Product Recall in Italy

General product obligations

What are the basic laws governing the safety requirements that products must meet?

In general, the Italian legislation governing product safety requirements is Legislative Decree No. 206 of 6 September 2005 (the Consumer Code), implementing both Directive 2001/95/EC (the General Product Safety (GPS) Directive) and Directive 85/374/EEC (the Product Liability Directive).

The application of the Consumer Code could be defined as being residual, as there are a number of other vertical regulatory instruments that apply to specific types of products, such as food, pharmaceuticals, food supplements, toys and medical devices.

Furthermore, the Consumer Code provisions apply to the aforementioned ‘excluded’ products when the sector-specific legislation does not cover certain matters.

The Consumer Code defines the following subjects as producers:

• the manufacturer of the finished product;
• an intermediary;
• the importer, in the case of a manufacturer established in a third country; and
• any other natural or legal person who presents himself or herself as a producer by affixing his or her trademark to the product.

The producer must also have the legal nature of an undertaking, because the production of the product must be the result of his or her professional activity and not of an occasional one.

The definition of ‘safe product’ essentially reflects the definition given within article 2(b) of the GPS Directive.

What requirements exist for the traceability of products to facilitate recalls?

The Consumer Code requires a producer, and its equivalent, to place on the market products that are safe and present no or minimum risk to the consumer. However, it does not impose any particular obligations on the producer, with the exception of the general obligation to trace products already on the market.

Of course, the best way to trace a product is by lot or lot number. However, the affixing of a barcode or batch number is not mandatory, with the exception of certain products, such as food and pharmaceutical products.

A particular obligation is imposed on the distributor, which, under article 104(6)(c), is required to maintain and provide the authority with appropriate documentation to trace the origin of the products for a period of 10 years from the date of transfer to the final consumer.

What penalties may be imposed for non-compliance with these laws?

Article 112 of the Consumer Code, relating to sanctions, concerns both criminal and administrative offences and applies where the act does not constitute a more serious offence, falling within the special legislation or the general criminal code.

Generally speaking, placing dangerous or unsafe products on the market, or failing to comply with an order from the authority about a dangerous product, is punishable with imprisonment for up to one year and a fine, ranging from €10,000 to €50,000, while failure to cooperate with authorities in carrying out checks on products and in acquiring information and samples thereof can be sanctioned with a fine ranging from €2,500 to €40,000.

In addition, the violation of product safety regulations may also attract general liability under the Italian Criminal Code - for example under article 442 (trade of counterfeit foodstuff).

From a criminal point of view, what is relevant is not only the liability for the direct placing on the market of unsafe goods or products intended for the consumer, but also the damage resulting from the consumer’s exposure to unsafe goods, for example, to toxic substances used in production processes.

During criminal investigations, the public prosecutor can also proceed with the precautionary seizure of products that may be subject to administrative confiscation, in the manner and within the limits of the code of criminal procedure.

Reporting requirements for defective products

What requirements are there to notify government authorities (or other bodies) of defects discovered in products, or known incidents of personal injury or property damage?

According to article 104, paragraph 7 of the Consumer Code, the manufacture (or distributor) that discovers a defective product is obliged, irrespective of a request from the authority, to immediately inform it of the risks relating to products that they place on the market and that are incompatible with the safety requirements, indicating the action taken or to be taken to avoid those risks.

Paragraph 8 clearly identifies the content of the information to be communicated by producers and distributors to public authorities where the product is likely to constitute a serious risk. This information includes:

• specific elements allowing precise identification of the product or batch of products in question;
• a full description of the risk presented;
• all available information enabling the product to be traced; and
• a description of the measures taken to prevent risks to consumers.

Finally, under the last paragraph, producers and distributors may be called upon to cooperate with the public authorities in carrying out the protective measures taken to avoid the risk inherent in the goods produced or distributed.

What criteria apply for determining when a matter requires notification and what are the time limits for notification?

The manufacturer and the distributor are obliged, when they discover a defective product, to immediately inform the authority.

