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AI can draft a Declaration of Conformity, classify a tariff code or build an import file in minutes. Under the pressure of a clearance, that speed feels like a gift. But it has quietly changed the question a regulator asks when the file lands on their desk: it is no longer “did you use AI?” — almost everyone does — but “who reviewed this, and who answers for it?”
The case that made it clear
In April 2026 the US FDA issued a warning to a drug manufacturer (Purolea Cosmetics Lab) for using AI agents to prepare its manufacturing documentation without a qualified person reviewing or approving it before use — a breach of 21 CFR 211.22(c). The problem was not the AI: it was delivering what the AI produced with no one to answer for it. The warning expressly mentions the use of AI. It is the first named, dated sign of where this is going. (For the broader picture, see who validates and signs AI regulatory files.)
What the EU already requires
Article 14 of the EU AI Act (Regulation (EU) 2024/1689) requires effective human oversight of high-risk AI systems: a person who understands what the system produced, can question it and can stop it. “A human glanced at it” is not oversight; “a qualified technician validated it and answers for it” is.
And one thing does not change with AI: as an importer, you answer for the product you place on the EU market. An AI-generated file with no signature behind it does not cover you before customs, the AEMPS or a marketplace: the liability stays human, and by default, yours.
Where an unreviewed AI import file fails
In the files we review, the failure modes of unchecked AI are consistent:
- An invented or inherited tariff code: a TARIC number that reads well but does not correspond — and changes the duty you pay. See TARIC classification.
- An out-of-date limit or standard: a REACH limit or a version of the rule that no longer applies.
- A generic Declaration of Conformity: one for the whole catalogue, with no technical file behind it.
- A missing responsible person: the manufacturer is non-EU and no one takes on the product in the Union (GPSR).
- A citation that does not exist: an article or regulation the AI states with confidence that corresponds to nothing real.
Every one is exactly what an inspector, a notified body or customs is trained to find — and what a qualified technician catches before it leaves.
The difference between a tool and a service
Read the small print of the cheap regulatory-AI tools: almost all of them make you accept that the responsibility for what you submit is yours. They automate a notification or generate a document; they do not take on the file or sign it. If customs, the AEMPS or a marketplace stops you, you are alone with an output no one validated.
We work the opposite way: AI prepares the file — faster, covering everything —, a regulatory technician validates it against the source (the rule, the test, the tariff) with a review built to catch exactly those failures, and signs it in their own name. If you are stopped, we answer. Twenty years and hundreds of approved dossiers.
How we work
We use AI to speed up the mechanical part of your import — data extraction, regulatory cross-checks, first drafts — but no file leaves without a technician reviewing, correcting and signing it. It is the same standard we apply to a product conformity review or a customs file, whether or not AI helped.
Frequently asked questions
Do you use AI on my files? Yes, to speed up the mechanical part. But a qualified technician validates and signs it: AI prepares, it does not decide or sign.
If I use a cheap app for my documentation, am I covered? Read its contract: the liability in an inspection almost always falls on you. They automate; they do not answer.
How do I know my provider really validates what it does with AI? Ask who reviews each document and whether that review is recorded. If the answer is “the system generates it and you accept it”, the risk is yours.
Does your import documentation have a signature behind it?
Tell us what you import and how you prepare your documentation today, and we will tell you whether it would survive an inspection — and fix it if not.
Want to clear it up now? Start with the Express Advisory. Reach us through our contact page.