- Home
- PLM & Compliance Blog
- ECHA Found 35% of Safety Data Sheets Non-Compliant: What EU Chemical Companies Must Do Now
ECHA Found 35% of Safety Data Sheets Non-Compliant: What EU Chemical Companies Must Do Now
|
ECHA
|
SDS
|
REACH
Posted By:
Danijel Radonjic
TL;DR:
ECHA’s EU-wide enforcement project examined over 2,500 safety data sheets across 28 countries and found 35% were non-compliant. 30% of companies were referred for enforcement. With CLP new hazard classes mandatory by November 2026, PFAS restrictions covering 10,000+ substances heading for EU legislation in 2027, and REACH enforcement intensifying, EU chemical companies face overlapping deadlines that manual SDS processes cannot address.
What Did ECHA’s EU-Wide SDS Enforcement Project Find?
ECHA’s enforcement project (REF-11) was the most comprehensive SDS quality examination across Europe. Inspectors in 28 countries reviewed 2,500+ SDSs. The headline: 35% were non-compliant.
| Metric | Finding | Source |
| 35% | SDSs non-compliant across 28 EU-EEA countries | ECHA REF-11 / KFT |
| 30% | Companies referred for enforcement | ECHA eval stats 2025 |
| 313 | Compliance checks in 2024 | ECHA eval stats |
| 34% | High-volume dossiers reviewed | ECHA eval stats |
| 1/3 | Imported mixtures failed REACH |
ECHA Enforcement Forum |
| 15,500 | Total registrations checked since 2009 | ECHA eval stats |
| KEY TAKEAWAY |
| 35% non-compliant across 28 countries. 30% enforcement referrals. Intensifying import checks. SDS quality gaps carry real consequences. |
Why Are 35% of EU Safety Data Sheets Non-Compliant?
Outdated classifications: When CLP Annex VI is updated — 22 new + 10 revised substances in the latest update — every affected SDS must be recalculated.
Incomplete content: EU REACH SDS requirements specify precise content for 16 sections, including exposure scenarios. Cloud platforms use the Cefic ESCom package (1,600+ phrases) to automate this.
Distribution gaps: Without automated tracking, companies cannot prove current versions were delivered.
| KEY TAKEAWAY |
| Non-compliance results from outdated classifications, incomplete content, and untracked distribution. Each gap is structural. |
What Is the ECHA Enforcement Escalation Path?
313 compliance checks in 2024, 208 data requests, 30% referred for enforcement. Referral to national authorities is formal enforcement — fines, market access restrictions, or product withdrawal. For 100+ tonnes/year chemicals, 34% of dossiers are now reviewed.
One-third of imported mixtures failed REACH requirements. Customs cooperation is intensifying.
| KEY TAKEAWAY |
| Compliance check → data request → enforcement referral. 34% of high-volume dossiers reviewed. Import checks intensifying. |
What Regulatory Deadlines Are Creating Urgency?
| Deadline | Applies To | SDS Impact |
| May 2025 (now) | New substances | Classify for ED, PBT/vPvB, PMT/vPvM |
| May 2026 | New mixtures | New mixture SDSs must include new hazard data |
| Nov 2026 | Existing substances | Portfolio-wide SDS update + label regeneration |
| End 2026 | PFAS evaluation | Scientific basis for 10,000+ substance restriction |
| Early 2027 | EU PFAS vote |
Mass recalculation + redistribution |
| May 2028 | Existing mixtures | Final wave — every SDS, label, language |
| KEY TAKEAWAY |
| Six overlapping deadlines 2025–2028. November 2026 CLP and 2027 PFAS are the two highest-impact milestones. |
How Does PFAS Regulation Affect SDS Portfolios?
The proposed EU-wide PFAS restriction covers 10,000+ substances across 14 sectors. ECHA evaluation concludes end 2026. For companies managing manually, weeks of work per restriction. Cloud platforms automate the cascade.
| KEY TAKEAWAY |
| PFAS restrictions will trigger mass portfolio updates. Cloud handles this through mass recalculation. Manual processes face weeks per event. |
How Are Companies Handling EU Regulatory Volume at Scale?
A €122M+ coatings manufacturer centralized on one cloud SDS platform: 500,000 items in 25 minutes across 15,000+ products and 50+ countries.
A chemical importer: 25%+ faster, under a week. A textile chemicals company: 25-year partnership, cloud upgrade. A building materials company: master system for SAP/Oracle data exchange.
| KEY TAKEAWAY |
| One pattern: centralized, automated cloud SDS. Fragmented manual processes cannot keep pace with overlapping deadlines. |
What Should EU Chemical Companies Do Now?
