SOURCE 0 - THE DIGITAL OMNIBUS ON AI: 33 QUESTIONS
Author: Jean-François ELSEN (Senior Forensic Auditor · Judicial Specialist in Digital Evidence · DGSA)
Location: Brussels – Charleroi, Belgium
Organization: Jean-François ELSEN · jfelsen.com
Classification: Authoritative Public Release · July 2026
Audience: C-Suite Executives, Boards of Directors, Regulators, Supervisory Authorities, Legal Departments, CISOs, Compliance Officers, AI Governance Architects, Forensic Analysts, Critical Infrastructure Operators, Public Authorities
Series: SOURCE 0 Doctrine Series
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Regulation (EU) 2026/1744, the Digital Omnibus on AI, was published in the Official Journal on 24 July 2026 and entered into force on 27 July 2026, amending Regulation (EU) 2024/1689 (the AI Act), Regulation (EU) 2018/1139 (civil aviation), and Regulation (EU) 2023/1230 (machinery). It defers high-risk obligations, refines AI Office powers, adds new prohibited practices, and simplifies compliance for SMEs and SMCs — while leaving Article 50 transparency obligations unchanged. This article answers thirty-three questions the text raises for organisations subject to it, and identifies, for each, the evidentiary gap that survives compliance with the letter of the regulation.
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ENTRY INTO FORCE AND THE CALENDAR
Q: When did the Digital Omnibus on AI enter into force?
A: Regulation (EU) 2026/1744 entered into force on 27 July 2026, three days after its publication in the Official Journal on 24 July 2026. What it does not settle is what any organisation decided or recorded during the twenty-five days between the Council's political agreement on 29 June 2026 and that publication. SOURCE 0 fixes, independently and before the fact, what was known and decided during exactly that kind of interval.
Q: Was the deferral already binding before the regulation was published?
A: No. Until publication in the Official Journal, the deferral was a political and legislative fact, not a legal one. An organisation that acted on the assumption it was already binding made a decision the law did not yet support. SOURCE 0 seals the record of such decisions independently of whether the underlying assumption later proves correct.
Q: What are the new deadlines for high-risk AI systems?
A: 2 December 2027 for standalone systems under Annex III, and 2 August 2028 for systems embedded in products under Annex I, per the amended Article 113(3)(c). An organisation that adjusted its compliance roadmap before these dates were legally fixed needs an independent record of when that adjustment was actually made. SOURCE 0 provides it.
Q: Does the new regulation affect Article 50 transparency obligations?
A: No. Article 50 remains due on 2 August 2026, unchanged. Organisations that treated Article 50 readiness as lower priority because of the broader deferral narrative made that call on a text the regulation never touched. SOURCE 0 fixes the state of an organisation's Article 50 disclosure practice at any given date, independent of unrelated regulatory noise.
Q: Is there a grace period for AI-generated content marking?
A: Yes — under the newly inserted Article 111(4), providers who placed generative AI systems on the market before 2 August 2026 have until 2 December 2026 to comply with Article 50(2). Whether a given system was genuinely placed on the market before that cutoff is the operative fact determining which deadline applies — and it is a fact only the provider currently attests to. SOURCE 0 fixes that placement date independently.
Q: When do the AI Office's governance powers actually start applying?
A: Articles 102 to 110 apply from 27 July 2026, per the amended Article 113(3)(d) — the same day the regulation entered into force. An organisation disputing an AI Office action taken shortly after that date may need to establish precisely what the AI Office's powers were on the day the action was taken, not what they became shortly after. SOURCE 0 fixes that operative date independent of either party's later account.
SCOPE AND DEFINITIONS
Q: What counts as a "safety component" under the amended AI Act?
A: An AI system component whose intended purpose, set by the provider, is to prevent or mitigate risks to health, safety, or property — excluding systems solely for user assistance, performance optimisation, or convenience, under the amended Article 3(14) and new Article 6(1a)-(1c). Providers self-classify against this definition, and that classification decision is exactly the kind of judgment call SOURCE 0 fixes at the moment it is made, before a market surveillance authority later disputes it.
