Legal provisions of COM(2022)142 - Framework for setting ecodesign requirements for sustainable products

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dossier COM(2022)142 - Framework for setting ecodesign requirements for sustainable products.
document COM(2022)142 EN
date March 30, 2022


Chapter I - General provisions

Contents

Article 1 - Subject matter and scope

1. This Regulation establishes a framework to improve the environmental sustainability of products and to ensure free movement in the internal market by setting ecodesign requirements that products shall fulfil to be placed on the market or put into service. Those ecodesign requirements, which shall be further elaborated by the Commission in delegated acts, relate to:

(a)product durability and reliability;

(b)product reusability;

(c)product upgradability, reparability, maintenance and refurbishment;

(d)the presence of substances of concern in products;

(e)product energy and resource efficiency; 

(f)recycled content in products; 

(g)product remanufacturing and recycling;

(h)products’ carbon and environmental footprints;

(i)products’ expected generation of waste materials.

This Regulation also establishes a digital product passport (‘product passport’), provides for the setting of mandatory green public procurement criteria and creates a framework to prevent unsold consumer products from being destroyed.

2. This Regulation shall apply to any physical good that is placed on the market or put into service, including components and intermediate products. However, it shall not apply to:

(a)food as defined in Article 2 of Regulation (EC) No 178/2002;

(b)feed as defined in Article 3(4) of Regulation (EC) No 178/2002;

(c)medicinal products for human use as defined in Article 1(2) of Directive 2001/83/EC;

(d)veterinary medicinal products as defined in Article 4(1) of Regulation (EU) 2019/6;

(e)living plants, animals and micro-organisms; 

(f)products of human origin;

(g)products of plants and animals relating directly to their future reproduction.

Article 2 - Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘product’ means any physical good that is placed on the market or put into service; 

(2) ‘component’ means a product intended to be incorporated into another product;

(3) ‘intermediate product’ means a product that requires further manufacturing or transformation such as mixing, coating or assembling to make it suitable for end-users;

(4) ‘energy-related product’ means any product that has an impact on energy consumption during use;

(5) ‘product group’ means a set of products that serve similar purposes and are similar in terms of use, or have similar functional properties, and are similar in terms of consumer perception;

(6) ‘ecodesign’ means the integration of environmental sustainability considerations into the characteristics of a product and the processes taking place throughout the product’s value chain;

(7) ‘ecodesign requirement’ means a performance requirement or an information requirement aimed at making a product more environmentally sustainable;

(8) ‘performance requirement’ means a quantitative or non-quantitative requirement for or in relation to a product to achieve a certain performance level in relation to a product parameter referred to in Annex I;

(9) ‘information requirement’ means an obligation for a product to be accompanied by information as specified in Article 7(2);

(10) ‘supply chain’ means all upstream activities and processes of the value chain of the product, up to the point where the product reaches  the end-user; 

(11) ‘value chain’ means all activities and processes that are part of the life cycle of a product, as well as its possible  remanufacturing;

(12) ‘life cycle’ means the consecutive and interlinked stages of a product’s life, consisting of raw material acquisition or generation from natural resources, pre-processing, manufacturing, storage, distribution, installation, use, maintenance, repair, upgrading, refurbishment and re-use, and end-of-life;

(13) ‘end-of-life’ means the life cycle stage that begins when a product is discarded and ends when the product is returned to nature as a waste product or enters another product’s life cycle; 

(14) ‘environmental impact’ means any change to the environment, whether adverse or beneficial, wholly or partially resulting from a product during its life cycle;

(15) ‘class of performance’ means a range of performance levels in relation to one or more product parameters referred to in Annex I, ordered into successive steps to allow for product differentiation;

(16) ‘remanufacturing’ means an industrial process in which a product is produced from objects that are waste, products or components and in which at least one change is made to the product that affects the safety, performance, purpose or type of the product typically placed on the market with a commercial guarantee; 

(17) ‘upgrading’ means enhancing the functionality, performance, capacity or aesthetics of a product;

(18) ‘refurbishment’ means preparing or modifying an object that is waste or a product to restore its performance or functionality within the intended use, range of performance and maintenance originally conceived at the design stage, or to meet applicable technical standards or regulatory requirements, with the result of making a fully functional product;

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

(20) ‘repair’ means returning a defective product or waste to a condition where it fulfils its intended use;

(21) ‘durability’ means the ability of a product to function as required, under specified conditions of use, maintenance and repair, until a limiting event prevents its functioning;

(22) ‘reliability’ means the probability that a product functions as required under given conditions for a given duration without a limiting event;

(23) ‘environmental footprint’ means a quantification of a product’s environmental impacts, whether in relation to a single environmental impact category or an aggregated set of impact categories based on the Product Environmental Footprint method;

(24) ‘Product Environmental Footprint method’ means the life cycle assessment method to quantify the environmental impacts of products established by Recommendation (EU) 2021/2279;

(25) ‘carbon footprint’ means the sum of greenhouse gas (GHG) emissions and GHG removals in a product system, expressed as CO2 equivalents and based on a life cycle assessment using the single impact category of climate change;

(26) ‘public contracts’ means public contracts as defined in Article 2(5) of Directive 2014/24/EU;

(27) ‘substance’ means a substance as defined in Article 3, point (1), of Regulation (EC) No 1907/2006;

(28) ‘substance of concern’ means a substance that:

(a)meets the criteria laid down in Article 57 and is identified in accordance with Article 59(1) of Regulation (EC) No 1907/2006; or

(b)is classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in one of the following hazard classes or hazard categories: 

–carcinogenicity categories 1 and 2, 

–germ cell mutagenicity categories 1 and 2, 

–reproductive toxicity categories 1 and 2, [to be added in the course of the legislative procedure once Regulation (EC) No 1272/2008 contains these hazard classes: Persistent, Bioacumulative, Toxic (PBTs), very Persistent very Bioaccumulative (vPvBs); Persistent, Mobile and Toxic (PMT), very Persistent very Mobile (vPvM); Endocrine disruption], 

–respiratory sensitisation category 1, 

–skin sensitisation category 1, 

–chronic hazard to the aquatic environment categories 1 to 4, 

–hazardous to the ozone layer, 

–specific target organ toxicity – repeated exposure categories 1 and 2,

–specific target organ toxicity – single exposure categories 1 and 2; or

(c)negatively affects the re-use and recycling of materials in the product in which it is present; 

(29) ‘product passport’ means a set of data specific to a product that includes the information specified in the applicable delegated act adopted pursuant to Article 4 and that is accessible via electronic means through a data carrier in accordance with Chapter III;

(30) ‘data carrier’ means a linear bar code symbol, a two-dimensional symbol or other automatic identification data capture medium that can be read by a device;

(31) ‘unique product identifier’ means a unique string of characters for the identification of products that also enables a web link to the product passport;

(32) ‘unique operator identifier’ means a unique string of characters for the identification of actors involved in the value chain of products;

(33) ‘unique facility identifier’ means a unique string of characters for the identification of locations or buildings involved in the value chain of a product or used by actors involved in the value chain of a product; 

(34) ‘processing’ means processing as defined in Article 3, point (2), of Regulation (EU) 2018/1807;

(35) ‘destruction’ means the intentional damaging or discarding of a product as waste with the exception of discarding for the only purpose of delivering a product for preparing for re-use or remanufacturing operations;

(36) ‘consumer product’ means any product, excluding components and intermediate products, primarily intended for consumers as defined in Article 2, point (2), of Directive (EU) 2019/771;

(37) ‘unsold consumer product’ means any consumer product that has not been sold or that has been returned by a consumer in view of their right of withdrawal in accordance with Article 9 of Directive (EU) 2011/83/EU;

(38) ‘self-regulation measure’ means a voluntary agreement or codes of conduct, concluded by industry sectors on their own initiative, which they are responsible for enforcing;

(39) ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(40) ‘placing on the market’ means the first making available of a product on the Union market;

(41) ‘putting into service’ means the first use, for its intended purpose, in the Union, of a product;

(42) ‘manufacturer’ means any natural or legal person who manufactures a product or who has such a product designed or manufactured, and markets that product under its name or trademark or, in the absence of such person or an importer, any natural or legal person who places on the market or puts into service a product;;

(43) ‘authorised representative’ means any natural or legal person established in the Union who has received a written mandate from the manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation;

(44) ‘importer’ means any natural or legal person established in the Union who places a product from a third country on the Union market;

(45) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

(46) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the dealer and the fulfilment service provider;

(47) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product, process or service;

(48) ‘harmonised standard’ means a standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012;

(49) ‘CE marking’ means a marking by which the manufacturer indicates that the relevant product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;

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

(51) ‘national accreditation body’ means a national accreditation body as defined in Article 2(11) of Regulation (EC) No 765/2008;

(52) ‘conformity assessment’ means the process demonstrating whether the requirements set out in the relevant delegated acts adopted pursuant to Article 4 have been fulfilled;

(53) ‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

(54) ‘notified body’ means a conformity assessment body notified in accordance with Chapter IX of this Regulation;

(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 covered by delegated acts adopted pursuant to Article 4;

(56) ‘dealer’ means a retailer or any other natural or legal person who offers products for sale, hire or hire purchase, or displays products to customers in the course of a commercial activity, whether or not in return for payment;

(57) ‘distance selling’ means the offer for sale, hire or hire purchase of products, online or through other means of distance sales, whereby the potential customer cannot physically access the product displayed;

(58) ‘product presenting a risk’ means a product that, by not complying with a requirement set out in or pursuant to this Regulation other than those listed in Article 65(1), may adversely affect the environment or other public interests protected by that requirement;

(59) ‘product presenting a serious risk’ means a product presenting a risk for which, based on an assessment, the degree of the relevant non-compliance or the associated harm is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the non-compliance are not immediate.

In addition, the definitions of ‘waste’, ‘hazardous waste’, ‘re-use’, ‘recovery’, ‘preparing for re-use’ and ‘recycling’ in Article 3, points (1), (2), (13), (15), (16) and (17), of Directive 2008/98/EC of the European Parliament and of the Council 83 shall apply.

The definitions of ‘market surveillance’, ‘market surveillance authority’, ‘fulfilment service provider’, ‘online interface’, ‘corrective action’, ‘end-user’, ‘recall’, ‘withdrawal’, ‘customs authorities’ and ‘release for free circulation’ in Article 3, points (3), (4), (11), (15), (16), (21), (22), (23), (24) and (25), of Regulation (EU) 2019/1020 shall also apply.

