The EU General Product Safety Regulation — GPSR, Regulation (EU) 2023/988 — has applied to consumer products across the EU since 13 December 2024, replacing the old General Product Safety Directive. If you sell silicone feeding products, pet items, kitchenware, or any other consumer silicone product in the EU — online or in stores — GPSR adds new obligations on top of material standards such as LFGB, FDA 21 CFR 177.2600, and EN 71. This guide explains what changed and what a silicone manufacturer should provide to help you comply.
NEWTOP SILICONE is a custom silicone product manufacturer based in China with 10+ years of export experience to the European market. We make baby, kitchen, pet, personal-care, and medical silicone products under OEM/ODM programs and hold ISO 9001, ISO 13485, FDA, LFGB, CE, and TÜV-certified testing documentation. This article is general guidance, not legal advice — verify your specific obligations with a compliance adviser for the markets you ship to.
What Is GPSR and Why Does It Matter for Silicone Products?
GPSR is the EU’s horizontal safety law for non-food consumer products. Unlike CE-marking directives (toys, electronics) or food-contact regulations (LFGB, EU 1935/2004), GPSR applies across the board — including products that have no dedicated EU directive. It requires that every consumer product placed on the EU market is safe, traceable, and backed by an accountable economic operator.
Key facts:
For a silicone supplier, the practical meaning: your product still needs the right material tests (LFGB, FDA, EN 71 for toys) — but now the chain of accountability must also be documented: who made it, who is responsible inside the EU, and how it can be traced per batch.
The Five Obligations That Most Affect Silicone Brands
1. An EU-based “responsible economic operator”
If the manufacturer is not established in the EU, the product can only be placed on the EU market if an economic operator based in the EU is responsible for it — typically the importer, an authorized representative, or a fulfillment service provider. That operator’s name, registered trade name, and contact address must appear on the product, its packaging, or an accompanying document.
Practical step: if you import silicone goods yourself, confirm that your EU importer or fulfillment provider accepts this role — and that their identity appears on the product label. If you sell under your own brand, you are the manufacturer and must designate a responsible operator for direct online sales into the EU.
2. Product traceability information
Every product must be identifiable by type, batch, or serial number, together with the manufacturer’s name and address. For silicone goods — teethers, slow feeders, baking mats — batch codes are the normal mechanism. This is what makes a recall or a market-surveillance check manageable.
3. Technical documentation
Manufacturers must keep technical documentation describing the product and its safety assessment and make it available to market surveillance authorities on request. For silicone this typically means: material certificates and test reports (LFGB, FDA, REACH, EN 71 where applicable), MSDS, and a short risk assessment (choking hazards, migration limits, temperature limits, intended users).
4. Online listings must show safety and identity information
GPSR puts specific duties on sellers offering products online (Article 19). Before a product is offered for sale on a marketplace, the listing must display:
- The product image, type, and batch/serial number
- The manufacturer’s identity (name, registered trade name or mark, address)
- The EU responsible operator’s identity and contact details where applicable
- Product warnings and safety information (in the official language of the member state where it is sold)
This matters for Amazon EU sellers in particular — incomplete listings can be de-listed even when the physical product is compliant.
5. Incident reporting and corrective actions
Economic operators must notify market surveillance authorities through the EU Safety Business Gateway when a product causes a serious accident or safety issue, and cooperate on recalls. Consumers must also be informed of corrective actions (Safety Gate). This is why batch traceability (point 2) is not paperwork — it is the mechanism that lets a small brand contain a problem fast.
GPSR vs. Food-Contact and Toy Rules: What Still Applies
GPSR sits on top of existing sector rules. For silicone products, brands commonly need three layers:
Many sellers assume “we have FDA/LFGB reports, so we are fine in the EU.” That is only half true: LFGB-type migration testing proves the material is food-safe; it does not satisfy the operator, traceability, and documentation duties that GPSR adds.
What a Silicone Manufacturer Should Provide to Support Your GPSR File
When you source custom silicone products for the EU market, your manufacturer should be able to supply, at minimum:
- Test reports for the relevant material standards (LFGB, FDA, REACH; EN 71 / CPC for children’s items) tied to your batch — not just a generic certificate scanned from a website
- MSDS for the silicone formulation used
- Batch traceability: production records that map a batch code to raw material lots and QC results
- Consistent product markings — including batch code placement agreed in the mold or via label/print
- Factory compliance evidence: ISO 9001 quality management, and audits such as BSCI or SEDEX that EU importers increasingly request
- Responsive documentation turnaround when your importer or marketplace asks for updated files
NEWTOP SILICONE supports OEM/ODM customers with documented material compliance and batch-level QC records across baby, kitchen, and pet silicone programs. Our export process includes inspection reports and test documentation per shipment — ask us for the exact document package for your product category.
FAQ
Q: Does GPSR apply to products I already sold before December 2024?
A: Products already on the EU market before 13 December 2024 can generally continue to be sold under the old regime, but new stock placed on the market after that date must comply. Check with your compliance adviser for your specific stock situation.
Q: I sell through Amazon EU — do I need my own responsible person?
A: For most direct-to-consumer online sales, yes: GPSR requires an EU-based responsible economic operator for products sold online, and marketplace listings must show the operator’s identity. If you have an EU importer, that importer can take the role; otherwise you need an authorized representative or fulfillment provider arrangement.
Q: Is GPSR the same as CE marking?
A: No. CE marking comes from specific product directives (e.g., toys under EN 71, electronics under the EMC/LVD directives). GPSR is a horizontal safety regulation that applies in addition to those rules. Many silicone products need no CE mark at all but still fall under GPSR.
Q: Do baby and pet silicone products need different compliance packages?
A: Yes. Baby feeding items need food-contact testing (LFGB/FDA) and, if they are toys or teethers, EN 71 / CPC testing plus choking-hazard review. Pet feeding products need food-contact testing; pet toys have their own durability and safety considerations. GPSR applies to all of them.
Next steps
GPSR is a documentation and accountability exercise, not a redesign of your product. Start by listing your EU SKUs and confirming (1) who your EU responsible operator is, (2) whether your labels carry batch codes and the operator’s identity, and (3) whether your online listings show the required information. Then collect the test reports and MSDS for each product from your manufacturer.
Planning an EU launch or updating an existing line? Request a quote or talk to our export team — we can walk you through the documentation package we provide per shipment.