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General climate and recent developments

State of legal development

In general terms, how developed are the product regulation and liability laws in your jurisdiction?

Product liability regulation in Spain is comparable to that of any other EU member state, as Spain has transposed all of the EU directives on product safety and defective products into domestic law. There is also a mature body of jurisprudence on these matters.

Recent developments

Have there been any notable recent developments in relation to product liability law and product safety law in your jurisdiction, including any regulatory changes and case law?

Recent decisions from Spanish courts have emphasised that the claimant is required to provide some solid or scientific evidence showing that the benefit/risk ratio was unfavourable and that, consequently, the product should not have been authorised. Other recent judgments have also made it clear that the burden is on the claimant to prove, based on the state of the art, that the producer/supplier did not act in accordance with the scientific data and evidence available at that time.

Legal framework

Legislation

What primary and secondary legislation governs product safety and liability in your jurisdiction?

The primary legislation governing product safety and product liability is:

  • Royal Legislative Decree 1/2007 approving the consolidated text of the General Consumer and User Protection Act, which included the transposition previously made of the Product Liability Directive (85/374/EEC); and
  • Royal Decree 1801/2003 concerning general product safety, which transposed into Spanish law the EU General Product Safety Directive (2001/95/EC).

In addition, there are specific regulations applicable to particular products such as medical devices, food, cosmetics, toys, machinery, etc. Examples include:

  • Legislative Royal Decree 1/2015 on guarantees and rational use of medications and healthcare products;
  • Law 14/1986 on general health;
  • Royal Decree 1205/2011 on toy safety; and
  • Royal Decree 750/2010 regarding type-approval procedure for motor vehicles and trailers (among other vehicles).

Regulatory and enforcement authorities

Which government authorities regulate and enforce product safety and liability laws in your jurisdiction, and what is the extent of their powers?

There are several authorities responsible for enforcing product safety and liability that regulate different product sectors. Examples of such authorities are:

  • the National Agency on Consumption and Food and Nutrition Safety;
  • the Spanish Agency of Medicines and Medical Devices; and
  • the Ministry of Industry, Energy and Tourism (which monitors type-approval requirements for vehicles). 

These authorities have nationwide competence.

Regional authorities have other types of competence – in particular concerning information, consumer assistance and advice on consumers’ claims – and are not responsible for enforcing product safety.

Liability

Product defects

How is a ‘product defect’ defined in your jurisdiction?

Article 137 of Royal Legislative Decree 1/2007 approving the consolidated text of the General Consumer and User Protection Act (hereinafter, the General Consumer and User Protection Act) defines a ‘defective product’ as:

1. Defective product shall mean any product which does not provide the safety that it could legitimately be expected to provide, taking all circumstances into account, especially the presentation of the product, its reasonable foreseeable use and the time when it was placed on the market.

2. Products are defective in all cases in which they do not provide the safety normally provided by other models in the same series.

3. A product shall not be considered defective solely due to the fact that an improved version of the product is put onto the market.

Compliance with the regulatory requirements does not imply that a product will not be ‘defective’; it merely authorises the commercialisation of the product.

Further, case law is clear that the risk/benefit analysis or risk/utility ratio alone does not determine whether a product is defective or not. The courts may, however, take these ratios into account or consider them as one relevant factor out of the many that are relevant when determining if a product is defective "taking all circumstances into account".

Causation and burden of proof

How is causation of loss or damage established in relation to product liability claims and where does the burden of proof lie? Can this burden be shifted in any way?

Article 139 of the General Consumer and User Protection Act establishes that the claimant/injured party seeking damages bears the burden of proving that the product was defective, a damage occurred and there is a causal relationship between the defect and the damage.

Article 386 of the Spanish Civil Procedure Act 1/2000 admits certain judicial presumptions. Thus, it is possible for the court to presume certainty of one fact based on another admitted or proven fact, if there is a precise and direct link between what is admitted or demonstrated and the presumption. When this occurs, the court is required to include its reasoning and how the presumption was established in any judgment. This reasoning can be applicable to cases of product liability for the purpose of establishing causation.

