@ansvar/eu-regulations-mcp 0.1.0 → 0.2.1

package/data/seed/pld.json

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+{
+  "id": "PLD",
+  "full_name": "Product Liability Directive",
+  "celex_id": "32024L2853",
+  "eur_lex_url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024L2853",
+  "articles": [
+    {
+      "number": "1",
+      "title": "Subject matter and objective",
+      "text": "This Directive lays down common rules on the liability of economic operators for damage suffered by natural persons and caused by defective products, and on compensation for such damage.\n\nThe objective of this Directive is to contribute to the proper functioning of the internal market while ensuring a high level of protection of consumers and other natural persons.",
+      "chapter": "I"
+    },
+    {
+      "number": "2",
+      "title": "Scope",
+      "text": "1.   This Directive shall apply to products placed on the market or put into service after 9 December 2026.\n\n2.   This Directive does not apply to free and open-source software that is developed or supplied outside the course of a commercial activity.\n\n3.   This Directive does not apply to damage arising from nuclear accidents in so far as liability for such damage is covered by international conventions ratified by Member States.\n\n4.   This Directive does not affect:\n\n(a)\n\nthe applicability of Union law on the protection of personal data, in particular Regulation (EU) 2016/679 and Directives 2002/58/EC and (EU) 2016/680;\n\n(b)\n\nany right which an injured person has under national rules concerning contractual liability or concerning non-contractual liability on grounds other than the defectiveness of a product as provided for in this Directive, including national rules implementing Union law;\n\n(c)\n\nany right which an injured person has under any special liability system that existed in national law on 30 July 1985.",
+      "chapter": "I"
+    },
+    {
+      "number": "3",
+      "title": "Level of harmonisation",
+      "text": "Member States shall not maintain or introduce, in their national law, provisions diverging from those laid down in this Directive, including more stringent or less stringent provisions, to achieve a different level of protection for consumers and other natural persons, unless otherwise provided for in this Directive.",
+      "chapter": "I"
+    },
+    {
+      "number": "4",
+      "title": "Definitions",
+      "text": "For the purposes of this Directive, the following definitions apply:\n\n(1)\n\n‘product’ means all movables, even if integrated into, or inter-connected with, another movable or an immovable; it includes electricity, digital manufacturing files, raw materials and software;\n\n(2)\n\n‘digital manufacturing file’ means a digital version of, or digital template for, a movable which contains the functional information necessary to produce a tangible item by enabling the automated control of machinery or tools;\n\n(3)\n\n‘related service’ means a digital service that is integrated into, or inter-connected with, a product in such a way that its absence would prevent the product from performing one or more of its functions;\n\n(4)\n\n‘component’ means any item, whether tangible or intangible, raw material or related service, that is integrated into, or inter-connected with, a product;\n\n(5)\n\n‘manufacturer’s control’ means that:\n\n(a)\n\nthe manufacturer of a product performs or, with regard to actions of a third party, authorises or consents to:\n\n(i)\n\nthe integration, inter-connection or supply of a component, including software updates or upgrades; or\n\n(ii)\n\nthe modification of the product, including substantial modifications;\n\n(b)\n\nthe manufacturer of a product has the ability to supply software updates or upgrades, themselves or via a third party;\n\n(6)\n\n‘data’ means data as defined in Article 2, point (1), of Regulation (EU) 2022/868 of the European Parliament and of the Council (18);\n\n(7)\n\n‘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;\n\n(8)\n\n‘placing on the market’ means the first making available of a product on the Union market;\n\n(9)\n\n‘putting into service’ means the first use of a product in the Union in the course of a commercial activity, whether in return for payment or free of charge, in circumstances in which that product has not been placed on the market prior to its first use;\n\n(10)\n\n‘manufacturer’ means any natural or legal person who:\n\n(a)\n\ndevelops, manufactures or produces a product;\n\n(b)\n\nhas a product designed or manufactured, or who, by putting their name, trademark or other distinguishing features on that product, presents themselves as its manufacturer; or\n\n(c)\n\ndevelops, manufactures or produces a product for their own use;\n\n(11)\n\n‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that manufacturer’s behalf in relation to specified tasks;\n\n(12)\n\n‘importer’ means any natural or legal person who places a product from a third country on the Union market;\n\n(13)\n\n‘fulfilment service provider’ means any natural or legal person offering, in the course of a commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching