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Why were international standards no longer listed in the EU Official Journal for an extended period – and what is the current situation? Due to unresolved copyright issues in connection with the so-called Malamud ruling, ISO and IEC initiated legal proceedings concerning the free provision of standards. As a result, new EN ISO and EN IEC standards were temporarily no longer proposed for publication in the EU Official Journal.
Update September 2026: The situation has changed significantly. Current EN ISO and EN IEC standards are now being published in the EU Official Journal again.
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. Impact of the legal dispute: Temporary halt to the publication of international standards
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)’.
Update: The situation described above has since changed. On 7 September 2026, EN ISO 10218-1:2025 and EN ISO 10218-2:2025 were published in the EU Official Journal under the Machinery Directive. The new editions of these two robot safety standards therefore now provide a presumption of conformity.
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:
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.
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. At the time, many of these frequently used standards were 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). Due to the temporary halt in publication, it was initially unclear when new editions of such internationally developed standards could once again be published in the EU Official Journal.
In the case of the Low Voltage Directive, the percentage is significantly higher: Of the 600 standards currently listed, only 60 documents are listed as EN ISO or EN IEC standards, but almost 500 of the currently valid standards were initially created at IEC level.3 Only the newer successor documents (since the Frankfurt Agreement) also bear the letters IEC in their title. This means that for the majority of LVD standards, the inclusion of current successor standards would be questionable at this point in time. Examples of this are EN 60204-1 (electrical equipment of machines), the comprehensive EN 60335 series of standards (Household and similar electrical appliances) and 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:
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’.
Since the end of October, there have been signs that the legal dispute will come to an end, at least for EN ISO standards. According to CEN/CENELEC, an agreement has been reached between the European Commission and ISO on the publication of ISO standards in the Official Journal of the European Union.
Details of this settlement are not yet known. However, according to statements made by a manager of the CEO Committee, the transmission of EN ISO standards to the Commission for publication in the Official Journal of the EU was resumed on 20 October. Although this only involves a small number of standards at this stage, this step gives confidence that comprehensive international standards will soon be proposed again.
However, the situation regarding electrotechnical standards, i.e. EN IEC documents, initially remained unclear.
On 4 September 2026, yet the standard EN IEC 60079-28:2026 was published as a harmonised standard in the EU Official Journal. The standard supports the ATEX Directive 2014/34/EU.
Update 2026
In March 2026, another issue of the Official Journal of the European Union was published, amending the list of harmonized standards under the Machinery Directive. Since this implementing decision again did not include any standards, we consulted CEN/CENELEC once more on this matter.
Upon inquiry, we were informed that the omission of such documents was due to a delay. The newly published standard data was reportedly submitted to the European Commission in August 2025 for publication in the Official Journal, but did not yet include any ISO or IEC standards.
The submission of such international standards did not take place until after the legal dispute was resolved (as mentioned above on October 20, 2025), due to the time required for the review as part of the HAS assessment. Provided this review follows a similar timeframe (approx. 7 months), publication is expected no earlier than mid-2026. According to CEN/CENELEC, however, this could happen sooner due to the urgency of the matter.
In September 2026, the situation changed significantly in practice.
On 4 September 2026, the standard EN IEC 60079-28:2026 was published in the EU Official Journal as a harmonised standard under the ATEX Directive.
Just a few days later, on 7 September 2026, an extensive update to the list of harmonised standards under the Machinery Directive followed. It includes numerous EN ISO and EN IEC standards.
Of particular interest are EN ISO 10218-1:2025 and EN ISO 10218-2:2025 on the safety of industrial robots. These two standards were the original reason for our investigation into the consequences of the Malamud ruling and the temporary halt in publication.
This means that both EN ISO and EN IEC standards are now once again being published in the EU Official Journal. The backlog of internationally developed standards is therefore visibly beginning to clear.
The Malamud ruling and the associated copyright issues had a significant impact on the publication of internationally developed standards in the EU Official Journal. For an extended period, new EN ISO and EN IEC standards were no longer proposed for publication.
Since September 2026, the situation has changed significantly: both EN ISO and EN IEC standards are once again being published in the EU Official Journal.
The EN ISO 10218 series provides a particularly illustrative example. The two robot safety standards were the original reason for our investigation into the publication halt. On 7 September 2026, EN ISO 10218-1:2025 and EN ISO 10218-2:2025 were finally published as harmonised standards under the Machinery Directive.
Nevertheless, users of standards should not rely solely on publication in the EU Official Journal. New editions of standards may already provide important guidance on the state of the art before their references are published in the Official Journal.
Footnotes:1 See information on the Vienna Agreement on the CEN/CENELEC website.2See information on the Frankfurt Agreement on the DKE website.3 Consolidated lists: Overview of harmonised standards with presumption of conformity4 See Guide to application of the Machinery Directive, Edition 2.3, §162
Posted on: 2025-10-31 (last amendment)
Daniel Zacek-Gebele, MSc Product manager at IBF for additional products and data manager for updating standards data on the Safexpert Live Server. Studied economics in Passau (BSc) and Stuttgart (MSc), specialising in International Business and Economics. Email: 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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