The roles, and why they decide everything
REACH (Regulation (EC) No 1907/2006) does not impose a single blanket duty on "the chemical industry". It attaches specific obligations to specific roles, and a company's role determines what it must do. The four roles that matter for an import transaction are these.
| Role | Who this is | Core REACH obligation |
|---|---|---|
| Manufacturer (EU) | A company producing the substance inside the EU | Register substances manufactured at ≥ 1 t/y |
| Importer | An EU company bringing the substance in from outside the EU | Register substances imported at ≥ 1 t/y per importer |
| Only Representative | An EU-established entity appointed in writing by the non-EU manufacturer | Registers on behalf of the non-EU manufacturer's EU importers, who become downstream users |
| Downstream user | A company sourcing the substance from within the EU, or covered by an OR registration | Use the substance safely, communicate information, and check supplier documentation |
The key structural point: the non-EU manufacturer has no formal obligations under REACH. A Chinese producer who exports into the EU is not the registrant and is not the addressee of the regulation. The registration obligation lands on the EU importer — the buyer. This is counter-intuitive for procurement teams, because in most other regulatory contexts the exporting manufacturer carries the burden. Under REACH it does not.
This is why the question "is your product REACH compliant?" produces so little useful information. The supplier is not the actor REACH addresses. The useful question is which role your company occupies, and what data the supplier must provide for you to discharge that role.
Where the threshold actually bites
Registration is triggered at one tonne or more per year, per importer. Below that volume, the registration obligation does not arise. But three common misreadings follow from that sentence, and each has practical consequences.
It is per importer, not per group
The threshold is assessed against each individual legal entity that imports. If two affiliates in different member states each import 700 kg of the same substance from the same supplier, each is below one tonne individually but together they exceed it. If an Only Representative has been appointed, the OR registers and the importers become downstream users — which is one reason the OR route is attractive to groups with multiple EU buying entities.
It is per year, and it accumulates
Volume decisions made early in a commercial relationship can cross the threshold later without anyone actively deciding to register. A buyer who starts at 200 kg in year one and grows to 1.2 tonnes in year three has a registration obligation in year three, and late discovery of that is a common and avoidable problem. Procurement should track annual tonnage per substance per entity, not per purchase order.
Below the threshold does not mean no obligations
Even under one tonne per year, other REACH obligations can apply independently of tonnage. Article 33 communication — informing customers when an SVHC is present above 0.1% by weight — is not tonnage-dependent. Substances on the Candidate List, Annex XIV and Annex XVII have their own regimes regardless of volume.
The Only Representative route, in plain terms
An Only Representative is an EU-established legal entity that the non-EU manufacturer appoints in writing to carry out the registration obligations of importers. The mechanism is set out in Article 8 of REACH. Four points are worth being precise about, because they are frequently misstated.
Who can appoint one
A non-EU manufacturer — including a formulator of a mixture or a producer of an article. Non-EU distributors are not named in Article 8(1) and therefore cannot appoint an Only Representative. If your supplier is a trader rather than a producer, the OR route may not be open at all. This is a concrete reason to establish whether a supplier actually manufactures.
One OR per substance
A non-EU manufacturer can appoint only one Only Representative per substance. The registration must specify which imported volume it covers — either the entire import from that manufacturer, or a defined portion of it.
The effect on the importer
Importers whose tonnage is covered by the OR's registration are treated as downstream users rather than importers. That removes the registration obligation, but only for the tonnage covered and only for that supply chain. If the same importer also buys the substance from a different non-EU source, that volume still has to be registered unless the other supplier has its own OR.
Written confirmation
Appointment must be made in writing, and the importer should obtain confirmation from the Only Representative itself that its tonnage and use are covered. Relying on a supplier's assurance that "we have an OR" without documentary confirmation leaves the importer exposed if the coverage is later found to be narrower than assumed.
If you buy from more than one EU-facing channel, the OR route is generally the more practical option: it centralises market access through a single registered channel instead of requiring each individual importer to register separately.
