Regulatory and compliance · EU market entry

The new EU product liability rules: who is liable for products made outside the EU

A new EU directive sets the rules for who pays when a product causes damage. It applies to products placed on the EU market after 9 December 2026. For products made outside the EU, it names liable companies inside the EU. This page explains who they are, what changes, and what an EU importer company of your own does for you.

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Short answer

For products placed on the market after 9 December 2026, the manufacturer outside the EU is liable, and so are the importer of the product and the authorised representative of the manufacturer. When both are missing in the EU, the fulfilment service provider is liable (Directive (EU) 2024/2853, Article 8).

For a manufacturer in China that sells to EU distributors: the distributor that brings the goods into the EU is the importer, and it is liable next to the manufacturer. EU buyers respond with contracts, indemnities and insurance demands. Some prefer a supplier with its own EU importer.

Your own EU importer company takes that role inside your group. The manufacturer remains liable as well, and the injured person chooses whom to claim from. The importer company is the place where the European liability, the insurance and the product records come together.

Software, firmware and apps count as products. The old threshold of €500 is gone, and liability towards the injured person is unlimited.

9 Dec 2026
the new rules apply to products placed on the EU market after this date
3 years
to bring a claim after the injured person knows the damage, the defect and the liable company
10 years
after the product was placed on the market, the right to claim ends; 25 years for latent personal injury

Who is liable from 9 December 2026

Article 8 of Directive (EU) 2024/2853 names the companies that are liable for a defective product:

  • the manufacturer of the product, and the manufacturer of a defective component;
  • for a manufacturer established outside the EU: the importer of the product and the authorised representative of the manufacturer;
  • the fulfilment service provider, when the EU side has only such a provider: a company that offers at least two of warehousing, packing, addressing and dispatching, for goods owned by others;
  • a distributor, when the injured person is unable to identify a liable company in the EU from this list and the distributor fails to name one, or its own supplier, within one month of a request; the same applies to online platforms that present a product the way a seller would;
  • anyone who substantially modifies a product outside the control of the manufacturer, who then counts as a manufacturer.

The directive defines the importer as the person who places a product from a third country on the EU market (Article 4(12)). A European distributor that buys your goods at the factory and brings them into the EU is the importer.

What counts as a product and as damage

A product includes electricity, digital manufacturing files, raw materials and software (Article 4(1)). Software includes operating systems, firmware, computer programs, applications and AI systems. Free and open-source software supplied outside a commercial activity is outside the scope. Digital services that a product needs to work, such as a connected app, count as well.

Damage means death and personal injury, including medically recognised damage to psychological health; damage to property, apart from the product itself and property used only for professional purposes; and the destruction or corruption of data that people use privately (Article 6).

The old threshold of €500 for property damage is gone. Liability towards the injured person is unlimited, and a contract clause that limits it is void (Article 15).

Easier to prove for the injured person

A court can order the defendant to disclose evidence once the claim is plausible (Article 9). The court presumes the product defective when the defendant withholds that evidence, when the product breaks mandatory safety rules, or when it shows an obvious malfunction (Article 10(2)).

The link between the defect and the damage is presumed when the damage is of a kind typically consistent with the defect (Article 10(3)). For technically complex products, such as AI systems, a court can presume the defect, the link or both when proof is excessively difficult and the claimant shows that they are likely (Article 10(4)). The liable company can rebut every presumption (Article 10(5)).

Time limits and defences

The injured person has three years from the moment he or she knew, or should reasonably have known, the damage, the defect and the identity of the liable company (Article 16). The right to claim ends ten years after the product was placed on the market or substantially modified, and after 25 years for personal injury that shows up late (Article 17).

A liable company is released when it proves, for example, that the defect probably arose after it placed the product on the market, that the defect results from compliance with the law, or that the state of science and technology at the time made the defect impossible to discover (Article 11). For defects in software, updates or related services within the control of the manufacturer, the defence that the defect arose later falls away (Article 11(2)).

Several liable companies are liable jointly and severally: the injured person can claim the full amount from any of them (Article 12). The company that pays can recover from the others under national law (Article 14).

In the Netherlands

The Dutch bill that transposes the directive, the Implementatiewet richtlijn herziening productaansprakelijkheid (Kamerstuk 36906), amends Book 6 and Book 7 of the Dutch Civil Code. The Council of State gave its advice on 3 December 2025, the bill was submitted on 2 March 2026, and the plenary debate in the House of Representatives is planned for the week of 18 January 2027.

The directive applies to products placed on the market after 9 December 2026, the deadline for transposition. The Dutch act follows later. Until it is in force, Dutch courts apply the current rules of the Civil Code and, after the deadline, interpret them in line with the directive. The Dutch bill retains the defence for the state of science and technology.

What your own EU importer company does

Your EU importer company takes the importer role for your group: it places the products on the EU market, its name is on the product and it keeps the product records. A BV is liable for what it does in its own name, and its shareholders are liable up to their share capital (Dutch Civil Code, Book 2, Article 175).

