What are EN Standards (European Norm)?

EN standards play an extremely important role as unified standards for Europe. “EN” is an abbreviation for “European Norm,” which refers to unified standards commonly applied within member countries of the European Union (EU) and the European Free Trade Association (EFTA).

The term “Norm” derives from “Normalisation” (standardization) and is read as “norma” in Russian. In Japan, the word “noruma” (ノルマ) is often understood to mean “strict standards or targets,” which stems from the historical context of labor standards during post-World War II Siberian internment. However, the original meaning of “Norm” or “norma” is simply a neutral term meaning “standard” or “criterion.” This etymological and historical background suggests that the essential purpose of standards is “standardization” rather than “enforcement.”

Definition and Purpose of EN Standards

The primary objectives of EN standards are to achieve technical unification among member countries, facilitate smooth trade within the European region, and ensure product safety and quality. By achieving these objectives, EN standards promote the free circulation of products in the European Single Market and strengthen consumer protection.

Organizations and Operational Structure for EN Standards Development

EN standards are developed by the following three European Standardization Organizations (ESOs):

CEN (European Committee for Standardization) is responsible for standards in almost all technical fields except electrical, electronic, and telecommunications areas. Specifically, it covers fields such as construction materials, chemical products, machinery, and medical devices. CEN was founded in 1961 and currently has 34 national members representing EU member states, EFTA countries, the United Kingdom, and other countries highly integrated into the European economy.

CENELEC (European Committee for Electrotechnical Standardization) is responsible for developing standards related to electrical and electronic equipment. It particularly focuses on areas such as electrical safety, electromagnetic compatibility (EMC), and home appliances. CENELEC also has 34 national members and works closely with the International Electrotechnical Commission (IEC) through the Dresden Agreement (signed in 1996) and the Frankfurt Agreement.

ETSI (European Telecommunications Standards Institute) is responsible for developing standards in the field of information and communication technology (ICT). It covers cutting-edge technology areas such as 5G communications, IoT devices, and cybersecurity. Unlike CEN and CENELEC, ETSI has more than 850 member organizations from over 60 countries, allowing industry to participate directly in the standards development process.

Characteristics and Legal Status of EN Standards

EN standards possess the following distinctive characteristics:

Mandatory Adoption

EU member countries are obligated to adopt new EN standards as their national standards, typically within six months of their publication. During this process, existing national standards that conflict with the EN standards must be withdrawn. This mechanism ensures technical harmonization across Europe and eliminates technical barriers to trade.

Relationship with National Standards

EN standards are integrated into each country’s standards system, such as Germany’s DIN standards (DIN EN), the United Kingdom’s BS standards (BS EN), and France’s NF standards (NF EN). This integration ensures consistency of standards across member states. When an EN standard is published, it automatically becomes a national standard in all 34 member countries, with all conflicting national standards withdrawn.

Relationship with CE Marking

EN standards function as specific technical specifications for meeting the Essential Requirements set forth in EU Directives and Regulations. These are known as “Harmonized Standards.” When products conform to these standards, they benefit from a “presumption of conformity” with the relevant EU legislation. The CE mark is affixed to demonstrate that products comply with these standards and meet essential safety, health, and environmental protection requirements.

It is important to note that while compliance with harmonized standards provides a presumption of conformity and is the most common path to CE marking, the use of harmonized standards is generally voluntary. Manufacturers may choose alternative technical solutions to fulfill essential requirements, provided they can demonstrate equivalent compliance through appropriate documentation and conformity assessment procedures.

Relationship with ISO and JIS Standards

The following relationships exist among EN standards, ISO standards, and JIS standards:

Scope of Application

EN standards primarily target the European region, ISO standards are international, and JIS standards primarily target Japan. However, with the advancement of globalization, the mutual consistency of these standards has become increasingly important.

Priority

In the European market, EN standards take highest priority. This is due to their position as “Harmonized Standards” within the EU legal system, which means they are specifically referenced in EU legislation as a means to demonstrate compliance with essential requirements.

Standards Access Methods and Costs

EN standards are generally available for purchase. This is to cover the costs of standards development and maintenance. On the other hand, JIS standards can be partially viewed for free on the website of the Japanese Industrial Standards Committee (JISC). Both CEN and CENELEC provide online databases where standards can be searched and purchased through their respective platforms or through national standardization bodies.