Audit SDS compliance. Map portfolio against CLP November 2026 deadlines. Assess PFAS exposure. Cloud SDS platforms address all three. Standard implementation: 5 business days.
| KEY TAKEAWAY |
| Audit now, map CLP deadlines, assess PFAS. Cloud SDS platforms address all three in 5 business days. |
Related Resources
Frequently Asked Questions About ECHA Enforcement and EU SDS Compliance
What happens if ECHA finds my safety data sheets non-compliant?
ECHA’s enforcement follows a structured escalation path. First, ECHA conducts a compliance check on your REACH registration dossier. If deficiencies are found, ECHA issues a formal data request requiring you to provide the missing or corrected information within a specified deadline. In 2024, ECHA issued 208 data requests from 313 compliance checks. Companies that fail to respond adequately are referred to their national enforcement authority — which happened to 30% of non-responding companies in 2024. At the national level, enforcement measures range from written recommendations for minor issues to administrative orders, fines, market access restrictions, and in serious cases, product withdrawal from the EU market. Criminal charges have been filed in some cases. The key point: referral to national authorities is not a warning — it is the beginning of formal legal proceedings.
Does the 35% non-compliance rate apply to all EU countries equally?
The ECHA REF-11 enforcement project covered 28 EU-EEA countries and examined more than 2,500 safety data sheets in 2023. The 35% non-compliance rate is an aggregate figure across this full geographic scope — not a single-country finding. Inspectors focused specifically on requirements arising from changes in Annex II of REACH (EU Regulation 2020/878), including nanoform information, endocrine-disrupting property data, and alignment with UN-GHS Revisions 6 and 7. The fact that over a third of SDSs failed across such a broad sample — spanning manufacturers, importers, and downstream users in 28 countries — indicates a systemic quality issue in EU SDS documentation, not a localized problem in a few member states.
How do the CLP new hazard classes affect existing products already on the market?
Under EU Delegated Regulation 2023/707, existing substances already on the EU market must be reclassified against the new hazard class criteria — endocrine disruptors (ED HH and ED ENV), PBT/vPvB, and PMT/vPvM — by November 2026. Existing mixtures must comply by May 2028. For each substance that meets a new classification threshold, every downstream mixture containing that substance must be recalculated. Every affected SDS must be regenerated in every applicable language and market. Every label must be updated with new hazard statements and potentially new GHS pictograms. And every updated document must be redistributed to downstream users with a traceable audit trail. For companies with large portfolios — thousands of products across dozens of markets — the volume of required updates is substantial. A €122M+ coatings manufacturer with 15,000+ products across 50+ countries handles this through mass recalculation on a cloud platform, processing 500,000 data items in 20–25 minutes.
How can a cloud SDS platform help with PFAS preparation specifically?
Cloud SDS platforms with mass recalculation capability are purpose-built for the kind of portfolio-wide cascade that PFAS restrictions will trigger. When a PFAS substance is restricted or reclassified, the platform automatically identifies every mixture containing that substance, recalculates the hazard classification for each affected mixture across every applicable GHS jurisdiction (20+ supported), regenerates every SDS in every required language (47 available), regenerates every label, and flags which downstream recipients need updated documents — with automated distribution and a full audit trail. For a company managing thousands of products, this process takes minutes on a cloud platform. Manually, the same cascade — identifying affected mixtures, recalculating each one, regenerating documents in multiple languages, and tracking distribution — is measured in weeks per restriction event. With 10,000+ PFAS substances potentially affected and EU legislation expected in 2027, the mass recalculation infrastructure must be in place before the restriction triggers, not after.
What is the connection between REACH enforcement and SDS compliance?
REACH and SDS compliance are directly linked. REACH requires registrants to provide accurate data in their dossiers and supply current, compliant SDSs to downstream users. When ECHA conducts compliance checks — 313 in 2024 alone — the SDS is often the document where non-compliance surfaces. If a substance’s classification has changed but the SDS has not been updated, or if exposure scenarios are missing or incomplete, these gaps appear in ECHA’s review. Additionally, ECHA’s Enforcement Forum found that one-third of substances in imported mixtures failed EU REACH import requirements. For importers, this means customs authorities are increasingly checking whether SDSs for imported products comply with EU requirements. Cloud SDS platforms that centralize compliance data and automate distribution with audit trails ensure that regulatory data is current, complete, and auditable — the three qualities ECHA inspectors verify. See also REACH Restriction 78: what the EU’s microplastics regulation means for your business for another example of how REACH restrictions cascade into SDS obligations.
35% Failed ECHA’s Check. How Would Yours Score?
About Trace One
With more than 30 years of industry expertise, Trace One partners with over 9,000 brands across food and beverage, cosmetics, and chemicals to accelerate product development and turn regulatory complexity into a competitive advantage. Our AI-powered PLM platform, with regulatory intelligence spanning 170+ countries, supports the entire product manufacturing lifecycle — helping brands bring market-leading products to shelf faster and thrive in new markets. Learn more at traceone.com