REACH
Which duties fall on a manufacturer, an importer and a downstream user, what the 0.1% threshold actually applies to, and where the information has to come from.
REACH is the EU chemicals regulation, Regulation (EC) No 1907/2006. It runs on no data, no market: a substance manufactured in or imported into the EU at one tonne or more per year per company must be registered with ECHA. Separate duties cover authorisation, restriction, and communicating substances of very high concern down the supply chain.
Requires registration of chemical substances, communication of substances of very high concern through the supply chain, and restriction of certain uses.
European Chemicals Agency (ECHA)
Manufacturers and importers of substances at one tonne or more a year, downstream users who formulate or use them industrially, and producers and importers of articles that contain Candidate List substances. A manufacturer outside the EU has no direct duty, so the burden falls on its EU importer unless it appoints an Only Representative under Article 8.
There is no certification and no certificate. Compliance is demonstrated by a registration dossier where one is required, by safety data sheets passed down the chain, by the Article 33 communication for articles, and by not placing a restricted use on the market. Enforcement is by national authorities, who audit documents and test product.
Manufacturers and importers of chemical substances in the European market, and anyone supplying articles that contain them.
| Requirement | Module | What It Does |
|---|---|---|
| Supplier documents stored against the item | Inventory | Safety data sheets, declarations and supplier statements attach to the item and the receiving lot they arrived with, rather than sitting in a mailbox. When an enforcement officer or a customer asks what evidence you held for a given part at a given time, the document is on the record that bought it. This is storage and retrieval, not substance management: there is no substance library, no Candidate List screening and no full material declaration engine in WorkCell. The regulation's unit of analysis is the substance, and WorkCell's unit is the item and the lot, so the two have to be joined by whatever tool actually holds your declarations. |
| Which lots went into which shipment | Inventory | Lot and serial genealogy holds through issues, completions and shipments, so when a supplier discloses that a component contained a newly listed substance you can determine which of your own shipments carry it and which customers received them. That is the question that turns an Article 33 disclosure from a panic into a list, because the declaration you collected sits on the item it covers and the genealogy tells you where that material went. |
| Bills of material that reflect what was built | Engineering | Bills of material are versioned and effective-dated, and a revision supersedes rather than overwrites, so a unit shipped last year resolves to the component list it was actually built from rather than today's. That versioned structure is what an article producer's REACH work rolls up through: the declaration you collected sits on each component, the bill says which components the article actually contained on the date it shipped, and the 0.1 percent question is answered against that build rather than against today's. |
| Purchase records that name the supplier and the date | Purchasing | A supplier catalog holds what each vendor is approved to supply and purchase orders are written against it, with receipts tied to the lot. REACH compliance in a discrete shop is largely a supplier data collection exercise, and the purchase record is where you anchor who you asked, what they returned and when. The outreach campaign, the chase list and the declaration format remain a process you run outside the system. Where a part has a second approved source, the receipt tells you which one actually shipped the lot, and that is usually the record that resolves an argument about whose declaration applies. |
| Nonconformance when a disclosure lands late | Quality | A supplier declaration that contradicts what you told a customer is a quality event, not just a paperwork problem. Severity-classified nonconformances record it against the affected lots, and an 8-D corrective action carries containment, root cause and verification of effectiveness. The regulatory assessment, the customer notification and the decision to withdraw product are judgement calls the record documents rather than makes. |
| Who recorded what, and when | Analytics | Every transaction records the user who performed it and the time, and a REST API and webhooks let compliance data be pulled out to whatever tool actually holds your substance declarations. There are only two live integrations, QuickBooks Online and Shopify, so a dedicated substance database would be connected through the API rather than selected from a marketplace. |
If you manufacture or import a substance into the EU at a tonne or more a year, the enforcement question is your registration number and whether the tonnage band and uses in the dossier match what you actually do. If you believe no registration is needed, the answer has to be an argued position with volumes behind it, not an assumption nobody has revisited since the tonnage grew.
A supplier of an article containing a Candidate List substance above 0.1% by weight must pass on the substance name and sufficient information for safe use, automatically to business customers and within 45 days free of charge to a consumer who asks. The auditor reads what you sent against what the substance data actually supported, which is why the supplier declaration behind it attaches to the item and the receiving lot it arrived with, dated and findable years later.
Enforcement and customer audits both reduce to whether you exercised diligence: who you asked, what form you asked in, what came back, and what you did when a supplier did not answer. Documents stored against the item and the lot give you the dated artefacts. The campaign management, the escalation and the risk-weighting of a non-responding supplier are yours.
Article 31 requires a safety data sheet in the prescribed sixteen-section format for hazardous substances and mixtures, supplied free of charge and updated when new information appears. Inbound sheets store against the item in WorkCell. Authoring, versioning, translating and redistributing your own outbound safety data sheets is not something WorkCell does.
Annex XVII restricts specific substances in specific uses outright, and Annex XIV substances cannot be used after their sunset date without an authorisation. Both lists change, and when one does, the item record and the supplier declarations attached to it are the list you re-screen against, with the genealogy showing which shipments already went out.
Does REACH apply to us if we only make metal parts?
Often yes, as an article producer rather than a registrant. If you import articles or place them on the EU market and they contain a Candidate List substance above 0.1% by weight, Article 33 makes you communicate it down the chain. Coatings, platings, alloying elements and fasteners are where this usually bites.
What exactly does the 0.1% threshold apply to?
Each article, not the finished assembly as a whole. ECHA's position, upheld by the Court of Justice, is that a component which remains an article after assembly is assessed on its own weight. A small plated screw can therefore trigger the duty even though the substance is negligible against the machine's mass.
Can a system make us REACH compliant?
No software confers compliance, and REACH has no certificate to confer. Compliance is a registration dossier where required, accurate supplier data, correct Article 33 communication and restricted uses avoided. WorkCell holds documents, lots and genealogy. The substance data, the assessment and the filings are yours.
Does WorkCell screen our bills of material against the Candidate List?
WorkCell stores the supplier declarations you collect against the item and the lot they arrived with, holds the effective-dated bill of material the article was actually built from, and resolves lot and serial genealogy forward to the shipments and customers that received it. When the Candidate List moves, that is the chain you re-screen and the list you notify from.
How is REACH different from RoHS?
REACH covers chemicals broadly across all sectors, with registration, authorisation, restriction and a growing Candidate List that triggers communication rather than a ban. RoHS restricts ten named substances in electrical and electronic equipment, measured in each homogeneous material, and is enforced through CE marking. A product can be RoHS compliant and still trigger REACH duties.
Keep the records as the work happens.
Tell us how your team collects and stores supplier substance declarations today and we will tell you straight which part of it WorkCell holds and which part needs a dedicated tool.