Summary
The General Product Safety Regulation (GPSR) is a new product safety directive that replaced the General Product Safety Directive on 13th December 2024. The regulation applies to all consumer products that don’t fall within the scope of the CE directives. Products that fall under the scope of this regulation do not require a CE Mark to be applied.
Purpose
The GPSR aims to modernise product safety standards, addressing challenges posed by digitalisation and eCommerce. The objectives that regulators are looking to achieve with this change are:
- Ensure the safety of all products, including those linked to new technologies.
- Address the challenges posed by the growth of online sales and eCommerce.
- Enforce the rules around product safety better.
- Implement highly efficient market surveillance.
- Improve product recalls of dangerous products.
Scope
GPSR applies to products that are placed or made available on the market, provided that there are no specific EU laws or directives in place that cover the same safety objectives for the product in question. However, if there are other specific directives or regulations that apply to the product, GPSR only applies to the risks and/or aspects of the product not covered by the regulations and directives that already apply.
There are several product categories that are excluded from GPSR, these include:
- Medicinal products for human or veterinary use.
- Food
- Animal Feed.
- Living Plants.
- Animals, genetically modified organisms, and related reproduction materials.
It is also important to note that the regulation also excludes; animal by-products, pesticides, transport equipment operated by service providers (for example, public transport vehicles), specific aircraft, and antiques.
The regulation covers products of all conditions such as new, used, repaired, or reconditioned products that are sold or made available on the market. Although, products that are intended for repair or reconditioning before consumer use are excluded if they are clearly marked as such.
Penalties
The penalties associated with GPSR are the responsibility of the member states where the regulation is applicable. This means that the penalty for non-compliance may vary depending on the market that the product is being sold in.
However, the regulation does state that the penalties should be “effective, proportionate and dissuasive”.
Safety Requirements
GPSR outlines comprehensive safety requirements for consumer products within the EU. The regulation sates that economic operators (this includes manufacturers, importers, distributors, and online marketplaces) must ensure that ONLY safe products are placed or made available on the market.
The safety assessment for GPSR considers factors such as; the design of the product, technical features, product composition, the packaging that product comes in, instructions, as well as the product’s effects on other products.
Obligations on all suppliers
This regulation mandates that suppliers ensure that their products are safe prior to making them available on the market. Suppliers must also provide consumers with all necessary and relevant information to ensure safe use of their products and remain informed of potential risks associated with the product.
GPSR also states that if a supplier becomes aware that a product on the market is unsafe, they are obligated to immediately notify the appropriate authorities. They must also cooperate with the relevant authorities when requested to ensure an effective recall, or other action, of the product(s) in question.
The relevant authorities that will be involved in this situation will vary depending on the product and the market it is being sold in but, in most cases, is the local authority.
Obligations on manufacturers
Manufacturers have specific obligations under GPSR to ensure consumer product safety within the EU, these obligations include:
- Ensuring Product Safety – Manufacturers must ensure that they design and produce products that are safe for consumer use and take into consideration factors such as product characteristics, instructions, and potential risks.
- Conducting Risk Assessments – Manufacturers are required to perform internal risk assessments as well as maintain technical documentation in order to demonstrate compliance with the safety requirements of the regulation.
- Providing Safety Information – Clear instructions and safety information must accompany the product to inform consumers about proper usage and potential risks.
- Ensuring Traceability – Manufacturers must include their contact details on products and ensure traceability throughout the supply chain of the product.
- Monitoring & Reporting – Manufacturers should monitor products on the market, maintain and keep a record of complaints, and inform authorities promptly if a product is found to be dangerous.
- Taking Corrective Actions – If a product is found to be unsafe, manufacturers must implement corrective measures, including but not limited to recalls and implementing remedies to consumers.
For further information on the obligations of Manufacturers please see Article 9 of the Regulation.
Obligations of importers & distributors
Similarly to manufacturers, importers and distributors also have specific obligations that are outlined under GPSR to ensure the safety of consumer products.
Obligations of importers
- Product Compliance – Importers must ensure that products comply with the product safety requirements and are accompanied by instructions and safety information before placing them on the market. They should refuse to market any product that does not meet the standards outlined by the General Product Safety Regulation.
- Traceability Information – Importers are also required to provide their contact details on products that they place on the market and verify that the products are accompanied by clear instructions and safety information.
- Product Handling – Importers must take responsibility for the items during transport and storage to prevent any safety issues.
- Incident Reporting – In an importer believes that a product is unsafe for consumers, they are obligated to inform the manufacturer and national market surveillance authorities through the Safety Business Gateway and ensure the public is alerted.
Obligations of distributors
- Verification of Compliance – Distributors must ensure that manufacturers and importers have complied with the requirements of the regulation. They should also refuse to market any product that does not meet the GPSR standards.
- Product Handling – Distributors must take responsibility for the items during transport and storage to prevent any safety issues.
- Incident Reporting – Similarly to importers, distributors must inform the manufacturer and national market surveillance authorities through the Safety Business Gateway and ensure the public is alerted if they believe that a product is unsafe for consumers.
For further information on the obligations of Importers and Distributors please see Articles 11 & 12 of the Regulation.
Obligations of online marketplaces
The obligations of online marketplaces under GPSR are:
- Establishing Points of Contact – Online marketplaces must implement two single points of contact; one for direct communication with market surveillance authorities and other for the public.
- Registration with Safety Gate Portal – Online marketplaces are required to register with the Safety Gate portal to facilitate the exchange of information in regards to any products that may be unsafe for consumers.
- Internal Product Safety Processes – Online marketplaces must have internal processes that ensure product safety as well as enable prompt compliance with the requirements of GPSR.
- Ensuring Minimum Product Information – Online marketplaces must ensure that product listings are not published without the minimum required product safety and traceability information provided by the relevant trader.
- Random Safety Checks – Online marketplaces are obligated to conduct random product safety checks utilising public databases in accordance with the Digital Services Regulation (EU) 2022/2065. Under GPSR these must include the Safety Gate portal.
- Timely Responses to Orders & Notices – If an online marketplace is issued a third-party notice or government order, they must react promptly and ensure that any listings that are removed due to product safety concerns do not reappear.
- Consumer Notification in Case of Recalls – If a product recall takes place, online marketplaces are required to inform all affected consumers directly and publish any relevant details on their website.
- Cooperation with Authorities – In the event of a product recall or accident, online marketplaces must inform the relevant economic operator and cooperate with market surveillance authorities.
Summary observations
- Only applicable to products used by consumers, whether they were intended for consumers or not.
- It either applies entirely (if no CE marking directives apply) or partially (if CE marking directives do apply); either way, the GPSD applies to all products used by consumers.
- Applies to all suppliers, e.g. manufacturers, importers, retailers, distributors, those who rework, repair or modify, service providers etc., but only if they are supplying a product as part of a commercial activity. It does not apply to personal transactions.
- Unlike the CE marking directives, it provides enforcement authorities with powers to deal with any supplier within their own country, not just the manufacturer.
- The maximum penalties are higher than those of the CE marking directives.
Useful Links
Further advice
As with all legislation, the actual requirements for any piece of equipment under the regulation are complex and dependent on not only the design but also the type of user, the intended use and what is claimed in the instructions or sales literature.
