Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (Text with EEA relevance)

Type Regulation
Publication 2024-06-13
Last updated 2024-06-28
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 80
Reform history JSON API

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, or 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 their parent or sister companies, subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

A conformity assessment body shall not delegate to a subcontractor or a subsidiary the establishment and the supervision of internal procedures, general policies, codes of conduct or other internal rules, the assignment of its personnel to specific tasks or the conformity assessment decisions.

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:

(a) the necessary personnel with technical knowledge, and sufficient and appropriate experience to perform the conformity assessment tasks;

(b) the necessary descriptions of the procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures including a description of how relevant personnel, their status and tasks correspond to the conformity assessment tasks in relation to which the body intends to be notified;

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

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

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.

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.

Personnel responsible for taking assessment decisions shall:

(a) be employed by the conformity assessment body under the national law of the notifying Member State;

(b) not have any potential conflict of interest;

(c) be competent to verify the assessments made by other staff, external experts or subcontractors;

(d) be sufficient in number to ensure business continuity and a consistent approach to conformity assessments.

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.

Article 53

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 52 insofar as the applicable harmonised standards cover those requirements.

Article 54

Subsidiaries of and subcontracting by notified bodies

Article 55

Application for notification

Article 56

Notification procedure

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

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 52.

Article 57

Identification numbers and lists of notified bodies

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

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

Article 58

Changes to notifications

Article 59

Challenge to the competence of notified bodies

The Commission shall update the list of notified bodies referred to in Article 57(2) within two weeks of the notification of the corrective measures taken by the notifying Member States in accordance with the first subparagraph of this paragraph.

Article 60

Operational obligations of notified bodies

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.

Article 61

Information obligation on notified bodies

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.

Where notified bodies have or receive evidence as to the following, they shall alert, and share that evidence with, the relevant market surveillance authority or notifying authority, as appropriate:

(a) that another notified body does not comply with the requirements laid down in Article 52 or its obligations;

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

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

Article 62

Exchange of experience

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

Article 63

Coordination of notified bodies

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

CHAPTER X

INCENTIVES

Article 64

Member State incentives

Article 65

Green public procurement

The minimum requirements shall be set in relation to the product aspects addressed in the delegated act adopted pursuant to Article 4 applicable to the product groups in question, as relevant for those product groups.

The minimum requirements shall be based on the two highest performance classes, the highest scores or, when not available, on the best possible performance levels as set out in the delegated act adopted pursuant to Article 4 applicable to the product groups in question.

Award criteria shall, where appropriate, have a minimum weighting of between 15 % and 30 % in the awarding process which enables them to have a significant impact on the outcome of the tendering procedure and which favours the selection of the most environmentally sustainable products.

Targets shall require, on an annual or multiannual basis, a minimum percentage of 50 % of procurement conducted at the level of contracting authorities or contracting entities, or at an aggregated national level, of the most environmentally sustainable products.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 73(3).

CHAPTER XI

MARKET SURVEILLANCE

Article 66

Planned market surveillance activities

The section referred to in the first subparagraph 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 (‘ADCO’), set up pursuant to Article 30(2) of Regulation (EU) 2019/1020, in accordance with Article 68(1), point (a), and the reports pursuant to Article 67(2);

(b) the market surveillance activities planned in order to reduce or bring non-compliance to an end for those products or requirements identified as priorities, including the nature of the checks to be performed during the period covered by the national market surveillance strategy.

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

(a) the levels of non-compliance observed in the market falling within the competence of the market surveillance authority;

(b) the environmental impacts of non-compliance;

(c) where available, the number of complaints received from end users or consumer organisations, or other information received from economic operators or the media;

(d) the number of relevant products made available on the market falling within the competence of the market surveillance authority; and

(e) the number of relevant economic operators active on the market falling within the competence of the market surveillance authority.

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

Article 67

Reporting and benchmarking

That report shall include:

(a) information on the nature and number of checks performed by market surveillance authorities during the four preceding calendar years pursuant to Article 34(4) and (5) of Regulation (EU) 2019/1020;

(b) information on the levels of non-compliance identified and on the nature and severity of penalties imposed for the four preceding calendar years in relation to products covered by delegated acts adopted pursuant to Article 4 of this Regulation;

(c) a comparison of the information referred to in points (a) and (b) of this paragraph with the activities planned in the context of the section on the market surveillance activities drawn up pursuant to Article 66(1);

(d) indicative benchmarks for market surveillance authorities in relation to the frequency of checks and the nature and severity of penalties imposed;

(e) a list of priorities for market surveillance authorities in terms of products and requirements.

