Do we need to register our AI system in the EU database?

Agriculture: AI system targeting land areas for chemical spraying

An AI system determines which areas of agricultural land are sprayed with chemicals. The intended purpose given to it by the provider is optimising the use of chemicals.

Provenance: The Commission draft guidelines of 19 May 2026 address this case when determining whether AI as a safety component falls under the Annex I product legislation. The document is a consultation version: non-binding and not yet final.

Do not limit your failure analysis to the product itself but include the environment in which it operates, because people nearby help determine whether a malfunction creates danger.

Ontwerprichtsnoeren classificatie hoog-risico AI, 19 mei 2026, bijlage over Bijlage I en productwetgeving

Agriculture: AI for yield forecasting and irrigation optimisation

An AI system is integrated into a drone or robot and used for agronomic purposes such as yield forecasting or irrigation optimisation.

Provenance: The Commission draft guidelines of 19 May 2026 address this case when determining whether AI as a safety component falls under the Annex I product legislation. The document is a consultation version: non-binding and not yet final.

Record per application why a malfunction in your setup creates no danger, because the same agronomic function can become a safety component in a different product design.

Ontwerprichtsnoeren classificatie hoog-risico AI, 19 mei 2026, bijlage over Bijlage I en productwetgeving

ATEX: AI system monitoring gas concentrations and commanding shutdown

Equipment for potentially explosive atmospheres contains an AI system intended to monitor gas concentrations and command shutdown when thresholds are exceeded.

Provenance: The Commission draft guidelines of 19 May 2026 address this case when determining whether AI as a safety component falls under the Annex I product legislation. The document is a consultation version: non-binding and not yet final.

Once you offer a system that monitors a dangerous value and itself commands an intervention, the safety function follows from your stated intended purpose, not from how reliably the system performs.

Ontwerprichtsnoeren classificatie hoog-risico AI, 19 mei 2026, bijlage over Bijlage I en productwetgeving

Gas appliances: AI optimising combustion efficiency

An AI system optimises combustion efficiency in a household gas appliance. The intended purpose is energy efficiency.

Provenance: The Commission draft guidelines of 19 May 2026 address this case when determining whether AI as a safety component falls under the Annex I product legislation. The document is a consultation version: non-binding and not yet final.

Whether an efficiency system is a safety component depends on the product design: if a malfunction can cause fire, explosion or carbon monoxide it counts, if it only raises the energy bill it does not.

Ontwerprichtsnoeren classificatie hoog-risico AI, 19 mei 2026, bijlage over Bijlage I en productwetgeving

Annex I lists legislation, not products

The draft guidelines of 19 May 2026, published for consultation and expressly non-binding, clarify that Annex I AI Act does not list individual products to be classified as high-risk, but Union harmonisation legislation regulating the safety aspects of certain products. Whether an AI system falls within the scope of Annex I therefore depends on whether the system, or the product of which it is a safety component, falls within the material scope of one of the listed legislative acts. According to the draft guidelines the list in Annex I is exhaustive; products can only be added or removed by amending the scope of the harmonisation legislation itself or by adding new harmonisation legislation to Annex I. The draft guidelines also state that through Article 6(1) the AI Act does not itself extend the scope of harmonisation legislation to new or additional products, and that the AI Act does not determine or change the risk profile of a product but builds on the sectoral risk classification. Products mentioned include machinery, toys, lifts, equipment and protective systems for potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft, cableway installations, appliances burning gaseous fuels, medical devices, in vitro diagnostic medical devices, and products in the automotive and aviation sectors.

Concept-richtsnoeren Annex I, punten (23) tot en met (26)

Section A and Section B of Annex I trigger different requirement sets

The Commission draft guidelines of 19 May 2026, which are non-binding as long as the final version has not been adopted, draw a distinction that is often missed in practice. AI systems classified as high-risk under Article 6(1) in respect of products covered by the harmonisation legislation in Section A of Annex I are subject to the requirements for high-risk systems in Section 2 of Chapter III AI Act. By contrast, for AI systems classified as high-risk under Article 6(1) in respect of products covered by the harmonisation legislation in Section B of Annex I, only Article 6(1), Articles 102 to 109 and Article 112 AI Act apply. The draft guidelines refer to Article 2(2) AI Act for this. Section A contains harmonisation legislation based on the New Legislative Framework, Section B the other Union harmonisation legislation.

Concept-richtsnoeren Annex I, punt (60), met verwijzing naar artikel 2 lid 2 AI Act

Two cumulative conditions for high-risk under Annex I

The European Commission draft guidelines of 19 May 2026, which are expressly non-binding and not final, read Article 6(1) as two cumulative conditions. First, the AI system must be intended to be used as a safety component of a product, or the AI system must itself be a product, covered by the Union harmonisation legislation listed in Annex I. Second, that product, or the AI system itself where it is the product, must be required to undergo a third-party conformity assessment. The draft guidelines state explicitly that not all AI systems that are components of regulated products are high-risk, but only the subset that satisfies both criteria.

Concept-richtsnoeren Annex I, punten (27) en (21)

The Article 6(3) filter: four exhaustive grounds, to be read narrowly

According to the non-binding draft guidelines of 19 May 2026 on the classification of high-risk AI, Article 6(3) sets out four grounds on which a provider may exempt a system from high-risk classification: performing a narrow procedural task, improving the result of a previously completed human activity, detecting decision-making patterns or deviations from prior patterns without replacing or influencing the previously completed human assessment absent proper human review, and performing a preparatory task. Paragraph (88) of this draft states these grounds are exhaustive but alternative, that there is no separate independent risk test, and that they must be interpreted narrowly because Article 6(3) is an exception to rules that among other things protect fundamental rights. Paragraph (87) states the filter applies only to systems under Article 6(2) and not to systems under Article 6(1). Paragraph (89) states a system always remains high-risk where it performs profiling. Paragraph (90) adds that the filter does not apply where the system forms part of a complex system whose combined intended purpose or joint outputs materially influence an individual decision, including agentic AI. Paragraphs (113) to (116) of this draft describe that this is a self-assessment by the provider, that Article 6(4) requires documenting the assessment before placing on the market and registering in the Article 71 EU database, and that the assessment must contain at least the intended purpose, why the system falls under Article 6(2), which Article 6(3) condition applies and why, and why the system does not perform profiling. Paragraph (117) of these draft guidelines points to Articles 80 and 99 where an authority finds a system was misclassified as non high-risk to circumvent the rules.

Concept-richtsnoeren classificatie hoog-risico AI (19 mei 2026), hoofdstuk Bijlage III, secties 2.7, 2.7.1, 2.7.3 en 2.7.4, randnummers (84) tot en met (90) en (113) tot en met (117)

prEN 18285: conformity assessment framework for AI systems

prEN 18285 (Conformity assessment framework) is the JTC 21 deliverable under M/613 covering the conformity assessment of high-risk AI systems under Article 43 and Annex VII of the AI Act. As at June 2026 the deliverable was at the drafting stage. It has not yet been published as an EN and is not cited in the Official Journal. Standardisation request M/613 was amended by Implementing Decision C(2025)3871 of 23 June 2025 and expires on 28 February 2027.