The product safety legal regime in Italy is regulated as follows.

General Regulation

Product liability was originally introduced by Directive No 374/1985/EEC, implemented in Italy by Decree of the President of the Republic No 224/1988, then merged into Legislative Decree No 206/2005 (and subsequent amendments), known as the “Consumer Code”.

The Consumer Code came into force in 2005, collecting into a consolidated Act all the different provisions already in force in Italy concerning consumers’ rights.

It consists of 146 Articles divided into six sections:

• Section I contains the general definitions of consumers and professionals;
• Section II contains the provisions on consumer education, information to be provided to the consumer and provisions on commercial advertising;
• Section III contains the rules on contractual matters;
• Section IV implements the Directive 2001/95/EC on general product safety – in particular, it contains provisions on liability for defective products, legal guarantees of conformity and commercial guarantees for goods;
• Section V contains provisions regarding consumers’ associations and the injunctions they can promote against professionals who are responsible for violating the collective interests of consumers; and
• Section VI contains the final provisions, including the fundamental Article 143, which states that the rights attributed to the consumer by the provisions of the Consumer Code are inalienable.

As of 1 January 2022, Legislative Decree No 170/2021, implementing EU Directive 2019/771, and Legislative Decree No 173/2021, implementing EU Directive 2019/770, have fully replaced Chapter I of Title III of Section IV of the Consumer Code, thereby reforming the rules on product compliance, introducing remedies with specific regard to lack of compliance, and pointing out the way such remedies and conventional guarantees can be enforced.

The new Articles 128–135-vicies ter of the Consumer Code apply to sales contracts, both online and offline, agreed after 01 January 2022 between a consumer and a seller (B2C) relating to the supply of digital content or services incorporated into the goods or sold together with the goods.

Sector-Specific Regulation

Besides the general provisions of the Consumer Code, there are also rules on product safety for specific product sectors:

• Legislative Decree No 23/2019 and Decree of the President of the Republic No 121/2019, adapting national legislation to the provisions of Regulation (EU) 2016/426 on appliances burning gaseous fuels;

• Legislative Decree No 17/2019, adapting national legislation to the provisions of Regulation (EU) 2016/426 on personal protective equipment;
• Legislative Decree No 106/2017, adapting national legislation to the provisions of Regulation (EU) 2011/305 laying down harmonised conditions for the marketing of construction products;
• Legislative Decree No 86/2016, implementing Directive 2014/35/EU on electrical equipment designed for use within certain voltage limits;
• Legislative Decree No 80/2016, implementing Directive 2014/30/EU on electromagnetic compatibility;
• Legislative Decree No 26/2016, implementing Directive 2014/68/EU on pressure equipment;
• Legislative Decree No 54/2011, implementing Directive 2009/48/EC on the safety of toys – it applies to products designed to be used by children under 14 years of age; and
• Legislative Decree No 17/2010, implementing Directive 2006/42/EC on machinery.

Authorities

According to Article 106 of the Consumer Code, the supervisory authorities in charge of product safety controls, recall and withdrawal measures are the Ministries of Economic Development, Health, Labour and Social Policies, Interior, Economy and Finance, Infrastructure and Transport, as well as any other entity responsible for carrying out safety checks on specific product sectors.

For example, in order to market a drug in Italy, the manufacturer must submit an application to the AIFA (Agenzia Italiana del Farmaco), the Italian Pharmaceutical Agency, which issues the Marketing Authorisation (Autorizzazione all’Immissione in Commercio, or AIC) following a scientific evaluation of the requirements of quality, safety and efficacy of the medicinal product.

Law No 580/1993 entrusts the Chambers of Commerce with numerous tasks and functions, including those of supervision and control on the safety and conformity of market products in the following areas:

• general product safety;
• new cars: fuel economy and CO₂ emissions;
• electrical products;
• toys;
• personal protective equipment, including sunglasses and protective masks;
• labelling of textile products;
• labelling of footwear;
• construction products; and
• appliances burning gaseous fuels.

