Product Safety

Product safety legal framework

In Italy, general product safety and product liability rules are contained in Legislative Decree No 206 of 6 September 2005, the so-called Consumer Code, which is a consolidated act collecting all the implementing laws into the Italian legal system of all EU consumer legislation and regulating all aspects of consumer protection, including advertising and labelling, consumer contracts and unfair commercial practices, safety and quality of products, and access to justice.

In particular, Articles 114-127 of the Consumer code are the transposition into the Italian legal system of the rules contained in the EU General Product Safety Directive (Directive 2001/95/EC).

Under the Consumer Code, manufactures have the obligation to place only products that are safe on the market and bear responsibility for any damages that result from the defects present in their products.

A product is considered defective when it does not offer the safety that can be legitimately expected, taking into account all the circumstances, including its characteristics, presentation and labelling, the instructions and warnings given to the users as well as any other indication concerning the product, the intended use of the product, and when it was put on the market.

Other pieces of legislation (more precisely the Italian transposition of EU rules) regulate some aspects of product safety and product liability with regard to specific types of products, such as drugs and medical devices, toys, machinery, electric and electronic equipment.

Regulatory authorities for product safety

The main regulatory authority in charge of overseeing several aspects of product liability is the Ministry for Enterprises and Made in Italy and, in particular, the General Division for Market, Competition, Consumers, Supervision and Technical Legislation.

The Ministry is the main point of contact for all safety issues related to       product safety and is also in charge of managing the European rapid exchange information system RAPEX.

The Consumer code identifies other competent authorities in charge of supervisory and control tasks for product liability issues, depending on the type of product involved in safety issues; such authorities are:

• the Ministry of Health for drugs and pharmaceutical products;
• the Ministry of Agricultural, Food and Forestry Policies for food products; and
• the Ministry of Transportation and Infrastructures for vehicles.

All such authorities have sector-specific regulatory competencies, aimed at ensuring that products placed on the market are safe and at taking all necessary measures to guarantee consumers’ safety. Such measures may include:

• carrying out checks on samples of the marketed products to ensure compliance;
• examining complaints;
• ordering changes to be made to products to make them compliant with safety requirements;
• ordering withdrawal and recall of products from the market; and
• prohibiting a product from being placed on the market.

Obligation to commence corrective action

Manufacturers are required to adopt measures commensurate with the characteristics of the products supplied, which inform consumers of the potential risks these products might pose.

Such measures include information and warning campaigns (consisting of press statements and press articles, notices to be displayed in local sales locations, instruction for distributors/dealers to contact customers, phone contact number with information and assistance), withdrawal of products from the market and recall of products.

The withdrawal, recall, and information procedures may be carried out on a voluntary basis or upon request of the competent authorities. In particular, a recall is deemed necessary when all other measures fail to mitigate specific hazards.

To enhance consumer protection, the authorities provide guidelines and standard recall models for manufacturers, facilitating swift and efficient implementation of corrective measures.

Obligation to notify regulatory authorities

Where producers and distributors know or ought to know, based on the information at their disposal, that a product they have placed on the market or otherwise supplied to the consumer may pose risks conflicting with general safety requirements, they must immediately inform the competent authorities, specifying any actions taken to prevent risks to consumers.

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

• specific elements permitting precise identification of the product or batch of products;
• a full description of the risk posed by the products concerned;
• all available information enabling the product to be traced; and
• a description of the measures taken to prevent risks to consumers.

The notification to the competent authority of an action undertaken to prevent any possible risks to consumers is essential to allow the authority to coordinate and harmonise the control activities with other public entities on the market and to allow the circulation of the information within the RAPEX system.

Penalties for breach of safety obligations

The Italian Consumer Code imposes a fine ranging from EUR1,500 to EUR30,000 for failure to notify the competent authorities when required.

Furthermore, Italian law provides for other more specific penalties if the manufacturer or the distributor places dangerous products on the market, violates a ban from the competent authorities not to market a certain product, or fails to adopt measures aimed at remedying the risks arising from an unsafe product. More specifically:

• unless the conduct constitutes a more severe criminal offence, the manufacturer or distributor that markets dangerous products, or violates a ban issued by a government authority to market a product, may face up to one year in prison and an administrative fine ranging from EUR10,000 to EUR50,000;
• unless the conduct constitutes a more severe criminal offence, the manufacturer or distributor that does not comply with an order issued by the competent authorities to ensure that a certain product placed on the market is safe or to warn consumers about possible dangers may face an administrative fine ranging from EUR10,000 to EUR25,000;
• a manufacturer or distributor that does not co-operate with the competent authorities in the performance of their monitoring and surveillance activities may face an administrative fine ranging from EUR2,500 to EUR40,000; and
• if a more serious crime is also involved (eg, injury or manslaughter), the relevant criminal provisions will also apply.