In some cases, courts have imposed the burden of proof on a party other than the claimant to establish certain facts where it is within the ability of that party to prove those facts (eg, Supreme Court's decisions of February 13 1992 and July 29 2010). This principle cannot imply a shift in the burden of proof if to do so would be against Article 139 of the General Consumer and User Protection Act, Article 4 of the Product Liability Directive (85/374/EEC) and EU case law. This principle also cannot be used to shift the burden of proof for causation.

Legal bases for claims

On what legal bases can a product liability claim be brought?

In general terms, product defects usually fall into three distinct categories: manufacturing defect, design defect or lack of information defect. Claims can therefore be brought alleging liability for one or more of these categories.

Article 137 of the General Consumer and User Protection Act establishes the general means by which a statutory claim involving an allegedly defective product is made in Spain. Importantly for producers, Article 137 also establishes that a product shall not be considered defective solely due to the fact that an improved version of the product is put on the market.

Claimants are not limited to statutory claims as the statutory product liability system coexists with the contractual and tort liability models in Spain. Such claims are contemplated under the Spanish Civil Code (eg, Article 1902 for tort liability). 

Criminal liability

Can a defendant be held criminally liable for defective products?

Although the Spanish Criminal Code does not specifically refer to crimes regarding the sale or distribution of defective products, some acts in relation to the sale or distribution of defective products are capable of being considered criminal offences. 

For example, Articles 359 and 360 of the Criminal Code concern felonies against public health for the dispatch, supply or trade of substances, chemical products or medicines that are harmful to health or may cause havoc. Likewise, Article 364 states that those who offer to manufacture or sell food products liable to cause damage to the health of persons may be held criminally liable.

Since December 23 2010, the Criminal Code has also been providing that legal entities may be held criminally liable for certain offences. Accordingly, both individuals and corporate entities can be liable for the behaviour and acts of their directors or legal representatives, general managers, proxies, employees and other persons that are within the company's corporate domain. Recent decisions of the Spanish Supreme Court (eg, Supreme Court's decisions of February 29 2016 and March 16 2016) indicate that the prosecution will need to prove that the compliance systems were non-existent or ineffective in order for a corporation to be held criminally liable. As against individual directors or managers, criminal liability will be established if it is shown that the individual intentionally participated and/or wilfully acted in breach.

The applicable criminal penalties include fines, temporary closure of the establishment/company, cessation of activities (eg, Supreme Court's decision of March 16 2016) or imprisonment of individuals.

Liable parties

Which parties can be held liable for defective products?

Under Article 146 the General Consumer and User Protection Act, suppliers may be held liable as if they were producers/manufacturers "where they have supplied a product in the knowledge of the existence of the defect". Where this occurs, the supplier retains a right to bring recovery proceedings against the producer.

The supplier's liability can be excluded if it indicates to the injured party the identity of the producer or such person as supplied or provided it with the product, within three months of the date when the claim is first raised by the consumer. The same rule applies to imported products, where the product does not give the name of the importer, even if the name of the manufacturer is stated.

Limitation of liability

Can liability be excluded or mitigated in any way?

In principle, liability for damages cannot be reduced in any way. This is because under Spanish regulations, which implement the EU Product Liability Directive, product liability is a strict liability regime.

Article 140 of the General Consumer and User Protection Act sets out that producers are liable if they can prove that:

  • they did not put the product into circulation;
  • given the circumstances of the case, it may be presumed that the defect did not exist when they put the product into circulation;
  • the product was not manufactured for sale or any other form of distribution with an economic purpose, nor was it manufactured, imported, supplied or distributed within the context of a professional or entrepreneurial activity;
  • the defect is due to the fact that the product was made in accordance with existing mandatory rules; or
  • the state of the scientific and technical knowledge at the time the product entered into circulation meant that the existence of the defect could not be perceived.

Article 141 of the General Consumer and User Protection Act also caps the civil liability of the producer as follows: “a) A release of €500 shall be deducted from the amount of compensation for material damages. b) The producer’s overall civil liability for death and personal injuries caused by identical products with the same defect shall be limited to the sum of €63,106,270.96."

Litigation

Procedure

What is the procedure for filing a product liability claim before the courts in your jurisdiction?

The Spanish Civil Procedure Act 1/2000 sets two main types of civil procedures to file a product liability claim: ordinary procedures (for claims in excess of €6,000) and oral procedures (for claims below €6,000).

