Euroopa Komisjoni digiõiguse lihtsustamise Omnibus pakett

Euroopa Komisjoni digiõiguse lihtsustamise Omnibus pakett (KOM(2025)836, KOM(2025)837)

Otsuse ettepanek koordinatsioonikogule

Kujundada seisukoht

Kaasvastutaja sisendi tähtpäev 18.12.2025

KOKi esitamise tähtpäev 07.01.2026

VV esitamise tähtpäev 15.01.2026

Peavastutaja Justiits- ja digiministeerium, kaasvastutajad Majandus- ja kommunikatsiooniministeerium, Rahandusministeerium, Kliimaministeerium, Sotsiaalministeerium, Välisministeerium, Kaitseministeerium, Kultuuriministeerium, Haridus- ja teadusministeerium, Regionaal- ja põllumajandusministeerium, Siseministeerium ning Riigikantselei julgeoleku ja riigikaitse koordinatsioonibüroo.

Seisukoha valitsusse toomise alus ja põhjendus

Algatuse reguleerimisala nõuab vastavalt Eesti Vabariigi põhiseadusele seaduse või Riigikogu otsuse vastuvõtmist, muutmist või kehtetuks tunnistamist (RKKTS § 152¹ lg 1 p 1);

Algatuse vastuvõtmisega kaasneks oluline majanduslik või sotsiaalne mõju (RKKTS § 152¹ lg 1 p 2);

Sisukokkuvõte

Ettepanek koosneb kahest eelnõust: esimene käsitleb ELi tehisintellekti määruse muudatusi (KOM(2025) 836) ning teine hõlmab andmealase õigusraamistiku, isikuandmete kaitse üldmääruse (IKÜM) ja küberintsidentidest teavituste muudatusi (KOM(2025) 837). Ettepaneku eesmärk on lihtsustada EL õigusaktidest tulenevaid nõudeid ning vähendada halduskoormust.

1) Tehisintellekti määruse muudatused. Muudatuste eesmärk on muuta tehisintellekti määruse rakendamine ettevõtetele lihtsamaks, ilma et nõrgendataks põhiõiguste kaitset ja turvalisuse taset. Kõige olulisem muudatus puudutab suure riskiga TI süsteemide nõuete rakendumise ajakava. Kuna vajalikud rahvusvahelised standardid ei valmi õigeaegselt, siis seotakse suure riskiga TI süsteemide nõuete kohaldumine vajalike standardite ja juhiste valmimisega kuni 16 kuud: III lisa süsteemidele 2027. aasta detsember ja I lisa süsteemidele 2028. aasta august. Ettepanek sisaldab ka muid muudatusi, mille eesmärk on tõhustada

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järelevalvet ning lihtsustada nõuete täitmist ja vastavuse tagamist, sealhulgas teatud erisuste laiendamine VKEdele ning väikestele keskmise turukapitalisatsiooniga ettevõtjatele).

2) Andmealane õigusraamistik. Praegune õigusraamistik on killustunud, mistõttu teeb komisjon ettepaneku koondada andmeid puudutavad õigusaktid (avaandmete direktiiv, andmehalduse määrus, isikustamata andmete vaba liikumise määrus) ühtseks raamistikuks andmemääruses. Lisaks leevendatakse teatavaid nõudeid, näiteks kaotatakse andmevahendusteenuse osutajate teavitamiskohustus, kitsendatakse B2G andmevahetuse kohaldamisala, luuakse mõningad erandid pilveteenuste vahetamise nõuetesse ning tugevdatakse ärisaladuse kaitset.

Isikuandmete kaitse üldmäärus. Muudatuste eesmärk on ühtlustada ja lihtsustada määruse kohaldamist, muuta IKÜMi järgimine ettevõtjatele lihtsamaks ning viia õigusraamistik kooskõlla viimase Euroopa Kohtu kohtupraktikaga, vähendamata seejuures isikuandmete kaitse taset. Muudetakse isikuandmete määratlust ning täpsustatakse, et ettevõtted võivad kasutada isikuandmeid AI arendamiseks, kui selleks on olemas õigustatud huvi. Lisaks soovitakse ettepanekuga vähendada küpsisebännerite arvu ning luua süsteem, kus kasutaja saab anda oma nõusoleku ühe klikiga.

Küberintsidentidest teavitamine. Mitmed ELi õigusaktid (nii horisontaalsed kui sektoripõhised) nõuavad küberintsidentidest teavitamist (nt NIS2, IKÜM, eIDAS, CER, DORA) ning samast intsidendist tuleb vahel raporteerida erinevatele asutustele eri liikmesriikides, kasutades seejuures erinevaid vorme. Komisjoni ettepanek on luua ühtne teavituskanal (single-entry-point), mida hakkab arendama ja haldama ELi Küberturvalisuse Amet (ENISA). Ettepaneku eesmärk on muuta küberintsidentidest teavitamine sujuvamaks, seejuures kehtivatesse nõuetesse sisulisi muudatusi tegemata.

Mõju ja sihtrühm

Mõju valdkonnad

Majandus

Ettevõtlus

Sihtrühm: Ettevõtjad

Mõju sihtrühmale: Edendatakse ettevõtlust. Ettevõtetele prognoositakse 2029. aastaks kulude kokkuhoidu 5 miljardi euro ulatuses.

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Halduskoormus

Kas lahendusega kaasneb mõju halduskoormusele? Jah

Kas ettevõtetele halduskoormus: Kahaneb

Kaasamine

Kaasata algatustega seotud huvigrupid.

    Resolutsiooni liik: Riigikantselei resolutsioon Viide: Justiits- ja Digiministeerium /  / ; Riigikantselei /  / 2-5/25-02177

Resolutsiooni teema: Euroopa Komisjoni digiõiguse lihtsustamise Omnibus pakett

Adressaat: Justiits- ja Digiministeerium Ülesanne: Tulenevalt Riigikogu kodu- ja töökorra seaduse § 152` lg 1 p 2 ning Vabariigi Valitsuse reglemendi § 3 lg 4 palun valmistada ette Vabariigi Valitsuse seisukoha ja otsuse eelnõu järgneva algatuse kohta, kaasates seejuures olulisi huvigruppe ja osapooli:

- Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI), COM(2025) 836

- Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2016/679, (EU) 2018/1724, (EU) 2018/1725, (EU) 2023/2854 and Directives 2002/58/EC, (EU) 2022/2555 and (EU) 2022/2557 as regards the simplification of the digital legislative framework, and repealing Regulations (EU) 2018/1807, (EU) 2019/1150, (EU) 2022/868, and Directive (EU) 2019/1024 (Digital Omnibus), COM(2025)837

EISi toimiku nr: 25-0581 Tähtaeg: 02.01.2026

Adressaat: Haridus- ja Teadusministeerium, Kaitseministeerium, Kliimaministeerium, Kultuuriministeerium, Majandus- ja Kommunikatsiooniministeerium, Rahandusministeerium, Regionaal- ja Põllumajandusministeerium, Riigikantselei, Siseministeerium, Sotsiaalministeerium, Välisministeerium Ülesanne: Palun esitada oma sisend Justiits- ja Digiministeerium seisukohtade kujundamiseks antud eelnõu kohta (eelnõude infosüsteemi (EIS) kaudu). Tähtaeg: 18.12.2025

Lisainfo: Eelnõu on kavas arutada valitsuse 15.01.2026 istungil ja Vabariigi Valitsuse reglemendi § 6 lg 6 kohaselt sellele eelneval nädalal (07.01.2026) EL koordinatsioonikogus. Esialgsed materjalid EL koordinatsioonikoguks palume esitada hiljemalt 02.01.2026. 

Kinnitaja: Merli Vahar, Euroopa Liidu asjade direktori asetäitja Kinnitamise kuupäev: 28.11.2025 Resolutsiooni koostaja: Sandra Metste [email protected],  

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EN EN

EUROPEAN COMMISSION

Brussels, 19.11.2025

COM(2025) 836 final

2025/0359 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the simplification

of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on

AI)

{SWD(2025) 836 final}

(Text with EEA relevance)

EN 1 EN

EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

In its Communication on a Simpler and Faster Europe (1), the Commission announced its

commitment to an ambitious programme to promote forward-looking, innovative policies that

strengthen the European Union’s (EU) competitiveness and lighten the regulatory burdens on

people, businesses and administrations, while maintaining the highest standard in promoting

its values.

Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024

laying down harmonised rules on artificial intelligence (‘AI Act’), which entered into force on

1 August 2024, establishes a single market for trustworthy and human-centric artificial

intelligence (‘AI’) across the EU. Its purpose is to promote innovation and the uptake of AI

while ensuring a high level of protection for health, safety, and fundamental rights, including

democracy and the rule of law.

The AI Act’s entry into application occurs in stages, with all rules entering into application by

2 August 2027. The prohibitions on AI practices with unacceptable risks and the obligations

for general-purpose AI models are already applicable. However, most provisions – in

particular those governing high-risk AI systems – will only start to apply from 2 August 2026

or 2 August 2027. These provisions include detailed requirements for data governance,

transparency, documentation, human oversight, and robustness, so as to ensure that AI

systems placed on the EU market are safe, transparent, and reliable.

The Commission is committed to a clear, simple, and innovation-friendly implementation of

the AI Act, as set out in the AI Continent Action Plan (2) and the Apply AI Strategy (3).

Initiatives such as the General-Purpose AI Code of Practice, Commission guidelines and

templates, the AI Pact and the launch of the AI Act Service Desk build clarity regarding the

applicable rules and support for their application. In particular, the website through which the

AI Act Service Desk is provided offers a single information platform (4) on all resources

available to stakeholders to navigate the AI Act, including guidelines, national authorities and

support initiatives, webinars, and harmonised standards. These efforts will continue, with

further guidance and digital tools under preparation.

Building on experience gained from the implementation of already applicable provisions, the

Commission held a series of consultations, including a public consultation to identify potential

challenges with implementing the AI Act’s provisions, a call for evidence in preparation of

the Digital Omnibus, a reality check allowing stakeholders to directly share their

implementation experiences and an SME panel to identify their particular needs in the

implementation of the AI Act.

1 COM(2025) 47 final. 2 COM(2025)165 final. 3 COM(2025) 723 final. 4 https://ai-act-service-desk.ec.europa.eu/

EN 2 EN

These consultations reveal implementation challenges that could jeopardise the effective

entry into application of key provisions of the AI Act. These include delays in designating

national competent authorities and conformity assessment bodies, as well as a lack of

harmonised standards for the AI Act’s high-risk requirements, guidance, and compliance

tools. Such delays risk significantly increasing the compliance costs for businesses and public

authorities and slowing down innovation.

To address these challenges, the Commission is proposing targeted simplification measures

to ensure timely, smooth, and proportionate implementation of certain of the AI Act’s

provisions. These include:

• linking the implementation timeline of high-risk rules to the availability of

standards or other support tools;

• extending regulatory simplifications granted to small and medium-sized

enterprises (SMEs) to small mid-caps (SMCs), including simplified technical

documentation requirements and special consideration in the application of penalties;

• requiring the Commission and the Member States to foster AI literacy instead

enforcing unspecified obligation on providers and deployers of AI systems in this

respect, while training obligations for high-risk deployers remain;

• offering more flexibility in the post-market monitoring by removing a

prescription of a harmonised post-market monitoring plan;

• reducing the registration burden for providers of AI systems that are used in high-

risk areas but for which the provider has concluded that they are not high-risk as they

are only used for narrow or procedural tasks;

• Centralising oversight over a large number of AI systems built on general-purpose

AI models or embedded in very large online platforms and very large search engines

with the AI Office;

• facilitating compliance with the data protection laws by allowing providers and

deployers of all AI systems and models to process special categories of personal data

for ensuring bias detection and correction, with the appropriate safeguards;

• a broader use of AI regulatory sandboxes and real-world testing, that will benefit

European key industries such as the automotive industry, and facilitating an EU-level

AI regulatory sandbox which the AI Office will set up as from 2028;

• targeted changes clarifying the interplay between the AI Act and other EU

legislation and adjusting the AI Act’s procedures to improve its overall

implementation and operation.

Beyond the legislative measures, the Commission is taking further measures to facilitate

compliance with the AI Act and address the concerns raised by stakeholders. Further

guidance is under preparation, focusing on offering clear and practical instructions to apply

the AI Act in parallel with other EU legislation. This includes:

• Guidelines on the practical application of the high-risk classification;

• Guidelines on the practical application of the transparency requirements under

Article 50 AI Act;

• Guidance on the reporting of serious incidents by providers of high-risk AI systems;

• Guidelines on the practical application of the high-risk requirements;

EN 3 EN

• Guidelines on the practical application of the obligations for providers and deployers

of high-risk AI systems;

• Guidelines with a template for the fundamental rights impact assessment;

• Guidelines on the practical application of rules for responsibilities along the AI value

chain;

• Guidelines on the practical application of the provisions related to substantial

modification;

• Guidelines on the post-market monitoring of high-risk AI systems;

• Gudelines on the elements of the quality management system which SMEs and

SMCs may comply with in a simplified manner;

• Guidelines on the AI Act’s interplay with other Union legislation, for example joint

guidelines of the Commission and European Data Protection Board on the interplay

of the AI Act and EU data protection law, guidelines on the interplay between the AI

Act and the Cyber Resilience Act, and guidelines on the interplay between the AI

Act and the Machinery Regulation;

• Guidelines on the competences and designation procedure for conformity assessment

bodies to be designated under the AI Act.

In particular, stakeholder consultations reveal the need to offer guidance on the practical

application of the AI Act’s research exemptions under Article 2(6) and (8), including how

they apply in sectoral contexts like in the pre-clinical research and product development in the

field of medicinal products or medical devices, which the Commission will work on with

priority.

These simplification efforts will help to ensure that the implementation of the AI Act is

smooth, predictable, and innovation-friendly, enabling Europe to strengthen its position as the

AI continent and to pursue an AI-first approach safely.

• Consistency with existing policy provisions in the policy area

The proposal is part of a broader Digital Package on Simplification composed of measures to

reduce the administrative costs of compliance for businesses and administrations in the EU,

which applies to several regulations of the EU’s digital acquis without compromising the

objectives of the underlying rules. The proposal builds on Regulation (EU) 2024/1689 and is

aligned with existing policies to make the EU a global leader in AI, to make the EU an AI

continent and to promote the uptake of human-centric and trustworthy a AI.

• Consistency with other Union policies

The proposal is part of a series of simplification packages.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

The legal basis for this proposal is Article 114 of the Treaty on the Functioning of the

European Union (TFEU) in line with the original legal basis for the adoption of the legal acts

which this proposal aims to amend.

EN 4 EN

• Subsidiarity (for non-exclusive competence)

Regulation (EU) 2024/1689 was adopted at EU level. Accordingly, amendments to that

Regulation need to be made at EU level.

• Proportionality

The initiative does not go beyond what is necessary to achieve the objectives of simplification

and burden reduction without lowering the protection of health, safety and fundamental rights.

• Choice of the instrument

The proposal amends Regulation (EU) 2024/1689 adopted by ordinary legislative procedure.