Article 68

Market surveillance coordination and support

In the context of performing its tasks set out in Article 32 of Regulation (EU) 2019/1020, ADCO shall support the implementation of the section on market surveillance activities drawn up pursuant to Article 66(1) and shall identify:

(a) common priorities for market surveillance as referred to in Article 66(1), point (a), based on objective criteria as referred to in Article 66(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 and that should be priorities for the organisation of common training programmes or adoption of guidelines pursuant to paragraph 2 of this Article.

Based on priorities identified by 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 training programmes for the staff of market surveillance authorities, customs authorities, notifying authorities and notified bodies, including programmes 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 requirements;

(d) draw up 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;

(e) where appropriate, consult with stakeholders and experts.

The Union shall, where appropriate, finance the actions referred to in the first subparagraph, points (a), (b) and (c).

CHAPTER XII

SAFEGUARD PROCEDURES

Article 69

Procedure for dealing with products presenting a risk at national level

Where, in the course of that evaluation, the market surveillance authorities find that the product does not comply with the requirements laid down in this Regulation or in the applicable delegated act 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. That corrective action may include, inter alia, the actions listed in Article 16(3) of Regulation (EU) 2019/1020.

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

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

The information to be provided to the Commission and the other Member States in accordance with paragraph 4 of this Article 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 risk 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) the failure of the product to meet requirements set out in the relevant delegated act adopted pursuant to Article 4 of this Regulation; or

(b) shortcomings in the harmonised standards or common specifications referred to in Articles 41 and 42 of this Regulation conferring a presumption of conformity.

Article 70

Union safeguard procedure

That implementing act shall be adopted in accordance with the examination procedure referred to in Article 73(3).

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 unjustified, the Member State concerned shall withdraw the measure.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 73(3).

Article 71

Formal non-compliance

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

(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 46 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 46 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 27(6) or Article 29(3) is absent, false or incomplete;

(h) any other administrative requirement provided for in Article 27 or Article 29 or in the applicable delegated act adopted pursuant to Article 4 is not fulfilled.

CHAPTER XIII

DELEGATED POWERS AND COMMITTEE PROCEDURE

Article 72

Exercise of the delegation

Article 73

Committee procedure

CHAPTER XIV

FINAL PROVISIONS

Article 74

Penalties

Member States shall ensure that the penalties established pursuant to this Article give due regard to the following, as applicable:

(a) the nature, gravity and duration of the infringement;

(b) where appropriate, the intentional or negligent character of the infringement;

(c) the financial situation of the natural or legal person held responsible;

(d) the economic benefits derived from the infringement by the natural or legal person held responsible, insofar as they can be determined;

(e) the environmental damage caused by the infringement;

(f) any action taken by the natural or legal person held responsible to mitigate or remedy the damage caused;

(g) the repetitive or singular character of the infringement;

(h) any other aggravating or mitigating factor applicable to the circumstances of the case.

Member States shall at least be able to impose the following penalties in the event of infringements of this Regulation:

(a) fines;

(b) time-limited exclusion from public procurement procedures.

Article 75

Monitoring and evaluation

Article 76

Consumer redress

In the event of non-compliance of a product with ecodesign requirements set in the delegated acts adopted pursuant to Article 4, the following economic operators shall be liable for damage suffered by the consumer:

(a) the manufacturer; or,

(b) in the event that the manufacturer is not established in the Union, and without prejudice to its own liability, the importer or the authorised representative of the manufacturer; or,

(c) in the event that the importer is not established in the Union or there is no authorised representative of the manufacturer, the fulfilment service provider.

The liability of those economic operators for damage shall be without prejudice to the application of other remedies available to consumers under Union or national law.

Article 77

Amendment of Directive (EU) 2020/1828

Point (27) of Annex I to Directive (EU) 2020/1828 is replaced by the following:

‘(27) Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L, 2024/1781, 28.6.2024, ELI: http://data.europa.eu/eli/reg/2024/1781/oj)’.

