Product Regulation and Safety: Overview (Spain)

Consumer products are highly regulated, which makes product safety and compliance an essential consideration in the global Product development, distribution, and retail process. Product safety regulation typically aims to balance consumer protection with innovation and competition. In Spain, product safety regulation poses a variety of issues that product manufacturers, importers, distributors, and retailers (in principle, where they appear on the labelling of the product), must be aware of when:

• Introducing a new product into Spain.
• Developing a product safety compliance programme.
• Facing a product safety hazard situation.

For example, in Spain, defective products placed on the market give rise to liability, unless the risks of those products were already known by the injured party (the theory of assumed risks). This can apply to manufacturers, importers of products manufactured outside the EU, and the company identified on the labelling of the product or packaging.

This Note discusses:

• The legal and regulatory requirements governing product safety in Spain, including:

1. regulatory agencies;
2. key legislative acts;
3. industry-specific regulation; and
4. basic requirements for compliant products.

• Key compliance considerations related to products imported into, manufactured, or sold in Spain, including:

1. product manufacturing requirements and testing;
2. identifying and addressing key areas of risk;
3. product hazard or defect disclosure requirements; and
4. corrective action.

• Enforcement of product safety issues in Spain, including:

1. sanctions; and
2. penalties

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