What is the GPSR? 

The General Product Safety Regulation (GPSR) is a comprehensive update to the EU’s product safety laws and has been in effect on December 13, 2024, replacing the General Product Safety Directive (GPSD) and the Food Imitating Product Directive.

The Regulation revises product safety standards by amending EU Regulation No 1025/2012 and Directive 2020/1828 and repealing the General Product Safety Directive 2001/95/EC (GPSD) and Directive 87/357/EEC. It establishes requirements for ensuring consumer products are safe, defines the responsibilities of Market Surveillance Authorities (MSAs), and introduces rules for sharing product safety information. This Regulation will directly apply to EU and Northern Ireland (NI).

The GPSR requires that all consumer products on the EU markets are safe, and it establishes specific obligations for businesses to ensure it.

The GPSR provides a safety net for non-food products or risks not regulated in other EU legislation. This safety net function means that EU consumers are always protected against dangerous products, be it now or in the future.

Read more: EU's General Product Safety Regulation (GPSR): A New Era of Consumer Protection

What are the objectives of GPSR?

• Ensuring the safety of all products, including those linked to new technologies. 
• Addressing challenges posed by the growth of online sales and in particular via online marketplaces. 
• Ensuring a 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.

What products are covered in the scope of the GPSR?

The regulation applies to new, used, repaired or reconditioned products:

• available for distribution, consumption or use in the EU (‘placed or made available on the market’), whether for free or against payment, which are not covered by other specific EU product safety legislation,
• subject to existing specific EU safety requirements regarding the risks and aspects that are not already covered therein;

The main industries that must comply with the GPSR include, but are not limited to:

• Electronics and Electrical Appliances: This includes household appliances, personal gadgets, and other electronic devices frequently used by consumers.
• Toys and Children's Products: Manufacturers of toys and other products specifically designed for children must adhere to strict safety standards to protect young users.
• Furniture and Home Goods: Furniture, home décor, and other household products must be safe and suitable for everyday use.
• Textiles and Apparel: Clothing, bedding, and other textile products must be free of harmful substances and safe for consumer use.
• Cosmetics and Personal Care: Cosmetics, skincare, and hygiene products must meet safety requirements to ensure they pose no harm to consumers.
• DIY and Gardening Products: Tools, equipment, and products for home improvement and gardening must be safe for consumer use.
• Automotive and Transportation Products: Items such as child car seats, accessories, and other related products must meet safety standards.
• Sports and Recreational Goods: Equipment and products used for sports and leisure must be safe and designed to minimize the risk of consumer injury.
• Medical Devices: Although medical devices are generally subject to specific regulatory frameworks, the general safety principles under the GPSR may still apply to ensure consumer protection.
• Household Chemicals and Detergents: This includes cleaning agents, disinfectants, and other chemicals used in the home.
• Food Contact Materials: Such as straws, cups, and food packaging materials.
• Other General Consumer Products: In addition to the categories listed above, other general consumer products not specifically regulated by sector-specific legislation also fall under the scope of the GPSR—for example, glue, adhesive tapes, candles, fragrance products, leather care items, and jewelry.

Exempted products:

• medicinal products for human or veterinary use,
•  food and feed,
• living plants and animals, genetically modified organisms and microorganisms in contained use,
• animal-derived and by-products,
• plant protection products,
• transport equipment operated by a service provider,
• low-risk aircraft,
• antiques,
• products clearly marked to be repaired or reconditioned prior to use.

Safety requirements of the GPSR

Economic operators will place or make available on the market only safe products (general safety requirement).

The safety of products must be assessed, taking into account, in particular, the following criteria:

• the characteristics of the product, such as design, technical features, composition, packaging and instructions;
• the effect on other products;
• the presentation of the product, the labelling, any warnings and safety instructions and information;
• the categories of consumers using the product;
• the appearance of the product, in particular food-imitating or child-appealing aspects;
• the cybersecurity features and any evolving, learning and predictive functionalities of the product.

This regulation also provides for cases where a product is presumed to be safe. Such cases include products in conformity with relevant European standards referenced in the Official Journal of the European Union.