Therefore, the amendments to that Regulation also must be adopted by regulation in

accordance with the ordinary legislative procedure.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER

CONSULTATIONS AND IMPACT ASSESSMENTS

• Ex-post evaluations/fitness checks of existing legislation

The proposal is accompanied by a Commission staff working document that provides a

detailed overview of the impact of the proposed amendments to certain provisions of

Regulation (EU) 2024/1689. It also provides an analysis of the positive impacts of the

proposed measures. The analysis is based on existing data, information gathered through

consultations and during a reality check and through written stakeholder feedback through a

call for evidence.

• Stakeholder consultations

Several consultations were carried out in the context of the proposal. They all complemented

one another, addressing either different topical issues or stakeholder groups concerned by the

initiative.

In the initial scoping phase of the Digital Package on Simplification, three public

consultations and calls for evidence were published on the key strands of the proposal in the

spring of 2025. A consultation was held on the Apply AI Strategy from 9 April to 4 June 2025

(5), another on the revision of the Cybersecurity Act from 11 April to 20 June 2025 (6), and

finally another on the European Data Union Strategy from 23 May to 20 July 2025 (7). Each

consultation included a questionnaire with a section (or at times multiple) on implementation

and simplification concerns, directly related to the reflections on the Digital Package on

Simplification. Taken together, 718 responses were received as part of this first consultation

exercise.

5 European Commission (2025) Call for evidence on the Apply AI Strategy. Available at: Apply AI

Strategy – strengthening the AI continent 6 European Commission (2025) Call for evidence on the revision of the Cybersecurity Act. Available at:

The EU Cybersecurity Act 7 European Commission (2025) Call for evidence on the European Data Union Strategy. Available at:

European Data Union Strategy

EN 5 EN

From 16 September to 14 October 2025, a call for evidence on the Digital Package on

Simplification was further published (8). Its aim was to cover the whole scope of the initiative

and give an opportunity to stakeholders to comment on a more targeted set of proposals in one

go. A total of 513 responses were received, by a wide range of stakeholders.

With a view to raising awareness on the Digital Package on Simplification among small and

medium-sized enterprises (SMEs), and collecting their feedback, a dedicated SME Panel was

organised through the Enterprise Europe Network (EEN) between 4 September and 16

October 2025. The EEN is the world’s largest support network for SMEs and is implemented

by the Commission’s European Innovation Council and SMEs Executive Agency (EISMEA).

SME Panels are a way to consult stakeholders falling under this framework. SMEs have the

opportunity to contribute their views to upcoming policy initiatives. In addition to the online

written consultation (where 106 SMEs’ responses were received), the Commission also

presented the Digital Package on Simplification to SME associations part of the EEN, in a

meeting that took place on 1 October 2025.

A large number of bilateral meetings were organised by the Commission services with

stakeholders in 2025, to address specific concerns. Discussions were also held with Member

States. In addition to bilateral exchanges, specific agenda points on the Digital Simplification

Package were discussed at Council Working Parties in June and September 2025, where the

Commission presented the current situation and asked Member States’ to express their views.

Overall, stakeholder feedback converged on the need for a simplified application of some of

the digital rules. Better coherence, and a focus on optimisation of compliance costs, was

largely supported by a cross-section of stakeholders. Some differences in opinion were

expressed regarding some of the more tailored measures. A more detailed overview of these

stakeholder consultations, and how they were reflected in the proposal can be found in the

staff working document accompanying the Digital Package on Simplification.

• Collection and use of expertise

In addition to the consultation outlined above, the Commission mainly relied on its own

internal analysis for the purpose of this proposal.

• Impact assessment

The amendments put forward in the proposal are technical in nature. They are designed to

ensure a more efficient implementation of rules that were already agreed at political level.

There are no policy options that could meaningfully be tested and compared in an impact

assessment report.

The accompanying staff working document examines the reasoning behind the amendments

and outlines the views of stakeholders on the different measures. It also presents the costs

savings and other types of impacts the proposal may entail. In many cases, it builds on the

impact assessments that was originally carried out for the Regulation (EU) 2024/1689.

8 European Commission (2025) Call for evidence on the digital package and omnibus. Available at:

Simplification – digital package and omnibus

EN 6 EN

The staff working document therefore serves as a reference point to inform the European

Parliament and the Council’s debate on the proposal, as well as the public, in a clear and

engaged way.

• Regulatory fitness and simplification

The proposal aims to produce a significant reduction in administrative burden for businesses,

national administrations, and the public at large. Initial estimates project possible savings of ≈

EUR 297.2 to 433.2 million. Non-quantifiable benefits are also expected, notably due to a

streamlined set of rules which will ease compliance and enforcement thereof.

SMEs already benefit from regulatory privileges under Regulation (EU) 2024/1689. Some

regulatory privileges already afforded to SMEs are extended to small mid-caps (SMCs). Since

SMEs and SMCs are disproportionality more impacted by the compliance burden, it is

expected that they will particularly benefit from these simplification measures.

The proposal is consistent with the Commission’s ‘Digital Fitness Check for the digital

rulebook’, which aims to ensure properly aligned policy proposals with real-world digital

environments (see Chapter 4 on Legislative and Financial Digital Statement).

• Fundamental rights

Regulation (EU) 2024/1689 is expected to promote the protection of a number of fundamental

rights and freedoms set out in the EU Charter of Fundamental Rights (9), as well as positively

impacting the rights of a number of special groups (10). At the same time, the Regulation (EU)

2024/1689 imposes some restrictions on certain rights and freedoms (11), which are

proportionate and limited to the minimum necessary. The proposal is not expected to modify

the impact of the Regulation (EU) 2024/1689 on fundamental rights since the targeted nature

of envisaged amendments do not affect the scope of the regulated AI systems or on the

substantive requirements applicable to those systems.

4. BUDGETARY IMPLICATIONS

The proposal amends the supervision and enforcement system of Regulation (EU) 2024/1689,

whereby oversight over certain AI systems will be transferred to the Commission’s AI Office.

In addition, to facilitate compliance by operators, the AI Office should set up an EU-level AI

regulatory sandbox. To implement these new tasks, to the Commission will need the

appropriate resources, which is estimated to stand at 53 FTE, of which 15 FTE can be covered

9 In detail: the right to human dignity (Article 1), respect for private life and protection of personal data

(Articles 7 and 8), non-discrimination (Article 21) and equality between women and men (Article 23),

freedom of expression (Article 11) and freedom of assembly (Article 12), right to an effective remedy

and to a fair trial, the rights of defence, and the presumption of innocence (Articles 47 and 48), right to

a high level of environmental protection and the improvement of the quality of the environment (Article

37). 10 In detail: workers’ rights to fair and just working conditions (Article 31), a high level of consumer

protection (Article 28), the rights of the child (Article 24) and the integration of persons with disabilities

(Article 26). 11 In detail: the freedom to conduct business (Article 16) and the freedom of art and science (Article 13).

EN 7 EN

by internal redeployment. These implications have to be considered against the backdrop of

reduced budgetary implications for the Member States which no longer have to ensure the

oversight for those certain AI systems. A detailed overview of the costs involved in this

transfer of competences is provided in the ‘Legislative and Financial Digital Statement’

accompanying this proposal.

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

The Commission will monitor the implementation, application, and compliance with the new

provisions. Furthermore, the Regulation that is amended by this proposal is regularly

evaluated for its efficiency, effectiveness in reaching its objectives, relevance, coherence and

value added in line with the EU’s better regulation principles. This proposal does not require

an implementation plan.

• Explanatory documents (for directives)

Not applicable.

• Detailed explanation of the specific provisions of the proposal

Article 1 amends Regulation (EU) 2024/1689 (‘AI Act’). In particular,

• Paragraph 1 adds a reference to SMCs in the subject matter of the AI Act.

• Paragraph 2 is a technical change that is necessary to enable extending the real-world

testing to high-risk AI systems embedded in products covered under Section B of

Annex I AI Act.

• Paragraph 3 adds legal definitions for SME and SMC to the definitions in Article 3

of the AI Act.

• Paragraph 4 transforms the obligation for providers and deployers of AI systems with

regards to AI literacy in Article 4 AI Act to an obligation on the Commission and the

Member States to foster AI literacy.

• Paragraph 5 introduces a new Article 4a, replacing Article 10(5) AI Act, which

provides a legal basis for providers and deployers of AI systems and AI models to

exceptionally process special categories of personal data for the purpose of ensuring

bias detection and correction under certain conditions.

• Paragraphs 6, 14 and 32 refer to the deletion of the obligation for providers to

register AI systems in the EU database for high-risk systems under Annex III, where

they have been exempted from classification as high-risk under Article 6(3) AI Act,

because they are for instance only used for preparatory tasks.

• Paragraph 7 contains editorial follow-up changes to amendments made by paragraph

4.

• Paragraphs 8 and 9 extend existing regulatory privileges of the AI Act for SMEs to

SMCs on technical documentation and putting in place a quality management system

that takes into account their size.

• Paragraph 10 introduces a new procedure in Article 28 AI Act, whereby Member

States are required to ensure that a conformity assessment body that applies for

designation both under this Regulation and Union harmonization legislation listed in

EN 8 EN

Section A of Annex I AI Act shall be provided with the possibility to submit a single

application and undergo a single assessment procedure to be designated.

• Paragraph 11 proposes to replace paragraph 4 of Article 29 AI Act which requires

conformity assessment bodies to submit a single application in the cases to which

reference is made in that paragraph.

• Paragraph 12 amends Article 30 AI Act by requiring conformity assessment bodies

which apply to be designated as notified bodies to make that application in

accordance with the codes, categories, and corresponding types of AI systems

referred to in a new Annex XIV for the Commission’s New Approach Notified and

Designated Organisations (‘NANDO’) information system, and empowers the

Commission to amend these codes, categories, and corresponding types in light of

technological developments.

• Paragraph 13 clarifies the conformity assessment procedure laid down in Article 43

AI Act where a high-risk AI system is covered by Union harmonisation legislation

listed under Section A of Annex I to the AI Act and where an AI system is classified

as high-risk both under Annex I and Annex III to the AI Act.

• Paragraphs 15 and 16 remove the Commission empowerments in Articles 50 and 56

AI Act to adopt implementing acts to give codes of practice for general purpose AI

models and transparency obligations for certain AI systems general validity in the

Union.

• Paragraph 17 introduces amendments to the rules on AI regulatory sandboxes in

Article 57 AI Act, inter alia, by providing the legal basis for the AI Office to

introduce an AI regulatory sandbox on EU level for certain AI systems within its

exclusive competence of supervision and require Member States to strengthen cross-

border cooperation of their sandboxes.

• Paragraph 18 specifies the empowerment of the Commission to adopt implementing

acts specifying the detailed arrangements for the establishment, development,

implementation, operation, governance and supervision of AI regulatory sandboxes.

• Paragraph 19 introduces changes to the testing of high-risk AI systems in real world

conditions outside AI regulatory sandboxes as governed by Article 60 AI Act, inter

alia extending this opportunity to high-risk AI systems covered by Section A of

Annex I.

• Paragraph 20 creates an additional legal basis for interested Member States and the

Commission, on voluntary basis, to enter into written agreements to test high-risk AI

systems referred to in Section B of Annex I in real world-conditions.

• Paragraph 21 extends the derogation from micro-enterprises to SMEs to comply with

certain elements of the quality management system required by Article 17 AI Act in

a simplified manner.

• Paragraph 22 removes an empowerment of the Commission in Article 69 AI Act to

adopt an implementing act in relation to the reimbursement of experts of the

scientific panel when called upon by Member States, to simplify the procedure.

• Paragraph 23 extends the focus of guidance which national authorities may provide

from SMEs to SMCs.

• Paragraph 24 replaces the empowerment of the Commission in Article 72 AI Act to

adopt an implementing act with regard to the post-market monitoring plan.

EN 9 EN

• Paragraph 25 makes amendments to the supervision and enforcement of certain AI

systems in Article 75 AI Act:

• Point (a) changes the heading.

• Point (b) reinforces the competence of the AI Office for the supervision and

enforcement of certain AI systems, that are based on a general-purpose AI

model, where the model and the system are provided by the same provider. At

the same time, the provision clarifies that AI systems related to products

covered under Annex I are not included in that supervision. Moreover, it is

clarified that the supervision and enforcement of the compliance of AI systems

embedded in designated very large online platforms or very large online search

engines should fall under the competence of the AI Office.

• Point (c) introduces several new paragraphs, empowering the Commission to

adopt implementing acts to define the enforcement powers and the procedures

for the exercise of those powers of the AI Office, introducing a reference to

Regulation (EU) 2019/1020 ensuring certain procedural safeguards apply to

providers covered and empowering the Commission to carry out conformity

assessments of AI systems within the scope of Article 75.

• Paragraph 26 amends Article 77 AI Act as regards the powers of authorities or

bodies protecting fundamental rights and cooperation with market surveillance

authorities.

• Paragraphs 27 and 28 extends provisions in Articles 95 and 96 that require that

voluntary support tools should take into account the needs of SMEs to SMCs.

• Paragraph 29 extends existing regulatory privileges in Article 99 AI Act on penalties

for SMEs to SMCs.

• Paragraph 30 contains amendments to Article 111 AI Act which result from

amendments made in paragraph 30 and introduces a transitional period of 6 months

for providers who need to retroactively include technical solutions in their generative

AI systems, to make them machine readable and detectable as artificially generated

or manipulated.

• Paragraph 31 introduces changes to the entry into application of certain provisions of

the AI Act:

• For the obligations for high-risk AI systems in Chapter III, a mechanism is

introduced that links the entry into application to the availability of measures in

support of compliance with the AI Act’s high-risk rules, such as harmonised

standards, common specifications, and Commission guidelines. This

availability will be confirmed by the Commission by decision, following which

the rules for high-risk AI systems start to apply after an appropriate transition

period. However, this flexibility should apply only for a limited time and a

definite date by which the rules apply in any case should be set. Moreover, it is

appropriate to distinguish between the two types of AI systems that classify as

high-risk and extend a longer transition period to AI systems that classify as

high-risk pursuant to Article 6(1) and Annex I to the AI Act.

• It is clarified that the amendments necessary to integrate the high-risk

requirements into sectoral law listed in Section B of Annex I apply with the

Digital Omnibus’ entry into force.

EN 10 EN

• Paragraph 33 is related to the change in paragraph 11 and introduces a new Annex

XIV setting out codes, categories, and corresponding types of AI systems referred to

in a new Annex XIV for the Commission’s New Approach Notified and Designated

Organisations (‘NANDO’) information system.

Article 2 makes amendments with regards to Regulation (EU) 2018/1139, to allow a smooth

integration of the AI Act’s high-risk requirements into that Regulation.

Article 3 provides the rule of entry into force and the binding nature of this Regulation.

