09 · Annex I Product-Safety High-Risk Track
- Base Act Annex I is from Regulation (EU) 2024/1689, Annex I. PE-CONS 30/26 amends Annex I by deleting Section A point 1, Directive 2006/42/EC, and adding Regulation (EU) 2023/1230 on machinery as Section B point 21.
- Apply from: 2 August 2028 under the Omnibus final text, pending OJ publication.
- See also: 06 · High-Risk Classification for classification logic; 08 · Annex III Use Cases for the use-case track.
Annex I is the product-safety track (Art. 6(1)). Unlike Annex III, it lists existing EU product-safety laws, not use cases. Apply from 2 August 2028 under the Omnibus final text, pending OJ publication.
Annex I is the product-safety track into high-risk classification (Article 6(1)). Unlike Annex III, it is not a list of use cases — it is a list of existing EU product-safety laws ("Union harmonisation legislation"). An AI system is high-risk under this track when both conditions hold:
- The AI system is a safety component of a product (or is itself a product) covered by one of the laws listed below, and
- That product is required to undergo third-party conformity assessment under that same law before being placed on the market.
The list is split into Section A (laws built on the New Legislative Framework) and Section B (other sectoral laws — transport, aviation, vehicles). Each entry below keeps the regulation's numbering.
Section A — New Legislative Framework legislation
| # | Plain-language sector | Legal instrument |
|---|---|---|
| 2 | Toys | Directive 2009/48/EC |
| 3 | Recreational craft & personal watercraft | Directive 2013/53/EU |
| 4 | Lifts & safety components for lifts | Directive 2014/33/EU |
| 5 | Equipment for potentially explosive atmospheres (ATEX) | Directive 2014/34/EU |
| 6 | Radio equipment | Directive 2014/53/EU |
| 7 | Pressure equipment | Directive 2014/68/EU |
| 8 | Cableway installations | Regulation (EU) 2016/424 |
| 9 | Personal protective equipment (PPE) | Regulation (EU) 2016/425 |
| 10 | Appliances burning gaseous fuels | Regulation (EU) 2016/426 |
| 11 | Medical devices | Regulation (EU) 2017/745 |
| 12 | In vitro diagnostic medical devices | Regulation (EU) 2017/746 |
Section B — Other Union harmonisation legislation
| # | Plain-language sector | Legal instrument |
|---|---|---|
| 13 | Civil aviation security | Regulation (EC) No 300/2008 |
| 14 | Two-/three-wheel vehicles & quadricycles | Regulation (EU) No 168/2013 |
| 15 | Agricultural & forestry vehicles | Regulation (EU) No 167/2013 |
| 16 | Marine equipment | Directive 2014/90/EU |
| 17 | Rail system interoperability | Directive (EU) 2016/797 |
| 18 | Motor vehicles & trailers (approval & market surveillance) | Regulation (EU) 2018/858 |
| 19 | Motor vehicles — general safety / occupant protection | Regulation (EU) 2019/2144 |
| 20 | Civil aviation (EASA) — limited to unmanned aircraft & remote-control equipment | Regulation (EU) 2018/1139 |
| 21 | Machinery | Regulation (EU) 2023/1230 |
Note on entry 20: the Annex I scope for Regulation (EU) 2018/1139 is limited to the design, production and placing on the market of unmanned aircraft (and their engines, propellers, parts, and remote-control equipment) referred to in Article 2(1)(a)–(b) of that Regulation.
Why the split matters
- Section A products follow the standard CE-marking / notified-body conformity model, so the AI Act's high-risk requirements are designed to be integrated into the existing assessment rather than duplicated.
- Section B covers transport and vehicle sectors largely governed by their own type-approval regimes; the AI Act coordinates with these rather than overriding them.
Cross-references
| Topic | Reference |
|---|---|
| Classification rules (Art. 6(1)) | Art. 6 · 06 · High-Risk Classification |
| Conformity assessment via notified bodies | Arts. 43–49 · 07 · Conformity Assessment |
| Annex III use-case track | 08 · Annex III Use Cases |
| Harmonised-product special provisions | Art. 6(1), Art. 8(2) |