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Yes, a small or non-EU company can have obligations under the EU AI Act. Coverage follows what your business does with an AI system—placing it on the EU market, putting it into service, importing or distributing it, or using it in professional activity—not your employee count. Start by inventorying every AI feature, assigning your legal role, classifying risk, stopping prohibited uses, recording AI-literacy training and preparing evidence that can be shown to a market-surveillance authority.
As of 20 October 2026, the prohibitions and AI-literacy duties have applied since 2 February 2025, GPAI-provider duties since 2 August 2025, and the main transparency and enforcement milestone since 2 August 2026. The next material dates are 2 December 2026, 2 December 2027 and 2 August 2028.
Who the EU AI Act covers
The Act is not a “large-company only” law. A two-person startup can be covered if it develops a model for EU customers, embeds an AI function in a product sold in the EU, imports an AI system, distributes one, or uses AI as part of professional economic activity. A business outside the EU may therefore be in scope when its system is placed on the Union market, put into service in the EU, or produces outputs used in the EU. Location of incorporation and headcount are not safe exemptions.
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Identify your operator role
Record the role that applies to each system; one company can hold several roles at once.
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| Role | Typical startup example | Why it matters |
|---|---|---|
| Provider | You develop an AI model or application and make it available under your name. | You carry the product-level duties for that system, including documentation and, where relevant, conformity assessment. |
| Deployer | Your team uses a third-party model for recruiting, customer support, fraud review or another business process. | You must follow use instructions, maintain oversight and meet deployer-specific transparency, logging and monitoring duties. |
| Importer | You bring an AI system from outside the EU into the EU market. | You have checks before making the system available and must retain required evidence. |
| Distributor | You supply an AI system made by another provider. | You must verify required markings, documentation and corrective-action arrangements. |
| Product manufacturer or other operator | You integrate AI into a regulated product or operate it under another legal role. | Additional product-safety and timing rules can apply, especially for AI embedded in regulated products. |
Do not classify a vendor’s tool only by its marketing label. Note the model, API, prompt workflow, plug-in, embedded feature, decision rule and output destination separately. Save the provider name, version, contract, deployment region, users, purpose, data categories and whether a human makes the final decision.
Build the inventory and risk decision
- List every AI-enabled component. Include internally trained models, hosted APIs, chatbots, image and code generators, ranking tools, biometric functions, recommendation engines and AI hidden inside ordinary business software.
- Describe the purpose and affected people. State whether the system evaluates workers, applicants, students, borrowers, tenants, consumers or members of the public, and whether an output merely assists or determines an outcome.
- Assign the role and geography. Record where the provider and deployer are established, where the system is offered or used, and which EU users or subjects are affected.
- Apply the highest applicable category. Screen prohibited practices first, then high-risk categories, transparency duties, GPAI obligations and finally minimal-risk status.
- Write the rationale. Keep the facts, legal category, assumptions, reviewer, decision date and next-review trigger in a versioned register.
The European Commission’s entry-into-force materials describe most spam filters and AI-enabled video games as minimal risk. Those examples do not automatically make a new system minimal risk: its purpose, data, users and deployment context control the result.
Stop prohibited AI practices before deployment
Prohibited practices are the first gate in your checklist. Remove or redesign a use that manipulates people through subliminal or purposefully deceptive techniques, exploits a person’s vulnerability, or creates unfair social scoring. The Act also restricts specified predictive-policing uses. A general “human review” step does not cure a design whose underlying practice is prohibited.
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Practical screening questions
- Could the system materially distort someone’s behavior without their awareness?
- Does it target vulnerability linked to age, disability, poverty or another known condition to cause harm?
- Does it rank people across unrelated aspects of life and use that score to deny opportunities?
- Is a police or security use predicting individual criminality from profiling rather than evidence of a specific, lawful risk?
Document a “no” answer with the intended purpose, test cases and approving owner. If the answer is “yes” or uncertain, pause launch and obtain specialist legal advice rather than trying to narrow the label.
