Guidelines and good practices for certification bodies (D4.5)

D4.5 Guidelines and good practices for certification bodies Ref. Ares(2025)8121926 - 26/09/2025 D4.5 Guidelines and good practices for certification bodies DELIVERABLE TYPE Report MONTH AND DATE OF DELIVERABLE Month 28, 30/09/2025 WORK PACKAGE WP 4 LEADER ENVI DISSEMINATION LEVEL Public AUTHORS Ilaria Schiavi PROGRAMMA HORIZON EUROPE GRANT AGREEMENT 101111933 START Jun.2023 DURATION 28 Months 3 Contributors NAME ORGANISATION Mattia Miglietta ENVI Peer Reviews NAME ORGANISATION María José Sánchez, María Panadero CNH2 Simon Habran TWEED Revision History The information and views set out in this report are those of the author(s) and do not necessarily reflect the official opinion of the European Union, neither the European Union Institutions and Bodies nor any person acting on their behalf. VERSION DATE REVIEWER MODIFICATIONS V1 09/09/2025 María José Sánchez María Panadero Comments on first version for consortium’s review V2 17/09/2025 Ilaria Schiavi Version for translation V3 26/09/2025 Ilaria Schiavi Final for upload 4 Index of Contents 1 Introduction ................................................................................................................................................. 8 2 General considerations for certification of hydrogen technologies ............................................... 9 2.1 Introduction ....................................................................................................................................... 9 2.2 CE Marking ......................................................................................................................................... 9 2.3 Application to hydrogen technologies .......................................................................................... 9 2.3.1 EU Directives and Regulations applicable to hydrogen technologies ............................................... 9 2.4 The Pressure Equipment Directive (PED) .................................................................................. 11 2.4.1 APPLICATION TO HYDROGEN TECHNOLOGIES ............................................................................ 11 2.4.2 CLASSIFICATION APPLICABLE TO HYDROGEN TECHNOLOGIES ............................................. 11 2.4.3 CONFORMITY ASSESSMENT PROCEDURE ...................................................................................... 13 2.4.4 APPLICABLE STANDARDS ..................................................................................................................... 14 2.5 The Machinery Directive (soon to be repealed by the Machinery Regulations) ................ 14 2.5.1 APPLICATION TO HYDROGEN TECHNOLOGIES ............................................................................ 14 2.5.2 CLASSIFICATION APPLICABLE TO HYDROGEN TECHNOLOGIES ............................................. 14 2.5.3 CONFORMITY ASSESSMENT PROCEDURE ...................................................................................... 14 2.5.4 APPLICABLE STANDARDS ..................................................................................................................... 15 2.6 The Electromagnetic Compatibility Directive (EMC) ............................................................... 15 2.6.1 APPLICATION TO HYDROGEN TECHNOLOGIES ............................................................................ 15 2.6.2 CLASSIFICATION APPLICABLE TO HYDROGEN TECHNOLOGIES ............................................. 15 2.6.3 CONFORMITY ASSESSMENT PROCEDURE ...................................................................................... 15 2.6.4 APPLICABLE STANDARDS ..................................................................................................................... 16 2.7 The Low Voltage Directive ........................................................................................................... 16 2.7.1 APPLICATION TO HYDROGEN TECHNOLOGIES ............................................................................ 16 2.7.2 CLASSIFICATION APPLICABLE TO HYDROGEN TECHNOLOGIES ............................................. 16 2.7.3 CONFORMITY ASSESSMENT PROCEDURE ...................................................................................... 16 2.7.4 APPLICABLE STANDARDS ..................................................................................................................... 16 2.8 Gas Appliances Regulations (GAR) .............................................................................................. 16 2.8.1 APPLICATION TO HYDROGEN TECHNOLOGIES ............................................................................ 17 2.8.2 CONFORMITY ASSESSMENT PROCEDURE ...................................................................................... 17 2.8.3 APPLICABLE STANDARDS ..................................................................................................................... 17 2.9 The Restriction of Hazardous Substances (RoHS) Directive .................................................. 17 2.9.1 APPLICATION TO HYDROGEN TECHNOLOGIES ............................................................................ 17 2.9.2 CONFORMITY ASSESSMENT PROCEDURE ...................................................................................... 17 2.9.3 APPLICABLE STANDARDS ..................................................................................................................... 18 2.10 ATEX 114 « equipment » Directive ............................................................................................. 18 5 2.10.1 APPLICATION TO HYDROGEN TECHNOLOGIES ....................................................................... 18 2.10.2 CLASSIFICATION APPLICABLE TO HYDROGEN TECHNOLOGIES ........................................ 19 2.10.2.1 CATEGORY 1 ................................................................................................................ 19 2.10.2.2 CATEGORY 2 ................................................................................................................ 19 2.10.2.3 CATEGORY 3 ................................................................................................................ 20 2.10.3 CONFORMITY ASSESSMENT PROCEDURE ................................................................................. 20 2.10.4 APPLICABLE STANDARDS ................................................................................................................ 