The definitions of ‘SMEs’, ‘small enterprises’ and ‘microenterprises’ in Article 2(1), (2) and (3), of Annex I to Commission Recommendation 2003/361/EC 84  shall also apply.

Article 3 - Free movement

1. Products shall only be placed on the market or put into service if they comply with the ecodesign requirements set out in the delegated acts adopted pursuant to Article 4 applicable to those products.

2. Member States shall not prohibit, restrict or impede the placing on the market or putting into service of products that comply with the performance requirements set out in delegated acts adopted pursuant to Article 4 for reasons of non-compliance with national performance requirements relating to product parameters referred to in Annex I covered by performance requirements included in such delegated acts.

Member States shall not prohibit, restrict or impede the placing on the market or putting into service of products that comply with the information requirements set out in delegated acts adopted pursuant to Article 4 for reasons of non-compliance with national information requirements relating to product parameters referred to in Annex I covered by information requirements included such delegated act.

3. Paragraph 2 shall not prevent Member States from setting minimum energy performance requirements in accordance with Article 4(1) and system requirements in accordance with Article 8 of Directive 2010/31/EU of the European Parliament and of the Council 85 .

4. Member States shall not prohibit, restrict or impede the placing on the market or putting into service of products on grounds of non-compliance with national requirements relating to product parameters referred to in Annex I, for which a delegated act adopted pursuant to Article 4 provides that no performance, no information or neither performance nor information requirements are necessary.

5. At trade fair, exhibitions and similar events, Member States shall not prevent the showing of products that do not comply with delegated acts adopted pursuant to Article 4, provided that a visible sign clearly indicates that such products do not comply and that they are not for sale until they have been brought into conformity.

Chapter II - Ecodesign requirements

Article 4 -   Empowerments to adopt delegated acts

The Commission is empowered to adopt delegated acts in accordance with Article 66 to supplement this Regulation by establishing ecodesign requirements for, or in relation to, products to improve their environmental sustainability. Those requirements shall include the elements listed in Annex VI and shall be established in accordance with Articles 5, 6 and 7 and Chapter III. The empowerment to adopt ecodesign requirements includes the power to establish that no performance requirements, no information requirements or neither performance nor information requirements are necessary for certain specified product parameters referred to in Annex I.

When establishing ecodesign requirements in delegated acts referred to in the first subparagraph, the Commission shall also supplement this Regulation by specifying the applicable conformity assessment procedures from among the modules set out in Annex IV to this Regulation and Annex II to Decision No 768/2008/EC, with the adaptations necessary in view of the product or ecodesign requirements concerned, in accordance with Article 36.

Delegated acts referred to in the first subparagraph may also supplement this Regulation by:

(a)requiring manufacturers, their authorised representatives or importers to make parts of the technical documentation related to the relevant product digitally available to the Commission or market surveillance authorities without request, in accordance with Article 30(3);

(b)requiring manufacturers, their authorised representatives or importers to make available to the Commission information on the quantities of a product covered by those delegated acts placed on the market or put into service, in accordance with Article 31(1);

(c)requiring products placed on the market to be able to measure the energy they consume or their performance in relation to other relevant product parameters referred to in Annex I while in use, in accordance with Article 31(2); 

(d)requiring manufacturers, their authorised representatives or importers to collect, anonymise, or report to the Commission the in-use data referred to in point (c), in accordance with Article 31(3);

(e)requiring the use of online tools to calculate the performance of a product in relation to a product parameter referred to in Annex I, in accordance with Article 32(2);

(f)specifying alternative rules on the declaration of conformity or markings indicating conformity with ecodesign requirements by way of derogation from Articles 37 and 39, in accordance with Article 40;

(g)specifying rules to direct Member States incentives in accordance with Article 57;  

(h)establishing requirements applicable to public contracts, including implementation, monitoring and reporting of those requirements by Member States. Those requirements shall be based on the product parameters referred to in Annex I and established in accordance with Article 58.

Article 5 -   Ecodesign requirements

1. The Commission shall, as appropriate to the relevant product groups and with due consideration for all stages of their life cycle, establish ecodesign requirements to improve the following product aspects:

(a)durability;

(b)reliability;

(c)reusability;

(d)upgradability;

(e)reparability;

(f)possibility of maintenance and refurbishment;

(g)presence of substances of concern;

(h)energy use or energy efficiency;

(i)resource use or resource efficiency;

(j)recycled content; 

(k)possibility of remanufacturing and recycling;

(l)possibility of recovery of materials;

(m)environmental impacts, including carbon and environmental footprint;

(n)expected generation of waste materials.

2. Ecodesign requirements shall be established for a specific product group. 

However, where two or more product groups display technical similarities allowing a product aspect referred to in paragraph 1 to be improved based on a common requirement, ecodesign requirements may be established horizontally for those product groups.

A horizontal ecodesign requirement established pursuant to the second subparagraph may cover products falling in the scope of a self-regulation measure established as a valid alternative pursuant to Article 18(3), where the Commission considers that that self-regulation measure does not address the product aspect covered by that horizontal ecodesign requirement. 

3. Ecodesign requirements shall, as appropriate, include:

(a)performance requirements as set out in Article 6; 

(b)information requirements as set out in Article 7.

4. When preparing ecodesign requirements, the Commission shall: 

(a)take into account the following elements:

(i)Union climate, environmental and energy efficiency priorities and other related Union priorities;

(ii)relevant Union legislation, including the extent to which it addresses the relevant product aspects listed in paragraph 1;

(iii)self-regulation measures, as provided for in Article 18;

(iv)relevant national environmental legislation;

(v)relevant European and international standards;

(b)carry out an impact assessment based on best available evidence and analyses, and as appropriate on additional studies and research results produced under European funding programmes. In doing so, the Commission shall ensure that the depth of analysis of the product aspects listed in paragraph 1 is proportionate to their significance. The establishment of ecodesign requirements on the most significant aspects of a product among those listed in paragraph 1 shall not be unduly delayed by uncertainties regarding the possibility to establish ecodesign requirements to improve other aspects of that product;

(c)take into consideration relevant technical information used as a basis for or derived from Union legislation or instruments, including Regulation (EC) No 66/2010, Directive 2010/75/EU, technical screening criteria adopted pursuant to Regulation (EU) 2020/852 and green public procurement criteria;

(d)take into account the views expressed by the Ecodesign Forum referred to in Article 17.

5. Ecodesign requirements shall meet the following criteria:

(a)there shall be no significant negative impact on the functionality of the product, from the perspective of the user;

(b)there shall be no adverse effect on the health and safety of persons;

(c)there shall be no significant negative impact on consumers in terms of the affordability of relevant products, also taking into account access to second-hand products, durability and the life cycle cost of products;

(d)there shall be no disproportionate negative impact on the competitiveness of economic actors, at least of SMEs;

(e)there shall be no proprietary technology imposed on manufacturers or other economic actors;

(f)there shall be no disproportionate administrative burden on manufacturers or other economic actors.

6. The Commission shall, where appropriate, require supply chain actors to:

(a)provide, upon request, manufacturers, notified bodies and competent national authorities with available information related to their supplies or services that is relevant in order to verify compliance with ecodesign requirements;

(b)allow, in the absence of information referred to in point (a), manufacturers to assess their supplies or services in order to verify compliance with ecodesign requirements and give access to relevant documents or facilities to those manufacturers;

(c)enable notified bodies and competent national authorities to verify the correctness of information related to their activities and relevant for verifying compliance with ecodesign requirements.

7. The Commission shall, where appropriate, identify appropriate means of verification for specific ecodesign requirements, including directly on the product or on the basis of the technical documentation.

8. The Commission shall publish relevant studies and analyses used in the establishment of ecodesign requirements in accordance with this Regulation.

Article 6 - Performance requirements

1. Products shall comply with performance requirements related to the product aspects listed in Article 5(1), as laid down in the delegated acts adopted pursuant to Article 4.

2. Performance requirements referred to in paragraph 1 shall be based on the product parameters referred to in Annex I and shall, as appropriate, include:

(a)minimum or maximum levels in relation to a specific product parameter referred to in Annex I or a combination thereof; 

(b)non-quantitative requirements that aim to improve performance in relation to one or more product parameters referred to in Annex I;

(c)requirements related to the functional performance of a product. 

3. Performance requirements based on the product parameter set out in Annex I, point (f), shall not restrict the presence of substances in products for reasons relating primarily to chemical safety.

4. When establishing performance requirements, the Commission shall follow the procedure set out in Annex II.

Article 7 - Information requirements

1. Products shall comply with information requirements related to the product aspects listed in Article 5(1), as laid down in the delegated acts adopted pursuant to Article 4. 

2. The information requirements referred to in paragraph 1 shall:

(a)include, as a minimum, requirements related to the product passport referred to in Chapter III and requirements related to substances of concern referred to in paragraph 5; and

(b)as appropriate, require products to be accompanied by:

(i)information on the performance of the product in relation to the product parameters referred to in Annex I;

(ii)information for consumers and other end-users on how to install, use, maintain and repair the product in order to minimise its impact on the environment and to ensure optimum durability, as well as on how to return or dispose of the product at end-of-life;

(iii)information for treatment facilities on disassembly, recycling, or disposal at end-of-life;

(iv)other information that may influence the way the product is handled by parties other than the manufacturer in order to improve performance in relation to product parameters referred to in Annex I.

Where a delegated acts contains horizontal ecodesign requirements for two or more product groups as referred to in Article 5(2), second subparagraph, point (a) of this paragraph shall not apply.

3. Information requirements based on the product parameter set out in Annex I, point (f), shall not provide obligations on the labelling of substances or mixtures for reasons relating primarily to their hazards to health or the environment.

4. When establishing the information requirements referred to in paragraph 2, point (b), point (i), the Commission shall, as appropriate, determine classes of performance.

Those classes of performance shall correspond to statistically significant improvements in performance levels.

5. The information requirements referred to in paragraph 1 shall enable the tracking of all substances of concern throughout the life cycle of products, unless such tracking is already enabled by another delegated act adopted pursuant to Article 4 covering the products concerned, and shall include at least the following:

(a)the name of the substances of concern present in the product;

(b)the location of the substances of concern within the product;

(c)the concentration, maximum concentration or concentration range of the substances of concern, at the level of the product, its main components, or spare parts;

(d)relevant instructions for the safe use of the product;  

(e)information relevant for disassembly.

Where the Commission sets out information requirements in a delegated act adopted pursuant to Article 4, it shall:

(a)establish which substances fall under the definition in Article 2(28), point (c), for the purposes of the product groups covered;

(b)lay down deadlines for the entry into application of the information requirements referred to in the first subparagraph, with possible differentiation between substances; and

(c)provide exemptions for substances of concern or information elements from the information requirements referred to in the first subparagraph. 

