New and revised European regulations and directives promote technical communication – An overview
By Gabriela Fleischer, tekom Germany
2024-09-19 (updated 2024-11-27)
Over its last term, 2019–2024, the European Commission, together with the European Parliament and the Council, have developed or revised several (new) legislative proposals. They strengthen technical communication in new ways and pose new challenges for technical communication – through new content of information for use and new formats and media for information products. It is a challenge to keep up to date. We want to provide an overview as to what stage the legislative projects are at and where the new challenges for technical communication lie.
We present the following legislative proposals or published laws:
Machinery Regulation 2023/1230[1]
Key facts
- For the first time in European legislative regulations for machinery, provisions have been established for the digital format for instructions for use. - The revised EC Guide to application of the Machinery Directive 2006/42/EC Edition 2.3[2] aims to make requirements of the Machinery Regulation 2023/1230 regarding instructions for use already possible under the Machinery Directive 2006/42/EC[3]. However, tekom has some concerns regarding this development. - The Machinery Regulation has been in force since 19 July 2023 and will be applicable from 20 January 2027 onward. - Will repeal Machinery Directive 2006/42/EC[4].
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tekom Europe has published the ‘Whitepaper 2/2023 Machinery Regulation (EU) 2023/1230 Instructions for use and technical documentation’, which explains the requirements for instructions for use, technical documentation and assembly instructions set with the Machinery Regulation and highlights concerns. There, you will find more information as to which articles and annexes are relevant. |
Read more: Machinery Regulation 2023/1230 – First-time requirements for digital format
[1]https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A32023R1230
[2]https://ec.europa.eu/docsroom/documents/60145
Ecodesign for Sustainable Products Regulation 2024/1781(ESPR)[1]
Key facts
- Establishes a framework for setting ecodesign requirements to improve product aspects such as e.g. durability, repairability, possibility of maintenance, and refurbishment.
- Sets information requirements that products are accompanied by information on performance, information for customers and other actors on how to install, use, maintain, and repair products, information for treatment facilities, and other information to influence sustainable product choices.
- Requires further specifications for products, product groups or horizontal specifications through what are commonly known as ‘delegated acts’.
- Applies to any physical product, including components, and intermediate products.
- Establishes digital product passport.
- Next products/product groups to be regulated by delegated acts according to the first working plan: (a) iron and steel; (b) aluminium; (c) textiles, in particular garments and footwear; (d) furniture, including mattresses; (e) tyres; (f) detergents; (g) paints; (h) lubricants; (i) chemicals; (j) energy-related products for which ecodesign requirements are to be set for the first time or for which existing measures adopted pursuant to Directive 2009/125/EC are to be reviewed under this Regulation; and (k) information and communication technology products and other electronics.
- Repeals Ecodesign Directive 2009/125/EC[2].
- Entered into force on 18 July 2024; first delegated act shall not enter into force before 19 July 2025.
tekom Europe is working on a whitepaper addressing the ESPR and its requirements for products and information accompanying the products relevant for technical communication.
Directive (EU) 2024/1799 on common rules promoting the repair of goods[1]
Key facts
- ‘Right to Repair’ only for products purchased by consumers.
- So far only intended for the following product groups stated in an annex: 1. Household washing machines and household washer-dryers, 2. Household dishwashers, 3. Refrigerating appliances with direct sales functions, 4. Refrigerating appliances, 5. Electronic displays, 6. Welding equipment, 7. Vacuum cleaners, 8. Servers and data storage products, 9. Mobile phones, cordless phones and tablets, 10. For goods incorporating light means of transport batteries,
- Producers need to provide repair-related information to independent repairers.
-Entered into force 30 July 2024.
- Directive needs to be transposed into national laws: Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 July 2026 at the latest.
tekom Europe scrutinises what is special about repair-related information and if/how technical communicators can be supported to conform with the directive. |
Artificial Intelligence Act 2024/1689 (AI Act)
Key facts
- High-risk AI systems need technical documentation before being placed on the market or put into service, and technical documentation shall be kept up to date.
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tekom Europe is working on a whitepaper for the AI Act addressing its requirements regarding instructions for use and technical documentation. |
Read more: Artificial Intelligence Act 2024/1689 – High risk AI systems in the focus of tc
Cyber resilience Act 2024/2847 (CRA)[1]
Key facts
- The regulation establishes horizontal cybersecurity requirements for products with digital elements - Applies to products with digital elements made available on the market, the intended purpose or reasonably foreseeable use of which includes a direct or indirect logical or physical data connection to a device or network - Before placing a product with digital elements on the market, manufacturers shall draw up the technical documentation - Manufacturers shall ensure that products with digital elements are accompanied by the information and instructions to the user set out in Annex II, in paper or electronic form. - Such information and instructions shall allow for the secure installation, operation and use of products with digital elements. - Manufacturers of products with digital elements shall identify and document vulnerabilities and components contained in products with digital elements, including by drawing up a software bill of materials in a commonly used and machine-readable format covering at the very least the top-level dependencies of the products; - Annex II addresses INFORMATION AND INSTRUCTIONS TO THE USER - This Regulation shall apply from 11 December 2027. Article 14 Reporting obligations of manufacturers shall apply from 11 September 2026 and Chapter IV (Articles 35 to 51) shall apply from 11 June 2026.
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tekom Europe will start to work on a whitepaper for the CRA addressing its requirements regarding technical documentation and instructions for user in early 2025. |
Read more: Cyber Resilience Act 2024/2847
[1]https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R2847#cpt_IV
Proposal for Construction Product Regulation
Key facts
| - Will establish a) harmonised rules on how to express the environmental and safety performance of construction products in relation to their essential characteristics, including life cycle assessment, b) environmental, functional and safety product requirements for construction products, (c) rights and obligations for economic operators dealing with construction products or their components, (d) obligations for other actors providing services linked to the manufacturing and commercialisation of construction products. - Applies to construction products, including used products, key parts of products and parts or materials intended to be used for construction products, if the manufacturer of those parts or materials so requests. - Article ‘General product information, instructions for use and safety information’ and related Annex ‘General product information, instructions for use and safety information’ state the requirements relevant for technical communication. - Article ‘Obligations of manufacturers’ states that e.g. the manufacturer shall draw up technical documentation including a calculation of environmental essential characteristics; the manufacturer shall ensure that the construction product is accompanied by general information, instructions for use and safety information; the manufacturer shall make available a product passport through the construction digital product passport system. - Chapter on Product Passport with articles for the construction digital product passport system, the product passport, general requirements for the product passport, the technical design and operation of the product passport, the unique identifiers and product passport registry. - Annex about general product information, instructions for use and safety information specifying required information. - Still as a proposal; the Regulation has not yet been published. |
tekom Europe will start work on a whitepaper on the Construction product regulation as soon as the Regulation is published in the Official Journal of the European Union. |
Machinery Regulation 2023/1230 – First-time requirements for digital format
The Machinery Regulation 2023/1230 (MR) was the first of the legislative proposals listed here to be published in the Official Journal of the European Union and has been in force since July 2023. It will repeal the Machinery Directive 2006/42/EC on 20 January 2027. As a Regulation, it is binding in its entirety and directly applicable in all Member States. According to Article 1 ‘Subject matter’, the MR lays down health and safety requirements for the design and construction of machinery, related products and for partly completed machinery. ‘Related products’ are listed in Article 2 ‘Scope’, and these are e.g. interchangeable equipment, safety components, and lifting accessories.