of a product, without having ownership of that product, excluding postal services as defined in Article 2, point (1), of Directive 97/67/EC of the European Parliament and of the Council (19), parcel delivery services as defined in Article 2, point (2), of Regulation (EU) 2018/644 of the European Parliament and of the Council (20), and any other postal services or freight transport services;\n\n(14)\n\n‘distributor’ means any natural or legal person in the supply chain who makes a product available on the market, other than the manufacturer or importer of that product;\n\n(15)\n\n‘economic operator’ means a manufacturer of a product or component, a provider of a related service, an authorised representative, an importer, a fulfilment service provider or a distributor;\n\n(16)\n\n‘online platform’ means online platform as defined in Article 3, point (i), of Regulation (EU) 2022/2065;\n\n(17)\n\n‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;\n\n(18)\n\n‘substantial modification’ means a modification of a product after it has been placed on the market or put into service:\n\n(a)\n\nthat is considered substantial under relevant Union or national rules on product safety; or\n\n(b)\n\nwhere relevant Union or national rules on product safety lay down no threshold on what is to be considered a substantial modification, that:\n\n(i)\n\nchanges the product’s original performance, purpose or type, without that change having been foreseen in the manufacturer’s initial risk assessment; and\n\n(ii)\n\nchanges the nature of the hazard, creates a new hazard or increases the level of risk.\n\nSPECIFIC PROVISIONS ON LIABILITY FOR DEFECTIVE PRODUCTS",
+      "chapter": "II"
+    },
+    {
+      "number": "5",
+      "title": "Right to compensation",
+      "text": "1.   Member States shall ensure that any natural person who suffers damage caused by a defective product (the ‘injured person’) is entitled to compensation in accordance with this Directive.\n\n2.   Member States shall ensure that claims for compensation pursuant to paragraph 1 may also be brought by:\n\n(a)\n\na person that succeeded, or was subrogated, to the right of the injured person by virtue of Union or national law or contract; or\n\n(b)\n\na person acting on behalf of one or more injured persons by virtue of Union or national law.",
+      "chapter": "II"
+    },
+    {
+      "number": "6",
+      "title": "Damage",
+      "text": "1.   The right to compensation pursuant to Article 5 shall apply in respect of only the following types of damage:\n\n(a)\n\ndeath or personal injury, including medically recognised damage to psychological health;\n\n(b)\n\ndamage to, or destruction of, any property, except:\n\n(i)\n\nthe defective product itself;\n\n(ii)\n\na product damaged by a defective component that is integrated into, or inter-connected with, that product by the manufacturer of that product or within that manufacturer’s control;\n\n(iii)\n\nproperty used exclusively for professional purposes;\n\n(c)\n\ndestruction or corruption of data that are not used for professional purposes.\n\n2.   The right to compensation pursuant to Article 5 shall cover all material losses resulting from the damage referred to in paragraph 1 of this Article. The right to compensation shall also cover non-material losses resulting from the damage referred to in paragraph 1 of this Article, in so far as they can be compensated for under national law.\n\n3.   This Article does not affect national law relating to compensation for damage under other liability regimes.",
+      "chapter": "II"
+    },
+    {
+      "number": "7",
+      "title": "Defectiveness",
+      "text": "1.   A product shall be considered defective where it does not provide the safety that a person is entitled to expect or that is required under Union or national law.\n\n2.   In assessing the defectiveness of a product, all circumstances shall be taken into account, including:\n\n(a)\n\nthe presentation and the characteristics of the product, including its labelling, design, technical features, composition and packaging and the instructions for its assembly, installation, use and maintenance;\n\n(b)\n\nreasonably foreseeable use of the product;\n\n(c)\n\nthe effect on the product of any ability to continue to learn or acquire new features after it is placed on the market or put into service;\n\n(d)\n\nthe reasonably foreseeable effect on the product of other products that can be expected to be used together with the product, including by means of inter-connection;\n\n(e)\n\nthe moment in time when the product was placed on the market or put into service or, where the manufacturer retains control over the product after that moment, the moment in time when the product left the control of the manufacturer;\n\n(f)\n\nrelevant product safety requirements, including safety-relevant cybersecurity requirements;\n\n(g)\n\nany recall of the product or any other relevant intervention relating to product safety by a competent authority or by an economic operator as referred to in Article 8;\n\n(h)\n\nthe specific needs of the group of users for whose use the product is intended;\n\n(i)\n\nin the case of a product whose very purpose is to prevent damage, any failure of the product to fulfil that purpose.\n\n3.   A product shall not be considered to be defective for the sole reason that a better product, including updates or upgrades for a product, has already been or is subsequently placed on the market or put into service.",