Powers

The competent authorities have the duty to check that all products placed on the market are safe.

In order to do this, the competent entities can:

• organise suitable checks on the safety properties of a product, even after it has been placed on the market as safe; and/or
• carry out inspections at production or packaging plant, warehouses and sales depots.

If a product proves to be dangerous to the health and safety of consumers, the competent authorities can implement all measures necessary to limit or prevent the placing on the market of the product or, if the product is already on the market, can request its withdrawal or recall. In any case financial penalties could be imposed.

According to Article 103 of the Consumer Code, a product is regarded as safe if, under normal or reasonably foreseeable conditions of use including duration and, where applicable, installation and maintenance, it presents no risks or only the minimum risk compatible with such product’s use.

Such minimum risk has to be acceptable with regard to a high level of personal health and safety protection, and also taking into account:

• product features (composition, packaging, instructions for assembly, installation and maintenance);
• the product’s effect on other products, when it is foreseeable that it will be used together with other products;
• packaging of the product, its labelling, warnings and user manual; and
• categories of consumers at risk when using such product (in particular, children and the elderly).

Products are assumed to be safe when they meet the minimum legal safety and health requirements.

If a competent authority deems that a product might be dangerous, they can ban its sale, marketing or display, or they can order the manufacturer to adapt the product to the safety requirements set out in legislation.

If a dangerous product is already on the market, and the actions already implemented by manufacturers and distributors are deemed insufficient or unsatisfactory by the competent authority, such authorities can:

• order or arrange for its immediate withdrawal, and for the consumer to be informed about the hazards of such product (all relative costs are to be borne by the manufacturer and, if this is not possible, by the distributor); and/or
• order, arrange or organise with manufacturer and/or distributors for the recall of the dangerous product and its destruction (all relative costs will be borne by the manufacturer and/or distributor).

The competent authorities, within the scope of the adopted measures, shall encourage and promote voluntary co-operation by manufacturers and distributors to comply with the legal requirements of product safety.

If manufacturers and distributors, on the basis of the information in their possession and as professional operators, know that a product which they have placed on the market, or otherwise supplied to the consumer, presents risks that are incompatible with the general safety obligation, they shall immediately inform the competent authorities (the Ministry of Economic Development and the Ministry competent for the product area involved), indicating the actions taken to prevent the risk to consumers.

In the event of a serious risk, the information to be provided shall include at least:

• specific elements allowing precise identification of the product or batch of products concerned;
• a full description of the risk presented by the products concerned;
• all available information allowing the traceability of the product; and
• a description of the measures taken to prevent risks to consumers.

The Consumer Code sanctions the breach of product safety obligations in different ways, depending on the relevance of the violation.

• A manufacturer or distributor who places dangerous products on the market shall be punished with imprisonment up to one year and with a fine from EUR10,000–50,000.
• A manufacturer or distributor who fails to comply with the measures issued by the competent authority shall be punished with a fine from EUR10,000–25,000.
• A manufacturer or distributor who does not ensure the due co-operation to the competent authority for the purpose of carrying out the product safety checks shall be subject to an administrative sanction from EUR2,500–40,000.
• A manufacturer or distributor who violate the provisions on information duties to consumers shall be subject to an administrative sanction varying from EUR1,500–30,000.

If the breach constitutes a more serious criminal offence, the manufacturer or the distributor shall be liable for that offence.

According to Article 114 of the Consumer Code, the manufacturer of a product is liable for any damages caused by such product.

The manufacturer is anyone who:

• produced the product in the European Union;
• presents themselves as the manufacturer by placing a name, trade mark or other distinctive mark on the product, or anyone who reconditions the product;
• represents the manufacturer, when the manufacturer is not established in the European Union;
• imports the product; or
• is involved in the supply chain insofar as their activities may affect the safety standards of a product.

If the manufacturer cannot be identified, each supplier of a product will be held liable should they fail to inform the injured person of the name and domicile of the manufacturer, within three months of the date of application by the injured consumer.

The main causes of action for product liability are tort liability, strict liability and contractual liability.