EN 11 EN

2025/0359 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the simplification

of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on

AI)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular

Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee1,

Having regard to the opinion of the Committee of the Regions2,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) Regulation (EU) 2024/1689 of the European Parliament and of the Council3 lays down

harmonised rules on artificial intelligence (AI) and aims to improve the functioning of

the internal market, to promote the uptake of human-centric and trustworthy artificial

intelligence, while ensuring a high level of protection of health, safety and

fundamental rights, and supporting innovation. Regulation (EU) 2024/1689 entered

into force on 1 August 2024. Its provisions enter into application in a staggered

manner, with all rules entering into application by 2 August 2027.

(2) The experience gathered in implementing the parts of Regulation (EU) 2024/1689 that

have already entered into application can inform the implementation of those parts that

are yet to apply. In this context, the delayed preparation of standards, which should

provide technical solutions for providers of high-risk AI systems to ensure compliance

with their obligations under that regulation, and the delayed establishment of

1 OJ C , , p. . 2 OJ C , , p. . 3 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying

down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No

167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives

2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689,

12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).

EN 12 EN

the governance and the conformity assessment frameworks at national level result in a

compliance burden that is heavier than expected. In addition, consultations of

stakeholders have revealed the need for additional measures that facilitate and provide

clarification on the implementation and compliance, without reducing the level of

protection for health, safety and fundamental rights from AI-related risks that the rules

of Regulation (EU) 2024/1689 seek to achieve.

(3) Consequently, targeted amendments to Regulation (EU) 2024/1689 are necessary to

address certain implementation challenges, with a view to the effective application of

the relevant rules.

(4) Enterprises outgrowing the micro, small and medium-sized enterprises (‘SME’)

definition – the ‘small mid-cap enterprises’ (‘SMCs’) – play a vital role in the Union’s

economy. Compared to SMEs, SMCs tend to demonstrate a higher pace of growth,

and level of innovation and digitisation. Nevertheless, they face challenges similar to

SMEs in relation to administrative burden, leading to a need for proportionality in the

implementation of Regulation (EU) 2024/1689 and for targeted support. To enable the

smooth transition of enterprises from SMEs into SMCs, it is important to address in a

coherent manner the effect that regulation may have on their activity once those

enterprises outgrow the segment of SMEs and are faced with rules that apply to large

enterprises. Regulation (EU) 2024/1689 provides for several measures for small-scale

providers, which should be extended to SMCs. In order to clarify the treatment of

SMEs and SMCs in Regulation (EU) 2024/1689, it is necessary to introduce

definitions for SMEs and SMCs, which should correspond to the definition set out in

the Annex to Commission Recommendation 2003/361/EC4 and Annex to Commission

Recommendation 2025/3500/EC5.

(5) Article 4 of Regulation (EU) 2024/1689 currently imposes an obligation on all

providers and deployers of AI systems to ensure AI literacy of their staff. AI literacy

development starting from education and training and continuing in a lifelong learning

manner is crucial to equip providers, deployers and other affected persons with the

necessary notions to make informed decisions regarding AI systems deployment.

However, experience shared by stakeholders reveals that a one-size-fits-all solution is

not suitable for all types of providers and deployers in relation to the promotion of AI

literacy, rendering such a horizontal obligation ineffective in achieving the objective

pursued by this provision. Moreover, data indicate that imposing such an obligation

creates an additional compliance burden, particularly for smaller enterprises, whereas

AI literacy should be a strategic priority, regardless of regulatory obligations and

potential sanctions. In light of that, Article 4 of Regulation (EU) 2024/1689 should be

amended to require the Member States and the Commission, without prejudice to their

respective competences, to individually, collectively and in cooperation with relevant

stakeholders encourage providers and deployers to provide a sufficient level of AI

literacy of their staff and other persons dealing with the operation and use of AI

4 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-

sized enterprises (OJ L 124, 20.5.2003, pp. 36–41, ELI: http://data.europa.eu/eli/reco/2003/361/oj). 5 Commission Recommendation (EU) 2025/1099 of 21 May 2025 on the definition of small mid-cap

enterprises (OJ L, 2025/1099, 28.5.2025, ELI: http://data.europa.eu/eli/reco/2025/1099/oj).

EN 13 EN

systems on their behalf, including through offering training opportunities, providing

informational resources, and allowing exchange of good practices and other non-

legally binding initiatives. The European Artificial Intelligence Board (‘Board’) will

ensure recurrent exchange between the Commission and Member States on the topic,

while the Apply AI Alliance will allow discussion with the wider community. This

amendment is without prejudice to the broader measures taken by the Commission and

the Member States to promote AI literacy and competences for the wider population,

including learners, students, and citizens at different ages and in particular through

education and training systems.

(6) Bias detection and correction constitute a substantial public interest because they

protect natural persons from biases’ adverse effects, including discrimination.

Discrimination might result from the bias in AI models and AI systems other than

high-risk AI systems for which of Regulation (EU) 2024/1689 already provides a legal

basis authorising the processing of special categories of personal data under Article

9(2), point (g), of Regulation (EU) 2016/679 of the European Parliament and of the

Council6. Given that discrimination might result also from those other AI systems and

models, it is therefore appropriate that Regulation (EU) 2024/1689 should provide for

a legal basis for the processing of special categories of personal data also by providers

and deployers of other AI systems and AI models as well as deployers of high-risk AI

systems. The legal basis is established in compliance with Article 9(2), point (g) of

Regulation (EU) 2016/679 Article 10(2), point (g) of Regulation (EU) 2018/1725 of

the European Parliament and of the Council7 and Article 10, point (a) of Directive

(EU) 2016/680 of the European Parliament and of the Council8 provides a legal basis

allowing, where necessary for the detection and removal of bias, the processing of

special categories of personal data by providers and deployers of all AI systems and

models, subject to appropriate safeguards that complement Regulations (EU)

2016/679, Regulation (EU) 2018/1725 and Directive (EU) 2016/680, as applicable.

(7) In order to ensure consistency, avoid duplication and minimise administrative burdens

in relation to the procedure for designating notified bodies under Regulation (EU)

2024/1689, while maintaining the same level of scrutiny, a single application and a

single assessment procedure should be available for new conformity assessment

6 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the

protection of natural persons with regard to the processing of personal data and on the free movement of

such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016,

p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj). 7 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the

protection of natural persons with regard to the processing of personal data by the Union institutions,

bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No

45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39, ELI:

http://data.europa.eu/eli/reg/2018/1725/oj). 8 Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the

protection of natural persons with regard to the processing of personal data by competent authorities for

the purposes of the prevention, investigation, detection or prosecution of criminal offences or the

execution of criminal penalties, and on the free movement of such data, and repealing Council

Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, pp. 89–131, ELI:

http://data.europa.eu/eli/dir/2016/680/oj).

EN 14 EN

bodies and notified bodies which are designated under the Union harmonisation

legislation listed in Section A of Annex I to Regulation (EU) 2024/1689, such as under

Regulations (EU) 2017/7459 and (EU) 2017/74610 of the European Parliament and of

the Council, where such a procedure is established under that Union harmonisation

legislation. The single application and assessment procedure aims at facilitating,

supporting and expediting the designation procedure under Regulation (EU)

2024/1689, while ensuring compliance with the requirements applicable to notified

bodies under that Regulation and the Union harmonisation legislation listed in Section

A of Annex I thereto.

(8) With a view to ensuring the smooth application and consistency of Regulation (EU)

2024/1689, amendments should be made to it. A technical correction to Article 43(3),

first subparagraph, of Regulation (EU) 2024/1689 should be added to align the

conformity assessment requirements with the requirements of providers of high-risk

AI systems in Article 16 of that Regulation. Moreover, it should be clarified that

where a provider of a high-risk AI system is subject to the conformity assessment

procedure under Union harmonisation legislation listed in Section A of Annex I to

Regulation (EU) 2024/1689, and the conformity assessment extends to compliance of

the quality management system of that Regulation and of such Union harmonisation

legislation, the provider should be able to include aspects related to quality

management systems under that Regulation as part of the quality management systems

under such Union harmonisation legislation, in line with Article 17(3) of Regulation

(EU) 2024/1689. Article 43(3), second subparagraph, should be amended to clarify

that notified bodies which have been notified under the Union harmonisation

legislation listed in Section A of Annex I to Regulation (EU) 2024/1689 and which

aim to assess high-risk AI systems covered by the Union harmonisation legislation

listed in Section A of Annex I to that Regulation, should apply for the designation as a

notified body under that Regulation within 18 months from [the entry into application

of this Regulation]. This amendment is without prejudice to Article 28 of Regulation

(EU) 2024/1689. Moreover, Regulation (EU) 2024/1689 should be amended to clarify

that where a high-risk AI system is both covered by the Union harmonisation

legislation listed in Section A of Annex I to Regulation (EU) 2024/1689 and falls

within one of the use-cases listed in Annex III to that Regulation, the provider should

follow the relevant conformity assessment procedure as required under that relevant

harmonisation legislation.

(9) To streamline compliance and reduce the associated costs, providers of AI systems

should not be required to register AI systems referred to in Article 6(3) of Regulation

(EU) 2024/1689 in the EU database pursuant to Article 49(2) of that Regulation.

Given that such systems are not considered high-risk under certain conditions where

9 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical

devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No

1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1,

ELI: http://data.europa.eu/eli/reg/2017/745/oj). 10 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro

diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

(OJ L 117, 5.5.2017, p. 176, ELI: http://data.europa.eu/eli/reg/2017/746/oj).

EN 15 EN

they do not pose significant risk of harm to the health, safety or fundamental rights of

persons, imposing registration requirements would constitute a disproportionate

compliance burden. Nevertheless, a provider who considers that an AI system falls

under Article 6(3) remains obligated to document its assessment before that system is

placed on the market or put into service. This assessment may be requested by national

competent authorities.

(10) Articles 57, 58 and 60 of Regulation (EU) 2024/1689 should be amended to strengthen

further cooperation at Union level of AI regulatory sandboxes, foster clarity and

consistency in the governance of AI regulatory sandboxes, and to extend the scope of

real-world testing outside AI regulatory sandboxes to high-risk AI systems covered by

the Union harmonisation legislation listed in Annex I to that Regulation. In particular,

to allow procedural simplification, where applicable, in the projects supervised in the

AI regulatory sandboxes that include also real-world testing, the real-world testing

plan should be integrated in the sandbox plan agreed by the providers or prospective

providers and the competent authority in a single document. In addition, it is

appropriate to provide for the possibility of the AI Office to establish an AI regulatory

sandbox at Union level for AI systems that are covered by Article 75(1) of Regulation

(EU) 2024/1689. By leveraging these infrastructures and facilitating cross-border

collaboration, coordination would be better streamlined and resources optimally

utilised.

(11) To foster innovation, it is also appropriate to extend the scope of real-world testing

outside AI regulatory sandboxes in Article 60 of Regulation (EU) 2024/1689,

currently applicable to high-risk AI systems listed in Annex III to that Regulation, and

allow providers and prospective providers of high-risk AI systems covered by the

Union harmonisation legislation listed in Annex I to that Regulation to also test such

systems in real-world conditions. This is without prejudice to other Union or national

law on the testing in real-world conditions of high-risk AI systems related to products

covered by that Union harmonisation legislation. To address the specific situation of

high-risk AI systems covered the Union harmonisation legislation listed in Section B

of Annex I to that Regulation, it is necessary to allow the conclusion of voluntary

agreements between the Commission and Member States to enable testing of such

high-risk AI systems in real-world conditions.

(12) Article 63 of Regulation (EU) 2024/1689 offers microenterprises who are providers of

high-risk AI systems the possibility to benefit from a simplified way to comply with

the obligation to establish a quality management system. With a view to facilitating

compliance for more innovators, that possibility should be extended to all SMEs,

including start-ups.

(13) Article 69 of Regulation (EU) 2024/1689 should be amended to simplify the fee

structure of the scientific panel. If Member States call upon the panel’s expertise, the

fees they may be required to pay the experts should be equivalent to the remuneration

the Commission is obliged to pay in similar circumstances. Furthermore, to reduce the

procedural complexity, Member States should be able to consult the experts of the

scientific panel directly, without involvement of the Commission.

(14) In order to strengthen the governance system for AI systems based on general-purpose

AI models, it is necessary to clarify the role of the AI Office in monitoring and

supervising compliance of such AI systems with Regulation (EU) 2024/1689, while

excluding AI systems related to products covered by the Union harmonisation

legislation listed in Annex I to that Regulation. While sectoral authorities continue to

EN 16 EN

remain responsible for the supervision of AI systems related to products covered by

that Union harmonisation legislation, Article 75(1) Regulation (EU) 2024/1689 should

be modified to bring all AI systems based on general-purpose AI models developed by

the same provider within the scope of the AI Office's supervision. This does not

include AI systems placed on the market, put into service or used by Union

institutions, bodies, offices or agencies, which are under the supervision of the

European Data Protection Supervisor pursuant to Article 74(9) of Regulation (EU)

2024/1689. To ensure effective supervision for those AI systems in accordance with

the tasks and responsibilities assigned to market surveillance authorities under

Regulation (EU) 2024/1689, the AI Office should be empowered to take the

appropriate measures and decisions to adequately exercise its powers provided for in

that Section and Regulation (EU) 2019/1020 of the European Parliament and of the

Council11. Article 14 of Regulation (EU) 2019/1020 should apply mutatis mutandis.

Furthermore, to ensure effective enforcement, the authorities involved in the

application of Regulation (EU) 2024/1689 should cooperate actively in the exercise of

those powers, in particular where enforcement actions need to be taken in the territory

of a Member State.

(15) Considering the existing supervisory and enforcement system under Regulation (EU)

2022/2065 of the European Parliament and of the Council12, it is appropriate to grant

the Commission the powers of a competent market surveillance authority under

Regulation (EU) 2024/1689 where an AI system qualifies as a very large online

platform or a very large online search engine within the meaning of Regulation (EU)

2022/2065, or where it is embedded in such a platform or search engine. This should

contribute to ensuring that the exercise of the Commission’s supervision and

enforcement powers under Regulation (EU) 2024/1689 and Regulation (EU)

2022/2065, as well as those applicable to general-purpose AI models integrated into

such platforms or search engines, are carried out in a coherent manner. In the case of

AI systems embedded in or qualifying as a very large online platform or search

engine, the first point of entry for the assessment of the AI systems are the risk

assessment, mitigating measures and audit obligations prescribed by Articles 34, 35

and 37 of Regulation (EU) 2022/2065, without prejudice to the AI Office’s powers to

investigate and enforce ex post non-compliance with the rules of this Regulation. In

the context of the analysis of this risk assessment, mitigating measures and audits, the

Commission services responsible for the enforcement of Regulation (EU) 2022/2065

may seek the opinion of the AI Office on the outcome of a potential earlier or parallel

risk assessment carried out under this Regulation and the applicability of prohibitions

under this Regulation. In addition, the AI Office and the competent national authorities

under (EU) 2024/1689 should coordinate their enforcement efforts with the authorities

11 Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market

surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No

765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1, ELI:

http://data.europa.eu/eli/reg/2019/1020/oj). 12 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a

Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L

277, 27.10.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2065/oj).