+      "chapter": "II"
+    },
+    {
+      "number": "8",
+      "title": "Economic operators liable for defective products",
+      "text": "1.   Member States shall ensure that the following economic operators are liable for damage in accordance with this Directive:\n\n(a)\n\nthe manufacturer of a defective product;\n\n(b)\n\nthe manufacturer of a defective component, where that component was integrated into, or inter-connected with, a product within the manufacturer’s control and caused that product to be defective, and without prejudice to the liability of the manufacturer referred to in point (a); and\n\n(c)\n\nin the case of a manufacturer of a product or a component established outside the Union, and without prejudice to the liability of that manufacturer:\n\n(i)\n\nthe importer of the defective product or component;\n\n(ii)\n\nthe authorised representative of the manufacturer; and\n\n(iii)\n\nwhere there is no importer established within the Union or authorised representative, the fulfilment service provider.\n\nThe liability of the manufacturer referred to in the first subparagraph, point (a), shall also cover any damage caused by a defective component where it was integrated into, or inter-connected with, a product within that manufacturer’s control.\n\n2.   Any natural or legal person that substantially modifies a product outside the manufacturer’s control and thereafter makes it available on the market or puts it into service shall be considered to be a manufacturer of that product for the purposes of paragraph 1.\n\n3.   Member States shall ensure that, where an economic operator from among those referred to in paragraph 1 and established in the Union cannot be identified, each distributor of the defective product is liable where:\n\n(a)\n\nthe injured person requests that distributor to identify an economic operator from among those referred to in paragraph 1 and established in the Union, or its own distributor that supplied it with that product; and\n\n(b)\n\nthat distributor fails to identify an economic operator or its own distributor, as referred to in point (a), within one month of receiving the request referred to in point (a).\n\n4.   Paragraph 3 of this Article shall also apply to any provider of an online platform that allows consumers to conclude distance contracts with traders and that is not an economic operator, provided that the conditions set out in Article 6(3) of Regulation (EU) 2022/2065 are fulfilled.\n\n5.   Where victims fail to obtain compensation because none of the persons referred to in paragraphs 1 to 4 can be held liable under this Directive, or because the liable persons are insolvent or have ceased to exist, Member States may use existing national sectoral compensation schemes or establish new ones under national law, preferably not funded by public revenue, to appropriately compensate injured persons who have suffered damage caused by defective products.",
+      "chapter": "II"
+    },
+    {
+      "number": "9",
+      "title": "Disclosure of evidence",
+      "text": "1.   Member States shall ensure that, at the request of a person who is claiming compensation in proceedings before a national court for damage caused by a defective product (the ‘claimant’) and who has presented facts and evidence sufficient to support the plausibility of the claim for compensation, the defendant is required to disclose relevant evidence that is at the defendant’s disposal, subject to the conditions set out in this Article.\n\n2.   Member States shall ensure that, at the request of a defendant that has presented facts and evidence sufficient to demonstrate the defendant’s need for evidence for the purposes of countering a claim for compensation, the claimant is required, in accordance with national law, to disclose relevant evidence that is at the claimant’s disposal.\n\n3.   Member States shall ensure that the disclosure of evidence pursuant to paragraphs 1 and 2, and in accordance with national law, is limited to what is necessary and proportionate.\n\n4.   Member States shall ensure that, when determining whether the disclosure of evidence requested by a party is necessary and proportionate, national courts consider the legitimate interests of all parties concerned, including third parties, in particular in relation to the protection of confidential information and trade secrets.\n\n5.   Member States shall ensure that, where a defendant is required to disclose information that is a trade secret or an alleged trade secret, national courts are empowered, upon a duly reasoned request of a party or on their own initiative, to take the specific measures necessary to preserve the confidentiality of that information when it is used or referred to in the course of or after the legal proceedings.\n\n6.   Member States shall ensure that, where a party is required to disclose evidence, national courts are empowered, upon a duly reasoned request of the opposing party or where the national court concerned deems it appropriate and in accordance with national law, to require such evidence to be presented in an easily accessible and easily understandable manner, if such presentation is deemed proportionate by the national court in terms of costs and effort for the required party.\n\n7.   This Article does not affect national rules relating to the pre-trial disclosure of evidence, where such rules exist.",