Tort Liability

Such liability is based on the “duty of care” concept. The general provision, contained in Article 2043 of the Italian Civil Code, establishes that “any person who wilfully or negligently commits an act causing another party to suffer unjust damages shall be required to pay compensation for such damages”.

Strict Liability

The Italian system, under Article 2050 of the Italian Civil Code, provides for strict liability based on the presumption of liability on any subject who performs a “dangerous activity”.

Such presumption of liability exempts the injured party from the burden of proving the fault of the allegedly liable party.

Contractual Liability

This type of liability is based on the breach of an obligation undertaken by one of the parties, including the supply of a defective product and, generally speaking, the non-performance or the partial performance of the obligation.

Any consumer who, as a consequence of a defective product, suffers:

• death or personal injury; or
• destruction or damages to any property other than the defective product itself, provided it is normally intended for private use and mainly used by the injured party as such,

has standing to bring a product liability claim in Italy.

Nevertheless, if the injured party negligently contributes to its own injury, compensation is assessed in accordance with the principles established by Article 1227 of the Italian Civil Code.

Compensation is not due if the product was used with the knowledge of the defect of the product and its danger, to which the consumer was nevertheless voluntarily exposed.

Besides the standing to bring a product liability claim of the consumer who has directly suffered damage from a defective product, the association of consumers registered on the list of national consumers and users’ associations pursuant to Article 137 of the Consumer Code are entitled to bring a claim to protect the collective interests of consumers and users.

The limitation period for bringing a claim for product liability is three years from the day on which the injured party was aware, or should have been aware, of the damage, the defect of the product, and the identity of the liable party.

In the event of worsening of the damage, the limitation period starts expiring from the day on which the injured party became aware, or should have become aware, of damage sufficient to justify a court action.

The right to compensation is extinguished after ten years from the day the product which caused damage was put on the market.

The limitation period may differ depending on the type of liability.

In the case of an action based on tort liability, the limitation period is five years from the day the consumer became aware.

In a contract liability action, the limitation period is ten years from the consumer’s first awareness.

Regulation (EU) No 1215/2012, read together with Law No 218/1995, establishes that the claimant can invoke the jurisdiction of the Italian courts for the compensation of any damage caused by a defective product that occurred in Italy, regardless of the fact that the parties involved (consumer, manufacturer and/or distributor) are domiciled or resident in Italy. Moreover, if the defendant is domiciled in Italy or the contract provides for Italian jurisdiction, the argument could be made that Italian courts have jurisdiction.

There is not a general duty to take mandatory steps before filing a product liability claim. However, for specific matters, it is mandatory to try a mediation proceeding prior to filing the case.

For instance, pursuant to Article 5 of Legislative Decree No 28/2010, mediation is mandatory when the dispute between two or more party concerns compensation for damages arising from medical and healthcare liability. In this case, the attempt to resolve the dispute through a mediation procedure is mandatory as it is a condition for proceeding with the action.

The Italian legal framework does not provide for a duty to preserve the relevant evidence supporting the product liability claim.

However, the claimant can file a specific action to the court, requesting the adoption of an interim measure to preserve the evidence.

For instance, the claimant may ask the judge to order the seizure of any document, sample or any other thing from which evidence can be taken.

The claimant may also request the adoption of measures of preventive investigation aiming to secure evidence in advance, when there is a risk of such evidence becoming unavailable before the proceeding.

The most common preventive investigation measures to preserve the evidence are:

• examination of a witness that might become unavailable at the hearing due to terminal illness;
• inspection of objects and places; and
• technical examination.

Formal US-style rules of discovery do not exist in the Italian product liability regime.

A party may request the judge to order the exhibition of evidence, pursuant to Article 210 of the Italian Code of Civil Procedure. The judge will assess the relevance of the document for evidentiary purposes and the possibility of proving the same circumstances through other means.

The third party who receives an order of exhibition may object to it before the expiry of the time limit set by the judge.