EN 17 EN

competent for the supervision and enforcement of Regulation (EU) 2022/2065,

including the Commission, in order to ensure that the principles of loyal cooperation,

proportionality and non bis in idem are respected, while information obtained under

the respective other Regulation would be used for the purposes of supervision and

enforcement of the other only provided the undertaking agrees. In particular, those

authorities should exchange views regularly and take into account, in their respective

areas of competence, any fines and penalties imposed on the same provider for the

same conduct through a final decision in proceedings relating to an infringement of

other Union or national rules, so as to ensure that the overall fines and penalties

imposed are proportionate and correspond to the seriousness of the infringements

committed.

(16) To further operationalise the AI Office’s supervision and enforcement set out in

Article 75(1) of Regulation (EU) 2024/1689, it is necessary to further define the which

of the powers listed in Article 14 of Regulation (EU) 2019/1020 should be conferred

upon the AI Office. The Commission should therefore be empowered to adopt

implementing acts to specify those powers, including the ability to impose penalties,

such as fines or other administrative sanctions, in accordance with the conditions and

ceilings referred to in Article 99, and applicable procedures. This should ensure that

the AI Office has the necessary tools to effectively monitor and supervise compliance

with Regulation (EU) 2024/1689.

(17) Additionally, it is essential to ensure that effective procedural safeguards apply to

providers of AI systems subject to monitoring and supervision by the AI Office. To

that end, the procedural rights provided for in Article 18 of Regulation (EU)

2019/1020 should apply mutatis mutandis to providers of AI systems, without

prejudice to more specific procedural rights provided for in Regulation (EU)

2024/1689.

(18) To enable access to Union market for AI systems which are under the supervision by

the AI Office pursuant to Article 75 of Regulation (EU) 2024/1689 and subject to third

party conformity assessment, the Commission should be enabled to carry out pre-

market conformity assessments of those systems.

(19) Article 77 and related provisions of Regulation (EU) 2024/1689 constitute an

important governance mechanism, as they aim to enable authorities or bodies

responsible for enforcing or supervising Union law intended to protect fundamental

rights to fulfil their mandate under specific conditions and to foster cooperation with

market surveillance authorities responsible for the supervision and enforcement of that

Regulation. It is necessary to clarify the scope of such cooperation, as well as to clarify

which public authorities or bodies benefit from it. With a view to reinforcing the

cooperation, it should be clarified that requests to access information and

documentation should be made to the competent market surveillance authority, which

should respond to such requests, and that the involved authorities or bodies should

have a mutual obligation to cooperate.

(20) To allow sufficient time for providers of generative AI systems subject to the marking

obligations laid down in Article 50(2) of Regulation (EU) 2024/1689 to adapt their

practices within a reasonable time without disrupting the market, it is appropriate to

introduce a transitional period of 6 months for providers who have already placed their

systems on the market before the 2 August 2026.

(21) To provide sufficient time for providers of high-risk AI systems and to clarify

applicable rules to the AI systems already placed on the market or put into service

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before the entry into application of relevant provisions of the Regulation (EU)

2024/1689, it is appropriate to clarify the application of a grace period provided in

Article 111(2) of that Regulation. The grace period, for the purpose of Article 111(2),

should apply to a type and model of AI systems already placed in the market. This

means that if at least one individual unit of the high-risk AI system has been lawfully

placed on the market or put into service before the date specified in Article 111(2),

other individual units of the same type and model of high-risk AI system are subject to

the grace period provided in Article 111(2) and thus may continue to be placed on the

market, made available or put into service on the Union market without any additional

obligations, requirements or the need for additional certification, as long as the design

of that high-risk AI system remains unchanged. For the purposes of application of the

grace period provided in Article 111(2), the decisive factor is the date on which the

first unit of that type and model of high-risk AI system was placed on the market or

put into service on the Union market for the first time. Any significant change to the

design of that AI system after the date specified in Article 111(2) should trigger the

obligation of the provider to comply fully with all relevant provisions of this

Regulation applicable to high-risk AI systems, including the conformity assessment

requirements.

(22) Article 113 of Regulation (EU) 2024/1689 establishes the dates of entry into force and

application of that Regulation, notably that the general date of application is 2 August

2026. For the obligations related to high-risk AI systems laid down in Sections 1, 2

and 3 of Chapter III of Regulation (EU) 2024/1689, the delayed availability of

standards, common specifications, and alternative guidance and the delayed

establishment of national competent authorities lead to challenges that jeopardise those

obligation’s effective entry into application and that risk to significantly increase

implementation costs in a way that does not justify maintaining their initial date of

application, namely 2 August 2026. Building on experience, it is appropriate to put in

place a mechanism that links the entry into application to the availability of measures

in support of compliance with Chapter III, which may include harmonised standards,

common specifications, and Commission guidelines. This should be confirmed by the

Commission by decision, following which the rules obligations for high-risk AI

systems should apply after 6 months as regards AI systems classified as high-risk

pursuant to Article 6(2) and Annex III and after 12 months as regards AI systems

classified as high-risk pursuant to Article 6(1) and Annex I to Regulation (EU)

2024/1689. However, this flexibility should only be extended until 2 December 2027

as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III

and until 2 August 2028 as regards AI systems classified as high-risk pursuant to

Article 6(1) and Annex I to that Regulation, by which dates those rules should enter

into application in any case. The distinction between the entry into application of the

rules as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex

III and Article 6(1) and Annex I to that Regulation is consistent with the difference

between the initial dates of application envisaged in Regulation (EU) 2024/1689 and

aims to provide the necessary time for adaptation and implementation of the

corresponding obligations.

(23) In light of the objective to reduce implementation challenges for citizens, businesses

and public administrations, it is essential that harmonised conditions for the

implementation of certain rules are adopted only where strictly necessary. For that

purpose, it is appropriate to remove certain empowerments bestowed on the

Commission to adopt such harmonised conditions by means of implementing acts in

cases where those conditions are not met. Regulation (EU) 2024/1689 should therefore

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be amended to remove the empowerments conferred on the Commission in Article

50(7), Article 56(6), and Article 72(3) thereof to adopt implementing acts. The

removal of the empowerment to adopt a harmonised template for a post-market

monitoring plan in Article 72(3) of Regulation (EU) 2024/1689 has as an additional

benefit that it will offer more flexibility for providers of high-risk AI systems to put in

place a system for post-market monitoring that is tailored to their organisation. At the

same time, recognising the need to offer clarity how providers of high-risk AI systems

are required to comply, the Commission should be required to publish guidance.

(24) Conformity assessment of high-risk AI systems under Regulation (EU) 2024/1689

may require involvement of conformity assessment bodies. Only conformity

assessment bodies that have been designated under that Regulation may carry out

conformity assessments and only for the activities related to the categories and types

of AI systems concerned. To enable the specification of the scope of the designation of

conformity assessment bodies notified under Article 30 of Regulation (EU)

2024/1689, it is necessary to draw up a list of codes, categories, and corresponding

types of AI systems. The list of codes should take into account whether the AI system

is a component of a product or itself a product covered by the Union harmonisation

legislation listed in Annex I (referred to as ‘AIP codes’, for AI systems covered by

product legislation) or a system referred in Annex III of Regulation (EU) 2024/1689,

which currently concerns only biometric AI systems referred to in point (1) of Annex

III (referred to as ‘AIB codes’, for biometric AI systems). Both AIP codes and AIB

codes are vertical codes. The AIP codes are reference codes to provide a link to the

Union harmonisation legislation listed in Section A of Annex I of Regulation (EU)

2024/1689. The AIB codes are new codes specific to Regulation (EU) 2024/1689 to

identify biometric AI systems referred in paragraph 1 of Annex III of that Regulation.

The list of codes should also take into account specific types and underlying

technologies of AI systems (referred to as ‘AIH codes’, for horizontal AI system

codes). The AIH codes are new AI technology-specific codes and can be applied in

conjunction with AIP or AIB vertical codes. The AIH codes cover AI systems’

underlying types and technologies. The list of codes, including three categories, should

provide for a multi-dimensional typology of AI systems which ensures that conformity

assessment bodies designated as notified bodies are fully competent for the AI systems

they are required to assess.

(25) Regulation (EU) 2018/1139 of the European Parliament and the Council13 lays down

common rules in the field of civil aviation. Article 108 of Regulation (EU) 2024/1689

sets out amendments to Regulation (EU) 2018/1139 to ensure that the Commission

takes into account, on the basis of the technical and regulatory specificities of the civil

aviation sector, and without interfering with existing governance, conformity

13 Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common

rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and

amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014

and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and

repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the

Council and Council Regulation (EEC) No 3922/91(OJ L 212, 22.8.2018, pp. 1–122, ELI:

http://data.europa.eu/eli/reg/2018/1139/oj).

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assessment and enforcement mechanisms and authorities established therein, the

mandatory requirements for high-risk AI systems laid down in Regulation (EU)

2024/1689 when adopting any relevant delegated or implementing acts on the basis of

that act. A technical correction extending specific articles of Regulation (EU)

2018/1139 is necessary to ensure that those mandatory requirements for high-risk AI

systems laid down in Regulation (EU) 2024/1689 are fully covered when adopting

relevant delegated or implementing acts on the basis of Regulation (EU) 2018/1139.

(26) In order to ensure legal certainty as soon as possible, with a view to the imminent

general application of Regulation (EU) 2024/1689, this Regulation should enter into

force as a matter of urgency,

HAVE ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EU) 2024/1689

Regulation (EU) 2024/1689 is amended as follows:

(1) in Article 1(2), point (g) is replaced by the following:

’(g) measures to support innovation, with a particular focus on small mid-cap

enterprises (SMCs) and small and medium-sized enterprises (SMEs),

including start-ups.’;

(2) in Article 2, paragraph 2 is replaced by the following:

‘2. For AI systems classified as high-risk AI systems in accordance with

Article 6(1) related to products covered by the Union harmonisation

legislation listed in Section B of Annex I, only Article 6(1), Article 60a,

Articles 102 to 109 and Articles 111 and 112 shall apply. Article 57 shall

apply only in so far as the requirements for high-risk AI systems under

this Regulation have been integrated in that Union harmonisation

legislation.;

(3) in Article 3, the following points (14a) and (14b) are inserted:

‘(14a) micro, small and medium-sized enterprise (‘SME’) means a micro, small

or medium-sized enterprise as defined in Article 2 of the Annex to

Commission Recommendation 2003/361/EC;

(14b) small mid-cap enterprise (‘SMC’) means a small mid-cap enterprise as

defined in point (2) of the Annex to Commission Recommendation (EU)

2025/1099’;

(4) Article 4 is replaced by the following:

‘ Article 4

AI literacy

‘The Commission and Member States shall encourage providers and deployers

of AI systems to take measures to ensure a sufficient level of AI literacy

of their staff and other persons dealing with the operation and use of AI

systems on their behalf, taking into account their technical knowledge,

experience, level of education and training and the context the AI

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systems are to be used in, and considering the persons or groups of

persons on whom the AI systems are to be used.’;

(5) the following Article 4a is inserted in Chapter I:

‘Article 4a

Processing of special categories of personal data for

bias detection and mitigation

1. To the extent necessary to ensure bias detection and correction in relation to

high-risk AI systems in accordance with Article 10 (2), points (f) and (g),

of this Regulation, providers of such systems may exceptionally process

special categories of personal data, subject to appropriate safeguards for

the fundamental rights and freedoms of natural persons. In addition to the

safeguards set out in Regulations (EU) 2016/679 and (EU) 2018/1725

and Directive (EU) 2016/680, as applicable, all the following conditions

shall be met in order for such processing to occur:

(a) the bias detection and correction cannot be effectively fulfilled by

processing other data, including synthetic or anonymised data;

(b) the special categories of personal data are subject to technical limitations on

the re-use of the personal data, and state-of-the-art security and privacy-

preserving measures, including pseudonymisation;

(c) the special categories of personal data are subject to measures to ensure that

the personal data processed are secured, protected, subject to suitable

safeguards, including strict controls and documentation of the access, to

avoid misuse and ensure that only authorised persons have access to

those personal data with appropriate confidentiality obligations;

(d) the special categories of personal data are not transmitted, transferred or

otherwise accessed by other parties;

(e) the special categories of personal data are deleted once the bias has been

corrected or the personal data has reached the end of its retention period,

whichever comes first;

(f) the records of processing activities pursuant to Regulations (EU) 2016/679

and (EU) 2018/1725 and Directive (EU) 2016/680 include the reasons

why the processing of special categories of personal data was necessary

to detect and correct biases, and why that objective could not be achieved

by processing other data.

2. Paragraph 1 may apply to providers and deployers of other AI systems and

models and deployers of high-risk AI systems where necessary and

proportionate if the processing occurs for the purposes set out therein and

provided that the conditions set out under the safeguards set out in this

paragraph.;

(6) in Article 6(4), paragraph 4 is replaced by the following:

‘4. A provider who considers that an AI system referred to in Annex III is not

high-risk shall document its assessment before that system is placed on

the market or put into service. Upon request of national competent

authorities, the provider shall provide the documentation of the

assessment.’;

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(7) Article 10 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. High-risk AI systems which make use of techniques involving the training

of AI models with data shall be developed on the basis of training,

validation and testing data sets that meet the quality criteria referred to in

paragraphs 2, 3 and 4 of this Article and in Article 4a(1) whenever such

data sets are used.’;

(b) paragraph 5 is deleted;

(c) paragraph 6 is replaced by the following:

‘6. For the development of high-risk AI systems not using techniques involving

the training of AI models, paragraphs 2, 3 and 4 of this Article and

Article 4a(1) shall apply only to the testing data sets.’;

(8) in Article 11(1), the second subparagraph is replaced by the following:

‘That technical documentation shall be drawn up in such a way as to

demonstrate that the high-risk AI system complies with the requirements

set out in this Section and to provide national competent authorities and

notified bodies with the necessary information in a clear and

comprehensive form to assess the compliance of the AI system with

those requirements. It shall contain, at a minimum, the elements set out in

Annex IV. SMCs and SMEs, including start-ups, may provide the

elements of the technical documentation specified in Annex IV in a

simplified manner. To that end, the Commission shall establish a

simplified technical documentation form targeted at the needs of SMCs

and SMEs, including start-ups. Where an SMC or SME, including a start-

up, opts to provide the information required in Annex IV in a simplified

manner, it shall use the form referred to in this paragraph. Notified

bodies shall accept the form for the purposes of the conformity

assessment.’;

(9) in Article 17, paragraph 2 is replaced by the following:

‘2. The implementation of the aspects referred to in paragraph 1 shall be

proportionate to the size of the provider’s organisation, in particular, if

the provider is an SMC or an SME, including a start-up. Providers shall,

in any event, respect the degree of rigour and the level of protection

required to ensure the compliance of their high-risk AI systems with this

Regulation.’;

(10) in Article 28, the following paragraph 8 is added:

‘8. Notifying authorities designated under this Regulation responsible for AI

systems covered by the Union harmonisation legislation listed in Section

A of Annex I shall be established, organised and operated in such a way

that ensures that the conformity assessment body that applies for

designation both under this Regulation and the Union harmonisation

legislation listed in Section A of Annex I shall be provided with the

possibility to submit a single application and undergo a single assessment

procedure to be designated under this Regulation and Union

harmonisation legislation listed in Section A of Annex I, where the

EN 23 EN

relevant Union harmonisation legislation provides for such single

application and single assessment procedure.

