This European Regulation, set to become mandatory in all its facets and directly enforceable across each Member State starting December 13th, 2024, primarily aims to ensure the health and safety of consumers concerning products designed for this demographic.

This objective is one of the fundamental principles of the European Union (EU), focusing on the most vulnerable consumers, such as children, the elderly, or people with disabilities, requiring Member States to have adequate instruments and measures to comply with this Regulation.

After outlining the objective of this European regulation, our discussion shifts to delineating those aspects that, in our assessment, are likely to be of utmost significance to manufacturers and importers.

What is its scope of application?

It will be applicable to products introduced or marketed in the market, unless there exist other specific provisions governing the safety of the products in question.

Therefore, it governs overarching principles, while acknowledging the existence and application of more specialized regulations.

In what cases will the Regulation not apply?

In human or veterinary medicinal products, in food, in feed, in plants and live animals, in animal by-products and derived products, in plant protection products, in equipment on which consumers ride or travel, in aircraft described in specific sections of Regulation (EU) 2018/1139 and in antiques.

Thus, the Regulation will be applicable to products not listed or lacking specific safety regulations.

What is meant by a safe product?

The Regulation defines it as a product that, under normal or reasonably foreseeable conditions of use, presents no risk (or minimal risk) to consumers.

When is a product presumed to be in compliance with the general safety requirement?

When the product complies with European standards on product safety, or in the absence of these standards, complies with the safety standards of the Member State in which it is marketed.

Therefore, the presumption of product safety occurs when it complies with European regulations or, in their absence, those of the Member State in which it is marketed.

However, this presumption does not absolve the manufacturer or importer of their responsibilities for monitoring, controlling, and rectifying any product incidents that may occur.

What obligations do manufacturers have?

Although the Regulation contains numerous obligations, we list those that are most relevant to manufacturers:

  • Ensure that the products have been designed and manufactured in accordance with the general safety requirements of the Regulation.
  • Before introducing their products to the market, they must analyze internal risks and prepare technical documentation with a general description of the products and the essential characteristics necessary to assess their safety.
  • Take corrective measures to ensure that the product complies with safety requirements (including withdrawal or recovery from the market if necessary).
  • Inform operators in the supply chain of any safety problems detected in the manufactured products.
  • Investigate filed complaints and information received about accidents affecting the safety of the products they have marketed, keeping an internal record of product incidents and corrective measures taken.

Additionally, the Regulation allows manufacturers to designate an authorized representative, who will be entrusted with, at least, the following actions: (i) providing all required information and documentation, (ii) alerting the manufacturer to the existence of a hazardous product, (iii) informing the competent national authorities of any measures taken to eliminate risks in the products through the Safety Business Gateway portal, and (iv) cooperating in any activities aimed at eliminating product risks.

What obligations do importers have?

Although the Regulation contains numerous obligations, we list those that are most relevant to importers:

  • Ensure that the product they are introducing into the market complies with the general safety requirements of the Regulation.
  • Refrain from introducing products into the market about which there are suspicions regarding their safety in accordance with the Regulation.
  • Ensure that products are stored or transported without compromising their safety.
  • Collaborate with market surveillance authorities and manufacturers to ensure product safety.

What obligations exist when an accident related to product safety occurs?

The manufacturer will ensure that any accidents caused by a product introduced or marketed in the market are promptly reported through the Safety Business Gateway portal to the relevant authorities in the Member State where the accident occurred.

The Regulation specifies that incidents resulting in death, severe impacts on health and safety—whether permanent or temporary, encompassing injuries, bodily harm, illnesses, and chronic health effects—must be reported.

Importers who become aware of a product-related accident will promptly report it to the manufacturer. The manufacturer will then be responsible for making the necessary notification as required by the Regulation, or may direct the importer to do so.

Regardless of the effective implementation that this Regulation entails, we can conclude that special attention is paid to the actions of product manufacturers and, secondarily, to their importers, with the aim of ensuring that these economic operators guarantee the safety of products when they leave the factory or are introduced into the market, continuously monitoring their safety.

This continuous monitoring translates into proactive action by the manufacturer and, secondly, the importer, in terms of reporting any anomalies that may jeopardize consumer safety or, in the event of risk occurrence, urgently adopting corrective measures to prevent the repetition of similar risks, even going as far as withdrawing the product from the market.

In conclusion, this Regulation represents a general legislative framework that fills gaps and complements existing or future legislation to ensure consumer protection with identical standards for all Member States.

If you have any questions or would like further information, please contact AGM Abogados.

Xavier de Bernat Jiménez

Senior Lawyer