REACH and Bile-Acid Imports: What EU Buyers Must Confirm
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An Italian importer sends a short enquiry about ursodeoxycholic acid. The first reply carries a price. The second carries a certificate of analysis. The third, usually two weeks later, carries one line: what is your REACH status? That is where a surprising number of otherwise workable supply conversations stop, not because the answer is bad, but because nobody on the supply side knows where the obligation actually sits.
REACH is not a certificate that can be scanned and attached. It is a registration duty attached to the legal entity that places the substance on the EU market. For a buyer outside the EU, that entity is almost always the importer. Getting this straight changes what you ask for, and it changes what any supplier can honestly promise.
Where the duty actually sits
Under Regulation (EC) No 1907/2006, a substance manufactured in or imported into the EU at one tonne or more per year per legal entity must be registered with ECHA before it is placed on the market. The registrant is the EU entity that manufactures or imports the substance. An exporter based outside the EU cannot register on the importer's behalf, and a registration number quoted by an exporter that does not belong to an EU legal entity deserves a question rather than a tick in a box.
Two routes exist in practice. The importer registers in its own name, which means it carries the cost, the substance identity dossier and the ongoing communication duties. Or an Only Representative established in the EU is appointed, and that entity becomes the registrant covering shipments to the exporter's customers. The second route is common for speciality substances with several small importers, because it avoids five separate registrations for the same tonnage.
The consequence for a purchasing decision is narrow. You are not buying a registration. You are buying a supply chain in which somebody has accepted the registrant role and can name itself. Ask which route applies and ask for the entity name. An answer that describes the chemistry but not the entity is not an answer.
The identity trap: one trade name, several substances
A registration covers a substance identity, not a product name. Bile acids present three identity questions that buyers routinely collapse into one.
- Free acid or salt. Ursodeoxycholic acid and sodium ursodeoxycholate are different substances for registration. A registration for the acid does not cover the salt.
- Hydrate state. Where both forms can be placed on the market, the identity must state which one is being supplied.
- Compositional profile. Material at 95 percent purity with a broad impurity spectrum is not automatically the same registered identity as material at 99.5 percent, if the dossier specifies a narrower profile.
This matters commercially because a buyer will often check the CAS number, see a match, and stop. The CAS number is necessary and not sufficient. The useful question is whether the registration covers the grade being shipped, at the purity being shipped, from the source being shipped.
What a buyer can realistically ask for
The evidence available at enquiry stage is modest, and it is reasonable to ask for all of it in one message.
| What to ask | What a good answer looks like | What should raise a question |
|---|---|---|
| Registrant identity | A named EU legal entity, either the importer or an Only Representative | "Our product is REACH compliant", with no entity named |
| Registration number | A number that can be checked against the named entity | A number offered without the entity holding it |
| Tonnage band | A band consistent with the volume you intend to buy | Silence on band when your volume sits at the boundary |
| Substance identity | Free acid or salt, hydrate state, compositional profile | Trade name only |
| Safety data sheet | Current EU-format version matching the grade shipped | An SDS from a different product line |
None of these items is as confidential as suppliers sometimes imply. The registration number and the registrant entity are the two data points that let a regulatory affairs team close the question in an afternoon.
Below one tonne the duty does not vanish
Small volumes are where the reasoning usually goes wrong. Registration has a tonnage threshold. The other duties do not. A safety data sheet in the EU format is required for classified substances and for certain unclassified ones, and downstream user obligations on safe use conditions apply regardless of tonnage.
For a research group ordering a few hundred grams, or a formulator running a feasibility batch, the practical answer is that registration may not be triggered while documentation still is. A supplier who declines to provide a safety data sheet because the volume is small is describing an internal process, not the regulation.
What a supply-chain partner can and cannot say
This is where language discipline matters more than chemistry. A supplier outside the EU cannot state that a product is REACH registered, because the registration belongs to an EU entity. What a supplier can do is provide the substance identity data, the compositional data, the safety data sheet content and the origin documentation that a registrant needs in order to hold or join a registration, and can confirm which route is in place for the customers it already serves.
