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Current developments regarding ISO and IEC standards in the EU Official Journal

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Consequences of the Malamud ruling: No more EN ISO and EN IEC standards in the EU Official Journal?


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Will international standards soon no longer be listed in the EU Official Journal? Due to unresolved copyright issues, ISO and IEC have filed a lawsuit against the free provision of standards in the wake of the so-called Malamud ruling. As a result, no standards created at ISO or IEC level are currently being proposed for publication in the Official Journal.

The technical article explains the background and context and provides recommendations to standard users on how best to respond in the current situation.
 

1. Review of previous events

Around a year ago, the ruling of the European Court of Justice (ECJ) in the Malamud case caused quite a stir. The plaintiffs had demanded that harmonised standards in the EU Official Journal must be freely accessible at no cost as part of EU law. The ECJ upheld this claim on 5 March 2024:

Every EU citizen and every natural or legal person must be granted access to documents held by the EU Commission. In the case in question, the requested documents form part of EU law, as the EU Commission has given them legal effect by publishing them in the EU Official Journal.

Following the ruling, the ESOs (the European standardisation organisations CEN and CENELEC) made platforms available via their national members on which a certain number of harmonised standards listed in the EU Official Journal can be accessed for reading. These platforms have been published in stages since September 2024.

A few weeks later, the international standardisation organisations ISO (the International Organisation for Standardisation) and IEC (the International Electrotechnical Commission) filed a lawsuit with the ECJ against this interpretation of the ruling and demanded that the previous decision be declared null and void. Among other things, they argued that the free provision of EN standards developed at international level infringed copyright and that the organisations should have been informed before such standards were published on the reading platforms. The official statement of claim was published in February 2025.

Interested readers can find a detailed chronology of events and summaries of the judgments in our article ‘ECJ judgment: harmonised standards in the EU Official Journal – the “Malamud” case’.
 

2. Current impact: No new international standards published in the EU Official Journal

During research into the presumption of conformity of the EN ISO 10218 series of standards (industrial robots), both parts of the standard were marked on the CEN/CENELEC website with the information that no listing in the EU Official Journal for the Machinery Directive 2006/42/EC is expected. This led to the possible conclusion that the HAS assessment had been negative and that publication in the EU Official Journal was not planned.

However, this conclusion was rejected by our expert Dr Matthias Umbreit, lecturer in our seminar ‘Safe Robots and Cobots’ and member of ISO/TC “Robotics”. According to him, no negative assessment is known. Instead, it took ‘a great deal of effort to obtain a positive assessment (in 2024)’.

According to information from the responsible committee manager at CEN, the non-inclusion of the standard is justified by the ISO/IEC lawsuit against the ECJ ruling. Due to the lawsuit, there is a copyright issue, which is why the ESOs are currently unable to propose any EN ISO or EN IEC standards for publication in the EU Official Journal. The main points of the lawsuit were as follows:

  1. The EU Commission published international standards without examining whether there was an overriding public interest (legal error)
  2. The publication of international standards infringes the intellectual property rights of ISO and IEC (Intellectual property infringement)
  3. The Commission did not inform ISO and IEC prior to publishing the documents (procedural error)

A request to CEN/CENELEC has received only a very vague response: CEN/CENELEC has stated that all parties involved are working towards a timely solution. It is hoped that more detailed information will be available shortly. In any case, the fact remains that no international ISO or IEC documents were published in the latest implementing decisions amending the harmonised standards for the Low Voltage Directive and the Machinery Directive, for example.

It is currently difficult to assess how serious the consequences of the lawsuit will be. The ISO/IEC lawsuit was published on the EUR-Lex portal on 17 February. Apparently, the standardisation bodies and the Commission are awaiting a further ruling by the ECJ in this case or are attempting to resolve the three main points of contention.

In any case, the established architecture of European standardisation is likely to have been damaged, as more and more European standards are based on international standards. The internal processes of CEN/CENELEC even favour this international orientation: the development of a technical standard that is not based on an existing international standard requires the unanimous approval of all national standardisation bodies. This facilitates the development of standards through international cooperation.

In recent years, the ESOs have worked more closely with international standardisation bodies on the basis of the Vienna Agreement (CEN and ISO)1 and the Frankfurt Agreement (CENELEC and IEC)2 in order to avoid duplication of work in the development of standards, save time and develop and publish identical European and international standards in parallel.

Provided that international standards comply with European legal and market requirements and are also implemented by non-European global players, priority is given to the content of the cooperation agreements with ISO and IEC.

