Changes from plenary report to adopted text

RemovedRecital 34: (34) National courts should also alleviate the burden of proving the defectiveness of a product or the causal link between the damage and the defectiveness, or both, where, notwithstanding the defendant’s disclosure of information and taking all relevant circumstances of the case into account, it would be excessively difficult for the claimant, in light of the technical or scientific complexity of the case, to prove its defectiveness or the causal link, or both. In such cases, requiring proof would undermine the effectiveness of the right to compensation. Therefore, given that manufacturers have expert knowledge and are better informed than the injured person, the claimant should be required to establish on the basis of relevant evidence that it is possible that the product contributed to the damage and, where the claimant’s difficulties relate to proving defectiveness, that it is possible that the product was defective, or where the claimant’s difficulties relate to proving the causal link, that its defectiveness is a possible cause of the damage. Technical or scientific complexity should be determined by national courts on a case-by-case basis, taking into account various factors. Those factors should include substantiated advice from experts in the relevant field, the complex nature of the product the complex nature of the technology used, such as machine learning; the complex nature of the information and data to be analysed by the claimant; and the complex nature of the …

RemovedRecital 35: deleted

RemovedRecital 36: (36) In the interest of a fair apportionment of risk, economic operators should be exempted from liability if they can prove the existence of specific exonerating circumstances. They should not be liable where they can prove that a person other than themselves has caused the product to leave the manufacturing process against their will or that compliance with legal requirements was the very reason for the product’s defectiveness.

RemovedRecital 36 a (new): (36a) In order not to hamper innovation in the software sector and acknowledging the challenges developers of software could be facing with respect to the rules laid down under this Directive, software manufacturers should be exempted from liability if another economic operator is liable under this Directive for damage caused by that software, and, at the time of the placing on the market of that software, that manufacturer was a microenterprise or a small enterprise, meaning an enterprise that, when assessed together with all of its partner enterprises and linked enterprises within the meaning of Article 3 of the Annex to Recommendation 2003/361/EC, if any, falls within the category of microenterprises or small enterprises within the meaning of Article 2(1) of that Annex.

RemovedRecital 38: (38) The possibility for economic operators to avoid liability by proving that a defect came into being after they placed the product on the market or put it into service should also be restricted when a product’s defectiveness consists in the lack of security updates or upgrades necessary to address cybersecurity vulnerabilities and maintain the product’s safety. Such vulnerabilities can affect the product in such a way that it causes damage within the meaning of this Directive. In recognition of manufacturers’ responsibilities under Union law for the safety of products throughout their lifecycle, such as under Regulation (EU) 2017/745 of the European Parliament and of the Council49 , manufacturers should also be liable for damage caused by their failure to supply security updates or upgrades that are necessary to address the product’s vulnerabilities in response to evolving cybersecurity risks. Such liability should not apply where the supply or installation of such updates or upgrades is beyond the manufacturer’s control, for example where the owner of the product does not install an update or upgrade supplied for the purpose of ensuring or maintaining the level of safety of the product insofar as that can be reasonably expected by the owner in terms of their technical capabilities and the knowledge required to be able to perform such update or upgrade.

RemovedRecital 39: (39) In the interests of a fair apportionment of risks, economic operators should also be exempted from liability if they prove that the general state of scientific and technical knowledge, determined with reference to the most advanced level of objective knowledge accessible and not to the actual knowledge of the economic operator in question, while the product was within their control was such that the existence of defectiveness could not be discovered.

RemovedRecital 40: (40) Situations may arise in which two or more parties are liable for the same damage, in particular where a defective component is integrated into a product that causes damage. In such a case, the injured person should be able to seek compensation both from the manufacturer that integrated the defective component into its product and from the manufacturer of the defective component itself. In order to ensure consumer protection, all parties should be held liable jointly and severally in such situations, with compensation mechanisms allowing the injured person to be compensated for the relevant damage.

