information exchanged amongst authorities in accordance with this Regulation and receive relevant information on products and on preventive, restrictive and corrective measures taken by these third countries or international organisations. The Commission shall share such information with national authorities, where relevant.

3. The information exchange referred to in paragraph 2 may take the form of either:

(a)a non-systematic exchange, in duly justified and specific cases;

(b)a systematic exchange, based on an administrative arrangement specifying the type of information to be exchanged and the modalities for the exchange.

4. Full participation in the database system referred to in Article 78, to the system referred to in Article 77 and to the information exchange amongst authorities set out in Article 80 may be open to applicant countries and third countries, provided that their legislation is aligned with this Regulation or that they recognise certificates issued by notified bodies or European technical assessments in accordance with this Regulation. Such participation is subject to the fulfilment of the same obligations as for EU Member States according to this Regulation, including notification and follow-up obligations. Full participation in the database or system referred to in Article 78 and to the system referred to in Article 77 shall be based on agreements between the European Union and those countries.

5. Where agreements with third countries permit the mutual support in terms of enforcement, Member States may, after consultation of the Commission, use the empowerments set out in Chapter VIII also for action against economic operators acting unlawful in or with respect to third countries, provided that the third countries respect the fundamental values referred to in Article 2 TEU, including the rule of law. Member States may request via the Commission third countries to enforce measures adopted in accordance with Chapter VIII. No cooperation under this Paragraph shall happen where there is no de facto reciprocity or where the Commission raises other concerns, namely with regard to the legal conditions set out in this Article or confidentiality of data.

6. Any information exchange under this article, to the extent it involves personal data, shall be carried out in accordance with EU 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 and only to the extent that such exchange is necessary for the sole purpose of the protection of health, safety or the environment.

7. The information exchanged pursuant to this Article shall be used for the sole purpose of the protection of health, safety or the environment and respect confidentiality rules.

CHAPTER XI

INCENTIVES AND PUBLIC PROCUREMENT

Article 83 - Member State incentives

1. Where Member States provide incentives for a product category covered by a delegated act establishing performance classes in accordance with Article 4(4), point (a) or a “traffic-light-labelling” in accordance with Article 22(5), those incentives shall aim at the highest two populated classes / colour codes, or at higher classes / better colour codes.

Where a delegated act defines classes of performance in relation to more than one sustainability parameter, it shall be indicated therein in relation to which parameter this Article should be implemented.

2. Where no delegated act is adopted pursuant to Article 4(4), the Commission may specify in the delegated acts adopted pursuant to Article 4(3), which levels of performance related to product parameters the Member States incentives shall concern.

When doing so, the Commission shall take into account the following criteria:

(a)the relative affordability of the products depending on their level of performance;

(b)the need to ensure sufficient demand for more environmentally sustainable products.

Article 84 - Green public procurement

1. The Commission is empowered to supplement this Regulation by delegated acts according to Article 87 by establishing sustainability requirements applicable to public contracts, including implementation, monitoring and reporting of those requirements by Member States.

2. Requirements adopted pursuant to paragraph 1 for public contracts awarded by contracting authorities, as defined in Article 2(1) of Directive 2014/24/EU or Article 3, point (1) of Directive 2014/25/EU, or contracting entities, as defined in Article 4(1) of Directive 2014/25/EU, may take the form of mandatory technical specifications, selection criteria, award criteria, contract performance clauses, or targets, as appropriate.

3. When establishing requirements pursuant to paragraph 1 for public contracts, the Commission shall take into account the following criteria:

(a)the value and volume of public contracts awarded for that given product family or category or for the services or works using the given product family or category;

(b)the need to ensure sufficient demand for more environmentally sustainable products;

(c)the economic feasibility for contracting authorities or contracting entities to buy more environmentally sustainable products, without entailing disproportionate costs.