The MR addresses for the first time digital formats directly for instructions for use, documentation, declaration of conformity, and assembly instructions in a statutory regulation for machinery. It allows the exclusive use of digital formats within a defined framework from 20 January 2027 onward. However, since April 2024, the European Commission has expressed support for digital formats of instructions for use and other information with the publication of edition 2.3 of the EC Guide to application of the Machinery Directive 2006/42/EC. The European Commission would like to bring forward the Machinery Regulation requirements and make them possible under the Machinery Directive. But the text in the relevant passage in the EC Guide in §255 ‘The form of the instructions’ is not consistent with the corresponding text and requirements of the Machinery Regulation, causing some concerns.
The backbone regarding instructions for use is Article 10 ‘Obligations of manufacturers of machinery and related products’ in paragraph 7. However, other articles and annexes as well have requirements for instructions for use, technical documentation, and assembly instructions.
Ecodesign for Sustainable Product Regulation 2024/1781 (ESPR) – Product/horizontal delegated acts are needed
The Ecodesign for Sustainable Product Regulation 2024/1781 was published in the Official Journal of the European Union on 28 June 2024 and entered into force in July 2024. It repeals the Ecodesign Directive 2009/125/EG (with exemptions regarding already regulated products with transitional provisions). As a Regulation, it is binding in its entirety and directly applicable in all Member States.
According to Article 1 ‘Subject matter and scope’, the Regulation establishes a framework for setting ecodesign requirements for products with the aim of improving the environmental sustainability of products in order to make sustainable products the norm and to reduce the overall carbon and environmental footprint of products over their life cycle. The Regulation establishes a digital product passport and applies to any physical goods/products, including components and intermediate products.
Article 3 ‘Definitions’ lists definitions for 58 terms e.g. for (1)‘product’, (6)‘ecodesign’, (9) ‘information requirement’, (12) ‘life cycle’, (13) ‘end of life’, (16) ‘remanufacturing’, (17) ‘upgrading’, (18) ‘refurbishing’, (19) ‘maintenance’, (20) ‘repair’, (22) ‘durability’, (24) ‘environmental footprint’, (28) ‘digital product passport’, (41) ‘putting into service’ (48) ‘professional repairer’.
The European Commission is empowered to adopt delegated acts to supplement this Regulation for the setting of ecodesign requirements on product/product group or horizontal[1] level including specified conformity assessment procedures to be applied. The first delegated act shall not enter into force before 19 July 2025.
To make it clear: Delegated acts must therefore be adopted so that the ESPR is applied on a product-specific or horizontal basis – without these delegated acts, there are no product regulations. Or to put it this way: ESPR sets the framework but does not itself specify any product-specific requirements – this is done only by delegated acts.
Ecodesign requirements shall improve product aspects relevant to the product group concerned such as durability, reliability, reusability, upgradability, repairability, the possibility of maintenance, and refurbishment (10 more product aspects are listed in Article 5). Ecodesign requirements shall include, as appropriate to improve the specific product aspects, either performance requirements or information requirements or both.
Article 7 ‘Information requirements’ gives many requirements relevant for technical communication. In the delegated acts, the digital product passport and the traceability of substances of concern (including ‘relevant instructions for the safe use of the product’) shall be included as a minimum.
According to Article 7, paragraph 2:
The information requirements shall…
(b) as appropriate, also require products to be accompanied by:
- information on the performance of the product…
- information for customers and other actors on how to install, use, maintain and repair the product, in order to minimise its impact on the environment and to ensure optimum durability, on how to install third-party operating systems where relevant, as well as on collection for refurbishment or remanufacture, and on how to return or handle the product at end-of-life;
- information for treatment facilities on disassembly, reuse, refurbishment, recycling, or disposal at end-of-life;
- other information that could influence sustainable product choices for customers and the way the product is handled by parties other than the manufacturer in order to facilitate appropriate use, value-retaining operations and correct treatment at end-of-life;
(c) be clear, easily understandable and tailored to the particular characteristics of the product groups concerned and the intended recipients of the information.
Also, the location/manner of the information to be made available needs to be addressed, and here, the Regulation states: Article 7, paragraph 7 ‘Where a digital product passport is available, the required information shall be provided therein…’
And last but not least, some requirements that technical communicators are already familiar with from other European laws: paragraph 8 states ‘The information to be supplied pursuant to information requirements shall be provided in a language which can be easily understood by customers, as determined by the Member State on whose market the product is to be made available or in which it is to be put into service.’
There is a separate Chapter III ‘DIGITAL PRODUCT PASSPORT’, and Article 9 ‘Digital product passport’ states in paragraph 1: ‘The information requirements shall provide that products can only be placed on the market or put into service if a digital product passport is available… The data in the digital product passport shall be accurate, complete and up to date.’
The other articles of this chapter (Article 10 ‘Requirements for the digital product passport’, Article 11 ‘Technical design and operation of the digital product passport’, Article 12 ‘Unique identifiers’, Article 13 ‘Digital product passport registry’, Article 14 ‘Web portal for data in the digital product passport’, Article 15 ‘Customs controls relating to the digital product passport’) also comprise information which technical communicators who want to find out more should read through.
On the question of which products are regulated first under ESPR Article 18 ‘Prioritisation and planning’ states for the first working plan the following product groups:
(a) iron and steel; (b) aluminium; (c) textiles, in particular garments and footwear; (d) furniture, including mattresses; (e) tyres; (f) detergents; (g) paints; (h) lubricants; (i) chemicals; (j) energy related products for which ecodesign requirements are to be set for the first time or for which existing measures adopted pursuant to Directive 2009/125/EC are to be reviewed under this Regulation; and (k) information and communication technology products and other electronics.
The obligations of economic operators are stated in Chapter VII, e.g. Article 27 ‘Obligation of manufacturers’ in paragraph 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: …
(b) those products are accompanied by the information required under Article 7 and the delegated acts adopted pursuant to Article 4; and
(c) a digital product passport is available in accordance with Article 9 and the delegated acts adopted pursuant to Article 4, including a back-up copy of the most up-to-date version of the digital product passport stored by a digital product passport service provider in accordance with Article 10(4).
…
7. Manufacturers shall ensure that a product covered by a delegated act adopted pursuant to Article 4 is accompanied by instructions in digital format concerning the product (‘digital instructions’) in a language that can be easily understood, as determined by the Member State concerned. Digital instructions shall be clear, understandable and legible and include at least the information set out in Article 7(2), point (b)(ii), as specified in that delegated act.
However, manufacturers shall provide in paper, in a concise format, safety information and the instructions relevant for the health and safety of customers and other relevant actors.
When providing the digital instructions, the manufacturer shall include them in the digital product passport and make them accessible through the corresponding data carrier, or, where the digital product passport is not applicable, indicate on the product, or, where that is not possible, on its packaging or in an accompanying document, how to access the digital instructions.
The manufacturer shall present the digital instructions in a format that makes it possible to download and save them on an electronic device so that the user can access them at all times and shall make them accessible online during the expected lifetime of the product, but in any event for at least 10 years after the placing on the market or putting into service of the product.
Where the customer so requests at the time of the purchase, or up to six months after that purchase, the manufacturer shall provide the digital instructions in a paper format, free of charge, within one month of receiving the request.
The delegated acts adopted pursuant to Article 4 may specify that certain information forming part of the digital instructions is also to be provided in paper format.