This information obligation falls on those persons at the time when the product is ‘placed on the market’. By this expression, the legislator intended to refer to the exit of the product from the sphere of production, to enter, in any way, into the sphere of use of the consumer.

In assessing whether a notification is required, manufacturers may find assistance in the sort of guidelines enshrined in Commission Decision 2004/905/CE - guidelines for the notification of dangerous consumer products to the competent authority by producers and distributors.

Indeed, while the obligation to inform authorities about dangerous products is an important element for improving market surveillance, a disproportionate burden on producers, distributors and competent authorities must be avoided.

Factors to be taken into account by manufacturers and producers that may affect the level of risk may be the utility of the product, the nature of the risk, the population groups exposed, previous experience with similar products, whether the product has adequate warnings and safeguards, and whether the hazard is sufficiently obvious.

Once the manufacturer or the distributor has evidence that the product is dangerous or does not satisfy the safety requirement of the relevant Community legislation and, because of that, the product may not remain on the market, the obligation to inform the authority is then triggered, as well as any other obligations envisaged by the applicable legislation (warnings, withdrawal, recall, etc).

In any case, the final decision to file a notification remains at the discretion of the manufacturer or distributor.

According to the Italian Consumer Code, the notification, if required, is to be given immediately, regardless of the degree of risk assumed and related to the product.

To which authority should notification be sent? Does this vary according to the product in question?

With Decree 115 of 1995, the Italian legislator confirmed the rules relating to distribution of enforcement of discipline on general safety of products among the various ministries, following their competence for the subject. However, they attributed to the Ministry of Economic Development the role of coordinating body and endowed it with autonomous powers of initiative.

Therefore, if the product to recall is a motor vehicle, the relevant authority concerned will be the Ministry of Transportation.

What product information and other data should be provided in the notification to the competent authority?

Manufacturers or distributors must provide authorities with the following details:

• contact details of the authority to which notification is sent;
• identification of the companies notified and their role in the marketing of the products;
• details and reference of the manufacturers or distributors or both;
• information enabling a precise identification of the product or batch of products in question (brand or trademark model, name, barcode CN tariff, country of origin, description of the product and its photograph);
• a full description of the risk that the products pose;
• details of the hazard and possible health or safety damage and conclusions on the risk assessment carried out;
• records of accidents; and
• a description of the actions taken to prevent risks to consumers and identification of the company responsible for the execution of aforesaid actions, their scope and duration.

What obligations are there to provide authorities with updated information about risks, or respond to their enquiries?

There is no specific obligation that can be found within the Consumer Code. However, in the general obligation stemming from that Code, it is implied to put only safe products on the market, namely products that do not cause any harm or present minimal risks when used by the consumer.

What are the penalties for failure to comply with reporting obligations?

Failure to comply with reporting obligations exposes the producer and the importer to administrative fines ranging from €1,500 to €30,000.

Failure to comply with reporting obligations could also be sanctioned under criminal law.

Is commercially sensitive information that has been notified to the authorities protected from public disclosure?

From a general point of view, commercially sensitive information is not disclosed to the public by the authorities that have been informed by the producer or distributor.

However, if a person has a duly funded relevant interest, the authority may grant him or her the requested access to the information.

May information notified to the authorities be used in a criminal prosecution?

Yes, any information notified to the competent authorities will be given to the public prosecutor for investigation and for the subsequent trial.

Product recall requirements

What criteria apply for determining when a matter requires a product recall or other corrective actions?

The Italian regulator has provided the competent public authorities with a series of powers that diversify the intervention of these authorities according to how dangerous the product is.

These powers are necessary to understand and estimate how much of a hazard a product is, the risks involved and any infringements. In particular, these are the powers to:

• organise adequate checks on the safety characteristics of the product;
• require all the necessary information from the parties concerned; and
• take samples of a product or series of products and subject them to safety analyses.

Once these activities have been completed, the competent authority may order the product to be recalled or withdrawn.

What are the legal requirements to publish warnings or other information to product users or to suppliers regarding product defects and associated hazards, or to recall defective products from the market?