Product Liability

Product liability causes of action and sources of law

According to the provisions of the Consumer Code, whoever is injured or suffers a loss because of a defective product is entitled to compensation for damages. The following damages can be compensated:

• damage caused by death or personal injury;
• the destruction or deterioration of an item other than the defective product, provided it is of a type normally intended for private use or consumption and so primarily used by the injured party.

Punitive damages are not allowed in the Italian legal system.

However, compensation is not due if the injured person was aware of the defect and hazard and willingly exposed themselves to it.

As stated above, a product is defective when it does not provide the safety a person can reasonably expect, taking into account all circumstances or, in the case of manufacturing defects, when it does not provide the safety normally provided by other items in the same category. Various factors influence this assessment, including how the product was distributed and marketed, its characteristics, the instructions provided, the intended use of the product and the time the product was put on the market.

Three categories of defects are set forth by the Consumer Code: manufacturing defects (eg, when the defect is the result of a fault in the production); design defects (eg, when the defect derives from the design of the product); and defects based on inadequate information (eg, when the product is well conceived and manufactured, but it is dangerous as it was placed on the market without providing adequate information to consumers).

Standing to bring product liability claims

Anyone claiming to be prejudiced by a product defect is entitled to bring a product liability claim before ordinary courts of first instance. Case law states that all persons who have been exposed, even occasionally, to the risk arising from a defective product, have a right of claim. This protection extends to “users” in a broad sense, encompassing natural persons, but not limited to “consumers” or non-professional users.

The Italian legal system also acknowledges class actions, where consumer associations with consumer protection within their remit can bring a product liability claim.

Time limit

According to the Consumer Code, the limitation period for bringing a claim with regard to compensation for damages allegedly caused by a defective product is limitation period is three years from the day the injured party became, or should have become, aware of the damage, the defect and the identity of the liable party. In cases where the damage intensifies over time, the limitation period does not commence until the day the injured party became, or should have become, aware of a damage severe enough to warrant initiating a lawsuit.

In addition, any rights to compensation for damages expire after ten years from the date the product was put on the market, unless a claim is initiated.

In case of damages caused by a defective product, the rules regulating general tort liability as set forth by the Italian Civil Code may also apply. In this case, the limitation period is five years starting from the event causing the damage. Depending on the circumstances, the claimant may consider submitting a product liability claim as regulated by the Consumer Code or a tort liability claim.

Jurisdictional requirements

Under the Italian Consumer Code, jurisdiction for a product liability claim falls to the court situated where the consumer, who has suffered damage from a defective product, resides. However, according to EU Regulation No 1215/2015 on jurisdiction, regardless of the claimant’s place of residence or nationality, Italian Courts have jurisdiction over product liability claims when the harm is caused by an event that occurred in Italy. Italian Courts also have jurisdiction over product liability claims when the defendant is domiciled or resides in Italy, or has a legal representative authorised to appear in the courts.

Pre-action procedures and requirements for product liability claims

No pre-action procedures or other requirements are provided under Italian law before commencing a product liability claim.

When the manufacturer is not identified, the distributor can be sued unless it has communicated the manufacturer’s identity within three months from receipt of a written request of the claimant indicating the allegedly defective product, the damage and the place where the damage occurred. If the distributor fails to respond, they can be sued in the manufacturer’s stead. However, if such request has not been made, once sued in the court, the distributor may communicate the manufacturer’s identity and, if the manufacturer does not contest this information, the distributor can be dismissed from the proceedings.

Rules for preservation of evidence in product liability claims

The general rules for preserving evidence in ordinary civil proceedings apply to product liability claims, irrespective of whether the evidence is documentary, testimonial, or concerns the conditions of a person or a location.

With regard to documentary evidence, Italian law mandates a preservation duty for companies and professionals, with retention periods varying depending on the nature of the documents and their intended use. Focusing specifically on product liability issues, Article 104 of the Italian Consumer Code provides that distributors must act diligently to help ensure that safe products are placed on the market. This includes an obligation to participate in product safety oversight by maintaining and providing relevant documentation that traces the product’s origin. This preservation obligation exists for a period of ten years from the date the product was made available to the end consumer.

With regard to witness evidence, the Italian legal system provides that parties may indicate witnesses to be heard by the court on some specific circumstances. Alternatively, parties may also submit to the court written documents containing the witnesses’ declaration.

