AI Agents Under EU Law
Organizations: Piccadilly Labs, Association of AI Ethicists, Centro Singular de Investigación en Tecnoloxías Intelixentes da USC · Piccadilly Labs, AIQI Consortium · Centro Singular de Investigación en Tecnoloxías Intelixentes da USC · Association of AI Ethicists, BeEthical ·
Abstract
AI agents - i.e. AI systems that autonomously plan, invoke external tools, and execute multi-step action chains with reduced human involvement - are being deployed at scale across enterprise functions ranging from customer service and recruitment to clinical decision support and critical infrastructure management. The EU AI Act (Regulation 2024/1689) regulates these systems through a risk-based framework, but it does not operate in isolation: providers face simultaneous obligations under the GDPR, the Cyber Resilience Act, the Digital Services Act, the Data Act, the Data Governance Act, sector-specific legislation, the NIS2 Directive, and the revised Product Liability Directive. This paper provides the first systematic regulatory mapping for AI agent providers integrating (a) draft harmonised standards under Standardisation Request M/613 to CEN/CENELEC JTC 21 as of January 2026, (b) the GPAI Code of Practice published in July 2025, (c) the CRA harmonised standards programme under Mandate M/606 accepted in April 2025, and (d) the Digital Omnibus proposals of November 2025. We present a practical taxonomy of nine agent deployment categories mapping concrete actions to regulatory triggers, identify agent-specific compliance challenges in cybersecurity, human oversight, transparency across multi-party action chains, and runtime behavioral drift. We propose a twelve-step compliance architecture and a regulatory trigger mapping connecting agent actions to applicable legislation. We conclude that high-risk agentic systems with untraceable behavioral drift cannot currently satisfy the AI Act's essential requirements, and that the provider's foundational compliance task is an exhaustive inventory of the agent's external actions, data flows, connected systems, and affected persons.
Figures & tables
| Agent Category | Concrete Actions | External Systems | Regulatory Triggers |
| Customer Service | Receives query in natural language. Searches knowledge base. Retrieves order history from CRM. Generates response. Processes refunds or modifies orders. Escalates, creates tickets, schedules callbacks. | CRM (Salesforce, HubSpot), ticketing, payment gateway, email/chat API, knowledge base | EU AI Act Art. 50 (transparency). GDPR (personal data in queries/orders). DSA (if on platform). If integrated into credit/insurance decisions: Annex III high-risk. |
| HR / Recruitment | Screens CVs against job requirements. Ranks candidates. Schedules interviews via calendar API. Drafts rejection/progression emails. Conducts initial screening via chat. | ATS (Workday, Greenhouse), calendar API, email, internal HR database | AI ACT Annex III, point 4(a): HIGH-RISK. Full Chapter III. GDPR Art. 22 (automated decision-making). Bias management critical (prEN 18283). |
| Coding / DevOps | Takes task description. Generates code. Runs tests. Debugs. Commits to repository. Deploys to staging. Creates pull requests. Monitors CI/CD pipeline. | Git repository, CI/CD pipeline, cloud infrastructure, IDE, terminal, package managers | EU AI Act Art. 50. CRA (if code deploys to products with digital elements). prEN 18282: open-ended code execution explicitly flagged as risk. |
| Finance / Accounting | Processes invoices: extracts data from PDFs, validates against POs, routes for approval, triggers payment. Reconciles accounts. Generates reports. Detects anomalies. | ERP (SAP, Oracle), banking APIs, document management, email, accounting software | GDPR (employee/vendor data). If creditworthiness: Annex III, point 5(b), HIGH-RISK. MiFID II if investment advice. |
| Sales / Marketing | Qualifies leads. Drafts personalised outreach. Schedules meetings. Updates pipeline. Generates content (social posts, blog drafts). Manages ad campaigns. | CRM, email platform, social media APIs, ad platforms, calendar, CMS | EU AI Act Art. 50 (transparency + synthetic content marking). GDPR (profiling). DSA (if publishing on platforms). ePrivacy Directive. |
| Research / Knowledge | Searches web and internal databases. Retrieves and synthesises documents. Generates summaries, reports, competitive analyses. Patent and regulatory scans. | Web search APIs, document repos, wikis, patent databases, regulatory databases | EU AI Act Art. 50. Copyright (DSM Dir., Arts. 3--4) 7 7 7 Where the agent provider is also the GPAI model provider, the GPAI Code of Practice additional copyright obligations under Article 53(1)(c) apply at the model layer . Data Act (if connected product data). CRA (if the agent operates within or as a browser with network connectivity 8 8 8 ETSI CYBER-EUSR explicitly excluded AI-agent-enabled browsers from EN 304 617’s scope precisely because of this trigger [ 36 ] . . Lower risk unless feeding into high-risk decisions. |
