Product Safety Directive before replacement

On 23 May 2023, the new Product Safety Regulation (GPSR) was published in the EU Official Journal. This means that nothing more stands in the way of the amendment of general product safety law, which will lead to the replacement of Directive 2001/95/EC (so-called General Product Safety Directive) and thus in large parts also of the German Product Safety Act (ProdSG). The GPSR is intended to ensure that only safe non-harmonised consumer products continue to be placed on the market. Particularly due to the advancing digitalisation of products and distribution channels, the European legislator has had to react and has provided for a large number of changes to general product safety law.

The GPSR establishes the framework for the safety of non-harmonised consumer products and also applies in part to the harmonised area (cf. e.g. Art. 19, 20, 22 GPSR and Chapter VIII). The GPSR thus serves to strengthen technical consumer protection. At the same time, the innovations of the GPSR pose challenges for economic operators in ensuring product compliance.

In detail, the following innovations and special features should be highlighted:
 

I. Extension of the personal scope of application: fulfilment service providers and providers of online marketplaces

As in market surveillance law and the ProdSG, fulfilment service providers within the meaning of Art. 3 No. 12 GPSR are economic operators pursuant to Art. 3 No. 13 GPSR. However, the GPSR (in contrast to § 6 para. 6 ProdSG) does not specify any specific obligations of the fulfilment service provider.

What is new is the inclusion of providers of online marketplaces in the personal scope of application. Due to the broad definition according to Art. 3 No. 13 GPSR, there is much to be said for including them among the economic operators, as they are subject to obligations according to Art. 22 GPSR.
 

II. New assessment criteria for the safety of products

The EU legislator has established new criteria for assessing the safety of products. In doing so, special attention has been paid to elements of smart products that have not yet been included in harmonisation legislation and will therefore also apply in the harmonised area. The extensive catalogue in Art. 6 GPSR essentially comprises the following assessment criteria:

• Characteristics of the product (design, construction, technical features, instructions, packaging), Art. 6 para. 1 lit. a) GPSR
• interaction with other products, Art. 6 para. 1 lit. b), c) GPSR
• labelling of the product, Art. 6 lit. d) GPSR
• consumer-specific aspects (e.g. consumer groups concerned, gender-specific differences on health and safety), Art. 6 para. 1 lit. e) GPSR
• 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 (Art. 6 para 1 lit. f) GPSR)
• cybersecurity features (Art. 6 para. 1 lit. g) GPSR)
• evolving, learning and predictive functions of the product (Art. 6 para. 1 lit. h) GPSR)
   

III. Obligation of the manufacturer to carry out an internal risk analysis

Manufacturers are obliged to carry out an internal risk analysis for each product without exception and to prepare technical documentation containing at least a general description of the product and its essential characteristics relevant for the safety assessment (Art. 9 para. 2 subpara. 1 GPSR). There is no minor clause that excludes less complex trivial products. Depending on the product risks, the manufacturer’s programme of obligations may become more stringent (Art. 9 para. 2 subpara. 2 GPSR). The manufacturer must keep the technical documentation for ten years (Art. 9 para. 3 GPSR).
 

IV. Substantial product change

Following the Blue Guide, Art. 13 para. 3 GPSR provides the legal practitioner with criteria for determining a substantial change to a product. According to this, a physical or digital modification of a product is considered to be substantial if it affects the safety of the product and

• alters the product in a way that was not envisaged in the original risk assessment of the product;;
• the nature of the hazard has changed, a new hazard has arisen or the level of risk has increased as a result of the change; and
• the changes have not been made by or on behalf of consumers for their own use.

The person who substantially alters the product is deemed to be the producer and enters into the producer’s obligations (Art. 13 para. 2 GPSR). Although not explicitly mentioned, the assumption of the role of manufacturer logically presupposes that the product is placed on the market again.
 

V. Linking the marketability of all consumer products to the existence of an EU economic operator

In future, the marketability of non-harmonised consumer products will also be linked to the existence of a so-called EU economic operator (Art. 16 para. 1 GPSR). For harmonised products, a corresponding regulation was already introduced with Art. 4 para. 1 of Regulation (EU) 2019/1020 (so-called EU Market Surveillance Regulation). The EU economic operator, who is usually the importer in the case of products from EU third countries, is subject to testing and labelling obligations (cf. Art. 16 para. 2, 3 GPSR).
 

VI. Traceability requirements

The GPSR opens up the possibility for the Commission to establish a traceability system. This is intended to facilitate the tracing of products that pose a serious risk to the health and safety of consumers (Art. 18 para. 1 GPSR). The central aspect will be the collection and storage of data by electronic means that can be used to identify the product, its components or the economic operators involved in its supply chain (Art. 18 para. 2 GPSR). The Commission is given the power to further develop the system, in particular to define the products covered (Art. 18 para. 3 GPSR).
 

VII. Reporting obligations in the event of accidents

Art. 20 GPSR sets out the obligations of economic operators in the event of accidents related to the safety of products. It is the primary responsibility of the manufacturer to report a product-related accident resulting in death or harm to health without delay (as soon as it becomes known) to the competent authorities of the Member State in which the accident occurred. The notification is made via the so-called Safety Business Gateway (Art. 20 para. 1 GPSR). Pursuant to Art. 20 para. 3 GPSR, importers and distributors must report such incidents to the manufacturer, who must then fulfil his obligation under Art. 20 para. 1 GPSR. If there is no manufacturer established in the Union, the EU economic operator must ensure notification (Article 20 para. 4 GPSR).
 