Furthermore, according to the Italian Civil Procedure Code, prior to commencing a claim, it is possible to ask the court to appoint a court expert in order to carry out an investigation and appraisal to determine the status of a place, condition of items or goods, or to ascertain the condition of a person. The investigation takes place in the context of urgent and preemptive proceedings that can be initiated when there is a risk that evidence may not be collected in subsequent ordinary proceedings (ie, when the status of a place or the health conditions of a person are likely to change). Therefore, the following requirements are necessary for such proceedings:

• a right to protect (fumus boni iuris) in ordinary proceedings; and
• a risk that, if the investigation is not carried out, the evidence will be lost (periculum in mora).

The report of the court appointed expert can be used as evidence in any  subsequent proceedings.

Document disclosure rules

During the proceedings, either party may ask the judge to order the other party or a third party to submit certain documents before the court. The judge, when issuing such an order, stipulates the method and extent of the disclosure. In addition, when ordering a third party to disclose a piece of evidence, the judge shall balance the interest of justice with the third party’s rights.

In the event of non-compliance with the order without a valid reason, the judge may interpret such conduct as circumstantial evidence.

Rules for expert evidence

When the case requires specific technical knowledge, the judge may appoint, also at the request of a party, one or more court technical experts (Consulente Tecnico d’Ufficio or CTU) who serve as assistants to the judge and provide their technical opinion.

CTUs are chosen from a list of experts at the competent court.

The expert cannot make legal assessments, since their role is strictly limited to answering the technical questions put to them by the judge. For product liability matters, the questions posed by the court are in most cases aimed at ascertaining the existence of the alleged defect and the causal relationship between the defect and the damage (if any), as well as the criteria for the quantification of the compensation for damages.

Each party may appoint its own expert (Consulente Tecnico di Parte or CTP) to co-operate with the court appointed expert.

The court expert provides their assessment by means of a written report, shared with the parties’ experts for their comments and remarks. The final report, which also contains the comments of the parties’ experts, is then filed at the court.

The judge may disagree with the conclusions reached by a CTU, provided that the disagreement is substantiated with adequate reasons in the decision.

Even if the judge does not appoint a CTU, the parties may appoint trusted experts who may prepare technical reports to be submitted to the judge as attachments to the case.

Burden of proof

According to Article 120 of the Italian Consumer Code, the injured party must give evidence of the defect of the product, the damage suffered, and the causal connection between the defect and the damage.

The producer must give evidence of the facts that can exclude liability, namely:

• that they did not place the product on the market;
• that the defect that caused the damage probably did not exist when the manufacturer placed the product on the market;
• that the producer did not manufacture the product for sale or any other form of economic distribution, nor did they manufacture or distribute it in the course of their professional activity;
• that the defect is due to the product’s compliance with a mandatory legal norm or binding measure;
• that the state of scientific and technical knowledge, at the time the producer placed the product on the market, did not yet allow the product to be considered defective; and
• in the case of the manufacturer or supplier of a component part or raw material, that the defect is entirely due to the design of the product into which the part or raw material was incorporated or the conformity of it with the instructions given by the manufacturer who used it.

In addition, when a product placed on the market is considered inherently dangerous due to its capacity to cause damages even in the absence of defects (eg, drugs, cars), the manufacturer is liable for damages unless they can prove that all possible measures (consistent with the state of scientific/technical knowledge) aimed at preventing damages were taken.

Courts in which product liability claims are brought

Product liability cases are typically handled by civil courts, except in situations where criminal conduct is involved.

In the Italian legal system, there are two first instance courts: the Justice of the Peace, which has jurisdiction over matters up to a value of EUR20,000, and the Tribunal, which has jurisdiction over matters in excess of the above-mentioned threshold.

In both first instance courts, a single judge presides, and there is no jury.

Appeal mechanism for product liability claims

An appeal against the judgment delivered by the first instance court can be lodged at the competent court of appeal within 30 days of receiving the judgment notification from another party involved in the proceedings. Alternatively, an appeal can be made within six months from the date of its publication by the court if no notification has been served.

New claims are not allowed and, if made, are declared inadmissible ex officio. Also, new objections that were not raised before the first instance court are not allowed. Furthermore, the court of appeal shall base its decision on the same evidence brought before the first instance court.

Under specific circumstances provided for by the Italian Civil Procedural Code, a court of appeal judgment can be appealed before the court of cassation.

Defences to product liability claims

The safety of a product shall be assessed on the basis of the non-mandatory national standards transposing European standards, the standards in force in the member state where the product is marketed, the recommendations of the European Commission for guidelines on product safety assessment, codes of good safety practice in force in the sector concerned, the latest state of the art, and the level of safety that consumers can reasonably expect.

