What Does That Mean, and What is the Current Status?

If you can prove with a conformity assessment that your product complies with the European (EN) harmonized standards, the “presumption of conformity” applies to your product in the European Union (EU). This means your product is in line with the corresponding EU rules, directives, and regulations. What this means in detail, and where the difficulties lie today (e.g., the James Elliott case,² the Malamud ruling,⁴ the ongoing ISO/IEC litigation,⁵ and the shift towards Common Specifications⁶) are explained in this article.

The world of technical standards can be confusing. This article should help you to understand the concept of harmonized EN standards, and especially why no new harmonized EN EMC standard has been cited in the Official Journal of the European Union (OJEU) under the EMC Directive 2014/30/EU since June 2022, and why the situation has, if anything, become more complicated in 2024–2026.

Glossary

Following is a list of some of the key terms that are essential in navigating the EU harmonized standards landscape:

• CEN = European Committee for Standardization. Responsible for European standardization. Together with ETSI (telecommunications) and CENELEC (electrical engineering), it forms the European system for technical standardization.
• CENELEC = European Committee for Electrotechnical Standardization. Responsible for European standardization in the area of electrical engineering.
• CJEU = Court of Justice of the European Union. The highest court of the EU in matters of EU law.
• CS = Common Specifications. Technical specifications adopted by the European Commission through implementing acts serve as a fallback when harmonized standards are missing, delayed, or insufficient.
• DoC = Date of Cessation.
• DOW = Date of Withdrawal.
• EMC = Electromagnetic Compatibility.
• EMCD = Electromagnetic Compatibility Directive (Directive 2014/30/EU).
• EN = European Norm (European Standard).
• ETSI = European Telecommunications Standards Institute. Responsible for European standardization for telecommunications, broadcasting, and other electronic communications networks and services.
• ESO = European Standards Organization (CEN, CENELEC, ETSI).
• HAS = Harmonized Standards (and, by extension, the Harmonized Standards consultants that assess them on behalf of the European Commission).
• hEN = Harmonized European Standard (a European standard cited in the OJEU under a piece of Union harmonization legislation).
• OJEU = Official Journal of the European Union. The OJEU is the official publication for EU legal acts, other acts, and official information from EU institutions, bodies, offices, and agencies.

Harmonized Standards: Definition and Purpose

Harmonized standards in the context of the EU are technical specifications adopted by one of the European standardization organizations and developed in accordance with EU directives and regulations. Products that comply with harmonized standards are presumed to meet the essential requirements of the relevant EU directives and regulations, making the compliance process more straightforward. This presumption of conformity reduces the risk of legal challenges and provides a clear path to demonstrate compliance with EU law.

Key Points About EU Harmonized Standards

Development and Adoption

• Standardization Organizations: The main bodies responsible for developing harmonized standards are the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI).
• Alignment with Legislation: These standards are created to align with specific essential requirements laid out in EU legislation, particularly directives and regulations concerning product safety and performance.

Citation in the Official Journal of the European Union (OJEU)

• Legal Effect: When a harmonized standard is cited in the OJEU, it gains a presumption of conformity with the relevant essential requirements of the applicable EU directive or regulation.
• Presumption of Conformity: Products manufactured in accordance with these cited standards are presumed to comply with the corresponding EU legislation, simplifying the regulatory process for manufacturers.

Voluntary Nature

• Optional Compliance: While harmonized standards provide a clear and recognized path to compliance, their use is voluntary. Manufacturers can choose alternative methods to demonstrate that their products meet EU requirements, as long as they can prove equivalence.

CE Marking

• Indication of Compliance: Products that meet harmonized standards and essential requirements can carry the CE marking, indicating conformity with EU directives and enabling free movement within the European Economic Area (EEA).

Presumption of Conformity

• Presumption of Conformity: When a product complies with harmonized EU standards, it benefits from the presumption of conformity. This means that it is automatically assumed to meet the essential requirements of the relevant EU directives and regulations.

Reversal of the Burden of Proof

• Normal: Normally, the burden of proof lies with the manufacturer to demonstrate that their product meets all applicable legal requirements.
• Reversal: With the presumption of conformity, the burden shifts away from the manufacturer. Instead, it is up to the regulatory authorities or other challengers to prove that the product does not comply with the essential requirements, despite adhering to the harmonized standards.