What the non-EU supplier must provide
Even though the supplier has no direct legal duty, the importer cannot register without data that only the supplier holds. In practice this is where most EU market access stalls. The document set that matters:
| Document | What the importer needs it for | When it is critical |
|---|---|---|
| Full substance identity | Accurate CAS, EC and IUPAC identity, plus known synonyms, to establish which registered substance the material corresponds to | Before any registration decision |
| Composition data | Substance composition, impurities and additives above the relevant reporting levels, plus the analytical basis | Before dossier preparation |
| REACH-compliant SDS (Annex II) | Hazard communication, storage and transport guidance, in the language of the destination member state | Before shipping and before downstream handling |
| Certificate of Analysis | Batch traceability and confirmation that the delivered material meets the registered specification | Before each commercial release |
| OR appointment confirmation | Evidence that the importer's tonnage is covered, if an OR route is used | Before the first commercial shipment |
| SVHC / Candidate List statement | Determines Article 33 communication duties and any SCIP notification obligation | Before placement on the market |
The instruction in the ECHA guidance is explicit that the non-EU manufacturer should provide the Only Representative with up-to-date information on the list of EU importers covered and the quantities imported. That information flow is contractual, not statutory — which is exactly why it should be written into the supply agreement rather than assumed.
The REACH / Cosmetics Regulation overlap
Cosmetic ingredients sit inside two regimes at once, and checking one does not discharge the other.
Cosmetic products are governed by Regulation (EC) No 1223/2009, which has its own Annexes of prohibited and restricted substances and its own Responsible Person framework. Separately, the substances themselves fall within REACH. The two interact in ways that catch people out. Substances restricted under REACH Annex XVII are also prohibited in cosmetics, so a cosmetic ingredient cannot be exempted from REACH by virtue of being cosmetic. And a substance can be prohibited under Annex II of the Cosmetics Regulation while simultaneously being handled under a distinct REACH restriction.
D4 is the clearest current example. It is prohibited in cosmetic products under Annex II of the Cosmetics Regulation, on the basis of classification as suspected toxic to reproduction and very toxic to aquatic life with long-lasting effects. In parallel, the REACH restriction on the cyclic siloxanes covers D4, D5 and D6 as a group, with a different timeline drawn by entry 70 of Annex XVII. Because D4 can occur as a technically unavoidable trace in D5 and D6 raw materials, a formulator using the remaining cyclosiloxanes must monitor D4 content in incoming materials to remain compliant with the Cosmetics Regulation. Two instruments, two mechanisms, one substance.
Our companion note, Dicaprylyl Ether vs Cyclomethicone, sets out the restriction timeline in full for formulators who are working through this one.
A practical checklist for buyers
- Classify your own role first. Are you the importer, or are you a downstream user covered by an OR? The answer determines your obligations entirely, and it is not a question for your supplier.
- Establish whether the supplier manufactures. Not a rhetorical question. Article 8 rights attach to manufacturers and formulators, not to distributors, so the answer affects whether an OR route is even available.
- Track tonnage per substance per legal entity per year. Registration is triggered by accumulated volume, not by purchase order size, and it is per entity rather than per group.
- Ask for the OR's own written confirmation. Not the supplier's statement that an OR exists — the OR's confirmation that your tonnage and use are covered.
- Get the SDS in the right language and the right version. An outdated SDS or one in the wrong member-state language is sufficient grounds for refusal or recall.
- Cross-reference both regimes. Check the substance against REACH Annex XVII, Annex XIV and the Candidate List, and separately against the Cosmetics Regulation Annexes. Overlaps are where gaps hide.
- Confirm the SVHC position in writing. Needed for Article 33 communication and, where applicable, for SCIP notification.
- Put the data flow in the contract. Specification change notification, batch traceability and document delivery timelines belong in the supply agreement, not in an informal understanding.
Sourcing note
Marram Chemical is a Chinese manufacturer, and we are direct about the position that follows from that: we are not the REACH registrant, and we do not claim to hold REACH registration. What we can do is supply the identity, composition, SDS, COA and traceability data that an EU importer or Only Representative needs in order to complete their own registration — and be specific rather than vague about it. Buyers who need to know exactly where a supplier stands should ask for the documents, not the assurance.