Q: What is a "small mid-cap enterprise" (SMC) under this regulation?
A: An enterprise defined by Commission Recommendation (EU) 2025/1099, larger than an SME but benefiting from certain simplified obligations extended by this regulation. Whether a growing company still qualifies at the moment a given obligation applies is a factual question SOURCE 0 can fix independently, rather than leaving it to a later self-assessment.
Q: Can a provider still process special categories of personal data for bias detection?
A: Yes, under the new Article 4a, subject to strict safeguards, and now extended to deployers and to AI systems beyond strictly high-risk ones. A provider relying on this exception needs to demonstrate, after the fact, that the conditions were met at the time of processing. SOURCE 0 seals that demonstration independently of the provider's own records.
PROHIBITED PRACTICES
Q: Does the AI Act now prohibit AI-generated deepfake nudity?
A: Yes. The amended Article 5 prohibits AI systems that generate or manipulate non-consensual intimate material of an identifiable person, effective 2 December 2026. Whether a system's safeguards were "reasonable and adequate" at a given moment, as the exemption requires, is a factual question a provider cannot certify to itself after an incident. SOURCE 0 fixes the state of those safeguards before the fact.
Q: What about AI-generated child sexual abuse material?
A: Also prohibited under the amended Article 5, subject only to a narrow "without right" defence for law enforcement and red-teaming purposes. An organisation invoking that defence needs an independent, pre-existing record of the authorisation and the testing conditions relied upon. SOURCE 0 seals that authorisation and those testing conditions independently, before the fact, rather than leaving the defence to rest on a record the same team later produces to justify itself.
AI OFFICE GOVERNANCE AND POWERS
Q: Does the AI Office now have direct investigation powers?
A: Yes. The new Article 75a gives the AI Office market-surveillance-equivalent powers — information requests, on-site inspections, binding commitments, fines — over AI systems within its exclusive competence. An organisation facing such an inspection will be judged on the diligence it can prove predates the inquiry, not on what it can produce during it. SOURCE 0 is that pre-existing proof.
Q: What happens if a national authority and the AI Office disagree on who supervises a given AI system?
A: The regulation sets a four-month response window under Article 75(2a) for the AI Office to act on a national authority's request. During that window and after, an organisation under dual potential scrutiny needs a single, independently dated record of its compliance state. SOURCE 0 provides that single record, sealed once and shared as-is, rather than two internal narratives assembled after the fact for two different regulators.
Q: Can a company negotiate its way out of an AI Office finding of non-compliance?
A: Yes, under the new Article 75b — an operator can offer commitments during proceedings, and the AI Office may make them binding by decision. But the AI Office can reopen proceedings if there is a material change in the facts the decision was based on, or if the operator acts contrary to its commitments. Whether the facts changed, and whether the operator's later conduct matches what it committed to, are exactly the kind of disputed factual questions SOURCE 0 fixes independently of either party's own account.
Q: What has to happen before the AI Office can impose a fine?
A: Under Article 75c(2), the AI Office must first communicate preliminary findings and explain what measures it expects. The operator then has to describe, after implementation, what measures it actually took. An operator's own after-the-fact description of its remediation is precisely the self-attested record the Endogenous Audit Paradox describes — SOURCE 0 seals what was actually done and when, independent of the operator's own compliance narrative.
Q: Is there a time limit on the AI Office's power to fine a company?
A: Yes — a five-year limitation period under Article 75c(8), running from the day the infringement was committed, or, for continuing infringements, from the day it ceased. Whether an infringement "ceased" on a given date, or continued past it, is a factual question with direct financial consequences — and the only account of when non-compliant conduct actually stopped is typically the operator's own. SOURCE 0 fixes that cessation date independently.
Q: Can a company see the evidence the AI Office is using against it?
A: Yes, under Article 75d(2), subject to a "negotiated disclosure" balancing access to the file against protection of business secrets. What was actually disclosed, withheld, and agreed between the parties during that negotiation is a fact the AI Office's own file does not neutrally record from the operator's side. SOURCE 0 fixes the operator's own record of that negotiation independently.
