Changes from plenary report to adopted text

RemovedRecital 5: (5) Considering the extensive nature of the amendments that would be required and in order to ensure easy and effective applicability, clarity and legal certainty, Directive 85/374/EEC should be repealed and replaced with a new Directive.

RemovedRecital 6: (6) In order to ensure the Union’s product liability regime is comprehensive and easy and effective to apply, no-fault liability for defective products should apply to all movables, including software, irrespective of the mode of supply and including when they are integrated into other movables or installed in immovables.

RemovedRecital 8: (8) In order to create a genuine internal market with a high and uniform level of consumer protection, and to reflect the case law of the Court of Justice, Member States should not, in respect of matters, within the scope of this Directive, maintain or introduce more, or less, stringent provisions than those laid down in this Directive. For matters other than those provided for under this Directive, national procedural rules should apply in so far as they do not undermine the effectiveness and objectives of the system of product liability provided for under this Directive.

RemovedRecital 9: (9) Under the legal systems of Member States an injured person may have a claim for damages on the basis of contractual liability or on grounds of non-contractual liability that do not concern the defectiveness of a product, for example liability based on warranty or on fault. Such provisions, which also serve to attain inter alia the objective of effective protection of consumers, should remain unaffected by this Directive.

RemovedRecital 10: (10) In certain Member States, injured persons may be entitled to make claims for damages caused by pharmaceutical products under a special national liability system, with the result that effective protection of consumers in the pharmaceutical sector is already attained in those Member States. When it comes to harm suffered due to pharmaceuticals that are not defective, all Member States cover basic losses through national health systems or social security schemes. To cover further losses, some Member States have created special insurance schemes for pharmaceuticals, under which victims of harm are able to get compensation if, despite being non-defective, the pharmaceutical product nonetheless caused harm, without any need to prove fault or defectiveness. The right to make such claims should remain unaffected by this Directive. Amendments to those special national liability systems, health systems and social security schemes as well as the possible introduction of insurance schemes should not be precluded. However, such amendments should not undermine the effectiveness and objectives of the system of product liability provided for under this Directive.

RemovedRecital 12: (12) Products in the digital age can be tangible or intangible. Software, such as operating systems, firmware, computer programs, applications or AI systems, is increasingly common on the market and plays an increasingly important role for product safety. Software is capable of being placed on the market as a standalone product and may subsequently be integrated into other products as a component or may be provided as one or more services, and is capable of causing damage through its execution. The risk of damage is proportionate to the extent to which software is essential to the functioning of a product into which it is integrated or with which it is inter-connected, and in how far it contributes to one or more of the functions of the product, or in how far its absence would prevent the product from performing one or more of its functions. In particular where software that ordinarily and of itself does not pose a significant risk of damage is included in a product with higher safety expectations, the assessment of defectiveness leading to damage should take the original intent of the software producer into account. In the interest of legal certainty it should therefore be clarified that software is a product for the purposes of applying no-fault liability, irrespective of the mode of its supply or usage, and therefore irrespective of whether the software is stored on a device or accessed through a communication network or cloud technologies, or supplied through a software a…

RemovedRecital 12 a (new): (12a) Software in its own right, where specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, should qualify as a medical device, while software intended for general purposes, even when used in a healthcare setting, or software intended for lifestyle and well-being purposes should not be considered a medical device. The qualification of software, either as a device or an accessory, should be independent of the software's location or the type of interconnection between the software and a device.

RemovedRecital 12 b (new): (12b) Individual natural persons who are typically employed in the context of a non-personal professional activity related to the development, manufacturing, production or design of a product and do not exert control over the manufacturing, integration, placing on the market or putting into service of the product should not be considered manufacturers in the meaning of this Directive.

RemovedRecital 13: (13) In order not to hamper innovation or research, this Directive should not apply to free and open-source software in accordance with the conditions laid down under this Directive. This is in particular the case for software, including its source code and modified versions, that is openly shared and freely accessible, usable, modifiable and redistributable. Free and open source software, where the source code is openly shared and users can freely access, use, modify and redistribute the software or modified versions thereof, can contribute to research and innovation on the market. Such software relies on public licences that guarantee the freedom to run, copy, distribute, study, change and improve the software. In order to ensure that innovation and research are not hindered, this Directive should not impact the use of such public licences. However where software is supplied in exchange for a price or personal data is used other than exclusively for improving the security, compatibility or interoperability of the software, the Directive should apply.

