This page is the compliance detail behind the OEM and private-label overview: who applies for CE and whose name goes on the declaration, the EU GPSR responsible person, intellectual-property ownership, and the Amazon FBA gated-category paperwork.
Certifications: who applies, whose name goes on the declaration
This is the single most misunderstood part of a private-label relationship, and it is misunderstood in the direction that costs the brand money. A factory can give you test reports. It cannot give you your declaration of conformity, because the declaration is the statement of the party placing the product on the market under its own name — that is, you.
CE is a self-declaration by the manufacturer, not a certificate issued by an authority, which is what the Wikipedia entry CE marking describes and what the CE mark on a product actually asserts. So when a supplier offers to “give you the CE certificate”, the useful question is whose name is printed on the declaration. If it is the factory’s, it is not yours, and it will not survive the first customs query or marketplace review that asks who placed the product on the market.
| Document | Who applies for it | Whose name it carries | When you need it |
|---|---|---|---|
| CE Declaration of Conformity | You, as the brand placing it on the EU market | Yours | Before the first unit is sold in the EU or NI |
| Test reports behind the DoC (LVD, EMC, RoHS) | The factory runs the tests; you hold the report | The laboratory’s, with your model number | At customs, at a marketplace review, at an audit |
| UKCA / UK DoC | You, for the GB market | Yours | Before the first unit is sold in Great Britain |
| REACH statement and SVHC declaration | The factory, against the material list | The factory’s, referencing your SKU | At onboarding for most EU retailers |
| FDA 21 CFR 177.2600 material compliance | The factory, for the material | The factory’s | For US retail and marketplace listings |
| UN38.3 and IEC 62133 | The cell or pack maker | The battery maker’s | Before any lithium-powered unit flies or sails |
| EU GPSR responsible person declaration | You appoint one; the operator accepts in writing | The operator’s, shown on the product or its packaging | Before the first unit is placed on the EU market |
The practical consequence: budget for certification as a cost of your own launch, not as something bundled with the goods. The parts a factory legitimately supplies — test reports, material declarations, MSDS, battery transport certificates — are the evidence your declaration rests on, and they should arrive as a document pack with the invoice, not as a PDF someone finds later.
The EU GPSR and the responsible person
Regulation (EU) 2023/988, the General Product Safety Regulation (see the regulation text on EUR-Lex), has applied across the EU since 13 December 2024 and replaced the General Product Safety Directive. For a private-label brand the two obligations that arrive first are documentary, and both have to be settled before packaging artwork is signed off rather than after.
Article 16 requires that a product may only be placed on the market if an economic operator established in the EU is responsible for the tasks listed in Article 4(3) of Regulation (EU) 2019/1020. That operator can be an EU manufacturer, an importer, or a representative appointed under a written mandate — and where none of those exists, a fulfilment service provider handling the goods.
An online marketplace is not automatically that operator merely because the product is listed on it. Article 16(3) then requires the operator’s name or registered trade mark and its postal and electronic address to appear on the product, the packaging, the parcel or an accompanying document; Article 19 adds a separate display duty for distance selling, where the offer itself has to show those details.
Two things follow for anyone briefing a factory. First, the address on the label is a launch blocker with a lead time: deciding it late means reprinting packaging. Second, the technical documentation has to be kept available to market surveillance authorities for ten years, which is a filing practice and not a document you can assemble in a week when someone asks. The Spanish-language version of this page is at /es/oem/compliance/.
IP: design, trademark, packaging artwork
Three different kinds of property get conflated in a manufacturing brief, and only one of them is usually discussed. The design is the shape and mechanism, protected by a registered design or a patent if anyone bothered. The trademark is your brand name and logo. The artwork is the packaging — and it is the one most often lost, because it is the one nobody thinks of as property.
What to put in writing, in order: an NDA before the first drawing is sent, covering the artwork and the source files as well as the product; a clear statement of who owns the design, which for ODM means the manufacturer unless the IP is purchased; the packaging artwork and dielines delivered back to you as editable source files on final payment; and a trademark registered in the markets you actually sell into, in your name. A flattened PDF of your carton is not ownership of a design, it is a picture of one, and a printer in another country cannot rebuild a dieline from it.
Amazon FBA readiness and gated categories
Sexual wellness is a gated category in most marketplaces, which means approval before listing rather than listing and hoping. The application is a document exercise: a commercial invoice from the supplier, test reports that match the product, and images that match the ASIN. The most common rejection is not a policy problem, it is a paperwork mismatch — a model number on the invoice that does not match the listing, or a test report covering a different variant.
Two details worth building into the packaging rather than fixing later. The manufacturer field on the listing is your company as the brand owner, not the factory, and a listing that names the factory invites a duplicate-listing dispute later. And the packaging itself has to be opaque, non-explicit and compliant with the marketplace’s adult-product rules, with a suffocation warning on any poly bag. Order the document pack and the cartons at the same time so the invoice, the carton and the ASIN agree with each other, because that agreement is what the reviewer is actually checking.
Back to the OEM overview, or on to procurement and quality control.