EU General Product Safety Regulation (GPSR) 2024: What Adult Wellness Importers Need to Know

What GPSR Is and Why It Replaced the GPSD

The EU General Product Safety Regulation (GPSR) — Regulation (EU) 2023/988 — came into force on December 13, 2024, replacing the General Product Safety Directive (GPSD) that had governed product safety across the EU since 2001. The change from a Directive to a Regulation is significant: Directives require transposition into national law (giving member states flexibility in implementation), while Regulations apply directly and uniformly across all 27 member states.

The GPSD was written before e-commerce existed at scale. Its successor was specifically designed to address the modern supply chain — one where Chinese manufacturers sell directly to EU consumers through online marketplaces, where supply chains are opaque, and where enforcement across borders is genuinely difficult. The GPSR represents Brussels' most serious attempt to close the regulatory gap.

For adult wellness importers, the GPSR matters because virtually every product in this category — vibrators, couples' devices, wearables, smart intimate tech — is a consumer product not covered by a harmonized EU product safety directive (like the Toy Safety Directive or Medical Devices Regulation). Products outside specific sector legislation fall under GPSR as the safety backstop. Even products that do carry CE marking under LVD or EMC must still comply with GPSR's additional obligations.

The transition period ended December 13, 2024. Products placed on the EU market after that date — including products manufactured before the date but sold after — must comply with GPSR. There is no grace period for existing inventory in the channel.

Key Changes From GPSD to GPSR

The GPSR introduced several obligations that did not exist or were only weakly enforced under the GPSD. Understanding the delta — what actually changed — is the fastest way to identify compliance gaps in your existing operation.

Expanded definition of "placing on the market": Under GPSD, the obligations primarily attached to physical distribution. Under GPSR, distance selling (including all e-commerce) is explicitly covered. An EU consumer buying your product from a Chinese marketplace or from your own website is a "placing on the market" event subject to GPSR.

Online marketplace obligations (Article 22): This is one of the most consequential changes. Marketplaces — Amazon, eBay, Etsy, Zalando — now bear direct obligations under GPSR. They must establish mechanisms for suppliers to provide safety information, verify that products meet minimum requirements, and remove non-compliant listings. Marketplaces that fail to do so face penalties. This creates strong incentives for Amazon EU to demand GPSR documentation from sellers.

EU Responsible Person (Article 16): Products placed on the EU market must have an EU-established Responsible Person named on the product or its packaging. This was loosely required under GPSD but is now mandatory and enforced. The Responsible Person must maintain technical documentation, cooperate with market surveillance authorities, and take corrective action if a product is found non-compliant.

Traceability requirements: Products must bear a unique product identifier and the manufacturer's name, registered trade name, and postal address — plus the Responsible Person's details. This information must be on the product itself or its packaging. A URL or QR code linking to this information is permitted for small products where physical space is limited.

Incident reporting: Manufacturers and Responsible Persons must notify market surveillance authorities immediately (within three business days of becoming aware) of any serious risk associated with their product. This obligation previously existed informally — under GPSR it is codified with timelines and penalty exposure.

The EU Responsible Person Requirement in Practice

Article 16 of GPSR requires that every product placed on the EU market has an EU-established economic operator who acts as the Responsible Person. For a brand owner based outside the EU — including UK, US, and Chinese companies — this means designating a European entity for this role.

The Responsible Person's obligations are substantive:

• Maintain a copy of the technical documentation (test reports, Declaration of Conformity, safety assessments) for at least 10 years after the last product was placed on the market
• Register the product in the EU Safety Gate (the EU's product safety notification portal) if the product is subject to notification requirements
• Ensure that the product bears a unique identifier, the manufacturer's details, and the Responsible Person's own name and address
• Cooperate with national market surveillance authorities — providing documentation upon request, facilitating recalls if required
• Immediately act on safety alerts and notify authorities of known risks within three business days

Who can serve as EU Responsible Person?

• Your own EU subsidiary (if you have one)
• A European distributor who agrees contractually to take on the role (common in established wholesale relationships)
• A third-party EU Responsible Person service provider (most practical for smaller importers)

Cost of third-party EU Responsible Person services ranges from approximately €500 to €3,000 per year depending on the number of SKUs, the complexity of your technical documentation, and whether the service provider must also maintain a local physical address for regulatory correspondence. Several specialized compliance firms in Germany, Netherlands, and France offer this service for adult wellness brands.

The Responsible Person's contact details — name (or trade name) and postal address — must appear on the product or its packaging. For small products where this is impractical, a QR code or URL leading to a page with this information is permitted under GPSR Article 19.