21 2.11 ATEX 137 « workplace » Directive .............................................................................................. 21 2.12 Summary of applicable Directives/ Regulations by hydrogen technology /systems ........ 22 3 Specific standards applicable to hydrogen technologies, including standards for safety of installation and operation of systems ........................................................................................................... 23 4 Conclusions ................................................................................................................................................ 41 Index of Tables Table 1 EU Directives E Regulations for CE marking of Hydrogen technologies .................................. 9 Table 2 Sources of information on harmonised standards related to Directives and Regulations above ................................................................................................................................................................... 10 Table 3 Correlation between modules needed for the conformity assessment and hazard category of the Pressure Equipment .............................................................................................................................. 13 Table 4 Examples of Harmonised standards under Pressure Equipment Directive for hydrogen technologies above 0,5 bar ............................................................................................................................. 14 Table 5 Examples of Harmonised standards under Machinery Directive ............................................. 15 Table 6 Examples of Harmonised standards under the EMC Directive ................................................. 16 Table 7 Examples of Harmonised standards under the Low Voltage Directive .................................. 16 Table 8 Examples of Harmonised standards under the GAR .................................................................. 17 Table 9 Examples of Harmonised standards under the RoHS Directive .............................................. 18 Table 10 Examples of Harmonised standards under ATEX Directive for electrolysers, storage systems and fuel cells ....................................................................................................................................... 21 Table 11 Summary of applicability of Directives /Regulations to hydrogen technologies ................ 22 Table 12 List of standards and codes specifically developed/including specific reference to hydrogen. ............................................................................................................................................................ 24 Index of Figures Figure 1 PS-V diagram for categorization of Pressure Equipment ......................................................... 12 Figure 2 PSDN diagram for categorization of Pressure Equipment ..................................................... 13 6 Partners short names ENVI Parco Scientifico Tecnologico Per L’ambiente Environment Park Torino Spa IMI Institute For Methods Innovation IME Fundacion IMDEA Energia APRE Agenzia per la Promozione della Ricerca Europea CNH2 Centro Nacional Del Hidrogeno RIGP Regionalna Izba Gospodarcza Pomorza CLUSTER TWEED Cluster Tweed BH2C Balkanski Vodoroden Klaster Abbreviations BOP Balance of Plant CEI Comitato Elettrotecnico Italiano EEA European Economic Area FCEV Fuel Cell Electric Vehicles JTC Joint Technical Committee SAE Society of Automotive Engineers PED Pressure Equipment Directive P2G Power-to-Gas P2P Power-to-Power TC Technical Committee TPED Transportable Pressure Directive WI Working Item 7 Executive Summary This deliverable complements deliverable D2.3 “Certification requirements” in providing guidance in the certification requirements for hydrogen technologies. D2.3 concluded that the certification requirements for hydrogen technologies are mostly governed by European Directives (many of which are being reviewed and recast as Regulations), hence providing a level-playing field for the hydrogen technologies stakeholders producing, importing or adopting hydrogen technologies, whichever the Country of origin. The analysis provided in D2.3 has been reviewed in this deliverable to update the reference regulatory framework and the standardisation activity. Standards support stakeholders in obtaining certification of their product and also in implementing safety in the design, production, installation and operation of their devices. Much work is being undertaken by the standardisation bodies and other stakeholders’ bodies to adapt existing standards to hydrogen’s peculiarities, to develop adhoc standards and to provide guidance to the stakeholders. The guideline is therefore organised so to provide information on the Directives/ Regulations and standards (harmonised or else) applicable to different hydrogen technologies and installations.D2.3 remain an important point of reference particularly for the examples of certification /standards adoptions by different hydrogen technology developers/adopters, while these Guidelines introduce the applicable Directives/regulations and supporting standards (harmonised and not harmonised) for the hydrogen value chain. The document also includes references to standards useful for the safety and environmental permitting of hydrogen installations. 8 1 Introduction HYPOP project aims to raise public awareness and trust towards hydrogen technologies and their systemic benefits. The project aims to deliver a set of guidelines focusing on the permitting, safety and certification issues. These guidelines have been produced by collection of information through a desktop exercise and through direct engagement of stakeholders. This document complements Deliverable D2.3 “Certification requirements” updating and rationalising the information collected within and since its drafting, so to provide an agile reference guide for hydrogen technologies’ producers, importers, adopters etc. More specifically, starting from D2.3, the list of applicable Directives/Regulations has been reviewed and linked to the reference harmonised standards and supporting information. Further standards relevant to the different applications have been collected according to the latest developments by the different Technical Committees of the main standardisation bodies at European and international level. Further guidance and information have been sought from existing database of industrial standards. Deliverable D2.3 remains an important reference document for an overview of the certification process and for examples of approaches adopted by stakeholders developing innovative hydrogen technologies/ applications. 