Exemptions referred to in the second subparagraph, point (c), may be provided based on the technical feasibility or relevance of tracking substances of concern, the need to protect confidential business information and in other duly justified cases.  

Substances of concern falling under the definition in Article 2(28), point (a), shall not be exempted from the information requirement referred to in the first subparagraph if they are present in the relevant products, their main components or spare parts in a concentration above 0,1 % weight by weight.

6. Information requirements shall indicate the manner in which the required information shall be made available.

The required information shall, as appropriate, be provided in at least one of the following manners:

(a)on the product itself;

(b)on the product’s packaging;

(c)in the product passport referred to in Article 8;

(d)on a label referred to in Article 14;

(e)in a user manual;

(f)on a free access website or application.

Information ensuring the traceability of substances pursuant to paragraph 5 shall be given either on the product or be accessible through a data carrier included on the product.

7. The information to be supplied pursuant to information requirements shall be provided in a language which can be easily understood by consumers and other end-users, as determined by the Member State in which the product is to be made available on the market or put into service.

Chapter III - Digital product passport

Article 8 - Product passport

1. The information requirements referred to in Article 7(1) shall provide that products can only be placed on the market or put into service if a product passport is available in accordance with the applicable delegated act adopted pursuant to Article 4 and Articles 9 and 10.

2. The requirements related to the product passport laid down in the delegated acts adopted pursuant to Article 4 shall, as appropriate for the product groups covered, specify the following:

(a)the information to be included in the product passport pursuant to Annex III;

(b)the types of data carrier to be used;

(c)the layout in which the data carrier shall be presented and its positioning;

(d)whether the product passport is to correspond to the model, batch, or item level;

(e)the manner in which the product passport shall be made accessible to customers before they are bound by a sales contract, including in case of distance selling;

(f)the actors that shall have access to information in the product passport and to what information they shall have access, including customers, end-users, manufacturers, importers and distributors, dealers, repairers, remanufacturers, recyclers, competent national authorities, public interest organisations and the Commission, or any organisation acting on their behalf;

(g)the actors that may introduce or update the information in the product passport, including where needed the creation of a new product passport, and what information they may introduce or update, including manufacturers, repairers, maintenance professionals, remanufacturers, recyclers, competent national authorities, and the Commission, or any organisation acting on their behalf;

(h)the period for which the product passport shall remain available.

3. The requirements referred to in paragraph 2 shall:

(a)ensure that actors along the value chain, in particular consumers, economic operators and competent national authorities, can access product information relevant to them;

(b)facilitate the verification of product compliance by competent national authorities; and

(c)improve traceability of products along the value chain.

4. When establishing the requirements related to the product passport, the Commission may exempt product groups from the requirement set out in paragraph 1 of this Article where:

(a)technical specifications are not available in relation to the essential requirements included in Article 10; or

(b)other Union law includes a system for the digital provision of information related to a product group for which the Commission considers that it achieves the objectives referred to in paragraph 3, points (a) and (b). 

Article 9 - General requirements for the product passport

1. A product passport shall meet the following conditions:

(a)it shall be connected through a data carrier to a unique product identifier;

(b)the data carrier shall be physically present on the product, its packaging or on documentation accompanying the product, as specified in the applicable delegated act adopted pursuant to Article 4;

(c)the data carrier and the unique product identifier shall comply with standard (‘ISO/IEC’) 15459:2015;

(d)all information included in the product passport shall be based on open, standards, developed with an inter-operable format and shall be machine-readable, structured, and searchable, in accordance with the essential requirements set out in Article 10;

(e)the information included in the product passport shall refer to the product model, batch, or item as specified in the delegated act adopted pursuant to Article 4;

(f)the access to information included in the product passport shall be regulated in accordance with the essential requirements set out in Article 10 and the specific access rights at product group level shall be identified in the applicable delegated act adopted pursuant to Article 4.

The Commission is empowered to adopt delegated acts in accordance with Article 66 to amend the first subparagraph, point (c), of this Article in light of technical and scientific progress by replacing the standard referred to in that point or adding other European or international standards with which the data carrier and the unique identifiers shall comply for the purposes of meeting the conditions set out in this Article.

2. Where other Union legislation requires or allows the inclusion of specific information in the product passport, that information may be added to the information to be included in the product passport pursuant to the applicable delegated act adopted pursuant to Article 4.

3. The economic operator placing the product on the market shall provide dealers with a digital copy of the data carrier to allow the dealer to make it accessible to customers where they cannot physically access the product. The economic operator shall provide that digital copy free of charge and within 5 working days of the dealer’s request.

Article 10 - Technical design and operation of the product passport

The technical design and operation of the product passport shall comply with the following essential requirements: 

(a)product passports shall be fully interoperable with other product passports required by delegated acts adopted pursuant to Article 4 in relation to the technical, semantic and organisational aspects of end-to-end communication and data transfer; 

(b)consumers, economic operators and other relevant actors shall have free access to the product passport based on their respective access rights set out in the applicable delegated act adopted pursuant to Article 4;     

(c)the data included in the product passport shall be stored the economic operator responsible for its creation or by operators authorised to act on their behalf; 

(d)if the data included in the product passport is stored or otherwise processed by operators authorised to act on their behalf, those operators shall not be allowed to sell, re-use or process such data, in whole or in part, beyond what is necessary for the provision of the relevant storing or processing services; 

(e)the product passport shall remain available for the period specified in delegated acts adopted pursuant to Article 4, including after an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the product passport;  

(f)the rights to access and to introduce, modify or update information in product passport shall be restricted based on the access rights specified in delegated acts adopted pursuant to Article 4;

(g)data authentication, reliability and integrity shall be ensured; 

(h)product passports shall be designed and operated so that a high level of security and privacy is ensured and fraud is avoided.

Article 11 - Unique operator identifier and unique facility identifier

1. The unique operator identifiers referred to in Annex III, points (g) and (h), and the unique facility identifiers referred to in Annex III, point (i), shall comply with the ISO/IEC standard 15459:2015.

2. Where a unique operator identifier referred to in Annex III, point (h), is not yet available, the economic operator creating the product passport shall request a unique operator identifier on behalf of the relevant actor.

Before issuing a request as referred to in the first subparagraph, the economic operator creating the product passport shall seek confirmation from the actor concerned that no unique operator identifier exists and shall provide the supply chain actor concerned with full details of the released unique operator identifier.

3. Where a unique facility identifier referred to in Annex III, point (i), is not yet available, the economic operator creating the product passport shall request a unique facility identifier on behalf of the actor responsible for the relevant location or building.

Before issuing a request as referred to in the first subparagraph, the economic operator creating the product passport shall seek confirmation from the responsible actor that no unique facility identifier exists and provide the responsible actor with the full details of the released unique facility identifier.

4. The Commission is empowered to adopt delegated acts in accordance with Article 66 to amend paragraph 1 of this Article in light of technical and scientific progress by replacing the standard referred to in that paragraph or adding European or international standards with which unique operator identifiers referred to in Annex III, points (g) and (h), and unique facility identifiers referred to in Annex III, point (i), may comply for the purposes of meeting the conditions set out in this Article.

Article 12 - Product passport registry

1. The Commission shall set up and maintain a registry storing information included in the product passports required by delegated acts adopted pursuant to Article 4.

The registry referred to in the first subparagraph shall at least include a list of the data carriers and unique product identifiers referred to in Article 9(1).

The Commission shall ensure that the information stored in the registry referred to in the first subparagraph is processed securely and in compliance with Union law, including applicable rules on the protection of personal data.

2. The Commission shall, in the delegated acts adopted pursuant to Article 4, specify the information which, in addition to being included in the product passport, shall be stored in the registry referred to in paragraph 1, taking into account at least the following criteria:

(a)the need to allow for the verification of the authenticity of the product passport;

(b)the relevance of information for improving the efficiency and effectiveness of market surveillance checks and customs controls in relation to products covered by delegated acts adopted pursuant to Article 4;

(c)the need to avoid disproportionate administrative burden for economic operators.

3. In relation to its responsibility to establish and manage the registry referred to in paragraph 1 and the processing of any personal data that might result from that activity, the Commission shall be regarded as controller as defined in Article 3, point (8), of Regulation (EU) 2018/1725.

4. The economic operator placing the product on the market or putting it into service shall upload, in the registry referred to in paragraph 1, the information referred to in paragraph 2.

5. The Commission, competent national authorities and customs authorities shall have access to the registry referred to in this Article for carrying out their duties pursuant to Union legislation.

Article 13 - Customs controls relating to the product passport

1. The Commission shall interconnect the registry referred to in Article 12(1) with the EU Customs Single Window Certificates Exchange (EU CSW-CERTEX), thus enabling the automated exchange of information with the national customs systems through the EU Single Window Environment for Customs established by Regulation (EU)…/…..

The Commission shall adopt an implementing act specifying the details of the implementation arrangements of the interconnection referred to in the first subparagraph.

This implementing act shall be adopted in accordance with the examination procedure referred to in Article 67(3).

The interconnection referred to in the first subparagraph shall be in place within four years from the date of adoption of the implementing act referred to in the second subparagraph.

Paragraphs 3 to 6 of this Article shall apply as from the moment the interconnection is in place.

2. Declarants as defined in Article 5, point (15), of Regulation (EU) 952/2013 shall include the unique product identifier referred to in Article 9(1), point (a), in the customs declaration for release for free circulation of any product covered by a delegated act adopted pursuant to Article 4.

This paragraph shall apply from the moment the registry referred to in Article 12(1) is in place.

3. Before allowing the release for free circulation, customs authorities shall verify whether the unique product identifier indicated by the declarant in accordance with paragraph 2 matches a unique product identifier included in the registry referred to in Article 12(1).

4. Where information included in the product passport is also stored in the registry referred to in Article 12(1), the Commission may specify, in the delegated acts adopted pursuant to Article 4, that customs authorities shall, in addition to the verification referred to in paragraph 3 of this Article, verify the consistency between the information stored in the registry and the customs declaration before allowing the release for free circulation. In such case, the Commission shall take into account at least the following criteria:

(a)the need to improve compliance of products placed on the Union market with ecodesign requirements;

(b)the need to avoid disproportionate burden for customs authorities.

Where customs authorities establish further to the verification laid down in this paragraph that there are discrepancies between the information stored in the registry and the customs declaration, customs authorities shall refuse the release of that product for free circulation. Customs authorities may take any other actions they deem appropriate in accordance with customs legislation, and also registering the refusal in the registry referred to in Article 12(1) and notifying competent national authorities of the refusal.

