REACH is the EU chemical regulation. Every substance that enters the EU above one tonne per year must be registered with ECHA (European Chemicals Agency) by either the manufacturer (if EU-based) or the importer (if extra-EU). For Chinese chemical exports into the EU, the importer carries the registration burden, unless the Chinese factory has appointed an EU-based Only Representative to register on their behalf.
Why REACH is harder than TSCA
TSCA is inventory-based: look up the CAS number, confirm it is on the EPA inventory, file a certification at entry, done. REACH is dossier-based: the registrant must compile a technical dossier covering substance identity, hazard data, exposure scenarios, risk assessment, and uses. For a 10-tonne-per-year registration the dossier alone runs hundreds of pages and the registration fee is in the tens of thousands of euros. This is not paperwork an importer can throw together in a week.
The Only Representative path
The pragmatic workaround for Chinese factories selling into the EU is the Only Representative (OR). The Chinese manufacturer appoints an EU-based legal entity (often a specialist consultancy) as the OR. The OR registers the substance in the OR’s name and the EU importer can then buy from the Chinese factory under a “covered importer” arrangement, meaning the importer benefits from the OR’s registration without needing to register independently.
When you buy a Chinese chemical that has an OR registration in place, ask the factory for:
- The substance registration number from ECHA
- The OR company name and contact details
- The annual tonnage band covered by the registration (1-10 tonnes, 10-100 tonnes, 100-1000 tonnes, etc.)
- Confirmation that your projected import volume falls within the covered tonnage
If your import volume exceeds the covered tonnage, the registration covers the factory’s existing customers, not necessarily you. You may need a separate registration or an upgrade to a higher tonnage band, which costs more.
SVHCs and the candidate list
REACH publishes a Candidate List of Substances of Very High Concern (SVHCs). If your imported substance is on the list at greater than 0.1 percent in an article, you face notification obligations and potential authorisation requirements. The list updates roughly twice a year. Always check current list status before booking, a substance that was clean in January can be on the list by July.
REACH vs TSCA in practical terms
The same chemical can be TSCA-listed in the US (clear at the port with a TSCA certification) and REACH-unregistered in the EU (cargo held until registration or OR coverage proven). This is the most common compliance trap for buyers servicing both markets, they assume one filing covers the other. It does not.
What we verify before EU shipments
For every chemical we ship into Rotterdam, Hamburg, or Antwerp, we confirm before booking: the substance has a current REACH registration covering the destination volume, the OR or EU manufacturer’s legal entity is named on the commercial invoice, and the MSDS Section 15 cites the REACH registration number. If the factory cannot produce that information, the cargo will be held at the destination port, and EU customs are stricter about REACH than US customs are about TSCA.
REACH tonnage bands and registration burden
REACH registration obligations scale with annual import or manufacturing volume per legal entity. The thresholds are 1 to 10 tonnes, 10 to 100 tonnes, 100 to 1,000 tonnes, and over 1,000 tonnes per year. The registration dossier requirements grow with each band: limited toxicology data at the lowest band, full chemical safety reports and downstream-use scenarios at the highest. Registration fees track the same scaling, from a few thousand euros at the lowest band to tens of thousands at the highest.
For a Chinese factory exporting to multiple EU buyers, the practical model is to appoint one Only Representative (OR) covering the substance under one registration, which all importers can rely on. The OR carries the regulatory liability and bills the factory or the importers pro-rata. For a buyer shipping under 10 tonnes per year of a previously-registered substance, the OR fee is typically USD 500 to USD 2,000 per year, modest against the avoided customs-hold risk.
SVHC authorisation and restriction lists
REACH includes two regulatory layers above standard registration: the Authorisation List (Annex XIV) covers substances of very high concern that require explicit authorisation for specific uses, and the Restriction List (Annex XVII) covers substances banned or restricted for specific uses. The Candidate List of SVHC substances feeds both layers. For a buyer shipping into the EU, checking the substance against both lists is part of the standard pre-booking compliance check; substances on the Restriction List are banned for the relevant uses regardless of registration status.
Related terms
TSCA is the US equivalent (inventory-based, not dossier-based). AICIS is the Australian equivalent. MSDS Section 15 carries the REACH registration reference.