+      "chapter": "II"
+    },
+    {
+      "number": "10",
+      "title": "Burden of proof",
+      "text": "1.   Member States shall ensure that a claimant is required to prove the defectiveness of the product, the damage suffered and the causal link between that defectiveness and that damage.\n\n2.   The defectiveness of the product shall be presumed where any of the following conditions are met:\n\n(a)\n\nthe defendant fails to disclose relevant evidence pursuant to Article 9(1);\n\n(b)\n\nthe claimant demonstrates that the product does not comply with mandatory product safety requirements laid down in Union or national law that are intended to protect against the risk of the damage suffered by the injured person; or\n\n(c)\n\nthe claimant demonstrates that the damage was caused by an obvious malfunction of the product during reasonably foreseeable use or under ordinary circumstances.\n\n3.   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 that the damage caused is of a kind typically consistent with the defect in question.\n\n4.   A national court shall presume the defectiveness of the product or the causal link between its defectiveness and the damage, or both, where, despite the disclosure of evidence in accordance with Article 9 and taking into account all the relevant circumstances of the case:\n\n(a)\n\nthe claimant faces excessive difficulties, in particular due to technical or scientific complexity, in proving the defectiveness of the product or the causal link between its defectiveness and the damage, or both; and\n\n(b)\n\nthe claimant demonstrates that it is likely that the product is defective or that there is a causal link between the defectiveness of the product and the damage, or both.\n\n5.   The defendant shall have the right to rebut any of the presumptions referred to in paragraphs 2, 3 and 4.",
+      "chapter": "II"
+    },
+    {
+      "number": "11",
+      "title": "Exemption from liability",
+      "text": "1.   An economic operator as referred to in Article 8 shall not be liable for damage caused by a defective product if that economic operator proves any of the following:\n\n(a)\n\nin the case of a manufacturer or importer, that it did not place the product on the market or put it into service;\n\n(b)\n\nin the case of a distributor, that it did not make the product available on the market;\n\n(c)\n\nthat it is probable that the defectiveness that caused the damage did not exist at the time the product was placed on the market, put into service or, in the case of a distributor, made available on the market, or that that defectiveness came into being after that moment;\n\n(d)\n\nthat the defectiveness that caused the damage is due to compliance of the product with legal requirements;\n\n(e)\n\nthat the objective state of scientific and technical knowledge at the time the product was placed on the market or put into service or during the period in which the product was within the manufacturer’s control was not such that the defectiveness could be discovered;\n\n(f)\n\nin the case of a manufacturer of a defective component, as referred to in Article 8(1), first subparagraph, point (b), that the defectiveness of the product in which that component has been integrated is attributable to the design of that product or to the instructions given by the manufacturer of that product to the manufacturer of that component;\n\n(g)\n\nin the case of a person that modifies a product as referred to in Article 8(2), that the defectiveness that caused the damage is related to a part of the product not affected by the modification.\n\n2.   By way of derogation from paragraph 1, point (c), an economic operator shall not be exempted from liability where the defectiveness of a product is due to any of the following, provided that it is within the manufacturer’s control:\n\n(a)\n\na related service;\n\n(b)\n\nsoftware, including software updates or upgrades;\n\n(c)\n\na lack of software updates or upgrades necessary to maintain safety;\n\n(d)\n\na substantial modification of the product.\n\nGENERAL PROVISIONS ON LIABILITY",
+      "chapter": "III"
+    },
+    {
+      "number": "12",
+      "title": "Liability of multiple economic operators",