Harmonization Status

EN standards emphasize consistency with ISO standards and adopt a policy of incorporating ISO standards whenever possible through the Vienna Agreement. The Vienna Agreement, signed between CEN and ISO in 1991, was established to prevent duplication of effort and reduce time when preparing standards. New standards projects are jointly planned between CEN and ISO, and wherever appropriate, priority is given to cooperation with ISO.

However, when it is necessary to ensure consistency with European-specific requirements or regulations, unique requirements may be added. For example, European standards may include additional annexes (Annex Z or ZA) that relate EN standards to the Essential Requirements of EU Directives, even when the core technical content is identical to the corresponding ISO standard.

Similarly, CENELEC maintains a high level of technical alignment with IEC through the Dresden Agreement and Frankfurt Agreement. As of recent reports, more than 80% of CENELEC standards are identical to or based on IEC publications, demonstrating the effectiveness of international cooperation in the electrotechnical field.

Practical Impact of EN Standards

EN standards affect the entire process of product design, manufacturing, testing, and certification. The following points require particular attention:

Product Development Stage

It is important to consider EN standards requirements from the initial design stage. This reduces the risk of requiring major design changes later. Design teams should identify all applicable EN standards early in the development process and integrate their requirements into product specifications and design reviews.

Quality Management

By applying test methods and inspection standards based on EN standards, product quality can be ensured. Manufacturers should establish quality management systems that systematically address EN standards requirements throughout the product lifecycle, from raw material procurement through final inspection and post-market surveillance.

Certification Process

Demonstrating conformity to applicable EN standards is essential for obtaining CE marking. In many cases, conformity assessment by a third-party certification body (Notified Body) is required. The specific conformity assessment procedure depends on the applicable EU Directive or Regulation and the classification of the product based on its risk level.

The technical file and Declaration of Conformity (DoC) must be maintained for at least 10 years after the product is placed on the market and must be available to market surveillance authorities upon request. Non-compliance with these requirements can result in product recalls, market restrictions, or other enforcement actions.

Future Outlook

EN standards continue to evolve in response to technological innovation and the advancement of globalization. In particular, standards development is progressing to address new challenges such as digitalization, sustainability, and the circular economy.

Recent Developments in 2024-2025

Recent standardization activities include:

Digital Product Passports (DPP): In support of the Ecodesign for Sustainable Products Regulation (ESPR) (EU) 2024/1781, CEN and CENELEC established Joint Technical Committee 24 (CEN/CLC/JTC 24) to develop standards for the Digital Product Passport Framework and System. The mandate (M/604) requires delivery of standards by December 31, 2025, representing a core instrument for implementing the European Green Deal.

Cybersecurity Standardization: In March 2024, CEN, CENELEC, and ETSI, together with ENISA (the EU Agency for Cybersecurity), organized their 8th Cybersecurity Standardization Conference, attracting over 2,000 participants. The conference focused on the evolving landscape of EU cybersecurity legislation and standardization challenges related to new requirements on digital products.

European Digital Identity Framework: Following the publication of Regulation (EU) 2024/1183 (eIDAS 2) in spring 2024, CEN and ETSI are collaborating to develop standards supporting the new European Digital Identity Framework, including digital identity wallets and trust services.

Artificial Intelligence: Standards development is underway to support the implementation of the EU Artificial Intelligence Act, addressing requirements for AI system safety, transparency, and risk management.

The direction toward further enhancing consistency with international standards is also being emphasized. CEN, CENELEC, and ETSI continue to work closely with ISO, IEC, and ITU under their respective cooperation agreements to ensure that European standards contribute to global harmonization while meeting specific European regulatory and market requirements.

Importance for Japanese Companies

For Japanese companies, conforming to EN standards is a critical issue for securing access to the European market. In particular, it is necessary to consider EN standards requirements from the product design stage and to systematically plan required testing and certification.

Companies should establish processes to:

• Monitor relevant EN standards and their updates
• Integrate EN standards requirements into product development workflows
• Select appropriate conformity assessment procedures and Notified Bodies when required
• Maintain comprehensive technical documentation
• Implement effective post-market surveillance and corrective action systems

Understanding the relationship between EN standards, EU regulations, and harmonized standards is essential for successful market access. While the technical requirements can be complex, the unified nature of EN standards across the European Single Market means that once conformity is achieved, products can circulate freely throughout all member states, providing significant market opportunities for compliant manufacturers.

Note: This column provides general information about EN standards and should not be construed as legal or regulatory advice. Companies should consult with qualified experts regarding specific compliance requirements for their products and markets.