The release for free circulation shall not be deemed to be proof of conformity with Union law.

5. The verification referred to in paragraphs 3 and 4 shall take place electronically and automatically via the EU Single Window Environment for Customs.

6. Customs authorities may retrieve and use the information included in the product passport and the registry referred to in Article 12(1) for carrying out their duties pursuant to Union legislation, including for risk management in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013.

Chapter IV - Labels

Article 14 - Labels

1. Where the information requirements referred in Article 7(1) specify that information shall be included in a label pursuant to Article 7(6), point (d), the delegated acts adopted pursuant to Article 4 shall specify:

(a)the content of the label;

(b)the layout of the label taking account visibility and legibility;

(c)the manner in which the label shall be displayed to customers including in case of distance selling, taking into account the requirements set out in Article 26 and the implications for the relevant economic operators;

(d)where appropriate, electronic means for generating labels.

2. Where an information requirement entails the inclusion in a label of the class of performance of a product as referred to in Article 7(4), the layout of the label referred to in paragraph 1, point (b), shall enable customers to easily compare product performance in relation to the relevant product parameter and to choose better performing products.

3. For energy-related products, where information on a relevant product parameter, including on classes of performance referred to in Article 7(4), cannot be incorporated in the energy label established pursuant to Regulation (EU) 2017/1369, the Commission, after assessing the best way to communicate about this particular information, may, if appropriate, require the establishment of a label in accordance with this Regulation.

4. When establishing the information requirements referred to in paragraph 1, the Commission shall, where appropriate, require the label to include data carriers or other means to allow customers to access additional information on the product, including means allowing access to the product passport referred to in Article 8.

5. The Commission may adopt implementing acts establishing common requirements for the layout of the labels required pursuant to Article 7(6), point (d).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 67(3).

Article 15 - Mimicking labels

Where delegated acts adopted pursuant to Article 4 do not require products to have a label, those products may not be placed on the market or put into service if they supply or display labels which are likely to mislead or confuse customers with respect to the labels provided for in Article 14.

Chapter V - Prioritisation, planning and consultation

Article 16 - Prioritisation and planning

1. When prioritising products to be covered by ecodesign requirements in accordance with this Regulation, the Commission shall take into account their potential contribution to achieving Union climate, environmental and energy efficiency objectives, as well as the following criteria:

(a)the potential for improving the product aspects listed in Article 5(1) without entailing disproportionate costs, taking into account in particular:

(i)the absence or insufficiency of Union law or failure of market forces or self-regulation measures adopted in accordance with Article 18 to address the objective properly; and

(ii)the disparity in the performance of products available on the market with equivalent functionality in relation to the product aspects listed in Article 5(1); 

(b)the volume of sales and trade of the product within the Union;

(c)the distribution of the environmental impacts, energy use and waste generation across the value chain, in particular whether they take place within the Union;

(d)the need to regularly review and adapt delegated acts adopted pursuant to Article 4 in light of technological and market developments.

2. The Commission shall adopt and regularly update a working plan, covering a period of at least 3 years, setting out a list of product groups for which it intends to establish ecodesign requirements in accordance with this Regulation. That list shall include products aspects referred to in Article 5(1) for which the Commission intends to adopt horizontal ecodesign requirements established pursuant to Article 5(2), second subparagraph.

When adopting or updating the working plan referred to in the first subparagraph, the Commission shall take into account the criteria set out in paragraph 1 of this Article and shall consult the Ecodesign Forum referred to in Article 17.

Article 17 - Ecodesign Forum

The Commission shall ensure that when it conducts its activities, it observes a balanced participation of Member States’ representatives and all interested parties involved with the product or product group in question, such as industry, including SMEs and craft industry, trade unions, traders, retailers, importers, environmental protection groups and consumer organisations. These parties shall contribute in particular to preparing ecodesign requirements, examining the effectiveness of the established market surveillance mechanisms and assessing self-regulation measures.

To that end, the Commission shall establish an expert group, in which those parties shall meet, referred to as the ‘Ecodesign Forum’.

Article 18 - Self-regulation measures

1. Two or more economic operators may submit a self-regulation measure establishing ecodesign requirements for products to the Commission as an alternative to a delegated act adopted pursuant to Article 4. Those operators shall provide evidence that the criteria referred to in paragraph 3, points (a) to (e), are fulfilled. With respect to paragraph 3, point (a), that evidence shall consist of a structured technical, environmental and economic analysis, justifying the ecodesign requirements and objectives of the self-regulation measure, and assessing the impacts of the ecodesign requirements set in that self-regulation measure. 

2. The self-regulation measure shall contain the following information:

(a)a list of the economic operators that are signatories to the self-regulation measure;

(b)the ecodesign requirements applicable to products covered by the self-regulation measure;

(c)a detailed, transparent and objective monitoring plan, with clearly identified responsibilities for industry and independent inspectors, including the criteria set out in point 6 of Annex VII;

(d)rules on information to be reported by signatories and on testing and inspections.

The information referred to in this paragraph shall be kept up-to-date and be available on a publicly accessible website.

3. The Commission shall assess the proposed self-regulation measure, and, where necessary, shall seek scientific advice from Union decentralised agencies. On the basis of that assessment, it shall establish whether it is a valid alternative to a delegated act adopted pursuant to Article 4 where the following criteria are fulfilled:

(a)the self-regulation measure contributes to improving the environmental sustainability of products and ensuring the free movement in the internal market quickly or at a lesser expense than a delegated act adopted pursuant to Article 4;

(b)the market share in terms of volume of the signatories to the self-regulation measure in relation to the products covered by that measure is at least 80 % of units placed on the market or put into service;

(c)the self-regulation measure complies with the criteria set out in Annex VII;

(d)the product covered by the self-regulation measure does not fall within the scope of a delegated act adopted pursuant to Article 4;

(e)the self-regulation measure is in line with Union legislation and international trade commitments of the Union.

The Commission shall adopt an implementing act containing a list of self-regulation measures established as valid alternatives to a delegated act adopted pursuant to Article 4. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 67(2).

4. The Commission may at any point in time request the signatories of a self-regulation measure to submit a revised and updated version of that measure in view of relevant market or technological developments within the product group concerned or where it has reason to believe that the criteria set out in paragraph 3 are no longer fulfilled.

5. Once a self-regulation measure has been listed in an implementing act adopted pursuant to paragraph 3, second subparagraph, the signatories of that measure shall report to the Commission, at regular intervals set out in that implementing act, on the progress towards achieving the objectives of the self-regulation measures and to demonstrate that the criteria set in paragraph 3, points (a) to (e), remain fulfilled. Those reports shall also be made available on a publicly accessible website.

6. Where the Commission considers, based on information received pursuant to paragraphs 4 or 5, that a self-regulation measure no longer fulfils the criteria set out in paragraph 3, it shall delete it from the list referred to in that paragraph. In such cases, the Commission may decide to adopt ecodesign requirements applicable to the product covered by that self-regulation measure.

Article 19 -   Micro, small and medium-sized enterprises

1. In the context of programmes from which SMEs can benefit, the Commission shall take into account initiatives which help SMEs to integrate environmental sustainability aspects including energy efficiency in their value chain.

2. When adopting delegated acts pursuant to Article 4 the Commission shall, where appropriate, accompany those acts with guidelines covering specificities of SMEs active in the product or product group sector affected for facilitating the application of this Regulation by SMEs.

3. Member States shall take appropriate measures to help SMEs apply ecodesign requirements set out in delegated acts adopted pursuant to Article 4..

Those measures shall at least include ensuring the availability of one-stop shops or similar mechanisms to raise awareness and create networking opportunities for SMEs to adapt to requirements.

In addition, without prejudice to applicable State aid rules, such measures may include:

(a)financial support, including by giving fiscal advantages and providing physical and digital infrastructure investments;

(b)access to finance;

(c)specialised management and staff training;

(d)organisational and technical assistance.

Chapter VI - Destruction of unsold consumer products

Article 20 - Destruction of unsold consumer products

1. An economic operator that discards unsold consumer products directly, or on behalf of another economic operator, shall disclose:

(a)the number of unsold consumer products discarded per year, differentiated per type or category of products;

(b)the reasons for the discarding of products;

(c)the delivery of discarded products to preparing for re-use, remanufacturing, recycling, energy recovery and disposal operations in accordance with the waste hierarchy as defined by Article 4 of Directive 2008/98/EC.

The economic operator shall disclose that information on a freely accessible website or otherwise make it publicly available, until a delegated act adopted pursuant to paragraph 3 starts applying to the category of unsold consumer products discarded by the operator in question.

2. The Commission may adopt implementing acts setting out the format for the disclosure of the information referred to in paragraph 1, including the type or category and how the information is to be verified.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 67(3).

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 66 to supplement this Regulation by prohibiting economic operators to destroy unsold consumer products in the Union, where the destruction of unsold consumer products falling within a certain product group has significant environmental impact.

In the delegated acts adopted pursuant to the first subparagraph, the Commission shall set out certain exemptions to those prohibitions where it is appropriate in view of:

(a)health and safety concerns;

(b)damage to products as a result of their handling or detected after a product has been returned by a consumer;

(c)fitness of the product for the purpose for which it is intended, taking into account, where applicable, Union and national law and technical standards;

(d)refusal of products for donation, preparing for re-use or remanufacturing.

4. When preparing a delegated act adopted pursuant to paragraph 3, the Commission shall:

(a)assess the prevalence and environmental impact of the destruction of specific consumer products; 

(b)take into account the information disclosed by economic operators pursuant to paragraph 1;

(c)carry out an impact assessment based on best available evidence and analyses, and on additional studies as necessary.

The Commission shall consult the Ecodesign Forum referred to in Article 17, and take account of its views on possible prohibitions of destruction of unsold consumer products referred to in paragraph 3, prior to the preparation of the delegated acts setting out those prohibitions.

5. Where unsold consumer products are destroyed under an exemption referred to in paragraph 3, second subparagraph, the responsible economic operator shall disclose on a freely accessible website or otherwise make publicly available:

(a)the number of unsold consumer products destroyed;

(b)the reasons for their destruction, referring to the applicable exemption;

(c)the delivery of the products destroyed to recycling, energy recovery and disposal operations in accordance with the waste hierarchy as defined by Article 4 of Directive 2008/98/EC.

The details and format for the disclosure of information provided in the implementing act adopted pursuant to paragraph 2 shall apply to the information to be disclosed pursuant to this paragraph, unless the delegated act adopted pursuant to paragraph 3 provides otherwise.

