From 9 December 2026 a missing technical file and an untested product stop being paperwork problems and start being evidence. We act as EU authorised representative for more than two hundred brands from outside the European Union, and across those files the same two gaps come back more often than any other: the supplier never had the product tested against REACH, and the supplier has never produced a technical file.
Until now that was an administrative problem. You could usually fix it afterwards, when a marketplace asked or an authority knocked. Under Directive (EU) 2024/2853 both gaps can be used in court as evidence that the product was defective, and the parties who carry that are the importer and the authorised representative inside the EU, not the factory in Asia.
The mechanism sits in two articles of the directive. The fix sits in two documents: a risk analysis and a test report on the finished article.
1. Two gaps: no REACH test and no technical file
The two gaps are the same in almost every file we open: nobody tested the finished article, and nobody wrote a risk analysis.
A brand from outside the EU usually has a certificate of some kind. A test report from a lab, a declaration from the factory, sometimes a CE marking that nobody can trace back to a standard. What is almost never there is the thing the law actually asks for.
The first gap is chemical testing. REACH restricts substances in finished consumer articles, and those restrictions apply to the article itself, not only to the raw material.
A supplier that has tested the plastic granulate has not tested the product. A supplier that says "our material is compliant" has usually never had the finished article tested at all.
The second gap is the technical file. Suppliers send a pile of documents when you ask, and almost none of it is a technical file in the sense the law means. A packing list, a material certificate and a photo of a label are not a risk analysis.
Both gaps have the same cause. Nobody in the chain was ever asked for the document in a way that had consequences. That is the part that changes.
2. What the new rules do to a missing technical file
Directive (EU) 2024/2853 gives a claimant a way to get at your documentation, and it attaches a price to keeping it closed.
Article 9, paragraph 1 says that where a claimant has presented facts and evidence sufficient to support the plausibility of the claim, the defendant is required to disclose relevant evidence that is at the defendant's disposal (source: Directive (EU) 2024/2853, article 9, paragraph 1). That is a disclosure duty, ordered by a national court.
Article 10, paragraph 2, point (a) then says the defectiveness of the product is presumed where the defendant fails to disclose relevant evidence pursuant to article 9, paragraph 1 (source: Directive (EU) 2024/2853, article 10, paragraph 2).
Read those two together. A court asks for the file. You do not have one. The product is presumed defective.
You may still rebut that presumption, because article 10, paragraph 5 gives the defendant that right. But you are rebutting it without the document that would have done the rebutting.
That is the shift in one line. The technical file used to be proof that you had done your homework, and it becomes the thing whose absence is held against you.
If you are not sure what your supplier actually gave you, send us one product file and we will tell you what is in it and what is missing, before it matters.
3. What a REACH breach does to your defence
A REACH breach triggers a second presumption, and this one is shorter and harder. Article 10, paragraph 2, point (b) says defectiveness is presumed where the product does not comply with mandatory product safety requirements laid down in Union or national law (source: Directive (EU) 2024/2853, article 10, paragraph 2).
REACH restrictions are exactly that kind of mandatory requirement. If a finished article exceeds a limit in annex XVII of Regulation (EC) No 1907/2006, the product does not comply.
Under the new rules that non-compliance is not only a market surveillance issue. It is evidence of a defect in a damages claim.
This is why "we never tested for REACH" is a different sentence after 9 December 2026 than before it. Without a test report you cannot show the article stayed within the limit, so you cannot remove the presumption with the one piece of evidence that would settle it.
Note the direction of the burden. The claimant does not have to prove that the substance caused the injury. The claimant has to show that the product did not meet a mandatory requirement, and the defect is then presumed.
The causal link has its own presumption in article 10, paragraph 3, where the damage is of a kind typically consistent with the defect in question.
4. Why liability lands on the importer and the authorised representative
Liability lands on the EU side of the chain because the directive puts it there. The obvious objection is that the factory made the product, so the factory should answer for it, but that is not how the directive works for manufacturers outside the EU.
Article 8, paragraph 1, point (c) covers the case of a manufacturer established outside the Union. Without prejudice to the liability of that manufacturer, liability falls on the importer of the defective product, on the authorised representative of the manufacturer, and, where there is no importer established within the Union and no authorised representative, on the fulfilment service provider (source: Directive (EU) 2024/2853, article 8, paragraph 1).
The importer and the authorised representative are named side by side. Neither is a fallback for the other.
An injured person in the EU can go to whichever of the two is easiest to reach. A supplier outside the EU that does not answer your emails today will not be answering a Dutch court either.
Our article on the EU Product Liability Directive sets out that order in full. What matters here is the practical consequence: the party with the weakest documentation sits inside the EU, and that is also the party the claim lands on.
5. What a technical file has to contain
A technical file is a risk analysis with the evidence behind it, and for a general consumer product the requirement sits in the GPSR.
Article 9, paragraph 2 of Regulation (EU) 2023/988 says that before placing a product on the market, manufacturers shall carry out an internal risk analysis and draw up technical documentation containing at least a general description of the product and its essential characteristics relevant for assessing its safety (source: Regulation (EU) 2023/988, article 9, paragraph 2). The documentation has to be kept for ten years after the product is placed on the market and made available to market surveillance authorities on request.