Paragraph 10 of Article 23 states
Manufacturers shall, for products covered by a delegated act adopted pursuant to Article 4, further to a reasoned request from a competent national authority, provide all the information and documentation necessary to demonstrate the conformity of those products, including the technical documentation, in a language that can be easily understood by that authority. That information and documentation shall be provided in paper or electronic form as soon as possible and in any event within 15 days of receipt of a request by that authority.
From a technical communication perspective, it is worth to mention that requirements for the format of instructions are different from the ones in the Machinery Regulation 2023/1230 (MR). The ESPR favours digital formats – especially with the digital product passport – where the MR opens the door for digital formats, but with restrictions in a defined framework. Both Regulations require safety information in paper format. For products falling within the scope of both Regulations, the preparatory work to reach compliance requires careful consideration and harmonisation of the requirements of both regulations.
The ESPR also relates to products addressed in what is called the ‘Right to Repair’ Directive or, to be more precise, the ‘DIRECTIVE (EU) 2024/1799 on common rules promoting the repair of goods’.
[1] Horizontal ecodesign requirements: Where two or more product groups display one or more similarities allowing a product aspect to be effectively improved based on common information requirements or performance requirements, horizontal ecodesign requirements may be set for those product groups.
Directive (EU) 2024/1799 on common rules promoting the repair of goods – only for goods purchased by consumers, for 10 products/product groups so far
As a Directive, this needs to be transposed into national law by member states and the final text can differ between member states. The Directive establishes common rules strengthening the provisions related to the repair of goods, with a view to contributing to the proper functioning of the internal market while providing for a high level of consumer and environmental protection. It applies to the repair of goods purchased by consumers in the event of a defect in the goods that occurs or becomes apparent outside the liability of the seller[1]. It establishes a European Repair Information Form – a compilation of necessary information which provides transparency about the repair, should facilitate it and organises the information relevant for affected consumers and repairers. An obligation to repair is introduced for manufacturers. However, this obligation is limited to products mentioned in Annex II with a list of Union Acts laying down reparability requirements. And these listed legal acts are based on the ecodesign framework and delegated acts introduced for the following 10 products/product groups: 1. Household washing machines and household washer-dryers, 2. Household dishwashers, 3. Refrigerating appliances, 4. Electronic displays, 5. Welding equipment, 6. Vacuum cleaners, 7. Servers and data storage products, 8. Mobile phones, cordless phones and slate tablets, 9. Household tumble dryers and 10. Goods incorporating light means of transport batteries. These Union acts can require manufacturers
to provide access to spare parts, repair and maintenance information or any repair related software tools, firmware or similar auxiliary means. Those requirements ensure the technical feasibility of repair, not only by the manufacturer, but also by other repairers. As a consequence, the repairers and, where applicable, consumers will have access to spare parts and repair-related information and tools in accordance with Union legal acts…
From the point of view of technical communication, it should be emphasised that a new target audience is being introduced with the (independent) repairers for which the manufacturer must provide information for use.
[1] Pursuant to Article 10 of Directive (EU) 2019/771 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC.
Artificial Intelligence Act 2024/1689 – High-risk AI systems in the focus of technical communication
The Artificial Intelligence Act 2024/1689 (AI Act) was published on 12 July 2024 in the Official Journal of the European Union and entered into force on 1 August 2024. It shall apply from 2 August 2026 with exceptions[1]. The Regulation shall be binding in its entirety and directly applicable in all Member States. Article 1: ‘Subject Matter’ states as its purpose ‘to improve the functioning of the internal market and promote the uptake of human-centric and trustworthy artificial intelligence (AI), while ensuring a high level of protection of health, safety, fundamental rights enshrined in the Charter, including democracy, the rule of law and environmental protection, against the harmful effects of AI systems in the Union and supporting innovation.’
The AI Act lays down e.g. harmonised rules for placing AI systems on the market, putting them into service and using them in the Union and specific requirements for high-risk AI systems and obligations for operators of such systems. Article 3: ‘Definitions’ is quite comprehensive, with 68 terms and explanations such as:
(1) ‘AI system’ means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;
…
(3) ‘provider’ means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge;
(4) ‘deployer’ means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;
…
(15) ‘instructions for use’ means the information provided by the provider to inform the deployer of, in particular, an AI system’s intended purpose and proper use[.]
Chapter III: ‘High-Risk AI Systems’ is particularly relevant for technical communicators. Section 2: ‘Requirements for High-Risk AI Systems’, Article 8: ‘Compliance with the Requirements’ describes requirements for products with AI systems that are also covered by other Union harmonisation legislation, e.g. the Machinery Directive 2006/42/EC, Regulation (EU) 2017/745 Medical devices as listed with 18 other legislations in Annex I: ‘List of Union Harmonisation Legislation’, Section A ‘List of Union harmonisation based on the New Legislative Framework’. It states that:
[P]roviders shall be responsible for ensuring that their product is fully compliant with all applicable requirements under applicable Union harmonisation legislation. In ensuring the compliance of high-risk AI systems…, and in order to ensure consistency, avoid duplication and minimize additional burdens, providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist and are required under the Union harmonisation legislation listed in Section A of Annex I[.]
Article 11: ‘Technical Documentation’ states that ‘The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date.’
Article 13: ‘Transparency and Provision of Information to Deployers’ states that
2. High-risk AI systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that include concise, complete, correct and clear information that is relevant, accessible and comprehensible to deployers.
3. The instructions for use shall contain at least the following information:
(a) the identity and the contact details of the provider and, where applicable, of its authorised representative;
(b) the characteristics, capabilities and limitations of performance of the high-risk AI system, including:
(i) its intended purpose;
(ii) the level of accuracy, including its metrics, robustness and cybersecurity…
(iii) any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights…;
(iv) where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information that is relevant to explain its output;
(v) when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used;
(vi) when appropriate, specifications for the input data, or any other relevant information in terms of the training, validation and testing data sets used, taking into account the intended purpose of the high-risk AI system;
(vii) where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it appropriately;
(c) the changes to the high-risk AI system and its performance which have been predetermined by the provider at the moment of the initial conformity assessment, if any;
(d) the human oversight measures…, including the technical measures put in place to facilitate the interpretation of the outputs of the high-risk AI systems by the deployers;
(e) the computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary maintenance and care measures, including their frequency, to ensure the proper functioning of that AI system, including as regards software updates;
(f) where relevant, a description of the mechanisms included within the high-risk AI system that allows deployers to properly collect, store and interpret the logs…
Further requirements regarding instructions for use and technical documentation are stated e.g. in Article 24: ‘Obligations of Distributors’, Article 26: ‘Obligations of Deployers of High-Risk AI Systems’, and Annex IV: ‘Technical Documentation Referred to in Article 11(1)’.
[1] (a) Chapters I: ‘General Provisions’ and II: ‘Prohibited AI Practices’ shall apply from 2 February 2025;
(b) Chapter III: ‘High-risk AI Systems’, Section 4: ‘Notifying Authorities and Notified Bodies’, Chapter V: ‘General-Purpose AI Models’, Chapter VII: ‘Governance’, Chapter XII: ‘Penalties’, and Article 78: ‘Confidentiality’ shall apply from 2 August 2025, with the exception of Article 101: ‘Fines for Providers of General-Purpose AI Models’;
(c) Article 6: ‘Classification Rules for High-Risk AI Systems’ (1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.