CE Marking and GPSR: How They Interact

Many adult wellness brands assume that CE marking resolves all EU compliance obligations. This is incorrect. CE marking under harmonized directives (LVD, EMC, Radio Equipment Directive) demonstrates conformity with the technical requirements of those directives. GPSR operates as a horizontal regulation that applies additional obligations on top of, and separate from, sector-specific CE requirements.

A vibrator with valid CE marking under LVD (electrical safety) and EMC (electromagnetic compatibility) still must:

• Have an EU Responsible Person named on the product or packaging
• Bear a unique product identifier
• Have technical documentation maintained for 10 years
• Comply with incident reporting obligations
• Be registered in the EU Safety Gate if it falls under a notification requirement

LVD (Low Voltage Directive 2014/35/EU): Applies to electrical equipment operating between 50–1000V AC or 75–1500V DC. Most battery-powered wellness devices (3.7V lithium-ion) operate below these thresholds and are technically outside LVD scope. However, the practice in the adult wellness industry is to certify to LVD standards (specifically EN 60335-2-97, "particular requirements for vibrating massagers") voluntarily, because it provides the clearest demonstration of electrical safety.

EMC Directive (2014/30/EU): Applies to most electronic products. A vibrator with a motor, circuit board, and wireless charging capability is within scope. EMC testing confirms the device does not emit electromagnetic interference beyond permitted levels and is not susceptible to interference from external sources.

Radio Equipment Directive (RED, 2014/53/EU): Applies to products with wireless connectivity — Bluetooth-enabled devices, app-controlled products. RED requires additional conformity assessment and notification to the national authority in the first EU country where the product is placed on the market.

For brands selling in the EU, the practical implication is that your compliance stack typically includes: LVD/EN standard testing + EMC testing + RED (if Bluetooth) + GPSR obligations + Battery Regulation (if rechargeable). Each element requires specific documentation from your OEM.

Battery Regulation 2023/1542: What It Adds for Rechargeable Devices

The EU Battery Regulation (Regulation (EU) 2023/1542), which entered into force in August 2023 with staggered implementation dates, adds a separate compliance layer for any product containing a rechargeable lithium-ion battery — which covers the vast majority of modern adult wellness devices.

Key obligations relevant to wellness importers:

Battery labeling: From February 2027, batteries in consumer products must carry a QR code linking to a "battery passport" — a digital record containing information about the battery's chemistry, capacity, performance, and origin. For products currently being designed and sourced, this means your OEM must be able to provide battery-level data: cell chemistry (typically lithium cobalt oxide or lithium iron phosphate), rated capacity (mAh), minimum average duration, and performance retention metrics.

Removability requirements: From February 2027, portable batteries in consumer products must be designed to be removable and replaceable by end users. This has significant implications for OEM product design — the waterproof-sealed housing common in IPX7/IPX8 wellness products conflicts directly with the removability requirement. The regulation includes provisions for products where removal compromises safety or function, but these exceptions must be documented.

Chemical restrictions: The Battery Regulation sets limits on hazardous substances in batteries, including mercury, cadmium, and lead. RoHS compliance on the battery itself (typically already required) covers most of these, but your OEM must provide battery-specific RoHS documentation, not just product-level documentation.

Extended producer responsibility: From 2026, economic operators placing batteries on the EU market must register with national producer responsibility schemes and contribute to battery collection and recycling programs. This parallels WEEE obligations for the electronic device itself.

Labeling Requirements Under GPSR

GPSR Article 19 establishes minimum labeling requirements for products placed on the EU market. These requirements are separate from — and in addition to — labeling requirements under sector-specific directives (LVD, EMC) and other regulations (REACH, RoHS).

Mandatory label elements:

• Manufacturer identification: Legal name (or registered trade name) and postal address. PO boxes are not sufficient — a physical address where the manufacturer can receive official correspondence is required.
• EU Responsible Person identification: The same information (name and postal address) for the EU Responsible Person, if different from the manufacturer.
• Unique product identifier: This can be a batch number, serial number, or other identifier that allows the specific product to be traced in the supply chain. The format is not prescribed — a model number + production batch code is sufficient.
• Product description: Sufficient to identify the product. For adult wellness products, this typically means the model name and product type.
• Warnings and safety information: In the official language(s) of the member state(s) where the product is sold. A vibrator sold in Germany requires German-language safety information. One sold across DE, FR, and IT requires German, French, and Italian.

QR code traceability: For products where physical size or practicality prevents full label text, GPSR permits the use of a QR code or other machine-readable code that links to a webpage with the required information. The webpage must be stable, publicly accessible, and maintained for as long as the product is on the market.