+      "text": "1.   Without prejudice to national law concerning rights 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.\n\n2.   A manufacturer that integrates software as a component in a product shall not have a right of recourse against the manufacturer of a defective software component that causes damage where:\n\n(a)\n\nthe manufacturer of the defective software component was, at the time of the placing on the market of that software component, a microenterprise or a small enterprise, meaning an enterprise that, when assessed together with all of its partner enterprises as defined in Article 3(2) of the Annex to Commission Recommendation 2003/361/EC (21) and linked enterprises as defined in Article 3(3) of that Annex, 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; and\n\n(b)\n\nthe manufacturer that integrated the defective software component in the product contractually agreed with the manufacturer of the defective software component to waive that right.",
+      "chapter": "III"
+    },
+    {
+      "number": "13",
+      "title": "Reduction of liability",
+      "text": "1.   Without prejudice to national law concerning rights of contribution or recourse, Member States shall ensure that the liability of an economic operator is not reduced or disallowed where the damage is caused both by the defectiveness of a product and by an act or omission of a third party.\n\n2.   The liability of an economic operator may be reduced or disallowed where 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.",
+      "chapter": "III"
+    },
+    {
+      "number": "14",
+      "title": "Right of recourse",
+      "text": "Where more than one economic operator is liable for the same damage, an economic operator that has compensated the injured person shall be entitled to pursue remedies against other economic operators liable pursuant to Article 8 in accordance with national law.",
+      "chapter": "III"
+    },
+    {
+      "number": "15",
+      "title": "Exclusion or limitation of liability",
+      "text": "Member States shall ensure that the liability of an economic operator pursuant to this Directive is not, in relation to the injured person, limited or excluded by a contractual provision or by national law.",
+      "chapter": "III"
+    },
+    {
+      "number": "16",
+      "title": "Limitation period",
+      "text": "1.   Member States shall ensure that a limitation period of three years applies to the initiation of proceedings to claim compensation for damage falling within the scope of this Directive. The limitation period shall run from the day on which the injured person became aware, or should reasonably have become aware, of all of the following:\n\n(a)\n\nthe damage;\n\n(b)\n\nthe defectiveness;\n\n(c)\n\nthe identity of the relevant economic operator that can be held liable for that damage under Article 8.\n\n2.   National law regulating the suspension or interruption of the limitation period referred to in paragraph 1 shall not be affected by this Directive.",
+      "chapter": "III"
+    },
+    {
+      "number": "17",
+      "title": "Expiry period",
+      "text": "1.   Member States shall ensure that an injured person is no longer entitled to compensation pursuant to this Directive upon the expiry of a period of 10 years, unless that injured person has, in the meantime, initiated proceedings against an economic operator that can be held liable pursuant to Article 8. That period shall run from:\n\n(a)\n\nthe date on which the defective product which caused the damage was placed on the market or put into service; or\n\n(b)\n\nin the case of a substantially modified product, the date on which that product was made available on the market or put into service following its substantial modification.\n\n2.   By way of exception from paragraph 1, where an injured person has not been able to initiate proceedings within 10 years of the dates referred to in paragraph 1 due to the latency of a personal injury, the injured person shall no longer be entitled to compensation pursuant to this Directive upon the expiry of a period of 25 years, unless that injured person has, in the meantime, initiated proceedings against an economic operator that can be held liable pursuant to Article 8.\n\nFINAL PROVISIONS",
+      "chapter": "IV"
+    },
+    {
+      "number": "18",
+      "title": "Derogation from development risk defence",
+      "text": "1.   Member States may, by way of derogation from Article 11(1), point (e), maintain in their legal systems existing measures whereby economic operators are liable even if they prove that the objective state of scientific and technical knowledge at the time the product was placed on the market or put into service or during the period in which the product was within the manufacturer’s control was not such that the defectiveness could be discovered.\n\nAny Member State wishing to maintain measures in accordance with this paragraph shall notify the text of the measures to the Commission no later than 9 December 2026. The Commission shall inform the other Member States thereof.\n\n2.   Member States may, by way of derogation from Article 11(1), point (e), introduce or amend in their legal systems measures whereby economic operators are liable even if they prove that the objective state of scientific and technical knowledge at the time the product was placed on the market or put into service or during the period in which the product was within the manufacturer’s control was not such that the defectiveness could be discovered.\n\n3.   