9 2 General considerations for certification of hydrogen technologies 2.1 Introduction In this section are described those aspects of certification valid for any hydrogen technology across the value chain, i.e. the CE marking and the Directives/ Regulations applicable. 2.2 CE Marking The commercialization of products within the European single market is governed by a set of regulations and Directives aimed at ensuring consumers that products meet minimum requirements in terms of safety, health, and environmental protection. Products, regardless of their place of production, must comply with EU requirements and can be marketed within the European Economic Area only if they bear the CE marking. The CE Marking signify that products have been assessed to meet high safety, health, and environmental protection requirements, i.e., they conform to the EU regulatory framework in those areas. All products must be subject to a conformity assessment procedure, as detailed in the Regulation (EC) No 765/2008 and in Council Decision No 768/2008/EC, with the range of Directives to be adhered to specific for the product. The process is discussed in detail in Deliverable 2.3, with this deliverable updating the regulatory framework of reference and the standards that might apply to hydrogen technologies. Please refer to Deliverable D2.3 for clarifications about the subsections titled CONFORMITY ASSESSMENT PROCEDURE in each of the following sections 2.4 to 2.10. 2.3 Application to hydrogen technologies Hydrogen technologies – the systems as they are delivered, not the industrial installations or the locations where they will be placed - must comply with various directives and regulations for being CE marked. Being subject to a conformity assessment and certification is a fundamental step by the manufacturers to ensure also safety for adopters, installers and users of hydrogen technologies. Indeed, through the process, the manufacturer ensures that hazards have been identified and risks pertaining to its product are managed. The involvement of a Notified Body might be required for those technologies representing a higher risk. 2.3.1 EU Directives and Regulations applicable to hydrogen technologies The following Table 1 lists the main EU Directives & Regulations that can be applicable to hydrogen technologies. Table 1 EU Directives E Regulations for CE marking of Hydrogen technologies Pressure Equipment Directive Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment Machinery Directive/ Regulations (from Jan 2027) Directive 2006/42/EC of the European Parliament and Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC Electromagnetic Compatibility Directive (EMC) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast) 16 2.6.4 APPLICABLE STANDARDS Table 6 Examples of Harmonised standards under the EMC Directive Harmonised standards for the EMC Directive EN IEC 61000 series Electromagnetic compatibility (EMC) 2.7 The Low Voltage Directive Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits applies to electrical equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current. 2.7.1 APPLICATION TO HYDROGEN TECHNOLOGIES The Directive is applicable to most of the hydrogen systems and technologies. In fuel cells, for example, voltage for alternating current is around 200 to 450 V according to the size of the technology. These products shall comply to the requirements described in the Directive to ensure public safety from physical injury, temperatures and radiation. 2.7.2 CLASSIFICATION APPLICABLE TO HYDROGEN TECHNOLOGIES N/A 2.7.3 CONFORMITY ASSESSMENT PROCEDURE Manufacturers do not need to involve a Notified Body in the conformity assessment. It is only required to comply with the information required in the Module A for the Internal production control. Specifically, technical documentation should contain (as an example): a general description of the electrical equipment; conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.; a list of the harmonised standards 6 applied in full or in part; results of design calculations made, examinations carried out, etc.; and test reports. 2.7.4 APPLICABLE STANDARDS Table 7 Examples of Harmonised standards under the Low Voltage Directive Harmonised standards for Low Voltage Directive EN 61349-1 Low-voltage switchgear and control gear assemblies Part 1: general rules 2.8 Gas Appliances Regulations (GAR) Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (GAR) covers appliances and fittings used for cooking, heating, refrigeration, air conditioning etc. that burn gaseous fuels. Gaseous fuel, according to Art. 2(6) is “any fuel which is in a gaseous state at a temperature of 15 °C under an absolute pressure of 1 bar”. 6 Harmonised standards for Low Voltage Directive: https://ec.europa.eu/docsroom/documents/59094 17 2.8.1 APPLICATION TO HYDROGEN TECHNOLOGIES The GAR applies to fuel cells used for space heating/ hot water generation and also to appliances burning hydrogen or mixtures of hydrogen and natural gas, as explicitly mentioned in the V4 of the GAR Guidance Sheet 7 . However, the regulations DO NOT cover appliances for use in industrial processes carried out on industrial premises, for use in aircrafts and railways and for temporary use in laboratories for research purposes. 2.8.2 CONFORMITY ASSESSMENT PROCEDURE The GAR always requires third party involvement in the conformity assessment of products. 2.8.3 APPLICABLE STANDARDS Table 8 Examples of Harmonised standards under the GAR Harmonised standards for GAR EN 88 Safety and control devices for gas burners and gas burning appliances - Part 1: Pressure regulators for inlet pressures up to and including 50 kPa EN 1854 Safety and control devices for burners and appliances burning gaseous and/or liquid fuels - Pressure sensing devices for gas burners and gas burning appliances EN 16898 Safety and control devices for gas burners and gas burning appliances - Gas filters having a maximum working pressure up to and including 600 kPa 2.9 The Restriction of Hazardous Substances (RoHS) Directive Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (EEE) applies to equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current. The directive targets the elimination of certain hazardous substances from electrical and electronic appliances, such as lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP). The Directive is under review, with inclusion of the proposal to re-attribute scientific and technical tasks under the RoHS Directive to the European Chemicals Agency, which is already in charge of many regulations including the REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) regulations. 