Part I. Hydrogen Regulations: European and International Regulatory Framework

Hydrogen is emerging as one of the pillars of the energy transition, but its adoption requires navigating a regulatory labyrinth that is still evolving. Beyond the major regulatory frameworks for production, storage or mobility, manufacturers and operators face a very specific challenge: to correctly understand and apply hydrogen regulations governing the components used throughout the entire value chain.

Valves, pipes, sensors, fittings, compressors or tanks must not only meet performance and safety criteria but also conform to a complex regulatory framework that is still in the process of international harmonization.

This article—structured in two parts—aims to offer a clear and systematized view of the applicable regulatory framework. In this first part, we focus on:

• The regulatory bases governing hydrogen systems.
• The main standards applicable in Europe and internationally.
• A classification of the regulations according to the field of application of hydrogen within its value chain.

The second part will focus on the application of hydrogen regulations to the different types of components, with special emphasis on hydrogen valves, which present specific technical and regulatory challenges.

1. Fundamentals of the Hydrogen Regulatory Framework 

When we talk about “hydrogen applicable regulations,” it is advisable to clearly distinguish between three levels:

1.1 Legal or Regulatory Framework

These are laws, directives or regulations approved by government entities (such as the European Commission or the US Government). They have a mandatory nature and establish the essential requirements that must be met to commercialize products, ensure safety, environmental protection, performance, etc.

1.2 Technical Standards

Technical standards are developed by standardization bodies such as CEN, ISO, ASME, SAE, among others, and specify the technical requirements and methods to demonstrate compliance with safety, quality or performance objectives. In general, they are voluntary, although many are “harmonized” with European legislation. This means that compliance grants presumption of conformity with the essential requirements of applicable legislation (for example, a directive or regulation), thereby facilitating CE marking and marketing in the European market.

1.3 Certifications and Conformity Assessments

To commercialize many technical components, a formal process of certification or conformity assessment is often required. This process may involve the participation of notified bodies or independent third parties that verify that the product meets the established legal and technical requirements. Certification provides an additional guarantee of safety, quality, and regulatory compliance, facilitating acceptance in national and international markets.

Example: For a pressurized hydrogen storage tank, certification in accordance with the Pressure Equipment Directive (PED 2014/68/EU) is common, where a notified body evaluates the tank’s design, materials, and tests before it can be marketed in Europe.

2. European Regulations applicable to Hydrogen Systems

In the European context, there is currently no single regulation specifically dedicated to hydrogen components (for example, an exclusive directive for hydrogen valves, sensors, or pipes). However, the regulations applicable to hydrogen components derive from a set of horizontal directives and general technical standards that cover fundamental aspects such as safety, materials, pressure, explosiveness, etc.

Below is a summary of the main European directives, regulations and technical standards relevant to components used in hydrogen systems:

2.1 Pressure Equipment Directive (PED) – 2014/68/EU

Applies to all equipment operating at a pressure above 0.5 bar, including valves, vessels, pipes, safety and pressure accessories. It is probably the most relevant for components such as:

• Shut-off, check, relief or control valves.
• Fittings, connectors, and pipes.
• Components integrated into storage tanks or refueling stations.

Compliance is mandatory and, depending on the equipment category, may require conformity assessment by a notified body.

2.2 ATEX Directive – 2014/34/EU

Applies to components intended for use in potentially explosive atmospheres, such as those that may occur in hydrogen systems in the event of a leak.

Mainly affects:

• Electrical/electronic equipment (sensors, actuators, PLCs, etc.)
• Mechanical components (valves, pumps) that may be a source of ignition.

To be marketed, these devices must carry the ATEX marking, which entails ignition risk analysis and specific certification.

2.3 Electromagnetic Compatibility Directive (EMC) – 2014/30/EU

Applies to electronic or electrical components that may emit or be affected by electromagnetic interference.

Applicable to: sensors, controllers, electric actuators, etc.

It must be ensured that the equipment neither interferes with other equipment nor is affected by it in its operational environment.