When Does a Harmonized EN Standard Lose Its Presumption of Conformity?

A harmonized European (EN) standard can lose its presumption of conformity under several circumstances:

Withdrawal or Replacement

• Withdrawal: If a harmonized standard is officially withdrawn by the relevant European standardization organization (CEN, CENELEC, or ETSI), it loses its presumption of conformity. This can happen if the standard becomes outdated or is no longer considered adequate to meet the essential requirements of the relevant EU legislation.
• Replacement: When a harmonized standard is replaced by a new or revised version, the presumption of conformity shifts to the updated standard. The old standard typically loses its presumption of conformity after a transitional period.

Changes in EU Legislation

• Amendment or Repeal of Directives/Regulations: If the underlying EU directive or regulation that the harmonized standard supports is amended or repealed, the standard may lose its presumption of conformity. New or revised legislation might require updated standards to ensure continued compliance.

Official Objection by the European Commission

• Formal Objection: The European Commission or an EU member state can raise a formal objection to a harmonized standard if it is found to no longer meet the essential requirements of the relevant EU directive or regulation. If the objection is upheld, the standard may be revised or withdrawn, leading to a loss of its presumption of conformity.

Judicial or Administrative Decisions

• Court Rulings: As highlighted in cases like “James Elliott Construction Limited v Irish Asphalt Limited” (see Endnote #2), a court may determine that a product does not comply with essential requirements despite adhering to a harmonized standard. Such judicial decisions can influence the perceived reliability and applicability of a standard.
• Market Surveillance Actions: If market surveillance authorities find that products conforming to a harmonized standard are unsafe or fail to meet essential requirements, this could lead to a reassessment or withdrawal of the standard.

Lack of Citation in the OJEU

• Omission from the OJEU: For a standard to confer a presumption of conformity, it must be cited in the OJEU. If a standard is removed from the OJEU, it loses its official status and, consequently, its presumption of conformity.

DOW vs. DoC

Figure 1 shows the simplified life-cycle of a harmonized EN EMC standard with DOW and DoC. (Note that not every EN standard is requested by the European Commission to be harmonized.)

The Date of Withdrawal (DOW) and the Date of Cessation (DoC) are both important dates in the lifecycle of harmonized EU standards, but they serve different purposes:

Date of Withdrawal (DOW)

• Definition: The DOW is the date by which the previous version of a harmonized standard must be formally withdrawn by the European standardization organizations (such as CEN, CENELEC, or ETSI).
• Purpose: It marks the end of the transition period during which both the old and the new versions of the standard can be used.
• Implications: After the DOW, the old standard is no longer available for use and is officially withdrawn from circulation. Products can no longer be assessed against the withdrawn standard for compliance purposes.

Date of Cessation (DoC)

• Definition: The DoC is the date after which the previous version of a harmonized standard loses its presumption of conformity.
• Purpose: It marks the end of the period during which products complying with the old standard are presumed to meet the essential requirements of the relevant EU directives and regulations.
• Implications: After the DoC, manufacturers must ensure their products comply with the new or revised version of the standard to maintain the presumption of conformity. Products still assessed against the old standard after the DoC will no longer be presumed to conform to EU requirements, which can lead to compliance issues.

Key Differences

• Function — DOW: Focuses on the withdrawal of the standard itself from use and circulation. DoC: Focuses on the loss of the legal benefit (presumption of conformity) that the old standard provides.
• Impact on Compliance — DOW: After this date, the old standard is no longer available for compliance assessment. DoC: After this date, products must meet the new standard to be presumed compliant with EU legislation.
• Sequence: Typically, the DOW precedes the DoC. The standard is withdrawn (DOW), and after a certain period, the presumption of conformity provided by the old standard ceases (DoC).

(Important: The DOW published by a European Standardization Organization (e.g., CENELEC) is not legally binding for the presumption of conformity. The legally binding date on which an EMC standard loses its presumption of conformity is the DoC published by the European Commission in the OJEU.¹)

Where to Find Harmonized EMC Standards?