6. This Article shall not apply to SMEs.

However, the Commission may, in the delegated acts adopted pursuant to paragraph 3, provide that the prohibition to destroy unsold consumer products referred to in paragraph 3 or the disclosure obligation referred to in paragraph 4 shall apply to:

(a)medium-sized enterprises, where there is sufficient evidence that they account for a substantial proportion of unsold consumer products being destroyed;

(b)microenterprises, small enterprises or medium-sized enterprises, where there is sufficient evidence that they may be used to circumvent the prohibition to destroy unsold consumer products referred to in paragraph 3 or the disclosure obligation referred to in paragraph 4.

Chapter VII - Obligations of economic operators

Article 21 - Obligations of manufacturers

1. When placing products covered by a delegated act adopted pursuant to Article 4 on the market or putting them into service, manufacturers shall ensure that:

(a)those products have been designed and manufactured in accordance with the requirements set out in Article 6 and the delegated acts adopted pursuant to Article 4;

(b)those products are accompanied by the information required by the Article 7 and the delegated acts adopted pursuant to Article 4;

(c)a product passport is available in accordance with Article 8 and the delegated acts adopted pursuant to Article 4. 

2. Before placing a product covered by a delegated act adopted pursuant to Article 4 on the market or putting it into service, manufacturers shall carry out the conformity assessment procedure specified in the delegated acts adopted pursuant to Article 4 and draw up the required technical documentation, or have it carried out on their behalf.

Where compliance of a product covered by a delegated act adopted pursuant to Article 4with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity in accordance with Article 37 and affix the CE marking in accordance with Article 39. However, where the Commission has specified alternative rules pursuant to Article 4, third subparagraph, point (f), the manufacturer shall draw up a conformity declaration and affix conformity marking in accordance with those rules.

3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the product has been placed on the market or put into service. Delegated acts adopted pursuant to Article 4 may specify a period longer or shorter than 10 years in order to take account of the nature of the products or requirements concerned.

4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with the applicable requirements. Changes in the production process, product design or in characteristics, as well as changes in harmonised standards, common specifications or other technical specifications by reference to which product conformity is declared or by application of which its conformity is verified, shall be adequately taken into account by manufacturers and, in case they found that the product’s conformity is affected, manufacturers shall carry out a re-assessment in accordance with the conformity assessment procedure specified in the delegated acts adopted pursuant to Article 4, or have it carried out on their behalf..

5. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow so, that the required information is provided on the packaging or in a document accompanying the product.

6. Manufacturers shall indicate on the product their name, registered trade name or registered trade mark and the postal address and, where available, electronic means of communication, where they can be contacted or, where this is not possible, on its packaging, in a document accompanying the product or, where available, in a product passport. The address shall indicate a single point where the manufacturer can be contacted. The contact details shall be clear, understandable and legible.

7. Manufacturers shall ensure that that a product covered by a delegated act adopted pursuant to Article 4 is accompanied by instructions that enable consumers and other end-users to safely assemble, install, operate, store, maintain, repair and dispose of the product in a language that can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions shall be clear, understandable and legible and include at least the information specified in the delegated acts adopted pursuant to Article 4 and pursuant to Article 7(2)(b), point (ii).

8. Manufacturers who consider or have reason to believe that a product covered by a delegated act adopted pursuant to Article 4 that they have been placed on the market or put into service is not in conformity with the requirements set out in those delegated acts shall immediately take the necessary corrective measures to bring that product into conformity, to withdraw it or recall it, if appropriate.

Manufacturer shall immediately inform the market surveillance authorities of the Member States in which they made the product available of the suspected non-compliance and of any corrective measures taken.

9. Manufacturers shall, further to a reasoned request from a competent national authority, provide all the information and documentation necessary to demonstrate the conformity of the product, including the technical documentation in a language that can be easily understood by that authority. That information and documentation shall be provided in either paper or electronic form. The relevant documents shall be made available within 10 days of receipt of a request by a competent national authority.

Manufacturers shall cooperate with the competent national authority, on any action taken to remedy any case of non-compliance with the requirements set out in a delegated act adopted pursuant to Article 4 by which the product in question is covered.

Article 22 - Authorised representatives

1. A manufacturer may, by a written mandate, appoint an authorised representative.

The obligations laid down in Article 21(1) and the drawing up of technical documentation shall not form part of the authorised representative’s mandate.

2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a)keep the EU declaration of conformity and technical documentation at the disposal of the national market surveillance authorities for 10 years after a product covered by a delegated act adopted pursuant to Article 4 has been placed on the market or put into service;

(b)cooperate with the competent national authorities, at their request, on any measures taken with regard to non-compliances of the product covered by the authorised representative’s mandate;

(c)further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product in a language that can be easily understood by that authority; 

(d)further to a request from a competent national authority, make available relevant documents within 10 days of the receipt of such a request ;

(e)terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation and the delegated act adopted pursuant to Article 4.

Article 23 - Obligations of importers

1. Importers shall only place on the market products covered by a delegated act adopted pursuant to Article 4 that comply with the requirements set out in the applicable delegated acts.

2. Before placing a product covered by a delegated act adopted pursuant to Article 4 on the market, importers shall ensure that:

(a)the appropriate conformity assessment procedure has been carried out by the manufacturer and that the manufacturer has drawn up the technical documentation;

(b)products are accompanied by the information required by the Article 7 and the delegated acts adopted pursuant to Article 4;

(c)a product passport is available in accordance with Article 8 and the delegated acts adopted pursuant to Article 4. 

The importer shall further ensure that the product bears the required CE marking referred to in Article 38, or the alternative conformity marking as laid down in a delegated act adopted pursuant to Article 4, third subparagraph, point (f), and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 21(5) and (6).

Where importers consider or have reason to believe that a product is not in conformity with the requirements set out in the applicable delegated acts adopted pursuant to Article 4, they shall not place the product on the market or put it into service until it has been brought into conformity.

3. Importers shall indicate on the product their name, registered trade name or registered trade mark and the postal address and, where available, electronic means of communication, where they can be contacted or, where this is not possible, on the packaging, in a document accompanying the product or, where available, in a product passport. The contact details shall be clear, understandable and legible.

4. Importers shall ensure that the product is accompanied by instructions that enable the consumer to assemble, install, operate, store, maintain, repair and dispose of the product, in a language that can be easily understood by consumers and other end users, as determined by the Member State concerned. Such instructions shall be clear, understandable and legible and shall include at least the information specified in the delegated acts adopted pursuant to Article 4.

5. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in a delegated act adopted pursuant to Article 4 by which it is covered.

6. Importers who consider or have reason to believe that a product covered by a delegated act adopted pursuant to Article 4, which they have placed on the market or put into service, is not in conformity with the requirements set out in that act shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate.

Importers shall immediately inform the market surveillance authorities of the Member States in which they made the product available of the suspected non-compliance and of any corrective measures taken.

7. Importers shall, for 10 years or the period specified by a delegated act adopted pursuant to Article 4, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

8. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product, including technical documentation, in a language that can be easily understood by that authority. That information and documentation shall be provided in either paper or electronic form. The relevant documents shall be made available within 10 days of receipt of a request by the competent authority of a Member State.

Importers shall cooperate with the competent national authority on any action taken to remedy any case of non-compliance with the requirements set out in a delegated act adopted pursuant to Article 4 by which the product in question is covered.

Article 24 - Obligations of distributors

1. When making a product covered by a delegated act adopted pursuant to Article 4 available on the market, distributors shall act with due care in relation to the requirements set out in that act.

2. Before making a product covered by a delegated act adopted pursuant to Article 4 available on the market, distributors shall verify that the following:

(a)the product bears the CE marking in accordance with Articles 38 and 39 or alternative conformity marking adopted pursuant to Article 4, third subparagraph, point (f), and, where relevant, is labelled or is linked to a product passport in accordance with that delegated acts;

(b)the product is accompanied by the required documents and by instructions, to enable the consumer to assemble, install, operate, store, maintain, and dispose of the product, in a language that can be easily understood by consumers and other end-users, as determined by the Member State in which the product is to be made available on the market, and that such instructions are clear, understandable and legible and include at least the information set out in Article 7(2), point (b), point (ii), as laid down in the delegated act adopted pursuant to Article 4;

(c)the manufacturer and the importer have complied with the requirements set out in Article 21(5) and (6) and Article 23(3).

3. Where a distributor considers or has reason to believe that a product, before making it available on the market, or its manufacturer is not complying with the requirements set out in a delegated act adopted pursuant to Article 4, they shall not make the product available on the market until the product has been brought into conformity or the manufacturer complies.

Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in in the delegated act adopted pursuant to Article 4.

4. Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with the requirements set out in a delegated act adopted pursuant to Article 4 shall make sure that the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate, are taken.

Distributors shall immediately inform the market surveillance authorities of the Member States in which they made the product available of the suspected non-compliance and of any corrective measures taken.

5. Distributors shall, further to a reasoned request from a competent national authority, provide the authority with all the information and documentation to which they have access and that is relevant for demonstrating the conformity of a product. That information and documentation shall be provided in either paper or electronic form.

Distributors shall cooperate with that authority on any corrective action taken to remedy any case of non-compliance with a delegated act adopted pursuant to Article 4 by which the product in question is covered.

Article 25 - Obligations of dealers

1. Dealers shall ensure that their customers have access to any relevant information required by the delegated acts adopted pursuant to Article 4, including in case of distance selling.

2. Dealers shall ensure that the product passport is easily accessible to customers, including in case of distance selling, as specified in Article 8 and delegated acts adopted pursuant to Article 4by which the product is covered.

3. Dealers shall: 

(a)display to customers, in a visible manner, including for online distance selling, labels provided in accordance with Article 26(2) or (3);

(b)make reference to the information included in labels provided in accordance with Article 26(2) or (3) in visual advertisements or in technical promotional material for a specific model, in accordance with delegated acts adopted pursuant to Article 4 by which the product is covered;

(c)not provide or display other labels, marks, symbols or inscriptions that are likely to mislead or confuse customers with respect to the information included on the label.

Article 26 - Obligations related to labels

1. Where a delegated act adopted pursuant to Article 4 requires products to have a label as referred to in Article 14, the economic operator placing the product on the market or putting it into service shall ensure that products are accompanied, for each individual unit and free of charge, by printed labels in accordance with that delegated act.

2. Where a delegated act adopted pursuant to Article 4 requires products to have a label as referred to in Article 14, the economic operator placing the product on the market or putting it into service shall deliver printed labels or digital copies of the label to the dealer free of charge, promptly and in any event within 5 working days of the dealer’s request.