2.4 Regulation (EU) 2019/2144

This regulation strengthens the legal framework for transportable pressure equipment in the EU (TPED), aligning technical requirements with updated international standards such as ISO 11120 for hydrogen cylinders. Key requirements include:

• New TPED marking
• Harmonized digital documentation
• Improved component traceability

2.5 Specific Hydrogen Regulatory Framework (H₂ Package – 2023)

This includes a set of new regulations that move toward more specific hydrogen regulation, although not yet focused on individual components.

• Regulation (EU) 2023/1804
  Regulates renewable hydrogen infrastructure, including transport networks, underground storage, and import terminals. It requires:
  • Certified materials (e.g., “hydrogen‑ready” pipes per EN 13480‑3).
  • Compliance with technical standards such as ISO 19880‑3 (refueling components) and ISO 16111 (transportable storage).
  • Third‑party access to infrastructure.
• Directive (EU) 2023/1791
  Amends the Natural Gas Directive to allow H₂ blends (up to 20 % by volume) in existing networks.
• Regulation (EU) 2023/1805
  Establishes transparency, access, and oversight rules for wholesale hydrogen markets.
• Regulation (EU) 2021/1119 (Climate Law)
  Defines the decarbonization framework through 2050, including binding hydrogen targets for 2030.

2.6 Certification and CE Marking

Any component destined for the European market and subject to the PED or ATEX Directives must:

• Pass conformity assessment procedures.
• Be tested by an accredited notified body.
• Bear the CE mark, along with the notified body number, manufacturer’s technical information, and Declaration of Conformity.

In many cases, compliance with harmonized standards (e.g., EN ISO series) provides a presumption of conformity with the Directives, easing the certification process. However, not all harmonized standards are fully updated for hydrogen, so it may be necessary to supplement them with bespoke technical documentation. Additionally, traceability and ongoing monitoring are essential to maintaining conformity over the component’s lifecycle.

2.7 Harmonized Technical Standards (EN/EN ISO)

The European Union recognizes a set of harmonized technical standards that facilitate the application of Directives and Regulations in the hydrogen sector. These standards cover key aspects such as design, installation, safety, gas purity, and material compatibility. Compliance confers a presumption of conformity with applicable legislation.

However, some standards are still under revision or do not yet address all hydrogen-specific issues, which may require complementary technical evaluations or additional documentation.

Key standards:

• EN ISO 19880‑1:2020 – Hydrogen refueling infrastructure (PED-harmonized): general requirements for design, installation, and testing.
• EN ISO 16111 – Transportable compressed hydrogen containers (PED-harmonized): covers materials, shut-off valves, pressure relief devices, and structural design.
• EN ISO 21011 – Compressed gas equipment – Valves: defines design, materials, leakage testing, working pressure, and functional reliability for hydrogen cylinder valves.
• EN 12516 (Parts 1–4) – Industrial valves: specification of mechanical strength calculation methods.
• EN 13480 – Industrial metallic piping: requirements for hydrogen piping systems in stationary installations.
• EN ISO 15848 – Industrial valves – Fugitive emissions (environmental safety): sets test criteria for hermeticity against external emissions.
• EN ISO 14687 – Hydrogen purity specifications: purity levels for fuel cell mobility applications.
• EN 17124:2018 – Hydrogen for fuel cells: impurity limits (CO, H₂S, NH₃, etc.) and sampling/analysis protocols in the EU.
• EN ISO 10297 – Gas cylinder valves: design, mechanical strength, leakage testing, and safe operation under pressure.
• EN ISO 14469 – Refueling connectors for light-duty vehicles.
• EN ISO 17268 – Refueling connectors for heavy-duty vehicles.
• DIN 3166 – Liquid hydrogen valves (widely used technical reference in Europe).

3. International Regulations of Hydrogen Systems

Once the European regulatory framework has been reviewed, it is essential to understand the international standards governing the same components outside the EU. The global expansion of hydrogen as an energy carrier has made its regulation a worldwide priority, driving the creation of an increasingly harmonized body of standards. Many of these standards are developed by organizations such as ISO, IEC, ASME, or API. Understanding and properly applying these standards is essential to ensure technical interoperability, regulatory compliance, and product competitiveness in international markets.

