The Role of the European Commission in the Control of Harmonised Standards Under the AI Act and the Challenges of “Opacity”

Abstract

This article examines the role of the European Commission in the European standardisation process, with a specific focus on the development of harmonised standards under the AI Act. Such standards, historically used in product safety regulation, are developed through a peculiar co-regulatory model (the New Legislative Framework). Thereby, private bodies, the European Standardisation Organisations (ESOs), draft technical standards that, once controlled by the Commission for compliance with the underlying legislation and subsequently referenced in the Official Journal, acquire binding public law relevance through the presumption of conformity. The latter allows products which respect the referenced harmonised standards to enter the internal market without the need for additional proof of compliance with the legislative requirements. While this model has long raised rule of law concerns, the AI Act presents an unprecedented challenge by requiring ESOs to design standards that not only safeguard health and safety but also protect fundamental rights—an inherently vague, value-laden, and contested task. The article argues that the Commission’s control over draft standards is the last crucial “public law check” in the European standardisation process. By retracing the evolution of this control before and after the CJEU’s James Elliott ruling and interpreting the Standardisation Regulation historically, systematically, and teleologically, the contribution demonstrates that Commission oversight is a fundamental step in the process which the Commission ought to carry out with adequate depth, so as to prevent the transfer of indirect normative power to private actors. Against the backdrop of delays in AI standardisation and pressure to operationalise the AI Act swiftly, the article warns against a “rubber stamping” approach and highlights the heightened importance of meaningful Commission scrutiny when standards affect not only market functioning but also the protection of fundamental rights and the very legitimacy of the EU legal order.