President European Commission

 

 

Dear President,

I have received a complaint against the European Commission from Corporate Europe Observatory. The complaint concerns how the Commission ensures that the European Standardisation Organisations (ESOs) tasked with developing ‘harmonised standards’ on artificial intelligence (AI) to implement the AI Act[1] do so in a transparent, inclusive, and accountable manner.

On 22 May 2023, the Commission issued a standardisation request concerning AI to two ESOs: the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (CENELEC).[2] The Commission asked CEN and CENELEC to ensure that the harmonised standards will contribute to minimising risks stemming from AI to health, safety and fundamental rights. This means that CEN and CENELEC will need to address not only technical but also broader discretionary choices with regard to how high-risk AI systems should be designed and used to ensure the appropriate level of safety and fundamental rights protection in the EU.

In this context, the complainant is concerned that the Commission has not yet ensured that the process of developing harmonised standards on AI by CEN and CENELEC is inclusive, transparent and accountable. The complainant is particularly concerned that the Commission has not required CEN and CENELEC to publish information about the members of the Joint Technical Committee 21 (referred to as ‘JTC 21’[3]) established to develop the standards and the interests these members represent. The complainant also points out that the minutes of meetings and other documents of the working group are not public. Moreover, the complainant argues that the Commission has failed to ensure a balanced representation of interests for the process of developing the standards, where, the complainant says, big technology companies prevail.

I have decided to open an inquiry into this complaint.

Although the Commission has replied to some of these concerns,[4] my view is that it has not yet fully addressed all the issues raised. I also note that the Commission, in its reply to the complainant, said that it is not responsible for the process and its outcomes, which seems to be difficult to reconcile with recent case law.

Therefore, I invite the Commission to state, in a written reply, its views concerning this complaint and, in particular, to the questions listed in the Annex 1 to this letter, by 15 January 2026. Please note that I intend to share your reply with the complainant and publish it.

I have also decided that it is necessary to inspect the documents listed in Annex 2 to this letter. Information or documents that the Commission considers to be confidential will not be disclosed to the complainant or any other person without the prior agreement of the Commission. [5] The Commission is invited to provide the requested documents by 27 October 2025.

In case of any questions, the Commission’s staff can contact Mr Michał Krajewski, the inquiries officer responsible for this inquiry.

Yours sincerely, 

Teresa Anjinho
European Ombudsman

Strasbourg, 26/09/2025

 

Annex 1: Questions about the Commission’s role in monitoring the development of harmonised standards on AI

Background information

The Commission can request ESOs to develop harmonised standards to give effect to essential safety requirements laid down in EU legislation for products marketed in the EU. In practice, adhering to harmonised standards can be the only way for economic operators to demonstrate compliance with the EU legislation concerning the safety of their products. For this reason, the Court of Justice has recently ruled that, although harmonised standards are developed by ESOs, that is, private organisations, these standards nonetheless “form part of EU law”.[6] Moreover, the Court has clarified that “the Commission plays a central role in the European standardisation system”.[7] In particular, the Commission must subject the work of ESOs to “detailed monitoring”[8] and verify, prior to publishing a reference to the harmonised standard in the Official Journal, whether this standard “satisfies the requirements which it aims to cover and which are set out in the corresponding Union harmonisation legislation”.[9]

Harmonised standards will play a crucial role in the implementation of the AI Act. In proposing this act, the Commission set out its desire for the EU to become the global leader in safe AI, by providing “a strong regulatory framework based on human rights and fundamental values”.[10]

In light of the Commission’s key role in the European standardisation system, as highlighted above, the Ombudsman invites the Commission to address the following issues.

Questions to the Commission

A. The Commission’s role in reviewing the process of developing harmonised standards on AI and its outcomes

In its reply to the complainant, the Commission said that it is involved in the standardisation process concerning AI much more than in other standardisation processes. At the same time, the Commission stated that it “is not responsible for the content [ESOs] produce or the way in which they produce it”.

The Ombudsman would like to obtain more information on how specifically the Commission is involved in managing and monitoring the standardisation process, and how it will review its outcomes.

As regards the process:

1. How can the Commission’s statement about the lack of its responsibility for the process and its outcomes be reconciled with the James Elliott Construction ruling, in which the Court of Justice held that the Commission must subject the work of the ESOs to “detailed monitoring” and confirm “the compliance of the final drafts of the harmonised standards, prior to their publication in the ‘C’ series of the Official Journal of the European Union”?[11]

2. How does the Commission generally ensure that its monitoring is sufficiently ‘detailed’ within the meaning of the above mentioned ruling? Does the Commission ensure that ESOs apply the Commission’s Vademecum on European Standardisation[12]? For instance, has the Commission nominated “observers and counsellors in the standardisation work”, as mentioned in the Vademecum[13]? If so, which departments of the Commission do they represent and what is their role?  

As regards the substance:

3. How will the Commission review the substance of harmonised standards concerning AI? In particular, which departments of the Commission will be involved in this review, what criteria will they apply, and how? Does the Commission have in-house expertise to perform this review and what will be the standard of review applied?

