Forthcoming GPSR regulations in the EU for US-based businesses

[aaloan]

I haven’t seen any official documentation from Shopify yet (I know Etsy and Amazon sellers have received notices) about the forthcoming GPSR requirements for selling in the EU market. 

I own a small online bookstore through Shopify and am totally confused on what I need to do ahead of Dec. 13 to continue shipping to the EU. It seems like no one outside the UK/small forums are talking about this. Are we not worried about it? Lol

If anyone has found solid guidance on complying with the new laws I would really appreciate it. 

[LinBow]

Hi,

I'm also confused why so few people are talking about this- I am based in the US and at this point I think I'll have to stop shipping to Europe altogether. It doesn't make up much of my business, but it's still frustrating.

There was someone on another thread advertising some kind of compliance app, but then they said it doesn't cover the EU-based representative required, so I'm not sure what the point would be for my business since I can't act as a representative from the US. It seems ridiculous that there is no threshold or concessions for small businesses- we are the only ones who are going to be hurt by such a vague and sweeping regulation, not the big companies with international headquarters.

I really wish Shopify would send out something- even if it's just to tell us to hold off on shipping there until things are clearer... Or better yet give us a checklist of how to stay compliant.

[CocoLoco]

I'm concerned about this also. I don't ship to the EU but I do ship to the UK - and the UK is caught up in this due to post-Brexit arrangements for Northern Ireland. What I really want to do is confine my shipping to England, Scotland and Wales only. I'm hoping that Shopify Markets will make this adjustment so that we can leave out Northern Ireland (sorry, anyone from NI reading).

[LinBow]

There is a way to do this currently- you have to configure your regions in the shipping rates editor under Shipping Zones (not Markets- that only allows you to select counties and not regions). There are 5 regions in the drop down menu for the UK (NI, Soctland, England, Wales, & British Forces). Just deselect the NI option from that list- then you can still ship to the rest of the UK! 🙂

[CocoLoco]

I checked this yesterday and could see no such option. But thanks, I'll look again!

[LinBow]

Looks like this

[CocoLoco]

Got it! Really helpful, many thanks 😀

[shubify]

Hi Aaloan,

Shopify lets merchants provide any required product information, either in their product description or by adding a metafield. We cannot provide direct legal advice, but hope this info helps!

[artofadornment]

It seems that no one has really received any truly helpful official guidance from Shopify, or elsewhere for that matter...  😕 but if you haven't seen it already, you might be interested in following the discussion here with many of us from Canada, USA, and parts of the EU chipping in with what we've found out so far.

EU/NI General Product Safety Regulations (GPSD / GPSR), Total Nightmare
https://community.shopify.com/c/international-commerce/eu-ni-general-product-safety-regulations-gpsd...

For myself, I've changed absolutely nothing so far - I'm still selling to the EU/NI, however since Dec. 13th I've only received one order from inside the EU and shipped it only a few days ago. So within the next couple of weeks I'll be finding out if it gets accepted and delivered just fine, is held in limbo forever without a word, is quietly rejected and returned to sender, or if I get contacted by some administration demanding I cough up the required info and/or have a local representative to vouch for me, lest I be hit with some penalty or have it returned, etc. Regardless, that's the forum where I'll be posting updates.

Meanwhile I'm definitely worried about it, but at this point it seems the only answer I'm likely to get about exactly what safety info I'm supposed to include (beyond the obvious "hand made [jewelry item] contains plastic and silver plated brass, DO NOT EAT") or how I'm supposed to prove I had the item available for sale to the EU before Dec. 13th is if someone contacts me to demand it. Sigh... 😑

[EaseCert]

You would typically be considered the economic operator under GPSR, which means you’re responsible for ensuring compliance.

Here’s what that means for you:

🔹 Responsible Person (RP) – If you’re selling into the EU/NI, you’ll need an EU-based RP to handle compliance documentation, report safety issues, and liaise with authorities. This can be a third-party compliance service, a distributor, or a fulfillment partner that offers this service.

🔹 Supplier Documentation – You don’t necessarily need to provide supplier details in listings, but you must ensure that all components meet EU safety standards. If suppliers provide declarations of conformity, safety test reports, or material composition details (e.g., nickel content in metals), keep these on file.

🔹 Labelling & Documentation – The product itself or packaging must include your name/address (or that of your RP), along with any relevant safety warnings or compliance markings.

It’s definitely a lot, and unfortunately, compliance costs hit small sellers hardest. If you’re looking for a service to help navigate this, EaseCert.com specializes in GPSR compliance, documentation, and EU RP services.

Let me know if you need more details—you’re not alone in this! 💡

[EaseCert]

Hey! These are great questions, and you’re definitely not alone in trying to figure out the details of GPSR. Here’s what I can share based on current guidance:

1️⃣ Product Testing – Whether you need to conduct your own testing depends on the final product and its intended use. If you’re using pre-tested materials (like inks with MSDS), you may not need additional testing, but you should still ensure that the final product meets general safety requirements. For example, if your prints include coatings or finishes that could pose a risk (e.g., flammability, skin contact issues), additional testing might be necessary. More details on compliance requirements are available at EaseCert.com.

