REACH Knowledge Series · Seven Blocks

The EU's umbrella chemicals law ((EC) No 1907/2006, in force since 1 June 2007): whoever sells chemicals into the EU must register them, submit data and manage risks by its rules.

What breaks: None of our European lines (APIs, intermediates, excipients, formulations) can enter the EU without it. When a customer asks "what is your REACH number" and you cannot answer, the deal is gone; making up a number is worse than having none.

Registration: put the substance on record and submit data by tonnage band; Evaluation: ECHA reviews what you submit; Authorisation: high-hazard substances need approval before use; Restriction: certain uses are banned or limited outright.

What breaks: When a customer says "REACH compliance" they may mean any one of the four. Ask which one first, then act on it — don't take the blame blindly.

The foundation of REACH: a substance above 1 tonne per year cannot be manufactured or imported into the EU without registration.

What breaks: This is not paperwork theatre — it is market access. Before discussing volumes for Europe, settle who owns the REACH obligation and whether a number exists.

If a substance is sold into the EU on its own or in a mixture, totalling ≥1 tonne per year, the EU manufacturer or importer must register it with ECHA.

What breaks: When a customer says "the volume is small, REACH doesn't apply" — calculate the annual tonnage first. 1 tonne is the floor, not a safety margin.

Four bands: 1–10 / 10–100 / 100–1000 / 1000+ tonnes per year — the higher the band, the more data to submit; ≥10 t/y also requires a Chemical Safety Report (CSR).

What breaks: Talking tonnage means talking money: one band up, data fees and testing costs step up with it. Keep room for this in the "certification share" line of quotations.

Nobody repeats the same tests: registrants form a SIEF (Substance Information Exchange Forum) to share data and submit jointly; data costs are shared by tonnage. New entrants pay a Letter of Access (LOA) fee.

What breaks: When a customer or we need to register an existing substance, the first question is not "run tests" — it is "who has data in the SIEF and what does the LOA cost".

A successful registration yields an ECHA registration number (format like 01-2xxxxxxxxxx-xx-xxxx); it goes in section 1.1 of the SDS (Safety Data Sheet) — customers will check.

What breaks: The number is the passport for the deal. If you have one, give it; if not, state clearly "who registers and when it will exist" — never invent one. Same rule as HS codes: a wrong number is worse than none.

Only three kinds of parties can register with ECHA: manufacturers inside the EU/EEA, EU importers, and an “Only Representative (OR)” appointed by a non-EU manufacturer. A Chinese factory cannot register directly — two routes: let the EU customer (the importer) register and we supply data, or we appoint an EU only representative to register and hold the number for us.

What breaks: Pick the wrong role and the money and time are wasted. When a customer says “you go and register”, ask back first: who imports the goods? The duty sits with the importer by default; registering ourselves is about owning market access — whoever holds the number calls the shots.

1 Settle role and tonnage band (1–10 / 10–100 / 100–1,000 / 1,000+ t/y) → 2 Inquiry (Article 26): ask ECHA whether anyone has registered the substance and whether a joint submission exists → 3 Join the joint submission: buy a Letter of Access (LoA) from the Lead Registrant (LR) → 4 Compile the dossier (IUCLID software); above 10 t/y also file a Chemical Safety Report (CSR) → 5 Submit and pay in REACH-IT → 6 ECHA completeness check; pass → registration number → 7 The number is not the finish line: tonnage changes and new hazard data all require dossier updates.

What breaks: Steps 2–3 are where people get stuck: compiling before searching means rebuilding data someone already has (hundreds of thousands wasted); filing alone instead of joining doubles the fee and invites rejection. Search first, join second, compile third — the order is money.

1 Official administrative fee: paid to ECHA by tonnage band (table under “Hard facts”, new rates since 5 Nov 2025); joint submission is cheaper than individual, and SMEs get up to 95% off. 2 Data fee (LoA): paid to the lead registrant for data access — a few thousand euros at low tonnage, tens of thousands where data is rich — this is the member registrant’s big item. 3 Testing fees: only where data gaps need new studies, thousands to hundreds of thousands. 4 Service fees: only representatives and consultants price by service; no official rate.

What breaks: Budgeting only the official fee is the classic crash — the data fee is usually the big one. Conversely, where a joint submission already exists, buying an LoA into the group is a small spend for a big result; search whether it is registered first, then decide how to spend.

1 ECHA (European Chemicals Agency, Helsinki): receives dossiers, issues registration numbers, runs the official Helpdesk — its word is the official line. 2 Lead Registrant (LR) / SIEF: negotiate the data access (LoA) with them. 3 Only Representative (OR): the legal channel for Chinese manufacturers, appointed by power of attorney. 4 National REACH helpdesks and compliance consultancies: for case-specific doubts ask the authorities, not hearsay.

What breaks: The wrong door wastes the most time: asking a consultant for the “official line”, or haggling with ECHA. Check the ECHA site before quoting anything to a customer — a wrong number is worse than no number.

Joining an existing joint submission as a member registrant (the route most Chinese manufacturers take): inquiry in weeks + LoA negotiation 4–8 weeks + dossier and checks 4–6 weeks ≈ 3–6 months to a number. Starting a new joint submission from scratch as lead registrant for a high-tonnage new substance: 18–36 months or more (testing, CSR). On ECHA’s side, the completeness check lands within 3 weeks of payment. There is no grace period — above 1 t/y, number first, sales second.