Which EMC standards are harmonized for the European Electromagnetic Compatibility Directive (EMCD, Directive 2014/30/EU) are published on the European Commission’s “Harmonised standards – Electromagnetic compatibility (EMC)” webpage (see Endnote #1). Since December 1, 2018, references of harmonized standards are published in, and withdrawn from, the OJEU exclusively by means of Commission implementing decisions. For the EMC Directive 2014/30/EU, the basic act is Commission Implementing Decision (EU) 2019/1326, last amended on 9 June 2022, and not amended since for new content. The Commission additionally publishes an explanatory Guide for the EMCD (Directive 2014/30/EU), a draft revision of which was circulated in March 2025.⁷

Why Are There No More Harmonized EMC EN Standards since the James Elliott Court Case?

To avoid regulatory uncertainty, economic operators and manufacturers of electric and electronic devices push for the harmonization of EN standards. Therefore, it is of high interest for the industry to have harmonized EN standards. However, since the James Elliott case, there have been significant challenges regarding the assessment and validation of harmonized standards by HAS consultants for the EMC Directive (2014/30/EU). Figure 2 shows that, as of May 2024, there was still not a single positive assessment by the HAS consultants when it comes to harmonized EN EMC standards.³

One of the main reasons for the absence of positive assessments is the increased scrutiny and legal uncertainty brought about by the court ruling. The James Elliott decision clarified that harmonized standards, although not legally binding themselves, have a quasi‑legal status when cited in the OJEU, making their precise compliance critical. The ruling assigned the Commission a broader responsibility for checking whether a hEN actually meets the essential requirements it covers under the relevant standardization request, and the Commission has since proceeded in a very formal manner.⁸

This ruling heightened the need for meticulous alignment of these standards with EU regulations, creating a complex and stringent environment for HAS consultants to operate within. Additionally, the standards need to meet both the technical specifications and the formal requirements set by the EU, which can be an intricate and lengthy process. Consequently, this has led to delays and a backlog in the positive assessment of EMC standards under the Directive 2014/30/EU.

In its 2025 Work Programme, the CEN-CENELEC Coordination Group on the EMC Directive
(CLC/COG EMCD) explicitly named the technical issues blocking citation in the OJEU: “The use of statistical methods, manufacturer defined performance criteria, and measurement uncertainty in standards.”⁹ CLC/COG EMCD continues to work with the European Commission and with CLC/TC 210 to find solutions for these obstacles.

On top of this, in 2025 the European Commission asked the EMC committees to withdraw any cited EMC standards that have been superseded by newer (and not yet harmonized) versions. Because EMC standards have been so difficult to (re-)cite in the OJEU over the past few years, the number of impacted standards is expected to be significant. The CLC Coordination Group on EMC (CLC/COG EMCD) is actively working to reduce the impact of this exercise.¹¹

The Malamud Ruling and the ISO/IEC Dispute (2024–2026)

A second tectonic shift has happened on top of the James Elliott case. On 5 March 2024 the Court of Justice of the European Union (CJEU) delivered its judgment in Case C-588/21 P, Public.Resource.Org and Right to Know v Commission (the so-called “Malamud” ruling), and held that there is an overriding public interest in disclosing four harmonized standards under the Toy Safety Directive, because harmonized standards form part of EU law and citizens must be able to read the rules with which their products must comply (see Endnote #4).

The wider consequence of this ruling reaches well beyond toy safety. National standardization bodies have since set up free reading portals for some hEN. ISO and IEC, the international parents of most EN IEC EMC standards, take the view that free disclosure of their content infringes the copyright on which their standardization model is built. On December 6, 2024, ISO and IEC filed proceedings against the European Commission before the General Court (Case T-631/24).

The practical effect on EMC compliance is severe. Since the beginning of 2025, no harmonized standard with an ISO or IEC reference has been published in the OJEU. The last citation of an IEC-based standard in the EU Official Journal was EN 60456/A12:2023, published via Commission Implementing Decision (EU) 2025/72 of 15 January 2025. As the great majority of harmonized EN EMC standards (the EN 55xxx, EN 61000-x-x and EN 61326 series, for example) are EN IEC adoptions, this de facto freeze hits the EMC Directive 2014/30/EU particularly hard — on top of the pre-existing James Elliott backlog described previously.

