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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?

Article 13(f) of the General Consumer and User Protection Act establishes the obligation for any entrepreneur to remove, suspend or recover from the consumer or user any goods or services that do not meet the necessary conditions or requirements, or that represent a foreseeable risk to personal health or safety on any other products.

Moreover, Article 52 of the act also contemplates the precautionary or definitive removal of goods or services from the market on the grounds of health and safety (if ordered by the competent public administration).

The Royal Decree on General Product Safety (1801/2003), which transposed into Spanish law the General Product Safety Directive (2001/95/EC), sets out the process to be undertaken by the administration in the event of an enforced recall of the products from the market.

Notification

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

Article 6 of the Royal Decree on General Product Safety imposes a duty on producers or distributors to notify competent administrative bodies where they know, or should know by the information they possess, that a product made available or supplied to consumers in Spain presents risks that are incompatible with the general duty of safety.

If a product has been supplied to consumers in more than one autonomous community (region) in Spain, notification should be made to the competent authority in the autonomous community where the producer has its registered office, and that authority is required to forward the notification to the National Consumer Institute, which is the entity responsible for notifying all other communities concerned.

Notifications to the competent authority must comply with the form set out by the National Consumer Institute and include the following information:

  • data enabling the accurate identification of the product or batch of products;
  • a full description of the risk that the products present;
  • all available information that is useful for locating the product; and
  • a description of the action undertaken to prevent risks to consumers.

Producers and manufacturers are prohibited from selling any of the products that may have been subject to restrictive measures until permitted by the competent administrative authorities.

Repairs, replacements and refunds

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

Articles 118 to 122 of the General Consumer and User Protection Act govern repairs, replacements and refunds for defective products. In general terms, if the product does not conform to the contract, consumers and users may choose between demanding the repair or the replacement of the product unless either of these two options is objectively impossible or disproportionate.

Article 10 of the Royal Decree on General Product Safety establishes that the market launch of any potentially unsafe product might be suspended until the product is declared safe, or may be prohibited if the product is considered unsafe. In the event that an unsafe product is already in the market, the competent authorities are entitled to order the withdrawal, recall or destruction of the product.

Non-compliance

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

Article 51 of the General Consumer and User Protection Act establishes sanctions for infringements in matters of consumer and user protection. Article 52 sets forth accessory penalties that the competent public administration is empowered to impose for the infringements of consumer and user protection. Such powers include the following:

  • seizure of merchandise that is adulterated, damaged, forged, fraudulent, unidentified or which may pose a risk to the consumer or user;
  • liability for expenses resulting from the measures adopted in the bullet point above, including expenses arising from transport, distribution and destruction; and
  • publication of the sanctions imposed, as well as the names of the individuals or company responsible (including the names of the individuals responsible for the legal entity), the nature and type of infringement, any repeated infringements of a similar nature or proven intent in the infringement.

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