On 12 June 2023, the General Product Safety Regulation (GPSR), known as Regulation (EU) 2023/988, entered into force. This new regulation ensures that only safe products are offered to consumers, regardless of the origin of the products and whether they are sold in shops or on online marketplaces. In addition, the GPSR not only ensures that only safe non-harmonised consumer products continue to be placed on the market, but also addresses safety aspects that may not be covered by sector-specific legislation governing harmonized products (e.g., the responsibilities of online marketplaces, obligations in the event of accidents, rights to information, and actions such as product recalls). These rules are enforceable in cases where similar provisions are absent in EU harmonization legislation.

In a nutshell

The new Regulation aims to ensure the safety of the product or risks not regulated in other EU legislation, by:

• taking into account important factors such as the dynamic nature of products and their interconnectedness when assessing consumer product safety;
• improving the conditions for product safety between online and offline sales;
• establishing specific product safety requirements for online marketplaces to protect consumers against dangerous products sold via online marketplaces;
• extending the obligation for all non-harmonised products imported to the EU to have an economic operator in the EU responsible for the product safety issues;
• providing national authorities with necessary tools, thus stepping up their enforcement powers;
• ensuring effective product recalls by requiring direct contact with consumers and standardised recall notices.

Moving from a directive to a common regulation, uniformly applicable across all Member States, offers significant advantages in ensuring the safety of consumer products throughout the European Union.

Important definitions

In Article 3 of the new regulation, there are, among others, the following definitions:

• product: an object, whether or not linked to other objects, which is supplied or provided, whether or not for consideration, including in connection with the provision of a service, which is intended for consumers or which, under reasonably foreseeable conditions, is likely to to be used by consumers even if the product is not intended for them.
• safe product: a product which, under normal or reasonably foreseeable conditions of use, including the actual period of use, poses no risk or only a minimal risk compatible with the product's use and which is considered acceptable and compatible with a high level of protection for the health and safety of consumers.
• authorised representative: means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation.
• economic operator: means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products or making them available on the market in accordance with this Regulation.
• manufacturer: means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under that person’s name or trademark.

Important changes

GPSR repeals and replaces the EU Food Imitation Safety Directive 87/357

The new regulation prohibits the marketing, importation, manufacturing, and exportation of non-food products that resemble or could be regarded as foodstuff, especially by children, and could be potentially placed in their mouths, sucked, or ingested. Such actions could result in serious risks such as suffocation, digestive tract obstruction, or poisoning. Examples of these products include candles, shower gel, and detergents. In accordance with the GPSR, these products will be classified as "dangerous," and may not be placed on, or made available in, the EU market.

Specific rules on product labelling

The products shall clearly and visibly contain the following:

• The manufacturer's name, registered company name, or registered trademark.
• Manufacturer's postal address AND electronic address, and, where different, the postal or electronic address of the single contact point at which they can be contacted. (If the manufacturer is not EU-based, the EU-based economic operator's name, postal address AND electronic address need to be labeled).
• The product type, batch, or serial number to ensure product identification.
• Warnings and age suitability (if applicable). This shall be translated in all languages of the countries where the product will be sold.
• Clear instructions: This shall be translated as well in all languages of the countries where the product will be sold. However, note that this requirement shall not apply where the product can be used safely and as intended by the manufacturer without such instructions and safety information.

The GPSR requires manufacturers to place the labelling information on their products. When the size or nature of the product does not permit the placement of such information, manufacturers should instead put it on the packaging or in an accompanying document.

Specific obligations of providers of online marketplaces related to product safety

(Article 19) When economic operators make products available on the market online or through other means of distance sales, the offer of these products must clearly and visibly contain at least the following information :

a) The manufacturer's name, registered company name or registered trademark as well as the postal address and electronic address where the manufacturer can be contacted, and where different, the postal or electronic address of the single contact point.

b) If the manufacturer is not established in the Union: name, postal address and electronic address of the responsible person within the meaning of Article 16(1) of this Regulation or Article 4(1) of Regulation (EU) 2019/1020.

c) Information that makes it possible to identify the product, including an image of it, its type and any other product designation.

d) any warning or safety information to be affixed to the product or to the packaging or included in an accompanying document in accordance with this Regulation or the applicable Union harmonization legislation in a language easily understood by consumers and determined by the Member State where the product is made available on the market.

Providers of online marketplaces shall designate a single point of contact allowing for direct communication, by electronic means, with Member States’ market surveillance authorities in relation to product safety issues.

Providers of online marketplaces must also register in the Safety Gate Portal and indicate, in the Safety Gate Portal, their single point of contact for the facilitation of communication of information on product safety issues (Article 22).

They have also the obligation to offer a comparable contact point through which consumers can communicate questions on product safety directly and quickly with the provider of the online marketplace.

Providers must also respond to market surveillance instructions within two working days, monitor and take into account notifications in the Rapid Alert System (formerly RAPEX), or inform customers about product recalls and market surveillance authorities about dangerous products and report accidents.

Safety assessment of the product

Before placing products on the market, manufacturers shall carry out an internal risk analysis (safety assessment of the product) and draw up technical documentation containing at least a general description of the product and its essential characteristics relevant for assessing its safety.