RemovedRecital 41: (41) Situations may arise in which the acts and omissions of persons other than a potentially liable economic operator contribute, in addition to the defectiveness of the product, to the cause of the damage suffered, such as a third party exploiting a cybersecurity vulnerability of a product. In the interests of consumer protection, where a product is defective, for example due to a vulnerability that makes the product less safe than an average person is entitled to expect, the liability of the economic operator should not be reduced, excluded or disallowed as a result of such acts or omissions by a third party. However, it should be possible to reduce or disallow the economic operator’s liability where injured persons themselves have negligently contributed to the cause of the damage, including where the injured person failed to install updates or upgrades provided by the economic operator that would have mitigated or avoided the damage.

RemovedRecital 43: (43) Given that products age over time, and that higher safety standards are developed as the state of science and technology progresses, it would not be reasonable to make manufacturers liable for an unlimited period of time for the defectiveness of their products. Therefore, the liability should be subject to a reasonable length of time, that is 10 years following placing on the market, without prejudice to claims pending in legal proceedings. In order to avoid unreasonably denying the possibility of compensation, the limitation period should be 30 years in cases where the symptoms of a personal injury are, according to medical evidence, slow to emerge.

RemovedRecital 45: (45) In order to facilitate harmonised interpretation of this Directive by national courts, Member States should be required to publish relevant court judgments on product liability. Furthermore, the Commission should set up and maintain an easily accessible and publicly available database containing such judgments as well as judgments delivered by the Court of Justice of the European Union in relation to proceedings launched pursuant to this Directive.

RemovedArticle 1 – title: Subject matter and objective

RemovedArticle 1 – paragraph 1: This Directive lays down common rules on the liability of economic operators for damage suffered by natural persons caused by defective products and is aimed at ensuring that such persons are entitled to compensation.

RemovedArticle 1 – paragraph 1 a (new): The objective of this Directive is to contribute to the proper functioning of the internal market, while ensuring a high level of consumer protection, and to remove divergences between the legal systems of Member States related to the liability of economic operators for damage suffered by natural persons caused by defective products.

RemovedArticle 2 – paragraph 1 a (new): 1a. This Directive does not apply to free and open-source software, unless such software is offered in exchange for a price or for personal data not exclusively used for improving the security, compatibility or interoperability of that software.

RemovedArticle 2 – paragraph 3 – point b: deleted

RemovedArticle 4 – paragraph 1 – point 1: (1) ‘product’ means all movables, even if integrated into or inter-connected with another movable or into an immovable. ‘Product’ includes electricity, digital manufacturing files, raw materials and software;

RemovedArticle 4 – paragraph 1 – point 2: (2) ‘digital manufacturing file’ means a digital version or a digital template of a movable, which contains the functional information necessary to produce a tangible item by enabling the automated control of machinery or tools;

RemovedArticle 4 – paragraph 1 – point 3: (3) ‘component’ means any item, whether tangible or intangible, including embedded software, raw materials or any related service, that is integrated into, or inter-connected with another product by the manufacturer of that product or by a third party within that manufacturer’s control;

RemovedArticle 4 – paragraph 1 – point 5: (5) ‘manufacturer’s control’ means that the manufacturer of a product performs or, with respect to the actions of a third party, explicitly authorises or consents to a) the integration, inter-connection or supply by a third party of a component including the specific software updates or upgrades, or b) the modification of the product, including substantial modifications;

RemovedArticle 4 – paragraph 1 – point 6: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

RemovedArticle 4 – paragraph 1 – point 7 a (new): (7a) ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

RemovedArticle 4 – paragraph 1 – point 9: deleted

RemovedArticle 4 – paragraph 1 – point 10: (10) ‘putting into service’ means the first use of a product by the end user in the Union in the course of a commercial activity, whether in return for payment or free of charge, in circumstances in which the product has not been placed on the market prior to its first use;

RemovedArticle 4 – paragraph 1 – point 11 – introductory part: (11) ‘manufacturer’ means any natural or legal person who:

RemovedArticle 4 – paragraph 1 – point 11 – point a (new): (a) develops, manufactures or produces a product; or

RemovedArticle 4 – paragraph 1 – point 11 – point b (new): (b) has a product designed or manufactured, or who markets that product under its name or trademark, thereby presenting itself as a manufacturer; or

RemovedArticle 4 – paragraph 1 – point 11 – point c (new): (c) develops, manufactures or produces a product for its own use;