VIII. Special requirements and obligations in distance selling

The GPSR lays down special rules for the making available of products through distance selling channels. Consumer products are deemed to be made available on the market if they are offered for sale to consumers in the Union online or via other distance selling channels (Art. 4 GPSR). This creates a parallel to the provision fiction in market surveillance law according to Art. 6 of Regulation (EU) 2019/1020.

In addition, the GPSR imposes special information obligations on economic operators in distance selling pursuant to Article 19 of the GPSR. Accordingly, the following information must already be provided at the time of the offer:

• Manufacturer identification: indication of the name, registered trade name or registered trade mark as well as the postal address and e-mail address.
• Identification of the so-called EU economic operator (if the manufacturer is located outside the EU): Indication of the name as well as the postal address and e-mail address.
• Identification marking: product image and type and other product identifiers
• any warnings or safety information
   

Providers of online marketplaces are now also subject to these obligations. They must, for example, independently of other obligations of economic operators, designate a central contact point through which the market surveillance authorities can communicate with them. The providers must also register with the safety gate portal and store the details of this contact point there (Art. 22 para. 1 GPSR). Finally, they have 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 (Art. 22 para. 2 GPSR). Furthermore, they are subject to organisational obligations (Art. 22 para. 3, 10 GPSR) as well as extensive reporting and cooperation obligations vis-à-vis the market surveillance authorities (Art. 22 para. 4 et seq. GPSR), so that they contribute to ensuring product safety.

Providers of online marketplaces are now also subject to these obligations. They must, for example, independently of other obligations of economic operators, designate a central contact point through which the market surveillance authorities can communicate with them. The providers must also register with the safety gate portal and store the details of this contact point there (Art. 22 para. 1 GPSR). Finally, they have 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 (Art. 22 para. 2 GPSR). Furthermore, they are subject to organisational obligations (Art. 22 para. 3, 10 GPSR) as well as extensive reporting and cooperation obligations vis-à-vis the market surveillance authorities (Art. 22 para. 4 et seq. GPSR), so that they contribute to ensuring product safety.
 

IX. Concrete requirements for consumer information

Economic operators and providers of online marketplaces must ensure that all affected consumers they can identify are informed directly and without delay about product recalls and other safety-related issues. If they collect personal data within the meaning of Art. 4 No. 1 Regulation (EU) 2016/679 (so-called General Data Protection Regulation), this information must be used for recalls and safety warnings (Art. 35 para. 1 GPSR). Moreover, according to Art. 35 para. 2 GPSR, economic operators are obliged to offer their customers the possibility to store separate contact details for safety purposes only. For certain products, more extensive registration options may also be made mandatory (Article 35 para. 3 GPSR).

Following on from Art. 35 GPSR, Art. 36 GPSR sets out detailed requirements for the design of a recall notice, which must be addressed to consumers in writing in the event of a recall. The recall notice must be formulated in a language that is easy for the consumer to understand and must meet certain requirements in terms of format and content (Art. 36 para. 2 GPSR). The Commission will provide a template to facilitate the handling of the rules by economic operators (Art. 36 para. 3 GPSR).
 

X. Obligation of the economic operator to remedy the situation in the event of a product recall

Although heavily criticised by the business community, the provision from Art. 37 GPSR was retained, which obliges economic operators to provide remedies to consumers in the event of a product safety recall. Without prejudice to civil claims, the economic operator responsible for the recall must proactively offer two of the following remedies free of charge to affected consumers:

• Repair of the recalled product,
• replacement of the recalled product with a safe product of the same type and of at least the same value and quality; or
• reasonable reimbursement of the value of the recalled product, provided that the amount of the reimbursement is at least equal to the price paid by the consumer.
   

This provision, framed as a regulatory obligation on economic operators, undermines the warranty law regime and, in a sense, creates an endless product safety law warranty right in the event of recall. This is likely to affect the prices of consumer products and the design of product liability and recall insurance.
 

XI. Future prospects

The GPSR came into force on 12 June 2023. After a transitional period of 18 months, during which non-harmonised consumer products may continue to be made available on the market in accordance with Directive 2001/95/EC or the ProdSG (see Art. 51 GPSR), it will apply directly in every Member State. This date of application is planned from 13.12.2024. The GPSR triggers a need to adapt the ProdSG, the scope of which will focus on non-harmonised B2B products in future. Translated with DeepL.com (free version)
 

Product Safety Regulation - Download (English)

On 23.5.2023, the new Product Safety Regulation was published in the EU Official Journal. You can open and download the full text of the legislation via the following link:

Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety
 

Amendments and corrections

Regulation (EU) 2024/2748 was published in the Official Journal of the European Union on 8 November 2024 and supplements the Product Safety Regulation with emergency procedures for times of crisis. It facilitates the rapid placing on the market of important products in order to support the internal market and to close supply gaps in the event of a crisis.

Rules for the application of the GPSR

• With the Implementing Regulation (EU) 2024/1435, the EU Commission established a template for a recall notice in accordance with Art. 36 para.3 GPSR. Details of this publication can be found in the short article standardised template for a recall notice.
• On 24 June 2024, the Commission Implementing Regulation (EU) 2024/1740 with rules for the application of the GPSR was published in the Official Journal of the EU. It lays down, inter alia, the arrangements for the provision of information by consumers and other interested parties to the Commission on products that may present a risk to the health and safety of consumers and for the transmission of such information to the competent national authorities.
• On 10 October 2024, the roles and tasks of the central national contact points of the ‘Safety Gate’ rapid alert system within the meaning of the Product Safety Regulation (EU) 2023/988 were published in the Implementing Regulation (EU) 2024/2639. This system enables the rapid exchange of information within the EU on dangerous products and product safety measures taken.
   

Do you have any questions about this news or would you like to discuss it with the author? Please feel free to contact: Dr. Gerhard Wiebe