(Article 6) When assessing whether a product is safe, the following aspects shall be taken into account.

• Characteristics of the product (design, construction, technical features, instructions, packaging)
• interaction with other products,
• labelling of the product,
• consumer-specific aspects (e.g. consumer groups concerned, gender-specific differences on health and safety),
• the appearance of the product if it is likely to mislead the consumer into using the product in a manner other than that for which it was intended,
• cybersecurity features,
• evolving, learning, and predictive functions of the product.

Technical documentation

For non-harmonised products (e.g. the simple table or chair, the bookshelf, a glass bottle, etc.), manufacturers should draw up technical documentation regarding the products they place on the market, which should contain the necessary information to prove that those products are safe. The technical documentation must be kept up to date, retained for ten years, and made available to the authorities. Importers must ensure compliance with the requirements. The content of the technical documentation will vary from product to product depending on the complexity of the product and the possible risks identified.

In particular, the technical documentation should contain the following:

• a general description of the product;
• essential product characteristics (e.g., composition, design, packaging, technical features, and instructions for assembly, installation, use, and maintenance);
• product-specific risk analysis and adopted solutions for risk mitigation (for complex products or products presenting possible risks, the information to be provided might need a more extensive description of the product);
• list of the relevant European standards or the other elements, as well as the testing reports.

The marketability of a product requires the existence of an economic operator established in the EU

It will be mandatory to have an economic operator based in the EU in order to sell products on the EU market. The European Market Surveillance Regulation (EU/2019/1020) has already implemented this requirement universally for harmonized products, and now it is being expanded to include non-harmonized products as well.

Traceability rules and products identification

There is a new obligation for manufacturers to ensure that their products come with information to identify the product (e.g., batch or serial number), which is easily visible and legible for consumers. For designated products likely to present a serious risk to the health and safety of consumers, the Commission may set up a specific traceability system requiring economic operators to collect and store data.

Available internal communication channels for consumer complaints

Manufacturers are required to provide a complaints portal, for example by telephone, email, website, etc. They must keep an internal record of complaints as well as product recalls and any corrective measures that have been taken.

The internal register of complaints shall only store the personal data that are necessary for the manufacturer to investigate the complaint about an alleged dangerous product. Such data shall only be kept as long as is necessary for the purposes of the investigation and in any event no longer than five years after the data have been entered.

New reporting obligations for accidents and dangerous products

Manufacturers shall notify through the online Safety Business Gateway of any serious accidents that it knows about, or that are reported by other operators or by consumers (for which appropriate communication channels shall be publicly available). Online marketplaces shall also notify through the portal and let the manufacturer know when they are informed of a serious accident.

New requirements for handling product recalls

In case of a product recall or where a safety warning has to be shared with consumers, economic operators, and online marketplaces must notify authorities and all affected consumers. The recall notice must be easily understood by consumers and thus must be available in the language(s) of the Member State(s) where the product has been made available on the market and meet certain requirements in terms of format and content. The Commission will provide a template to facilitate the handling of the rules by economic operators.

For specific products or categories of products, economic operators and providers of online marketplaces shall provide the possibility for consumers to register a product they have purchased in order to be notified directly in the case of a product safety recall or safety warning in relation to that product. Also, economic operators shall offer the possibility to contact consumers in the event of a recall or safety warning.

Remedy in case of a product recall

Economic operators initiating a product recall should offer consumers at least two options repair, replacement, or adequate refund of the value of the recalled product, except where impossible or disproportionate. Offering consumers a choice between remedies can improve the effectiveness of a recall.

Second-hand, repaired, or reconditioned products under certain conditions

The requirements laid down in this Regulation should apply to second-hand products or products that are repaired, reconditioned, or recycled, that re-enter the supply chain in the course of commercial activity, except for those products for which the consumer cannot reasonably expect that they fulfill state-of-the art safety standards, such as products which are explicitly presented as to be repaired or to be reconditioned, or which are made available on the market as collectible items of historical significance.

Waste disposal requirements

The GPSR clarifies that disposal of waste products after a product recall should be carried out with due consideration of the environmental and sustainable objectives set at the Union and national levels. For instance, the waste electrical and electronic equipment (e.g., waste electronic displays or mobile phones) will have to be disposed of in compliance with the provisions of Directive 2012/19 on Waste Electrical and Electronic Equipment, as implemented in the EU member states.

In addition, repair by consumers should only be considered as a possible remedy if it can be carried out easily and safely by the consumer, for instance through the replacement of a battery. Moreover, the repair by the consumer should be without prejudice to consumers’ rights under Directives (EU) 2019/770 and (EU) 2019/771. Therefore, in such situations, economic operators should not oblige consumers to repair a dangerous product.

Entry into force and applicability

The new legislation entered into force on 12 June 2023 and must apply from 13 December 2024.

Member States shall not impede the making available on the market of products covered by Directive 2001/95/EC which are in conformity with that Directive and which were placed on the market before 13 December 2024.

Read the new EU regulation 2023/988