Article 78

Amendment of Regulation (EU) 2023/1542

In Article 77 of Regulation (EU) 2023/1542, the following paragraph is added:

Article 79

Repeal and transitional provisions

Directive 2009/125/EC is repealed with effect from 18 July 2024, with the exception of:

(a) Articles 1 and 2, Article 8(2), Articles 11, 14, 15, 18 and 19 of, and Annexes I, II, IV, V and VII to, Directive 2009/125/EC in the version applicable on 17 July 2024, which, instead of Articles 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 19 and 20 of, and Annexes I, II, III and IV to, this Regulation, shall continue to apply: (i) until 31 December 2026, as regards photovoltaic panels, space and combination heaters, water heaters, solid fuel local space heaters, air conditioners including air-to-air heat pumps and comfort fans, solid fuel boilers, air heating and cooling products, ventilation units, vacuum cleaners, cooking appliances, water pumps, industrial fans, circulators, external power supplies, computers, servers and data storage products, power transformers, professional refrigeration equipment and imaging equipment; (ii) until 31 December 2030, as regards products regulated by implementing measures that are adopted pursuant to Article 15 of Directive 2009/125/EC, however only insofar as amendments are necessary to address technical issues with regard to those implementing measures;

(b) Article 1(3), Article 2, Article 3(1), Articles 4, 5 and 8, Article 9(3), Articles 10, 14 and 20 of, and Annexes IV, V and VI to, Directive 2009/125/EC in the version applicable on 17 July 2024, which, instead of Articles 1, 2, 27 and 29, Article 41(4), Article 43(2), Articles 44, 45 and 46 and Article 74 of, and Annexes IV and V to, this Regulation, shall continue to apply as regards products regulated by implementing measures that are adopted pursuant to Article 15 of that Directive until such measures are repealed or declared obsolete.

Point (b) of this paragraph shall apply once the Commission has adopted implementing measures pursuant to Article 15 of Directive 2009/125/EC for the products referred to in points (a)(i) and (ii).

Article 80

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.

ANNEX I

The following parameters shall, as appropriate, and where necessary supplemented by others, be used, individually or in combination, as a basis for improving the product aspects:

(a) durability and reliability of the product or its components as expressed through the product’s guaranteed lifetime, technical lifetime, mean time between failures, indication of real use information on the product, resistance to stresses or ageing mechanisms;

(b) ease of repair and maintenance, as expressed through characteristics, availability, delivery time and affordability of spare parts, modularity, compatibility with commonly available tools and spare parts, availability of repair and maintenance instructions, number of materials and components used, use of standard components, use of component and material coding standards for the identification of components and materials, number and complexity of processes and whether specialised tools are needed, ease of non-destructive disassembly and re-assembly, conditions for access to product data, conditions for access to or use of hardware and software needed;

(c) ease of upgrading, reuse, remanufacturing and refurbishment as expressed through number of materials and components used, use of standard components, use of component and material coding standards for the identification of components and materials, number and complexity of processes and tools needed, ease of non-destructive disassembly and re-assembly, conditions for access to product data, conditions for access to or use of hardware and software needed, conditions of access to test protocols or not commonly available testing equipment, availability of guarantees specific to remanufactured or refurbished products, conditions for access to or use of technologies protected by intellectual property rights, modularity;

(d) design for recycling, ease and quality of recycling as expressed through use of easily recyclable materials, safe, easy and non-destructive access to recyclable components and materials or components and materials containing hazardous substances and material composition and homogeneity, possibility for high-purity sorting, number of materials and components used, use of standard components, use of component and material coding standards for the identification of components and materials, number and complexity of processes and tools needed, ease of non-destructive disassembly and re-assembly, conditions for access to product data, conditions for access to or use of hardware and software needed;

(e) avoidance of technical solutions detrimental to reuse, upgrading, repair, maintenance, refurbishment, remanufacturing and recycling of products and components;

(f) use of substances, and in particular the use of substances of concern, on their own, as constituents of substances or in mixtures, during the production process of products, or leading to their presence in products, including once those products become waste, and their impacts on human health and the environment;

(g) use or consumption of energy, water and other resources in one or more life cycle stages of the product, including the effect of physical factors or software and firmware updates on product efficiency and including the impact on deforestation;

(h) use or content of recycled materials and recovery of materials, including critical raw materials;

(i) use or content of sustainable renewable materials;