The claim is filed by writ identifying the claimant, the defendant, the address for notification, the facts and the legal basis of the claim. The evidence on which the facts are based should also be filed with the claim and a fee of €300 is payable to initiate an ordinary procedure claim.

In ordinary procedures, after the claim has been filed the defendant must file a statement of defence or a counterclaim within 20 working days. After this, the court will call the parties to a preliminary hearing before the trial. In this preliminary hearing, parties request evidence to take place at the trial (eg, witnesses, interrogations) and the court orally decides on whether the evidence requested is useful and appropriate. Documents should be filed with the claim and with the statement of defence. There is limited discretion for a party to rely on a document filed at a later point, but only if the party satisfies the court that it was not possible to file at the usual time (eg, newly disclosed documents, documents created after proceedings started but material to the issues). The court clerk sets a hearing date. In the trial, the parties present orally their conclusions on the facts and the evidence. Lastly, the court will give its judgment.

In oral procedures, the main differences are that:

  • the defendant has only 10 working days to file the statement of defence or a counterclaim; and
  • there is no preliminary hearing before the trial, and the trial cannot take place unless it is requested by any of the parties or the court considers it necessary.

The parties should announce which evidence they wish to examine prior to trial (eg, witnesses or documents required for cross-examination). Where a party has control over evidence (eg, documents in the party's possession, his or her expert witness), that party should ensure that the evidence is available for the trial. 

Interlocutory motions

Can the court issue interlocutory orders or judgments in product liability cases? If so, what rules and procedures apply?

The court can issue procedural court orders, orders and judgments:

  • A procedural court order is issued when the decision refers to procedural matters requiring a judicial decision by virtue of the law;
  • An order is issued when a decision is adopted on appeal against a procedural court order or decree, or when a decision is adopted on the admission or rejection of a claim, counterclaim, joinder of actions, admission or rejection of evidence, judicial approval of settlements, mediation agreements and covenants, injunctions and nullity, validity of the procedures or any other incidental matters; and
  • A judgment is issued to end the proceedings and resolve the case, at first or second instance.

Although the First Transitional Provision of the Civil Procedure Act provides that "[t]he system of ordinary appeals set forth herein shall apply to any interlocutory or non-definitive decisions issued in all kinds of proceedings and instances after the entry into force of this Act", in practice some interlocutory orders are substantially limited in terms of appeals, such as the decisions admitting or refusing the taking of evidence's proposal. The admission or refusal of evidence can be appealed only at second instance.

Pre-trial disclosure

What pre-trial disclosure/discovery mechanisms are available in product liability cases, if any?

Article 256 of the Civil Procedure Act provides some pre-trial disclosure mechanisms. According to this provision, to help parties prepare for any hearing applications, disclosure of the following documents may be requested:

  • documents proving the capacity, representation or legal competence of an individual; and/or
  • documents/objects that may be in the possession of an individual that shall be referred to at the hearing.

The claimant can make an application for disclosure under Article 256 and, if the court upholds the application, the other party is required to submit this information. The application is limited to some cases (eg, in proceedings for the defence of common interests of consumers, in order to specify the members of the affected group when such members can be easily determined).

Evidence standards

What evidence is accepted to support claims in product liability cases? What formalities apply to evidence submission?

Evidence is governed by Articles 281 to 386 of the Civil Procedure Act. Article 299 of the act lists the accepted methods for taking evidence, which include, but are not limited to:

  • questioning the parties;
  • public documents;
  • private documents;
  • experts’ opinions;
  • witness evidence;
  • taking of evidence by the court (eg, an inspection);
  • any recordings of words, sounds and images; and
  • any instruments that allow words, data and mathematical operations.

Evidence is submitted at the preliminary hearing in ordinary procedures or trial in oral procedures, and will be examined by the judge and cross-examined by each party. The court weighs and evaluates the evidence before it when determining the claim.

Expert evidence

Under what circumstances will the court appoint an expert to assist it in examining the merits of the case? What rules and procedures apply?

While the court has the power under Article 339.5 of the Civil Procedure Act to appoint an expert ex officio in certain proceedings, this does not apply to product liability claims. Therefore, the proposal and appointment of experts in product liability cases is a matter for the parties.