Information campaigns targeted at consumers are a burden on the producer or distributor when a product placed on the market presents elements of danger. Such a measure may be taken at the behest of the producer or distributor, or following an indication to that effect by the public authority.

Are there requirements or guidelines for the content of recall notices?

Italian law does not impose any specific requirements regarding the content of the recall notice. Generally, it is at the manufacturer’s discretion to decide which content the recall notice will contain. The notice has to be issued in a way that enables the average customer to understand the content of the recall notice itself. It should also inform the consumers about the reason for the recall and any danger that may arise from use of the product.

What media must be used to publish or otherwise communicate warnings or recalls to users or suppliers?

There is no prescriptive list of media that must be used to publish or communicate warnings or recall to suppliers or users. Of course, the chosen method should relate to the assessed levels of risk.

A warning communication can be given by using different methods such as point-of-sale information, websites, radio and TV news, and consumer telephone services.

Do laws, regulation or guidelines specify targets or a period after which a recall is deemed to be satisfactory?

Italian legislation does not provide for such targets or periods. The authorities will ask the manufacturer to communicate updates on the status of a recall on a regular basis. Then it will be up to negotiations with the authorities to consider if the recall is satisfactory.

Must a producer or other supplier repair or replace recalled products, or offer other compensation?

There is no specific obligation in this regard contained in the Consumer Code. However, in the event of damage stemming from a defective product, all aspects concerning the possibility to claim compensation for damages and breach of the sales contract are governed by the Civil Code.

What are the penalties for failure to undertake a recall or other corrective actions?

Failure to undertake a recall or another corrective action is punishable by up to one year of imprisonment. If not having withdrawn the product also causes damage (injury, manslaughter), the other sanctions of the Criminal Code will apply.

Authorities' powers

What powers do the authorities have to compel manufacturers or others in the supply chain to undertake a recall or to take other corrective actions?

Given the general obligation to take all measures deemed necessary to ensure that products placed on the market are safe, authorities are entitled to indicate to producers all the measures they consider appropriate. Authorities can also order product recall directly from consumers, as well as destruction of the product.

Can the government authorities publish warnings or other information to users or suppliers?

No. However, competent authorities should encourage and instruct manufacturers to voluntarily take all the necessary safety measures to recall products. Furthermore, authorities can also order the manufacturer to duly inform consumers.

Usually, an authority’s official website, such as the Health Ministry, publishes a summary of the recall notice already issued by the producer, within dedicated sections of the website.

Can the government authorities organise a product recall where a producer or other responsible party has not already done so?

In some serious cases that require urgent action, competent authorities do recall products at their own initiative.

Are any costs incurred by the government authorities in relation to product safety issues or product recalls recoverable from the producer or other responsible party?

Any cost is recoverable from the producers or, if that is not possible, from the distributor.

How may decisions of the authorities be challenged?

Decisions may be challenged before the competent regional administrative court. However, they are immediately enforceable.

Implications for product liability claims

Is the publication of a safety warning or a product recall likely to be viewed by the civil courts as an admission of liability for defective products?

From a certain point of view, it can. However, this does not mean that the producer will be automatically condemned by the court for the defectiveness of the product.

First, the burden of proof is on the injured party. The consumer code also allows the producer to prove facts that exclude his or her own responsibility. In this case it will be sufficient to prove that, taking the circumstances into account, it is possible that the defect did not yet exist when the product was put into circulation. Obviously, the manufacturer may also prove the fault of the injured party, or object to the forfeiture or prescription.

Can communications, internal reports, investigations into defects or planned corrective actions be disclosed through court discovery processes to claimants in product liability actions?

From the civil law point of view, the party might require the judge to order the other party to exhibit specific documents.

From a criminal law point of view, while the public prosecutor carries out an investigation, it has extensive powers to request, collect and present to the judge (during proceedings) all documents belonging to the manufacturer that relate to the crime being investigated. These documents will always be available to the injured party.

Updates and trends

Are there any emerging trends or hot topics in product recall litigation in your jurisdiction?