EU Product Safety Law: 2024 Risks for US Firms

When you see major U.S. law firms like Kirkland & Ellis setting up big new offices in Brussels, it’s not a coincidence. It’s a direct response to the rising tide of global product safety law and the money involved. These moves show just how tangled the regulatory web has become, especially for product safety, and what it means for manufacturers facing potential global litigation or catastrophic injury claims. There’s a ton of bad advice out there about how these changes affect businesses, and following it often leads to disasters like entire shipments getting impounded.

Myth 1: EU Product Safety Laws Don’t Apply to U.S. Manufacturers Unless They Have a Physical Presence There

This is a flat-out dangerous misconception. I hear it all the time from U.S. manufacturers: “We don’t have a factory in France or an office in Spain, so we’re clear of EU rules.” The reality is that the EU’s regulatory reach is far longer than that. The General Product Safety Regulation (GPSR), which becomes fully enforceable on December 13, 2024, applies to any product available on the EU market, no matter where the manufacturer is located. Selling your product through your website to a customer in Germany or using a distributor in Italy means you are absolutely on the hook.

The GPSR introduces a requirement that’s tripping up a lot of companies: every product sold in the EU must have a designated “responsible person” based inside the EU. This can be the manufacturer (if they’re EU-based), an importer, an authorized representative you appoint, or even a fulfillment service. Their job is to be the contact for market surveillance authorities and have the technical documentation ready to go. Failing to name this person is a critical error. I’ve seen companies have entire shipments quarantined at the port of Rotterdam because they treated this as a minor administrative detail, bringing their whole European supply chain to a grinding halt.

Myth 2: Product Safety Compliance is Just About Getting a CE Mark

The CE marking is a familiar sight on products in the European Economic Area, but too many companies wrongly believe that getting the mark is the end of their compliance journey. It’s not even close. Affixing the CE mark is a declaration that your product meets basic EU health, safety, and environmental standards at a specific point in time, but it doesn’t cover everything, and it certainly doesn’t let you off the hook for what happens next.

For example, the GPSR puts new, tougher obligations on online marketplaces, forcing them to be much more active in booting unsafe products off their platforms. It also beefs up traceability rules so that authorities can quickly track down and recall a dangerous product’s entire batch. After you get that initial certification, you have an ongoing duty to maintain technical files, run post-market surveillance to watch for problems, report any serious incidents to the authorities, and have a plan ready for corrective actions or recalls. A CE mark is the beginning. Real compliance is defined by your constant vigilance and your ability to adapt to changing standards, because regulators can and will take action against products that have a valid CE mark if a problem arises later.

Myth 3: My Product Isn’t “High Risk,” So I Don’t Need Extensive Safety Protocols

Companies consistently misjudge what “high risk” actually means, and it leads them to dangerously underestimate their safety duties. The common thinking is that only things like medical devices, heavy machinery, or children’s toys get intense safety scrutiny, while their own supposedly harmless products are fine. That’s a dangerous way to think. The GPSR covers all consumer products, and its definition of “unsafe” is extremely broad. A product can get you in trouble because of a design flaw, but also because of bad instructions, insufficient warnings, or a type of misuse that you should have seen coming.

Think about a simple kitchen appliance. If its power cord frays and creates a shock hazard, it’s unsafe. If the assembly instructions are so confusing that a person could put it together wrong and get hurt, it’s unsafe. What determines the level of regulatory scrutiny is the severity of a potential injury, not the product’s category. Even a product that seems low-risk on the surface can generate massive product liability claims and regulatory fines if a defect ends up hurting someone. It is the manufacturer’s job to perform a solid risk assessment, enforce quality control, and provide crystal-clear user information for every single product. Skipping that work is basically inviting litigation.

Myth 4: My Company’s U.S. Insurance Policy Will Cover Global Product Liability Claims

Having a domestic insurance policy gives many U.S. businesses a false sense of security. Relying on that same policy to cover a major product liability claim from overseas is a huge gamble. Insurance contracts are notoriously complex, and they are filled with geographic limitations that you won’t find until it’s too late. A policy written for your operations in Ohio might have a clear exclusion for claims that come from a product sold or used in the European Union. I’ve seen companies get completely blindsided when a catastrophic injury claim comes out of Belgium and they discover their U.S. policy is worthless, leaving them exposed to a judgment that could cripple the business.

On top of that, what’s considered a reasonable settlement or a jury award in Georgia is worlds apart from a court judgment in Germany or France. Companies selling products globally need to work with insurance brokers who specialize in international coverage to get policies that are actually built for the legal environments and risks of each market they’re in. This usually means buying local policies or getting specific endorsements that extend your coverage to foreign courts and provide high enough limits for class actions or large-scale recalls. Don’t just assume your policy travels with your product. You have to verify it with an expert.

Myth 5: AI-Driven Product Development Doesn’t Change Product Safety Liability

The speed at which Artificial Intelligence (AI) is being integrated into product design and operation is creating new and complicated liability questions that most companies are not ready for. There’s a belief that if the hardware is safe, then the software (especially the AI parts) doesn’t really change the liability picture. This is a deep miscalculation. AI algorithms are designed to learn and change, often in ways no one predicted which can create brand-new hazards in a product that was perfectly safe when it left the factory.

Take an autonomous car or an AI-powered medical diagnostic tool. If an algorithmic bias causes a crash or a bad medical recommendation that hurts someone, who is liable? Is it the AI developer, the product manufacturer who used the AI, or maybe even the end-user whose data inadvertently “taught” the AI a bad habit? The EU is already tackling this head-on with its AI Act, which sorts AI systems by risk and puts very strict rules on the high-risk ones, demanding specific data governance, transparency, and human oversight. If you’re building or using AI in your products, you have to adopt intense testing protocols that go far beyond standard safety checks, focusing specifically on things like algorithmic fairness, robustness, and the potential for unexpected dangerous behavior. The law is moving fast, and any company that doesn’t adapt its liability strategy for AI’s unique problems will be at a major disadvantage.

Staying on top of global product safety law isn’t a “set it and forget it” project. It demands constant vigilance and a proactive compliance mindset. Businesses have to ditch their old assumptions, get in front of the new regulations, and build systems that protect both their customers and their bottom line.