General Product Safety Regulation (GPSR)

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General Product Safety Regulation (GPSR)

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GPSR at a glance

• The General Product Safety Regulation (EU) 2023/988 (GPSR) is the latest piece of legislation from the EU. The GPSR aims to ensure that consumer products are safe. This Regulation, which replaces Directive 2001/95/EC, emphasizes product safety, including for online sales, and introduces detailed requirements for safety with an emphasis on manufacturer traceability, documentation, and incident reporting.
• The primary objective of the GPSR is to modernize EU legislation to address safety concerns, especially for mass-produced items, often from sources that are hard to trace. Our analysis including conversation with legal and industry experts have indicated that the GPSR has specific interest in marketplaces who often evade responsibility for products ‘placed on the market’.
• There is unfortunately a secondary effect on ‘legitimate’ brands selling safe products, however we believe that this regulation doesn’t add new or heavy burdens.
• We anticipate that enforcement will focus on un-safe, less sophisticated outfits (such as marketplaces), and less regulated countries of origin. The focus of regulators will be ensuring that products can be traced back to a responsible party in the event of safety issues, and this is likely to primarily impact comparatively high-risk goods.
• As long as your brand’s products are safe (based on their nature and the standards the brand already follows when selling domestically or for other regulated markets), and maintains clear documentation, the products and the brand are unlikely to be affected by the more stringent parts of this regulation.

• GPSR defines ‘safe product’ as any product which, under normal or reasonably foreseeable conditions of use, including the actual duration of use, does not present any risk or only the minimum risks compatible with the product’s use, considered acceptable and consistent with a high level of protection of the health and safety of consumers.
• The requirement, practically speaking, is to conduct an internal risk analysis and compile the necessary technical documentation to be able to demonstrate that safety. There is a high probability that brands already selling in domestic regulated markets (US, Japan, Canada etc.) have such documentation anyhow to follow local requirements (in case of the UK, the standards are generally the same). The EU (and UK) safety laws rely on the presumption that products are declared to be safe.
• Technical documentation is a comprehensive term that includes various documents, which can differ depending on the product. Generally, the higher the risk associated with the product, the more extensive the documentation required. This may include a risk assessment, a declaration of conformity, test reports, instructions for use, and more.
• However, for lower-risk products, such as a plain t-shirt, the technical documentation may simply consist of a product description and high-level risk analysis, and there is typically no need for external assessments or conformity declarations in such a case.
• If your product is already being made available in the EU, then you might already have an “Economic Operator” (EO) established in the EU (for example, marketplaces, or even yourself directly by way of your own manufacturing, stores or other EU sales channels such as distributor/re-sellers). This entity will take on several tasks in relation to those products, including the responsibility for their safety. Think of the EO as your brand’s local representative in the EU. They’re responsible for handling all the roles of the EO, including verifying necessary documentation has been drawn up and communicating (as needed) with European authorities to ensure your products meet safety standards.
• In this case, you probably don’t need another EO like Global-e to handle compliance for the products sold through Global-e.
• Global-e can take on the role of responsible person in the EU through appointment as an Authorized Representative (AR) for e-commerce activities through Global-e.
• The AR serves as the point of contact for EU market surveillance authorities, helps maintain compliance documentation, and assist your brand in case of regulatory issues.
• It is important to stress that when acting as the brand’s AR, we will rely on your statements in regards to the safety of the products, and will expect full cooperation in that regard, mainly if there is a safety incident or regulatory review.
• Global-e will not charge for acting as the AR as long as the sale to the EU are carried through Global-e.
• As your AR, Global-e will:
  • Communicate with Authorities: Act as the primary contact for EU market surveillance authorities and ensure prompt communication if safety issues arise.
  • Manage Compliance Reporting: Use the EU Safety Business Gateway to report safety incidents and will assist with handling recalls as needed.
  • Provide Incident Support: Coordinate with you in the event of a product issue, from notifying relevant authorities to helping manage corrective actions, ensuring timely responses to maintain market compliance.
• First, we will need a written mandate from you, setting out the responsibilities Global-e will take on. Formally, our Irish Global-e entity will be the nominated AR.
• Then, we will need you to confirm that the following documents are readily available and can be furnished promptly when we ask for them (at the request of the authorities):
  • Inhouse-prepared safety confirmation: A statement prepared internally that a safety assessment has been conducted and it was internally decided that your products are safe. No need to provide further documentation, unless requested at time of need. Of course, if your products underwent formal or external risk assessments and safety checks, your confirmation may rely on that.
  • Incident Records: If any of your products were subject to any previous incident records (or you experience such incidents after our appointment), we’ll need to have them available as well.

• It is important to understand that import clearance process (for e-commerce) does not change by virtue of the GPSR.
• Taking into consideration the nature and purpose of the legislation and the inherent safety and low risk of the brand’s products – the market anticipates gradual uptake, with some focus on the targeted audience of the GPSR (marketplaces or massproduct importers).