2.9.1 APPLICATION TO HYDROGEN TECHNOLOGIES RoHS Directive applies to hydrogen technologies when they contain EEE. 2.9.2 CONFORMITY ASSESSMENT PROCEDURE The intervention of a notified body is not required. 7 https://ec.europa.eu/docsroom/documents/60254 accessed Aug 2025; the latest version of the guidance sheets must be accessed from https://single-market-economy.ec.europa.eu/sectors/pressure-equipmentand-gas-appliances/gas-appliances-sector/gas-appliances-regulation_en 18 2.9.3 APPLICABLE STANDARDS Table 9 Examples of Harmonised standards under the RoHS Directive Harmonised standards for RoHS Directive EN IEC 63000 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances 2.10 ATEX 114 « equipment » Directive Directive 2014/34/EU on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres, also called ATEX 114 "equipment" Directive, applies to hydrogen technologies ONLY if the system does generate an explosive atmosphere outside (but not accidentally, e.g. because of leaks) or it is used in an explosive atmosphere; internal components used in hydrogen technology systems however must be classified ATEX as they work in the (internal) explosive atmosphere. Potentially explosive atmospheres are those where gases, vapours, or flammable dusts can mix with air and therefore explode under certain conditions. The ATEX "equipment" Directive sets requirements for equipment and protection systems intended for use in potentially explosive atmospheres, including electrical equipment used on the surface, underground, and in fixed offshore installations. Additionally, the ATEX Directive is extended to all safety, control, and regulation devices not used within an explosive atmosphere but necessary for the operation of the systems. To achieve compliancy under this Directive, there are several Harmonised standards that can be applied, and they are listed at the link provided below. Harmonised standards ATEX Equipment Directive (ATEX 114) https://single-market-economy.ec.europa.eu/singlemarket/goods/european-standards/harmonisedstandards/equipment-explosive-atmospheres-atex_en The link also contains Guidance on CE Marking and Guidelines on application of the Directive 2.10.1 APPLICATION TO HYDROGEN TECHNOLOGIES Hydrogen, being a flammable gas, requires careful risk management, and compliance with the ATEX Directive is essential to ensure safety in environments where this fuel is used. The ATEX directive applies, but it is not limited to, electrolysers, fuel cells, and storage systems. Thus, it is a fundamental reference for the certification of hydrogen technologies to be employed in industrial fields and, where necessary, also for mobility sector. Exceptions must be considered as in some cases products are excluded from the scope of this directive, for example, if intended for: • Use in a domestic and non-commercial environment, where a potentially explosive atmosphere can rarely be caused and only by an accidental gas leak; • Maritime ships and mobile offshore units, as well as the equipment used on board such ships or units; • Means of transport, such as vehicles and their trailers, intended solely for the transportation of people by air, on road networks, railways, or via waterways, and means of transporting goods by air, on road networks or railways, or via waterways; however, vehicles intended to 19 be used in potentially explosive atmospheres are not excluded from the scope of the ATEX regulations. In the case of the ATEX Directive, it is not the type of hydrogen device but where it is used that determines the classification. 2.10.2 CLASSIFICATION APPLICABLE TO HYDROGEN TECHNOLOGIES Hydrogen technologies fall within the classification "Group II devices" as devices intended to be used in “other sites” liable to be endangered by explosive atmospheres. In this ATEX classification, within Group II, categories 1, 2, and 3 are distinguished. These categories are associated with the level of safety a product can guarantee and the related risk on the environment. Group II devices are further distinguished based on the type of substances present in the explosive atmosphere. If there is not a risk of a potentially explosive atmosphere outside, the ATEX Directive applies in any case to components that should be used inside the technology. The category depends on the required safety level and the environment in which hydrogen technology operates. To define such categories, zoning is necessary and the technical standard EN 60079 -10-1 is used for this scope. For example, in Italy the classification of dangerous zones is reported in the CEI EN 60079-10-1 Standard. According to this technical standard, dangerous areas can be classified based on the frequency and duration of occurrence of explosive atmospheres into the defined zones: • Zone 0: An area where an explosive atmosphere consisting of a mixture of air and flammable substances in the form of gas, vapor, or mist is present continuously/ for long periods/ frequently; • Zone 1: An area where, during normal activities, the formation of an explosive atmosphere consisting of a mixture of air and flammable substances in the form of gas, vapours, or mist is likely; • Zone 2: An area where, during normal activities, the formation of an explosive atmosphere consisting of a mixture of air and flammable substances in the form of gas, vapor, or mist is not likely and, if it does occur, it is only of short duration. 