RemovedArticle 4 – paragraph 1 – point 12: (12) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks for the purposes of this Directive;

RemovedArticle 4 – paragraph 1 – point 17: (17) ‘online platform’ means online platform as defined in Article 3, point (i) , of Regulation (EU) 2022/2065; / (deleted)

RemovedArticle 4 – paragraph 1 – point 17 a (new): (17a) ‘trade secret’ means a trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

RemovedArticle 4 – paragraph 1 – point 17 b (new): (17b) ‘substantial modification’ means a modification to a product, made after the product has been placed on the market or put into service: / (a) that is considered substantial under relevant Union or national rules on product safety; or / (b) where relevant Union or national rules lay down no threshold on what is to be considered substantial modification, that: / (i) changes the product’s original performance, purpose or type, without such change being foreseen in the manufacturer’s initial risk assessment of the product; and / (ii) changes the nature of the hazard, creates a new hazard or increases the level of risk.

RemovedArticle 5 – paragraph 2 – point b: (b) a person acting on behalf of one or more injured persons in accordance with Union or national law.

RemovedArticle 5 a (new): Article 5a / Damage / 1. For the purpose of this Directive, ‘damage’ means material losses resulting from: / (a) death or personal injury, including medically recognised damage to psychological health; / (b) damage to, or destruction of, any property, except: / (i) the defective product itself; / (ii) a product damaged by a defective component of that product that is integrated into, or inter-connected with, a product by the manufacturer of that product within that manufacturer’s control; / (iii) property used exclusively for professional purposes. / (c) destruction or irreversible corruption of data that are not used for professional purposes, provided that the material loss exceeds EUR 1 000. / 2. This Article shall not affect national rules relating to non-material damage as well as those relating to the compensation of damage under other liability regimes.

RemovedArticle 5 b (new): Article 5b / Guidance / 1. Member States shall ensure that the competent national consumer protection authorities provide information and tailored guidance to consumers to enable them to effectively exercise their right to compensation in accordance with Article 5. / 2. Member States shall ensure that market surveillance authorities regularly exchange relevant information with national consumer protection agencies and bodies to ensure a high level of consumer protection and that national consumer protection agencies and bodies regularly exchange relevant information at their disposal.

RemovedArticle 6 – paragraph -1 (new): -1. A product shall be considered defective when it does not provide the safety that an average person is entitled to expect or that is required under Union or national law.

RemovedArticle 6 – paragraph 1 – introductory part: 1. In assessing the defectiveness of a product, all circumstances shall be taken into account, including:

RemovedArticle 6 – paragraph 1 – point a: (a) the characteristics of the product, including its labelling, design , technical features, composition, packaging, any other information regarding the product and the instructions for assembly, installation, use and maintenance;

RemovedArticle 6 – paragraph 1 – point b: (b) the reasonably foreseeable use of the product, taking into account the expected lifespan of the product;

RemovedArticle 6 – paragraph 1 – point c: (c) the effect on the product of any ability to acquire new features or knowledge after it is placed on the market or put into service;

RemovedArticle 6 – paragraph 1 – point d: (d) the effect that other products might have on the product to be assessed, where, at the time of placing on the market or putting into service, it can reasonably be expected that the product will be used together with other products, including the interconnection of those products;

RemovedArticle 6 – paragraph 1 – point f: (f) relevant product safety requirements, including safety-relevant cybersecurity requirements laid down in Union or national law, that are intended to protect against the risk of the damage that has occurred;

RemovedArticle 6 – paragraph 1 – point g: (g) any recall of the product or any other relevant intervention decided by a regulatory authority or by an economic operator referred to in Article 7 relating to product safety.

RemovedArticle 6 – paragraph 1 – point h: deleted

RemovedArticle 7 – paragraph 1 – subparagraph 2: Member States shall ensure that, where a defective component has caused the product to be defective, the manufacturer of a defective component can also be held liable for the same damage, unless the defect is attributable to the design of the product in which the component has been integrated or to the instructions given by the manufacturer of that product to the manufacturer of the component.

RemovedArticle 7 – paragraph 2: 2. Member States shall ensure that, where the manufacturer of the defective product or component is established outside the Union, the importer of the defective product or component and, where applicable, the authorised representative of the manufacturer can be held liable for damage caused by that product.

