Product Safety Testing Requirements for Cross-Border Sellers

CE marking indicates a product meets EU health, safety, and environmental protection requirements. It's mandatory for products covered by EU directives (electronics, toys, machinery, PPE, etc.). You need a Declaration of Conformity and supporting technical documentation.

Products under EU 'New Approach' directives often require third-party testing (Notified Body assessment) for higher-risk categories: medical devices, pressure equipment, lifts, PPE, and certain toys. Self-declaration is possible for lower-risk products with proper technical documentation.

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is an EU regulation requiring manufacturers and importers to register chemical substances. It restricts Substances of Very High Concern (SVHCs) and maintains a Candidate List updated twice yearly.

Harmonized standards are published in the Official Journal of the EU and provide a presumption of conformity with specific EU legislation. If your product meets a harmonized standard, it is presumed safe for the aspects covered by that standard. Non-harmonized standards (national standards, ISO standards, industry standards) can be used to demonstrate safety but do not provide automatic presumption of conformity. Under GPSR, you must assess product safety using the most appropriate available standards, whether harmonized or not.

Existing test reports remain valid if they were conducted against the same safety requirements. However, GPSR introduces new requirements (responsible person, enhanced labeling, product traceability) that may require additional documentation even if the physical product has not changed. You should review your existing safety file against GPSR requirements and add any missing elements. Re-testing is only required if new safety concerns have been identified for your product category.