The single application and single assessment procedure referred to in this

paragraph shall also be made available to notified bodies already

designated under the Union harmonisation legislation listed in Section A

of Annex I, when those notified bodies apply for designation under this

Regulation, provided that the relevant Union harmonisation legislation

provides for such a procedure.

The single application and single assessment procedure shall avoid any

unnecessary duplications, build on the existing procedures for

designation under the Union harmonisation legislation listed in Section A

of Annex I and ensure compliance with the requirements both relating to

notified bodies under this Regulation and the relevant Union

harmonisation legislation.’;

(11) in Article 29, paragraph 4 is replaced by the following:

‘4. For notified bodies which are designated under any other Union

harmonisation legislation, all documents and certificates linked to those

designations may be used to support and expedite their designation

procedure under this Regulation, as appropriate.

Notified bodies, which are designated under any of the Union harmonisation

legislation listed in Section A of Annex I and which apply for the single

assessment referred to in Article 28(8), shall submit the single application

for assessment to the notifying authority designated in accordance with

that Union harmonisation legislation.

The notified body shall update the documentation referred to in paragraphs 2

and 3 of this Article whenever relevant changes occur, in order to enable

the authority responsible for notified bodies to monitor and verify

continuous compliance with all the requirements laid down in

Article 31.’;

(12) in Article 30, paragraph 2 is replaced by the following:

‘2. Notifying authorities shall notify the Commission and the other Member

States, based on the list of codes, categories, and corresponding types of

AI systems referred to in Annex XIV, and using the electronic

notification tool developed and managed by the Commission, of each

conformity assessment body referred to in paragraph 1.

The Commission is empowered to adopt delegated acts in accordance with

Article 97 to amend Annex XIV, in the light of technical progress,

advances in knowledge or new scientific evidence by adding to the list of

codes, categories, and corresponding types of AI systems a new code, a

category or a type of AI system, withdrawing an existing code, category

or a type of AI system from that list or moving a code or type of AI

system from one category to another.’;

(13) in Article 43, paragraph 3 is replaced by the following:

‘For high-risk AI systems covered by the Union harmonisation legislation

listed in Section A of Annex I, the provider of the system shall follow the

relevant conformity assessment procedure as required under the relevant

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Union harmonisation legislation. The requirements set out in Section 2 of

this Chapter shall apply to those high-risk AI systems and shall be part of

that assessment. Assessment of the quality management system set out in

Article 17 and Annex VII shall also apply.

For the purposes of that conformity assessment, notified bodies which have

been notified under the Union harmonisation legislation listed in Section

A of Annex I shall have the power to assess the conformity of high-risk

AI systems with the requirements set out in Section 2, provided that the

compliance of those notified bodies with the requirements laid down in

Article 31(4), (5), (10) and (11) has been assessed in the context of the

notification procedure under the relevant Union harmonisation

legislation. Without prejudice to Article 28, such notified bodies which

have been notified under the Union harmonisation legislation in Section

A of Annex I, shall apply for designation in accordance with Section 4 at

the latest [18 months from the entry into application of this Regulation].

Where Union harmonisation legislation listed in Section A of Annex I provides

the product manufacturer with an option to opt out from a third-party

conformity assessment, provided that that manufacturer has applied

harmonised standards covering all the relevant requirements, that

manufacturer may use that option only if it has also applied harmonised

standards or, where applicable, common specifications referred to in

Article 41, covering all requirements set out in Section 2 of this Chapter.

Where a high-risk AI system is both covered by the Union harmonisation

legislation listed in Section A of Annex I and it falls within one of the

categories listed in Annex III, the provider of the system shall follow the

relevant conformity assessment procedure as required under the relevant

Union harmonisation legislation listed in Section A of Annex I.’;

(14) in Article 49, paragraph 2 is deleted;

(15) in Article 50, paragraph 7 is replaced by the following:

‘7. The AI Office shall encourage and facilitate the drawing up of codes of

practice at Union level to facilitate the effective implementation of the

obligations regarding the detection, marking and labelling of artificially

generated or manipulated content. The Commission may assess whether

adherence to those codes of practice is adequate to ensure compliance

with the obligation laid down in paragraph 2, in accordance with the

procedure laid down in Article 56(6), first subparagraph. If it deems the

code is not adequate, the Commission may adopt an implementing act

specifying common rules for the implementation of those obligations in

accordance with the examination procedure laid down in Article 98(2).’;

(16) in Article 56(6), the first subparagraph is replaced by the following:

‘6. The Commission and the Board shall regularly monitor and evaluate the

achievement of the objectives of the codes of practice by the participants

and their contribution to the proper application of this Regulation. The

Commission, taking utmost account of the opinion of the Board, shall

assess whether the codes of practice cover the obligations provided for in

Articles 53 and 55, and shall regularly monitor and evaluate the

EN 25 EN

achievement of their objectives. The Commission shall publish its

assessment of the adequacy of the codes of practice.’;

(17) Article 57 is amended as follows:

(a) the following paragraph 3a is inserted:

‘The AI Office may also establish an AI regulatory sandbox at Union level for

AI systems covered by Article 75(1). Such an AI regulatory sandbox

shall be implemented in close cooperation with relevant competent

authorities, in particular when Union legislation other than this

Regulation is supervised in the AI regulatory sandbox, and shall provide

priority access to SMEs.’;

(b) paragraph 5 is replaced by the following:

‘5. AI regulatory sandboxes established under this Article shall provide for a

controlled environment that fosters innovation and facilitates the

development, training, testing and validation of innovative AI systems

for a limited time before their being placed on the market or put into

service pursuant to a specific sandbox plan agreed between the providers

or prospective providers and the competent authority, ensuring that

appropriate safeguards are in place. Such sandboxes may include testing

in real world conditions supervised therein. When applicable, the

sandbox plan shall incorporate in a single document the real-world

testing plan.’;

(c) paragraph 9, point (e) is replaced by the following:

‘(e) facilitating and accelerating access to the Union market for AI systems, in

particular when provided by SMCs and SMEs, including start-ups.’;

(d) paragraph 13 is replaced by the following:

’13. The AI regulatory sandboxes shall be designed and implemented in such a

way that they facilitate cross-border cooperation between national

competent authorities.’;

(e) paragraph 14 is replaced by the following:

’14. National competent authorities shall coordinate their activities and

cooperate within the framework of the Board. They shall support the

joint establishment and operation of AI regulatory sandboxes, including

in different sectors.’;

(18) Article 58, paragraph 1, is replaced by the following:

‘1. In order to avoid fragmentation across the Union, the Commission shall

adopt implementing acts specifying the detailed arrangements for the

establishment, development, implementation, operation, governance, and

supervision of the AI regulatory sandboxes. The implementing acts shall

include common principles on the following issues:

(a) eligibility and selection criteria for participation in the AI regulatory

sandbox;

(b) procedures for the application, participation, monitoring, exiting from and

termination of the AI regulatory sandbox, including the sandbox plan and

the exit report;

EN 26 EN

(c) the terms and conditions applicable to the participants;

(d) the detailed rules applicable to the governance of AI regulatory sandboxes

covered under Article 57, including as regards the exercise of the tasks of

the competent authorities and the coordination and cooperation at

national and EU level.’;

(19) Article 60 is amended as follows:

(a) in paragraph 1, the first subparagraph is replaced by the following:

‘Testing of high-risk AI systems in real world conditions outside AI regulatory

sandboxes may be conducted by providers or prospective providers of

high-risk AI systems listed in Annex III or covered by Union

harmonisation legislation listed in Section A of Annex I, in accordance

with this Article and the real-world testing plan referred to in this Article,

without prejudice to the prohibitions under Article 5.’;

(b) paragraph 2 is replaced by the following:

‘2. Providers or prospective providers may conduct testing of high-risk AI

systems referred to in Annex III or covered by Union harmonisation

legislation listed in Section A of Annex I in real world conditions at any

time before the placing on the market or the putting into service of the AI

system on their own or in partnership with one or more deployers or

prospective deployers.’;

(20) the following Article 60a is inserted:

‘Article 60a

Testing of high-risk AI systems covered by Union harmonisation

legislation listed in Section B of Annex I in real-world conditions

outside AI regulatory sandboxes

1. Testing of high-risk AI systems in real world conditions outside AI

regulatory sandboxes may be conducted by providers or prospective

providers of AI enabled products covered by Union harmonisation

legislation listed in Section B of Annex I, in accordance with this Article

and a voluntary real-world testing agreement, without prejudice to the

prohibitions under Article 5.

2. The voluntary real-world testing agreement referred to in paragraph 1

shall be concluded in writing between interested Member States and the

Commission. It shall set the requirements for the testing of those AI-

enabled products covered by Union harmonisation legislation listed in

Section B of Annex I in real-world conditions.

3. Member States, the Commission, market surveillance authorities and

public authorities responsible for the management and operation of

infrastructure and products covered by Union harmonisation legislation

listed in Section B of Annex I shall cooperate closely with each other and

in good faith, and shall remove any practical obstacles, including on

procedural rules providing access to physical public infrastructure, where

this is necessary, to successfully implement the voluntary real-world

testing agreement and test AI-enabled products covered by Union

harmonisation legislation listed in Section B of Annex.

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4. The signatories of the voluntary real-world testing agreement, shall

specify conditions of the testing in real world conditions and establish

detailed elements of the real-world testing plan for AI systems covered

by Union harmonisation legislation listed in Section B of Annex I.

5. Article 60(2), (5) and (9) shall apply.’;

(21) Article 63(1) is replaced by the following:

‘1. SMEs, including start-ups, may comply with certain elements of the quality

management system required by Article 17 in a simplified manner. For

that purpose, the Commission shall develop guidelines on the elements of

the quality management system which may be complied with in

a simplified manner considering the needs of SMEs, without affecting the

level of protection or the need for compliance with the requirements in

respect of high-risk AI systems.’;

(22) Article 69 is amended as follows:

(a) paragraph 2 is replaced by the following:

‘2. The Member States may be required to pay fees for the advice and support

provided by the experts at a rate equivalent to the remuneration fees

applicable to the Commission pursuant to the implementing act referred

to in Article 68(1).’;

(b) paragraph 3 is deleted.

(23) in Article 70, paragraph 8 is replaced by the following:

‘8. National competent authorities may provide guidance and advice on the

implementation of this Regulation, in particular to SMCs and SMEs,

including start-ups, taking into account the guidance and advice of the

Board and the Commission, as appropriate. Whenever national

competent authorities intend to provide guidance and advice with regard

to an AI system in areas covered by other Union law, the national

competent authorities under that Union law shall be consulted, as

appropriate.’;

(24) in Article 72, paragraph 3 is replaced by the following:

‘3. The post-market monitoring system shall be based on a post-market

monitoring plan. The post-market monitoring plan shall be part of the

technical documentation referred to in Annex IV. The Commission shall

adopt guidance on the post-market monitoring plan.’;

(25) Article 75 is amended as follows:

(a) the heading of Article 75 is replaced by the following:

‘Market surveillance and control of AI systems and mutual assistance’;

(b) paragraph 1 is replaced by the following:

‘1. Where an AI system is based on a general-purpose AI model, with the

exclusion of AI systems related to products covered by the Union

harmonisation legislation listed in Annex I, and that model and that

system are developed by the same provider, the AI Office shall be

exclusively competent for the supervision and enforcement of that system

with the obligations of this Regulation in accordance with the tasks and

EN 28 EN

responsibilities assigned by it to market surveillance authorities. The AI

Office shall also be exclusively competent for the supervision and

enforcement of the obligations under this Regulation in relation to AI

system that constitute or that are integrated into a designated very large

online platform or very large online search engine within the meaning of

Regulation (EU) 2022/2065.

When exercising its tasks of supervision and enforcement under the first

subparagraph, the AI Office shall have all the powers of a market

surveillance authority provided for in this Section and in Regulation (EU)

2019/1020. The AI Office shall be empowered to take appropriate

measures and decisions to adequately exercise its supervisory and

enforcement powers. Article 14 of Regulation (EU) 2019/1020 shall

apply mutatis mutandis.

The authorities involved in the application of this Regulation shall cooperate

actively in the exercise of these powers, in particular where enforcement

actions need to be taken in the territory of a Member State.’;

(c) the following paragraphs 1a to 1c are inserted:

‘1a. The Commission shall adopt an implementing act to define the

enforcement powers and the procedures for the exercise of those powers

of the AI Office, including its ability to impose penalties, such as fines or

other administrative sanctions, in accordance with the conditions and

ceilings identified in Article 99, in relation to AI systems referenced to in

paragraphs 1 and 1a of this Article that are found to be non-compliant

with this Regulation, in the context of its monitoring and supervision

tasks under this Article.’

‘1b. Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to

providers of AI systems referred to in paragraph 1, without prejudice to

more specific procedural rights provided for in this Regulation.’

‘1c. The Commission shall organise and carry out pre-market conformity

assessments and tests of AI systems referred to in paragraph 1 that are

classified as high-risk and subject to third-party conformity assessment

under Article 43 before such AI systems are placed on the market or put

into service. These tests and assessments shall verify that the systems

comply with the relevant requirements of this Regulation and may be

placed on the market or put into service in the Union in accordance with

this Regulation. The Commission may entrust the performance of these

tests or assessments to notified bodies designated under this Regulation,

in which case the notified body shall act on behalf of the Commission.

Article 34(1) and (2) shall apply mutatis mutandis to the Commission

when exercising its powers under this paragraph.

The fees for testing and assessment activities shall be levied on the provider of

a high-risk AI system who has applied for third-party conformity

assessment to the Commission. The costs related to the services entrusted

by the Commission to the notified bodies in accordance with this Article

shall be directly paid by the provider to the notified body.’;

(26) Article 77 is amended as follows:

(a) the heading is replaced by the following:

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‘Powers of authorities protecting fundamental rights and cooperation with

market surveillance authorities’

(b) paragraph 1 is replaced by the following:

‘1. National public authorities or bodies which supervise or enforce the respect

of obligations under Union law protecting fundamental rights, including

the right to non-discrimination, shall have the power to make a request

and access any information or documentation created or maintained from

the relevant market surveillance authority under this Regulation in

accessible language and format where access to that information or

documentation is necessary for effectively fulfilling their mandates

within the limits of their jurisdiction.’;

(c) the following paragraph 1a and 1b are inserted:

‘1a. Subject to the conditions specified in this Article, the market surveillance

authority shall grant the relevant public authority or body referred to in

paragraph 1 access to such information or documentation, including by

requesting such information or documentation from the provider or the

deployer, where necessary.’