Meet AI-literacy duties
AI-literacy obligations have applied since 2 February 2025. Providers and deployers must take measures to ensure staff and other people operating systems have sufficient skills, knowledge and understanding for their role. A one-time generic slide deck is weak evidence.
What to record
- Person or role trained, business unit and date.
- Systems and versions covered, including known limitations, hallucination or error modes, security risks and prohibited uses.
- Role-specific content: prompting and verification for ordinary users; bias, escalation and human-oversight procedures for decision staff; documentation and incident duties for technical teams.
- Delivery method, trainer or course owner, assessment or practical check, score or completion result, and remedial training.
- Next review date and the event that triggers an update, such as a model change, new use case or regulatory guidance.
Keep attendance and competence records with the system inventory. Train contractors or temporary staff who operate the system, not just employees with “AI” in their job title.
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Transparency controls for chatbots and synthetic content
The main transparency and enforcement milestone began on 2 August 2026. For covered systems, users may need to be told that they are interacting with AI; synthetic audio, image, video or text may need clear labelling; and providers or deployers may need machine-readable marking or detection controls. Implement the control in the user interface and in the generation pipeline, then test that it survives export, editing and downstream publication.
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- Display a clear notice at the first interaction with a chatbot or other system that communicates directly with people, unless a documented exception applies.
- Label deepfakes and other synthetic content in a way an ordinary viewer can understand.
- Store the marking method, detector or watermark configuration, model version and test results.
- Tell staff when an AI output must be reviewed before it is sent externally or used in a decision.
- Keep screenshots, test prompts, output samples and remediation tickets as evidence.
Certain Article 50(2) marking and detection duties for systems already placed on the market have a transition deadline of 2 December 2026. Confirm whether your system qualifies for that transition; do not treat it as a general extension for newly launched systems.
When a general-purpose AI (GPAI) provider has extra work
If your startup provides a general-purpose model—rather than merely calling someone else’s model through an API—GPAI obligations have applied since 2 August 2025. Prepare a provider file that can be updated for each model version.
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Core GPAI provider file
- Technical documentation describing the model, capabilities, limitations, evaluation approach and intended integrations.
- A policy for complying with EU copyright law, including how training-data rights reservations are handled.
- A public summary of the content used to train the model, in the format required by the Commission.
- Information and cooperation processes for downstream providers integrating the model.
Systemic-risk GPAI
A GPAI model classified as presenting systemic risk has additional obligations: notify the relevant authority, perform and document systemic-risk assessment, apply mitigation, report serious incidents and maintain appropriate cybersecurity. Assign an executive owner and an independent technical reviewer; keep dated evidence when a risk assessment concludes that a threshold is or is not met.
High-risk systems: the management system you need
High-risk status generally arises in two ways: a use listed in Annex III, such as certain employment, education, essential-service, law-enforcement, migration, justice or democratic-process applications; or an AI system that is a safety component of, or itself a product covered by, specified EU product legislation. The exact classification depends on the function and context, not the fact that the system uses machine learning.
Required controls
- Risk management: identify foreseeable risks across the lifecycle, test mitigations, and reassess after incidents or major changes.
- Data governance: document data sources, relevance, representativeness, quality controls, bias testing and handling of errors.
- Technical documentation: maintain the required description of architecture, training or testing, intended purpose, performance and limitations.
- Automatic logging: retain logs needed to trace operation, inputs, outputs, overrides and incidents for the applicable period.
- Human oversight: define who can interpret outputs, intervene, stop the system and escalate a concern; provide usable controls rather than nominal approval.
- Accuracy, robustness and cybersecurity: set measurable targets, monitor drift and attacks, test failure modes and remediate deviations.
- Conformity and registration: follow the applicable conformity-assessment route, prepare the EU declaration and register the system where required before placing it on the market or putting it into service.
Annex III high-risk rules apply from 2 December 2027. High-risk AI embedded in regulated products follows the later date of 2 August 2028. Keep these tracks separate in your calendar; the later date does not postpone obligations that already apply to another role or category.
