Reporting requirements for defective products in Italy

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.