RemovedRecital 13 a (new): (13a) A manufacturer should be allowed to decide to integrate free and open-source software as a component of a product or authorise its integration, inter-connection or supply by a third party, which should then, in the interest of legal certainty, be considered to be modifications under the manufacturer’s control. In such cases, if the product is placed on the market or put into service in the course of a commercial activity, this Directive should apply, meaning that in that case the manufacturer of the product could be held liable for damage arising from a defect in the free and open source software. However, it should not be possible to hold the developer or producer of the free and open-source software liable for such damage unless the software is supplied to the manufacturer of the product for payment or for personal data other than data exclusively for improving the security, compatibility or interoperability of the software.

RemovedRecital 14: (14) Digital manufacturing files, which contain the functional information necessary to produce a tangible item by enabling the automated control of machinery or tools, such as drills, lathes, mills and 3D printers, should be considered as products, in order to ensure consumer protection in cases where such files are defective. For the avoidance of doubt, it should also be clarified that raw materials and electricity are products. Products that are digital manufacturing files, which are licensed under free and open-source licenses, should be treated analogously to how free and open-source software products are treated.

RemovedRecital 15: (15) It is becoming increasingly common for digital services to be integrated in or inter-connected with a product in such a way that the absence of the service would prevent the product from performing one of its functions, for example the continuous supply of traffic data in a navigation system. The relevant functions that should be considered for the purposes of this Directive are those that have been attributed to the product by its manufacturer or the functions that an average person would reasonably expect the product to have in light of the description of the product provided by the manufacturer. While this Directive should not apply to services as such, it is necessary to extend no-fault liability to such digital services as they determine the safety of the product just as much as physical or digital components. Such related services should be considered as components of the product to which they are inter-connected, when they are within the control of the manufacturer of that product, in the sense that they are supplied by the manufacturer itself or that the manufacturer authorises them or otherwise influences their supply by a third party.

RemovedRecital 15 a (new): (15a) Related services and other components, including software updates and upgrades, should be considered to be within the manufacturer's control where they are integrated, inter-connected or supplied by the manufacturer itself or where the manufacturer authorises or consents to their supply by a third party. In addition, once a product has been placed on the market, it should be considered to be within the manufacturer’s control in so far as the manufacturer decides to supply software updates or upgrades, or authorises or consents to the supply thereof by a third party.

RemovedRecital 16: (16) In recognition of the growing relevance and value of intangible assets, economic loss due to the destruction or irreversible corruption of data, such as digital files deleted from a hard drive, should also be compensated, when consumers cannot access data in the way they could before the damage and they have to pay a price for recovering and restoring that data. This should include, where relevant, the cost of recovering or restoring the data. As a result, the protection of consumers requires compensation for material losses resulting not only from death or personal injury, such as funeral or medical expenses or lost income, and from damage to property but also for destruction or irreversible corruption of data. However, in order to avoid the potential risk of litigation in an excessive number of cases, the destruction or irreversible corruption of data should not be compensated if the economic value of the damage is below EUR 1 000. Nevertheless, destruction or irreversible corruption of data is distinct from data leaks or breaches of data protection rules, and compensation for infringements of Regulation (EU) 2016/679 of the European Parliament and of the Council41, Directive 2002/58/EC of the European Parliament and of the Council42, Directive (EU) 2016/680 of the European Parliament and of the Council43 and Regulation (EU) 2018/1725 of the European Parliament and of the Council44 is not affected by this Directive. Destruction or corruption of data does not automatica…

RemovedRecital 17: (17) In the interests of legal certainty, it should be clarified that Member States should provide that personal injury includes medically recognised damage to psychological health, certified by a court ordered medical expert, including psychologists, and limited to serious adverse effects on the victim’s psychological integrity of such gravity or intensity that it affects the victim’s general state of health and cannot be resolved without therapy or medical treatment, taking , in particular, the International Classification of Diseases of the World Health Organisation into account.

RemovedRecital 18: (18) While Member States should provide full, proportionate and proper compensation for all material losses resulting from death, or personal injury, or damage to or destruction of property, Member States should ensure that their national rules on calculating compensation allow for injured persons to obtain full and proper compensation from the economic operator who is ultimately liable or from any other relevant party.