Article 213 of the Italian Code of Civil Procedure provides that the judge may voluntarily request the public administration to provide written information on acts and documents of the administration itself, should they deem that the acquisition of such evidence is necessary for the proceeding.

Court-Appointed Technical Consultancy (CTU)

In court proceedings, the judge can order the appointment of a Technical Consultant (Consulente Tecnico d’Ufficio or CTU) if they deems it necessary to acquire more in-depth knowledge of a certain technical matter.

With the appointment order, the judge sets the hearing during which the technical consultant must appear for their oath. The CTU will then draw up minutes of the operations performed and a final report must be filed within the time limit set by the judge.

Party-Appointed Technical Consultancy (CTP)

The parties in a proceeding for which the judge ordered a CTU, may appoint a consultant they trust to take on the role of Party-Appointed Technical Consultant (Consulente Tecnico di Parte or CTP).

The CTP assists the party who appointed them, attending all the operations performed by the CTU.

At the end of the judge’s expert operations, the CTP examines the written report produced by the CTU and, if necessary, formulates specific observation in written form. The CTU will have to assess such observations prior to the drafting of the final report for the judge.

The judge may disregard the technical arguments contained in the report made by the court-appointed expert, by resorting to arguments drawn from their own personal technical knowledge.

However, the judge has a duty to give reasons for departing from the assessments made by the expert. In most cases, judges follows the instructions of the appointed Technical Consultant.       

Pursuant to Article 120 of the Consumer Code, the injured party bears the burden of proving the defect in the product, the damages and the causal relationship between the two.

In the past, courts tended to presume the existence of the defect on the basis of the damage caused by the product. This approach has been superseded by the rulings of the Supreme Court, which has taken a more severe approach, ruling that the injured party will have to prove the causal link between the product’s defect and the damage, while the defendant will have to prove that the defect did not exist at the time the product was placed on the market, or that it could not be defined as “defect” at the time it was put on the market on the basis of the state of technical-scientific knowledge (Supreme Civil Court, Sect. III, 20.11.2018 No 29828).

The injured party will also have to provide the evidence that the product was defective pursuant to Article 117 of the Consumer Code, according to which “a product is defective when it does not offer the safety that can legitimately be expected from it”.

Product liability cases in Italy must be brought before a Justice of Peace or an Ordinary Civil Court, depending on the value of the claim:

• the Justice of Peace shall have jurisdiction in cases with a value not exceeding EUR5,000; or
• if the value of the claim is higher than EUR5,000, the Ordinary Civil Courts shall have jurisdiction.

There are no juries in civil proceedings; cases are decided by a single judge.

If the claim is totally or partially unsuccessful, the claimant can appeal against the judgment of first instance.

Pursuant to Article 341 of the Italian Code of Civil Procedure:

• the decisions of a Justice of Peace can be appealed before an Ordinary Civil Court; and
• the decisions of the Ordinary Civil Courts can be appealed before the Court of Appeal.

The appeal act must contain:

• a reference to the parts of the first instance decision that the appellant intends to contest;
• the requests of the appellant; and
• a refutation of the arguments of the first instance judge.

The appeal proceeding must deal with the same issues against which the claimant brought the first instance’s judgment. Therefore, no new claims can be made.

If new claims or objections are raised, they must be declared inadmissible ex officio. An application that has been declared inadmissible is not dismissed on the merits, and the party may therefore relitigate it in an autonomous action.

Moreover, pursuant to Article 345 of the Italian Code of Civil Procedure, the general principles are:

• no new evidence shall be admitted; and
• no new documents may be produced.

Such limitation is subject to one exception: new documents can be submitted by proving that they could not be produced in the first instance proceeding for reasons that cannot be ascribed to the appellant.

The act of appeal must be noticed:

• within the short time limit of 30 days from the date of service of the first instance decision; or
• within the long time limit of six months from the date of publication of the first instance decision.

Exclusion of liability

Such defence has proven to be fairly effective in product liability cases.

