REACH Safety Data Sheet Requirements: What EU Suppliers and Importers Must Get Right

Since January 1, 2023, every Safety Data Sheet circulating in the EU must conform to the revised format introduced by Commission Regulation (EU) 2020/878. That deadline passed more than two years ago, yet we still routinely encounter non-compliant documents from suppliers — some from established chemical distributors who should know better.

The reasons vary. Some companies updated their SDS templates in a hurry and missed critical new fields. Others are relying on documents originally authored by non-EU suppliers who drafted them under GHS conventions that don’t fully align with REACH Annex II. And a few are simply unaware that the 2020 amendment changed more than just formatting requirements — it introduced substantive new disclosure obligations that touch everything from nanomaterial identification to endocrine disruptor flagging.

What follows is a practical breakdown of what REACH-compliant SDS documents must contain, where the updated rules bite hardest, and the specific gaps we see most often when supporting EU market entry for clients across the cosmetics, nutraceutical, and specialty chemicals sectors.

Why Commission Regulation (EU) 2020/878 Changed More Than You Think

REACH Regulation (EC) No 1907/2006 has always required Safety Data Sheets for hazardous substances and mixtures placed on the EU market. What changed under Commission Regulation (EU) 2020/878 — which amended Annex II of REACH — was the level of technical detail required and the integration of several other regulatory frameworks into the SDS itself.

Three changes in particular caught many suppliers off guard.

The UFI requirement. For mixtures that must be notified to the EU Product Notification Portal (PCN Portal) under the CLP Regulation (EC) No 1272/2008, the Unique Formula Identifier (UFI) must now appear in Section 1 of the SDS. The UFI is a 16-character alphanumeric code generated through ECHA’s PCN portal, and it ties the SDS directly to emergency health response notifications — data that national Poison Centres across all 27 Member States depend on. If your SDS for a classified mixture doesn’t carry a UFI, it’s non-compliant, full stop.

Mandatory nanomaterial identification. Section 3 of the SDS must now explicitly identify nano-forms if the substance or mixture contains them. This was a clear gap in the previous Annex II text and reflects growing regulatory scrutiny of nanomaterials under both REACH and EU cosmetics law. The obligation isn’t limited to substances subject to nano-specific registration requirements; it applies wherever nano-forms are present.

Endocrine disruptor disclosure. Substances identified as endocrine disruptors under EU criteria must be flagged in Section 11 (Toxicological Information) and Section 12 (Ecological Information) of the SDS. This is no longer optional language or best practice — it’s a mandatory disclosure. Given that ECHA’s work on endocrine disruptor identification continues to expand, the list of substances triggering this obligation will only grow.

The 16 Sections: Where REACH Compliance Actually Lives

Every REACH-compliant SDS must contain exactly 16 sections in a fixed order. That structure hasn’t changed since REACH came into force, but what must appear within those sections has evolved considerably under successive amendments.

Section 1 covers product identification — name, supplier details, recommended use, and (since 2020/878) the UFI code for classified mixtures. The emergency telephone number must reach a person capable of providing relevant toxicological information, and it must be accessible around the clock or clearly state the hours it is staffed.

Section 2 must reflect current CLP classification and labelling. Any mismatch between the hazard classification on the product label and the hazard statements in Section 2 of the SDS is an immediate red flag for competent authority inspectors. We see this mismatch surprisingly often when SDSs are authored in one country and the product is relabelled for distribution in another.

Section 3 — composition and information on ingredients — is where SVHC disclosure obligations sit. Any substance appearing on the ECHA SVHC Candidate List at or above 0.1% w/w in a mixture must be identified by name, EC number, CAS number, and concentration range. As of early 2026, the Candidate List contains more than 240 substances — and it is updated twice per year, typically in January and June. That means an SDS that was accurate 18 months ago may now be out of date simply because a component’s SVHC status changed. Version-lag on Section 3 is one of the most common compliance failures we encounter.

Sections 4 through 8 cover first aid, fire-fighting, accidental release measures, handling and storage, and exposure controls. All must reference current EU occupational exposure limits (OELs) where they exist, including the indicative OELs published in Commission Directive 2017/164/EU and subsequent amendments.

Section 9 — physical and chemical properties — was significantly expanded under 2020/878. Where the old Annex II specified a relatively short list of properties, the updated text requires a considerably longer set including particle size distribution, specific gravity, and additional parameters relevant to safety assessment. Leaving fields blank is not acceptable unless you explicitly note the information is not applicable and document why. Generic “not available” entries across multiple properties will not survive regulatory scrutiny.