(j) weight and volume of the product and its packaging, and the product-to-packaging ratio;

(k) incorporation of used components;

(l) quantity, characteristics and availability of consumables needed for proper use and maintenance as expressed, inter alia, through yield, technical lifetime, ability to reuse, repair, and remanufacture, mass-resource efficiency, and interoperability;

(m) the environmental footprint of the product, expressed as a quantification, in accordance with the applicable delegated act, of a product’s life cycle environmental impacts, whether in relation to one or more environmental impact categories or an aggregated set of impact categories;

(n) the carbon footprint of the product;

(o) the material footprint of the product;

(p) microplastic and nanoplastic release as expressed through the release during relevant product life cycle stages, including manufacturing, transport, use and end-of-life stages;

(q) emissions to air, water or soil released in one or more lifecycle stages of the product as expressed through quantities and nature of emissions, including noise;

(r) amounts of waste generated, including plastic waste and packaging waste and their ease of reuse, and amounts of hazardous waste generated;

(s) functional performance and conditions for use, including as expressed through the ability to perform its intended use, precautions for use, skills required and compatibility with other products or systems;

(t) lightweight design as expressed through reduction of material consumption, load- and stress-optimisation of structures, integration of functions within the material or into a single product component, use of lower density or high-strength materials and hybrid materials, with regard to material savings, recycling and other circularity aspects, and waste reduction.

ANNEX II

Product specific or horizontal performance requirements shall be set as follows:

a technical, environmental and economic analysis shall select a number of representative models of the product or products in question on the market and identify the technical options for improving the product performance in relation to the product parameters referred to in Annex I, taking into account the economic viability of the options and avoiding any significant increase of other life cycle environmental impacts, and significant loss of performance or of usefulness for consumers.

The analysis referred to in the first paragraph shall also identify, for the parameter under consideration, the best-performing products and technologies available on the market, as well as emerging technology improvements.

The performance of products available on international markets and benchmarks set in other countries’ law shall be taken into consideration during the analysis referred to in the first paragraph as well as when setting requirements.

Based on the analysis referred to in the first paragraph, and taking into account economic and technical feasibility, including the availability of key resources and technologies, as well as the potential for improvement, levels or non-quantitative requirements shall be defined.

Any concentration limit for substances as referred to in Annex I, point (f), shall be based on a thorough analysis of the sustainability of the substances and their identified alternatives, and shall not have significant adverse effects on human health or the environment. Any performance requirement concerning substances as referred to in Annex I, point (f), shall take into consideration existing chemical safety assessments performed by the relevant Union bodies for the substances concerned, as well as safe and sustainable by design criteria for chemicals and materials developed by the Commission. Proposed concentration limits shall also consider aspects of enforceability, such as analytical detection limits.

Where relevant, the analysis referred to in the first paragraph shall take into account the likely impacts of climate change on the product during its prospective lifetime, and the product’s potential to improve climate resilience throughout its life cycle.

A sensitivity analysis covering the relevant factors, such as the price of energy or other resources, the cost of raw materials and necessary technologies, production costs, discount rates, and, where appropriate, external environmental costs, including avoided greenhouse gas emissions, shall be carried out.

For the development of the analysis referred to in the first subparagraph, relevant information available in the framework of other Union activities, including, among others, existing sectoral roadmaps as referred to in Regulation (EU) 2021/1119, shall be taken into account and shall include technical information used as a basis for or derived from Regulation (EC) No 66/2010, Directive 2010/75/EU, technical screening criteria adopted pursuant to Regulation (EU) 2020/852 and EU green public procurement criteria.

That shall also apply for information available from existing programmes applied in other parts of the world for setting the specific ecodesign requirements for products traded with the Union’s economic partners.