2.10.2.1 CATEGORY 1 If a hydrogen technology device is intended for environments where an explosive atmosphere due to mixtures of air and gas, vapours, mists, or air and dust mixtures is always, often, or for long periods present, then the classification requires the highest safety requirements (category 1). Devices in this category must meet additional requirements. In particular, in the case of gas, vapour, or mist atmospheres, the following information may be of interest to authorities involved in safety aspects. The device: • must be equipped with independent protection features; • the temperature of surfaces that can heat up must be kept below the maximum prescribed; • must be designed so that the parts that can constitute a source of ignition can only be opened in the absence of energy or in conditions of intrinsic safety. If it is not possible to deactivate the devices, the manufacturer must affix a warning label on the accessible parts of the devices. If necessary, the devices must be equipped with suitable additional opening mechanisms. 2.10.2.2 CATEGORY 2 Devices classified as category 2 are intended for environments where explosive atmospheres due to gas, vapours, mists, or mixtures of air and dust are likely to occur. Devices in this category must 20 also meet additional requirements. For example, requirements concern the temperature of heating surfaces and access to parts of the plant that can constitute an ignition source. 2.10.2.3 CATEGORY 3 Devices classified as category 3 are intended for environments where there is a low probability of explosive atmospheres due to gas, vapours, mists, or mixtures of air and dust occurring, and if it does occur, it is only for a short duration. Devices in this category must meet additional requirements. In particular, surface temperatures must not exceed the maximum temperatures indicated by the manufacturer. Exceeding is tolerable, in exceptional cases, if the manufacturer adopts additional special protection measures. 2.10.3 CONFORMITY ASSESSMENT PROCEDURE The conformity assessment procedures for Group II devices and the different categories 1,2,3 vary according to the component of risk. Regarding the modules to be submitted, ATEX directive requires the Module C1: conformity to the type based on Internal production control plus supervised product testing. In this case, together with the technical documentation, the manufacturer should test for each individual product under all those aspects considered relevant. The Notified Body is present to supervise and control such tests. Furthermore, for Group II and category 1 devices, the conformity assessment procedure requires the involvement of a notified body and consists of the EU type examination procedure (Module B) plus one of the following procedures: • conformity to type procedure based on the quality assurance of the production process (Module D); or • conformity to type procedure based on product verification (Module F). For hydrogen technologies configured as category 2 devices, the conformity assessment procedure is structured as follows: • for internal combustion engines and electrical devices belonging to Group II and category 2, the EU type examination procedure (Module B) must be followed, combined with one of the following procedures: o conformity to type based on internal production control combined with product testing under official control (Module C1), or o conformity to type based on product quality assurance (Module E); • for other devices belonging to Group II and category 2, the internal production control (Module A) and submission to a notified body of the technical documentation must be done. For Group II devices, category 3, the conformity assessment procedure consists of the internal production control (Module A). For Group II devices, in addition to the previously described procedures, it is possible to follow the conformity assessment procedure based on unit verification (Module G). 21 2.10.4 APPLICABLE STANDARDS The table below shows some of the standards that apply to hydrogen technologies. Table 10 Examples of Harmonised standards under ATEX Directive for electrolysers, storage systems and fuel cells Harmonised standards for ATEX Directive EN 1127-1 Explosive atmospheres – Explosion prevention and protection - Part 1: Basic concepts and methodology EN 60079-0 to -32 Explosive atmospheres - Explosive atmospheres, in particular Part 0 : equipment - General requirements; Part 29-1: Gas detectors - Performance requirements of detectors for flammable gases; Part 30: Electrical resistance trace heating - General and testing requirements EN ISO/IEC 80079-34 and -36 Explosive atmospheres - Part 34: Application of quality systems for equipment manufacture; Part 36 : non-electrical equipment for use in explosive atmospheres - Basic methods and requirements 2.11 ATEX 137 « workplace » Directive Directive 1999/92/EC of the European Parliament and of the Council of 16 December 1999 on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres is relevant for the operation of hydrogen technologies, and, specifically, for the protection of the operators themselves. A useful standardisation document has been produced by the European Industrial Gases Association (EIGA): Doc 250, Standard Procedures for Hydrogen Supply Systems 8 . This is part of an effort of harmonisation of the industry standards and it is intended to be used worldwide by the members of the European, Asia, Japan and American Gas Associations. 8 https://www.eiga.eu/uploads/documents/DOC250.pdf 22 2.12 Summary of applicable Directives/ Regulations by hydrogen technology /systems The table below maps the applicability of the Directives and Regulations vs hydrogen technologies /systems, summarising the information provided in the sections above. Table 11 Summary of applicability of Directives /Regulations to hydrogen technologies Pressure Equipment Directive and harmonised standards9 Machinery Directive/ Regulations (from Jan 2027) and harmonised standards10 Electromagnetic Compatibility Directive (EMC) and harmonised standards11 Low Voltage Directive and harmonised standards12 Gas Appliances regulations and harmonised standards13 RoHS Directive and harmonised standards14 ATEX equipment Directive and harmonised standards15 General components ✔ (if pressurised) ✔ ✔ ✔ ✔ ✔ Hydrogen storage ✔ ✔ ✔ ✔ ✔ Electrolysers ✔ ✔ ✔ ✔ ✔ Fuel Cells ✔ ✔ ✔ ✔ ✔ Compressors ✔ ✔ ✔ ✔ ✔ Residential and industrial appliances burning gaseous fuels ✔ ✔ ✔ ✔ ✔ Please refer to Section 3 for additional, non-harmonised standards that might support the certification of hydrogen components/ devices/ systems. 