3. How many and which standards are affected?

In absolute terms, this means, for example, that of the 800 standards in the EU Official Journal relating to the Machinery Directive 2006/42/EC, just over 200, or just under a quarter, are EN ISO or EN IEC standards that have been drawn up at international level. These standards include numerous globally used standards that are of great importance to machinery manufacturers. Many of these frequently used standards are currently undergoing revision, including the new EN ISO 12100 (risk assessment and risk reduction), EN ISO 20607 (operating instructions for machinery) and EN ISO 13855 (positioning of safeguards). As things stand at present, publication of these standards in the EU Official Journal in accordance with the Machinery Directive (and in future in accordance with the new Machinery Regulation) is not currently foreseeable.

In the case of the Low Voltage Directive, the percentage is slightly lower: of the 600 standards currently listed, just over 60 have an ISO or IEC background3. However, this percentage is likely to be significantly higher in future years, as previous pure EN standards will also be published on the basis of the international IEC standard. Examples of this are the future prEN IEC 60204-1 (electrical equipment of machines), EN IEC 60669-2-1 (switches for household and similar fixed electrical installations) or the EN IEC 60269 series of standards (low-voltage fuses).
 

4. Application in practice: EU Official Journal, presumption of conformity and state of the art

In the European product law system, the close interaction between legal provisions such as EU directives and EU regulations and harmonised European standards has proven its worth:

  • Directives and regulations define essential requirements
  • The legislations state that if standards are listed in the relevant EU Official Journal, it can be assumed that their application also fulfils the requirements covered by the legislation (= presumption of conformity principle)
  • EN standards are reviewed by the EU Commission with the involvement of so-called HAS consultants and published in the EU Official Journal
  • Those subject to EU legislation benefit from clearer requirements developed in collaboration with industry in the form of harmonised European standards with presumption of conformity

It is often not mentioned that EU legislation not only permits the application of the above standards, but also requires compliance with the state of the art.

The new Machinery Regulation, like the current Machinery Directive, requires, for example, that the essential health and safety requirements defined in the legal act ‘should be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements.’.

In order to meet the requirements and subsequently the state of the art, the contents of harmonised standards ‘provide a good indication of the state of the art at the time of their adoption’4. However, as these do not codify the state of the art, but merely document it at a specific point in time, their application remains voluntary under product safety law. 

Even if standards merely document the state of the art, it can change more quickly than the standard can be revised and – particularly relevant now – published in the EU Official Journal. Users are therefore closer to the state of the art with the corresponding successor standard or a comparable document, even without presumption of conformity.

Users should therefore not rely solely on the presumption of conformity of a harmonised standard in the EU Official Journal. The state of the art must be complied with by law; the legal effect of the presumption of conformity is often overestimated. Further information on this topic, including a legal assessment, can be found in the technical article ‘Standard topicality vs. presumption of conformity’.

5. Conclusion

In recent years, there have been repeated delays in the publication of harmonised standards and their listing in the EU Official Journal. One example of this is the renegotiation of the so-called HAS Agreement, as a result of which no new harmonised standards were published in the Official Journal between April 2022 and August 2023.

In the current case, the solution is somewhat more difficult, as it involves the interpretation of a European Court of Justice ruling and its legal aftermath. Although CEN/CENELEC emphasise that they are striving for a quick solution, legal disputes can drag on for several years. This was also observed in the past in the ‘Malamud’ case.

Users of harmonised standards are advised to check whether newer editions of standards impose different and, if necessary, more extensive requirements than the versions currently published in the EU Official Journal. There is a legal obligation to comply with the state of the art. If this can be better achieved by newer standards that are not listed in the EU Official Journal, it would generally be very difficult to justify why the outdated standard was used.


Posted on: 2025-08-19

Authors

Daniel Zacek-Gebele, MSc
Produktmanager bei IBF für Zusatzprodukte sowie Datenmanager für die Aktualisierung der Normendaten am Safexpert Live Server. Studium der Wirtschaftswissenschaften in Passau (BSc) und Stuttgart (MSc) im Schwerpunkt International Business and Economics.

E-Mail: daniel.zacek-gebele@ibf-solutions.com | www.ibf-solutions.com

 

Johannes Windeler-Frick, MSc ETH
Member of the IBF management board. Specialist in CE marking and Safexpert. Presentations, podcasts and publications on various CE topics, in particular CE organisation and efficient CE management. Management of the further development of the Safexpert software system. Degree in electrical engineering from ETH Zurich (MSc) with a focus on energy technology and specialisation in the field of machine tools.

Email: johannes.windeler-frick@ibf-solutions.com | www.ibf-solutions.com

 


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