Practical implementation: Most adult wellness brands printed in English, German, French, Italian, Spanish, and Dutch on a single multilingual label. This approach works but requires adequate label real estate. Small products (travel-size devices) may require the QR code approach.

Your OEM in China must produce packaging that meets these requirements before the product is exported. Applying EU-compliant labels in a European warehouse adds cost and logistics complexity. Designing compliance into the packaging at the production stage is always cheaper.

GPSR Article 22: Online Marketplace Liability

Article 22 of GPSR fundamentally changed the liability exposure of online marketplaces selling consumer products in the EU. This section deserves close attention from any brand selling adult wellness products through Amazon EU, Zalando, or similar platforms.

Under Article 22, online marketplaces are required to:

• Establish internal processes to verify that products listed on their platform comply with GPSR
• Provide mechanisms for economic operators (sellers) to submit safety documentation
• Remove listings promptly when notified of non-compliant or unsafe products by market surveillance authorities or through their own verification
• Cooperate with safety investigations
• Notify consumers who purchased a non-compliant product if the marketplace has their contact data

For sellers, the practical impact is twofold. First, Amazon and other EU marketplaces will increasingly demand documentary proof of GPSR compliance — EU Responsible Person details, unique product identifiers, and technical documentation access. Second, the marketplace will act faster on compliance failures because they bear liability for inaction.

This creates an incentive structure where compliant sellers are protected (marketplaces want to keep compliant supply) and non-compliant sellers face faster enforcement. For a brand investing in proper OEM documentation and EU compliance infrastructure, this is a competitive advantage — marketplace platforms prefer working with sellers who do not create regulatory exposure for them.

Incident Reporting and Market Surveillance Cooperation

Under GPSR, manufacturers and EU Responsible Persons have a mandatory obligation to report safety incidents to the relevant national market surveillance authority. This is codified in Article 20 and is considerably more prescriptive than anything that existed under the GPSD.

What triggers a reporting obligation: Any serious risk associated with the product — meaning a risk that requires rapid intervention, including risks that do not immediately produce a harmful effect. In the adult wellness context, this includes:

• Reports of electrical shock or burn injuries
• Skin reactions that suggest a formulation or material safety issue (for lubricants or products with skin-contact coatings)
• Battery failures (swelling, heat, smoke) that suggest a defect beyond normal use
• Mechanical failures that could cause injury (broken components with sharp edges)

Reporting timeline: Within three business days of becoming aware of a serious risk. This is not three business days after your internal investigation concludes — it is three days after your awareness of the risk begins. If a customer emails you describing an electrical burn from your product, the clock starts from the date of that email.

Where to report: The EU Safety Gate (formerly RAPEX) is the EU's product safety notification system. You report through the national market surveillance authority of the member state where you first placed the product on the market, which then propagates the alert EU-wide through Safety Gate.

Cooperation with market surveillance: If a national authority contacts you requesting documentation, you must respond. The GPSR grants authorities powers to request technical files, test reports, and corrective action plans. Non-cooperation is itself a violation.

For most adult wellness brands, the practical implication is building a customer complaint intake process that flags potential safety issues with a legal or compliance team member, rather than routing all complaints exclusively through customer service. The three-day clock creates urgency that informal complaint handling cannot accommodate.

Enforcement Timeline and What to Prioritize Now

GPSR took effect December 13, 2024, with no transition period for products entering the market after that date. Enforcement intensity varies by member state — Germany and France have historically been the most active in market surveillance for consumer products — but the regulation's direct effect means any EU authority can act.

Immediate priorities for adult wellness importers as of 2026:

1. EU Responsible Person designation: If you do not have one, this is the highest priority. Without an EU Responsible Person, your products are non-compliant on their face, and marketplace platforms are beginning to require this information as a condition of listing.

2. Unique product identifier on packaging: If your current packaging does not carry a batch number, model number, or other traceable identifier, this is a straightforward fix to implement at the next production run.

3. Technical documentation audit: Review your existing test reports and certifications. Are they current? Do they cover all products in your EU catalog? Are they stored accessibly so you can respond to an authority request within 72 hours?

4. Incident reporting protocol: Establish a written process for identifying, escalating, and reporting safety incidents. This does not need to be complex — it needs to be documented and followed.

5. Battery Regulation preparation: If your products contain rechargeable batteries, begin engaging your OEM on battery-level data collection now. The February 2027 deadlines for battery labeling and removability will require design changes that take time to implement.

The adult wellness category is not currently the highest enforcement priority for EU authorities — products like children's toys, electrical appliances, and medical devices attract more scrutiny. However, GPSR's explicit coverage of e-commerce means that the mechanism for enforcement through marketplace platforms is being built out actively. The window to get compliant before enforcement pressure increases is narrowing.