Annex II: List of Union Harmonisation Legislation (Section B)
Annex II lists the Union harmonisation legislation under which AI systems that are safety components of products, or are themselves products, trigger high-risk classification under Article 6(2). Unlike Annex I (Section A — existing product laws where third-party conformity assessment already exists), Annex II Section B lists legislation where the AI system itself becomes high-risk because it is a safety component requiring third-party conformity assessment. This annex is the second pillar of the product-based high-risk classification pathway.
Who does this apply to?
- -Providers of AI systems that are safety components of products covered by Annex II legislation
- -Manufacturers integrating AI into products subject to Annex II harmonisation laws
- -Notified bodies assessing conformity under the listed legislation
Scenarios
A manufacturer develops an AI-based collision avoidance system embedded in a toy drone regulated under Directive 2009/48/EC (toy safety). The AI system is a safety component.
An AI-powered pressure monitoring system is integrated into equipment covered by Directive 2014/68/EU (pressure equipment). The AI controls safety-critical release valves.
What Annex II covers (plain terms)
Annex II lists Union harmonisation legislation where AI systems may be safety components of products or products themselves that require third-party conformity assessment. When an AI system falls under one of these listed laws AND requires third-party assessment under that law, it is automatically classified as high-risk under Article 6(2).
The key legislation listed includes directives and regulations covering: - Toy safety (Directive 2009/48/EC) - Recreational craft (Directive 2013/53/EU) - Lifts (Directive 2014/33/EU) - Equipment for explosive atmospheres (ATEX) (Directive 2014/34/EU) - Radio equipment (Directive 2014/53/EU) - Pressure equipment (Directive 2014/68/EU) - Cableway installations (Regulation (EU) 2016/424) - Personal protective equipment (Regulation (EU) 2016/425) - Gas appliances (Regulation (EU) 2016/426) - Machinery (Regulation (EU) 2023/1230)
Always verify the exact list on EUR-Lex Annex II — the Commission may update it via delegated acts.
Annex I vs Annex II — the two product-based classification paths
| | Annex I (Section A) | Annex II (Section B) | |---|---|---| | Reference | Article 6(1) — first classification pathway | Article 6(2) — second classification pathway | | Trigger | AI system is a product or safety component under the listed law | AI system is a product or safety component under the listed law | | Additional condition | Must be high-risk under Annex III or the product itself requires third-party conformity assessment | Requires third-party conformity assessment under the listed law | | Integration with product law | Article 8(2) allows integrated conformity procedures | Article 8(2) likewise allows integration |
Both paths lead to the same Chapter III high-risk obligations (Articles 8-15, 16-27).
How Annex II connects to the rest of the Act
- Article 6(2) — The classification trigger that references Annex II.
- Article 8 — Compliance with Section 2 requirements, including product-law integration.
- Annex I — Section A: the companion product-law list for Article 6(1).
- Annex III — Stand-alone high-risk areas (not product-based).
- Article 7 — Commission power to amend Annex III (and indirectly update classification criteria).
- Article 43 — Conformity assessment procedures that apply to Annex II-classified systems.
Official text: key entries in Annex II
Editorial note: The following summarises the types of legislation listed. For the exact references including directive/regulation numbers and amendments, see EUR-Lex Annex II.
Section B of Annex II lists other Union harmonisation legislation not already covered in Section A of Annex I. It covers product categories where AI may serve as a safety component but which follow different conformity assessment frameworks. The Commission may add or remove entries via delegated acts under Article 7.
Compliance checklist
- Identify whether your AI system is a safety component of a product covered by Annex II legislation.
- Confirm whether the product requires third-party conformity assessment under the listed law — this triggers Article 6(2).
- If triggered: apply full Chapter III Section 2 requirements (Articles 8-15).
- Map overlap between AI Act and product-law conformity requirements — Article 8(2) permits integration.
- Engage a notified body competent for both the product law and AI Act assessment.
- Check EUR-Lex for any delegated acts updating Annex II since the original publication.
- Document the classification analysis in your conformity file (Annex IV).
Check if your product triggers Annex II classification—free assessment.
Start Free AssessmentRelated Articles
Article 6: Classification Rules for High-Risk Systems
Article 7: Amendments to Annex III
Article 8: Compliance with the requirements
Annex I: Union Harmonisation Legislation — Product Law List
Annex III: High-Risk AI System Areas
Annex IV: Technical Documentation for High-Risk AI Systems
Article 43: Conformity Assessment for High-Risk AI Systems
Article 113: Entry into Force and Application Dates
Related annexes
- Annex I — Union harmonisation legislation (Section A)
- Annex III — High-risk areas (stand-alone classification)
Frequently asked questions
What is the difference between Annex I and Annex II?
Annex I Section A lists product laws for the Article 6(1) high-risk pathway (often where CE marking and third-party assessment already exist). Annex II Section B lists additional product laws for the Article 6(2) pathway where AI as a safety component requires third-party assessment.
Can the Commission update Annex II?
Yes, through delegated acts under Article 7, the Commission can add or remove legislation from Annex II to keep the high-risk classification aligned with market developments.
Does every AI in a product on the Annex II list become high-risk?
Only if the AI system is itself a safety component AND the product requires third-party conformity assessment under the listed legislation. Not every AI feature in a listed product qualifies.