General Product Safety Regulation (EU) 2023/988 (GPSR), which came into force on 12 June 2023, has replaced the General Product Safety Directive and the Food Imitating Product Directive. GPSR covers many safety aspects of consumer products with strict inspection requirements including documentation, test reports, authorized representatives, and so on.

Among those, one critical requirement is that, to place products on the EU market, there should be an EU responsible person in charge of corresponding obligations under GPSR. This obligation will matter to products manufactured by both EU and non-EU companies, as well as also apply to distance sales such as online markets.

Applying from December 2024, this Regulation with reinforced market surveillance rules directly impacts many companies: requirements for products to be legally placed on the EU markets shall be stricter. It is expected that authority inspection, both at the desk and on the field, shall be significantly increased and become a regular practice.

Regarding the proactive preparation of businesses, below are key points derived from the Regulation.

General Product Safety Regulation: Overview

Type of products: consumer products

When applied: from 13 Dec 2024

Where: EU countries (Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden)

Duty holders:

• Manufacturer (EU or non-EU entities)
• Importer (EU entities)
• Distributor (EU entities)
• Authorised representative (EU entities)
• Fulfilment service provider (EU or non-EU entities)

Each of the above duty holders shall be subjected to corresponding tasks under GPSR.

Important: duty holders shall ensure that they have internal processes for product safety that allow them to comply with the relevant requirements of this Regulation. This includes test reports, technical documentation, traceability management, and accident reporting, to name a few.

Objectives:

• Ensuring the safety of all products including those linked to new technologies
• Addressing challenges posed by the growth of online sales in particular via online marketplaces
• Ensuring better enforcement of the rules and more efficient and even market surveillance
• Improving the effectiveness of recalls of dangerous products in the hands of consumers

“Under GPSR, market surveillance is increased to enhance consumer protection”

Safety aspects to be assessed

• Characteristics of the product including its design, technical features, composition, physical & chemical characteristics, packaging, and instruction for assembly, installation, use, and maintenance
• Effects on other products where it is foreseeable that the product will be used with other products
• Effects other products might have on the assessed product when they are likely to be used together
• The presentation of the product, the labeling, any warnings and instructions for its safe use and disposal, and any other indication or information regarding the product
• The categories of consumers using the product
• The appearance of the product where it is likely to lead consumers to use the product in a way different from what it was designed for
• The appropriate cybersecurity features necessary to protect the product against external influences
• The evolving, learning, and predictive functionalities of the product

Standards to confirm compliance

According to Article 7 of GPSR, a product is compliant with the general safety requirement of GPSR if it complies with relevant European standards published in the Official Journal of the European Union.

In case no relevant European standard is available, the product needs to conform to the national standards of the EU country where the product is placed on the market, provided that such law complies with the EU law.

Where the above cases do not apply, according to Article 8, companies are advised to consider the below standards when assessing if the product is safe:

• European standards other than those published in the Official Journal of the European Union
• International standards
• International agreements
• Voluntary certification schemes or similar third-party conformity assessment frameworks, in particular, those conceived to support EU law
• European Commission recommendations or guidelines on product safety assessment
• National standards of the EU countries where the product is made available
• The state of the art and technology, including the opinion of recognized scientific bodies and expert committees
• Product safety codes of good practice in force in the sector concerned
• Reasonable consumer expectations concerning safety
• Safety requirements adopted by the European Commission, where relevant.

Authorized representative under GPSR

As defined by GPSR, an authorized representative is any EU-based natural or legal person who gets a written mandate from an EU or non-EU manufacturer to act on behalf of that manufacturer to fulfill specified tasks corresponding to that manufacturer’s duties under GPSR.

According to Article 10 of the Regulation, the manufacturer’s mandate should allow the authorized representative to perform at least the following tasks:

• provide the authority with all information and documentation necessary to demonstrate the safety of the product in the official language of that authority
• informing the manufacturer when having reason to believe that the product is dangerous
• informing the competent authority about action(s) taken to eliminate risks
• cooperating with the authority on action(s) taken to effectively eliminate risks

In short, authorized representative:

• must be an EU company
• will fulfill GPSR duties on behalf of the manufacturer

Non-EU companies under GPSR

According to Article 16 of the Regulation, products can be placed on the EU market only if there is an EU-based company acting as a responsible person to fulfill regulated tasks set out in Article 4(3) of Regulation (EU) 2019/1020 as well as the following tasks:

• regularly check and ensure the compliance of the product
• provide market surveillance authorities with documented evidence of the checking activities
• contact details of the responsible person shall be indicated on the product or its packaging, the parcel, or an accompanying document.

Therefore, for non-EU companies who would like to legally sell products in the EU, there must be an EU-based responsible person for such products.

Safety Gate

The non-compliance of products under GPSR will be made public & alerted on the Safety Gate system.

This is the EU rapid alert system for dangerous non-food products where each EU national authority and the Commission can quickly exchange information on non-compliant products for collaborative actions.

Safety Gate allows the public to be informed about dangerous products as well as to submit complaints. Providers of online marketplaces can do research regarding products of interest on Safety Gate before placing them on their sales platform.

This system provides an effective and strong tool for communication and alerts on non-compliant products. To maintain a good record on the system and hence the company’s reputation, it is critical that duty holders strictly comply with all obligations applied to them.

Contact our experts for more information about GPSR and let us assist you with your questions and needs.

FAQ

Which products are out of the scope of the General Products Safety Regulation?

Categories of products to which GPSR does not apply:

• medicinal products for human or veterinary use
• food
• feed
• living plants and animals, genetically modified organisms and genetically modified microorganisms in contained use, as well as products of plants and animals relating directly to their future reproduction
• animal by-products and derived products
• plant protection products
• equipment on which consumers ride or travel where that equipment is directly operated by a service provider within the context of a transport service provided to consumers and is not operated by the consumers themselves
• aircraft referred to in Article 2(3), point (d) of Regulation (EU) 2018/1139
• antiques

What are the new key points of GPSR?

GPSR aims at a comprehensive product safety management system on the EU market, therefore several new points have been included:

• Precautionary principle shall be widely applied by all stakeholders for product safety
• Specific product safety obligations for both economic operators and providers of online marketplaces
• Reinforced requirements on traceability for certain products, categories, or groups of products that are likely to present a serious risk to the health and safety of consumers based on statistics or authority decisions.
• List of aspects to be covered when assessing the safety of products, including new technologies
• Accident notification duty to competent authorities where the accident has happened.
• Reinforced market surveillance rules

Specific rules and processes on how to handle product safety recalls