3. Where a delegated act adopted pursuant to Article 4 requires products to have a label as referred to in Article 14, the economic operator placing the product on the market or putting it into service shall ensure that its labels are accurate and shall, as part of the applicable conformity assessment procedure, produce technical documentation sufficient to enable the accuracy to be assessed.

4. Where a delegated act adopted pursuant to Article 4 requires products to have a label as referred to in Article 14, the economic operator placing the product on the market or putting it into service shall:

(a)make reference to the information included in the label, in visual advertisements or in technical promotional material for a specific model in accordance with the relevant delegated act adopted pursuant to Article 4;

(b)not provide or display other labels, marks, symbols or inscriptions that are likely to mislead or confuse customers with respect to the information included on the label.

Article 27 - Obligations of fulfilment service providers

Fulfilment service providers shall ensure that, for products that they handle that are covered by a delegated act adopted pursuant to Article 4, the conditions during warehousing, packaging, addressing or dispatching, do not jeopardise the products’ compliance with the requirements set out in that delegated act .

Article 28 - Cases in which obligations of manufacturers apply to importers and distributors

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 under Article 21, where they:

(1) place a product covered by a delegated act adopted pursuant to Article 4 on the market under their name or trademark;

(2) modify such a product already placed on the market in a way that affects compliance with the requirements set out in delegated acts adopted pursuant to Article 4 by which the product is covered.

Article 29 - Obligations of online marketplaces and online search engines

1. The cooperation referred to in Article 7(2) of Regulation (EU) 2019/1020 shall, with regard to online marketplaces and for the purposes of this Regulation, include in particular:

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

(b)informing the market surveillance authorities of any action taken;

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

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

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

2. For the purpose of the requirements of [Article 22(7)] of Regulation (EU) …/… [the Digital Services Act], online marketplaces shall design and organise their online interface in a way that enables dealers to fulfil their obligations set out in Article 25 and allows economic operators to fulfil their obligations under Article 30(1) of this Regulation.

The information shall be able to be provided for each product offered and displayed or otherwise made easily accessible by customers on the product listing.

In particular, where delegated acts adopted pursuant to Article 4 require online visual advertising for certain products to be accompanied by online electronic information to be displayed on the display mechanism, online marketplaces shall enable dealers to show it. This obligation shall also apply to online search engines and other online platforms that provide online visual advertising for the products concerned.

3. As far as powers conferred by Member States in accordance with 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 a relevant delegated act adopted pursuant to Article 4, to order an online marketplace to remove specific illegal content referring to a non-compliant product from its online interface, disable access to it or 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].

4. Online marketplaces shall take the necessary measures to receive and process the orders referred to in paragraph 2 in accordance with [Article 8] of Regulation (EU) …/… [the Digital Services Act]. 

5. Online marketplaces shall establish a single contact point allowing for direct communication with Member States’ market surveillance authorities in relation to compliance with this Regulation and the delegated acts adopted pursuant to Article 4. 

This contact point may be the same contact point 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].

Article 30 - Information obligations of economic operators

1. Where products are made available on the market online or through other means of distance sales by the relevant economic operators, the relevant product offer shall clearly and visibly provide at least the following information:

(a)the name, registered trade name or registered trade mark of the manufacturer, as well as the postal or electronic address where they can be contacted;

(b)in case the manufacturer is not established in the Union, the name, address, telephone number and email address of the economic operator established in the Union within the meaning of Article 4 of Regulation (EU) 2019/1020;

(c)information to identify the product, including its type and, where available, batch or serial number and any other product identifier.

2. Economic operators shall, upon request, provide the market surveillance authorities with:

(a)the name of any economic operator who has supplied them with a product falling within the scope of a delegated act adopted pursuant to Article 4;

(b)any economic operator to whom they have supplied such products, as well as the quantities and exact models.

Economic operators shall be able to provide this information for 10 years after they have been supplied with the relevant products and for 10 years after they have supplied such products. When adopting delegated acts pursuant to Article 4, the Commission may specify a period of more or less than 10 years to take account of the nature of the relevant products or requirements.

3. When requiring manufacturers, their authorised representatives or importers to make parts of the technical documentation related to the relevant product digitally available pursuant to Article 4, third subparagraph, point (a), the Commission shall take into account the following criteria:

(a)the need to facilitate the verification of compliance with the applicable requirements by market surveillance authorities;

(b)the need to avoid disproportionate administrative burden for economic operators. 

The Commission shall specify the manner in which the relevant parts of the technical documentation shall be made available. Where available, technical documentation shall be made available through the product passport.

Article 31 - Monitoring and reporting obligations of economic operators

1. When requiring manufacturers, their authorised representatives or importers to make available to the Commission, information on the quantities of a product covered by delegated acts adopted pursuant to Article 4, third subparagraph, point (b), the Commission shall take into account the following criteria:

(a)the availability of evidence on the market penetrations of the relevant product in order to facilitate the review of delegated acts adopted pursuant to Article 4 applicable to that product;

(b)the need to avoid disproportionate administrative burden for economic operators. 

The Commission shall specify the period of time to which the information referred to in the first subparagraph shall relate. That information shall be differentiated per product model.

The Commission shall ensure that the resulting data is processed securely and in compliance with Union law.

The Commission shall specify in those delegated acts the means through which the relevant information shall be made available and its periodicity.

2. When requiring a product to be able to measure the energy it consumes or its performance in relation to other relevant product parameters referred to in Annex I while in use, pursuant to Article 4, third subparagraph, point (c), the Commission shall take into account the following criteria:

(a)the usefulness of in-use data for end-users to understand and manage the energy use or performance of the product;

(b)the technical feasibility of recording in-use data;

(c)the need to avoid disproportionate administrative burden for economic operators.

Products covered by a requirement set pursuant to Article 4, third subparagraph, point (c), shall record the resulting in-use data and make it visible to the end-user.

3. When requiring manufacturers, their authorised representatives or importers to collect, anonymise or report to the Commission in-use data referred to in paragraph 2, pursuant to Article 4, third subparagraph, point (d), the Commission shall take into account the following criteria:

(a)the usefulness of in-use data for the Commission when reviewing ecodesign requirements or assisting market surveillance authorities with  statistical information for their risk-based analysis; 

(b)the need to avoid disproportionate administrative burden for economic operators.

Such requirements referred to in the first subparagraph may in particular consist of:

(a)collecting the in-use data if it can be accessed remotely via the internet, unless the end-user expressly refuses to make that data available; 

(b)anonymising the data collected under point (a) and report it to the Commission at least once a year. The economic operator shall include the product database identification number of the model as referred to in Article 12(5) of Regulation (EU) No 2017/1369 and, if relevant to their performance, geographical information on the products. 

The Commission shall specify the details and format for reporting the in-use data as referred to in the second subparagraph, point (b).

4. The Commission shall periodically assess the in-use data received pursuant to paragraph 3 and shall, where appropriate, publish aggregated datasets. 

Chapter VIII - Conformity of products

Article 32 - Test, measurement and calculation methods

1. For the purposes of compliance and verification of compliance with ecodesign requirements, tests, measurements and calculations shall be made using reliable, accurate and reproducible methods that take into account the generally recognised state-of-the art methods. Such methods shall fulfil the test, measurement and calculation requirements set out in the relevant delegated acts adopted pursuant to Article 4.

2. Where necessary to ensure compliance with ecodesign requirements set out in delegated acts adopted pursuant to Article 4, third subparagraph, point (e), the Commission may require the use of online tools for the calculation of the performance of products in relation to the relevant product parameter referred to in Annex I reflecting the applicable calculation requirements.

Where setting such requirements for the use of online tools, the Commission shall take into account the following criteria:

(a)the need to ensure the harmonised application of calculation requirements;

(b)the need to minimise administrative burden imposed on economic operators complying with the relevant requirements.

Online tools shall be freely accessible for economic operators complying with the relevant requirements.

Article 33 - Circumvention

1. Products falling within the scope of a delegated act adopted pursuant to Article 4 shall not be placed on the market or put into service if they are designed to alter their behaviour or properties when they are tested in order to reach a more favourable result for any of the product parameters regulated in delegated acts adopted pursuant to Article 4 by which the products are covered. 

For the purposes of this paragraph, products designed to be able to detect they are being tested and automatically alter their performance in response and products pre-set to alter their performance at the time of testing shall constitute products designed to alter their behaviour or properties when they are tested.

2. Economic operators placing a product covered by a delegated act adopted pursuant to Article 4 shall not prescribe instructions specific to testing that alter the behaviour or the properties of products in order to reach a more favourable result for any of the product parameters regulated in delegated acts adopted pursuant to Article 4 by which the products are covered.

For the purposes of this paragraph, instructions leading to a manual alteration of the product before a test that alters the performance of the product shall constitute instructions specific to testing that alter the behaviour or the properties of products.

3. Products falling within the scope of a delegated act adopted pursuant to Article 4 shall not be placed on the market or put into service if they are designed to alter their behaviour or properties within a short period after putting the product into service leading to a worsening of their performance in relation to any of the product parameters regulated in delegated acts adopted pursuant to Article 4 by which the products are covered or their functional performance from the perspective of the user.

4. Software or firmware updates shall not worsen product performance in relation to any of the product parameters regulated in delegated acts adopted pursuant to Article 4 by which the products are covered or the functional performance from the perspective of the user when measured with the test method used for the conformity assessment, except with explicit consent of the end-user prior to the update. No performance change shall occur as a result of rejecting the update.

Software or firmware updates shall not worsen performance referred to in the first subparagraph to the extent that the product becomes non-compliant with the requirements set out in delegated acts adopted pursuant to Article 4 applicable at the time of the placing on the market or putting into service of the product.

Article 34 - Presumption of conformity

1. Tests, measurement or calculation methods referred to in Article 32  which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements set out in that Article and with test, measurement and calculation requirements set out in delegated acts adopted pursuant to Article 4 to the extent that those requirements are covered by such harmonised standards or parts thereof.

2. Products which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with ecodesign requirements set out in delegated acts adopted pursuant to Article 4 to the extent that those requirements are covered by such harmonised standards or parts thereof.

3. Products covered by a delegated act adopted pursuant to Article 4, which have been awarded the EU Ecolabel pursuant to Regulation (EC) No 66/2010 shall be presumed to comply with the ecodesign requirements set out in that delegated act in so far as those requirements are covered by the EU Ecolabel criteria established according to Article 16(2) of Regulation (EC) No 66/2010.