REGULATORY SANDBOXES AND REAL-WORLD TESTING
Q: Can high-risk AI systems now be tested in real-world conditions outside a sandbox?
A: Yes, extended by the amended Article 60 and new Article 60a to systems covered by Union harmonisation legislation under Annex I, subject to a real-world testing plan agreed with the competent authority. SOURCE 0 seals that plan and its actual execution independently, at the moment testing began, before any post-hoc dispute over what was tested and when.
Q: Does the AI Office now run its own EU-level regulatory sandbox?
A: Yes, under the new Article 57(3a), for AI systems under its Article 75(1) competence, with priority access for SMEs and SMCs. Participation in a sandbox does not by itself prove what an organisation disclosed to the sandbox authority at a given stage — SOURCE 0 fixes that disclosure record independently of the sandbox's own administrative file.
SIMPLIFICATION AND DOCUMENTATION OBLIGATIONS
Q: Does the new regulation reduce documentation requirements for SMEs?
A: Yes — simplified technical documentation forms under Article 11(1), extended simplified quality-management-system compliance under Article 63(1), and streamlined EU database registration under Annex VIII. A simplified form still has to be accurate at the date it was filed. SOURCE 0 fixes the state of the underlying facts at that date, independent of the form's own self-reported content.
Q: Is there still an obligation to ensure staff AI literacy?
A: Yes, now reframed under the amended Article 4 as an obligation to take supportive measures rather than guarantee a specific literacy level. SOURCE 0 fixes the record of what measure was taken and when, at the time it was implemented, rather than letting that record be reconstructed once literacy is questioned after an incident.
INTERACTION WITH SECTORAL LEGISLATION
Q: Why was machinery moved to a different annex of the AI Act?
A: Regulation (EU) 2023/1230 on machinery moves from Section A to Section B of Annex I, meaning AI-enabled machinery will be governed through a sectoral approach rather than direct dual compliance. Until the Commission's delegated acts on Annex III of the Machinery Regulation are adopted — due by 2 August 2028 — manufacturers operate in a transitional zone where the applicable standard is unsettled. SOURCE 0 fixes which regime a manufacturer actually relied on, and when, during that transition.
Q: Does compliance with the Cyber Resilience Act now cover AI Act cybersecurity requirements?
A: Yes, under the new Article 42(3): where a high-risk AI system meets Regulation (EU) 2024/2847's essential cybersecurity requirements, it is deemed to comply with Article 15 of the AI Act, to the extent covered by the EU declaration of conformity. Whether a given system's declaration actually covered the relevant requirements at a given date is a documentary fact — SOURCE 0 fixes it independently of the declaration's own drafting history.
Q: Do civil aviation AI systems follow the same rules as other high-risk systems?
A: No — Regulation (EU) 2018/1139 is amended so the Commission must account for AI Act Chapter III, Section 2 requirements when adopting aviation-specific delegated or implementing acts, without overriding existing aviation governance. An operator relying on aviation-sector conformity assessment instead of the AI Act's own procedure needs to prove which regime it followed and since when — exactly the kind of dual-regime evidentiary question SOURCE 0 is built to fix.
NOTIFIED BODIES AND CONFORMITY ASSESSMENT
Q: Can a notified body under medical devices law also assess AI Act compliance?
A: Yes — the new Article 28(8)-(9) introduces a single application and unified assessment procedure so a conformity assessment body already notified under sectoral legislation like the Medical Devices Regulation can be designated under the AI Act through one combined process. Which specific scope a notified body was actually authorised for, and from what date, is a fact the body's own notification file does not settle on its own — SOURCE 0 seals the operative scope independently.
Q: Until when can a sectoral notified body assess high-risk AI systems without separate AI Act designation?
A: For 18 months from 27 July 2026, under the amended Article 43(3), provided the body already meets the relevant AI Act notified-body requirements through its existing sectoral notification. SOURCE 0 fixes, independently, that the body's qualifying conditions were actually met at the time the assessment occurred, rather than leaving that fact to be asserted after the fact by the body or the organisation relying on it.