RemovedRecital 19: (19) In order to protect consumers, damage to any property owned by a natural person should be compensated. Since property is increasingly used for both private and professional purposes, it is appropriate to provide for the compensation of damage to such mixed-use property. In light of this Directive’s aim to protect consumers, property used exclusively for professional purposes should be excluded from its scope. However, several Member States provide for the possibility to extend consumer protection rules to other weaker parties, such as microenterprises as defined in Commission Recommendation 2003/361/EC1a. Member States should therefore be encouraged to compensate damage to property used exclusively for professional purposes by microenterprises. / 1a Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

RemovedRecital 20: (20) This Directive should apply to products placed on the market or, where relevant, put into service in the course of a commercial activity, whether in return for payment or free of charge, for example products supplied in the context of a sponsoring campaign or products manufactured for the provision of a service financed by public funds, since this mode of supply still has an economic or business character. Neither the collaborative development of free and open-source software nor making such software available on open repositories should constitute placing on the market or putting into service. A commercial activity within the understanding of making available on the market might, however, be characterised by monetisation or paid software updates, unless that serves only to recover actual costs, or by the use of personal data for reasons other than exclusively for improving the security, compatibility or interoperability of the software. Occasional supplies by charities or hobbyists should not be considered as taking place in a business-related context.

RemovedRecital 20 a (new): (20a) Products which are not intended to be placed on the market or to be put into service, due to them, for example, being intended only for personal use or for use only in a controlled and confined setting, but which appear on the market or are put into service after, for example, being stolen, should be excluded from the scope of this Directive.

RemovedRecital 20 b (new): (20b) Taking into account the increased complexity of products, of business models and of supply chains, and considering that the aim of this Directive is to ensure that consumers can easily exercise their right to get compensation in case of damage caused by defective products, Member States should ensure that competent national consumer protection authorities and bodies provide all relevant information and tailored guidance to affected consumers to enable them to effectively exercise their right to compensation in accordance with this Directive. National consumer protection agencies and bodies should regularly exchange relevant information they become aware of and closely cooperate with market surveillance authorities.

RemovedRecital 22: (22) In order to protect the health and property of consumers, the defectiveness of a product should be determined by reference not to its fitness for use but to the lack of the safety an average person is entitled to expect or that is required under Union or national law. The assessment of defectiveness should involve an objective analysis and not refer to the safety that any particular person is entitled to expect. The safety that an average person is entitled to expect should be assessed by taking into account, inter alia, reasonably foreseeable use, the presentation, the objective characteristics and the properties of the product in question as well as the specific requirements of the group of users for whom the product is intended. In addition, the compliance with relevant product safety requirements laid down in Union and national law should be taken into account, in particular if non-compliance increased the risk of the product causing damage of the type suffered by the injured person and that risk has materialised. Economic operators should not be liable, however, if they prove that the damage suffered by the injured person would also have occurred if the relevant mandatory requirements under Union or national law had been complied with. Some products, such as life-sustaining medical devices, entail an especially high risk of damage to people and therefore give rise to particularly high safety expectations. In order to take such expectations into account, it should be…

RemovedRecital 23: (23) In order to reflect the increasing prevalence of inter-connected products, the assessment of a product’s safety should also take into account the reasonably foreseeable effects of other products on the product in question. The effect on a product’s safety of its ability to learn after it is placed on the market or put into service should also be taken into account, to reflect the legitimate expectation that a product’s software and underlying algorithms are designed in such a way as to prevent hazardous product behaviour. In particular where software that ordinarily and of itself does not pose a significant risk of damage is included in a product with higher safety expectations, such as in case of life-sustaining medical devices as defined in Article 2, point (1), of Regulation (EU) 2017/745 of the European Parliament and of the Council1a, the assessment of defectiveness leading to damage should take the original intent of the developer or manufacturer of the software into account. In order to reflect that in the digital age many products remain within the manufacturer’s control beyond the moment at which they are placed on the market, the moment in time at which a product leaves the manufacturer’s control should also be taken into account in the assessment of a product’s safety. A product can also be found to be defective on account of its cybersecurity vulnerability where the product does not fulfil safety-relevant cybersecurity requirements laid down in Union or natio…

RemovedRecital 24: (24) In order to reflect the relevance of product safety and market surveillance legislation for determining the level of safety that an average person is entitled to expect, it should be clarified that relevant product safety requirements, including safety-relevant cybersecurity requirements laid down in Union or national law, and interventions by regulatory authorities, such as issuing product recalls, or by economic operators themselves, should also be taken into account in that assessment. Voluntary interventions should, however, not of themselves create a presumption of defectiveness.

