CE, RoHS, FDA: The Complete Quality Certification Guide for B2B Imports

The certification that customs actually scans

Buyers ask us "does this have CE?" hundreds of times a year. The honest answer: CE marking is a manufacturer self-declaration for some categories but a third-party-verified certification for others. Customs at Rotterdam scans the Declaration of Conformity (DoC) and the technical file, not the sticker.

EU market: the real certification stack

For most B2B consumer goods entering the EU, three documents must be present at customs:

• Declaration of Conformity (DoC). Manufacturer signs that the product meets all applicable EU regulations.
• Technical file. Engineering drawings, test reports, raw material certificates. Stored by the manufacturer for 10 years.
• Notified Body certificate (when required). For PPE, medical devices, machinery and certain electrical goods.

Get this wrong and your container sits in port at €450/day demurrage.

Food contact — the regulation everyone underestimates

For plastic, ceramic or stainless products that touch food, EU Regulation 10/2011 applies:

• Specific Migration Limit (SML) testing. Cost: €300–€800 per SKU at an accredited lab.
• Declaration of Compliance for Food Contact (DoC-FCM). Must reference specific food types.

What "fake" certificates look like

Three patterns we catch:

• Issued by an unrecognized lab. Not accredited by ILAC. Customs cross-checks against ILAC's MRA list.
• Expired but not crossed out. Certificate from 2019 used in 2024.
• Wrong product variant. Certificate covers Model A but supplier ships Model B.

Our quality team runs accreditation verification on every certificate before contract signature. Send a compliance check request →