Q: What list determines which AI systems a notified body is qualified to assess?
A: The new Annex XIV, which sets out AIP codes (product-linked), AIB codes (biometric systems), and AIH codes (technology-specific, including a dedicated code for agentic AI). Which code a given assessment body was actually designated under, and since when, is a documentary fact a dispute over scope will eventually turn on — SOURCE 0 fixes it independently of the body's own notification record.
DATA PROTECTION AND FUNDAMENTAL RIGHTS
Q: Can a GDPR data protection impact assessment be reused for the AI Act's fundamental rights assessment?
A: Yes — the amended Article 27(4) allows deployers to cross-reference or incorporate a Regulation (EU) 2016/679 Article 35 DPIA into the AI Act's fundamental rights impact assessment rather than duplicating it. Which sections were actually cross-referenced, and as of which version of the DPIA, is a fact that matters the moment either assessment is challenged — SOURCE 0 fixes that correspondence independently of the deployer's own document trail.
Q: Does a fine under the AI Act preclude a criminal prosecution for the same conduct?
A: The regulation requires Member States to respect the ne bis in idem principle where the same conduct is sanctioned both administratively under the AI Act and criminally under related directives. Establishing that the conduct sanctioned was genuinely the same — not merely similar — depends on a precise, dated factual record. SOURCE 0 provides that record independent of either proceeding's own case file.
LIABILITY ON CHANGE OF PROVIDER
Q: What happens if I don't hand over full documentation when transferring an AI system to a new provider?
A: Article 99(4)(da), newly inserted, makes non-compliance with Article 25(2) and (4) — the cooperation and documentation obligations on a change of provider — directly subject to administrative fines. What was actually transferred, and on what date, is no longer just a contractual question between two providers; it is now a fineable compliance fact. SOURCE 0 fixes what was handed over, and when, independently of either provider's own account.
COSTS AND ACCESS TO EXPERTS
Q: Are Member States required to pay the same fees as the Commission for scientific panel experts?
A: Yes, under the amended Article 69(2) — Member States calling on the scientific panel's expertise pay fees equivalent to the Commission's own remuneration rate. Whether a given engagement's fee was correctly benchmarked, and when, is a minor but auditable fact — the kind SOURCE 0 fixes as a matter of course when broader diligence records are being constituted.
Q: Is there a deadline for the Commission to publish post-market monitoring guidance?
A: Yes — by 2 September 2027, including a voluntary template, following the removal of the Commission's power under the amended Article 72(3) to impose a mandatory harmonised template. Until that guidance exists, providers are designing their own post-market monitoring plans under interpretive uncertainty. SOURCE 0 fixes the state of a provider's plan and its underlying rationale at the date it was adopted, independent of whatever guidance later arrives.
THE LIMITS OF WHAT THE REGULATION SETTLES
Q: Does complying with every provision of Regulation (EU) 2026/1744 prove an organisation acted diligently?
A: No. The regulation sets substantive obligations, deadlines, and enforcement mechanics. It does not specify how an organisation proves, to a court or a contesting third party, what it knew and decided at a given moment, using a record it did not produce and cannot control. That is the residual gap the regulation leaves open at every one of the thirty-three points above, and it is the gap SOURCE 0 closes.
CLOSING AXIOM
The law does not require material truth. It requires proof of diligence. A regulation can fix every deadline, every threshold, every procedure with precision — and still leave open the one question that decides every later dispute: what did this organisation actually know, decide, and do, and can it prove it without relying on its own word.
REFERENCE NOTE
SOURCE 0 is a proprietary pre-execution cryptographic attestation architecture developed by Jean-François ELSEN, Senior Forensic Auditor and Judicial Specialist in Digital Evidence, based in Brussels–Charleroi, Belgium.
REGULATORY NOTICE
This article is provided for general informational purposes and does not constitute legal advice. Organisations should consult qualified legal counsel to assess their specific obligations under Regulation (EU) 2024/1689 (AI Act) as amended by Regulation (EU) 2026/1744.