9 https://single-market-economy.ec.europa.eu/single-market/goods/europeanstandards/harmonised-standards/pressure-equipment_en 10 https://single-market-economy.ec.europa.eu/single-market/goods/europeanstandards/harmonised-standards/machinery-md_en 11 https://single-market-economy.ec.europa.eu/single-market/goods/europeanstandards/harmonised-standards/electromagnetic-compatibility-emc_en 12 https://single-market-economy.ec.europa.eu/single-market/goods/europeanstandards/harmonised-standards/low-voltage-lvd_en 13 https://single-market-economy.ec.europa.eu/single-market/goods/europeanstandards/harmonised-standards/gas-appliances_en 14 https://single-market-economy.ec.europa.eu/single-market/goods/europeanstandards/harmonised-standards/restriction-use-certain-hazardous-substances-rohs_en 15 https://single-market-economy.ec.europa.eu/single-market/goods/europeanstandards/harmonised-standards/equipment-explosive-atmospheres-atex_en 23 3 Specific standards applicable to hydrogen technologies, including standards for safety of installation and operation of systems In this section are collected the references to all standards and codes that specifically refer to hydrogen and its technologies, including technical documents dealing with installation and operation of the hydrogen technologies. Where specifically indicated by the issuer, the standards to be used for certification purposes have been identified with “CERT”. This table has been compiled mostly on the basis of the Hysafe project documentation 16 , the experience presented in D2.3, the European Hydrogen Observatory 17 , and recent standardisation activity being conducted by the standardisation bodies, starting from the CEN-CENELEC 18 . Only SPECIFIC, non-harmonised standards are included, and examples of those for which development is known (or reference working groups within standard organisations); for harmonised standards, reference must be made to the lists linked from Table 2. Further references are provided to available industrial codes and guidance being applied, taking as main reference, but not limiting to, European-based associations. These Codes of practice and guidance documents are based on experience by members of the associations but do not undertake the same validation process as standards from standardisation bodies, hence their application is voluntary with no liability by the issuers of the documents themselves. Furthermore, the information provided is updated at August 2025 but must be checked by the users for validity and latest updates. The European Industrial Gases Association, together with the sister associations from Asia (AIGA), US and Canada (CGA) and Japan (JIMGA) have developed the H2safety web platform 19 , which constitutes an important reference point for hydrogen standards and codes with a specific attention to safety. These have been incorporated in the table below and highlighted with an asterisk. 16 https://hysafe.info/uploads/papers/2021/171.pdf 17 https://observatory.clean-hydrogen.europa.eu/hydrogen-landscape/policies-and-standards/codes-andstandards 18 https://www.cencenelec.eu/areas-of-work/cen-sectors/energy-and-utilities-cen/hydrogen/ and the Hydrogen Standardisation Landscape version June 2025 https://www.cencenelec.eu/media/CENCENELEC/AreasOfWork/CEN%20sectors/Energy%20and%20Utilities/annex-1_hydrogen-standardizationlandscape_2025-06-25.pdf 19 https://www.h2safety.info/ 24 Table 12 List of standards and codes specifically developed/including specific reference to hydrogen. Key: • “*” mostly related to safety; sourced from the H2safety.info website and the Publication area of the EIGA https://www.eiga.eu/publications • (CER) can be used for certification purposes; • (UNDER DEVELOPMENT) or (UNDER REVISION) refer to standards not yet finalised or under review; f • for all other standards, the latest version MUST be used Hydrogen and hydrogen technology/device/system Relevant specific standards and codes Hydrogen and hydrogen technologies/systems: generalities including safety aspects also during operation EN ISO 24078 Hydrogen in energy systems – Vocabulary ISO/TS 15916 Hydrogen technologies — Basic considerations for the safety of hydrogen systems (UNDER DEVELOPMENT) EN 1839 Determination of the explosion limits and the limiting oxygen concentration(LOC) for flammable gases and vapours EN 15198 Methodology for the risk assessment of non-electrical equipment and components for intended use in potentially explosive atmospheres (UNDER DEVELOPMENT) EN 15967 Determination of maximum explosion pressure and the maximum rate of pressure rise of gases and vapours EN 17624 Determination of explosion limits of gases and vapours at elevated pressures, elevated temperatures or with oxidizers other than air EN ISO/IEC 80079-20 and -49 Explosive atmospheres – Part Part 20-1: Material characteristics for gas and vapour classification and Part 49: Flame arresters EN 1776 Gas infrastructure - Gas measuring systems – Functional requirements 25 Hydrogen and hydrogen technology/device/system Relevant specific standards and codes ISO 13734 Natural gas -- Organic components used as odorants -- Requirements and test methods OIML R 81 Dynamic measuring devices and systems for cryogenic liquids EIGA DOC 255 / 24 - EIGA Cryogenic Gases Couplings for Tanker Filling* EIGA DOC 252 / 24 - Safety Critical Devices* EIGA DOC 250 / 24 - Standard Procedures for Hydrogen Supply Systems* EIGA DOC 243 / 22 - Guideline on Remedial Actions for HYCO Plant Components Subject to High Temperature Hydrogen Attack* EIGA DOC 238 / 22 - Prevention of Plant Instrument and Utility Gas System Cross Contamination* EIGA DOC 233 / 20 - Emergency Response Planning* EIGA DOC 215 / 18 - HYCO Plant Gas Leak Detection and Response Practices* EIGA DOC 190 / 21 - Plant Integrity Management* EIGA DOC 10201 / 20 - Listing of Safety Audit Assessment Tools and referred documents thereof* EIGA DOC 15 / 21 - Gaseous Hydrogen Installations* EIGA DOC 6 / 19 - Safety in Storage, Handling and Distribution of Liquid Hydrogen* NFPA 2, Hydrogen Technologies Code* NFPA 55, Compressed Gases and Cryogenic Fluids Code* See also specific technologies/ systems 32 Hydrogen and hydrogen technology/device/system Relevant specific standards and codes EN 331 Manually operated ball valves and closed bottom taper plug valves for gas installations for buildings EN 334+A1 Gas pressure regulators for inlet pressure up to 10 MPa (100 bar) EN 14382+A1 Gas safety shut-off devices for inlet pressure up to 10 MPa (100 bar) EN ISO 15848 (series) Industrial valves - Measurement, test and qualification procedures for fugitive emissions ISO 21011 Cryogenic vessels — Valves for cryogenic service Detection systems ISO 26142 Hydrogen detection