RemovedRecital 25: (25) In the interests of consumer choice and in order to encourage innovation, research and easy access to new technologies, the existence, or subsequent placing, on the market of a better product should not in itself lead to the conclusion that a previous product is defective. Equally, the supply of updates or upgrades to a product should not in itself lead to the conclusion that a previous version of the product is defective.

RemovedRecital 28: (28) Online selling has grown consistently and steadily, creating new business models and new actors in the market such as online platforms. Regulations (EU) 2022/20651a and (EU) 2023/9881b of the European Parliament and of the Council regulate, inter alia, the responsibility and accountability of online platforms with regard to illegal content, including products. When online platforms perform the role of manufacturer, importer or distributor in respect of a defective product, they should be liable on the same terms as such economic operators. When online platforms play a mere intermediary role in the sale of products between traders and consumers, they are covered by a conditional liability exemption under the Digital Services Act. However, the Digital Services Act establishes that online platforms that allow consumers to conclude distance contracts with traders are not exempt from liability under consumer protection law where they present the product or otherwise enable the specific transaction in question in a way that would lead an average consumer to believe that the product is provided either by the online platform itself or by a trader acting under its authority or control. In keeping with this principle, when online platforms do so present the product or otherwise enable the specific transaction, it should be possible to hold them liable, in the same way as distributors under this Directive. That means that they would be liable only when they do so present the produc…

RemovedRecital 29: (29) In the transition from a linear to a circular economy, products are designed to be more durable, reusable, reparable and upgradable. The Union is also promoting innovative and sustainable ways of production and consumption that prolong the functionality of products and components, such as remanufacturing, refurbishment and repair.47. In addition, products allow for modifications through changes to software, including upgrades. When a product is modified substantially outside the control of the original manufacturer, it is considered to be a new product and it should be possible to hold the person that made the substantial modification liable as a manufacturer of the modified product, and subject to the same obligations of a manufacturer, since under relevant Union legislation they are responsible for the product’s compliance with safety requirements. However, those requirements should only apply with respect to the modified part of the product, provided that the modification does not affect the product as a whole. Therefore, the liability of the person that made the substantial modification should be limited to the modified part of the product when the modification does not have an impact on the product as a whole. Whether a modification is substantial is determined according to criteria set out in relevant Union law, including Regulation (EU) 2023/988, and national product safety legislation. Modifications should be considered substantial, for instance, if they change t…

RemovedRecital 29 a (new): (29a) Where victims fail to obtain compensation because no economic operator is liable under this Directive or because the liable economic operators are insolvent or have ceased to exist, Member States should be able to use existing national sectorial compensation schemes or establish new ones under national law, which should not be funded by public revenues, to appropriately compensate injured persons who suffered damage caused by defective products.

RemovedRecital 30: (30) In light of the imposition on economic operators of liability irrespective of fault, and with a view to achieving a fair apportionment of risk, the injured person claiming compensation for damage caused by a defective product should bear the burden of proving the damage, the defectiveness of a product and the causal link between the two. It should be possible for Member States to empower national consumer protection bodies to represent the interests of consumers in the process of gathering the evidence necessary to prove the defectiveness of a product, the damage caused by the defective product and the causal link between the two. Injured persons, are, however, often at a significant disadvantage compared to manufacturers in terms of access to, and understanding of, information on how a product was produced and how it operates. This asymmetry of information can undermine the fair apportionment of risk, in particular in cases involving technical or scientific complexity. The Commission Impact Assessment Report accompanying the proposal for this Directive highlighted the fact that the most frequent reasons to reject claims relate to the proof of the defect and its link with the damage, which together account for 53 % of the cases of rejection. On the other hand, the 2018 Commission Evaluation of Council Directive 85/374/EEC assessed that around 60 % of the claims for defective products were successful from 2000 to 2016.

