Important changes this year for importing goods from outside the EU

The new European Product Safety Regulation, which affects importers and manufacturers will be mandatory for all Member States as of December 13, 2024. It seeks the objective of guaranteeing the health and safety of consumers when purchasing any type of item and the entry of dangerous products into European territory is limited, in addition to preparing the ground – still to be developed – for the Digital Product Passport, an element that will serve to investigate their traceability.

The experts consulted point out that this regulation will affect those online or physical businesses that buy products in third countries (those outside the EU), and especially where the price is very cheap, and they obtain large margins by selling them in Europe.

Thus, these measures seek to protect consumers, with special attention, as explained by Xavier de Bernat, lawyer in the Litigation and Arbitration area of ​​AGM Abogados, to the most vulnerable, such as children, the elderly, or people with disabilities. In addition, equal conditions of competition will be established in the territory, which EU states must comply with through appropriate instruments.

This regulation will apply to new, used, repaired, or reconditioned products, as well as all items offered to EU consumers through all sales channels – with the exception of medicines, food, feed, plants and plant protection products, among others-.

Those companies or self-employed workers who import items for sale in Spain or Europe must adapt to regulation 2023/988 before December of this year.

According to the regulations, a product that is considered dangerous in one EU Member State will be considered the same in all the others, so it is important for companies and self-employed workers who import products for sale – for example, those who purchase items or materials from countries outside the EU for subsequent sale – that comply with the regulations before the indicated date.

This regulation applies to all products marketed in the EU that do not already have a specific regulation, excluding:

• Medicines for human or veterinary use.
• Food and feed.
• Live plants and animals, genetically modified organisms and microorganisms in confined use.
• Animal by-products and derived products.
• Phytosanitary products.
• Transportation equipment managed by a service provider,
• Aircraft whose design, production, maintenance and operation entail a low safety risk.
• Products that clearly indicate that they must be repaired or reconditioned before use.

What requirements will the products imported have to have to be considered safe?

The regulation understands a “safe product” as any product that, under normal or reasonably foreseeable conditions of use, “including the actual duration of use, does not present any risk or only minimal risks”, compatible with the use of the article or object and considered acceptable. within a high level of protection of the health and safety of consumers”, as the lawyer clarified.

This implies certified health, safety, environmental and technical requirements, depending on the product, which must sometimes carry the European CE label. To facilitate this procedure, the EU has enabled a guide for the importation of products in its Electronic Office, which includes information, references and links intended for this purpose, as well as guidelines regarding its specific requirements.

Parallel to the application of this regulation, there is the implementation of a key element for analysing the traceability of products. This is the development and implementation of the Digital Product Passport – which the European Commission announced in December 2023 -. to “increase transparency” between the supply chain and consumers. According to the Commission itself, it is possible that its use “will contribute to facilitating the control and application of regulations by the authorities of the EU and the Member States”, as well as providing “a market intelligence tool that can be used to review and refine obligations in the future.

According to the OCU consumer association, it is an electronic record with detailed information that accompanies the product throughout its life cycle and where all its characteristics and environmental information are specified, which allows its exhaustive traceability in order to identify problems, eliminate them and act preventively, allowing access through electronic means.

Currently, the data requirements for each group of articles or subjects are being determined, and their implementation is expected soon, although the OCU warns that the proposed definition is, for the moment, “ambiguous and not very detailed” , and there is no exact dates established.

What information should a product include for it to be safe?

The general security requirement will be evaluated taking into account, in particular, the following criteria:

• The characteristics of the product, such as its design, technical characteristics, composition, packaging and instructions.
• Its effect on other products.
• Its presentation, labelling, any warnings and instructions and information relating to safety.
• The categories of consumers who are going to use the product.
• The appearance of the product; in particular, aspects related to food imitation or appeal to children.
• The cybersecurity features and any evolution, learning and prediction functionality of the product.

It will apply to products that are introduced or marketed on the market “when there are no other more specific provisions that regulate this matter in that type of specific articles,” Bernat clarified.

What obligations must importers comply with?

Starting in December, all companies and self-employed workers who import products from outside the European Union will have to ensure that they comply with the general safety requirement of the regulation, that is, “refusing to place on the market any product that entails risks to the safety of the consumers”. To do this, they will have to:

• Provide your contact information on articles and ensure that they are accompanied by clear instructions and provided with information related to safety.
• Take responsibility for the objects in your charge during transportation and storage.
• Inform manufacturers and national market surveillance authorities, through the Safety Business Gateway portal, when they are about to purchase a product and identify its danger.
• When products that do not comply with regulations are identified, ensure that the public is notified.
• Ensure that the product you are going to introduce on the market meets the general safety requirements of the regulation.
• Refrain from introducing products on the market whose safety is suspected in accordance with the regulations.
• Ensure that products are stored or transported without compromising their security.
• Cooperate with market surveillance authorities and the manufacturer to ensure safe manufacturing.

Companies will have to report security incidents

According to the regulations, companies and self-employed workers must notify, through the Safety Business Gateway portal, incidents caused by the introduction or marketing of an unsafe article through the authorities of the Member State. In addition, companies and self-employed workers will also have to inform the manufacturer, according to the regulations.

In addition, the regulation clarifies, as Bernat explained, that it will have to specify what type of incident it is. For example, the death of a person or serious effects on their health and safety, permanent or temporary, including injuries, other bodily harm, illnesses and chronic consequences.

Regardless of the effective application that this regulation entails, as Bernat explained, emphasis is placed on the actions, not only of the manufacturer, but “also of the importers”, so that both operators guarantee safety continuously, especially in cases when it is necessary to remove the items from the market.

The European Commission will impose high sanctions on businesses that fail to comply with the regulation

Although the Commission has yet to evaluate the application of the established sanctions that will be applied as set out in the regulation, it will adopt a legislative proposal in relation to these sanctions that will have a “deterrent effect”.

Thus, according to European regulations, when irregularities are detected, “the imposition of effective, proportionate and dissuasive administrative and financial sanctions will be applied in cases where appropriate”, aimed primarily at avoiding “the introduction of dangerous products into the European market.

When there are, they will be appropriate to the seriousness of the infringement, as well as the magnitude of the injuries or damages suffered by the consumer.

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