Legal framework

The rules an AI system has to meet

Before an agent goes into real work, we check it against these laws, regulations and standards. Not all of them apply to every system — for each one we note when it applies and from which date.

Last reviewed: 15.10.2026 Items: 41

How to read this list

Almost always affects almost every business AI system Depends on the case applies under certain conditions — see "When"
In forcePartly in forceUpcomingIn progress

European level

Almost alwaysPartly in force

Artificial Intelligence Act

Regulation (EU) 2024/1689

The EU's core AI law: prohibited practices, AI literacy, transparency, and requirements for high-risk systems and general-purpose models.

02.02.2025
Prohibited practices and AI literacy
02.08.2025
Obligations for general-purpose AI models
02.08.2026
Transparency: disclosing chatbots, labelling generated content
02.12.2026
Machine-readable marking for generative systems placed on the market before 2 Aug 2026 · upcoming
02.12.2027
High-risk systems under Annex III · upcoming
02.08.2028
High-risk systems under Annex I (in regulated products) · upcoming
Almost alwaysIn force

Digital Omnibus on AI

Regulation (EU) 2026/1744

Amends the AI Act: postpones the high-risk deadlines, clarifies the AI literacy duty and adds a new prohibition.

27.07.2026
In force
Almost alwaysIn force

General Data Protection Regulation (GDPR)

Regulation (EU) 2016/679

Lawful basis, data minimisation, security and the rights of people whose data the system processes. Affects almost every business AI system.

25.05.2018
Applies
Depends on the caseIn force

Transfers of personal data outside the EU

GDPR, Chapter V

The EU–US Data Privacy Framework and standard contractual clauses: the legal basis for sending data to cloud models outside the EEA.

When: When the model or cloud processes data outside the EEA (for example in the US).

27.06.2021
Standard contractual clauses (2021/914)
10.07.2023
EU–US Data Privacy Framework (2023/1795)
Depends on the caseIn force

ePrivacy Directive

Directive 2002/58/EC

Cookies and access to information on the user's device. Implemented in Bulgaria through the Electronic Communications Act.

When: When the AI runs on a website or app: chat widgets, cookies, tracking.

31.10.2003
Transposition deadline
Depends on the caseIn force

NIS2 Directive

Directive (EU) 2022/2555

Cyber-risk management, supply-chain security and incident reporting. In Bulgaria, through the Cybersecurity Act.

When: When the client is an essential or important entity under NIS2, or supplies one.

18.10.2024
Applies in the EU
Depends on the caseIn force

Data Act

Regulation (EU) 2023/2854

Access to and sharing of data from connected products, fair contract terms and switching between cloud providers.

When: When the system uses data from connected devices or cloud data-processing services.

12.09.2025
Applies
12.09.2026
Design requirements for new connected products
Depends on the casePartly in force

Cyber Resilience Act

Regulation (EU) 2024/2847

Mandatory cybersecurity requirements for products with digital elements, including software, across their whole life cycle.

When: When the AI solution is placed on the market as a product (software or device).

11.09.2026
Reporting of actively exploited vulnerabilities and incidents
11.12.2027
All requirements · upcoming
Depends on the caseUpcoming

Product Liability Directive

Directive (EU) 2024/2853

Explicitly covers software and AI systems. Until Bulgaria transposes it, Section IV (Art. 130 ff.) of the Consumer Protection Act applies.

When: When the system is offered as a product and could cause damage.

09.12.2026
Transposition deadline; for products placed on the market after this date · upcoming
Depends on the caseIn force

Digital Services Act (DSA)

Regulation (EU) 2022/2065

Content moderation, transparency of recommender systems and protection of users online.

When: When the system is part of an online platform or hosting service.

17.02.2024
Fully applicable
Depends on the caseIn force

European Accessibility Act

Directive (EU) 2019/882

Accessibility requirements for products and services for people with disabilities, including chatbots and customer interfaces.

When: When the AI serves consumers in e-commerce, banking, transport, e-books and similar services.

28.06.2025
Applies
Depends on the caseIn force

General Product Safety Regulation

Regulation (EU) 2023/988

Safety of consumer products, including risks from software updates and connectivity.

When: When the AI is part of a consumer product.

13.12.2024
Applies
Depends on the caseUpcoming

Platform Work Directive

Directive (EU) 2024/2831

Rules on algorithmic management of people: transparency, human oversight and the right to review automated decisions.

When: When the system assigns, evaluates or manages people's work through a digital platform.

02.12.2026
Transposition deadline · upcoming
Depends on the caseIn force

DORA — Digital Operational Resilience Act

Regulation (EU) 2022/2554

ICT risk management and oversight of third-party ICT providers in the financial sector.

When: When the client is a bank, insurer, investment firm or other financial entity.

17.01.2025
Applies
Depends on the caseIn force

Medical devices (MDR and IVDR)

Regulations (EU) 2017/745 and 2017/746

Software, including AI, with a medical purpose is a medical device and must pass a conformity assessment.

When: When the system has a medical or diagnostic purpose.

26.05.2021
MDR applies
26.05.2022
IVDR applies (with transitional periods)
Depends on the caseUpcoming

Machinery Regulation

Regulation (EU) 2023/1230

Safety requirements for machinery, including machines with self-learning safety functions.

When: When the AI controls or protects a machine or industrial equipment.

20.01.2027
Applies · upcoming

Bulgarian level

Almost alwaysIn progress

National authorities under the AI Act

Council of Ministers Decision 398/2025

The fundamental-rights authorities are designated (including the data protection, consumer protection and anti-discrimination commissions). According to BTA, the Communications Regulation Commission is national coordinator. Market-surveillance authorities are not yet designated.

