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If your business imports chemical substances or mixtures into the European Union, you almost certainly have to provide a Safety Data Sheet (SDS). It is one of the most common — and most commonly botched — obligations under REACH. Customers, distributors and inspectors all expect a correct, up-to-date SDS in the right language, and getting it wrong can stop a shipment or a sale. Here is what an SDS is, when it is mandatory, and exactly what you, as an importer, must deliver.
What an SDS is and why REACH requires it
A Safety Data Sheet is the standardised document that communicates the hazards of a substance or mixture and how to handle, store, transport and dispose of it safely. The obligation comes from Regulation (EC) No 1907/2006 (REACH), Article 31 and Annex II. The format was most recently overhauled by Regulation (EU) 2020/878, mandatory for all SDS since 1 January 2023. The SDS is the backbone of hazard communication down the supply chain: it is how a downstream user knows what they are handling.
When an SDS is mandatory (and when it is not)
You must supply an SDS, free of charge, when a substance or mixture is:
- Classified as hazardous under the CLP Regulation (EC) No 1272/2008;
- Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB); or
- Included in the Candidate List of substances of very high concern (SVHC) for authorisation.
There are also cases where a mixture is not classified as hazardous but still requires an SDS on request — for example, mixtures containing certain concentrations of substances that are hazardous to health or the environment, or that have EU workplace exposure limits. When no SDS is required, you may still owe downstream users specific safety information under Article 32. In short: «not classified» does not automatically mean «no obligations».
The importer becomes the «supplier» — your obligations
This is the point importers most often miss. Under REACH, when you import a chemical into the EU you step into the shoes of the supplier. You cannot simply forward the SDS your non-EU manufacturer sent you: you are legally responsible for providing an SDS that is correct, complete and compliant with EU law. That means:
- The classification must follow CLP, not the supplier’s home-country system (a US, Chinese GB or other national SDS is not, by itself, valid in the EU).
- It must be in the official language(s) of every Member State where the product is placed on the market.
- It must reference EU legislation, EU exposure limits and, where relevant, the substance’s REACH registration number.
- You must keep it up to date and re-issue it when new hazard information, a new restriction or a registration changes the content.
Do not confuse the SDS with REACH registration: registration is a separate duty that applies to importers of substances at one tonne per year or more. The SDS is the communication document; registration is the dossier you file with ECHA. Many importers need both.
The 16-section format (Annex II)
Every compliant SDS follows the same 16-section structure, in order. Getting the structure right is not cosmetic — inspectors check it section by section:
- 1. Identification · 2. Hazards identification · 3. Composition/information on ingredients · 4. First-aid measures
- 5. Firefighting · 6. Accidental release · 7. Handling and storage · 8. Exposure controls/personal protection
- 9. Physical and chemical properties · 10. Stability and reactivity · 11. Toxicological information · 12. Ecological information
- 13. Disposal · 14. Transport information · 15. Regulatory information · 16. Other information
Since Regulation (EU) 2020/878, sections must also address nanoforms, endocrine-disruptor information and, where assigned, the Unique Formula Identifier (UFI) in Section 1.1.
Extended SDS and exposure scenarios
For a registered substance manufactured or imported at 10 tonnes/year or more that is hazardous, the registrant must carry out a chemical safety assessment and annex the relevant exposure scenarios to the SDS. This «extended SDS» (eSDS) tells the downstream user the conditions under which use is safe. If you import such substances, your SDS must carry those scenarios — a bare 16-section sheet is not enough.
Language and updates
The SDS must be provided in the official language of the Member State where the product is placed on the market (Spanish for Spain, and so on), unless that State provides otherwise. You must update it without delay when new information on hazards or risk management becomes available, when an authorisation is granted or refused, or when a restriction is imposed — and provide the updated version to everyone you supplied in the previous 12 months.
Common mistakes importers make — checklist
- Reusing a non-EU SDS as-is — the classification and legal references are wrong for the EU market.
- Wrong or missing language — an English-only SDS for the Spanish market is non-compliant.
- Outdated format — still using the pre-2020/878 layout.
- No exposure scenarios where the tonnage triggers an eSDS.
- Confusing SDS with registration — providing an SDS but skipping the REACH registration you also owe.
- Never updating — the SDS is a living document, not a one-off.
A practical example
Imagine you import a cleaning concentrate from a supplier in Asia. Their sheet classifies it under the local system and is written in English only. Before you can sell it in Spain you must: reclassify the mixture under CLP from the actual composition; build a 16-section SDS in Spanish (and any other market language) to Regulation (EU) 2020/878; check whether any component is on the Candidate List or restricted; confirm whether the tonnage triggers REACH registration and, if a registered substance is present at 10 t/y or more, attach the exposure scenarios. Only then is the document fit to hand to a customer or an inspector. Skipping any of these steps is the difference between «we have an SDS» and «we have a compliant SDS».
Frequently asked questions
My Chinese supplier already sent an SDS — isn’t that enough? No. As the EU importer you are the supplier under REACH and are responsible for an SDS that complies with CLP and EU rules, in the correct language. A foreign SDS is a starting point, not a compliant document.
Do I need an SDS if my mixture isn’t classified as hazardous? Sometimes yes — on request, or where specific substances or exposure limits are present. And even without an SDS you may owe Article 32 safety information.
Is the SDS the same as REACH registration? No. The SDS communicates hazards; registration is a dossier filed with ECHA for substances at ≥1 t/y. Importers often need both.
How we handle it at ASC
At ASC we prepare and validate Safety Data Sheets for importers and distributors: we reclassify under CLP, build the 16-section SDS in the required language(s) to Regulation (EU) 2020/878, add exposure scenarios where the tonnage demands it, and check whether you also trigger REACH registration — with a qualified specialist validating and signing off each document. We do not simply relabel your supplier’s sheet: we produce a document you can put in front of a customer or an inspector with confidence. If you import chemicals into the EU, talk to us through our contact page; see also our note on food contact materials and on the EU Packaging Regulation (PPWR). Official sources: ECHA — Safety Data Sheets and REACH (Reg. 1907/2006).