GPSR Certification

Regulation (EU) 2023/988, known as the General Product Safety Regulation (GPSR), sets stricter safety requirements for consumer products sold in the EU. It replaces Directive 2001/95/EC and introduces new responsibilities for manufacturers, importers, distributors, fulfillment service providers, and online marketplaces to ensure product safety.

Scope of the GPSR

Effective from December 13, 2024, the GPSR applies to all products placed on the EU market, irrespective of the sales channel, encompassing both physical stores and online platforms. The GPSR applies to most consumer products in the EU, except for specific categories like medicinal products. It also holds fulfillment service providers and online marketplaces accountable for safety, making sure every player in the supply chain takes responsibility. Products already covered by other EU safety regulations may be partially or fully exempt from certain GPSR requirements.

Economic Operators

The GPSR establishes in §3(13) the following economic operators:

  • Manufacturer
  • Authorised representative
  • Importer
  • Distributor
  • Fulfillment service provider

Non-EU economic operators (such as those from the US, UK, Canada, Switzerland, Australia, or China) may name an authorised representative in the European Union as a contact point for market surveillance authorities. The GPSR delineates clear obligations for various economic operators to uphold product safety standards.

Responsibilities of Economic Operators

The GPSR defines roles and responsibilities for the following economic operators:

  • Manufacturers: Entities that produce or have products designed and manufactured under their name or trademark are responsible for ensuring that these products comply with GPSR requirements before entering the market. This includes conducting comprehensive risk assessments and maintaining technical documentation. For products manufactured outside the EU and sold online (or through other forms of distance selling), there may also be an importer who either sells the product directly online or supplies it to a distributor who then offers it for sale online.

  • Importers: Products manufactured outside the EU and sold in physical retail within the EU are placed on the market by an importer within the EU. The importer assumes the role of an economic operator under Article 4 unless the manufacturer has appointed an authorised representative to fulfill these duties. Firms importing products from non-EU countries must verify that these products meet EU safety standards. Importers are required to ensure that the manufacturer has fulfilled their obligations, and they must keep copies of the EU declaration of conformity and technical documentation for a specified period.
  • Distributors: For products manufactured outside the EU and sold online (or through other forms of distance selling), there may also be an importer who either sells the product directly online or supplies it to a distributor who then offers it for sale online. Distributors should verify that products bear the required conformity markings and are accompanied by necessary documentation and instructions.
  • Authorised Representatives: Appointed by manufacturers or importers, authorized representatives based within the EU act on behalf of the manufacturer or importer concerning specific tasks, such as maintaining technical documentation and cooperating with market surveillance authorities. If the manufacturer or importer (whether based inside or outside the EU) has appointed an authorised representative in writing to carry out specific tasks under Article 4, this representative assumes the role of an economic operator under Article 4.
  • Fulfillment Service Providers: Companies offering services like warehousing, packaging, and shipping, without owning the products, are considered fulfillment service providers. In scenarios where no other economic operator is established within the EU, these providers must ensure product compliance with the GPSR.

  • Online Marketplace Operators: Digital platforms facilitating the sale of products must register with the EU Safety Gate portal, designate a single point of contact for EU authorities, and ensure compliance with product safety reporting obligations. They are also required to act swiftly in removing unsafe products upon notification.

Online Marketplace Registration

Article 22 of the GPSR introduces new requirements for online marketplaces. Providers of online shops and other digital marketplaces must:

Marketplaces must also cooperate with regulatory bodies to remove unsafe products swiftly and prevent repeat violations.

Distance Sales, Economic Operators, and Authorised Representatives

The GPSR includes provisions for distance selling that apply to online providers. These providers must register on the Safety Gate portal. Online providers of products covered by the GPSR are also required to fulfill information obligations for consumers. According to Article 19 of the regulation, details about the manufacturer (name or trade name) or the EU authorised representative of the manufacturer, as well as product identification information (including a product image) and any warnings or safety information about the product, must be provided on the offering website (online interface).

Non-EU importers, such as those from the US, UK, Switzerland, Canada, Australia, or China, must also comply with the GPSR, including appointing an EU-based economic operator. This can be an EU-based importer, distributor, or an authorised representative.

The EU-based economic operator is responsible for:

If a non-EU manufacturer does not designate an EU-based economic operator, the fulfillment service provider automatically assumes legal responsibility for product compliance.

Risk Assessment and Safety Evaluation

To comply with GPSR requirements, manufacturers are obligated to perform thorough risk assessments of their products. This process involves evaluating various factors, including the product’s design, composition, packaging, and potential interactions with other products. Utilizing relevant European standards can aid in this assessment. The findings must be documented meticulously and made available to market surveillance authorities upon request. Neglecting proper risk assessment can lead to severe consequences, such as fines, product recalls, or market access restrictions. 

To confirm compliance with the general safety requirement under Section 5 of the GPSR ("Economic operators shall place or make available on the market only safe products."), manufacturers are obligated to assess the safety of the product as part of an internal risk analysis. Various aspects, such as the product's characteristics, composition, packaging, and interaction with other products, are evaluated. Relevant European standards may be used for this assessment.

The internal risk analysis and a list of any relevant European standards form part of the technical documentation for a product. This risk assessment must be documented and made available to market surveillance authorities upon request. Failure to conduct an adequate assessment may result in penalties, recalls, or restrictions on market access.

Labeling Requirements

To improve transparency and consumer safety, GPSR mandates specific labeling requirements. Products must display:

  • The manufacturer's name, registered trade name, and contact details.
  • A reference for product traceability, such as a batch or serial number.
  • Safety warnings in a language easily understood by consumers in the target market.

The regulation also encourages the use of digital labels and QR codes to provide additional compliance documentation and safety instructions.

Market Surveillance and Penalties

To fortify consumer protection, the GPSR enhances market surveillance mechanisms across EU member states by:

  • Mandating that economic operators report serious product safety incidents to the relevant authorities within two working days.
  • Promoting collaboration among national authorities through platforms like the EU Safety Gate.
  • Standardizing penalties for non-compliance, which may include substantial fines or bans on product sales. 

Transitional Provision

GPSR applies to all products within its scope that are placed on the market from 13 December 2024. The making available on the market of products covered by Directive 2001/95/EC, which comply with that directive and were placed on the market before 13 December 2024, shall not be impeded by EU member states.

EaseCert’s Role in Facilitating Compliance

Navigating the complexities of the GPSR requirements can be challenging for businesses. EaseCert offers comprehensive services to assist companies in achieving compliance with the GPSR requirements. Our service scope includes:

By partnering with EaseCert, companies can confidently navigate the regulatory landscape, ensuring their products are safe, compliant, and ready for the EU market.

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