What breaks: Asked “how soon can we have the number”, “3–6 months joining an existing joint submission” sounds like a professional; “soon” does not. Count back from the order date before taking EU business: selling without a number is running naked.

The "substances of very high concern" watch list — listing does not ban sale, but supply-chain duties attach immediately. After the 4 Feb 2026 update it has 253 entries (adding n-hexane and Bisphenol AF and its salts); updated roughly twice a year.

What breaks: Check our products against the list regularly (at least twice a year); every update means declarations and SDSs must follow — otherwise we hand customers an outdated position.

An article containing a Candidate List substance above 0.1% (w/w): (1) tell the customer the substance name and safe-use information — consumers get it free within 45 days; (2) above 1 t/y, notify ECHA within 6 months of listing; (3) also report to the SCIP database (Waste Framework Directive).

What breaks: 0.1% is the number customers love to dig into when auditing suppliers. Always give the test report (SVHC screening) and the declaration together — miss one and QA sends it back.

Only "promoted" Candidate List entries reach the Authorisation List: once there, use needs an authorisation, and there is a sunset date — after it, no exemption and no authorisation means stop.

What breaks: If one of our products is on the Authorisation List, ask the factory early: has an authorisation been applied for, and which uses does it cover. Don't wait for the customer to raise it.

Directly bans or caps certain substances/uses (e.g. azo dyes, phthalates, hexavalent chromium, PAHs, lead).

What breaks: The Restriction List is the "you cannot sell it this way" red line. Quoting "REACH restriction entry X" to a customer is far harder than saying "we think it's fine".

Once goods enter the EU, the importer is legally the "importer" and carries the registration duty. We support: data, LOA/letters of access, SIEF liaison.

What breaks: When a customer asks us to "provide a REACH registration number", ask back first: are you the importer? If the duty is yours, we support the registration rather than do it for you — that sentence saves you from carrying other people's obligations.

We appoint an EU-based agent (OR) to fulfil registration for us; the registration number stays in our hands and the EU customers in that supply chain become downstream users.

What breaks: Upside: the number is our asset — it survives customer changes. Cost: OR service fee + data fees + real ongoing management. Choose this when volumes are large, customers are scattered and you want to protect the customer base.

Set up a company in the EU to import yourself and carry the registration duty yourself.

What breaks: Don't take this step before the scale justifies it — fixed costs are high; it is an option for when the business is big, not for starting out.

The standard 16-section document; in the EU written per REACH Annex II; language must be the official language of the importing country (German version for Germany).

What breaks: It is the first thing customer QA asks for. Wrong version, wrong language, missing registration number — deals get stuck on documents more often than on price.

If you have a number, put it in (identification section) so the customer's check matches; if the number changes, update and reissue the SDS.

What breaks: "You said you have a number — why isn't it in the document?" That question exposes you instantly. Keep the story consistent: number, tonnage and uses must all match.

The classification, labelling and packaging rules: pictograms, signal words (Danger/Warning), H hazard statements and P precautionary statements.

What breaks: SDS and label inconsistencies are a top reason audits bounce documents. Submit both together, with one consistent story.

Customers usually want an "SVHC declaration" (0.1% declaration) plus a third-party screening report (e.g. 200+ SVHC screening) to back it up.

What breaks: Declaration without report = words without proof; report without declaration = nothing for the customer to file. Give both — making the customer's life easy is our edge.

Standard three steps: (1) confirm substance and annual volume (which CAS, how many tonnes); (2) state who registers (if they are the importer they register; if we have an OR, give the number); (3) give a timeline (how long LOA purchase / registration support takes).

What breaks: Finish the three steps and the customer sees you know the trade; say "yes we have" and fail to produce a number, and trust drops to zero once.

Registration numbers are not free: data costs are shared by tonnage and the LOA (Letter of Access) is charged once or annually. Either the customer bears it, or it goes into our cost.

What breaks: The "certification share" line in quotation v3 exists for exactly this. Quote without settling it and you eat the data fee out of your own margin.

Whether you can sell depends on someone on the EU side fulfilling registration (importer or OR); our supporting duties (data transfer, SDS, labels, SVHC information) all still apply.

What breaks: Don't turn "we are not registered" into "we cannot sell" and scare the customer off, and don't turn "we can sell" into "nothing needs doing" — both versions lose the deal.

The SDS is one document; registration, notification and restriction are separate duties. Complete files ≠ discharged duties.

What breaks: Treat the SDS as a lucky charm and it is the first thing to collapse when something goes wrong.

A number covers "this substance + this tonnage + these uses". Uncovered uses and exceeded tonnage both need topping up.

What breaks: When the customer's volume grows, the tonnage band may step up — proactively remind them; it scores points.

Candidate List ≠ banned (it triggers information/notification duties); Authorisation List ≠ banned immediately (sunset date and exemptions apply); what actually bans is the Restriction List.

What breaks: Scare a customer with "SVHC can't be sold" and you lose the deal; say "no problem at all" and something breaks — explain by list type.

Test reports are only evidence; the duties sit with the companies in the supply chain. Buy a pile of reports with nobody doing the registration and you are still non-compliant.

What breaks: Testing labs love to sell reports as "REACH certification" — there is no such thing as REACH certification. Don't let the sales talk lead you.

What is exempt is the "used in a medicinal product" use; the same thing sold as a chemical (industrial use) still needs registration.

What breaks: Excipients sold into both worlds (pharma + industrial) trip over this most often. Ask the use first, then set the position.