apparatus — Stationary applications (CERT) Industrial applications EN 746 series Industrial thermoprocessing equipment EN ISO 135772 and -4 Industrial furnaces and associated processing equipment — Safety EN ISO 21789 Gas turbine – Safety EN 12309 series Gas-fired sorption appliances for heating and/or cooling with a net heat input not exceeding 70 kW ISO 2314 Gas turbines — Acceptance tests ISO 3977 (series) Gas turbines – Procurement ISO 11042 (series) Gas turbines — Exhaust gas emissions ISO 11086 Gas turbines — Vocabulary 33 Hydrogen and hydrogen technology/device/system Relevant specific standards and codes ISO 18888 2017 Gas turbine combined cycle power plants — Thermal performance tests (UNDER REVISION) ISO 19372 2015 Microturbines applications — Safety Industrial application ISO 19859 2016 Gas turbines — Power generation applications ISO 19860 2005 Gas turbines — Data acquisition and trend monitoring system requirements for gas turbine installations ISO 3046 (series) Reciprocating internal combustion engines — Performance ISO 15550 2016 Internal combustion engines — Determination and method for the measurement of engine power — General requirements Electrolysers and other systems connected with production, other production methods ISO 22734 Hydrogen generators using water electrolysis process - Industrial, commercial, and residential applications ISO/TS 22734-2 Hydrogen generators using water electrolysis — Part 2: Testing guidance for performing electricity grid service (UNDER DEVELOPMENT) ISO 16110 series Hydrogen generators using fuel processing technologies ISO/TS 19883 Safety of pressure swing adsorption systems for hydrogen separation and purification EIGA DOC 246/23 Guideline for small scale hydrogen production* EIGA DOC 242 / 22 - Safety of Hydrogen, HyCO production and Carbon Capture* EIGA DOC 210 / 23 - Hydrogen Pressure Swing Adsorber (PSA) Mechanical Integrity Requirements* EIGA DOC 185 / 20 - Safe Start Up and Shutdown Practices for Steam Reformers* 34 Hydrogen and hydrogen technology/device/system Relevant specific standards and codes EIGA DOC 172 / 24 - Combustion Safety for Steam Reformer Operation* EIGA DOC 155 / 21 - Best Available Techniques for Hydrogen Production by Steam Methane Reforming* Compressors, pumps EIGA DOC 244 / 23 - Reciprocating Cryogenic Pumps and Pump Installations for Hydrogen and Liquified Natural Gas* EIGA DOC 102 Safety Audit /Assessment Tool – Hydrogen Compression, Purification and Cylinder Filling High pressure storage EN 17533 Gaseous hydrogen - Cylinders and tubes for stationary storage Storage as metal hydrides ISO 16111 Transportable gas storage devices – Hydrogen absorbed in reversible metal hydride (only applicable to transportable storage systems) Other storage21 ISO 19888 Hydrogen Technologies — Aerial Vehicles — Part 1: Liquid Hydrogen Fuel Storage System EN 13371 Cryogenic vessels - Couplings for cryogenic service EIGA DOC 171 / 23 - Storage of Hydrogen in Systems Located Underground* EIGA DOC 006 Safety in Storage, Handling and Distribution of Liquid Hydrogen* See also Hydrogenfuelled vehicles incl. ships and railway vehicles Fuel cells EN IEC 62282 series: Fuel cell technologies See also Hydrogenfuelled vehicles incl. ships and railway vehicles 21 Standards related to storage in aquifers, oil& gas depleted field, salt mines etc has not been considered here 35 Hydrogen and hydrogen technology/device/system Relevant specific standards and codes Hydrogen refuelling stations EN 17127: Outdoor hydrogen refuelling points dispensing gaseous hydrogen and incorporating filling protocols EN ISO 17268 : Gaseous hydrogen land vehicle refuelling connection devices (UNDER DEVELOPMENT) ISO 19880-1 to 8 series : Gaseous hydrogen - Fuelling stations (only part 1, 3, 5 and 8 have been published, the other are still work in progress at ISO TC 197) ISO 19885 series Gaseous hydrogen — Fuelling protocols for hydrogen-fuelled vehicles ISO 13984 Liquid hydrogen -- Land vehicle fuelling system interface N ___ (00268090) Outdoor hydrogen refuelling points dispensing liquified hydrogen and incorporating filling protocols (UNDER DEVELOPMENT) EN ___ (00268091) Specifications for gaseous hydrogen refuelling points for maritime and inland waterways vessels (UNDER DEVELOPMENT) The following SAE standards are cited as reference in ISO 198801 and EN 17127 for interoperability and management of the fuelling protocols SAE J2600-2015 Compressed Hydrogen Surface Vehicle Fuelling Connection Devices SAE J2601 Series : SAE J2601-2020 Fuelling Protocols for Light Duty Gaseous Hydrogen Surface Vehicles SAE J2601-2-2014 Fuelling Protocol for Gaseous Hydrogen Powered Heavy Duty Vehicles 36 Hydrogen and hydrogen technology/device/system Relevant specific standards and codes SAE J2601-3-2013 Fuelling Protocol for Gaseous Hydrogen Powered Industrial Trucks SAE J2799-2019 Hydrogen Surface Vehicle to Station Communications Hardware and Software See also Hydrogen vehicles Hydrogenfuelled vehicles incl. ships and railway vehicles ISO 12619 series Road Vehicles -- Compressed gaseous hydrogen (CGH2) and hydrogen/natural gas blends fuel system components ISO 15500 series Road Vehicles -- Compressed natural gas (CNG) fuel system components ISO/TR 11954 Fuel cell road vehicles -- Performance measurement -- Vehicles fuelled with compressed hydrogen ISO 23273 Fuel cell Road Vehicles -- Safety specifications -- Protection against hydrogen hazards for vehicles fuelled with compressed hydrogen OIML R139-1 Compressed gaseous fuel measuring systems for vehicles ISO 19881 Gaseous hydrogen — Land vehicle fuel containers ISO 19882 Gaseous hydrogen Thermally activated pressure relief devices for compressed hydrogen vehicle fuel containers ISO 13985 Liquid hydrogen — Land vehicle fuel tanks ISO 19887-1 Gaseous Hydrogen -- Fuel system components for hydrogen-fuelled vehicles -- Part 1: Land vehicles 37 Hydrogen and hydrogen technology/device/system Relevant specific standards and codes ISO 23828 Fuel cell road vehicles -- Energy consumption measurement -- Vehicles fuelled with compressed hydrogen ISO/TR 8713 Electrically propelled road vehicles -- Vocabulary ISO 21498-2 Electrically propelled road vehicles -- Electrical specifications and tests for voltage class B systems and components -- Part 2: Electrical tests for components ISO 21782 series Electrically propelled Road Vehicles -- Test specification for electric propulsion components ISO 6469 series Electrically