3.1 ISO Standards

• ISO 19880‑3:2023 – A key standard for hydrogen infrastructure. It establishes critical requirements:

Part 1: Design and safety of hydrogen refueling stations.

Part 3: High-pressure components (valves, couplings), requiring:

– Ultra-tight leak tests (<0.0001 ml/s)
– Resistance to over 500 pressure cycles
– Materials certified against embrittlement

Ensures safety in mobility (350–700 bar) and industrial systems.

• ISO 16111 – Transportable compressed hydrogen storage systems.
• ISO/TR 15916 – Safety in hydrogen systems; provides guidance on hazard identification, risk assessment and mitigation.
• ISO 11114 (Parts 1–4) – Metal materials’ compatibility with gases, assessing susceptibility to hydrogen embrittlement, high‑pressure corrosion, etc.
• ISO 14687 – Hydrogen quality specifications for mobility, refueling stations and stationary applications. Also adopted as EN ISO 14687 in Europe.
• ISO 23273:2024 – Safety requirements for hydrogen-powered vehicles; addresses leak/fire prevention and material compatibility.

3.2 ASME and API Standards (USA)

• ASME B31.12 – Piping code for hydrogen systems: design and construction of gaseous/liquid hydrogen pipelines.
• ASME BPVC Section VIII – Pressure vessels: covers tanks, accumulators, regulators and integrated valves (including U-stamp marking).
• API 607 – Fire resistance testing for valves to ensure functionality after exposure to fire.
• API 6D – Pipeline valves: leakage, functionality, identification, traceability.
• NFPA 2 – Hydrogen systems code: covers installations, ventilation, zoning, fire protection and general infrastructure design.
• CGA G‑5.4 – Connectors and refueling systems requirements.
• SAE J2600 – Hydrogen refueling connection standards for light- and heavy-duty vehicles.
• SAE J2719 – Hydrogen quality specifications for fuel-cell vehicles.

3.3 Other Relevant International Standards

Global:

• IEC 60079: Electrical equipment for explosive atmospheres; basis for ATEX and IECEx; critical in hydrogen environments.

Asia-Pacific:

• Japan (JIS/METI): Applies the High Pressure Gas Safety Act and standards such as JIS B8248 for cylinders and refueling stations.
• South Korea (KGS): Mandatory certification under KGS-AC, KGS-FA, etc.
• China (GB/TSG): Requires national approval under GB or TSG standards for hydrogen cylinders, valves and stations.

In all cases, acceptance of ISO or EN standards may depend on additional local testing by accredited bodies.

4. Regulatory Classification by Application Area

To facilitate understanding of the regulatory framework governing hydrogen components, it is useful to classify the main directives and standards according to their application area within the hydrogen value chain—from generation and storage to transport, refueling, industrial uses and mobility.

The following table presents a structured summary of the most relevant regulations—both European and international—for each stage:

SUMMARY TABLE: REGULATORY FRAMEWORK FOR HYDROGEN SYSTEMS

Source: Own elaboration

NOTE: this document reflects regulations current as of July 2025. For subsequent updates, please consult official sources (ISO, UNECE, EUR-Lex, etc.)

5. Sources and Official Links

• • Directive 2014/68/EU (PED) – Pressure Equipment:
    Consolidated version on EUR-Lex
  • ISO 19880-1 – Hydrogen fueling stations:
    Technical sheet on ISO /
    UNE version at AENOR
  • EN Standards – Hydrogen and high-pressure materials:
    CEN/TC 197 – Hydrogen technologies
  • Hydrogen Europe – Leading hydrogen association:
    Official website
  • European Chemicals Agency (ECHA):
    Official portal
  • European Committee for Standardization (CEN):
    CEN/CENELEC official site

 

In this first part, we have explored the hydrogen regulatory framework, from generation to safety, comparing European and international regulations. Additionally, in the bibliography section, you’ll find direct links to official sources to delve deeper into each regulation. In the second part, we’ll analyze specific requirements for critical components such as valves, electrolyzers, storage tanks, connectors and other critical components for hydrogen systems. Don’t miss it!