The manufacturer must give evidence of the facts that can exclude liability, namely:

• that they did not place the product on the market;
• that the defect that caused the damage probably did not exist when the manufacturer placed the product on the market;
• that the producer did not manufacture the product for sale or any other form of economic distribution, nor did they manufacture or distribute it in the course of their professional activity;
• that the defect is due to the product’s compliance with a mandatory legal norm or binding measure;
• that the state of scientific and technical knowledge, at the time the producer placed the product on the market, did not yet allow the product to be considered defective; and
• in the case of the manufacturer or supplier of a component part or raw material, that the defect is entirely due to the design of the product into which the part or raw material was incorporated or the conformity of it with the instructions given by the manufacturer who used it.

The impact of regulatory compliance on product liability claims

Failing to comply with technical mandatory requirements provided by sector-specific regulations is considered as a defect, therefore giving rise to product liability should the non-compliance be in causal relationship with the damage suffered.

Case law states that, although the evidence of the defectiveness of a product may be based on simple inferences or logical deductive reasoning, the damage suffered as a result of using a product does not unequivocally establish evidence of alleged defectiveness without additional corroborating evidence. Furthermore, evidence is required to demonstrate that the injured party was using the product appropriately at the time of the incident.

Rules for payment of costs in product liability claims

As a general rule, the “loser pays” principles applies.

However, when the case is of particular complexity, the court may decide that each party bears its own legal costs.

Available funding in product liability claims

The Italian legal system provides public legal aid to citizens with insufficient means, provided their claims are not manifestly unfounded. This system grants exemption from certain costs, which are borne by the state.

Access to public legal aid is assessed on a case-by-case basis.

Existence of class actions, representative proceedings or coordinated proceedings in product liability claims

Class actions are available in Italy. In particular, there are two different procedures that can be followed:

• The procedure sets forth by Articles 840bis of the Italian Civil Procedural Code: any subject having suffered the violation of a homogeneous right can take action, whether or not it is a consumer.
• The procedure sets forth by the Italian Consumer Code, as the result of the implementation of EU Directive 1828/2020: consumers and consumers’ associations included in the relevant list provided by Regulation (EU) 2017/2394, national independent public bodies referred to in Article 3(6) of Regulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017, who make the relevant request, as well as the bodies designated by another member state per the list indicated in Article 5(1) of Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020, are entitled to bring representative actions.

Both procedures are based on an opt-in system and are aimed at granting compensation for damages and/or injunctive relief.

The procedure provides for a first phase where the admissibility of the case is assessed and a subsequent phase for the joining of the members, the collection of evidence and the final decision.

Summary of significant recent product liability claims

In a recent case, a claimant sued a pharmaceutical company, alleging the defectiveness of a drug.

The manufacturer objected that the adverse reactions of the drug were duly indicated in the package leaflet and that the adverse reaction affecting the claimant arose in combination with other diseases he was suffering from.

In 2021, the Italian Supreme Court stated that the manufacturer’s liability was not absolved by the presence of generic safety warnings in the product’s package leaflet. Instead, it necessitates a specific warning that provides consumers with sufficient awareness of potential risks associated with the use of the drug as outlined in the package leaflet. This ensures consumers can evaluate the risks and benefits of the product. Where the consumer knowingly exposes themselves to risk, they might be deemed to have contributory negligence under Article 1227 of the Civil Code, particularly in cases of drug misuse or underestimation of risk.

The Supreme Court rejected the appeal by the pharmaceutical company, stating that the defect, damage, and causal link between the defect and damage were established, and that the generic warning about the product’s potential risks contained in the package leaflet was not sufficient to absolve the manufacturer’s liability.

Recent policy changes and outlook

Trends in product liability and product safety policy

products and beverages, toys, electrical/electronic appliances as well as other equipment (eg brush cutters, bike racks). The automotive sector is also involved in public liability matters. With regard to software, the rules on product liability also apply to the supply of goods that incorporate or are inter-connected with digital content and to digital services.

Future policy in product liability and product safety

In Italy, there are currently no developments involving new technologies, such as AI, IoT and cybersecurity. However, as a member state, Italy will be required to implement/directly apply any forthcoming EU rules on such matters. 

Crisis management/situations/business disruption and product liability and product safety laws

In case of a product liability issue, it is advisable to set up an efficient internal case management. This includes supplementary activities such as scrutinising legislative and case law developments, monitoring of forthcoming or proposed actions, and forming a dedicated team that can oversee all potentially impacted areas, such as legal, corporate, distribution, project planning, and engineering.

The rules on product liability have not been affected by the emergency legislation issued during the pandemic period.