RemovedRecital 31: (31) Therefore, in legal proceedings to adjudicate on 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 should be able to order the defendant to disclose relevant evidence that is at its disposal, in accordance with national procedural law. At the request of the defendant, national courts should also be able to order the claimant to disclose relevant evidence that is at its disposal, in accordance with national procedural law. The requested disclosure of evidence should be limited to what is necessary and proportionate, and should be carried out in such a way as to ensure that trade secrets, in line with the Directive (EU) 2016/943 of the European Parliament and of the Council1a, are protected. Such evidence should also include documents that have to be created ex novo by the defendant by compiling or classifying the available evidence. Taking in consideration the complexity of certain types of data, especially those from digital products, the evidence to be disclosed should be delivered in an easily accessible and easily understandable manner. / 1a Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).

RemovedRecital 31 a (new): (31a) This Directive should not affect national law relating to the pre-trial disclosure of evidence.

RemovedRecital 32: (32) In respect of trade secrets within the meaning of Directive (EU) 2016/943, national courts should be empowered to take all necessary measures to ensure their confidentiality during and after the proceedings, while achieving a fair and proportionate balance between the interest of the trade-secret holder to secrecy and the interest of the injured person. This should include at least measures to restrict access to documents containing trade secrets or alleged trade secrets and access to hearings to a limited number of people, or allowing access to redacted documents or transcripts of hearings. When deciding on such measures, national courts should take into account: (i) the need to ensure the right to an effective remedy and to a fair trial; (ii) the legitimate interests of the parties, including the amount of damage, and, where appropriate, of third parties; and (iii) any potential harm for either of the parties, and, where appropriate, for third parties, resulting from the granting or rejection of such measures. / (deleted)

RemovedRecital 33: (33) It is also necessary to alleviate the claimant’s burden of proof provided that certain conditions are fulfilled. Rebuttable presumptions of fact are a common mechanism for alleviating a claimant’s evidential difficulties, and allow a court to base the existence of defectiveness or causal link on the presence of another fact that has been proven, while preserving the rights of the defendant. In order to provide an incentive to comply with the obligation to disclose information, national courts should presume the defectiveness of a product where a defendant fails to comply with such an obligation. Many legislative and mandatory safety requirements have been adopted in order to protect consumers and the public from the risk of harm, including under Regulation (EU) 2023/988. In order to reinforce the close relationship between product safety rules and liability rules, non-compliance with such requirements should also result in a presumption of defectiveness. This includes cases in which a product is not equipped with the means to log information about the operation of the product as required under Union or national law. The same should apply in the case of obvious malfunction, such as a glass bottle that explodes in the course of normal use, since it is unnecessarily burdensome to require a claimant to prove defectiveness when the circumstances are such that its existence is undisputed.

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

RemovedArticle 9 – paragraph 4 – subparagraph 1 – point b: (b) the claimant establishes, on the basis of relevant evidence, that it is possible that the product contributed to the damage, and it is possible that the product is defective or that its defectiveness is a possible cause of the damage, or both.

RemovedArticle 9 – paragraph 4 – subparagraph 2: The defendant shall have the right to contest the existence of excessive difficulties or the possibility referred to in the first subparagraph.

RemovedArticle 10 – paragraph 1 – point a a (new): (aa) in the case of a manufacturer of software that, at the time of the placing on the market of that software, the 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, is a microenterprise as defined in Article 2(3) of that Annex or a small enterprise as defined in Article 2(2) of that Annex, provided that another economic operator is liable under this Directive for damage caused by that software;

RemovedArticle 10 – paragraph 1 – point b: (b) in the case of a distributor or an online platform acting as a distributor, that it did not make the product available on the market;

RemovedArticle 10 – paragraph 1 – point c: (c) that, having regard to the circumstances, it is probable that the defectiveness that caused the damage did not exist when the product was placed on the market, put into service or, in respect of a distributor, made available on the market, or that this defectiveness came into being after that moment, provided that that defectiveness did not result from any update or supply under the control of that economic operator and was not due to the failure of that economic operator to provide an update as required by Union or national law;

RemovedArticle 10 – paragraph 1 – point d: (d) that the defectiveness is due to compliance of the product with legal requirements and that the economic operator exercised all reasonable due care required in the circumstances;

RemovedArticle 10 – paragraph 1 – point e: (e) the objective state of scientific and technical knowledge at the time when the product was placed on the market, put into service or the last update supplied under the control of the manufacturer in the period in which the product was within the manufacturer’s control was not such that the defectiveness could be discovered;

RemovedArticle 10 – paragraph 2 – point b: (b) software, including software updates or upgrades for the reasonably expected lifespan of the product; or

RemovedArticle 10 – paragraph 2 – point c: (c) the lack of software updates or upgrades necessary to maintain safety for the reasonably expected lifespan of the product.