ANNEX III

The requirements related to the digital product passport laid down in the delegated acts adopted pursuant to Article 4 shall specify what data are to or can be included in the digital product passport from among the following elements:

(a) information required under Article 7(2), point (b), and Article 7(5) or by other Union law applicable to the relevant product group;

(b) the unique product identifier at the level indicated in the applicable delegated act adopted pursuant to Article 4;

(c) the Global Trade Identification Number as provided for in International Organization for Standardisation/International Electrotechnical Commission standard ISO/IEC 15459-6 or equivalent of products or their parts;

(d) relevant commodity codes, such as a TARIC code as defined in Regulation (EEC) No 2658/87;

(e) compliance documentation and information required under this Regulation or other Union law applicable to the product, such as the declaration of conformity, technical documentation or conformity certificates;

(f) user manuals, instructions, warnings or safety information, as required by other Union law applicable to the product;

(g) information related to the manufacturer, such as its unique operator identifier and the information referred to in Article 27(7);

(h) unique operator identifiers other than that of the manufacturer;

(i) unique facility identifiers;

(j) information related to the importer, including the information referred to in Article 29(3) and its Economic Operators Registration and Identification (EORI) number;

(k) the name, contact details and unique operator identifier of the economic operator established in the Union responsible for carrying out the tasks set out in Article 4 of Regulation (EU) 2019/1020 or Article 15 of Regulation (EU) 2023/988, or similar tasks pursuant to other Union law applicable to the product;

(l) the reference of the digital product passport service provider hosting the back-up copy of the digital product passport.

The data carrier, the unique product identifier referred to in point (b), the unique operator identifiers referred to in points (g), (h) and (k), and the unique facility identifiers referred to in point (i) shall, where relevant for the products concerned, comply with standards ISO/IEC 15459-1:2014, ISO/IEC 15459-2:2015, ISO/IEC 15459-3:2014, ISO/IEC 15459-4:2014, ISO/IEC 15459-5:2014 and ISO/IEC 15459-6:2014.

The delegated acts adopted pursuant to Article 4 shall identify information relevant to ecodesign requirements that manufacturers may include in the digital product passport in addition to the information required pursuant to Article 9(2), point (a), including information on specific voluntary labels applicable to the product. That shall include whether an EU Ecolabel has been awarded to the product in line with Regulation (EC) No 66/2010.

ANNEX IV

1.

Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on its sole responsibility that the product satisfies the requirements of the delegated act adopted pursuant to Article 4.

2.

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the requirements of the delegated act adopted pursuant to Article 4. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever applicable, contain at least the following elements:

3.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the product with the technical documentation referred to in point 2 and with requirements of the delegated act adopted pursuant to Article 4.

4.

The manufacturer shall affix the required conformity marking to each individual product that satisfies requirements of the delegated act adopted pursuant to Article 4.

The manufacturer shall draw up a written declaration of conformity for each product model in accordance with Article 44 and keep it, together with the technical documentation, at the disposal of the competent national authorities for ten years after the product has been placed on the market or put into service. The declaration of conformity shall identify the product for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

5.

The manufacturers’ obligations set out in point 4 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that the obligations are specified in the mandate.

ANNEX V

1.No … (unique identification of the product):

2.Name and address of the manufacturer and, where applicable, the manufacturer’s authorised representative:

3.This declaration of conformity is issued under the sole responsibility of the manufacturer:

4.Object of the declaration (description of the product sufficient for its unambiguous identification and allowing traceability; it may, where necessary for the identification of the product, include an image):

5.The object of the declaration referred to in point (4) is in conformity with this Regulation, the delegated act adopted pursuant to Article 4 and, where applicable, other Union harmonisation legislation:

6.References to the relevant harmonised standards or to the common specifications used or references to the other technical specifications in relation to which conformity is declared:

7.Where applicable, the notified body … (name, number) performed … (description of intervention) and issued the certificate or approval decision … (number):

8.Where appropriate, the reference to other Union law providing for the affixing of the CE mark that is applied:

9.The identification and signature of the person empowered to bind the manufacturer or the manufacturer’s authorised representative:

10.Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

ANNEX VI

The following non-exhaustive list of criteria shall be used to assess self-regulation measures in accordance with Article 21:

1.

Openness of participation

Self-regulation measures must be open to the participation of any operators placing on the market a product covered by the self-regulation measure, including SMEs and third country operators, both in the preparatory and in the implementation phases. Economic operators intending to establish a self-regulation measure should make a public announcement of their intention to do so before the process of developing the measure is started.

2.

Sustainability and added value

Self-regulation measures must respond to the policy objectives of this Regulation and must be consistent with the economic and social dimensions of sustainable development. Self-regulation measures must have an integrated approach to the protection of the environment, interests of consumers, health, quality of life and economic interests.

3.

Representativeness

Industry and its related associations taking part in a self-regulation measure must represent a large majority of the relevant economic sector, in accordance with Article 21(3), first subparagraph, point (b). Care must be taken to ensure respect for Union competition law, in particular Article 101 TFEU regarding anti-competitive agreements.