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Evidence, ownership and incident response
Market-surveillance authorities can ask how you classified and operated a system. Name an accountable owner for each evidence set and use access-controlled, versioned storage.
| Evidence set | Minimum contents | Owner |
|---|---|---|
| Inventory and classification | System identity, version, role, geography, purpose, affected groups, risk rationale and approval. | AI governance lead or compliance owner |
| Vendor due diligence | Provider documentation, contract, data-use terms, security answers, service changes and review date. | Procurement with legal/security |
| Transparency | Notices, labels, marking or detection configuration, test outputs and remediation. | Product owner |
| AI literacy | Role, course, systems covered, assessment, completion and refresh record. | People operations or training owner |
| High-risk/GPAI file | Technical documents, risk assessments, data governance, logs, evaluations, copyright policy and training-content summary where applicable. | Technical lead with compliance |
| Incidents | Detection time, affected version, impact, containment, notification decision, corrective action and closure approval. | Incident-response lead |
Define an escalation path for harmful outputs, discrimination reports, security compromise, unexplained model drift and supplier changes. Preserve the original prompt or input, output, timestamp, model version and reviewer decision where lawful and necessary. Apply retention limits and access controls to personal data in logs.
Deadlines and a 90-day implementation plan
| Date | Milestone | Startup action |
|---|---|---|
| 2 February 2025 | Prohibited-practice and AI-literacy provisions applied. | Screen uses and maintain dated, role-based training records. |
| 2 August 2025 | GPAI obligations and governance provisions applied. | Complete provider documentation, copyright policy and training-content summary; add systemic-risk controls if applicable. |
| 2 August 2026 | Transparency requirements and related enforcement powers began. | Deploy notices, labels and synthetic-content marking or detection; retain test evidence. |
| 2 December 2026 | Transition deadline for certain pre-existing Article 50(2) marking and detection duties. | Confirm eligibility and finish controls for systems already on the market. |
| 2 December 2027 | Annex III high-risk rules apply. | Complete the management system, conformity route and registration steps for covered uses. |
| 2 August 2028 | High-risk rules for AI embedded in regulated products apply. | Align AI evidence with the product’s sectoral conformity process. |
- Days 1–30: discover. Interview engineering, sales, HR, support and procurement; export software inventories; collect vendor contracts; create one record per AI function.
- Days 31–60: decide. Assign roles, screen prohibited practices, classify risk, identify GPAI status and map each control to an owner. Freeze launches with unresolved high-risk or prohibited questions.
- Days 61–90: prove. Publish notices and labels, run transparency and security tests, complete role-based training, establish incident handling and conduct an evidence review with an executive sign-off.
Refresh the checklist whenever a model, vendor, purpose, data source, market or legal classification changes. Commission guidance, the AI Office, the AI Board, national authorities and harmonised standards continue to develop implementation details.
Choosing implementation help without outsourcing accountability
An internal program gives direct control and lower recurring spend but requires staff time and specialist knowledge. A compliance platform can accelerate inventory, risk registers, versioned evidence, Article 50 monitoring and vendor integrations; check EU data residency, exportability, support for GPAI and high-risk documentation, and total cost before purchase. Neither option transfers the legal responsibility from your company.
For training, compare EU-specific currency, role-based content, completion records and coverage of deployer versus provider duties. For advisers or conformity specialists, verify jurisdiction, high-risk experience, sector knowledge, independence and the ability to update work as guidance changes. Treat availability and scope as items to confirm in writing rather than as a promise of certification or a legal outcome.
Potential penalties and governance exposure
The Commission’s Article 50 FAQ cites a maximum of €15 million or 3% of worldwide annual turnover for relevant transparency infringements. The applicable amount depends on the infringement, the operator and the authority’s assessment. Preserve evidence of good-faith controls, rapid containment and cooperation, but do not assume that a small turnover or startup status removes enforcement risk.
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