2️⃣ Warnings – If there’s no specific hazard associated with your product when used as intended, a general safety statement should suffice. The key is to consider any foreseeable misuse—so while “don’t get a paper cut” might be excessive, something like “Not suitable for children under 3 due to small parts” (if applicable) would be more relevant.

3️⃣ Packaging & Labelling – The responsible economic operator’s name and address must be included, but it doesn’t necessarily have to be on the outer packaging. It can be on the product itself, the accompanying documentation, or the packaging—whichever is most practical. For compliance details, you can check EaseCert.com for guidance on labeling and documentation.

It’s a lot to navigate, but hope that helps! 🚀

[EaseCert]

FYI, here's the latest status:

The European Union has introduced the General Product Safety Regulation (GPSR), which replaces the previous General Product Safety Directive (GPSD). This regulation came into full effect on December 13, 2024, and applies to all consumer products placed on the EU market, including those imported from countries such as the United States, Canada, the UK, Switzerland, and Australia.

For importers and manufacturers selling goods in the EU, it is essential to understand the expanded obligations under the GPSR to ensure compliance and maintain market access.

Key Updates Under the GPSR

1. Expanded Scope and Definitions

• A manufacturer is defined as a company that produces or commissions the production of a product and markets it under its name or trademark.
• An importer is an entity established within the EU that places products from third countries onto the EU market.
• The GPSR broadens the definition of “safe products”, emphasizing that safety considerations must account for foreseeable misuse, evolving functionalities, and other threats.

2. New Risk Analysis and Technical Documentation Requirements

• Manufacturers / importers must conduct a comprehensive risk assessment and prepare technical documentation that demonstrates the product’s safety.
• Importers must retain copies of this technical documentation and ensure manufacturers have conducted proper risk assessments.
• Records must be kept for at least 10 years after a product is placed on the market.

3. Introduction of the “EU Responsible Person” Requirement

• Non-EU manufacturers must designate an EU-based Responsible Person who will act as a point of contact for compliance and product safety issues.
• This entity can be an authorized representative, importer, distributor, or fulfillment service provider.
• The Responsible Person is required to hold access to technical documentation and cooperate with EU regulators.
• An EU Authorised Representative can act as Responsible Person.

4. Stronger Product Traceability and Labeling Obligations

• All products must carry a serial number or equivalent identifier that is visible and legible.
• A manufacturer’s or importer's name, registered trade name, and a physical and electronic address must be clearly displayed on the product or its packaging.
• QR codes cannot replace required physical labeling.

5. Enhanced Market Surveillance and Online Marketplace Compliance

• Online marketplaces must verify that third-party sellers comply with EU safety regulations.
• Operators of an online marketplace in the EU Market, for example a Shopify store, are required by law to register their business with the Safety Gate Portal. Registration ensures compliance with EU regulations and facilitates communication with national market surveillance authorities.
• Importers and manufacturers distributing via e-commerce must ensure their products meet the same safety requirements as those sold in physical stores.
• National authorities will have increased powers to conduct market surveillance and enforce compliance, including product recalls and penalties.

Compliance Checklist for Importers and Manufacturers

To ensure a seamless transition into the new GPSR framework, businesses should take the following steps:

1. Register at the EU Safety Gate: This registration is mandated by GPSR to ensure better communication and compliance with safety requirements.
   
   
2. Appoint an EU-Based Responsible Person: If you are a manufacturer outside the EU, designate a responsible person who can store technical documentation and liaise with authorities. An EU Authorised Representativecan act as Responsible Person.
   
   
3. Ensure Full Product Traceability: Implement batch tracking and serial numbering systems to facilitate recall management and regulatory compliance.
   
   
4. Conduct a GPSR Risk Assessment: Ensure your products comply with EU safety regulations, addressing foreseeable risks and potential misuse.
   
   
5. Update Packaging and Labeling: Confirm that all required identification details (manufacturer / importer name, address, and contact information) are correctly displayed.
   
   
6. Prepare for Enhanced Market Surveillance: Maintain 10-year records of compliance documentation and be ready to provide them to regulators upon request.
   
   
7. Adapt for E-Commerce Compliance: If selling via Amazon, eBay, or other platforms, ensure that all listings meet EU safety regulations.
   
   
8. Monitor EU Regulatory Updates: Keep track of additional guidance from the European Commission and adjust compliance strategies accordingly.

Penalties for Non-Compliance

Failure to comply with the GPSR can result in:

• Product bans or recalls
• Fines and legal action
• Loss of market access in the EU
• Reputational damage for non-compliant brands

Final Thoughts

The GPSR represents a significant shift in EU product safety laws, particularly for importers and manufacturers from third countries. By proactively updating compliance strategies, businesses can avoid costly penalties and ensure a smooth transition into the new regulatory landscape.

For more insights or assistance in navigating the GPSR, stay updated through industry portals and the European Commission’s official channels.

Learn More About GPSR:

• EU Product Safety and GPSR Overview
• General Product Safety Regulation (2023) – EU Summary
• EU Safety Gate – RAPEX Alerts for Dangerous Products