CHAPTER XII

REGULATORY STATUS OF PRODUCTS

Article 85 - Regulatory status of products

Upon a duly substantiated request of a Member State or on its own initiative, the Commission may, by means of implementing acts, determine whether or not a specific item, or category of items, falls within the definition of ‘construction product’ or constitute an item referred to in Article 2(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(2) of this Regulation.

CHAPTER XIII

AMENDMENTS

Article 86 - Amendments to Regulation (EU) 2019/1020 

Regulation (EU) 2019/1020 is amended as follows:

(1) in Article 4(5), the following text is added: “[(EU) 2020/…(* 51 )]”

(2) in Annex I, the following point 72 is added to the List of Union harmonisation legislation:

“72. Regulation of the European Parliament and of the Council laying down harmonised conditions for the marketing of construction products, amending Regulation (EU) 2019/1020 and repealing Regulation (EU) 305/2011 (the Publications Office to fill in the OJ publication details);”.

CHAPTER XIV

FINAL PROVISIONS

Article 87 - 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(3), (4) and (5), Article 5(2) and (3), Article 6(1) to (3), Article 8, Article 11(3), Article 22(4) and (5), Article 35(4), Article 44(1), Article 73(1) and (2), Article 78(1), Article 84(1) and Article 90(4) shall be conferred on the Commission for a period of five years from … [the date of entry into force of this Regulation]. 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. 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 52 .

4. The delegation of powers referred to in Article 4(3), (4) and (5), Article 5(2) and (3), Article 6(1) to (3), Article 8, Article 11(3), Article 22(4) and (5), Article 35(4), Article 44(1), Article 73(1) and (2), Article 78(1), Article 84(1) and Article 90(4) 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.

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(3), (4) and (5), Article 5(2) and (3), Article 6(1) to (3), Article 8, Article 11(3), Article 22(4) and (5), Article 35(4), Article 44(1), Article 73(1) and (2), Article 78(1), Article 84(1) and Article 90(4) 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 88 - Committee

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. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply (advisory procedure).

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

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

Article 89 - Electronic applications, decisions, documentation and information

1. All applications from or to notified bodies or TABs and decisions made by these bodies or authorities made in accordance with this Regulation can be provided on paper or in a commonly used electronic format provided that the signature is compliant with Regulation (EU) No 910/2014 and the signing person is entrusted to represent the body or economic operator, according to the law of the Member States or Union law respectively.

2. All documentation required by Article 19(7),Article 21(3), Articles 64 to 66 and Annex V can be provided on paper or in a commonly used electronic format and in a way that permits downloads via unmodifiable links (permalinks).

All information obligations set up by Article 7(3), (4) and (6), Article 19(1), (3), (5) and (6), Article 20(2) and (3), Article 21(6) to (9), Article 22(2), points (f) and (i), Article 23(5), Article 24(6), Article 25(2), Article 26(4), Article 27(2), Articles 28 to 39, Article 41(3), Article 44(3), (4), (6) and (7), Article 45(3), Article 46(2), Article 47, article 49(5), Article 50(11), Article 53(1), Article 58(1), Article 59(2), Article 61, Article 70(1), (2), (4) and (6), Article 71(2), Article 72(1), (3) and (5), Article 76, Article 77, Article 78(3), Article 79(2), Article 79(3), Article 80(2), Article 82(1) to (3), (6) and (7) and Article 91 can be satisfied by electronic means. However, information to be provided in accordance with Annex I Part D and harmonised technical specifications specifying it shall be provided on paper for products not labelled “not for consumers” or “only for professional use”. Moreover, consumers may request any other information to be provided on paper.