4.

Quantified and staged objectives

The objectives defined by the signatories in their self-regulation measures must be set in clear, quantifiable and unambiguous terms, starting from a well-defined baseline. If the self-regulation measure covers a long time-span, interim targets must be included. It must be possible to monitor compliance with objectives and interim targets in an affordable and credible way using clear and reliable indicators.

5.

Involvement of civil society

With a view to ensuring transparency, self-regulation measures must be publicised, including online on a publicly and freely accessible website and via other electronic means of disseminating information. Stakeholders, including Member States, industry, environmental NGOs and consumers’ associations, shall be invited to comment on a self-regulation measure.

6.

Monitoring and reporting

An independent inspector must be selected and nominated in order to monitor compliance of signatories with the self-regulation measure. The self-regulation measure must empower the independent inspector to verify compliance with its requirements. The self-regulation measure must also lay down the procedure to select the independent inspector and the rules to ensure that the inspector has no conflict of interest and has the necessary skills for verifying compliance with its requirements. Every year, each signatory must report all the information and data necessary for the independent inspector to reliably verify the signatory's compliance with the self-regulation measure. The independent inspector must draw up a compliance report at the end of each one-year reporting period. Where a signatory does not comply with the requirements of the self-regulation measure, it must take corrective action. The independent inspector shall notify the other signatories participating in the self-regulation measure of a lack of compliance by a signatory and of the corrective action the signatory intends to take. The results of any market surveillance activity conducted by a market surveillance authority during which non-compliance with the self-regulation measures requirements has been identified shall be taken into account by the independent inspector, in particular in the compliance report, and corrective action shall be taken.

7.

Cost-effectiveness of administering a self-regulation measure

The cost of administering the self-regulation measure, in particular as regards monitoring, must not lead to a disproportionate administrative burden, as compared to its objectives and to other available policy instruments.

ANNEX VII

The commodity codes and descriptions are taken from the combined nomenclature as referred to in Article 1(2) of Regulation (EEC) No 2658/87 and as set out in Annex I thereto, in the version in force on 28 June 2024.

Commodity code Description
1. Apparel and clothing accessories
4203 Articles of apparel and clothing accessories, of leather or composition leather
61 Articles of apparel and clothing accessories, knitted or crocheted
62 Articles of apparel and clothing accessories, not knitted or crocheted
6504 Hats and other headgear, plaited or made by assembling strips of any material, whether or not lined or trimmed
6505 Hats and other headgear, knitted or crocheted, or made up from lace, felt or other textile fabric, in the piece (but not in strips), whether or not lined or trimmed; hairnets of any material, whether or not lined or trimmed
2. Footwear
6401 Waterproof footwear with outer soles and uppers of rubber or of plastics, the uppers of which are neither fixed to the sole nor assembled by stitching, riveting, nailing, screwing, plugging or similar processes
6402 Other footwear with outer soles and uppers of rubber or plastics
6403 Footwear with outer soles of rubber, plastics, leather or composition leather and uppers of leather
6404 Footwear with outer soles of rubber, plastics, leather or composition leather and uppers of textile materials
6405 Other footwear

ANNEX VIII

Directive 2009/125/EC This Regulation
Article 1 Article 1
Article 2 Article 2
Article 3
Article 4 Article 29
Article 5 Articles 44, 45 and 46
Article 6 Article 3
Article 7 Articles 69, 70 and 71
Article 8 Articles 27 and 43
Article 9 Article 41
Article 10
Article 11 Article 38
Article 12 Article 68
Article 13 Article 22
Article 14 Article 7
Article 15 Articles 4 and 5
Article 16 Article 18
Article 17 Article 21
Article 18 Article 19
Article 24
Article 28
Articles 30 to 40
Article 42
Articles 47 to 67
Article 72
Article 19 Article 73
Article 20 Article 74
Article 21 Article 75
Article 22
Article 23
Article 24 Article 79
Article 25 Article 80
Article 26
Annex I Articles 5, 7, Annex I
Annex II Annex II
Annex III
Annex III
Annex IV Annex IV
Annex V
Annex VI Annex V
Annex VII Article 8 -
Annex VIII Annex VI
Annex IX
Annex X Annex VIII

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