Cyber resilience Act 2024/2847 (CRA)[1]
Regulation (EU) 2024/2847 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) No 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) was published on 2024-11-20 in the Official Journal of the European Union and enters into force 2024-12-10.
The Cyber Resilience Act (CRA) lays down in accordance with Article 1 Subject matter:
(a) rules for the making available on the market of products with digital elements to ensure the cybersecurity of such products;
(b) essential cybersecurity requirements for the design, development and production of products with digital elements, and obligations for economic operators in relation to those products with respect to cybersecurity;
(c) essential cybersecurity requirements for the vulnerability handling processes put in place by manufacturers to ensure the cybersecurity of products with digital elements during the time the products are expected to be in use, and obligations for economic operators in relation to those processes;
(d) rules on market surveillance, including monitoring, and enforcement of the rules and requirements referred to in this Article.
According to Article 2 Scope it applies to products with digital elements made available on the market, the intended purpose or reasonably foreseeable use of which includes a direct or indirect logical or physical data connection to a device or network.
Article 3 Definitions states 51 definitions e.g.:
(1) ‘product with digital elements’ means a software or hardware product and its remote data processing solutions, including software or hardware components being placed on the market separately;
(39) ‘software bill of materials’ means a formal record containing details and supply chain relationships of components included in the software elements of a product with digital elements.
Article 13 Obligations of manufacturers requires that:
1. When placing a product with digital elements on the market, manufacturers shall ensure that it has been designed, developed and produced in accordance with the essential cybersecurity requirements set out in Part I of Annex I.
2. For the purpose of complying with paragraph 1, manufacturers shall undertake an assessment of the cybersecurity risks associated with a product with digital elements and take the outcome of that assessment into account during the planning, design, development, production, delivery and maintenance phases of the product with digital elements with a view to minimising cybersecurity risks, preventing incidents and minimising their impact, including in relation to the health and safety of users.
12. Before placing a product with digital elements on the market, manufacturers shall draw up the technical documentation referred to in Article 31.
13. Manufacturers shall keep the technical documentation and the EU declaration of conformity at the disposal of the market surveillance authorities for at least 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer.
18. Manufacturers shall ensure that products with digital elements are accompanied by the information and instructions to the user set out in Annex II, in paper or electronic form. Such information and instructions shall be provided in a language which can be easily understood by users and market surveillance authorities. They shall be clear, understandable, intelligible and legible. They shall allow for the secure installation, operation and use of products with digital elements. Manufacturers shall keep the information and instructions to the user set out in Annex II at the disposal of users and market surveillance authorities for at least 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer. Where such information and instructions are provided online, manufacturers shall ensure that they are accessible, user-friendly and available online for at least 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer.
Article 31 Technical documentation specifies e.g. that
1. The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that the product with digital elements and the processes put in place by the manufacturer comply with the essential cybersecurity requirements set out in Annex I. It shall at least contain the elements set out in Annex VII.
2. The technical documentation shall be drawn up before the product with digital elements is placed on the market and shall be continuously updated, where appropriate, at least during the support period.
3. For products with digital elements as referred to in Article 12, which are also subject to other Union legal acts which provide for technical documentation, a single set of technical documentation shall be drawn up containing the information referred to in Annex VII and the information required by those Union legal acts.
ANNEX I ESSENTIAL CYBERSECURITY REQUIREMENTS consists of Part I Cybersecurity requirements relating to the properties of products with digital elements and Part II Vulnerability handling requirements. Part II requires e.g.: Manufacturers of products with digital elements shall:
(1) identify and document vulnerabilities and components contained in products with digital elements, including by drawing up a software bill of materials in a commonly used and machine-readable format covering at the very least the top-level dependencies of the products.
ANNEX II INFORMATION AND INSTRUCTIONS TO THE USER states:
At minimum, the product with digital elements shall be accompanied by:
1. the name, registered trade name or registered trademark of the manufacturer, and the postal address, the email address or other digital contact as well as, where available, the website at which the manufacturer can be contacted;
2. the single point of contact where information about vulnerabilities of the product with digital elements can be reported and received, and where the manufacturer’s policy on coordinated vulnerability disclosure can be found;
3. name and type and any additional information enabling the unique identification of the product with digital elements;
4. the intended purpose of the product with digital elements, including the security environment provided by the manufacturer, as well as the product’s essential functionalities and information about the security properties;
5. any known or foreseeable circumstance, related to the use of the product with digital elements in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to significant cybersecurity risks;
6. where applicable, the internet address at which the EU declaration of conformity can be accessed;
7. the type of technical security support offered by the manufacturer and the end-date of the support period during which users can expect vulnerabilities to be handled and to receive security updates;
8. detailed instructions or an internet address referring to such detailed instructions and information on:
(a) the necessary measures during initial commissioning and throughout the lifetime of the product with digital elements to ensure its secure use;
(b) how changes to the product with digital elements can affect the security of data;
(c) how security-relevant updates can be installed;
(d) the secure decommissioning of the product with digital elements, including information on how user data can be securely removed;
(e) how the default setting enabling the automatic installation of security updates, as required by Part I, point (2)(c), of Annex I, can be turned off;
(f) where the product with digital elements is intended for integration into other products with digital elements, the information necessary for the integrator to comply with the essential cybersecurity requirements set out in Annex I and the documentation requirements set out in Annex VII.
9. If the manufacturer decides to make available the software bill of materials to the user, information on where the software bill of materials can be accessed.
[1]https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R2847#cpt_IV
Proposal for Marketing of Construction Products 01
For the Proposal for a Regulation laying down harmonised rules for the marketing of construction products, the content-related discussions are not finished. According to the European Union’s website EUR-LEX for the proposal[1], the latest stage is the adoption of the text after the first reading in the European Parliament (11 July 2024). The Regulation is not published yet in the OJEU – so it is still a Proposal. The cited quotes are taken from the adopted text after first reading in the EP published as P9_TA(2024)0188[2] on 10 April 2024.
The Regulation will establish a) harmonised rules on how to express the environmental and safety performance of construction products in relation to their essential characteristics, including life cycle assessment and b) environmental, functional and safety product requirements for construction products. It will also establish (a) rights and obligations for economic operators dealing with construction products or their components; and (b) obligations for other actors providing services linked to the manufacturing and commercialisation of construction products.
It also aims to contribute to the objectives of a green and digital transition by preventing and reducing the impact that construction products have on the environment and on the health and safety of people. It will apply to construction products, including used products, key parts of products and parts or materials intended to be used for construction products, if the manufacturer of those parts or materials so requests. According to an annex, the following basic requirements for construction products are listed as the basis for the identification of essential characteristics of products and preparation of further provisions:
- Structural integrity of construction works
- Fire safety of construction works
- Protection against adverse hygiene and health impacts related to construction works
- Safety and accessibility of construction works
- Resistance to the passage of sound and acoustic properties of construction works
- Energy efficiency and thermal performance of construction works
- Emissions into the outdoor environment of construction works
- Sustainable use of natural resources of construction works
According to the article ‘Definitions’, 64 terms will be defined, such as:
(1) ‘construction product’ means any formed or formless physical item, including 3Dprinted products, or a kit that is placed on the market, including by means of supply to the construction site, for incorporation in a permanent manner into construction works or parts thereof with the exception of items that need first to be integrated into a kit or another construction product prior to being incorporated in a permanent manner into construction works;
(23) ‘repair’ means the process of fixing a faulty product or replacing its defective components, in order to return the product to a condition where it can fulfil its declared use;
(24) ‘maintenance’ means an action carried out to retain a product in a condition where it is able to function as specified;
(40) ‘permalink’ means an internet link to a website which is stable both for its content and the address (“URL”);
(41) ‘data carrier’ means a linear bar code symbol, a two-dimensional symbol, or other automatic identification data capture medium that can be read by a device;
(53) ‘life cycle’ means the consecutive and interlinked stages of a product’s life, from raw material acquisition or generation from natural resources, or in the case of products which have previously been incorporated in a construction work, from the latest de-installation from the construction work, to final disposal[…]
The article ‘General product information, instructions for use and safety information’ will require more specification relevant for technical communication:
1. General product information, instructions for use and safety information shall be provided in relation to construction products covered by a harmonised technical specification or a European technical assessment. The content of the general product information, instructions for use and safety information is set out in Annex IV.