The measures referred to in paragraph 2 shall be:\n\n(a)\n\nlimited to specific categories of products;\n\n(b)\n\njustified by public interest objectives; and\n\n(c)\n\nproportionate in that they are suitable for securing the attainment of the objectives pursued and do not go beyond what is necessary to attain those objectives.\n\n4.   Any Member State wishing to introduce or amend a measure referred to in paragraph 2 shall notify the text of the proposed measure to the Commission and shall provide a justification of how that measure complies with paragraph 3. The Commission shall inform the other Member States thereof.\n\n5.   The Commission may, within six months of receiving a notification pursuant to paragraph 4, issue an opinion on the text of the proposed measure and the justification for that measure, taking into account any observations received from other Member States. The Member State wishing to introduce or amend that measure shall hold that measure in abeyance for six months following its notification to the Commission, unless the Commission issues its opinion earlier.",
+      "chapter": "IV"
+    },
+    {
+      "number": "19",
+      "title": "Transparency",
+      "text": "1.   Member States shall publish, in an easily accessible and electronic format, any final judgment delivered by their national courts of appeal or of the highest instance in proceedings launched pursuant to this Directive. The publication of such a judgment shall be carried out in accordance with national law.\n\n2.   The Commission shall set up and maintain an easily accessible and publicly available database containing the judgments referred to in paragraph 1.",
+      "chapter": "IV"
+    },
+    {
+      "number": "20",
+      "title": "Evaluation",
+      "text": "The Commission shall by 9 December 2030, and every five years thereafter, evaluate the application of this Directive and submit a report to the European Parliament, to the Council and to the European Economic and Social Committee. Those reports shall include information about the cost and benefits of the transposition of this Directive, a comparison with OECD countries and the availability of product liability insurance.",
+      "chapter": "IV"
+    },
+    {
+      "number": "21",
+      "title": "Repeal and transitional provision",
+      "text": "Directive 85/374/EEC is repealed with effect from 9 December 2026. However, it shall continue to apply with regard to products placed on the market or put into service before that date.\n\nReferences to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in the Annex.",
+      "chapter": "IV"
+    },
+    {
+      "number": "22",
+      "title": "Transposition",
+      "text": "1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 9 December 2026. They shall immediately inform the Commission thereof.\n\nWhen Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.\n\n2.   Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive.",
+      "chapter": "IV"
+    },
+    {
+      "number": "23",
+      "title": "Entry into force",
+      "text": "This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.",
+      "chapter": "IV"
+    },
+    {
+      "number": "24",
+      "title": "Addressees",
+      "text": "This Directive is addressed to the Member States.\n\nDone at Strasbourg, 23 October 2024.\n\nFor the European Parliament\n\nThe President\n\nR. METSOLA\n\nFor the Council\n\nThe President\n\nZSIGMOND B. P.\n\n(1)\n\nOJ C 140, 21.4.2023, p. 34.\n\n(2)  Position of the European Parliament of 12 March 2024 (not yet published in the Official Journal) and decision of the Council of 10 October 2024.\n\n(3)  Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).\n\n(4)  Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).\n\n(5)  Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).\n\n(6)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).\n\n(7)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).\n\n(8)  Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).\n\n(9)  Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89).\n\n(10)  Regulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (OJ L 345, 27.12.2017, p. 1).\n\n(11)  Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1).\n\n(12)  Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).\n\n(13)  Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (OJ L 135, 23.5.2023, p. 1).\n\n(14)  Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).\n\n(15)  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).\n\n(16)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).\n\n(17)\n\nOJ L 123, 12.5.2016, p. 1.\n\n(18)  Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act) (OJ L 152, 3.6.2022, p. 1).\n\n(19)  Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ L 15, 21.1.1998, p. 14).\n\n(20)  Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross-border parcel delivery services (OJ L 112, 2.5.2018, p. 19).\n\n(21)  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).\n\nANNEX\n\nCorrelation table\n\nDirective 85/374/EEC\n\nThis Directive",
+      "chapter": "IV"
+    }
+  ],
+  "definitions": [
+    {
+      "term": "product",