RemovedArticle 11 – paragraph 1: Without prejudice to national law concerning the right of contribution or recourse, Member States shall ensure that where two or more economic operators are liable for the same damage pursuant to this Directive, they can be held liable jointly and severally.

RemovedArticle 12 – paragraph 1: 1. Without prejudice to national law concerning the right of contribution or recourse, Member States shall ensure that the liability of an economic operator is not reduced, excluded or disallowed when the damage is caused both by the defectiveness of a product and by an event outside the control of the economic operator, such as one attributable to an act or omission of a third party.

RemovedArticle 12 – paragraph 2: 2. Without prejudice to the compensation mechanisms provided under this Directive, the liability of an economic operator may be reduced or disallowed when the damage is caused both by the defectiveness of the product and by the fault of the injured person or any person for whom the injured person is responsible, including when the injured person does not install updates or upgrades provided by the economic operator that would have mitigated the defect,

RemovedArticle 12 a (new): Article 12a / Right of recourse / 1. Where more than one economic operator is liable for the same damage, any economic operator that has compensated the injured person or was ordered to do so by an enforceable judgment shall have a right of recourse against any other jointly and severally liable economic operator. Member States shall lay down the conditions for exercising such right of recourse which shall not be less favourable to the claimant than in comparable national cases. / 2. National courts may, where appropriate, apply Article 9(2) to (5) in cases in which the right of recourse is exercised.

RemovedArticle 14 – paragraph 2: 2. Member States shall ensure that the rights conferred upon the injured person pursuant to this Directive are extinguished upon the expiry of a limitation period of 10 years from the date on which the actual defective product, or the last update or supply under the control of the manufacturer, which caused the damage was placed on the market, put into service or substantially modified as referred to in Article 7(4), or in case of an update or upgrade, should have been made available on the market in order to bring it into conformity with applicable product safety requirements under Union or national law, unless a claimant has, in the meantime, initiated proceedings before a national court against an economic operator that can be held liable pursuant to Article 7. A software update or upgrade and related services which do not amount to a substantial modification under Article 7(4) shall not trigger or restart the limitation period.

RemovedArticle 14 – paragraph 3: 3. By way of exception from paragraph 2, where an injured person, despite exercising all due care, has not been able to initiate proceedings within 10 years due to the latency of a personal injury, the rights conferred upon the injured person pursuant to this Directive shall be extinguished upon the expiry of a limitation period of 30 years.

RemovedArticle 15 – paragraph 2: 2. The Commission shall set up and maintain a an easily accessible and publicly available database containing the judgments referred to in paragraph 1. This database shall contain, in addition to the judgements referred to in paragraph 1, the judgments delivered by the Court of Justice of the European Union relating to proceedings launched pursuant to this Directive.

RemovedArticle 16 – paragraph 1: The Commission shall by [OP, please insert the date: 6 years after the date of entry into force of this Directive], and every 5 years thereafter, review the application of this Directive and submit a report to the European Parliament, to the Council and to the European Economic and Social Committee including information about:

RemovedArticle 16 – paragraph 1 – point a (new): (a) the costs entailed by this Directive for economic operators as a percentage of their operation costs;

RemovedArticle 16 – paragraph 1 – point b (new): (b) the net benefit of this Directive or its qualified estimation for consumers;

RemovedArticle 16 – paragraph 1 – point c (new): (c) a comparison of the protection provided by this Directive with the protection provided in relevant third countries belonging to the Organisation for Economic Co-operation and Development and world leading economies;

RemovedArticle 16 – paragraph 1 – point d (new): (d) the availability of insurance and other products to cover the risks of economic operators related to this Directive.