propelled road vehicles -- Safety specifications ISO 8714 Electric road vehicles -- Reference energy consumption and range -- Test procedures for passenger cars and light commercial vehicles ISO 8715 Electric Road Vehicles -- Road operating characteristics ISO/TS 5474-5 Electrically propelled road vehicles -- Functional and safety requirements for power transfer between vehicle and external electric circuit -- Part 5: Automatic conductive power transfer ISO 18243 Electrically propelled mopeds and motorcycles -- Test specifications and safety requirements for lithium-ion battery systems ISO 23274 series Hybrid-electric road vehicles -- Exhaust emissions and fuel consumption measurements EN 45545-7 Railway applications - Fire protection on railway vehicles – Part 7: Fire safety requirements for flammable liquid and flammable gas installations IEC 63341-3 Railway applications - Fuel cell systems for rolling stock – Part 3: Performance test methods for fuel cell power systems 38 Hydrogen and hydrogen technology/device/system Relevant specific standards and codes EN IEC 63341-1 Railway applications - Rolling stock - Fuel cell systems for propulsion - Part 1: Fuel cell system EN IEC 63341-2 Railway applications - Hydrogen and fuel cell systems for rolling stock - Part 2: Hydrogen fuel system EN ISO 20519 2022 Ships and marine technology — Specification for bunkering of liquefied natural gas fuelled vessels EN ISO 21593 Ship and marine technology - Technical requirements for drydisconnect/connect couplings for bunkering liquefied natural gas ISO 24132 Ships and marine technology — Design and testing of marine transfer arms for liquefied hydrogen (UNDER REVISION) ISO 11326 Ships and marine technology — Test procedures for liquid hydrogen storage tank of hydrogen ships Hydrogen technologies in the built environment (residential and stationary applications) – generic, safety CEN/TR (WI JT006002) Safe use of hydrogen in built constructions (UNDER DEVELOPMENT) CEN/TS (WI J006004) Hydrogen Gas Safety in Enclosed Spaces (UNDER DEVELOPMENT) CEN/TR 17924 Safety and control devices for burners and appliances burning gaseous and/or liquid fuels - Guidance on hydrogen specific aspects EN 125+A1 Flame supervision devices for gas burning appliances - Thermoelectric flame supervision devices EN 126 Safety and control devices for burners and appliances burning gaseous fuels - Multifunctional controls 39 Hydrogen and hydrogen technology/device/system Relevant specific standards and codes EN 50194 (series) Electrical apparatus for the detection of combustible gases in domestic premises (to revise for H2) EN 437 Test gases - Test pressures - Appliance categories EN 15069 Safety gas connection valves for metal hose assemblies used for the connection of domestic appliances using gaseous fuel IEC 62932 Flow battery energy systems for stationary applications -- Part 1: Terminology and general aspects See also Generic components, also including safety aspects at installation: Heat pumps EN 16905 - 2 Gas-fired endothermic engine driven heat pumps - Part 2: Safety (UNDER REVISION) Gas appliances incl. domestic cooking appliances, decorative appliances, space heaters EN 50465+A1 Gas appliances - Combined heat and power appliance of nominal heat input inferior or equal to 70 kW EN 509 Decorative fuel-effect gas appliances EN 30-1-2 Domestic cooking appliances burning gas - Part 1-2: Safety - Appliances having forced-convection ovens EN 13278 Open fronted gas-fired independent space heaters EN 14829 Independent gas-fired flueless space heaters for nominal heat input not exceeding 6 kW EN 14438 Gas-fired insets for heating more than one room EN 1266 Independent gas-fired convection heaters incorporating a fan to assist transportation of combustion air and/or flue gases 40 Hydrogen and hydrogen technology/device/system Relevant specific standards and codes See also Industrial burners above Water heaters (instantaneous and storage) EN 26 Gas-fired instantaneous water heaters for the production of domestic hot water EN 89 Gas-fired storage water heaters for the production of domestic hot water See also Industrial burners above Heating boilers EN 303 1-6 Heating boilers EN 15502 series – Gas-fired heating boilers (UNDER DEVELOPMENT) and specifically: CEN/TS 15502-3-3 Gas-fired central heating boilers — Part 3-3: Hydrogen —Expansion of EN 15502—1 Safety and -2 Specific standards for type B1 appliances See also Industrial burners above Key: • “*” mostly related to safety; sourced from the H2safety.info website and the Publication area of the EIGA https://www.eiga.eu/publications • (CER) can be used for certification purposes; • (UNDER DEVELOPMENT) or (UNDER REVISION) refer to standards not yet finalised or under review; f • or all other standards, the latest version MUST be used 41 4 Conclusions Project HYPOP interacted with stakeholders, more specifically manufacturers and developers of innovative technologies, to understand how they achieved or worked to achieve CE marking. The most relevant Directives and Regulations for hydrogen technologies have been identified, on the basis of the experience shared and a desktop review of the main reference tools on standards relevant to hydrogen. Such Directives and Regulations are widely applied in Europe as they support the single market: CE marking is indeed a prerequisite for the commercialisation of any product within Europe. The common regulatory framework and the experience of manufacturers and certifying bodies with pre-existing Directives and Regulations means that a strong reference base exists for the certification of hydrogen systems, including for innovative systems. The body of harmonised standards is also complemented by specific standards and industry guidance being developed (or existing standards to be revised) to take into account the specificities of hydrogen. Significant ongoing effort among various standardisation bodies to address sector-specific needs while ensuring that hydrogen technologies can be safely integrated into existing and new markets. The collaboration between these technical committees and stakeholders is crucial for the innovative and safe expansion of hydrogen technology applications across residential, mobility, and industrial sectors. This cooperative approach not only addresses the current regulatory and safety challenges but also prepares the hydrogen economy for future growth and integration into diverse markets.