+      "definition": "all movables, even if integrated into, or inter-connected with, another movable or an immovable; it includes electricity, digital manufacturing files, raw materials and software;",
+      "article": "4"
+    },
+    {
+      "term": "digital manufacturing file",
+      "definition": "a digital version of, or digital template for, a movable which contains the functional information necessary to produce a tangible item by enabling the automated control of machinery or tools;",
+      "article": "4"
+    },
+    {
+      "term": "related service",
+      "definition": "a digital service that is integrated into, or inter-connected with, a product in such a way that its absence would prevent the product from performing one or more of its functions;",
+      "article": "4"
+    },
+    {
+      "term": "component",
+      "definition": "any item, whether tangible or intangible, raw material or related service, that is integrated into, or inter-connected with, a product;",
+      "article": "4"
+    },
+    {
+      "term": "manufacturer",
+      "definition": "that: (a) the manufacturer of a product performs or, with regard to actions of a third party, authorises or consents to: (i) the integration, inter-connection or supply of a component, including software updates or upgrades; or (ii) the modification of the product, including substantial modifications; (b) the manufacturer of a product has the ability to supply software updates or upgrades, themselves or via a third party;",
+      "article": "4"
+    },
+    {
+      "term": "data",
+      "definition": "data as defined in Article 2, point (1), of Regulation (EU) 2022/868 of the European Parliament and of the Council (18);",
+      "article": "4"
+    },
+    {
+      "term": "making available on the market",
+      "definition": "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;",
+      "article": "4"
+    },
+    {
+      "term": "placing on the market",
+      "definition": "the first making available of a product on the Union market;",
+      "article": "4"
+    },
+    {
+      "term": "putting into service",
+      "definition": "the first use of a product in the Union in the course of a commercial activity, whether in return for payment or free of charge, in circumstances in which that product has not been placed on the market prior to its first use;",
+      "article": "4"
+    },
+    {
+      "term": "manufacturer",
+      "definition": "any natural or legal person who: (a) develops, manufactures or produces a product; (b) has a product designed or manufactured, or who, by putting their name, trademark or other distinguishing features on that product, presents themselves as its manufacturer; or (c) develops, manufactures or produces a product for their own use;",
+      "article": "4"
+    },
+    {
+      "term": "authorised representative",
+      "definition": "any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that manufacturer's behalf in relation to specified tasks;",
+      "article": "4"
+    },
+    {
+      "term": "importer",
+      "definition": "any natural or legal person who places a product from a third country on the Union market;",
+      "article": "4"
+    },
+    {
+      "term": "fulfilment service provider",
+      "definition": "any natural or legal person offering, in the course of a commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching of a product, without having ownership of that product, excluding postal services as defined in Article 2, point (1), of Directive 97/67/EC of the European Parliament and of the Council (19), parcel delivery services as defined in Article 2, point (2), of Regulation (EU) 2018/644 of the European Parliament and of the Council (20), and any other postal services or freight transport services;",
+      "article": "4"
+    },
+    {
+      "term": "distributor",
+      "definition": "any natural or legal person in the supply chain who makes a product available on the market, other than the manufacturer or importer of that product;",
+      "article": "4"
+    },
+    {
+      "term": "economic operator",
+      "definition": "a manufacturer of a product or component, a provider of a related service, an authorised representative, an importer, a fulfilment service provider or a distributor;",
+      "article": "4"
+    },
+    {
+      "term": "online platform",
+      "definition": "online platform as defined in Article 3, point (i), of Regulation (EU) 2022/2065;",
+      "article": "4"
+    },
+    {
+      "term": "trade secret",
+      "definition": "trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;",
+      "article": "4"
+    },
+    {
+      "term": "substantial modification",
+      "definition": "a modification of a product after it 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 on product safety lay down no threshold on what is to be considered a substantial modification, that: (i) changes the product's original performance, purpose or type, without that change having been foreseen in the manufacturer's initial risk assessment; and (ii) changes the nature of the hazard, creates a new hazard or increases the level of risk. SPECIFIC PROVISIONS ON LIABILITY FOR DEFECTIVE PRODUCTS",
+      "article": "4"
+    }
+  ]
+}