The manufacturer remains directly liable, and the injured person chooses whom to claim from. The importer company is therefore the place to manage the European risk, together with insurance at group level. In the Netherlands, product liability is usually part of the general business liability insurance, according to the explanatory memorandum to the Dutch bill.

Directors of a Dutch company are liable in a bankruptcy for manifestly improper management that is an important cause of it. Incomplete books or late annual accounts count as improper management (Book 2, Article 248). Complete bookkeeping and annual accounts filed on time are part of the protection.

The link with the product safety rules

Since 13 December 2024 a consumer product may be placed on the EU market only when an economic operator established in the EU is responsible for it (General Product Safety Regulation (GPSR), Regulation (EU) 2023/988, Article 16). For many CE-marked products, such as machinery, toys and electrical and radio equipment, the same rule applies since 16 July 2021 (Regulation (EU) 2019/1020, Article 4). One EU company can be the importer for both sets of rules.

Sources: Directive (EU) 2024/2853 on liability for defective products; European Commission, liability for defective products; House of Representatives, bill 36906 and its explanatory memorandum; Dutch Civil Code, Book 2, Articles 175 and 248; General Product Safety Regulation (EU) 2023/988; Regulation (EU) 2019/1020. Checked on 25 September 2026.

Who does what

Holdwise sets up and manages the EU importer company. Insurance brokers, compliance specialists and lawyers do the specialist work. You keep one contact.

You

Your company

  • Design, production and the technical file
  • Product safety tests and certificates
  • Group insurance and supplier contracts
Holdwise

The Dutch base

  • Sets up the Dutch BV that is your EU importer, by power of attorney
  • Customs number (EORI), VAT number and the Article 23 application
  • Contracts with EU buyers in the name of the Dutch company
  • Bookkeeping and annual accounts filed on time
Partner, via Holdwise

Insurance, compliance, contracts

  • Insurance broker for product liability
  • Product compliance: GPSR, CE marking, labels
  • Lawyer for supply terms and indemnities

Step by step

From selling to EU distributors to an EU importer of your own.

  1. Your products and buyers. You share your product types, your markets and how your buyers import today. Holdwise answers in writing which importer set-up fits.
  2. The company. The notary sets up the Dutch BV by power of attorney, usually within one week once all documents are complete.
  3. The numbers. Customs number (EORI), VAT number and the Article 23 application.
  4. Insurance and contracts. The product liability cover is checked for the Dutch company, and the supply terms between your factory and the Dutch company are signed.
  5. The label. The name and address of the Dutch company go on the product or its packaging.
  6. Every year. Bookkeeping, annual accounts filed on time and complete product records.

Common questions

From December 2026, who is liable for products made in China and sold in the EU? +
For products placed on the market after 9 December 2026: the manufacturer, the importer of the product and the authorised representative of the manufacturer. When both are missing in the EU, the fulfilment service provider is liable. Distributors are liable when a liable company in the EU is impossible to identify and they fail to name one, or their supplier, within one month of a request.
Does the new directive require us to have our own EU importer? +
The directive names who is liable and leaves the choice of importer to you. An EU distributor that imports your goods is the importer and is liable. Your own EU importer company takes that role within your group.
Is software covered? +
Yes. Software counts as a product, including firmware, apps and AI systems. Free and open-source software supplied outside a commercial activity is outside the scope.
Which products stay under the old rules? +
Products placed on the market before 9 December 2026 stay under the rules of Directive 85/374/EEC. The new directive applies to products placed on the market after that date.
Can a Dutch importer company limit the liability of our group? +
A BV is liable for what it does in its own name, and its shareholders are liable up to their share capital. The manufacturer remains directly liable, and the injured person chooses whom to claim from. The importer company is the place to manage the European risk, together with insurance.
Does business liability insurance include product liability? +
In the Netherlands product liability is usually part of the general business liability insurance, according to the explanatory memorandum to the Dutch bill. Check the policy for products made outside the EU and for software.
When do the new rules apply in the Netherlands? +
The directive applies to products placed on the market after 9 December 2026. The Dutch act (Kamerstuk 36906) is planned for debate in the House of Representatives in January 2027. Until it is in force, Dutch courts apply the current rules and interpret them in line with the directive.

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Why founders choose the Netherlands

Three practical reasons. First: your money stays available. The Netherlands lets an importing company pay import VAT on its tax return instead of at the border (the Article 23 licence). You can put that money into stock straight away. Other countries, including France, also handle import VAT through the VAT return. The rules and conditions differ by country.

Second: profit passes freely between the companies in your structure. Profit from your operating company can go to your holding company free of tax (the participation exemption). Dividends to many foreign parent companies are paid with 0% withholding tax under treaty rules. The first €200,000 of profit is taxed at 19%.

Third: you can do everything from abroad, in English. Incorporation usually takes less than a week once all documents are complete, with a power of attorney that allows the notary to sign for you. The tax authority works digitally, and every document you need is available in English. You never have to board a plane to own and run a Dutch company.

See how this applies to your situation

Holdwise Assistant
Knowledge on doing business in the Netherlands · based on the 2026 figures