RemovedArticle 16 – paragraph 1 a (new): The Commission shall clearly specify the methodologies used for calculation of any qualified estimation contained in the report referred to in paragraph 1. The Commission shall gather information for that report without increasing the reporting obligations of economic operators, using information from all relevant and reliable sources, including Union institutions, bodies, offices and agencies, national competent authorities and internationally recognised bodies and organisations.

RemovedIntroduction

RemovedThe Co-Rapporteurs welcome the Commission’s proposal for a Directive on liability for defective products (hereafter: PLD). Ensuring that persons, who suffer physical injury or damage to property due to defective products, have possibilities to claim compensation, is an important element of EU liability legislation.

RemovedSince the adoption of the Product Liability Directive in 1985, there have been considerable changes with regard to the kinds of products available on the market in light of new market trends and global value chains. The green and digital transitions are also radically transforming the world of products. Today many products are digital products and they include embedded software. Many products are also refurbished products. As regards the distribution of products nowadays, more and more sales are concluded online via market places and other online platforms. These novelties have created challenges with respect to the liability regime that the PLD from 1985 has put in place.

RemovedAn updated liability framework that addresses these new challenges and that removes divergences between the legal systems of Member States, which may distort competition and affect the movement of goods within the internal market, is therefore necessary to ensure a high level of consumer protection in the Union.

RemovedFair allocation of risk

RemovedThe Co-Rapporteurs believe that the PLD needs to strike the right balance between the interests of injured persons and those of economic operators liable for defective products. Ensuring a fair allocation of risk is essential in their view for the revision of the rules of the PLD.

RemovedBy aligning the rules in the Union to get a fair compensation when defective products cause harm, the Co-Rapporteurs want to strengthen the level of consumer protection across the EU. At the same time, the new legal framework should enhance legal certainty for economic operators in the internal market, without overburdening them, thereby preventing a decline of innovative products in Europe, higher consumer prices and less product variety.

RemovedThe Co-Rapporteurs therefore commit to striking the right balance and ensuring a proportionate product liability framework for economic operators and consumers. In their vision, strengthening consumer rights through harmonisation and ensuring an innovation friendly liability regime, which is fair to economic operators go together.

RemovedDamages recognised under the PLD framework

RemovedThe Co-Rapporteurs acknowledge that the digitalisation requires adaptations of the liability framework. They support the recognition of damages, which foresee compensation for material losses resulting from death or personal injury, such as funeral or medical expenses or lost income, and from damage to property. They also recognise that Member States may consider that personal injury includes medically recognised damage to psychological health amounting to an effect on the victim’s psychological health that affects the general state of health as confirmed by a court-ordered medical expert.

RemovedThe Co-Rapporteurs consider that loss or corruption of data are appropriately dealt with under Regulation (EU) 2016/679 of the European Parliament and of the Council, Directive 2002/58/EC of the European Parliament and of the Council, Directive (EU) 2016/680 of the European Parliament and of the Council, and Regulation (EU) 2018/1725 of the European Parliament and of the Council. They do therefore not see a need to include this type of harm in the framework of the PLD.

RemovedDefectiveness of a product

RemovedThe Co-Rapporteurs consider that a product should be considered defective when it does not provide the safety, which an average person is entitled to expect, taking into consideration in particular the standard of safety applicable to the product in question. Moreover, in assessing the defectiveness of a product, all circumstances should be taken into account, including the effect that other products might have on the defective product, where, at the time of placing on the market or putting into service, it can reasonably be expected, that it will be used with other products.

RemovedDisclosure of evidence and the alleviation of the burden of proof

RemovedAcknowledging that the burden of proof can be more fairly shared between injured persons and manufacturers, especially in technically or scientific complex cases, the Co-Rapporteurs oppose however a general reversal of the burden of proof. In order to facilitate the claimant’s burden of proof, the Co-Rapporteurs estimate that a court-ordered disclosure of evidence, without which the claimant is unable to prove the claim for compensation, should be made possible when it is necessary and proportionate. The interests of all parties should be taken into account for this assessment, and confidential information and trade secrets within the meaning of Directive (EU) 2016/943 of the European Parliament and of the Council, deserve special protection by ensuring their confidentiality. Moreover, the Co-Rapporteurs pursue to alleviate the claimant’s burden of proving the defectiveness on a case-by-case basis, where it can plausibly be presumed that it was highly likely that the product was defective and that it was highly likely that this defectiveness caused the damage.