‘1b. Market surveillance authorities and public authorities or bodies referred to

in paragraph 1 shall cooperate closely and provide each other with

mutual assistance necessary for fulfilling their respective mandates, with

a view to ensuring coherent application of this Regulation and Union law

protecting fundamental rights and streamlining procedures. This shall

include, in particular, exchange of information where necessary for the

effective supervision or enforcement of this Regulation and the

respective other Union legislation.’;

(27) Article 95, paragraph 4 is replaced by the following:

‘4. The AI Office and the Member States shall take into account the specific

interests and needs of SMCs and SMEs, including start-ups, when

encouraging and facilitating the drawing up of codes of conduct.’;

(28) in Article 96(1), the second subparagraph is replaced by the following:

‘When issuing such guidelines, the Commission shall pay particular attention

to the needs of SMCs and SMEs including start-ups, of local public

authorities and of the sectors most likely to be affected by this

Regulation.’;

(29) Article 99 is amended as follows:

(a) paragraph 1 is replaced by the following:

‘1. In accordance with the terms and conditions laid down in this Regulation,

Member States shall lay down the rules on penalties and other

enforcement measures, which may also include warnings and non-

monetary measures, applicable to infringements of this Regulation by

operators, and shall take all measures necessary to ensure that they are

properly and effectively implemented, thereby taking into account the

guidelines issued by the Commission pursuant to Article 96. The

penalties provided for shall be effective, proportionate and dissuasive.

The Member States shall take into account the interests of SMCs and

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SMEs, including start-ups, and their economic viability when imposing

penalties.’;

(b) paragraph 6 is replaced by the following:

‘6. In the case of SMCs and SMEs, including start-ups, each fine referred to in

this Article shall be up to the percentages or amount referred to in

paragraphs 3, 4 and 5, whichever thereof is lower.’;

(30) Article 111 is amended as follows:

(a) paragraph 2 is replaced by the following:

‘2. Without prejudice to the application of Article 5 as referred to in Article

113(3), third paragraph, point (a), this Regulation shall apply to operators

of high-risk AI systems, other than the systems referred to in paragraph 1

of this Article, that have been placed on the market or put into service

before the date of application of Chapter III and corresponding

obligations referred to in Article 113, only if, as from that date, those

systems are subject to significant changes in their designs. In any case,

the providers and deployers of high-risk AI systems intended to be used

by public authorities shall take the necessary steps to comply with the

requirements and obligations laid down in this Regulation by 2 August

2030.’;

(b) the following paragraph 4 is added:

‘4. Providers of AI systems, including general-purpose AI systems, generating

synthetic audio, image, video or text content, that have been placed on

the market before 2 August 2026 shall take the necessary steps in order to

comply with Article 50(2) by 2 February 2027.’;

(31) Article 113 is amended as follows:

(a) in the third paragraph, point (d) is added:

‘(d) Chapter III, Sections 1, 2, and 3, shall apply following the adoption of a

decision of the Commission confirming that adequate measures in

support of compliance with Chapter III are available, from the following

dates:

(i) 6 months after the adoption of that decision as regards AI systems classified

as high-risk pursuant to Article 6(2) and Annex III, and

(ii) 12 months after the adoption of the decision as regards AI systems

classified as high-risk pursuant to Article 6(1) and Annex I.

In the absence of the adoption of the decision within the meaning of

subparagraph 1, or where the dates below are earlier than those that

follow the adoption of that decision, Chapter III, Sections 1, 2, and 3,

shall apply:

(i) on 2 December 2027 as regards AI systems classified as high-risk pursuant

to Article 6(2) and Annex III, and

(ii) on 2 August 2028 as regards AI systems classified as high-risk pursuant to

Article 6(1) and Annex I.’;

(b) in the third paragraph, point (e) is added:

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‘ 3. Articles 102 to 110 shall apply from [the date of entry into application of

this Regulation].’;

(32) in Annex VIII, section B is deleted;

(33) the following Annex XIV is added:

‘Annex XIV

The list of codes, categories and corresponding types of AI systems for the purpose of

the notification procedure referred to in Article 30 specifying the scope of the

designation as notified bodies

1. Introduction

Conformity assessment of high-risk AI systems under this Regulation may require

involvement of conformity assessment bodies. Only conformity assessment bodies that

have been designated in accordance with this Regulation may carry out conformity

assessments and only for the activities related to the types of AI systems concerned. The

list of codes, categories, and corresponding types of AI systems sets the scope of the

designation of conformity assessment bodies notified under Article 30 of this Regulation.

2. List of Codes, categories, and corresponding AI systems

1. AI systems subject to Annex I of the AI Act

AIA Code

AIP 0101 AI systems subject to Annex I.A.1. of the AI Act.

AIP 0102 AI systems subject to Annex I.A.2. of the AI Act.

AIP 0103 AI systems subject to Annex I.A.3. of the AI Act.

AIP 0104 AI systems subject to Annex I.A.4. of the AI Act.

AIP 0105 AI systems subject to Annex I.A.5. of the AI Act.

AIP 0106 AI systems subject to Annex I.A.6. of the AI Act.

AIP 0107 AI systems subject to Annex I.A.7. of the AI Act.

AIP 0108 AI systems subject to Annex I.A.8. of the AI Act.

AIP 0109 AI systems subject to Annex I.A.9. of the AI Act.

AIP 0110 AI systems subject to Annex I.A.10. of the AI Act.

AIP 0111 AI systems subject to Annex I.A.11. of the AI Act.

AIP 0112 AI systems subject to Annex I.A.12. of the AI Act.

2. AI systems subject to Annex III.1 of the AI Act

EN 32 EN

AIA Code

AIB 0201 Remote biometric identification systems under Annex III.1.a. of the

AI Act intended to be put into service by Union institutions, bodies,

offices or agencies.

AIB 0202 Biometric categorisation AI systems under Annex III.1.b. of the AI

Act intended to be put into service by Union institutions, bodies,

offices or agencies.

AIB 0203 Emotion recognition AI systems under Annex III.1.c. of the AI Act

intended to be put into service by Union institutions, bodies, offices

or agencies.

AIB 0204 Remote biometric identification systems under Annex III.1.a. of the

AI Act intended to be put into service by law enforcement,

immigration or asylum authorities.

AIB 0205 Biometric categorisation AI systems under Annex III.1.b. of the AI

Act intended to be put into service by law enforcement, immigration

or asylum authorities.

AIB 0206 Emotion recognition AI systems under Annex III.1.c. of the AI Act

intended to be put into service by law enforcement, immigration or

asylum authorities.

AIB 0207 Remote biometric identification systems under Annex III.1.a. of the

AI Act (general).

AIB 0208 Biometric categorisation AI systems under Annex III.1.b. of the AI

Act (general).

AIB 0209 Emotion recognition AI systems under Annex III.1.c. of the AI Act

(general).

3. AI technology-specific codes

a) Symbolic AI, expert systems and mathematical optimization

AIA Code

AIH 0101 Logic- and knowledge-based AI systems that infer from encoded

knowledge or symbolic representation, expert systems

AIH 0102 Logic-based AI systems, excluding basic data processing

b) Machine learning, excluding GPAI and single modality generative AI

AIA Code

AIH 0201 AI systems that process structured data

AIH 0202 AI systems that process signal and audio data

AIH 0203 AI systems that process text data

EN 33 EN

AIH 0204 AI systems that process image and video

AIH 0205 AI systems that learn from their environment, excluding agentic AI

c) AI systems based on GPAI or single modality generative AI

AIA Code

AIH 0301 Single modality generative AI systems

AIH 0302 Multimodal generative AI systems, including AI systems based on

GPAI models

d) Agentic AI

AIA Code

AIH 0401 Agentic AI

3. Application for designation

Conformity assessment bodies shall use the lists of codes, categories and

corresponding types of AI systems set out in this Annex when specifying the types of

AI systems in the application for designation referred to in Article 29 of this

Regulation.’.

Article 2

Amendments to Regulation (EU) 2018/1139

Regulation (EU) 2018/1139 is amended as follows:

(1) in Article 27, the following paragraph is added:

‘3. Without prejudice to paragraph 2, when adopting implementing acts

pursuant to paragraph 1 concerning Artificial Intelligence systems which

are safety components within the meaning of Regulation (EU) 2024/1689

of the European Parliament and of the Council14, the requirements set out

in Chapter III, Section 2, of that Regulation shall be taken into account.’;

(2) in Article 31, the following paragraph is added:

14 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying

down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No

167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives

2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689,

12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).

EN 34 EN

‘3. Without prejudice to paragraph 2, when adopting implementing acts

pursuant to paragraph 1 concerning Artificial Intelligence systems which

are safety components within the meaning of Regulation (EU) 2024/1689

of the European Parliament and of the Council, the requirements set out

in Chapter III, Section 2, of that Regulation shall be taken into account.’;

(3) in Article 32, the following paragraph is added:

‘3. When adopting delegated acts pursuant to paragraph 1 concerning Artificial

Intelligence systems which are safety components within the meaning of

Regulation (EU) 2024/1689 of the European Parliament and of the

Council (*), the requirements set out in Chapter III, Section 2, of that

Regulation shall be taken into account.’;

(4) in Article 36, the following paragraph is added:

‘3. Without prejudice to paragraph 2, when adopting implementing acts

pursuant to paragraph 1 concerning Artificial Intelligence systems which

are safety components within the meaning of Regulation (EU) 2024/1689

of the European Parliament and of the Council, the requirements set out

in Chapter III, Section 2, of that Regulation shall be taken into account.’;

(5) in Article 39 the following paragraph is added:

‘3. When adopting delegated acts pursuant to paragraph 1 concerning Artificial

Intelligence systems which are safety components within the meaning of

Regulation (EU) 2024/1689 of the European Parliament and of the

Council, the requirements set out in Chapter III, Section 2, of that

Regulation shall be taken into account.’;

(6) in Article 50, the following paragraph is added:

‘3. Without prejudice to paragraph 2, when adopting implementing acts

pursuant to paragraph 1 concerning Artificial Intelligence systems which

are safety components within the meaning of Regulation (EU) 2024/1689

of the European Parliament and of the Council, the requirements set out

in Chapter III, Section 2, of that Regulation shall be taken into account.’;

(7) in Article 53, the following paragraph is added:

‘3. Without prejudice to paragraph 2, when adopting implementing acts

pursuant to paragraph 1 concerning Artificial Intelligence systems which

are safety components within the meaning of Regulation (EU) 2024/1689

of the European Parliament and of the Council, the requirements set out

in Chapter III, Section 2, of that Regulation shall be taken into account.’.

Article 3

Entry into force and application

This Regulation shall enter into force on the third day following that of its publication in the

Official Journal of the European Union.

EN 35 EN

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

EN 1 EN

LEGISLATIVE FINANCIAL AND DIGITAL STATEMENT

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE ................................................. 3

1.1. Title of the proposal/initiative ...................................................................................... 3

1.2. Policy area(s) concerned .............................................................................................. 3

1.3. Objective(s) .................................................................................................................. 3

1.3.1. General objective(s) ..................................................................................................... 3

1.3.2. Specific objective(s) ..................................................................................................... 3

1.3.3. Expected result(s) and impact ...................................................................................... 3

1.3.4. Indicators of performance ............................................................................................ 3

1.4. The proposal/initiative relates to: ................................................................................. 4

1.5. Grounds for the proposal/initiative .............................................................................. 4

1.5.1. Requirement(s) to be met in the short or long term including a detailed timeline for

roll-out of the implementation of the initiative ............................................................ 4

1.5.2. Added value of EU involvement (it may result from different factors, e.g.

coordination gains, legal certainty, greater effectiveness or complementarities). For

the purposes of this section ‘added value of EU involvement’ is the value resulting

from EU action, that is additional to the value that would have been otherwise

created by Member States alone. ................................................................................. 4

1.5.3. Lessons learned from similar experiences in the past .................................................. 4

1.5.4. Compatibility with the multiannual financial framework and possible synergies with

other appropriate instruments ....................................................................................... 5

1.5.5. Assessment of the different available financing options, including scope for

redeployment ................................................................................................................ 5

1.6. Duration of the proposal/initiative and of its financial impact .................................... 6

1.7. Method(s) of budget implementation planned ............................................................. 6

2. MANAGEMENT MEASURES................................................................................... 8

2.1. Monitoring and reporting rules .................................................................................... 8

2.2. Management and control system(s) ............................................................................. 8

2.2.1. Justification of the budget implementation method(s), the funding implementation

mechanism(s), the payment modalities and the control strategy proposed .................. 8

2.2.2. Information concerning the risks identified and the internal control system(s) set up

to mitigate them............................................................................................................ 8

2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio between

the control costs and the value of the related funds managed), and assessment of the

expected levels of risk of error (at payment & at closure) ........................................... 8

2.3. Measures to prevent fraud and irregularities ................................................................ 9

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE ............ 10

3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s)

affected ....................................................................................................................... 10

EN 2 EN

3.2. Estimated financial impact of the proposal on appropriations ................................... 12

3.2.1. Summary of estimated impact on operational appropriations.................................... 12

3.2.1.1. Appropriations from voted budget ............................................................................. 12

3.2.1.2. Appropriations from external assigned revenues ....................................................... 17

3.2.2. Estimated output funded from operational appropriations......................................... 22

3.2.3. Summary of estimated impact on administrative appropriations ............................... 24

3.2.3.1. Appropriations from voted budget .............................................................................. 24

3.2.3.2. Appropriations from external assigned revenues ....................................................... 24

3.2.3.3. Total appropriations ................................................................................................... 24

3.2.4. Estimated requirements of human resources.............................................................. 25

3.2.4.1. Financed from voted budget....................................................................................... 25

3.2.4.2. Financed from external assigned revenues ................................................................ 26

3.2.4.3. Total requirements of human resources ..................................................................... 26

3.2.5. Overview of estimated impact on digital technology-related investments ................ 28

3.2.6. Compatibility with the current multiannual financial framework.............................. 28

3.2.7. Third-party contributions ........................................................................................... 28

3.3. Estimated impact on revenue ..................................................................................... 29

4. DIGITAL DIMENSIONS .......................................................................................... 29

4.1. Requirements of digital relevance .............................................................................. 30

4.2. Data ............................................................................................................................ 30

4.3. Digital solutions ......................................................................................................... 31

4.4. Interoperability assessment ........................................................................................ 31

4.5. Measures to support digital implementation .............................................................. 32

EN 3 EN

1. FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1. Title of the proposal/initiative

Proposal for a Regulation of the European Parliament and of the Council amending

Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the simplification of the

implementation of harmonised rules on artificial intelligence (Digital Omnibus on

AI)

1.2. Policy area(s) concerned

Communications Networks, Content and Technology;

Internal Market, Industry, Entrepreneurship and SMEs

The budgetary impact concerns the new tasks entrusted with the AI Office.

1.3. Objective(s)

1.3.1. General objective(s)

1. To strengthen the monitoring and supervision of certain categories of AI systems

by the AI Office.

2. To facilitate the development and testing at EU level of innovative AI systems

under strict regulatory oversight before these systems are placed on the market or

otherwise put into service.

1.3.2. Specific objective(s)

Specific objective No 1

To enhance governance and effective enforcement of the AI Act rules related to AI

systems by reinforcing the powers and procedures applicable as well as by providing

for new resources for the AI Office in charge of the enforcement.

