msds-tds/references/compliance-sds-quality.md
2026-07-08 13:12:20 +00:00

4.2 KiB

SDS Compliance & Quality Specification

REACH Annex II requirements (Regulation (EU) 2020/878)

Every SDS MUST contain all 16 sections as per REACH Article 31 + Annex II:

# Section Bare Minimum Recommended Best-in-Class
1 Identification Product name, CAS, EC, supplier, emergency phone + REACH reg no, index no, formula, identified uses list + molecular weight, product form
2 Hazards Classification, H-statements, signal word, pictograms + P-statements, EUH-statements, PBT/ED statements + full classification table (hazard class/category/H), precautionary table
3 Composition Component name, CAS, concentration + EC no, classification per component + index no, REACH reg no per component
4 First aid Measures per route (inhale/skin/eye/ingest) + symptoms/effects table + medical attention subsection
5 Firefighting Suitable/unsuitable media + fire hazards, decomposition products + firefighters advice, fire class
6 Accidental release Personal precautions, cleaning methods + environmental precautions, references + emergency procedures for non-emergency/responders
7 Handling & storage Safe handling, storage conditions + hygiene measures, incompatibilities + specific end uses
8 Exposure controls OEL value + DNEL/PNEC tables, PPE per type + engineering controls, environmental exposure
9 Physical/chemical State, colour, odour, flash point, density, boiling point + vapour pressure, solubility, log Pow + viscosity, flammability limits, auto-ignition
10 Stability/reactivity Reactivity, stability + hazardous reactions, conditions to avoid, incompatible materials + decomposition products
11 Toxicological Acute toxicity classification + skin/eye corrosion, sensitisation, STOT + mutagenicity, carcinogenicity, reproductive toxicity
12 Ecological Aquatic toxicity + persistence, bioaccumulation, PBT/vPvB + mobility in soil, ED properties
13 Disposal Waste treatment methods + packaging disposal + additional information
14 Transport UN number, class, PG for dangerous goods + ADR/RID/IMDG/IATA per mode + tunnel code, Kemler, transport category, EAC, EmS
15 Regulatory REACH restrictions, SVHC + Annex XVII, PIC, POP, national regulations + CSA statement, WGK, VOC
16 Other H-statements full text + abbreviations table + training info, key literature references

Scoring Rubric

PASS (7+ points per section)

  • All bare minimum content present
  • ≥70% of recommended content present
  • No missing mandatory REACH Annex II elements
  • Document ≥5 pages for classified substances

BARELY PASS (4-6 points per section)

  • All bare minimum present
  • 40-69% of recommended content present
  • May lack some "nice to have" elements
  • Document 3-4 pages

NO PASS (<4 points per section or missing mandatory)

  • Missing bare minimum elements
  • <40% of recommended content
  • Missing entire sections
  • Document <3 pages despite classified hazards
  • Missing REACH registration number on substances ≥1t

Product-Specific Data Requirements

Every product entry MUST have:

  1. ✅ Bulgarian name (Cyrillic)
  2. ✅ Latin/English name
  3. ✅ CAS number
  4. ✅ EC number
  5. ✅ CLP Index number (if harmonised)
  6. ✅ REACH registration number
  7. ✅ Molecular formula
  8. ✅ Classification text (CLP)
  9. ✅ H-statements list
  10. ✅ EUH-statements (if applicable)
  11. ✅ P-statements (precautionary)
  12. ✅ UN number, Class, PG (transport)
  13. ✅ Pictogram codes
  14. ✅ Signal word
  15. ✅ Flash point
  16. ✅ Boiling point/range
  17. ✅ Density
  18. ✅ OEL (occupational exposure limit)
  19. ✅ ADR Kemler number
  20. ✅ ADR Tunnel code
  21. ✅ Transport category
  22. ✅ Limited quantities

Narrative text requirements

All 16 sections must have product-specific narrative where applicable, not generic placeholders:

  • First aid measures: specific to the product's hazard profile
  • Firefighting: specific to the product's flammability
  • Toxicological: should reference the product's H-statements
  • Ecological: should reference the product's ecotoxicity classification