Other elements that can be taken into account for assessing the safety of a product are national and international standards, voluntary certification schemes, good-practice codes and reasonable consumer expectations.

Requirement to have a responsible economic operator in the EU

For each product covered by the regulation, there has to be a responsible economic operator in the EU (an EU manufacturer, importer, authorised representative or a fulfilment service provider) entrusted with tasks relating to the safety of the product.

Main obligations of manufacturers:

• ensure products are safe by design;
• carry out internal risk analyses and draw up relevant technical documentation;
• act immediately and inform consumers and national authorities, through the Safety Business Gateway, if they believe a product on the market is dangerous;
• share information on accidents;
• provide essential product safety and traceability information on products or their packaging;
• provide contact details to receive complaints, investigate them and keep an internal register of complaints received.
• Manufacturers may appoint an authorised representative to carry out their obligations.

Main obligations of importers:

• ensure products comply with the regulation’s general safety requirement, refusing to place on the market any they consider do not meet this requirement;
• provide their contact details on the products and check that they are accompanied by clear instructions and safety information;
• take responsibility for the items in their care during transport and storage;
• inform manufacturers and national market surveillance authorities, through the Safety Business Gateway, if they believe a dangerous product is on the market and ensure the public is alerted.

Main obligations of distributors:

• ensure manufacturers and, where applicable, importers comply with the regulation’s requirements, refusing to place on the market any they consider do not meet these requirements;
• inform manufacturers, importers and national surveillance authorities, through the Safety Business Gateway, if they believe a dangerous product is on the market and ensure suitable action is taken.

Economic operators' horizontal obligations:

• establish internal product safety processes to comply with the regulation;
• cooperate with market surveillance authorities to eliminate or mitigate risks from any products they place on the market;
• on request by authorities, provide specific product information (risks, complaints, corrective measures) for 10 years and supply chain traceability information for 6 years;
• inform authorities about accidents caused by a product;
• provide data to a traceability system the European Commission may establish to store details of products likely to present a serious risk to public health and safety;
• directly inform all affected consumers about product safety recalls and safety warnings, in the case of product recalls using a mandatory recall notice template;
• offer consumers the choice of at least two of the following remedies when a product is recalled: either repair or replacement of the product or an adequate refund;
• follow specific rules for distance sales by giving details, as part of the pre-contractual product offer, of the manufacturer or their representative, a clear description of the product and any warning or safety information, as in a brick-and-mortar shop.
• Specific product safety obligations of providers of online marketplaces

The following product-specific obligations build on the horizontal requirements of the Digital Services Act:

• implement two single points of contact for direct communication on safety issues: one for market surveillance authorities, the other for the public;
• register with the Safety Gate portal;
• have in place internal product safety processes;
• ensure that without the minimum product safety and traceability information, to be provided by the relevant trader, a listing cannot be published (compliance by design obligation);
• check at random whether products offered are safe by using public databases, including the Safety Gate portal;
• react within a short deadline to governmental orders and third-party notices and ensure that listings that were taken down cannot reappear;
• supply appropriate and timely information to consumers when a product is recalled by directly contacting all who bought the item on their site and publishing details on their web page;
• inform, in the event of a recall or an accident, the relevant economic operator and inform and cooperate with market surveillance authorities.

What is meant by a technical file and what should it contain?

The technical file is a comprehensive set of documents that manufacturers must compile to demonstrate that their products meet safety requirements. This file is crucial for ensuring compliance with the GPSR and must be maintained and updated throughout the product lifecycle. and it should contain all the relevant information on the design, manufacture and operations of a product being placed on themarket.

Here are the key components typically included in a technical file.