Specific objective No 2

To provide for the establishment of a sandbox at EU level, enabling cross border

activities and testing.

1.3.3. Expected result(s) and impact

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.

AI providers should benefit from a centralised level of governance and the access to

an EU-level sandbox for certain categories of AI systems, avoiding duplication of

procedures and costs.

1.3.4. Indicators of performance

Specify the indicators for monitoring progress and achievements.

Indicator 1

Number of AI systems falling under the scope of the monitoring and supervision

tasks to be carried out by the AI Office.

Indicator 2

Number of providers and prospective providers requesting access to the sandbox at

EU level.

EN 4 EN

1.4. The proposal/initiative relates to:

 a new action

 a new action following a pilot project / preparatory action26

 the extension of an existing action

 a merger or redirection of one or more actions towards another/a new action

1.5. Grounds for the proposal/initiative

1.5.1. Requirement(s) to be met in the short or long term including a detailed timeline for

roll-out of the implementation of the initiative

The additional elements relevant for the enhancement of the governance structure of

the AI Office should be in place before the entry into application of the provisions

applicable to AI systems.

The first EU sandbox is expected to be operational in 2028, although some key

setting details should be established beforehand.

1.5.2. Added value of EU involvement (it may result from different factors, e.g.

coordination gains, legal certainty, greater effectiveness or complementarities). For

the purposes of this section 'added value of EU involvement' is the value resulting

from EU action, that is additional to the value that would have been otherwise

created by Member States alone.

The AI Office will have the power to monitor and supervise the compliance of all AI

systems based on general-purpose AI (GPAI) models, where the model and the

system are developed by the same provider, as well as all AI systems embedded in or

constituting very large online platforms or search engines, even if the system and

GPAI model provider are different. The tasks that the AI Office would need to carry

out for this vast range of AI systems include requesting full access to documentation,

training/validation/testing datasets, and, when necessary, the source code of high-risk

AI systems, supervising real-world testing, identifying and evaluating risks, dealing

with serious incidents, taking preventive and corrective measures while ensuring

cooperation with national market surveillance authorities, dealing with AI systems

classified as not high-risk by the provider, dealing with complaints of non-

compliance, and imposing penalties. Moreover, to allow market access for AI

systems in the scope of this provision which are also subject to pre-market third-

party conformity assessment under the AI Act, the AI Office will be the responsible

body to carry out conformity assessments. All these actions require resources and a

set of enforcement procedures to be developed and implemented, as well as the

appropriate technical support to assess and evaluate systems.

The AI Office’s role in ensuring compliance would also involve ensuring synergies

with the evaluation of the GPAI models, which would strengthen the overall

evaluations of models and systems provided by the same provider. This would enable

a more comprehensive understanding of the AI systems and their associated risks,

26 As referred to in Article 58(2), point (a) or (b) of the Financial Regulation.

EN 5 EN

allowing for more effective monitoring and enforcement. The AI Office will also

need to consider the unique challenges posed by agentic AI, which can operate

autonomously and make decisions that may have significant consequences, and

develop strategies to address these risks in line with Commission policies.

The enhancement of the AI Office’s governance would bring numerous benefits to

the regulation of AI systems in the EU. One of the primary advantages is the

consistency and coherence it would ensure in the application of the AI Act across the

EU. By having a single authority overseeing the implementation of the AI Act in

relation to certain categories of AI systems, the risk of conflicting interpretations and

decisions would be significantly reduced, providing clarity and certainty for

companies operating in the EU.

Furthermore, this would simplify the regulatory landscape for companies, as they

would only need to deal with one regulator, rather than multiple national authorities.

This would reduce the complexity and administrative burden associated with

navigating different regulatory frameworks, allowing companies to focus on

innovation and growth. The centralised approach would also enable the development

within the Commission of specialised expertise in AI systems and GPAI models,

enabling more effective monitoring and enforcement of the AI Act.

This approach would avoid diverging national enforcement actions on the AI systems

concerned that may lead to the fragmentation of the internal market and decrease

legal certainty for operators. This would also address the challenges faced by

Member States in securing specialised resources to staff their authorities responsible

for implementing the AI Act and overseeing AI systems within their territories. By

centralizing market surveillance authorities’ powers within the AI Office, this

scenario would enable the AI Office to assume responsibility for evaluating and

monitoring complex AI systems provided by the same model provider, as well as AI

systems constituting or embedded into platforms, thereby alleviating the burden on

national authorities. This would leverage the AI Office's existing expertise in

evaluating GPAI models and monitoring their compliance, creating a unique

concentration of specialized knowledge and capabilities. As a result, the AI Office

would be well-positioned to provide consistent and effective oversight, while also

supporting Member States in their efforts to implement the AI Act and ensure a

harmonized regulatory environment across the EU. With the AI Office handling

these additional tasks, national authorities could focus more on their enforcement

actions under the AI Act, allowing for a more efficient allocation of resources and a

more effective implementation of the AI Act across the EU.

1.5.3. Lessons learned from similar experiences in the past

The European Commission's experience in enforcing the Digital Services Act (DSA)

provides valuable lessons that can be applied to the enforcement of the AI Act. In

particular, the establishment of a robust and transparent enforcement framework,

which sets out clear procedures for investigating and addressing breaches of the DSA

and the close cooperation with national authorities, to ensure that enforcement

actions are coordinated and effective, represent relevant elements in this context.

The Commission’s experience with DSA enforcement has shown that this approach

can be effective in promoting compliance and protecting users' rights. For example,

the Commission has already taken action against several online platforms for

breaches of the DSA, and has worked with national authorities to develop guidance

and best practices for compliance.

EN 6 EN

By building on the lessons learned from DSA enforcement, the Commission can

develop an effective enforcement framework for the AI Act that promotes

compliance, and supports the development of a trustworthy and innovative AI

ecosystem in the EU. This will involve enhancing the AI Office enforcement role to

duly monitor and supervision certain categories of AI systems, and working closely

with national authorities to ensure that the AI Act is enforced in a consistent and

effective manner.

The possibility to provide for an EU-level sandbox should be seen as complementing

the sandboxes established at national level and should be implemented in a way to

facilitate cross-border cooperation between national competent authorities.

1.5.4. Compatibility with the multiannual financial framework and possible synergies with

other appropriate instruments

The amendments proposed to the AI Act within this initiative would result in a

significant increase in the number of AI systems subject to the monitoring and

supervision of the AI Office, with a corresponding rise in the number of systems

potentially eligible to participate in an EU-level sandbox. To effectively manage this

expansion, it is essential to strengthen the European regulatory and coordination

function, as proposed in this initiative. This reinforcement would enable the AI

Office to efficiently oversee the growing number of AI systems, ensure compliance

with the regulatory framework, and provide a supportive environment for innovation

and testing through the EU-level sandbox.

1.5.5. Assessment of the different available financing options, including scope for

redeployment

The AI Office will make an effort in order to redeploy part of the staff allocated but

could do it only partially (15 FTEs) as the staff is currently fully allocated to tasks

directly linked to ensuring a timely and correct implementation of the AI Act. New

resources will be needed (estimated in 38 additional FTEs) to efficiently exercise the

new enforcement tasks.

In particular, the AI Office plans to identify colleagues with legal and procedural

expertise who can take on part of the upcoming new enforcement tasks. At this stage,

we estimate that around 5 CAs with relevant profiles can be redeployed for this

purpose.

In addition, the AI Office will make an effort to redeploy 5 officials.

The AI Office envisages to make fully operational the EU-level sandbox for AI

systems falling under its monitoring in 2028, which will make possible a

redeployment of 3 CAs needed to set up and run the sandbox. This phased approach

would enable to ensure the full operational capacity of the sandbox by 2028, and in

particular will also give the AI Office the time to identify the most suitable staff to

cover this task and ensure proper project management for facilitating the

development, training, testing, and validation of innovative AI systems.

In addition, the AI Office will explore opportunities to expand the scope of IT tools

(currently mostly in development or pre-launch phase) supporting the AI Act to also

cover relevant new enforcement activities (i.e. case handling, AI system registry,

monitoring and reporting, exchange of information with authorities). 2 FTEs with IT

and administrative profiles will be redeployed to manage these IT tools. This would

help to partially cover the management needs related to the new tasks.

EN 7 EN

Overall, these redeployment efforts and synergies will help to address some of the

staffing needs for the new enforcement tasks, while additional resources will be

necessary to ensure the effective implementation of the AI Act.

Additional staff will be funded under DEP support, given that the objectives of the

proposed amendments contribute directly to one key objective of Digital Europe –

accelerating AI development and deployment in Europe.

EN 8 EN

1.6. Duration of the proposal/initiative and of its financial impact

 limited duration

–  in effect from [DD/MM]YYYY to [DD/MM]YYYY

–  financial impact from YYYY to YYYY for commitment appropriations and

from YYYY to YYYY for payment appropriations.

 unlimited duration

– Implementation with a start-up period from 2026 to 2027,

– followed by full-scale operation.

1.7. Method(s) of budget implementation planned

 Direct management by the Commission

–  by its departments, including by its staff in the Union delegations;

–  by the executive agencies

 Shared management with the Member States

 Indirect management by entrusting budget implementation tasks to:

–  third countries or the bodies they have designated

–  international organisations and their agencies (to be specified)

–  the European Investment Bank and the European Investment Fund

–  bodies referred to in Articles 70 and 71 of the Financial Regulation

–  public law bodies

–  bodies governed by private law with a public service mission to the extent that

they are provided with adequate financial guarantees

–  bodies governed by the private law of a Member State that are entrusted with

the implementation of a public-private partnership and that are provided with

adequate financial guarantees

–  bodies or persons entrusted with the implementation of specific actions in the

common foreign and security policy pursuant to Title V of the Treaty on

European Union, and identified in the relevant basic act

– bodies established in a Member State, governed by the private law of a

Member State or Union law and eligible to be entrusted, in accordance with

sector-specific rules, with the implementation of Union funds or budgetary

guarantees, to the extent that such bodies are controlled by public law bodies or

by bodies governed by private law with a public service mission, and are provided

with adequate financial guarantees in the form of joint and several liability by the

controlling bodies or equivalent financial guarantees and which may be, for each

action, limited to the maximum amount of the Union support.

EN 9 EN

2. MANAGEMENT MEASURES

2.1. Monitoring and reporting rules

Specify frequency and conditions.

The strengthened dispositions will be reviewed and evaluated with the entire AI Act

in August 2029. The Commission will report on the findings of the evaluation to the

European Parliament, the Council and the European Economic and Social

Committee.

2.2. Management and control system(s)

2.2.1. Justification of the budget implementation method(s), the funding implementation

mechanism(s), the payment modalities and the control strategy proposed

The regulation reinforces the European policy with regard to harmonised rules for

the provision of artificial intelligence systems in the internal market while ensuring

the respect of safety and fundamental rights. The simplified single supervision

ensures consistency for the cross-border application of the obligations under this

Regulation.

In order to face these new tasks, it is necessary to appropriately resource the

Commission’s services. The enforcement of the new regulation is estimated to

require 53 FTE.

2.2.2. Information concerning the risks identified and the internal control system(s) set up

to mitigate them

The risks correspond to the standard risks of Commission operations and are

adequately covered by existing standard risk minimising procedures.

2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio between

the control costs and the value of the related funds managed), and assessment of the

expected levels of risk of error (at payment & at closure)

For the meeting expenditure, given the low value per transaction (e.g. refunding

travel costs for a delegate for a meeting), standard control procedures seem

sufficient.

2.3. Measures to prevent fraud and irregularities

Specify existing or envisaged prevention and protection measures, e.g. from the anti-

fraud strategy.

The existing fraud prevention measures applicable to the Commission will cover the

additional appropriations necessary for this Regulation.

EN 10 EN

3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE

3.1. Heading(s) of the multiannual financial framework and expenditure budget

line(s) affected

• Existing budget lines

In order of multiannual financial framework headings and budget lines.

Heading of

multiannual

financial

framework

Budget line Type of

expenditure Contribution

Number

Diff./Non-

diff.27

from

EFTA

countries 28

from

candidate

countries

and

potential

candidates 29

From

other

third

countries

other assigned

revenue

7 20 02 06 Administrative expenditure Nondiff No

1 02 04 03 DEP Artificial Intelligence Diff. YES NO yes NO

1 02 01 30 01 Support expenditure for the

Digital Europe programme Nondiff yes yes

27 Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 28 EFTA: European Free Trade Association. 29 Candidate countries and, where applicable, potential candidates from the Western Balkans.

EN 11 EN

3.2. Estimated financial impact of the proposal on appropriations

3.2.1. Summary of estimated impact on operational appropriations

–  The proposal/initiative does not require the use of operational appropriations

–  The proposal/initiative requires the use of operational appropriations, as explained below

3.2.1.1. Appropriations from voted budget

[

EUR million (to three decimal places)

Heading of multiannual financial framework 1

DG: CNECT Year Year Year Year After 2027

TOTAL MFF

2021-2027 2024 2025 2026 2027 After 2027

Budget line 02 04 03

Commitments (1a) 0,50030 0,50031 1,000

Payments (2a) 0,500 0,500 1,000

Appropriations of an administrative nature financed from the envelope of specific programmes

30 This budget is already eamarked in the DEP WP 26-27 for the AI office 31 This budget is already eamarked in the DEP WP 26-27 for the AI office

EN 12 EN

Budget line 02 01 30 01 (3) 2,64232 6,283 33 7,283

8,925

TOTAL appropriations

for DG CNECT

Commitments =1a+1b+3 3,142 6,783 7,283 9,925

Payments =2a+2b+3 2,642 6,783 7,783 9,925

TOTAL

Year Year Year Year After 2027 TOTAL MFF

2021-2027 2024 2025 2026 2027 After 2027

Budget line 02 04 03

Commitments (1a) 0,50034 0,50035 1,000

Payments (2a) 0,500 0,500 1,000

Appropriations of an administrative nature financed from the envelope of specific programmes

32 This budget corresponds to [48] additional FTEs for 6 months [(43 CAs and 5 SNEs)], the baseline being the staffing level agreed in the context of the 2026

budgetary procedure. The budget will be redeployed in the DEP admin envelope to cover the additional costs. 33 The amount will be redeployed from 02.0403 (SO2 artificial intelligence) in 2027, the request will be introduced in the 2027 budgetary procedure.

34 This budget is already earmarked in the DEP WP 26-27 for the AI Office. 35 This budget is already earmarked in the DEP WP 26-27 for the AI Office.