RemovedArticle 7 – paragraph 3: 3. Member States shall ensure that, where the manufacturer of the defective product is established outside the Union and neither of the economic operators referred to in paragraph 2 is established in the Union, the fulfilment service provider can be held liable for damage caused by the defective product or, where applicable, component.

RemovedArticle 7 – paragraph 4: 4. Any natural or legal person that substantially modifies a product outside the manufacturer’s control and thereafter makes it available on the market or put into service shall be considered a manufacturer of the product for the purposes of paragraph 1.

RemovedArticle 7 – paragraph 6: 6. Paragraph 5 shall also apply to any provider of an online platform that allows consumers to conclude distance contracts with traders and that is not a manufacturer, importer or distributor, provided that the conditions of Article 6(3) set out in Regulation (EU) 2022/2065 are fulfilled. / (deleted)

RemovedArticle 7 – paragraph 6 a (new): 6a. Where victims fail to obtain compensation because none of the economic operators referred to in paragraphs 1 to 6 can be held liable under this Directive, or because the liable economic operators are insolvent or have ceased to exist, Member States may use existing national sectorial compensation schemes or establish new ones under national law, which shall not be funded by public revenues, to appropriately compensate injured persons who suffered damage caused by defective products.

RemovedArticle 8 – paragraph 1: 1. Member States shall ensure that in proceedings for claiming compensation for damage caused by a defective product, at the request of a claimant who has presented facts and evidence sufficient to support the plausibility of the claim for compensation, national courts may order the defendant to disclose relevant evidence that is at its disposal, subject to the conditions set out in this Article.

RemovedArticle 8 – paragraph 1 a (new): 1a. Member States shall ensure that, if requested by the defendant, national courts are able to order the claimant to disclose relevant evidence that is at its disposal, subject to the same conditions that apply to the disclosure of evidence by the defendant set out in this Article.

RemovedArticle 8 – paragraph 3: 3. When determining whether the disclosure requested by a party is necessary and proportionate, national courts shall consider the legitimate interests of all parties, including third parties concerned, in particular in relation to the protection of trade secrets within the meaning of Article 2, point 1, of Directive (EU) 2016/943 and the need to prevent non-specific searches for information, which is unlikely to be of relevance for the parties to the procedure.

RemovedArticle 8 – paragraph 4: 4. Member States shall ensure that, where a defendant is ordered to disclose information that is a trade secret or an alleged trade secret, national courts take specific measures necessary to preserve the confidentiality of that information when it is used or referred to in the course of and after the legal proceedings.

RemovedArticle 8 – paragraph 4 a (new): 4a. Member States shall ensure that, where a party is ordered to disclose information, the information is presented without undue delay to the other party in an easily accessible and easily understandable manner.

RemovedArticle 8 – paragraph 4 b (new): 4b. This Article does not affect national law relating to the pre-trial disclosure of evidence.

RemovedArticle 9 – paragraph 2 – point b: (b) the claimant establishes that the product does not comply with mandatory product safety requirements laid down in Union law or national law that are intended to protect against or reduce the risk of the occurrence of the damage suffered by the injured party; or

RemovedArticle 9 – paragraph 2 – point c: (c) the claimant establishes that the damage was caused by an obvious malfunction of the product during normal use as intended by the manufacturer or under ordinary circumstances.

RemovedArticle 9 – paragraph 3: 3. The causal link between the defectiveness of the product and the damage shall be presumed, where it has been established that the product is defective and the damage caused is typically consistent with the defect in question, or where the product belongs to the same production series as a product already proven to be defective.

RemovedArticle 9 – paragraph 4 – subparagraph 1 – introductory part: A national court shall presume the defectiveness of the product or the causal link between its defectiveness and the damage, or both, where, notwithstanding the disclosure of evidence in accordance with Article 8 and taking into account all relevant circumstances of the case:

RemovedArticle 9 – paragraph 4 – subparagraph 1 – point a: (a) the national court considers that the claimant faces excessive difficulties, due to technical or scientific complexity to be able to prove the defectiveness of the product or the causal link between its defectiveness and the damage, or both; and