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Freshfields Risk & Compliance

| 5 minutes read

Text of the new EU Product Liability Directive is agreed – what happens next?

In brief: 

The text of the revised new EU Product Liability Directive (PLD) has now been agreed. After intense negotiations resulting in provisional political agreement at the end of last year, the updated text was released in January and in February it was agreed by two key European Parliament Committees. It is well-on track for formal endorsement by the Parliament before the summer elections. 

The new regime is - as we have said in previous updates - pro-claimant. Among other things, the core presumptions as to defect and causation persist, new disclosure obligations are introduced and the longstop limitation period is extended significantly for latent harm cases. The legislation remains poised to swing the pendulum further in favour of claimants, in particular, in complex cases.

EU Member States are required to bring into force national law implementing the new regime two years after it enters into force at a European level - so likely some time in the second half of 2026.

For our previous analysis on this topic, please see here and here.

In further detail: 

Where has the text ended up following EU negotiations? 

The agreed text reflects the outline of the Commission’s original proposals, including:

  • the introduction of rebuttable presumptions to assist claimants in proving their case;
  • the extension of the scope of the regime to include software, and to impose obligations on additional economic operators to the list of existing potential defendants (e.g. fulfilment service providers and authorised representatives); 
  • the inclusion of psychological harm and loss or corruption of data to the recognised categories of compensable damage; and 
  • the removal of de minimis threshold limits for claims;

However, the agreed text is even more claimant/consumer-friendly than the Commission’s original proposal in several respects.

Compliance with law becomes a key determinant of defect

To recover under the current PLD, a consumer needs to show that a product was defective and that this caused them compensable damage. A product is defective if it does not present the level of safety which the public is entitled to expect.

The test for defect under the agreed text of the new PLD is similar to the existing text, except that a product that does not present the level of safety “that is required under Union or national law” will also be considered defective. In other words, a breach of applicable product safety regulations, for example, may well give rise to a finding that a product has a defect.  (Conversely, the legislator has dodged the question of whether a product that is compliant with EU or national law is not defective.) 

When assessing whether a product is defective, the court is still directed to consider all the surrounding circumstances. This includes the reasonably foreseeable use (and misuse, per the recitals) of the product, although the new text emphasises that “warnings or other information provided with a product cannot by themselves make an otherwise defective product safe”, and that liability “cannot be circumvented simply by listing all conceivable side effects of a product”.  Also new is the direction for the court to consider the “specific needs of the group of users for whom the product is intended” – this is an improvement on the Commission’s original proposal in this regard, but its impact is unclear. 

Defect and causation will still be presumed

In its original proposal, the Commission suggested that the new PLD should include various rebuttable presumptions to make it easier for claimants to prove defect and/or causation in specific circumstances.

The rebuttable presumptions as to defectiveness and/or causation are ultimately similar to the original Commission proposals (despite some back and forth during the negotiation process between the EU institutions):

  • defectiveness shall be presumed where: the claimant demonstrates that the product does not comply with mandatory product safety requirements intended to protect against the risk of the damage suffered; or where the damage was caused by an “obvious malfunction” of the product during reasonable foreseeable use or under “ordinary circumstances”; or where the defendant fails to comply with its disclosure obligations (see below);
  • causal link shall be presumed where it has been established that the product is defective and the damage caused is of a kind “typically consistent” with the defect in question; and
  • defectiveness or causal link or both, shall be presumed where the claimant faces “excessive difficulties, in particular, due to technical or scientific complexity” to be able to prove either defectiveness or causation or both, and where the claimant demonstrates that it is “likely” that the product is defective or that there is a causal link (or both).

New disclosure/discovery requirements remain, but at least they are reciprocal

The Commission’s proposed requirement for defendants to disclose “necessary and proportionate” evidence provided the claimant can show a “plausible” case, remains, together with a presumption of defectiveness if a defendant fails to comply. 

However, in a positive development, at the insistence of the European Parliament, an element of reciprocity has been introduced via Article 8.1a, which will enable a defendant to require disclosure of “relevant evidence at [the claimant’s disposal]” in certain circumstances. 

These new disclosure obligations are likely to pose one of the most challenging practical developments for defendants, in particular, in those Member States without a meaningful existing disclosure practice or procedure. Further, the uncertainty around precisely when a failure to disclose will engender a presumption of defectiveness against a defendant is concerning (e.g. this is not expressly linked to any materiality limitation). 

Extension of longstop in cases of latent harm

Under the current PLD, there is no liability once ten years have passed from the date that the relevant product is put into circulation. This is often referred to as the “longstop” period for liability and is an important limitation on liability for defendants. However, concerns have been expressed that this is unfair on claimants, particularly in cases involving latent damage – e.g. where there may be a long period between the exposure to the defective product and the development of a disease or other injury.

The Commission proposed to extend the longstop in cases of latent personal injury from 10 to 15 years. The European institutions’ proposals during the negotiations ranged from 20-30 years. The final text contains the (somewhat arbitrary) compromise figure of 25 years. 

In our view, this is arguably the most significant development of all. Defending a claim 25 years after a product has been put into circulation could, in practice, be very difficult for defendants – documents may no longer be available, and people with knowledge of the matter may no longer be with the business. There are also significant implications for the insurability of product liability risks. 

What next? 

  • Once approved formally by the European Parliament, the Directive will enter into force in the EU shortly afterwards, which is expected before the European Parliament breaks for the elections this summer. 
  • The Directive will then require national implementation into the domestic law of each Member State. EU Member States are required to bring into force national law implementing the new regime two years after it enters into force at a European level (a year longer than the Commission had originally proposed). This takes us to the second half of 2026.  
  • Focus for further industry and stakeholder engagement on the PLD will now naturally shift from the European institutional level to the national level. 
  • Those who will be affected by the new rules will now need to begin preparing practically for their implementation. 
  • The meaning and scope of many of the new provisions are unclear. They will need to be fleshed out in guidance and, in time, tested by the courts.


product liability, life sciences, litigation, consumer, consumer protection, europe, regulatory framework