The Consumer Code allows for total exclusion of compensation in the following circumstances:

• the manufacturer has not distributed the product;
• the defect that caused the damage did not exist when the product was placed on the market;
• the manufacturer did not produce the product for sale or any other form of distribution;
• the defect is due to the conformity of the product with a mandatory rule of law or a binding measure;
• when the product was placed on the market, technical knowledge did not allow the manufacturer or supplier to know that such product was defective; and
• in the case of the manufacturer or supplier of a component part or raw material, the defect is wholly due to the design of the product into which the component or raw material has been incorporated.

Negligence

Another circumstance that might exclude or reduce the manufacturer’s/distributor’s liability consists in the contributory negligence of the injured party, as detailed in 2.2 Standing to Bring Product Liability Claims.

Adherence to regulatory requirements can be a valid defence in product liability cases because Article 118 of the Consumer Code provides that “if the defect is due to the conformity of the product with a mandatory rule of law or a binding measure” there is a specific provision of exclusion of liability.

In a civil proceeding, the court must also rule on the payments of costs by the parties involved.

Such costs include:

• taxes (unified contribution for registration of the cause and registration tax);
• payment of fees such as costs for revenue stamps; and
• fees for lawyers, party-appointed technical consultants and court-appointed technical consultants.

The main principle that regulates how the judge will rule on such costs provides that the winning party must not be burdened with the costs of the case, otherwise it would suffer unjust financial damage for the sole reason of taking legal action for the recognition of its right.

The judge may also decide not to reimburse the legal costs to the winning party, establishing that each party will have to pay their own legal expenses.

Set-off operates in two cases:

• when all parties have brought requests, and some of them have been rejected; or
• when the proceeding results in a conciliation between the parties.

Third-party litigation funding is possible in Italy by observing the general principle of contractual autonomy set out in the second paragraph of Article 1322 of the Italian Civil Code. However, this contractual form is little known and even less practised.

Contingency fees are also quite rare. They have historically been illegal, but with Decree Law No 233/2006 the prohibition on contingency fees has been repealed. However, there is little evidence of their actual implementation.

The most common form of funding in civil proceedings in Italy is public funding. This is a form of legal aid granted to citizens who do not have the means to pay for a lawyer. Such citizens have to provide proof, with all possible documents, of their lack of means to sustain the costs of a defence. In this case, legal expenses are borne by the State, from which the lawyer will receive their fees.

A citizen may apply for legal aid to defend themselves, or to take action. If the claimant supported by legal aid is unsuccessful, there will not be the possibility to bring an appeal through public funding.

In order to benefit from legal aid, one must be admitted to it: the law prescribes the necessary requirements for access to legal aid, among which is the requirement that the claim the citizen intends to bring must not be manifestly unfounded.

On 3 April 2019, the Italian Parliament finally approved Law No 31/2019, which came into force on 19 May 2021, reforming the regulations on class actions in Italy, previously provided by the Consumer Code and now brought back into the Code of Civil Procedure, and introducing the new Articles 840 bis–840 sexiesdecies.

According to current provisions, any member of the “class” (the people who have suffered the violation of homogeneous individual rights) has the right to file a claim for violation against companies or entities in charge of the provision of public services, but not against a public administration.

Class actions must be filed before the specialised business division of the court where the Company is registered. The trial will be governed by the “procedimento sommario” provided by Articles 702-bis of the Italian Civil Procedure Code and ff, but there are some peculiarities.

The procedure is “opt-in”: during the “admission phase” of the class action, the court sets a deadline for any potential member of the “class” to opt-in. Moreover, potential members of the class can also opt-in after the ruling which upholds the class action.

At the moment, there are few precedents for this type of action in Italy. However, the changes introduced by the reform may lead to an increase of its use, since they have widened the scope of application of class actions and made it easier for the claimant to fulfil the burden of proof.

In recent years, the most significant product liability cases have focused on matters including defects in industrial machinery, cosmetic products, food and toys.

In relation to the significant principles of product liability, the following judgments can be highlighted.

Judgment No 16601/2017 of the Supreme Court

The Italian legal system has not historically allowed punitive damages. However, there has been a new development in product liability matters in Italy.