Either party may, however, request in its preliminary writs that the court appoint an expert if it deems that an expert’s report is appropriate or necessary. The court-appointed expert's opinion is at the expense of the applicant, without prejudice to whatever may be decided regarding the legal costs.

Can the parties rely on expert witness testimony to support their claims? If so, what rules and procedures apply?

Yes, generally each party appoints its own experts, although there is always the possibility to request the court to appoint an expert. Under Articles 336 and 337 of the Civil Procedure Act, the experts' opinions on which each party wishes to rely must be provided with the claim or the statement of defence. If the expert report is not drafted at that time, the parties must signal this in the claim or statement of defence, and file it no later than five working days prior to the preliminary hearing or five working days before the trial in oral procedures.

At trial, the expert may be questioned by all the parties and may be asked to provide an explanation regarding one or more aspects of the report, as well as answer questions and respond to objections as regards the method, premises, conclusions and other aspects of the evidence.

Class actions

Are class actions or any other collective proceedings available for product liability claims in your jurisdiction? If so, what is the procedure for their formation and what benefits do they afford claimants? Are class actions formed on an opt-in or an opt-out basis?

Article 11 of the Civil Procedure Act establishes the possibility of collective proceedings for the defence of the rights and interests of consumers and users.

Various parties can bring a collective action, depending on the circumstances:

  • Where the membership of a group of affected consumers or users can be easily determined, the following can bring a collective action:
    • a group of consumers or users affected by the defective product/harmful event;
    • a consumer association;
    • legally incorporated entities that have the defence or protection of consumers or users as their object; and
  • Where the membership of a group of affected consumers or users cannot be easily determined or is unknown, only the representative associations of consumers and users, in accordance with the General Consumer and User Protection Act (as registered in the Associations of Consumer and User Registry), can bring a collective action.

According to Articles 15, 221 and 519 of the Civil Procedure Act:  

  • in proceedings where the affected consumers or users can easily be determined, all the affected should be informed of a claim to appear in the proceeding. The appearance is possible at any point, but such parties can participate only in certain acts; and
  • in proceedings where the affected consumers or users cannot be easily determined or is unknown, all possible affected parties should be informed of the possibility to appear in the proceeding, but only those who actually appear can be part of the claim.

It is important to take into consideration that consumers who have suffered the damage will always have individual legal standing to file an action, and the court cannot force individuals to join a class action.

Appeals

What rules and procedures govern appeals of court decisions?

Articles 457 to 467 of the Civil Procedure Act provide that, in product liability proceedings, it is always possible to appeal first-instance judgments before provincial courts.

Appeal judgments can be further appealed on only two bases:

  • an extraordinary appeal for infringement of procedure (under Articles 468 to 476 of the Civil Procedure Act); or
  • a cassation appeal as long as:
    • they are issued to provide fundamental rights with the effective protection of the civil courts;
    • the amount exceeds € 600,000; or
    • the decision on the appeal has reversal interest.

‘Reversal interest’ means that the judgment subject to appeal:

  • contradicts the Supreme Court’s jurisprudence;
  • decides on points and issues about which contradictory jurisprudence from the provincial courts exists; or
  • applies rules that have been in force for less than five years (as long as there is no Supreme Court jurisprudence regarding prior rules of equal or similar content).

Statute of limitations

What is the statute of limitations for filing product liability claims?

Article 143 of the General Consumer and User Protection Act provides that actions for the recovery of damages caused by defective products must be brought within three years of the date when the injured party suffered the damage, whether it is due to the product defect or to the damage that this defect caused, provided that the injured party knows who the responsible ‘producer’ of the product is.

Actions seeking the payment of compensation from all other parties liable for damages must be brought within one year, counting from the date of compensation payment. Any interruption to the statutory limitation periods is governed by the provisions of the Civil Code.

Lastly, the recognised rights of the injured party under the General Consumer and User Protection Act with regards to damages caused by defective products expire after a period of 10 years counting from the date on which the specific product that caused the damage was put into circulation, unless judicial proceedings are initiated within that period.

Timeframe

What is the typical duration of proceedings in product liability cases?

Duration and timeframes for proceedings depend on the jurisdiction involved and whether the case is submitted to the civil, criminal or administrative jurisdiction.

Civil proceedings typically last between nine and 18 months (subject to the capacity of the particular area or place where the case is assigned).

