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Product recalls

General requirements

Are there any statutory criteria under which a product must be recalled or other corrective action be taken?

There are no fixed statutory criteria under which a product must be recalled or other corrective actions must be taken. The manufacturer or the competent product safety authorities must evaluate the circumstances on a case-by-case basis. Products may be recalled by the manufacturer on a voluntary basis or following a request from the competent product safety authority. In particular, as the manufacturer must adopt proportionate measures to avoid safety risks, a product will be recalled when other measures are insufficient to prevent the risks that could arise from its use. The competent product safety authority may also recall a product when the measures adopted by the manufacturer or distributor are insufficient or unsatisfactory. This provision must:

  • be reasoned;
  • contain the terms by which it can be appealed; and
  • be served on the manufacturer or distributor of the concerned product within seven days from its adoption.

Notification

What rules and procedures govern notification of the product recall to government authorities and the public?

Pursuant to general product safety provisions, which also apply to product recalls, if a manufacturer or distributor becomes aware that a product in circulation is unsafe, it must immediately inform the competent product safety authorities, specifying the measures that it adopted or proposes to adopt to avoid the risks. If a serious safety risk is posed, the information provided to the authorities must include:

  • specific elements allowing precise identification of the product or the batch of products;
  • a complete description of the risk;
  • all the available information to retrace the product; and
  • a description of the measures adopted to prevent the risks for consumers.

The manufacturer must also keep consumers informed about the measures adopted to prevent any risks, including any product recalls. Further, the rapid alert system under the EU General Product Safety Directive (2001/95/EC) allows for the rapid exchange of information between EU member states and the commission on the measures and action taken in relation to products posing a serious risk to the health and safety of consumers. In Italy, the relevant point of contact for rapid alert notifications is the Ministry of Economic Development.

Repairs, replacements and refunds

What rules and procedures govern repairs, replacements and refunds for defective products?

Repairs, replacements and refunds for defective products are governed by Article 130 of the Consumer Code, under which consumers can request that the seller repair or replace the defective product, without any further costs, unless one remedy is impossible or too expensive compared to the other. The repair or replacement of the defective product must be carried out within a reasonable timeframe. Consumers can request a partial refund, alternatively to the contract resolution, if:

  • the repair and replacement are impossible or too expensive;
  • the seller did not repair or replace the product within a reasonable timeframe; or
  • the repair or replacement carried out by the seller has caused serious inconvenience to the consumer.

To determine the sum of the partial refund, the use of the product must be taken into account. After a complaint is filed by the consumer, the seller can offer one of the above remedies (ie, repair or replacement); however, if the consumer requests a specific remedy in the complaint, the seller must implement it, unless the consumer accepts an alternative proposed by the seller.

Non-compliance

What penalties apply for non-compliance with the legal provisions governing product recalls?

The penalties for non-compliance with the legal provisions on product recalls range from a fine of between €1,500 and €30,000 to the penalties applicable for a felony offence, where the non-compliance and conduct caused serious consequences (eg, personal injury or death).

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