Article 35 - Common specifications

1. The Commission may adopt implementing acts laying down common specifications for ecodesign requirements, the essential requirements for product passports referred to in Article10 or for test, measurement or calculation methods referred to in Article 32, in the following situations:

(a)it has requested one or more European standardisation organisations to draft a harmonised standard in relation to an ecodesign requirement or method that is not covered by a harmonised standard or part thereof, the references of which have been published in the Official Journal of the European Union, and there are either undue delays in the standardisation procedure or the request has not been accepted by any of the European standardisation organisations;

(b)the Commission has decided in accordance with the procedure referred to in Article 11(5) of Regulation (EU) No 1025/2012 to maintain with restriction or to withdraw the references to the harmonised standards or parts thereof by which an ecodesign requirements or method is covered.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 67(3).

2. Test, measurement and calculation methods referred to in Article 32which are in conformity with common specification or parts thereof shall be presumed to be in conformity with the requirements set out in that Article and with test, measurement and calculation requirements set out in delegated acts adopted pursuant to Article 4 to the extent that those requirements are covered by such common specification or parts thereof.

3. Products which are in conformity with common specifications or parts thereof shall be presumed to be in conformity with ecodesign requirements set out in the delegated act adopted pursuant to Article 4 by which those products are covered to the extent that those requirements are covered those common specifications or parts thereof.

Article 36 - Conformity assessment

1. When specifying the applicable conformity assessment procedure pursuant to Article 4, second subparagraph, the Commission shall consider the following criteria:

(a)whether the module concerned is appropriate to the type of product and proportionate to the public interest pursued;

(b)the nature of the product parameters referred to in Annex I on which the relevant ecodesign requirements are based, in particular whether performance in relation to those product parameters can be verified on the product itself;

(c)where third party involvement is mandatory, the need for the manufacturer to have a choice between quality assurance and product certification modules set out in Annex II of Decision No 768/2008/EC.

2. Where relevant, records and correspondence relating to the conformity assessment shall be drawn up in an official language of the Member State where a notified body involved in a conformity assessment procedure referred to in paragraph 1 is established, or in a language accepted by that body.

Article 37 - EU declaration of conformity

1. The EU declaration of conformity shall state that the fulfilment of ecodesign requirements specified in the applicable delegated acts adopted pursuant to Article 4 has been demonstrated.

2. The EU declaration of conformity shall have the model structure set out in Annex V, shall contain the elements specified in the applicable conformity assessment procedure and a reference to the applicable delegated acts adopted pursuant to Article 4. It shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the product is placed or made available.

3. Where a product covered by a delegated act adopted pursuant to Article 4 is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall state the Union acts concerned and their publication references. It may be a dossier made up of relevant individual EU declarations of conformity.

4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product.

Article 38 - General principles of the CE marking

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Article 39 - Rules and conditions for affixing the CE marking

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

2. The CE marking shall be affixed before the product is placed on the market.

3. For a product in the conformity assessment of which a notified body participates, the CE marking shall be followed by the identification number of that notified body.

The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or its authorised representative.

4. The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating a special risk or use.

5. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and take appropriate action in the event of improper use of the marking.

Article 40 -   Alternative conformity declarations and markings

When specifying alternative rules on the declaration of conformity or markings indicating conformity with the applicable requirements under Union law pursuant to Article 4, third subparagraph, point (f), the Commission shall take into account the following criteria:

(a)the need to minimise administrative burden for economic operators; 

(b)the need to ensure coherence with other conformity declarations and markings applicable to a specific product;

(c)the need to prevent confusion about the meaning of conformity declarations and markings under other Union law. 

Chapter IX - Notification of conformity assessment bodies

Article 41 - Notification

Member States shall notify the Commission and the other Member States of bodies authorised to carry out the third-party conformity assessment tasks provided for under the delegated acts adopted pursuant to Article 4.

Article 42 - Notifying authorities

1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with the provisions of Article 47.

2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.

3. Where the notifying authority delegates or entrusts 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 entity and shall comply mutatis mutandis with the requirements laid down in Article 43. In addition, it shall have arrangements to cover liabilities arising out of its activities.

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

Article 43 - Requirements relating to notifying authorities

1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies or notified bodies occurs.

2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.

4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, or consultancy services on a commercial or competitive basis.

5. A notifying authority shall safeguard the confidentiality of the information it obtains. 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. A notifying authority shall take as a basis for notification only the specific conformity assessment body applying for notification and not take account of the capacities or personnel of parent or sister companies.  The authority shall assess that body against all relevant requirements and conformity assessment tasks.

7. A 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 equivalents 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 42(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 67(3).

Article 44 - Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

The Commission shall make that information publicly available.

Article 45 - Requirements relating to notified bodies

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

2. A conformity assessment body shall be established under the national law of a Member State and have legal personality.

3. A conformity assessment body shall be a third-party body independent of the organisation or the product it assesses. It shall not have any business ties with organisations that have an interest in the products it assesses, in particular manufacturers, their trade partners and their shareholding investors. This shall not preclude the conformity assessment body from carrying out conformity assessment activities for competing manufacturers.

4. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, importer, distributor, installer, purchaser, owner, user or maintainer of the products which they assess, 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 conformity assessment body or the use of such products for personal purposes.

A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall apply in particular to consultancy services.

Conformity assessment bodies shall ensure that the activities of its parent or sister companies, subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment 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. Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field. They shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it underthe relevant delegated act adopted pursuant to Article 4 and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

At all times and for each conformity assessment procedure, and for each kind or category of products in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:

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

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the of these procedures and the ability to reproduce them. This shall include a qualification matrix that matches 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 to distinguish the tasks it carries out as a notified body from other activities;

(d)procedures for the performance of activities, which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

It shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

7. The personnel responsible for carrying out conformity assessment activities shall have the following:

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b)satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments, including appropriate knowledge and understanding of the relevant legislation, test, measurement and calculation requirements, of the applicable harmonised standards or common specifications and of the relevant provisions of this Regulation, and of the delegated acts adopted pursuant to Article 4;

(c)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

8. The impartiality of the conformity assessment bodies and their top-level management and of the assessment personnel shall be guaranteed.

The remuneration of the top-level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or their results.

9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

10. The personnel of a conformity assessment body shall observe professional secrecy regarding all information obtained in carrying out the conformity assessment tasks under the relevant delegated acts adopted pursuant to Article 4, except in relation to the notifying authorities and other national authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

11. Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed about, the relevant standardisation activities and apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

Article 46 - Presumption of conformity of conformity assessment bodies

Where a conformity assessment body 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 it shall be presumed to comply with the requirements set out in Article 45 in so far as the applicable harmonised standards cover those requirements.

Article 47 - Subsidiaries of and subcontracting by notified bodies

1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 45 and shall inform the notifying authority accordingly.

2. Notified bodies 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 45(6).

3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment and monitoring of the qualifications of the subcontractor or the subsidiary and the work carried out by them under the relevant delegated acts adopted pursuant to Article 4.

Article 48 - Application for notification

1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.

2. That application shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which that body claims to be competent, the qualification matrix referred to in Article 45(6), as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 45. The accreditation certificate shall relate only to the precise legal body applying for notification and shall be based, in addition to relevant harmonised standards, on the specific requirements and conformity assessment tasks set out in the relevant delegated act adopted pursuant to Article 4.

3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 45.

Article 49 - Notification procedure

1. Notifying authorities only notify conformity assessment bodies which have satisfied the requirements laid down in Article 45.

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

3. The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and product or products concerned and the relevant attestation of competence.

4. Where a notification is not based on an accreditation certificate as referred to in Article 48(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment 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 45.

5. The body concerned may perform the activities of a notified body if the Commission or the other Member States do not raise any objections within 2 weeks of a notification where an accreditation certificate is used, or within 2 months of a notification where accreditation is not used.

Only such a body shall be considered a notified body for the purposes of this Regulation.

6. The notification shall become valid the day after the body is included in the list of notified bodies referred to in Article 50(2) by the Commission. The body concerned may perform the activities of a notified body only after the notification has become valid.

The Commission shall not publish a notification if it is aware or becomes aware that the relevant notified body does not meet the requirements laid down in Article 45.

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

Article 50 - Identification numbers and lists of notified bodies

1. The Commission shall assign an identification number to a notified body.

It shall assign a single such number even where the body is notified under several Union acts.

2. The Commission shall make the list of the bodies notified under this Regulation publicly available, including the identification numbers that have been allocated to them and the activities for which they have been notified.

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

Article 51 - Changes to notifications

1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 45, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.

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

Article 52 - 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 relating to the basis for the notification or the maintenance of the competence of the body concerned.

3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requiring the notifying Member State to take the necessary corrective action, including withdrawal of the notification if necessary. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 67(2).

The Commission shall update the list of notified bodies referred to in Article 50(2) within 2 weeks of the implementing act being adopted.

Article 53 - Operational obligations of notified bodies

1. Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in the delegated acts adopted pursuant to Article 4.

2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking 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.

In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the product with the relevant requirements.

3. Where a notified body finds that a manufacturer does not meet the relevant requirements or corresponding harmonised standards, common specifications or other technical specifications, it shall require that manufacturer to take appropriate corrective measures in view of a second and final conformity assessment, unless the deficiencies cannot be remedied, in which case it shall not issue a certificate or approval decision.

4. Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision, a notified body finds that a product or the manufacturer does not comply or no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or approval decision if necessary.

5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate.

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

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

Article 54 - Information obligation on notified bodies

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

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

(b)any circumstances affecting the scope of and conditions for notification;

(c)any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

(d)on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

2. Notified bodies shall provide the other bodies notified under this Regulation which carry out similar conformity assessment activities that cover the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results.

3. Where the Commission or a Member State’s market surveillance authority submits a request to a notified body established on the territory of another Member State relating to a conformity assessment carried out by that notified body, it shall send a copy of that request to the notifying authority of that other Member State. The notified body concerned shall respond without delay and within 15 days at the latest to the request. The notifying authority shall ensure that such requests are resolved by the notified body unless there is a legitimate reason for not doing so.

4. Where notified bodies have or receive evidence that:

(a)another notified body does not comply with the requirements laid down in Article 45 or its obligations; or

(b)a product placed on the market does not comply with ecodesign requirements set out in delegated acts adopted pursuant to Article 4 by which that product is covered; or

(c)a product placed on the market, due to its physical condition, is likely to cause a serious risk;

they shall alert and share such evidence with the relevant market surveillance or notifying authority, as appropriate.

Article 55 - Exchange of experience

The Commission shall provide for the organisation of exchange of experience between the Member States' authorities responsible for notification policy.