Criminal proceedings tend to be longer, despite an amendment to reduce their duration, particularly if the case involves or attracts media attention.

Administrative proceedings typically take 12 to 18 months.

Costs, fees and funding

Can the successful party to the litigation recover court and attorneys’ fees and any other related expenses from the losing party? If so, what rules and procedures apply?

Under the Civil Procedure Act (in particular, Article 394), costs in the first instance are borne by the unsuccessful party, unless the court considers that the case may pose serious de facto or de iure questions. If the upholding or dismissal of the pleas is partial, each party normally pays its own costs of the proceedings and the common costs are shared equally. This general rule can be displaced if the court considers it appropriate to impose the costs on one of the parties due to its conduct during the course of the litigation.

The unsuccessful party will have to pay the full amount corresponding to the opposing party's attorneys or experts' fees, as long as these costs do not exceed one-third of the cost of the total amount claimed. The one-third mentioned does not include the costs borne as a result of professionals' fees subjected to rates or dues (eg, procurators).

To calculate recoverable legal costs, the recommended fees issued by the Bar Associations of Spain are useful reference points.

What rules and restrictions (if any) govern contingency fee arrangements?

Contingency fee arrangements, known as cuota litis, are allowed under Spanish law. Until 2008, contingency fees were admissible if the agreement between the lawyer and the client did not consist of an understanding, prior to the termination of the case, whereby the client agreed to pay the lawyer solely through a percentage of the result of the case, regardless of whether it consisted of money or any other benefit, good or value that the client may achieve by means of the case. Following a Supreme Court judgment of November 4 2008 (JUR\2009\2800), a change of doctrine occurred allowing more freedom in agreements between lawyers and clients on the amount and percentage to receive in relation to the result of the case.

Is third-party litigation funding permitted in your jurisdiction? If so, do any rules or restrictions apply?

Third-party litigation funding is not prohibited in Spain. While still rare, it is a developing area due to recent large-scale banking litigation.

Is legal aid (ie, public funding) available to claimants in product liability cases? If so, what rules, restrictions and procedures apply?

The Legal Aid Act 1/1996 makes legal aid available to Spanish citizens, nationals of other EU member states and any foreigners that may be in Spain, as long as they satisfy the threshold requirements and can show that they lack sufficient resources to litigate on their own. Article 2 of the Legal Aid Act sets out the people and entities that can qualify for legal aid; this includes not-for-profit organisations, managing entities and foundations registered in the Public Registry.

The threshold requirements for a grant of legal aid are that the person's income is not:

  • twice as high as the public income index if the person has no family income to count on;
  • two and a half times higher than the public income index when the person is part of a family of less than four people; or
  • three times higher than the referred index when the family consist of four or more members, or is considered a ‘large family’ under Spanish law.

Legal entities' right to legal aid is recognised for as long as the entities prove that they lack sufficient resources, and the accounting result for a financial year is inferior to the quantity corresponding to three times the annual public income index.

The annual public income index for 2018 is €6,454.03 in terms of 12 payments, and €7,519.59 in terms of 14 payments (www.iprem.com.es/).

Settlement

What rules and procedures govern the settlement of product liability cases?

Articles 415 and 443 of the Civil Procedure Act, which apply to all ordinary proceedings, provide that the parties may state at court if they have reached a settlement, or if they are ready to do so and the court has authority to validate the matters settled upon.

Any settlement agreement validated by the court shall have the effect granted to court settlements and may be put into effect through the procedures laid down to execute judgments and court-approved agreements. Such agreement may be appealed under Article 510 of the Civil Procedure Act (revision of a judgment by the Supreme Court or the Superior Court of Justice) that applies to court settlements. This revision should be filed in cases where:

  • new documents become available that were not field due to force majeure;
  • the decision was based on false documents or interrogations; or
  • bribery, violence or other fraudulent acts occurred.

Additionally, Article 517.2 of the Civil Procedure Act establishes that court rulings that approve or validate court settlements and agreements achieved in the proceedings, accompanied, if necessary in order to record its specific content, by the corresponding records of the proceedings are enforceable.

Any enforcement action based on a judgment, a decision of the court or of the Court Clerk, approving a court settlement or agreement reached in the proceedings, or in an arbitration or mediation agreement, will expire if the relevant enforcement claim is not lodged within five years of the date when the judgment or decision became final.