EN 13 EN

Budget line 02 01 30 01 (3) 2,64236 6,283 37 7,283

8,925

TOTAL appropriations

for DG CNECT

Commitments =1a+1b+3 3,142 6,783 7,283 9,925

Payments =2a+2b+3 2,642 6,783 7,783 9,925

]

[

Heading of multiannual financial framework 7 ‘Administrative expenditure’

DG: CNECT Year Year Year Year TOTAL

MFF 2021-

2027 2024 2025 2026 2027

 Human resources 0,940 0,940 1,880

 Other administrative expenditure 0,025 0,025 0,050

TOTAL DG CNECT Appropriations 0,965 0,965 1,930

36 This budget corresponds to 48 additional FTEs for 6 months (43 CAs and 5 SNEs), the baseline being the staffing level agreed in the context of the 2026

budgetary procedure. The budget will be redeployed in the DEP admin envelope to cover the additional costs. 37 The amount will be redeployed from 02.0403 (SO2 artificial intelligence) in 2027, the request will be introduced in the 2027 budgetary procedure.

EN 14 EN

TOTAL appropriations under HEADING 7 of the multiannual financial

framework

(Total

commitments

= Total

payments)

0,965 0,965 1,930

EUR million (to three decimal places)

Year Year Year Year After 2027 TOTAL

MFF 2021-

2027 2024 2025 2026 2027

TOTAL appropriations under HEADINGS 1 to 7 Commitments 4,107 7,748 8,248 11,855

of the multiannual financial framework Payments 3,607 7,748 8,748 11,855

]

3.2.2. Estimated output funded from operational appropriations (not to be completed for decentralised agencies)

Commitment appropriations in EUR million (to three decimal places)

Indicate

objectives and

outputs



Year 2024

Year 2025

Year 2026

Year 2027

Enter as many years as necessary to show the

duration of the impact (see Section1.6) TOTAL

OUTPUTS

Type38

Avera

ge

cost

N o

Cost N o

Cost N o

Cost N

o

Cost N o

Cost N o

Cost N o

Cost Total

No

Total

cost

SPECIFIC OBJECTIVE No 139…

38 Outputs are products and services to be supplied (e.g. number of student exchanges financed, number of km of roads built, etc.).

EN 15 EN

- Output

- Output

- Output

Subtotal for specific objective No 1

SPECIFIC OBJECTIVE No 2 ...

- Output

Subtotal for specific objective No 2

TOTALS

39 As described in Section 1.3.2. ‘Specific objective(s)’

EN 16 EN

3.2.3. Summary of estimated impact on administrative appropriations

–  The proposal/initiative does not require the use of appropriations of an administrative nature

–  The proposal/initiative requires the use of appropriations of an administrative nature, as explained below

3.2.3.1. Appropriations from voted budget

[

VOTED APPROPRIATIONS Year Year Year Year

TOTAL 2021 - 2027 2024 2025 2026 2027

HEADING 7

Human resources 0,940 0,940 1,880

Other administrative expenditure 0,025 0,025 0,050

Subtotal HEADING 7 0,965 0,965 1,930

Outside HEADING 7

Human resources 2,429 4,858 7,287

Other expenditure of an administrative nature 0,213 1,425 1,638

Subtotal outside HEADING 7 2,642 6,283 8,925

]

The appropriations required for human resources and other expenditure of an administrative nature will be met by appropriations from the DG that are already

assigned to management of the action and/or have been redeployed within the DG, together, if necessary, with any additional allocation which may be granted to the

managing DG under the annual allocation procedure and in the light of budgetary constraints.

3.2.4. Estimated requirements of human resources

–  The proposal/initiative does not require the use of human resources

–  The proposal/initiative requires the use of human resources, as explained below

EN 17 EN

3.2.4.1. Financed from voted budget

Estimate to be expressed in full-time equivalent units (FTEs)

[

VOTED APPROPRIATIONS Year Year Year Year

2024 2025 2026 2027

 Establishment plan posts (officials and temporary staff)

20 01 02 01 (Headquarters and Commission’s Representation Offices) 0 0 5 5

20 01 02 03 (EU Delegations) 0 0 0 0

01 01 01 01 (Indirect research) 0 0 0 0

01 01 01 11 (Direct research) 0 0 0 0

Other budget lines (specify) 0 0 0 0

• External staff (in FTEs)

20 02 01 (AC, END from the ‘global envelope’) 0 0 0 0

20 02 03 (AC, AL, END and JPD in the EU Delegations) 0 0 0 0

Admin. Support line

[XX.01.YY.YY]

- at Headquarters 0 0 0 0

- in EU Delegations 0 0 0 0

01 01 01 02 (AC, END - Indirect research) 0 0 0 0

01 01 01 12 (AC, END - Direct research) 0 0 0 0

Other budget lines (specify) - Heading 7 0 0 0 0

Other budget lines (02 01 30 01) - Outside Heading 7 0 0 48 48

TOTAL 0 0 53 53

]

The staff required to implement the proposal (in FTEs):

To be covered by

current staff

Exceptional additional staff*

EN 18 EN

available in the

Commission

services

To be financed

under Heading 7

or Research

To be financed

from BA line

To be financed

from fees

Establishment

plan posts

5 N/A

External staff

(CA, SNEs, INT)

10 38

Description of tasks to be carried out by:

Officials and temporary staff The strengthening of the central supervision by the AI Office will lead to a significant

increase in the number of AI systems. These task cannot be carried out by the current

staff levels, which are only sufficient for the current scope of supervision. External staff

3.2.5. Overview of estimated impact on digital technology-related investments

Compulsory: the best estimate of the digital technology-related investments entailed by the proposal/initiative should be included in the table

below.

Exceptionally, when required for the implementation of the proposal/initiative, the appropriations under Heading 7 should be presented in the

designated line.

The appropriations under Headings 1-6 should be reflected as ‘Policy IT expenditure on operational programmes’. This expenditure refers to

the operational budget to be used to re-use/ buy/ develop IT platforms/ tools directly linked to the implementation of the initiative and their

associated investments (e.g. licences, studies, data storage etc). The information provided in this table should be consistent with details

presented under Section 4 ‘Digital dimensions’.

EN 19 EN

TOTAL Digital and IT appropriations

Year Year Year Year TOTAL

MFF

2021 -

2027 2024 2025 2026 2027

HEADING 7

IT expenditure (corporate) 0.000 0.000 0.000 0.000 0.000

Subtotal HEADING 7 0.000 0.000 0.000 0.000 0.000

Outside HEADING 7

Policy IT expenditure on operational programmes

0.000 0.000 0.000 0.000 0.000

Subtotal outside HEADING 7 0.000 0.000 0.000 0.000 0.000

TOTAL 0.000 0.000 0.000 0.000 0.000

3.2.6. Compatibility with the current multiannual financial framework

The proposal/initiative:

–  can be fully financed through redeployment within the relevant heading of the multiannual financial framework (MFF)

The amounts will be redeployed from 02.013001 support expenditure for the Digital Europe Programme for 2026 and from 02.0403 (SO2 artificial intelligence) for 2027.

–  requires use of the unallocated margin under the relevant heading of the MFF and/or use of the special instruments as defined in the

MFF Regulation

–  requires a revision of the MFF

3.2.7. Third-party contributions

The proposal/initiative:

–  does not provide for co-financing by third parties

–  provides for the co-financing by third parties estimated below:

Appropriations in EUR million (to three decimal places)

EN 20 EN

Year 2024

Year 2025

Year 2026

Year 2027

Total

Specify the co-financing body

TOTAL appropriations co-financed

3.3. Estimated impact on revenue

–  The proposal/initiative has no financial impact on revenue.

–  The proposal/initiative has the following financial impact:

–  on own resources

–  on other revenue

–  please indicate, if the revenue is assigned to expenditure lines

EUR million (to three decimal places)

Budget revenue line: Appropriations available for the

current financial year

Impact of the proposal/initiative40

Year 2024 Year 2025 Year 2026 Year 2027

Article ………….

For assigned revenue, specify the budget expenditure line(s) affected.

40 As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 20% for collection

costs.

EN 21 EN

Other remarks (e.g. method/formula used for calculating the impact on revenue or any other information).

4. DIGITAL DIMENSIONS

4.1. Requirements of digital relevance

Reference to the

requirement Requirement description

Actors affected or concerned

by the requirement

High-level

Processes Categories

Article 1(5) Inserting Article 4a: Allowing providers and

deployers of AI systems and AI models to

exceptionally process special categories of

personal data to the extent necessary for the

purpose of ensuring bias detection and

correction, subject to certain conditions.

Providers and deployers of AI

systems and AI models

Concerned data subjects

Data processing Data

Article 1(8) Amending Article 11(1), second

subparagraph: Relating to the technical

documentation of high-risk AI systems that

needs to be drawn up before that system is

placed on the market or put into service.

SMEs and SMCs are given certain regulatory

privileges as concerns this provision of

information.

Providers of high-risk AI

systems (including SMCs and

SMEs)

National competent authorities

Notified bodies

European Commission

Technical

documentation

Data

EN 22 EN

Article 1(10)

Amending Article 28, inserting paragraph

(1a): Conformity assessment bodies that apply

for a designation may be offered the

possibility to submit a single application and

undergo a single assessment procedure.

Conformity assessment bodies

Notifying authorities

Application

submission

Data

Article 1(11) Amending Article 29(4): Notified bodies

which apply for a single assessment shall

submit the single application to the notifying

authority. The notified body shall update the

documentation if relevant changes occur.

Notified bodies

Notifying authority

Application

submission

Data

Article 1(16) Amending Article 56(6): The Commission

shall publish its assessments on the adequacy

of the codes of practice.

European Commission Assessment

publication

Data

Article 1(26) Amending Article 77:

• Paragraph 1: National public

authorities/bodies which

supervise/enforce EU law obligations

protecting fundamental rights may

make a reasoned request and access

any information/documentation from

the relevant market surveillance

authority

• Paragraph 1a: market surveillance

authority shall grant access and, where

needed, request the information from

the provider/deployer

• Paragraph 1b: where necessary, the

aforementioned market surveillance

National public

authorities/bodies which

supervise/enforce EU law

obligations protecting

fundamental rights

Market surveillance authorities

Providers/deployers of AI

systems

Information

exchange

Data

EN 23 EN

authorities and public

authorities/bodies shall exchange

information.

4.2. Data

High-level description of the data in scope

Type of data Reference to the requirement(s) Standard and/or specification (if applicable)

Special categories of personal data (where the

processing is needed for bias detection/correction)

Article 1(5) //

Technical documentation for high-risk AI systems Article 1(8) Technical documentation shall contain, at a

minimum, the elements set out in Annex IV of the

AI Act. The Commission shall establish a simplified

technical documentation form targeted at SMCs and

SMEs.

Applications of conformity assessment bodies for

designation

Article 1(10) //

Applications of a conformity assessment bodies for

notification

Article 1(11) The notified body shall update the relevant

documentation whenever relevant changes occur.

Commission assessment of the adequacy of the

codes of practice

Article 1(16) //

EN 24 EN

Request for access to information on AI systems Article 1(26) //

Information or documentation requested by national

public authorities/bodies which supervise/enforce

obligations relating to fundamental rights

Article 1(26) To be provided in accessible language and format.

Alignment with the European Data Strategy

Explanation of how the requirement(s) are aligned with the European Data Strategy

Article 1(4) establishes that the processing of special categories of personal data shall be subject to appropriate safeguards for fundamental

rights and freedoms of natural persons. This is in alignment with Regulations (EU) 2016/679 (GDPR) and (EU) 2018/1725 (EUDPR).

Alignment with the once-only principle

Explanation of how the once-only principle has been considered and how the possibility to reuse existing data has been explored

Article 1(10) states that conformity assessment bodies may be provided the possibility to submit a single application and undergo a single

assessment procedure.

Explanation of how newly created data is findable, accessible, interoperable and reusable, and meets high-quality standards

Data flows

High-level description of the data flows

Type of data Reference(s) to

the

Actors who

provide the data

Actors who

receive the data

Trigger for the data

exchange

Frequency (if

applicable)

EN 25 EN

requirement(s)

Applications of a conformity

assessment bodies for notification

Article 1(11) Notified bodies

which are

designated under

Union

harmonisation

legislation listed

in Section A of

Annex I

Notifying authority

designated in

accordance with

Union

harmonisation

legislation listed in

Section A of Annex

I

Application being

made for single

assessment

//

Commission assessment of the

adequacy of the codes of practice

Article 1(16) European

Commission

General Public Performance of an

assessment as

regards the codes of

practice

Regularly

Request for access to information on

AI systems

Article 1(26) National public

authorities or

bodies which

supervise or

enforce the

respect of

obligations under

Union law

protecting

fundamental

rights

Market surveillance

authority

National public

authorities/bodies

require the

information in order

to fulfil their

mandates

//

Information or documentation

requested by national public

Article 1(26) Market

surveillance

National public

authorities or

Submission of a

reasoned request to

//

EN 26 EN

authorities/bodies which

supervise/enforce obligations relating

to fundamental rights

authority bodies which

supervise or

enforce the respect

of obligations

under Union law

protecting

fundamental rights

access information

Information or documentation

requested by market surveillance

authorities

Article 1(26) Market

surveillance

authorities

Providers/

deployers of AI

systems

Market surveillance

authority is in need

of the information so

as to answer to a

request from national

public

authorities/bodies

which

supervise/enforce

obligations relating

to fundamental

rights)

//

Information exchanges as part of the

cooperation of market surveillance

authorities and public

authorities/bodies which

supervise/enforce obligations relating

to fundamental rights

Article 1(26) Market

surveillance

authorities

/ Public

authorities/bodies

Market surveillance

authorities

/ Public

authorities/bodies

Information

exchange need

identified in the

course of

cooperation and

mutual assistance

//

4.3. Digital solutions

High-level description of digital solutions

EN 27 EN

Digital

solution

Reference(s) to

the

requirement(s)

Main mandated

functionalities Responsible body

How is

accessibility

catered for?

How is

reusability

considered?

Use of AI

technologies

(if

applicable)

N.A. (the

proposed

amendments

to the AI Act

do not foresee

the adoption

of new digital

solutions)

For each digital solution, explanation of how the digital solution complies with applicable digital policies and legislative enactments

Digital Solution #1

Digital and/or sectorial policy (when these are

applicable)

Explanation on how it aligns

AI Act

EU Cybersecurity framework

eIDAS

Single Digital Gateway and IMI

Others

EN 28 EN

4.4. Interoperability assessment

High-level description of the digital public service(s) affected by the requirements

Digital public

service or category

of digital public

services

Description Reference(s) to the

requirement(s)

Interoperable Europe

Solution(s)

(NOT APPLICABLE)

Other interoperability solution(s)

N.A. (the proposed

amendments to the

AI Act do not affect

digital public

services)

Impact of the requirement(s) as per digital public service on cross-border interoperability

Digital Public Service #1

Assessment Measure(s) Potential remaining barriers

(if applicable)

Alignment with existing digital

and sectorial policies

Please list the applicable digital

and sectorial policies identified

EN 29 EN

Organisational measures for a

smooth cross-border digital public

services delivery

Please list the governance

measures foreseen

Measures taken to ensure a

shared understanding of the data

Please list such measures

Use of commonly agreed open

technical specifications and

standards

Please list such measures

4.5. Measures to support digital implementation

High-level description of measures supporting digital implementation

Description of the measure Reference(s) to the

requirement(s)

Commission role

(if applicable)

Actors to be involved

(if applicable)

Expected timeline

(if applicable)

N.A.