• General Description:This section provides a comprehensive overview of the product. It includes the manufacturer’s name and address, or those of any authorized representatives, and identification of the product, such as the product’s serial number. It shouldalso cover the product’s design, materials, intended use, and essential safety characteristics. For example, in the case of footwear, this might include details about the materials used for the sole and upper parts, and any safety features like non-slip soles. It should highlight any features that are relevant to the product’s safety.
• Risk Analysis: This involves identifying potential hazards associated with the product and assessing the risks they pose to users. The analysis should include both foreseeable and unforeseeable risks. Measures taken to eliminate or mitigate these risks should be documented. For instance, for apparel, this might involve assessing risks related to flammability, chemical exposure from dyes, or choking hazards from small parts.
• Test Reports: These are the results from any safety tests conducted on the product. Thetests should be relevant to the identified risks and comply with applicable standards. For example, test reports for footwear might include slip resistance tests, while apparel might require tests for flammability.
• Standards Compliance: This section lists the European standards or other criteria that the product complies with. Compliance with these standards often provides a presumption of conformity with the GPSR. For example, compliance with EN 14682 and CEN/TR 16792 for children’s clothing safety.
• Instructions and Labels: Copies of any labels and instructions for use provided with the product should be included if applicable. These warnings and documents are crucial for informing consumers about the safe use of the product. Labels might include information on care instructions, size, and safety warnings, while instructions for use might detail how to properly wear or maintain the product.
• Traceability Information: This includes details that allow the product to be traced back through the supply chain. It might involve batch numbers, supplier details, and manufacturing dates. This information is essential for managing recalls and ensuring accountability

FAQs

Q1. Do I need to label the product with any specific details?

Yes, the product must have full traceability either on the product itself, or where this is not possible, its packaging or accompanying documents.

Details to include are;

  • Product Identification

      o Type, batch, or serial number (or equivalent identifier).

  • Manufacturers identification

      o Name, trade name/trademark, postal and electronic address.

      o If applicable, contact details for a single contact point (If different from the above)

  • Instructions and Safety Information

      o Clear instructions and safety information in the relevant language for the Member State where the product is marketed.

      o Exceptions apply if the product can be safely used without such information

For products manufactured outside the EU, if a contact point exists within the EU in the form of an economic operator other than the manufacturer, both the manufacturer's details and the contact point information must appear on the product or its packaging

Q2. Do I need to be established in the EU?

No, but you must have an authorised representative who can act on your behalf and has received a written mandate from you to do so.

Q3. What are the obligations of an authorized representative?

The authorised representative’s responsibilities are defined in the mandate provided by the manufacturer. The representative must provide a copy of the mandate to market surveillance authorities upon request.

The mandate must include at least the following tasks:

Providing Information to Authorities:

  • Upon a reasoned request from a market surveillance authority, the authorised representative must:

      o Provide all necessary information and documentation demonstrating the product’s safety.

      o Use an official language that the authority can understand.

Reporting Dangerous Products to the Manufacturer:

  • If the authorised representative considers or has reason to believe that a product is dangerous, they must:

      o Inform the manufacturer.

Notifying Authorities of Risk Elimination Actions:

  • The representative must inform competent national authorities via the Safety Business Gateway about any action taken to mitigate risks posed by products under their mandate. This applies when:

      o The manufacturer has not already provided the information.

      o The representative acts upon the manufacturer’s instructions.

Cooperation with National Authorities:

  • The representative must cooperate with competent national authorities at their request to ensure effective risk mitigation for products under their mandate. The obligations ensure that authorised representatives act as a reliable link between manufacturers and regulators, particularly when manufacturers are located outside the EU. They help uphold product safety standards and facilitate compliance with regulatory requirements.

Q4. Do I need to create a declaration of conformity?

There is no requirement to create a declaration of conformity under the GPSR but one can be created if you are sure that you have fulfilled all your obligations in placing only safe products on the market. 

Q5. What about the CE mark?

The GPSR does not require the CE mark to be affixed to products. However, if any function of the product is covered by a directive or a regulation, for example, Directive 2009/48/EC, the Toy Safety Directive (TSD), then CE marking requirements will still be applicable.

Q6. What about instructions for use?

Instructions for use must be provided with the product as soon as they are necessary to enable safe use. It should always be remembered not everyone has access to the internet and so there should always be the facility for them to receive instructions in paper format.