2. As part of the standardisation request referred to in Article 5(2), the Commission may also request the European standardisation organisation to issue guidelines, including technical details, necessary for drawing up general product information, instructions and safety information in accordance with Annex IV.
3. If the Commission considers that the guidelines issued by the European standardisation organisation pursuant to paragraph 2 of this Article for a specific product family or category do not ensure adequate and homogeneous implementation of paragraph 1 of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation by establishing rules on the provision of general product information, instructions for use and safety information for the respective product family or category.
4. The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend Annex IV in order to adapt it to technical progress and new information needs.
The article ‘Obligations of all economic operators’ states the requirement to keep information for a period of ten years after supply unless the information has been made available through the product passport.
4. An economic operator shall keep all documents and all information referred to in this Chapter at the disposal of competent national authorities for a period of ten years after the economic operator supplied or was supplied with the product or service in question, unless the documents or the information have been made available through the product passport referred to in Article 76. An economic operator shall present the documentation and information within 10 days of receipt of a request by a competent national authority.
5. An economic operator may register itself in its respective national system established in accordance with Article 71(5).
An economic operator shall make available to consumers and users communication channels, including telephone numbers, e-mail or dedicated sections of its website, allowing them to communicate any accident, other incident or safety issue they have experienced with the product.
Article 21 Rights of manufacturers
1. A manufacturer shall have the right to request from its suppliers and service providers the information necessary in relation to their products to fulfil its obligations under this Regulation.
…
3. The rights established in paragraph 1 also apply to a manufacturer placing a used or remanufactured product on the market in relation to the supplier of the used product, including the de-installer where applicable. The information required may include, but is not limited to, information about the previous use of the product and about the process of deinstalling it
Article 22 Obligations of manufacturers
3. The manufacturer shall, as the basis for the declaration of performance and conformity draw up a technical documentation including:
(a) the declared use, which shall fall within the scope of the applicable intended use;
(b) all the relevant elements necessary to demonstrate performance and conformity;
(c) information on procedures in place referred to in paragraph 4 of this Article;
(d) information on the application of the system or systems applicable in Annex IX;
(e) where relevant, information on the application of simplified procedures applied in
accordance with Articles 59 to 61; and
(f) the calculation of environmental essential characteristics as referred to in Article 15(2).
…
5. The manufacturer shall ensure that its products bear a manufacturer-specific unique identification code of the product type and, where available, a batch or serial number which is easily visible and legible for users. Where that is not possible on account of the nature of the product, the required information shall be provided on the packaging, on an affixed label or, where that is also not possible, in a document accompanying the product. The manufacturer shall, in the same way as set out in the first subparagraph, label a product as “Only for professional use” if expertise is needed in order to use it and shall display the label to customers before it is bound by a sales contract, including in the case of distance selling. Products not labelled “Only for professional use” shall be deemed to also be intended for non-professional users and consumers within the meaning of this Regulation and of Regulation (EU) 2023/988.
The manufacturer shall, in a visible manner, display to customers before it is bound by a sales contract, including in the case of distance selling, the information which must be provided pursuant to this Regulation.
6. When making a product available on the market, the manufacturer shall ensure that it is accompanied by general information, instructions for use and safety information, as set out in Annex IV in a language to be determined by the Member State concerned or, in absence of such determination, in a language which can be easily understood by users.
7. By the date 18 months after the entry into force of the delegated act referred to in Article 75(1) the manufacturer shall make available a product passport referred to in Article 76, through the construction digital product passport system referred to in Article 75, connected to a data carrier referred to in Article 18(2), point (g).
9. In order to ensure transparency for users and to promote sustainable products, the Commission is empowered to adopt delegated acts in accordance with Article 89 to supplement this Regulation, by establishing specific environmental sustainability labelling requirements for particular product families and categories when the following conditions are fulfilled:
(a) the product is typically chosen or purchased by consumers; and
(b) the product does not have a significantly different overall environmental performance over its life cycle depending on its installation. The labelling shall be based on the performance of the product, as assessed in accordance with Article 5(1) or Article 6(1), and shall provide consumer-friendly information understandable by non-experts.
10. The delegated acts referred to in paragraph 9 shall determine the way in which the manufacturer is to affix the label, by specifying the following:
(a) the content of the label;
(b) the layout of the label, taking into account its visibility and legibility;
(c) the manner in which the label is to be displayed to customers, including in the case of distance selling;
(d) where appropriate, the electronic means to be used for generating labels.
Article 35 Content of the European assessment document
1. A European assessment document shall contain the following elements:
(a) a description of the product or product category covered and its intended use; and
(b) the list of essential characteristics, relevant for the intended use of the product or product category as agreed between the manufacturer and the organisation of TABs as well as predetermined environmental characteristics as set out in Annex II, and the methods and criteria for assessing the performance of the product in relation to the essential characteristics listed.
2. The European assessment document shall set out:
(a) the technical details necessary for the implementation of the assessment and verification systems that are to be applied in accordance with the delegated acts adopted under Article 10(2);
(b) the guidelines, including technical details necessary for drawing up instructions and safety information as referred to in Annex IV;
Article 35 Content of the European assessment document
1. A European assessment document shall contain the following elements:
(a) a description of the product or product category covered and its intended use; and
(b) the list of essential characteristics, relevant for the intended use of the product or product category as agreed between the manufacturer and the organisation of TABs as well as predetermined environmental characteristics as set out in Annex II, and the methods and criteria for assessing the performance of the product in relation to the essential characteristics listed.
2. The European assessment document shall set out:
(a) the technical details necessary for the implementation of the assessment and verification systems that are to be applied in accordance with the delegated acts adopted under Article 10(2);
(b) the guidelines, including technical details necessary for drawing up instructions and safety information as referred to in Annex IV;
(c) the guidelines to ensure interoperability of the human and machine readable formats for the declaration of performance and conformity in accordance with paragraph 16(2), point (b).
3. Where the performance of the product can appropriately be assessed by reference to its essential characteristics, including assessment methods and criteria, already established for them in harmonised technical specifications or other European assessment documents, those existing essential characteristics and their methods and criteria shall be incorporated as parts of the European assessment document, unless it is technically necessary to deviate from that rule.
Where applicable, these principles shall also apply for thresholds levels and classes of performance adopted in accordance with Article 5(5).
[1]eur-lex.europa.eu/legal-content/EN/HIS/
[2]https://www.europarl.europa.eu/RegistreWeb/search/simpleSearchHome.htm?references=P9_TA(2024)0188&sortAndOrder=DATE_DOCU_DESC
Proposal for Marketing of Construction Products 02
CHAPTER X PRODUCT PASSPORT
Article 75 Construction digital product passport system
1. The Commission shall adopt delegated acts in accordance with Article 89 to supplement this Regulation by setting up a construction digital product passport system, in accordance with the conditions set out in this Chapter.