Sections 10 through 12 carry stability, toxicological, and ecological data. This is where endocrine disruptor flags must appear, and where PBT (persistent, bioaccumulative and toxic) or vPvB (very persistent, very bioaccumulative) characterisation must be stated explicitly. Burying these determinations in a footnote or corporate safety annex does not satisfy the requirement.

Section 15 must confirm whether the substance requires authorisation under REACH Annex XIV or is subject to restriction under Annex XVII. Writing “no specific requirements” as a catch-all is not sufficient if the substance — or a component — appears in either annex. Each entry needs to be specifically addressed.

Section 16 — the revision history — matters more than most companies give it credit for. ECHA guidance recommends clearly identifying what changed in each revision. When a competent authority inspector reviews an SDS, an opaque or missing revision history is a reliable signal that the rest of the document hasn’t been actively maintained. It invites closer scrutiny of everything else.

When a Standard SDS Isn’t Enough: Extended SDS Obligations

For substances subject to a Chemical Safety Report (CSR) — generally those registered in quantities above 10 tonnes per year by a single registrant — suppliers must provide an extended SDS (eSDS) that includes exposure scenarios developed as part of the Chemical Safety Assessment under REACH Title II.

These exposure scenarios are attached as an annex to the SDS. They describe the conditions under which the registrant has assessed safe use — specific uses, operational conditions, risk management measures. Downstream users who receive an eSDS have their own obligations: they must either operate within the conditions described, generate their own Chemical Safety Report covering their specific use, or communicate a “use descriptor” back upstream so the registrant can incorporate it.

In practice, this creates a communication chain that many distributors and formulators find administratively demanding. But ignoring it doesn’t make the obligation disappear. REACH enforcement actions in France — coordinated through the DGPR (Direction générale de la prévention des risques) — have increasingly targeted downstream users who cannot demonstrate they’ve reviewed and operationally implemented the exposure scenarios contained in the eSDS they received from their supplier.

Documenting that review is not bureaucratic box-ticking. It’s your primary evidence of due diligence if enforcement comes knocking.

Four Common Gaps That Surface in SDS Audits

After reviewing several hundred SDS documents submitted by clients preparing for EU market entry, four problem areas appear with enough regularity that they’re worth naming directly.

Language compliance — under-enforced until it isn’t. REACH Article 31(5) requires that SDSs be provided in the official language(s) of the Member State where the substance is marketed. A supplier providing a single English-language SDS to customers in France, Germany, Italy, and Spain is non-compliant in at least three of those four markets. French inspectors from the DGCCRF have issued non-conformity notices for precisely this reason. If you sell into multiple Member States, you need language-specific SDS versions for each.

Candidate List lag after SVHC updates. Because the Candidate List grows twice per year, companies that review their SDS templates annually will fall behind. An ECHA monitoring subscription — or a compliance partner who tracks updates in real time — is not optional at scale. A Section 3 that was accurate in June may be incorrect by December.

Missing or mismatched UFI codes. The PCN notification system is still relatively new, and we regularly encounter SDSs for classified mixtures that either omit the UFI entirely or carry a code that doesn’t correspond to the product registered in the PCN Portal. That mismatch isn’t a paperwork technicality — it directly affects whether Poison Centres can retrieve the correct formulation data in an emergency response scenario. ECHA has stated it will increase scrutiny of PCN Portal consistency going forward.

Incomplete Section 9 data. With the expanded property list under 2020/878, Section 9 now has considerably more required entries than under the old template. Suppliers who updated their header to reference the new regulation but didn’t rebuild the section content are holding non-compliant documents. Auditors check Section 9 systematically precisely because it’s a reliable indicator of whether the entire SDS was genuinely updated or just re-dated.

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If your supply chain runs through the EU — or you’re preparing a product for European market entry — reviewing your SDS portfolio against the 2020/878 requirements is a concrete, finite exercise that substantially reduces your enforcement exposure. Start with your highest-volume substances and classified mixtures. Cross-check Section 3 against the current SVHC Candidate List. Verify that UFI codes in your SDS files match your PCN Portal submissions. Confirm language versions are in place for each Member State where you have active distribution.

That’s not a months-long remediation programme. With a structured approach, most SDS portfolios can be audited and corrected within a matter of weeks — before, not after, a competent authority review.

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Written by Sam Sammane, Founder, Care Europe. Learn more about our team

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