18.06.2025
Fundamental-rights authorities designated
Almost alwaysIn force

Personal Data Protection Act

Personal Data Protection Act

Supplements the GDPR in Bulgaria: powers of the data protection commission, special processing cases and penalties.

01.01.2002
In force (last amended: SG No. 69/2026)
Depends on the caseIn force

Cybersecurity Act

Cybersecurity Act

Transposes NIS2 in Bulgaria: risk-management measures, incident reporting, supplier security.

When: When the client is in scope of NIS2 or supplies an in-scope entity.

13.11.2018
Promulgated
13.02.2026
NIS2 amendments (SG No. 17/2026)
Depends on the caseIn force

Electronic Communications Act

Electronic Communications Act

Implements the ePrivacy Directive, including the rules on cookies and storing information on the user's device.

When: When the AI runs on a website or app.

22.05.2007
Promulgated (last amended: SG No. 66/2026)
Depends on the caseIn force

Protection against Discrimination Act

Protection against Discrimination Act

Prohibits direct and indirect discrimination, including where a decision is made or prepared by an algorithm.

When: When the system takes part in decisions about people: hiring, credit, pricing, access to services.

01.01.2004
In force (last amended: SG No. 88/2026)
Depends on the caseIn force

Labour Code

Labour Code

Employee rights, workplace monitoring, and informing and consulting employees.

When: When the system affects employees: hiring, evaluation, monitoring, assigning work.

01.01.1987
In force
Depends on the caseIn force

Copyright and Related Rights Act

Copyright and Related Rights Act

Rights in the content a system is trained on or produces; implements the text-and-data-mining exception.

When: When the system uses or produces protected content.

01.08.1993
In force
Depends on the caseIn force

Electronic Commerce Act

Electronic Commerce Act

Information online providers must give, commercial communications and concluding contracts electronically.

When: When the AI is part of an online service or sale.

24.12.2006
In force
Depends on the caseIn force

Consumer Protection Act

Consumer Protection Act

Unfair commercial practices, consumer information and liability for damage caused by defective goods (Section IV, Art. 130 ff.).

When: When the AI interacts with consumers or is part of a product for them.

10.06.2006
In force (last amended: SG No. 87/2026)
Almost alwaysIn force

Obligations and Contracts Act

Obligations and Contracts Act

Contractual and tort liability: who is responsible when an AI system makes a mistake or causes harm.

01.01.1951
In force
Almost alwaysIn force

Trade Secrets Protection Act

Trade Secrets Protection Act

Protection of confidential business information, which matters when company data is sent to external AI models.

05.04.2019
Promulgated (SG No. 28/2019)

Guidelines and standards

Almost alwaysIn force

Guidelines of the European Commission and the AI Office

European Commission / AI Office

Interpret the AI Act: the AI-system definition, prohibited practices and obligations for general-purpose models. Draft guidelines on high-risk classification (May 2026) are expected in final form by the end of 2026.

02.2025
Guidelines on the definition and on prohibited practices
07.2025
Guidelines on general-purpose models
Depends on the caseIn force

General-Purpose AI Code of Practice

Code of Practice

Voluntary code on transparency, copyright and safety. It binds model providers directly; for us it is a criterion when choosing a model.

When: When choosing or providing a general-purpose model.

10.07.2025
Published
Almost alwaysIn force

Opinions and guidelines of the European Data Protection Board

EDPB

How GDPR applies to AI models: legitimate interest, model anonymity, consequences of unlawful training, web scraping.

17.12.2024
Opinion 28/2024 on AI models
07.2026
Guidelines 03/2026 on web scraping for generative AI
Almost alwaysIn force

Positions and guidance of the Commission for Personal Data Protection

CPDP

Bulgaria's GDPR supervisory authority and a fundamental-rights authority under the AI Act.

—
Ongoing publications
Depends on the caseIn force

ISO/IEC 42001 — AI management system

ISO/IEC 42001:2023

International certifiable standard for managing AI responsibly within an organisation.

When: Voluntary; recommended for larger or regulated clients.

12.2023
Published
Depends on the caseIn force

ISO/IEC 27001 — information security

ISO/IEC 27001:2022

The information security management system the AI solution has to fit into.

When: Voluntary; often required by clients and under NIS2.

10.2022
Published
Depends on the caseIn force

ISO/IEC 23894 — AI risk management

ISO/IEC 23894:2023

Guidance on identifying, assessing and reducing AI-related risks.

When: Voluntary; useful for any risk assessment.

02.2023
Published
Depends on the caseIn force

ISO/IEC 42005 — AI system impact assessment

ISO/IEC 42005:2025

How to assess an AI system's impact on people and society before and during use.

When: Voluntary; useful for systems that affect people.

2025
Published
Depends on the caseIn progress

Harmonised standards under the AI Act

CEN-CENELEC JTC 21

Will give a presumption of conformity for high-risk systems. Not yet published; the Commission expects the first in 2026.

When: When the system is high-risk.

2026
First standards expected · upcoming

Contractual terms

Depends on the caseIn force

API provider’s terms of service

API

Data retention, whether your data is used for training, ownership of outputs and permitted uses.

When: When a cloud model is used (Anthropic, OpenAI, Microsoft, Google, etc.).

—
Depends on the current version of the terms

Which of these rules apply to your system?

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This page is for information only and is not legal advice. We review it every two weeks; for a specific case, consult a lawyer.