4. How will the Commission address any deficiencies that it identifies in harmonised standards delivered by CEN and CENELEC? In particular, will the Commission consider issuing its own ‘common specifications’[14] to replace deficient harmonised standards?

5. Has the Commission performed any interim reviews of the preliminary results of CEN and CENELEC’s work?

B. The transparency of the process

In its reply to the complainant, the Commission said that the meeting minutes and the list of participants of JTC 21 are shared among the participants. However, “for both personal data protection and copyright reasons, [the meeting minutes] cannot be shared broadly with the general public”.

This raises questions about the transparency of the standardisation process, with regard to the participants involved in the process, the interests they represent, and the substance of ongoing discussions.

Therefore, the Ombudsman would like to obtain more information on the following issues:

6. What are the confidentiality rules applied by CEN and CENELEC in the process of developing harmonised standards on AI?

7. What are the transparency practices applied by CEN and CENELEC in the process of developing harmonised standards on AI? Please share with the Ombudsman references to information published by CEN and CENELEC regarding the process in question.

8. What are the Commission’s views on the complainant’s argument that there is an overriding public interest in disclosure of information about the membership of JTC 21, the interest(s) they represent and their ongoing work, given the impact of the standards on fundamental rights and the legal status of the standards?

C. The inclusiveness of the standardisation process

In its reply to the complainant, the Commission said that the inclusiveness of this process is its priority, which is why it ensures funding to Annex III organisations[15], among others, to enable their participation. It also mentioned a task force on inclusivity organised by the ESOs, which is supposed to provide figures on the actors involved. Although the Commission acknowledged room for further improvement, it observed that the number of experts coming from civil society is exceptionally high in this standardisation process.

The Ombudsman would like to obtain more information on how the Commission ensures the inclusiveness of the standardisation process concerning AI:

9. How many members of the JTC 21 represent industry, private consultancies, other private entities, public authorities, civil society organisations and academic institutions? Please share with the Ombudsman any statistical data in this regard.

10. Please provide the list of the Annex III organisations that participate in the standardisation process concerning AI.

11. How has the Vademecum on European Standardisation helped Annex III organisations overcome obstacles to their effective participation in the standardisation process?

12. Please share more information about the composition and work of the task force on inclusivity.

13. Could the Commission take a position on the complainant’s suggestion to introduce rules for ESOs based on the rules for the Commission’s expert groups concerning the composition of groups, conflicts of interest, and transparency[16]?

Annex 2: Documents for inspection

Please provide the following documents for inspection:

• the results of any interim reviews of the draft harmonised standards produced by CEN and CENELEC and any documents relating to these reviews,
• transparency and confidentiality rules or policies applicable to the work of CEN and CENELEC on the harmonised standards on AI,
• a list of the names and affiliations (companies, authorities, organisations etc.) of the members of JTC 21,
• a list of the names and affiliations of the members of the task force on inclusivity,
• a list of meetings of the task force on inclusivity, including any agendas, minutes or reports,
• outcomes of the meetings of the task force on inclusivity, including any decisions taken.

 

[1] Regulation 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence, OJ L 2024/1689, https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng.

[2] https://ec.europa.eu/transparency/documents-register/detail?ref=C(2023)3215&lang=en

[3] https://jtc21.eu/

[4] https://corporateeurope.org/sites/default/files/2025-01/response-CEO-8Jan.pdf

[5] Please clearly mark such material ‘Confidential’. Encrypted emails can be sent to our dedicated mailbox. Information and documents of this kind will be deleted from the European Ombudsman’s files shortly after the inquiry has ended.

[6] Judgment of the Court of Justice of 5 March 2024, Public.Resource.Org Inc. v Commission, Case C‑588/21 P, paragraph 80, https://curia.europa.eu/juris/document/document.jsf?text=&docid=283443&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=26696941.

[7] Ibid, paragraph 72.

[8] Judgment of the Court of Justice of 27 October 2016, James Elliott Construction Limited, Case C‑613/14, paragraph 45, https://curia.europa.eu/juris/document/document.jsf?text=&docid=184891&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=26431641.

[9] Article 10(6) of Regulation 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation (...), OJ L 316/12, https://eur-lex.europa.eu/eli/reg/2012/1025/oj/eng.

[10] https://commission.europa.eu/news-and-media/news/ai-act-enters-force-2024-08-01_en

[11] Judgment of the Court of Justice of 27 October 2016, James Elliott Construction Limited, Case C‑613/14, paragraph 45, https://curia.europa.eu/juris/document/document.jsf?text=&docid=184891&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=26431641.

[12] Commission Staff Working Document - Vademecum on European Standardisation in support of Union Legislation and policies, SWD(2015) 205 final, https://single-market-economy.ec.europa.eu/single-market/european-standards/vademecum-european-standardisation_en.

[13] As foreseen in its Vademecum, ibid., Part 1, point 4.2.2., p. 12.

[14] Under Article 41 of the AI Act.

[15] That is, organisations meeting the criteria laid down in Annex III to Regulation 1025/2012 (footnote 9), such as organisations of a non-governmental and non-profit nature.

[16] https://ec.europa.eu/transparency/documents-register/detail?ref=C(2016)3301&lang=en.