Article 90 - Penalties

1. Member States shall lay down the rules on penalties applicable to non-compliances 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 [insert date - 3 months after to the date of entry into force of this Regulation], notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

2. Member States shall especially lay down rules on penalties for the following non-compliances of economic operators:

(a)placing on the market or making available on the market of a product which is not CE marked whilst an CE marking is mandatory;

(b)affixing the CE marking in violation of Article 17(1) or without the correct information to be provided together with the CE marking in accordance with Article 17(2);

(c)affixing of the CE marking without prior issuing of a declaration of performance;

(d)issuing of a declaration of performance or declaration of conformity where the conditions therefore have not been met;

(e)the declaration of performance or the declaration of conformity is incomplete or incorrect;

(f)the technical documentation is missing, incomplete or incorrect;

(g)information to be provided in accordance with Annex I Part D and harmonised technical specifications is missing, incomplete or incorrect;

(h)the information referred to in paragraph Article 21(4), Article 22(2), points (f) and (i) or Article 21(7) and Article 24 is missing, incomplete or incorrect;

(i)any other administrative requirement provided for in Articles 21, 22 or 24 is not fulfilled;

(j)information due to notified bodies, TABs or authorities is not provided or is incorrect;

(k)measures requested in case of non-compliance or risk, mandatory according to Article 21(8) and (9), Article 23(3), points (d) and (e), Article 24(5), Article 25(2) in conjunction with Article 24(5), Article 27(2), point (c) in conjunction with Article 24(5) and Article 27(2), points (d), (e) and (g) are not taken;

(l)the product and documentation verification obligations incumbent on economic operators according to Articles 23 to 27 are not fulfilled; and

(m)3D-printing services are provided under infringement of Article 28.

3. Member States shall also lay down rules on penalties for the following non-compliances of TABs and notified bodies:

(a)issuing of certificates, test reports, or European technical assessments whilst the conditions therefore are not fulfilled;

(b)non-withdrawal of certificates, test reports, or European technical assessments where the withdrawal is mandatory;

(c)information to be provided to notified bodies, TABs or authorities is not provided, incomplete or is incorrect; and

(d)instructions of authorities are not followed.

4. The Commission is empowered to supplement this Regulation by delegated act adopted in accordance with Article 87 in order to establish proportionate minimum penalties, targeting all economic operators, TABs and notified bodies directly or indirectly involved in the infringement of obligations of this Regulation.

Article 91 - Evaluation

No sooner than 8 years after the date of application of this Regulation, 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. 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 amendment of the relevant provisions of this Regulation.

Article 92 - Repeal

Regulation (EU) 305/2011 is repealed with effect from 1 January 2045.

References to Regulation (EU) 305/2011 shall be construed as references to this Regulation in accordance with the correlation table in Annex VII.

Article 93 - Derogations and transitional provisions

1. Product contact points for construction designated under Regulation (EU) 305/2011 shall be deemed to be designated under this Regulation as well.

2. TABs and notified bodies designated under Regulation (EU) 305/2011 shall be deemed to be designated 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 [5 years after entry into force]. The objection procedure set-out in Article 56(5), also applicable to TABs in accordance with Article 43(2), shall apply.

3. The following standards remain valid under this Regulation, as standards referred to in the first subparagraph of Article 4(2):

(a)

(b)

(c)[to be inserted during the negotiations of the legislators].


4. European assessment documents issued before [1 year after entry into force] remain valid until [3 years after entry into force], unless they have expired for other reasons. Products placed on the market on the basis of these may be further made available on the market for another five years.

5. Notified bodies’ certificates or test reports and European technical assessments issued under Regulation (EU) 305/2011 remain valid for five years after the entry into force of harmonised technical specifications for the respective product family or category adopted in accordance with Article 4(2), unless these documents have expired for other reasons. Products placed on the market on the basis of these documents may be further made available on the market for another five years.

6. The requirements set out in Chapters I, II and III applicable to economic operators with regard to a certain product group or product family shall apply as from one year after the entry into force of the harmonised technical specification covering that product group or family. However, economic operators may apply those harmonised technical specifications as from their entry into force by undergoing the procedure leading to a declaration of performance or of conformity.

7. Within two years following the entry into force of a harmonised technical specification covering a certain product group or family, the Commission shall withdraw from the Official Journal references of harmonised standards and EADs covering the respective product group or family.

Article 94 - 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 [1 month after entry into force].

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