GPSR Compliance
The General Product Safety Regulation (GPSR), officially known as Regulation (EU) 2023/988, is a legislative framework established by the European Union (EU) to ensure that products marketed within its member states are safe for consumers. Effective from December 13, 2024, the GPSR replaces the General Product Safety Directive (GPSD), introducing comprehensive measures to address modern challenges posed by digitalization and online sales.
Key Objectives of the GPSR
- Ensuring Comprehensive Safety: The GPSR aims to guarantee the safety of all consumer products, especially those incorporating new technologies. This proactive approach is essential in a rapidly evolving market where technological advancements are frequent.
- Regulating E-commerce: The regulation addresses challenges related to online sales, particularly for online marketplaces. These platforms are now required to perform thorough checks to ensure that all products listed meet EU safety standards, marking a move towards greater accountability in the digital marketplace.
- Enhancing Enforcement and Surveillance: The GPSR places increased responsibility on member states to enforce the regulation, including market surveillance authorities and corrective actions in cases of non-compliance.
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Streamlining Recalls: The regulation seeks to enhance consumer trust and safety by promptly informing consumers and providing necessary remedies for unsafe products.
Scope of the GPSR
The GPSR applies to all products placed on the EU market, irrespective of the sales channel, encompassing both physical stores and online platforms. Certain categories, such as medicinal products, are exempt. The regulation also holds fulfillment service providers and online marketplaces accountable for safety, ensuring that every player in the supply chain takes responsibility.
Economic Operators Defined by the GPSR
The regulation identifies several key roles within the supply chain:
- Manufacturers: Entities that produce or have products designed and manufactured under their name or trademark. They are responsible for ensuring product compliance before market entry, conducting comprehensive risk assessments and maintaining technical documentation.
- Importers: Firms importing products from non-EU countries must verify that these products meet EU safety standards. Importers are required to perform risk assessments and technical documentation as well to ensure that the manufacturer has fulfilled their obligations and must keep copies of the EU declaration of conformity and technical documentation for a specified period.
- Distributors: Entities that make products available on the market must 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.
- 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.
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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.
Responsibilities of Economic Operators
- Manufacturers: Ensure products are safe by design, conduct risk assessments, and implement safety features. They must prepare and maintain technical documentation demonstrating compliance and ensure traceability of products throughout the supply chain. Before marketing, manufacturers must perform internal testing, and establish procedures for effective recalls.
- Importers: Verify that products comply with EU safety standards and ensure manufacturers have carried out appropriate conformity assessments with proper documentation. They are also expected to conduct random checks on imported products to verify ongoing compliance and ensure proper labeling and safety information are included.
- Distributors: Act with due care to ensure that products comply with safety requirements, verify that products bear the required conformity markings, and ensure that the manufacturer and importer have complied with labeling and documentation requirements.
- Authorised Representatives: The authorized representative acts on behalf of manufacturers or importers concerning specific tasks, such as maintaining technical documentation and cooperating with market surveillance authorities.
- Fulfillment Service Providers: Ensure product compliance with the GPSR in scenarios where no other economic operator is established within the EU.
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Online Marketplace Operators: Ensure that products offered through their services comply with the GPSR, cooperate with market surveillance authorities, and take corrective actions when necessary.
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.
Online Marketplace Registration
Article 22 of the GPSR introduces new requirements for online marketplaces. Providers of online shops and other digital marketplaces must:
- Register with the EU Safety Gate portal
- Designate an EU authorised representative as single point of contact for EU authorities.
- Ensure compliance with product safety reporting obligations.
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 with the EU 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 or importer, 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 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:
- Holding and maintaining the product’s technical documentation.
- Cooperating with EU market surveillance authorities.
- Acting as the official contact point for regulatory compliance inquiries.
If a non-EU manufacturer does not designate an EU-based economic operator in form of an authorized representative, the fulfillment service provider automatically assumes legal responsibility for product compliance.
EaseCert’s Role in GPSR Compliance
Authorised Representative Representation
Official representation of your business to ensure GPSR compliance for your products.
GPSR Certification
Proof of compliance for Amazon and other marketplaces as well as EU market surveillance authorities. This includes:
- Technical Documentation Management: Preparing and maintaining required documents such as the product's risk analysis.
- Product Traceability and Labeling Guidance: Ensuring proper documentation and labeling for compliance.
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Product Safety Compliance: Advising which documentation is required from the manufacturer such as pre-existing test reports, BOMs, etc.
Registered EU Address
Required for regulatory and market surveillance purposes. EaseCert is headquartered in New York City, with our EU Authorised Representative service based in Germany.
Support for EU Market Surveillance Inquiries
Assistance in case of EU market surveillance compliance checks as well as marketplace compliance guidance for Amazon, eBay, Shopify, and more.
Product Risk Assessment and Regulatory Consulting
Assisting with product safety evaluations. Regulatory compliance support on GPSR requirements and related EU laws. Unlike other service providers, EaseCert charges a one-time fee for all GPSR certification and EU Authorised Representative services. Once certified, we remain your EU Representative for as long as your product is on the market - no annual renewals, no hidden fees.
By partnering with EaseCert, companies can confidently navigate the regulatory landscape, ensuring their products are safe, compliant, and ready for the EU market. Download our GPSR checklist for a step-by-step guide to ensure your products meet EU safety, labeling, and documentation requirements, helping you stay compliant and successfully navigate the EU market.