| Standard | Full Title | AI Act Art. | Key Content for Agents |
| prEN 18286 | Quality Management System for AI | Art. 17 | Backbone. Identifies all essential requirements (cl. 4.4.2), selects compliance approaches (cl. 4.4.3). Post-market monitoring (cl. 9.4). Sector-specific QMS integration. |
| prEN 18228 | Risk Management for AI Systems | Art. 9 | Continuous life cycle risk management. Scope covers health, safety, and fundamental rights per Article 9 mandate. Considers level of autonomy as one of relevant characteristics. |
| prEN 18229-1 | Trustworthiness Pt.1: Logging, Transparency, Human Oversight | Art. 12–14 | Scoped to operationalise Articles 12–14 for all AI system types including autonomous multi-step systems. Covers oversight modalities and documentation of system behavior characteristics. |
| prEN 18229-2 | Trustworthiness Pt.2: Accuracy, Robustness | Art. 15 | Performance metrics, testing frameworks, adversarial resilience. Cross-references NLP and computer vision evaluation standards. |
| prEN 18284 | Dataset Quality and Governance | Art. 10 | Training/validation/test data lifecycle. Significant portions remain under development, particularly regarding Art. 10(5) (special category data). Normatively references prEN 18283 (Bias). |
| prEN 18282 | Cybersecurity for AI Systems | Art. 15(4) | AI-specific cybersecurity threat framework. Scoped to address privilege management, access control, and threat mitigation for AI system architectures including those with tool-invocation capabilities. |
| Standard | Scope | Relationship to Primary Standards |
| prEN ISO/IEC 24970 | AI System Logging | Operationalises prEN 18229-1 logging requirements. Specifies operational event recording for audit and traceability. |
| prEN ISO/IEC 23282 | NLP Evaluation Methods | Supports prEN 18229-2 accuracy/robustness for NLP-based agents. Evaluation metrics for text generation, comprehension. |
| prEN 18281 | Computer Vision Evaluation | Supports prEN 18229-2 for vision-based systems. Test protocols, dataset requirements. |
| ISO/IEC 4213 ed.2 | Functional Correctness Assessment | Supports prEN 18229-2 for classification/regression tasks. Correctness metrics, verification methods. |
| Instrument | Trigger for AI Agent Providers | Interaction with AI Act |
| GDPR (Reg. 2016/679) | Whenever agents are trained on personal data or process personal data in operation, e.g. in prompts, outputs and logs. | Art. 10(1)-(4) establishes data governance and data quality obligations relevant for personal data protection. Art. 10(5) addresses use of special category data for bias detection and correction. Data protection is woven into essential requirements. |
| Data Act (Reg. 2023/2854) | If the agent is a connected product or a related service generating data through user interaction. | Governs access rights to data generated by products/services. Applicable since September 2025. |
| DSA (Reg. 2022/2065) | If the agent operates as or within an intermediary, hosting, or platform service. | Recital 118: systemic risk compliance under DSA creates presumption of AI Act conformity for that area. Art. 9(10) permits integrated risk management. VLOP/VLOSE (45M+ EU users): mandatory systemic risk assessment. |
| CRA (Reg. 2024/2847) | If the agent is a product with digital elements or standalone software placed on the EU market with network connectivity 24 24 24 It is important to distinguish between AI software in general and a “product with digital elements” as strictly defined by the EU Cyber Resilience Act (CRA). Under Article 3 of the CRA, this refers to any software or hardware product and its remote data processing solutions, placed on the market, whose intended or foreseeable use includes a direct or indirect logical or physical data connection to a device or network. Consequently, an AI agent provided purely as a web-based service (SaaS) may fall outside the CRA’s scope unless it is embedded into distributable software or connected hardware. . | prEN 18282 states CRA conventional cybersecurity outside its scope except AI-specific. CRA and AI Act apply in parallel. M/606: 41 standards. Vulnerability reporting from Sep 2026. |
| PLD (Dir. 2024/2853) | If the agent causes damage through defective output or behaviour. | Revised PLD explicitly covers software and AI. Non-compliance with Art. 15 (accuracy) is strong evidence of product defect. Strict liability on producer. |