Article 56 - Coordination of notified bodies

1. The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of a group or groups of notified bodies, where appropriate including groups of bodies notified under the same delegated act adopted pursuant to Article 4 or in relation to similar conformity assessment tasks.

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

2. Notified bodies shall apply as general guidance any relevant documents produced as a result of the work of the groups referred to in paragraph 1.

3. Coordination and cooperation in the groups referred to in paragraph 1 shall aim at ensuring the harmonised application of this Regulation and of the delegated acts adopted pursuant to Article 4. In doing so, the groups shall follow as general guidance any relevant documents produced by the administrative cooperation group set up pursuant to Article 30(2) of Regulation (EU) 2019/1020.

Chapter X - Incentives

Article 57 - Member State incentives

1. Member States incentives relating to products covered by a delegated act adopted pursuant to Article 4 that determines classes of performance in accordance with Article 7(4), in relation to a product parameter referred to in Annex I, shall concern the highest two classes of performance that are populated at Union level or, where relevant, products with an EU Ecolabel, unless otherwise specified in that delegated act.

2. Where a delegated act adopted pursuant to Article 4 determines classes of performance pursuant to Article 7(4), in relation to more than one product parameter referred to in Annex I or where classes of performance are established both under Regulation (EU) 2017/1369 and under this Regulation , the Commission may further specify in the delegated acts adopted pursuant to Article 4, third subparagraph, point (g), which product parameters the Member States incentives shall concern.

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

(a)the number of products in each class of performance;

(b)the relative affordability of the products in each class of performance;

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

3. Where a delegated act adopted pursuant to Article 4 does not determine classes of performance, the Commission may specify in the delegated acts adopted pursuant to Article 4, third subparagraph, point (g), requirements related to product parameters that products concerned by Member State incentives shall meet. 

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

(a)the relative affordability of the products meeting those requirements;

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

Article 58 - Green public procurement

1. Requirements pursuant to Article 4, third subparagraph, point (h) for public contracts awarded by contracting authorities, as defined in Article 2(1) of Directive 2014/24/EU or Article 3(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.

2. When establishing requirements pursuant to Article 4, third subparagraph, point (h), 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 group or for the services or works using the given product group;

(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 XI - Market surveillance

Article 59 - Market surveillance action plans 

1. Without prejudice to Article 13 of Regulation (EU) 2019/1020, each Member State shall, at least every 2 years, draw up an action plan outlining the market surveillance activities planned to ensure that appropriate checks are performed on an adequate scale in relation to this Regulation and the delegated acts adopted pursuant to Article 4. Each Member State shall draw up the first such action plan by [16 July 2024].

The action plan referred to in paragraph 1 shall at least include:

(a)the products or requirements identified as priorities for market surveillance, taking into account the common priorities identified by the administrative cooperation group pursuant to Article 62(1), point (a), and in accordance with the implementing acts referred to in paragraph 5;

(b)the market surveillance activities planned in order to reduce non-compliance for those products or requirements identified as priorities, including the nature and minimum number of checks to be performed during the period covered by the action plan.

2. The priorities for market surveillance referred to in paragraph 1, point (a), shall be identified on the basis of objective criteria, including:

(a)the levels of non-compliance observed in the market;

(b)the environmental impacts of non-compliance;

(c)the number of relevant products made available on national markets; and

(d)the number of relevant economic operators active on those markets.

3. The nature and number of checks planned pursuant to paragraph 1, point (b), shall be proportionate to the objective criteria used to identify the priorities in line with paragraph 2.

4. Member States shall communicate their action plans to the Commission and other Member States through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020.

5. The Commission may adopt implementing acts listing the products or requirements that Member States shall at least consider as priorities for market surveillance pursuant to paragraph 1, point (a). 

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 67(2).

Article 60 - Minimum number of checks

1. The Commission is empowered to adopt delegated acts in accordance with Article 66 to supplement 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 delegated acts adopted pursuant to Article 4 or in relation to specific requirements set out in such delegated acts. The delegated act may, where relevant, specify the nature of the checks required and methods to be used.

The minimum number of checks shall be established on the basis of the following criteria:

(a)the criteria listed in Article 59(2);

(b)the activities planned in Member States' action plans;

(c)the common priorities identified by the administrative cooperation group pursuant to Article 62(1), point (a);

(d)where relevant, the priorities included in the implementing acts referred to in Article 59(5).

2. Market surveillance authorities shall have the right to recover from the responsible economic operator the costs of document inspection and physical product testing in case of non-compliance with delegated acts adopted pursuant to Article 4.

Article 61 - 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 Article 4 of this Regulation;

(c)a comparison of this information with the activities planned in the context of the action plans drawn up pursuant to Article 59(1);

(d)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.

 Article 62
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 the action plans drawn up pursuant to Article 59(1) and shall identify:

(a)common priorities for market surveillance as referred to in Article 59(1), point (a), based on objective criteria as referred to in Article 59(2);

(b)priorities for Union support pursuant to paragraph 2;

(c)requirements set out in delegated acts adopted pursuant to Article 4 that are applied or interpreted differently that should be priorities for the organisation of common trainings or adoption of guidelines pursuant to paragraph 2 of this Article.

2. Based on priorities identified by 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 requirements set out in delegated acts adopted pursuant to Article 4 and on methods and techniques relevant for applying or verifying compliance with such;

(d)elaborate guidelines for the application and enforcement of requirements set out in delegated acts adopted pursuant to Article 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.

Chapter XII - Safeguard procedures

Article 63 - Procedure for dealing with products presenting a risk at national level

1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a product covered by a delegated act adopted pursuant to Article 4presents a risk, they shall carry out an evaluation covering all requirements relevant to the risk and laid down in this Regulation or in the relevant delegated act. The relevant economic operators shall cooperate as necessary with the market surveillance authorities.

Where, in the course of that evaluation, the market surveillance authorities find that the product does not comply with the requirements laid down in the applicable delegated acts adopted pursuant to Article 4, they shall without delay require the relevant economic operator to take appropriate and proportionate corrective action, within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature and where relevant the degree of the non-compliance, to bring the non-compliance to an end. The corrective action required to be taken by the economic operator may include the actions listed in Article 16(3) of Regulation (EU) 2019/1020.

The market surveillance authorities shall inform the relevant notified body accordingly.

2. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union.

4. Where the relevant economic operator does not take corrective action within the period referred to in the second subparagraph of paragraph 1 or the non-compliance persists, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the making available of the product concerned on their national market, to withdraw the product from that market or to recall it.

They shall inform the Commission and the other Member States, without delay, of those measures.

5. The information to the Commission and the other Member States referred to in paragraph 4 shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the non-compliance alleged and the non-compliance involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. The market surveillance authorities shall also indicate whether the non-compliance is due to either:

(a)failure of the product to meet requirements set out in the relevant delegated act adopted pursuant to Article 4; or

(b)shortcomings in the harmonised standards or common specification referred to in Articles 34 and 35 conferring a presumption of conformity.

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 product concerned, and, in the event of disagreement with the notified national measure, of their objections.

7. Where, within three 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, that measure shall be deemed justified. Measures may specify a period longer or shorter than three months in order to take account of the specificities of the products or requirements concerned.

8. Member States shall ensure that appropriate restrictive measures are taken in respect of the product or manufacturer concerned, such as withdrawal of the product from their market, without delay.

Article 64 - Union safeguard procedure

1. Where, on completion of the procedure set out in Article 63(3) and (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 operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide by means of an implementing act whether the national measure is justified or not. 

That implementing act shall be adopted in accordance with the examination procedure referred to in Article 67(3).

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

If the national measure is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant product is withdrawn from their market, 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 justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards referred to in Article 34 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

4. Where the national measure is considered justified and the non-compliance of the product is attributed to shortcomings in the common specifications referred to in Article 35, the Commission shall, without delay, adopt implementing acts amending or repealing the common specifications concerned.

The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 67(3).

Article 65 - Formal non-compliance

1. Where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a)the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 39 of this Regulation;

(b)the CE marking has not been affixed;

(c)the identification number of the notified body has been affixed in violation of Article 39 or has not been affixed where required;

(d)the EU declaration of conformity has not been drawn up;

(e)the EU declaration of conformity has not been drawn up correctly;

(f)the technical documentation is not available, not complete or contains errors;

(g)the information referred to in Article 21(6) or Article 23(3) is absent, false or incomplete;

(h)any other administrative requirement provided for in Article 21 or Article 23 or in the applicable delegated act adopted pursuant to Article 4, is not fulfilled.

2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the market.

Chapter XIII - Delegated powers and committee procedure

Article 66 - Exercise of the delegation

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, Article 9(1), second subparagraph, Article 11(4), Article 20(3), and Article 61(1) shall be conferred on the Commission for a period of six years from [one month after the entry into force of this act]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the six-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3. The delegation of power referred to in Article 4, Article 9(1), second subparagraph, Article 11(4), Article 20(3), and Article 61(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State acting in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Article 4, Article 9(1), second subparagraph, Article 11(4), Article 20(3), and Article 61(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 67 - Committee procedure

1. The Commission shall be assisted by a Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

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

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

Chapter XIV - Final provisions

Article 68 - Penalties

Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive, taking into account the extent of non-compliance and the number of units of non-complying products placed on the Union market. Member States shall notify the Commission of those provisions by [one year after the date of application of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 69 - 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. 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 the Commission finds it appropriate, the report shall be accompanied by a legislative proposal for amendment of the relevant provisions of this Regulation.

Article 70 - Repeal and transitional provisions

1. Directive 2009/125/EC is repealed.

2. References to the repealed Directive shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VIII.

3. Article 1(3), Article 2, Article 3(1), Articles 4, 5 and 8, Article 9(3), Article 10 and Annexes IV, V and VI of Directive 2009/125/EC, as applicable on [OP: please insert the day before the date of application of this Regulation] shall continue to apply to implementing measures adopted pursuant to Article 15 of that Directive.

4. Articles 3, 33 and Articles 59 to 65 of this Regulation shall apply to implementing measures adopted pursuant to Article 15 of Directive 2009/125/EC.

5. For products placed on the market or put into service in accordance with Directive 2009/125/EC before the date of application of a delegated act adopted pursuant to Article 4 of this Regulation covering the same products, the manufacturer shall, for a period of 10 years as from the date when the last of that product was manufactured, make an electronic version of documentation relating to the conformity assessment and the declaration of conformity available for inspection within 10 days of a request received from market surveillance authorities or the Commission.

Article 71 - Entry into force

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

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