The Shift Towards Common Specifications and the Omnibus IV Package

Faced with this double bottleneck (James Elliott + Malamud), the European Commission has increasingly turned to a different legal tool, that is, Common Specifications (CS). Common Specifications are technical specifications adopted directly by the Commission via implementing acts, intended as a fallback when harmonized standards are missing, delayed, or insufficient. They are already foreseen in roughly ten sectoral acts, for instance, in the Medical Devices Regulation (EU) 2017/745, the Machinery Regulation (EU) 2023/1230, the AI Act (EU) 2024/1689, and the Cyber Resilience Act (EU) 2024/2847 (see Endnote #6).

Within the “Omnibus IV” simplification package (COM(2025) 503 final and COM(2025) 504 final), the Commission has proposed to extend the Common Specifications instrument to roughly sixteen further directives and regulations. Initially framed as a narrowly defined fallback, Common Specifications are now positioned as a much broader plan B for legislation that is starved of citations in the OJEU.

For EMC, this matters in two ways. First, the EMC Directive 2014/30/EU does not currently foresee Common Specifications as an alternative route to the presumption of conformity. So, the immediate effect of any further Commission CS activity for EMC will depend on whether (and when) a future revision of the EMCD adopts the instrument. Second, even where Common Specifications are available, they replace internationally aligned ISO/IEC content with EU-only documents, which is problematic for globally trading manufacturers because such specifications are typically not accepted in non-EU certification systems (US, China, Japan, etc.) This is exactly the opposite of what the European industry, including the EMC industry, asks for.

Until the situation is resolved, the practical guidance for manufacturers placing EMC-relevant equipment on the EU market remains unchanged, but is more important than ever: “Legal conformity takes precedence over conformity to standards.” The essential requirements of Annex I of the EMC Directive must be met, regardless of which standards (harmonized, withdrawn-but-still-state-of-the-art, ISO/IEC-based or otherwise) are used as the supporting technical evidence.

Summary

EU harmonized standards are critical tools for ensuring product compliance with EU legislation. They facilitate market access and enhance product safety while providing legal certainty through the “presumption of conformity” and reducing trade barriers within the EU.

However, since the Court’s ruling in the James Elliott case, the harmonization of EN EMC standards has stalled: the last substantive amendment to the EMC list in the OJEU was published on June 9, 2022, and, as of May 2024, none of the six completed HAS consultant assessments for EMC standards had received a positive outcome. The CLC/COG EMCD 2025 Work Programme has now identified the recurring obstacles, including statistical methods, manufacturer-defined performance criteria, and measurement uncertainty, and is actively working to remove them.

In parallel, the CJEU’s 2024 Malamud ruling and the ensuing ISO/IEC lawsuit against the European Commission have effectively suspended the citation of new ISO/IEC-based harmonized standards in the OJEU during 2025 and into 2026. Meanwhile, the Commission is preparing a broader fallback via Common Specifications under Omnibus IV. The next twelve to twenty-four months will determine whether harmonized EN EMC standards return to their historic role as the principal route to the presumption of conformity, or whether industry will permanently have to combine residual hEN, current EN/IEC versions, and Commission-issued Common Specifications to demonstrate compliance with the EMC Directive.

Endnotes

1. European Commission, Harmonised standards – Electromagnetic compatibility (EMC).
2. InfoCuria, Case-law, C-613/14 – James Elliott Construction.
3. CEN and CENELEC, European Harmonised Standards: A Journey from Legal Framework to Citation in the OJEU, HAS Seminar, 22–23 May 2024.
4. InfoCuria, Case-law, C-588/21 P – Public.Resource.Org and Right to Know v Commission (“Malamud”), judgment of 5 March 2024.
5. Globalnorm GmbH, “Current situation regarding the ISO/IEC complaint against the European Commission (Case T-631/24).”
6. Kommerskollegium (National Board of Trade Sweden), Common Specifications: Fallback or challenge for harmonised standards within the EU?, Policy Brief, 2025.
7. European Commission, Guide for the EMCD (Directive 2014/30/EU), draft, 1 March 2025.
8. Globalnorm GmbH, “EU: The backlog in the publication of harmonized standards continues.”
9. CEN-CENELEC, Work Programme 2025 – Electrotechnology sector (CLC/COG EMCD).
10. Keller, R., “EU Harmonized Standards – What does that mean?” Academy of EMC.
11. Belgian Electrotechnical Committee (BEC), Update on Harmonized Standards – EMC Directive (2014/30/EU), September 2025.