How common are settlements in product liability cases?

It is difficult to assess how common settlements are in product liability cases as the parties’ appetite for and ability to reach a settlement depends on the circumstances of each case. The greatest change in recent years in product liability cases has been the increased use of confidentiality agreements, with their corresponding penalties – all of which makes the environment much more favourable for settlements, but also makes it more difficult to assess how commonly disputes are resolved via this method.

Alternative dispute resolution

Are any alternative dispute resolution (ADR) methods required or advised before or in lieu of proceeding with litigation?

The General Consumer and User Protection Act proposes a Consumer Arbitration System, which is an out-of-court system for resolving disputes between consumers/users and businesses. Under this system, consumer and user complaints are resolved, provided that the dispute does not involve intoxication, injury or death, and that there are no reasonable indications of crime. Submitting to the Consumer Arbitration System is voluntary, and the agreement to submit must be expressly stated in writing, via electronic media or in any other legally admissible form. The decisions are binding and enforceable on both parties.

Possible ADR measures with regards to defective products also include voluntary submission to mediation or arbitration proceedings as set out in the Civil and Commercial Matters Mediation Law 5/2012 and the Arbitration Law 60/2003.

How commonly is ADR used in relation to product liability cases in your jurisdiction?

ADR is not commonly used in relation to product liability cases in Spain.

Defences

Available defences

What defences are available to defendants in product liability cases?

Under Article 140 of the General Consumer and User Protection Act, producers (which include the manufacturers, suppliers or importers of the product into the European Union  (including component parts and/or raw materials)) is not liable if it can be proved that:

  • they did not put the product into circulation;
  • given the circumstances of the case, it may be presumed that the defect did not exist when the product was put into circulation;
  • the product was not manufactured for sale or any other form of distribution with an economic purpose, nor was it manufactured, imported, supplied or distributed within the context of a professional or entrepreneurial activity;
  • the defect is due to the fact that the product was made to comply with existing mandatory rules; or
  • the state of the scientific and technical knowledge at the time the product entered into circulation meant that the existence of the defect could not be perceived (the ‘state of the art’ defence).

The producer of a component part of a finished product is not held liable if the defect is attributable to the design of the product into which it was incorporated, or to the instructions given by the manufacturer of this product.

In accordance with Chapter III of the General Consumer and User Protection Act on damages caused by defective products, the state of the art defence cannot be relied upon where the case involves medicines, food or foodstuffs intended for human consumption.

In addition, liability may be reduced or avoided if the damage is caused jointly by a product defect and the fault of the injured party or of another individual who is also liable for that damage.

Preliminary actions

What preliminary procedural mechanisms are available to defendants, if any?

Article 256 of the Civil Procedure Act enables prospective claimants to take preliminary procedural steps (eg, gather certain specific information such as medical records). These mechanisms are to allow a defence to be identified or, in the case of collective actions, for the rights and interests of consumers to be identified. In other words, they are mechanisms that are necessary to prepare a claim. There are no similar preliminary powers available to prospective defendants under the Civil Procedure Act. 

Defendants nevertheless maintain the right to request directly from the prospective claimant that it provide certain information or documents pre-action, to enable the defendant to conduct an investigation of the claim or allegations.

Remedies

Damages

What types of damages may be awarded in product liability cases? What rules and standards govern their calculation? Are damages capped?

By virtue of Article 141 of the General Consumer and User Protection Act, the civil liability of the producer for damages caused by defective products is calculated as follows:

  • A threshold of €500 is deducted from the amount of compensation for material damage.
  • The producer’s overall civil liability for death and personal injuries caused by identical products with the same defect is limited to €63,106,270.96.

Are punitive damages allowed?

Punitive damages are not allowed under Spanish law, although the courts can grant moral damages in certain cases if special punishment of the guilty party is warranted (eg, in cases of extremely serious injury).

Other remedies

Are any other remedies available?

Property damages to the product itself cannot be indemnified according to the provisions of the General Consumer and User Protection Act. Instead, such damages will give the injured party the right to compensation in accordance with civil and commercial legislation.

Likewise, moral damages are available under civil law. There are no other remedies available.

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.