| NIS2 (Dir. 2022/2555) | If the agent is deployed by or serves essential/important entities under NIS2. | Cybersecurity risk management and incident reporting overlap with AI Act cybersecurity. Supply chain security for AI suppliers. |
| Law | Concrete Agent Scenario | Why Triggered | Key Obligation |
| GDPR | Customer service agent receives personal data in query, queries CRM, logs conversation, sends confirmation email. | Name, order number, address, payment data = personal data. CRM query = processing. | Lawful basis (Art. 6). Purpose limitation. Data minimisation in logs. DPIA if systematic profiling. |
| Data Act | Smart home agent monitors IoT sensors, compiles energy usage report, presents optimisation recommendations. | Smart meter and thermostat = “connected products.” Agent = “related service.” | Data access rights for user. Portability to third parties on request. |
| DSA | Content moderation agent flags post, demotes in feed, sends notification. Marketing agent publishes AI-generated reviews. | Both operate within intermediary/hosting/platform service. | Statement of reasons (Art. 17). Recommender transparency. Systemic risk assessment if VLOP. |
| CRA | Coding agent sold as standalone software (VS Code extension, CLI tool) with network connection. | Agent = “product with digital elements”: software placed on market with network connectivity. | Secure-by-design. Vulnerability reporting from Sep 2026. SBOM. Full CRA conformity by Oct 2027. |
| PLD | Financial advisory agent recommends selling based on stale data (RAG caching bug). Client incurs significant loss. | Agent output caused measurable harm. Stale data as current falls below legitimate safety expectations. | Strict liability. Art. 15 non-compliance = strong evidence of defect. |
| MDR | Clinical agent analyses patient notes, suggests differential diagnosis via FHIR API, outputs ranked conditions. | Intended purpose includes diagnosis suggestion = medical device under MDR. | Full MDR conformity assessment. AI Act Chapter III in parallel. ISO 13485. GDPR Art. 9. |
| Obligation Layer | Instrument(s) | Status | Interaction Pattern |
| AI system essential requirements | AI Act Ch. III, Sec. 2 + harmonised standards | Mandatory for high-risk. Standards create presumption once cited in OJ. | Overarching framework. Risk management under Art. 9 must integrate all layers below. |
| GPAI model obligations | AI Act Ch. V + GPAI Code of Practice | Mandatory (Art. 53–55). Code creates presumption. | Model-level. Agent provider inherits duty to integrate model limitations into system-level risk assessment. |
| Transparency | AI Act Article 50 | Mandatory for all AI systems. | Cross-cutting. Extends to all affected persons, not only direct users (Section 6.3). |
| Data protection | GDPR | Mandatory if training or operation involves personal data processing. | Integrated via AI Act Art. 10(1)-(5). Single integrated process, not parallel. |
| Product cybersecurity | CRA + M/606 (41 stds) | Products with digital elements. Vulnerability reporting Sep 2026. | Parallel to AI-specific cyber (prEN 18282). Conventional + AI-specific = dual standard sets. |
| Platform duties | DSA | If intermediary/hosting/platform. VLOP: systemic risk. | Recital 118 presumption for AI Act conformity on covered risks. Art. 9(10) permits integration. |
| Research Direction | Legislative Anchor | Key Standards | Contribution Type |
| International vs. European standards divergence for GPAI | Arts. 40, 53–55 | ISO/IEC 42001, ISO/IEC 42005, prEN 18286, Annex Z | Comparative legal-technical analysis; interoperability mapping |
| Human oversight in agentic architectures | Art. 14, Art. 97 | ISO/IEC 42105, prEN 18229-1, NIST Agent Initiative | Empirical HCI evidence base; normative interpretation; formal specification |
| Conformity assessment for continuously learning systems | Art. 43(4)–(5), Annexes VI–VII | ISO/IEC 42006, ISO/CASCO toolbox (ISO/IEC 17021-1, ISO/IEC 17065), prEN 18286 ch. 9 | Decision framework; monitoring protocol; assessor competence criteria |
| Risk taxonomy for compound AI systems | Art. 56, recital 116 | ISO/IEC 42005 Annex C, ISO/IEC 23894, ISO/IEC 42102 | Taxonomy development; composition methodology; empirical validation |
| Sandboxes as standardisation feedback infrastructure | Arts. 57–63 | All JTC 21 deliverables | Institutional design; cross-sandbox comparative study |
| Cross-standard cybersecurity requirements mapping | Art. 15(4), CRA Annex I | prEN 18282, EN 40000 series, ISO/IEC DIS 27090, ETSI EN 304 223 | Requirements mapping; gap analysis; industry compliance reference |
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