Judgment No 16601/2017 of the Supreme Court allowed, for the first time, a form of punitive damages into the Italian system.

It is worth noting that this applies only to the recognition of punitive damages awarded in a foreign judgment. This decision must be seen as an absolute novelty for the Italian legal framework, because it establishes that punitive damages are enforceable in Italy, although not directly, and are recoverable on the basis of a proportional criterion between the reparative-compensatory segment and punitive sanctioning.

Judgment No 29828/2018 of the Supreme Court

This judgment of the Supreme Court clarified (as already anticipated by significant judgments of territorial courts) the nature of product liability in Italy.

The judges established that product liability for defective product is presumed, but is not a strict liability, since it does not only depend on assessing the manufacturer/distributor’s fault, but also on the proof of the existence of a product’s defect.

Therefore, the injured party will have to prove the causal link between the product’s defect and the damage, while the defendant will have to prove that the defect did not exist at the time the product was placed on the market, or that it could not be defined as “defect” at the time it was put on the market on the basis of the state of technical-scientific knowledge.

On 1 January 2022, Legislative Decrees No 170/2021 and No 173/2021 amended the Consumer Code.

The amendments concern the sale of goods between sellers and consumers both online, via any means of distance communication, and through traditional marketing channels, extending the notion of “goods” to now include “goods with digital elements” and “animals”.

Moreover, the reform introduces specific provisions concerning the updating of goods, in particular digital goods.

The rules on conformity requirements, both subjective and objective, are now more specific and analytical than before. The renewed Article 135 of the Consumer Code provides that a lack of conformity, which becomes evident within a period of one year from delivery, is presumed to already exist at the date of sale, instead of six months from delivery as previously established.

The range of remedies available to the consumer in the event of a lack of conformity of the goods has been expanded. The consumer can choose between:

• repair of the goods;
• replacement of the goods;
• a proportional reduction in the price; and
• termination of the contract.

The consumer’s obligation to report defects within two months of discovery has been removed.

The future policy development of product safety in Italy is strictly linked to the EU’s legislative developments.

GPSD

The general safety of products in areas that are not regulated by sector-specific regulations finds its regulatory framework in the General Product Safety Directive, Directive (EU) 2001/95/CE (GPSD).

More than 20 years have passed since its enactment, and the GPSD now requires updating for a number of reasons, among which is the aim to integrate the framework with recent EU strategies and action plans (eg, those having to do with digital services, artificial intelligence, the “Green Deal” and the circular economy).

GSPR

On 30 June 2021, the European Commission adopted a proposal for a General Product Safety Regulation (GPSR).

The GPSR aims to ensure the safety of consumer products placed on the internal market, online and offline, regardless of whether they originate from EU or non-EU countries.

The proposed regulation increases the enforcement powers of the relevant regulatory authorities, similar to those of the General Data Protection Regulation (GDPR).

Such a proposal will now be discussed, amended and eventually approved by the EU Council and the European Parliament, but the iter legis is still long and some time may pass between the proposal and the Regulation actually coming into force.

The COVID-19 pandemic has led to an increase in demand for certain products, such as disinfectants, ventilators and masks.

In order to ease such production, the government issued provisions such as the so-called Decreto Cura Italia (the “Healing Italy Decree”), that introduced some derogations to facilitate the marketing of devices such as surgical masks and personal protective equipment.

The new emergency regulations, however, do not derogate in any case from the general rules on health and product safety found in the Consumer Code.

The derogation provided by the emergency legislation concerns the validation procedure and its timing, not the quality standards of the products, which must ensure compliance with the standards already in force.

The manufacturer is still liable for product defects, and the injured party still bears the burden of proving the causal link between the defect and the damage suffered, as well as the amount of such damage.

It is also worth noting that, during the pandemic period, in order to avoid or limit the negative consequences connected with the limitation placed on both social and commercial aspects, the parties involved in commercial and contractual relationships have promptly modified their agreements with specific modifications.