We take that position deliberately. Where the customer is the importer, the registration is theirs to hold, and the most useful help is to make their dossier easier to build: consistent identity across batches, a stable impurity profile, and a specification that does not drift between shipments. Where an Only Representative route exists, the question becomes whether the grade being shipped matches the registered identity, which is a question about our specification rather than about our paperwork.
Why the question always arrives after the price
Purchasing and regulatory affairs work on different clocks. The buyer needs a number to compare. Regulatory needs an entity name, a tonnage band and an identity statement, and it usually gets involved once the number looks acceptable. By then a supplier has already invested in a quotation and a sample, which is why the REACH conversation so often arrives with an implicit deadline attached.
The remedy is procedural rather than technical. Put the four identity lines into the first technical exchange and the question stops arriving late, because it has already been answered before anybody discusses price.
What goes wrong when the answer is wrong
A shipment that arrives without a registrant in place is not simply delayed. The importer is exposed for placing an unregistered substance on the market, the material may be held while the position is established, and the registration that eventually gets built may not cover the tonnage already imported. The cost is rarely the registration fee. It is the weeks of standing inventory and the internal credibility of the person who approved the supplier.
That asymmetry is the reason this article exists. The check takes twenty minutes at enquiry stage and considerably longer afterwards.
Six lines for the first email
If you want to close the topic before it becomes a delay, put six items into your first message: substance name and form, estimated annual volume, whether you will be the importer of record, whether an Only Representative is already appointed for this substance, the grade you need, and the intended use. Six lines produce a precise answer instead of a brochure.
The reverse holds too. A supplier who answers a REACH question with a paragraph about quality systems has not understood the question, and that is useful information about how the rest of the relationship will run.
What the answer looks like in practice
A usable reply names the route, the entity and the identity, and nothing else. Where the customer is the importer, the reply says so and offers the data needed to build the dossier. Where an Only Representative is in place, the reply names it and states which grade the coverage extends to.
Two related questions usually follow, and both are already documented on this site. How a CEP, a DMF and a written confirmation differ by market decides which of the three the customer actually needs. What an EP grade claim asserts decides whether the grade being quoted is the grade being registered. And how animal-origin claims are documented decides whether the source description in the file will survive a regulatory review.
Where the authoritative text sits
The regulation itself, and the guidance that interprets it, are public. The European Chemicals Agency publishes the registration process, the tonnage bands and the role of the Only Representative. The EudraLex collection carries the pharmaceutical side, including the import provisions that sit alongside REACH. The European Directorate for the Quality of Medicines publishes the monograph that defines the substance identity in the first place.
Reading those three sources takes an hour and settles most of the argument. The reason the argument persists is not that the text is obscure. It is that nobody in the commercial conversation has read it.
Frequently asked questions
Who is the REACH registrant when we buy from outside the EU?
The EU importer of record, unless the exporter has appointed an Only Representative established in the EU. In the first case the registration belongs to your company. In the second it belongs to the Only Representative, who covers shipments to that exporter's customers. A supplier outside the EU cannot hold the registration in its own name.
Can a supplier send us a REACH registration number?
It can send the number that applies to the route it uses, together with the name of the legal entity holding it. A number without an entity name cannot be checked, and a registration that belongs to somebody else's import chain does not cover your shipment.
We only buy a few kilograms a year. Does REACH still apply?
Registration has a one-tonne threshold per year per legal entity, so a few kilograms will usually fall below it. The other duties do not disappear. A safety data sheet in the EU format, safe-use information and downstream user obligations can all apply at any tonnage.
Does a registration for ursodeoxycholic acid cover the sodium salt?
No. The free acid and its salt are different substances for registration purposes. The same logic applies to hydrate and anhydrate forms, and to grades with materially different compositional profiles. Match the registration to the identity you actually receive.
How long before shipment should we raise this?
Before the first purchase order, and ideally in the first technical exchange. Registration is not a document that can be produced in a week if the route has not been established, and discovering the gap at the customs stage is the expensive version of the same conversation.
Does REACH replace a certificate of analysis?
No, the two answer different questions. REACH addresses the legal right to place a substance on the EU market. A certificate of analysis addresses the properties of a specific batch. A buyer needs both, and neither substitutes for the other.