Product safety

Product safety

Protection against risks to consumers’ health and safety is one of their fundamental rights. Goods and services placed on the market must be safe, which means they must not, under normal or reasonably foreseeable conditions, pose health or safety risks to consumers.

Product safety is mainly regulated in the harmonised legislation. This legislation lays down the essential requirements products must meet and is linked to the alert network established by Directive 2001/95/EC for cases where there is a serious risk. All authorities responsible for implementing the essential requirements in the harmonised legislation have responsibilities in relation to product safety. Furthermore, where no harmonised legislation exists or where the legislation does not cover certain safety aspects, Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, as implemented by Royal Decree 1801/2003 of 26 December on general product safety, applies.

Directive 2001/95/EC has been repealed by Regulation (EU) 2023/988 on general product safety , but its requirements remain in force until 13 December 2024.

What is the definition of a safe product?

Article 2 of Royal Decree 1801/2003 of 26 December on general product safety defines a ‘safe product’ as:

• Any product which, under normal or reasonably foreseeable conditions of use, including duration and, where applicable, start-up, installation and maintenance, poses no risk at all, or only minimum risks which are considered acceptable and compatible with the usage of the product, while assuring a high level of personal health and safety protection’.

The elements to be taken into account to determine the safety of a product are:

• The characteristics of the product, including its composition and packaging.
• The effect on other products, where the use of the former together with the latter can reasonably be foreseen.
• The information accompanying the product. In particular, labelling; any warnings and instructions for use and disposal; instructions for assembly and, where appropriate, installation and maintenance, as well as any other indication or information relating to the product.
• The presentation and advertising of the product.
• Categories of consumers who are at risk when using the product, in particular children and the elderly.

On the other hand, risk is defined as: the possibility of consumers and users suffering damage to their health or safety, derived from the use, consumption or presence of a product. The likelihood of damage and the severity of the damage will be assessed jointly in order to classify a risk from the point of view of its seriousness, among other possible circumstances. A risk which requires rapid intervention by public administrations under these criteria will be considered a serious risk, even if the potential damage to health and safety does not become apparent immediately.

A product intended to be placed on the market in Spain will be considered safe if it complies with the mandatory regulatory provisions in Spain laying down health and safety requirements.

Who is responsible for product safety?

Both producers and distributors have a duty to ensure that only safe products are placed on the market and sold. ‘Producer’ can mean the manufacturer, if the manufacturer is established in the European Union, which affixes its name, trade mark or other distinguishing feature to the product, the manufacturer’s authorised representative or other professionals in the marketing chain insofar as their activities may affect the safety characteristics of the product.

Producers and distributors have a number of duties with regard to the products they place on the market. These duties include keeping themselves informed about the compliance of their products with the safety requirements, and acting and informing the authorities, other economic operators and consumers accordingly, where appropriate. They must withdraw any unsafe products from the market, make the necessary corrections to avoid risks, or even recall the products from consumers.

With the entry into force of Regulation (EU) 2023/988 on general product safety , the obligations of all economic operators involved in the marketing chain are extended and new requirements are introduced for providers of online marketplaces.

Which authorities are competent for product safety?

Consumer authorities in the autonomous communities are responsible for ensuring that the duties laid down in Royal Decree 1801/2003 of 26 December on general product safety are properly fulfilled. Given the distribution of these competences, it is the consumer authorities in the autonomous communities that carry out market inspections and checks. They must therefore carry out extensive monitoring of the market to check that products sold on the market and economic operators comply with all the obligations laid down in the applicable legislation.

The autonomous communities’ consumer services act as contact points in relation to general product safety and for the national alert network for non-food products in cases where safety is not regulated by other legislative arrangements for which another authority is exclusively responsible.

As far as central government is concerned, the Directorate-General for Consumer Affairs, under the Ministry of Social Rights, Consumer Affairs and Agenda 2030, coordinates market monitoring authorities and is the national contact point in the European rapid alert system for non-food products (Safety Gate, formerly known as RAPEX), where information is shared with the European Commission and other Member States. It is also responsible for managing the national alert network for non-food products as the national contact point through which information is exchanged between central government and the autonomous communities.

The Directorate-General for Consumer Affairs provides cooperation and technical support to the consumer services of the autonomous communities and other public authorities on official controls or market monitoring of goods and services, with a view to combatting fraud and protecting consumers’ health and safety and economic interests.

The Directorate-General for Consumer Affairs also coordinates Spain’s position and, where appropriate, its representation in matters affecting the protection of consumer rights before the European Union and international organisations.

What action is taken when an unsafe product is identified?

When it is found that a product is likely to pose health and safety risks, it must be prevented from reaching consumers. In order for information to be exchanged effectively, a rapid information exchange system needs to be set up, enabling the information to be disseminated quickly to all the authorities involved. In Spain, there is an alert network for non-food products, which serves to provide notifications of products presenting a serious risk between authorities in the autonomous communities and the Directorate-General for Consumer Affairs under the Ministry of Social Rights, Consumer Affairs and Agenda 2030. A rapid alert system (Safety Gate) operates in parallel, for exchanging information between Member State authorities.

In order to determine whether a product is unsafe, the appropriate checks are carried out to see whether or not it complies with the applicable regulations. If an instance of non-compliance is identified that might pose a risk to consumer safety, restrictive measures (prohibition of placing on the market, withdrawal of stock from the market and recall from consumers) are taken and notified through the national alert network for non-food products and, at European level, through the rapid alert system (Safety Gate).

The alert network is triggered when an authority decides to take restrictive measures against a product due to the risk it poses. Under certain circumstances, a national alert is then escalated to European level.

All information related to the alert network can be found here. 

How is an unsafe product identified?

• By information obtained from market surveillance by the competent authorities.
• By European alert system notifications from other Member States.
• By notifications from the European Commission.
• By information from producers, in accordance with the provisions laid down in Article 6(1) of Royal Decree 1801/2003.
• By information from complaints or reports received from economic operators or industry associations, consumers, consumer organisations, etc.
• By notifications from health professionals via the website of the STATE SYSTEM FOR REPORTING CONSUMER PRODUCT INCIDENTS.

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Information for each Autonomous Community

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