Two details are worth knowing.
The risk analysis is the file, not an attachment to it. A folder of certificates without an analysis that links hazards to measures and to evidence is not technical documentation. It is a folder of certificates.
The importer also has a duty of its own. Article 11, paragraph 1 of the same regulation says that before placing a product on the market, importers shall ensure that the product complies with the general safety requirement in article 5 and that the manufacturer has complied with the requirements in article 9, paragraphs 2, 5 and 6 (source: Regulation (EU) 2023/988, article 11, paragraph 1).
So "the factory keeps that" is not an answer. Checking that the factory has it is your obligation.
There is also the question of who inside the EU has to produce the file. Article 16, paragraph 1 says a product may not be placed on the market unless there is an economic operator established in the Union responsible for the tasks in article 4, paragraph 3 of Regulation (EU) 2019/1020 (source: Regulation (EU) 2023/988, article 16, paragraph 1). That is the responsible person, and in most set-ups run from outside the EU that is the authorised representative.
For a file that would survive being asked for, our technical file service builds one and tells you which products can share it, and our test report review tells you whether what your supplier already sent is worth anything.
6. What REACH asks of you
REACH asks three things of a seller of finished articles, and none of them is the registration duty most sellers worry about.
Restrictions. Annex XVII of Regulation (EC) No 1907/2006 sets limits for specific substances in specific uses, and many of those limits apply to finished consumer articles rather than to chemicals. This is the part that turns into article 10, paragraph 2, point (b) in a damages claim.
Communication. If an article contains a substance on the candidate list above a concentration of 0.1 % weight by weight, the supplier has to give recipients enough information for safe use, under article 33 of REACH. A consumer who asks has to be answered within 45 days (source: ECHA, obligations following inclusion in the candidate list).
Notification. If such an article contains the substance above 0.1 % weight by weight and the quantities total over one tonne per producer or importer per year, ECHA has to be notified, under article 7, paragraph 2 of REACH (source: ECHA, obligations following inclusion in the candidate list).
The candidate list grows. A product that was clean when you first ordered it can fall inside a communication duty two years later without anything about the product changing.
That is a good reason to keep the test report and the bill of materials together, and to know the date of the last test.
7. Seven questions for your supplier before the next order
These are the questions we put to a supplier when we open a new file. They cost one email and they show quickly whether the supplier has anything real.
- Which laboratory tested the finished article, not the raw material, and on what date?
- Which annex XVII entries was it tested against, and what were the measured values?
- Is there a risk analysis that names the hazards, the measures taken and the evidence behind each measure?
- Who inside your company signed that analysis, and when was it last updated?
- Which substances on the candidate list are present above 0.1 % weight by weight?
- If the design, the material or the supplier of a component changed since the last test, when was it retested?
- Will you supply the file itself, not a summary, and may we keep it for ten years?
Question three separates a real file from a pile of certificates. Question six catches the most problems in practice, because a factory that changes a resin or a coating rarely tells the brand and almost never retests.
If you want help reading what comes back, book a short call and we will go through one supplier file with you.
8. When the supplier will not or cannot deliver
You have three options when the answer is silence or a certificate that turns out to belong to a different article, and they are not equally good.
Test it yourself. You commission the test on the finished article and build the file from the result. That costs money and takes weeks, but it produces a document that is yours, that names your product, and that you can hand to a court.
Change what you sell. If the product is cheap and replaceable, and the supplier cannot show what is in it, a different product is often cheaper than a different document.
Accept the gap knowingly. Sometimes a brand decides the volume is too small to justify testing. That is a business decision, but from 9 December 2026 make it with the presumption in mind, and write down that you made it. A decision that is recorded is easier to defend than a gap nobody noticed.
What we would not advise is the fourth option, which is to keep selling on a supplier declaration that nobody has read. That is the position the new presumptions were written for.
9. What to do before December
Three things are worth doing before December.
Sort your range by risk, not by revenue. Items in prolonged skin contact, items used by children, and anything with a soft plastic or a coating are where restricted substances turn up.
For the top of that list, ask the seven questions above and see what comes back. The quality of the answers tells you more than the certificates do.
Where the answer is thin, decide now whether you test, replace or accept, and record the decision. The presumptions in article 10 do not punish a safe product. They punish a company that cannot show its product is safe.
If you sell into the EU without an operator here who holds the file, the EU authorised representative service is the place to start, because that is the party a claim reaches first.
Sources
- Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products: article 8, paragraph 1 (liable economic operators), article 9, paragraph 1 (disclosure of evidence), article 10, paragraphs 2, 3 and 5 (presumptions and the right to rebut)
- Regulation (EU) 2023/988 on general product safety (GPSR): article 9, paragraph 2 (internal risk analysis and technical documentation), article 11, paragraph 1 (importer obligations), article 16, paragraph 1 (responsible person in the Union)
- Regulation (EC) No 1907/2006 (REACH): annex XVII (restrictions), article 33 (duty to communicate information on substances in articles), article 7, paragraph 2 (notification of substances in articles)
- European Chemicals Agency, summary of obligations resulting from inclusion of substances in the candidate list, consulted 18 September 2026