2. The construction digital product passport system shall:
(a) be compatible with, interoperable with and based upon the product passport established by Regulation (EU) .../... [Regulation on eco design for sustainable products], without compromising interoperability with Building Information Modelling (BIM), and taking into account the specific characteristics and requirements related to construction products;
(b) have the functionalities required to implement and manage product passports referred to in Article 76;
(c) determine the actors, including economic operators, clients, deinstallers, users and competent national authorities, which are to have access to information in the product passport and to other information to which they need to have access, taking into account the need to protect intellectual property rights, and sensitive commercial information, and to ensure the safety of construction works;
(d) determine the actors, including manufacturers, authorised representatives, importers, distributors and digital product passport service providers, which are allowed to introduce or update the information in the product passport, including where necessary the creation of a new product passport, and what information they may introduce or update;
(e) lay down detailed arrangements for updating the information in the product passport of an existing product;
(f) establish procedures to ensure the availability of product passports after an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the product passport or, if necessary, after the obligations of manufacturers to ensure its availability have expired, including the establishment of a back-up system by product passport service providers;
(g) establish requirements for digital product passport service providers, including, if required, a certification scheme to verify such requirements, to be based upon developments under Regulation (EU).../... [Regulation on eco design for sustainable products] for the same purpose, as far as possible;
(h) when required, lay down more detailed or alternative rules and procedures related to the life cycle of identifiers, data carriers, digital credentials and the product passport registry to those established by Regulation (EU) .../... [Regulation on ecodesign for sustainable products] for the same purpose;
(i) ensure that the system is accessible for period of 25 years after the last product corresponding to its product type has been placed on the market and that the economic operator makes available the digital product passport for at least 10 years, without, in the case of a longer period, creating a disproportionate cost and burden for the economic operators;
(j) take into account the need to ensure the availability of information for the reuse and remanufacturing of products.
Article 76 Product passport
1. The information in the product passport shall be accurate, complete, and up-to-date.
2. A product passport for a product under this Regulation shall:
(a) include the following information:
(i) the declaration of performance and conformity referred to in Article 15, including the information referred to in Article 15(6) which can be included through a connection to other Union databases where it is available and the documentation provided together in accordance with Annex V;
(ii) the general information, instructions for use and safety information referred to in Article 22(6); and
(iii) the technical documentation referred to in Article 22(3) including the specific sections required pursuant to Articles 59 to 61;
(iv) the label in accordance with Article 22(9);
(v) unique identifiers issued in accordance with Article 79(1);
(vi) documentation required under other Union law applicable to the product;
(vii) data carriers of key parts for which a product passport is available;
(b) be connected to one or more data carriers;
(c) be accessible by electronic means through the data carrier displayed, in accordance with Article 18(2), point (g);
(d) correspond to the product type and its unique identification code referred to in Article 22(5);
(e) be accessible free of charge to all economic operators, clients, users and authorities through the data carrier;
(f) give different levels of access to the construction digital product passport system;
(g) allow actors specified in the construction digital product passport system to introduce or to update the information in the product passport;
(h) be accessible for an established period after the last product corresponding to its product type has been placed on the market.
3. The requirements referred to in paragraph 2 shall:
(a) ensure that actors along the value chain can easily access and understand product information relevant to them;
(b) facilitate the verification of product compliance by competent national authorities; and
(c) improve traceability of products along the value chain.
4. Products in respect of which the exemption established in Article 14 is applied are also exempt from the obligation to provide a product passport.
Article 77 General requirements for the product passport
1. A product passport shall meet the following conditions:
(a) it shall be connected through one or more data carriers to a persistent unique identification code of the product type;
(b) the data carrier shall be affixed in accordance with Article 18(2), point (g);
(c) the data carrier shall comply with Article 79(1);
(d) all information included in the product passport shall be based on open standards, developed with an interoperable format and shall, as appropriate, be machine readable, structured, searchable and transferable through an open interoperable data exchange network, without ‘vendor lock-in’, in accordance with the essential requirements set out in Article 78; documents provided together with the declaration of performance and conformity referred to in Article 76(2)(a)(i) and technical documentation referred to in Article 76(2)(a)(iii) shall be exempted from this obligation when justified for technical reasons;
(e) personal data related to the end-user of the product shall not be stored in the product passport without the explicit consent of the end-user in compliance with Article 6 of Regulation (EU) 2016/679 of the European Parliament and of the Council27;
(f) the information in the product passport shall include a reference to the product type referred to in Article 76(2), point (d);
(g) the access to information included in the product passport shall be regulated in accordance with the essential requirements set out in Article 78 and the specific access rights shall be identified in accordance with construction digital product passport system levels of access;
(h) the declaration of performance and conformity referred to in Article 76(2), point (a)(i), shall follow the guidelines issued in accordance with Article 16(3).
2. Where other Union legislation requires or allows the inclusion of specific information in the product passport, that information may be included in the product passport in accordance with the delegated act referred to in Article 75(1).
3. The manufacturer placing the product on the market shall provide actors making the products available on the market online or through other means of distance sales with a digital copy of the data carrier and the product identifier to allow them to make it accessible to customers where they cannot physically access the product. The economic operator shall provide that digital copy or a webpage link free of charge and within 5 working days of receiving the request.
Article 78 Technical design and operation of the 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 as regards the technical, semantic and organisational aspects of end-to-end communication and data transfer;
(b) a recipient of the product passport shall have easy access, free of charge, to it based on the recipient’s respective access right in the construction digital product passport system;
(c) the data included in the product passport shall be stored as specified in the construction digital product passport system referred to in Article 75;
(d) if the data included in the product passport is stored or otherwise processed by authorised operators or digital product passport providers, they shall not be allowed to sell, reuse or process such data, in whole or in part, beyond what is necessary for the provision of the relevant storing or processing services, unless this is specifically agreed with the economic actor placing the product on the market or putting it into service;
(e) the product passport shall remain available for the period specified in Article 76(2), point (h), including after an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the product passport, and shall fulfil the conditions established in accordance with Article 75(2), point (f), as regards the obligation to establish a back-up system;
(f) the right to access and to introduce, modify or update information in the product passport shall be restricted to the access rights specified in the construction digital product passport system;
(g) protection of information that constitutes trade secrets within the meaning of Article 2(1) Directive (EU) 2016/943 of the European Parliament and of the Council28 or intellectual property rights shall be ensured;
(h) data authentication, reliability and integrity shall be ensured;
(i) product passports shall be designed and operated so that a high level of security and privacy is ensured and fraud is avoided.
Article 79 Unique identifiers and product passport registry
1. Article 12 of Regulation (EU) .../... [Regulation on eco design for sustainable products] shall apply for the purposes of the implementation of this Regulation as regards unique identifiers and data carriers unless the delegated act referred to in Article 75(1) of this Regulation lays down more detailed or alternative rules related to those unique identifiers and data carriers, as referred to in Article 75(2)(h) of this Regulation.
2. Article 13 of Regulation (EU) .../... [Regulation on eco design for sustainable products] shall apply for the purposes of the implementation of this Regulation as regards the product passport registry unless the delegated act referred to in Article 75(1) of this Regulation lays down more detailed or alternative rules related to that registry, as referred to in Article 75(2)(h) of this Regulation.
28Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).
3. Article 14 of Regulation (EU) .../... [Regulation on eco design for sustainable products] shall apply for the purposes of implementation of this Regulations as regards the web portal for information in the digital product passport.
Article 91 Electronic applications, decisions, documentation and information
1. All applications from or to notified bodies or TABs and decisions made by these bodies made in accordance with this Regulation can be provided on paper or in a commonly used electronic format provided that the signature complies with the requirements of Regulation (EU) No 910/2014 and the signing person has been entrusted with the task of representing the body or economic operator, in accordance with the law of the Member States or Union law respectively.
2. All information obligations under this Regulation may, unless otherwise stated, be satisfied by electronic means. Where the information is provided by electronic means, the information shall be issued in a commonly readable electronic format that enables the recipient to download and print that information.
When the obligation is established in accordance with Article 22(7), economic operators shall fulfil information obligations related to documents referred to in Article 76(2) by providing the product passport.
ANNEX IV GENERAL PRODUCT INFORMATION, INSTRUCTIONS FOR USE AND SAFETY INFORMATION
1. General product information
1.1. Product identification: unique identification code of the product type.
1.2. Product description:
(a) declared uses;
(b) intended users;
(c) conditions of uses;
(d) estimated average and minimum service life span for declared use (durability);
(e) main materials used.
1.3. Contact details of the manufacturer or the authorised representative:
(a) name;
(b) postal address;
(c) telephone;
(d) email address;
(e) website, where available.
1.4. Where different from point 1.3., contact details of the manufacturer or the authorised representative dealing with:
(a) information on installation, maintenance, use, deconstruction and demolition;
(b) information on risks;
(c) information in the event of product failure.
1.5. Contact details of the product contact point for construction in the Member State in which the product is made available.
2. Instructions for use and safety information
2.1. Safety during transport, installation, deinstallation, maintenance, deconstruction and demolition:
(a) potential risks of the product and any reasonably foreseeable misuse thereof;
(b) instructions for the assembly, installation and connection, including drawings, diagrams and, where relevant, the means of attachment to other products and parts of construction works;
(c) instructions for operation and maintenance to be carried out safely, including the protective measures that should be taken during these operations;
(d) if necessary, instructions for the training of the installers or operators;
(e) information on what to do in the event of product failure or accidents.
2.2. Compatibility and integration into systems or kits:
(a) compatibility with other materials or products, regardless of whether they are covered by this Regulation or not;
(b) electric and electro-magnetic compatibility;
(c) software compatibility;
(d) integration in systems or kits.
2.3. Maintenance needs with a view to maintaining the performance of the product during its service life span:
(a) description of the adjustment and maintenance operations that should be carried out by the users and the preventive maintenance measures that should be observed;
(b) the type and frequency of the inspections and the maintenance required for reasons of
safety and durability and, where appropriate, the parts subject to wear and the criteria for replacement;
(c) information on what to do in the event of product failure or accident.
2.4. Safety during use:
(a) instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;
(b) instructions designed for the safe use of the product, including the protective measures that should be taken during its use;
(c) information on what to do in the event of product failure or accident during use.
2.5. Training and other requirements necessarily to be fulfilled for safe use.
2.6. Risk mitigation possibilities going beyond points 2.1 to 2.5.
2.7. Recommendations for a product’s:
(a) repair;
(b) de-installation;
(c) reuse;
(d) remanufacturing;
(e) recycling;
(f) safe deposit.
2.8. Where applicable, information on the performance of the product as measured in terms of its climate change effects - total, as referred to in point (a) of Annex II, and human toxicity, cancer, as referred to in point (p) of Annex II.
3. The information provided on the elements listed in point 2 shall be enough, both in terms of quantity and quality, to enable potential purchasers to make informed decisions before proceeding with their purchase, including information on the necessary quantity, installation, use, maintenance, dismantling, reuse and recycling of the respective product. It may include all the drawings, diagrams, descriptions and explanations necessary for it to be fully [understood].
The information shall, as appropriate, take into account as far as possible the needs of designers, building authorities, construction professionals, building control authorities, consumers and other users, occupant and, use managers, as well as of maintenance professionals.
4. Guidelines and technical details issued in accordance with Article 9(2) shall also recommend where the respective information is to be provided. That location shall be one where the information is least likely to be overlooked.
ANNEX V MODEL FOR THE DECLARATION OF PERFORMANCE AND CONFORMITY REFERRED TO IN ARTICLE 151
Name of the Manufacturer
Declaration Code...2
Version No…3
Date of that version…
1. Product description
(a) unique identification code of the product type and, where available, the batch or serial number;
(b) product category as defined by harmonised technical specifications or European Assessment Documents;
1Where a Declaration of Performance and Conformity is issued in relation to a product not subject to product requirements established by delegated acts referred to in Article 7(1), points 10 and 11(c). are omitted. 2Only one unique, unequivocal declaration code per product type shall be used, even where there are variants, variants being variations of the product type that do not influence performance or conformity of the product.
3 Different versions may be issued, e.g. to correct mistakes or add complementary information.
(c) declared uses of the product, within the scope of the applicable harmonised technical specification or European Assessment Document;
(d) nominal dimensions or grading of the product;
(e) key parts of the product, where applicable;
(f) estimated average and minimum service life time for the declared use (durability);
(g) variants, if any, and their descriptions;
(h) in cases where the product has been previously installed in a construction work, the date and place of the latest de-installation.
2. Permalinks or data carriers as regards the following, unless the information is available in the product passport pursuant to Article 76:
(a) the manufacturer’s product registrations in Union databases, if any;
(b) information to be provided in accordance with Regulation (EC) 1907/2006, where applicable;
(c) general information, instructions for use and safety information in accordance with Annex IV.
3. Manufacturer:
(a) name;
(b) registered trade name;
(c) registered place of business;
(d) postal address;
(e) telephone;
(f) email address;
(g) website.
4. Authorised representative, where applicable:
(a) name;
(b) registered trade name;
(c) registered place of business;
(d) postal address;
(e) telephone;
(f) email address;
(g) website.
5. Notified body or bodies, where applicable:
(a) name;
(b) identification number;
(c) registered trade name, where available;
(d) registered place of business;
(e) postal address;
(f) telephone;
(g) email address;
(h) website.
6. Technical Assessment Body, where applicable:
(a) name;
(b) identification number;
(c) registered trade name, where available;
(d) place of business;
(e) postal address;
(f) telephone;
(g) email address;
(h) website.
7. Reference to certificates or validation reports issued by notified bodies and TABs.
8. Technical reference documents:
(a) harmonised technical specifications laying down essential characteristics applied (reference number and date of issue); or
(b) European assessment document applied (reference number and date of issue) and European Technical Assessment issued (technical assessment body, reference number and date of issue).
9. Declared performances and sustainability characteristics:
(a) the complete list of essential characteristics, as determined in the harmonised technical specification or European assessment document for the respective product category for which a performance is declared and the applicable assessment and verification system applicable to them;
(b) the performance of the product, by calculated values, levels or classes, or in a description. Respective values, levels or classes shall be reproduced in the declaration of performance itself and thus cannot be expressed solely by inserting references to other documents. For essential characteristics where no performance is declared, the word “NULL” shall be inserted in the place for the declaration of the value. The performance of structural behaviour of a product may be expressed by referring to attached production documentation or structural design calculations;
(c) the environmental sustainability expressed, for the applicable essential characteristics of the applicable life cycle modules, in accordance with Article 15(2);
(d) reference to the version of the software used as provided by the Commission.
