4.2 KiB
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:
- ✅ Bulgarian name (Cyrillic)
- ✅ Latin/English name
- ✅ CAS number
- ✅ EC number
- ✅ CLP Index number (if harmonised)
- ✅ REACH registration number
- ✅ Molecular formula
- ✅ Classification text (CLP)
- ✅ H-statements list
- ✅ EUH-statements (if applicable)
- ✅ P-statements (precautionary)
- ✅ UN number, Class, PG (transport)
- ✅ Pictogram codes
- ✅ Signal word
- ✅ Flash point
- ✅ Boiling point/range
- ✅ Density
- ✅ OEL (occupational exposure limit)
- ✅ ADR Kemler number
- ✅ ADR Tunnel code
- ✅ Transport category
- ✅ 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