10. Applicable product requirements specified by harmonised technical specifications, the applicable assessment and verification system applicable to them and the reference to the harmonised standard or common specifications or parts thereof applied including the date.
Where applicable, information on the performance of the product measured in terms of its product requirements.
11. Declarations:
(a) the performance of the product identified above is in conformity with the set of declared performances referred to in point 9;
(b) the sustainability data of the product identified above have been correctly calculated on the basis of the product category rules applicable to it;
(c) the product identified above is in conformity with the requirements listed under point 10.
Signed for and on behalf of the manufacturer by:
[name, function4]
At [place]
on [date of issue]
[signature]
4The person signing must be authorised under national law to represent the manufacturer, either on the basis of a mandate, or by virtue of his or her role as a legal representative.
Proposal for Marketing of Construction Products 03
2. Instructions for use and safety information
2.1. Safety during transport, installation, deinstallation, maintenance, deconstruction and demolition:
(a) potential risks of the product and any reasonably foreseeable misuse thereof;
(b) instructions for the assembly, installation and connection, including drawings, diagrams and, where relevant, the means of attachment to other products and parts of construction works;
(c) instructions for operation and maintenance to be carried out safely, including the protective measures that should be taken during these operations;
(d) if necessary, instructions for the training of the installers or operators;
(e) information on what to do in the event of product failure or accidents.
2.2. Compatibility and integration into systems or kits:
(a) compatibility with other materials or products, regardless of whether they are covered by this Regulation or not;
(b) electric and electro-magnetic compatibility;
(c) software compatibility;
(d) integration in systems or kits.
2.3. Maintenance needs with a view to maintaining the performance of the product during its service life span:
(a) description of the adjustment and maintenance operations that should be carried out by the users and the preventive maintenance measures that should be observed;
(b) the type and frequency of the inspections and the maintenance required for reasons of
safety and durability and, where appropriate, the parts subject to wear and the criteria for replacement;
(c) information on what to do in the event of product failure or accident.
2.4. Safety during use:
(a) instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;
(b) instructions designed for the safe use of the product, including the protective measures that should be taken during its use;
(c) information on what to do in the event of product failure or accident during use.
2.5. Training and other requirements necessarily to be fulfilled for safe use.
2.6. Risk mitigation possibilities going beyond points 2.1 to 2.5.
2.7. Recommendations for a product’s:
(a) repair;
(b) de-installation;
(c) reuse;
(d) remanufacturing;
(e) recycling;
(f) safe deposit.
2.8. Where applicable, information on the performance of the product as measured in terms of its climate change effects - total, as referred to in point (a) of Annex II, and human toxicity, cancer, as referred to in point (p) of Annex II.
3. The information provided on the elements listed in point 2 shall be enough, both in terms of quantity and quality, to enable potential purchasers to make informed decisions before proceeding with their purchase, including information on the necessary quantity, installation, use, maintenance, dismantling, reuse and recycling of the respective product. It may include all the drawings, diagrams, descriptions and explanations necessary for it to be fully [understood].
The information shall, as appropriate, take into account as far as possible the needs of designers, building authorities, construction professionals, building control authorities, consumers and other users, occupant and, use managers, as well as of maintenance professionals.
4. Guidelines and technical details issued in accordance with Article 9(2) shall also recommend where the respective information is to be provided. That location shall be one where the information is least likely to be overlooked.
ANNEX V MODEL FOR THE DECLARATION OF PERFORMANCE AND CONFORMITY REFERRED TO IN ARTICLE 151
Name of the Manufacturer
Declaration Code...2
Version No…3
Date of that version…
1. Product description
(a) unique identification code of the product type and, where available, the batch or serial number;
(b) product category as defined by harmonised technical specifications or European Assessment Documents;
1Where a Declaration of Performance and Conformity is issued in relation to a product not subject to product requirements established by delegated acts referred to in Article 7(1), points 10 and 11(c). are omitted. 2Only one unique, unequivocal declaration code per product type shall be used, even where there are variants, variants being variations of the product type that do not influence performance or conformity of the product.
3 Different versions may be issued, e.g. to correct mistakes or add complementary information.
(c) declared uses of the product, within the scope of the applicable harmonised technical specification or European Assessment Document;
(d) nominal dimensions or grading of the product;
(e) key parts of the product, where applicable;
(f) estimated average and minimum service life time for the declared use (durability);
(g) variants, if any, and their descriptions;
(h) in cases where the product has been previously installed in a construction work, the date and place of the latest de-installation.
2. Permalinks or data carriers as regards the following, unless the information is available in the product passport pursuant to Article 76:
(a) the manufacturer’s product registrations in Union databases, if any;
(b) information to be provided in accordance with Regulation (EC) 1907/2006, where applicable;
(c) general information, instructions for use and safety information in accordance with Annex IV.
3. Manufacturer:
(a) name;
(b) registered trade name;
(c) registered place of business;
(d) postal address;
(e) telephone;
(f) email address;
(g) website.
4. Authorised representative, where applicable:
(a) name;
(b) registered trade name;
(c) registered place of business;
(d) postal address;
(e) telephone;
(f) email address;
(g) website.
5. Notified body or bodies, where applicable:
(a) name;
(b) identification number;
(c) registered trade name, where available;
(d) registered place of business;
(e) postal address;
(f) telephone;
(g) email address;
(h) website.
6. Technical Assessment Body, where applicable:
(a) name;
(b) identification number;
(c) registered trade name, where available;
(d) place of business;
(e) postal address;
(f) telephone;
(g) email address;
(h) website.
7. Reference to certificates or validation reports issued by notified bodies and TABs.
8. Technical reference documents:
(a) harmonised technical specifications laying down essential characteristics applied (reference number and date of issue); or
(b) European assessment document applied (reference number and date of issue) and European Technical Assessment issued (technical assessment body, reference number and date of issue).
9. Declared performances and sustainability characteristics:
(a) the complete list of essential characteristics, as determined in the harmonised technical specification or European assessment document for the respective product category for which a performance is declared and the applicable assessment and verification system applicable to them;
(b) the performance of the product, by calculated values, levels or classes, or in a description. Respective values, levels or classes shall be reproduced in the declaration of performance itself and thus cannot be expressed solely by inserting references to other documents. For essential characteristics where no performance is declared, the word “NULL” shall be inserted in the place for the declaration of the value. The performance of structural behaviour of a product may be expressed by referring to attached production documentation or structural design calculations;
(c) the environmental sustainability expressed, for the applicable essential characteristics of the applicable life cycle modules, in accordance with Article 15(2);
(d) reference to the version of the software used as provided by the Commission.
10. Applicable product requirements specified by harmonised technical specifications, the applicable assessment and verification system applicable to them and the reference to the harmonised standard or common specifications or parts thereof applied including the date.
Where applicable, information on the performance of the product measured in terms of its product requirements.
11. Declarations:
(a) the performance of the product identified above is in conformity with the set of declared performances referred to in point 9;
(b) the sustainability data of the product identified above have been correctly calculated on the basis of the product category rules applicable to it;
(c) the product identified above is in conformity with the requirements listed under point 10.
Signed for and on behalf of the manufacturer by:
[name, function4]
At [place]
on [date of issue]
[signature]
4The person signing must be authorised under national law to represent the manufacturer, either on the basis of a mandate, or by virtue of his or her role as a legal representative.