80 lines
4.2 KiB
Markdown
80 lines
4.2 KiB
Markdown
# SDS Compliance & Quality Specification
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## REACH Annex II requirements (Regulation (EU) 2020/878)
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Every SDS **MUST** contain all 16 sections as per REACH Article 31 + Annex II:
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| # | Section | Bare Minimum | Recommended | Best-in-Class |
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|---|---------|-------------|-------------|---------------|
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| 1 | Identification | Product name, CAS, EC, supplier, emergency phone | + REACH reg no, index no, formula, identified uses list | + molecular weight, product form |
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| 2 | Hazards | Classification, H-statements, signal word, pictograms | + P-statements, EUH-statements, PBT/ED statements | + full classification table (hazard class/category/H), precautionary table |
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| 3 | Composition | Component name, CAS, concentration | + EC no, classification per component | + index no, REACH reg no per component |
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| 4 | First aid | Measures per route (inhale/skin/eye/ingest) | + symptoms/effects table | + medical attention subsection |
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| 5 | Firefighting | Suitable/unsuitable media | + fire hazards, decomposition products | + firefighters advice, fire class |
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| 6 | Accidental release | Personal precautions, cleaning methods | + environmental precautions, references | + emergency procedures for non-emergency/responders |
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| 7 | Handling & storage | Safe handling, storage conditions | + hygiene measures, incompatibilities | + specific end uses |
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| 8 | Exposure controls | OEL value | + DNEL/PNEC tables, PPE per type | + engineering controls, environmental exposure |
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| 9 | Physical/chemical | State, colour, odour, flash point, density, boiling point | + vapour pressure, solubility, log Pow | + viscosity, flammability limits, auto-ignition |
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| 10 | Stability/reactivity | Reactivity, stability | + hazardous reactions, conditions to avoid, incompatible materials | + decomposition products |
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| 11 | Toxicological | Acute toxicity classification | + skin/eye corrosion, sensitisation, STOT | + mutagenicity, carcinogenicity, reproductive toxicity |
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| 12 | Ecological | Aquatic toxicity | + persistence, bioaccumulation, PBT/vPvB | + mobility in soil, ED properties |
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| 13 | Disposal | Waste treatment methods | + packaging disposal | + additional information |
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| 14 | Transport | UN number, class, PG for dangerous goods | + ADR/RID/IMDG/IATA per mode | + tunnel code, Kemler, transport category, EAC, EmS |
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| 15 | Regulatory | REACH restrictions, SVHC | + Annex XVII, PIC, POP, national regulations | + CSA statement, WGK, VOC |
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| 16 | Other | H-statements full text | + abbreviations table | + training info, key literature references |
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## Scoring Rubric
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### PASS (7+ points per section)
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- All bare minimum content present
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- ≥70% of recommended content present
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- No missing mandatory REACH Annex II elements
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- Document ≥5 pages for classified substances
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### BARELY PASS (4-6 points per section)
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- All bare minimum present
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- 40-69% of recommended content present
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- May lack some "nice to have" elements
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- Document 3-4 pages
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### NO PASS (<4 points per section or missing mandatory)
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- Missing bare minimum elements
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- <40% of recommended content
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- Missing entire sections
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- Document <3 pages despite classified hazards
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- Missing REACH registration number on substances ≥1t
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## Product-Specific Data Requirements
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Every product entry MUST have:
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1. ✅ Bulgarian name (Cyrillic)
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2. ✅ Latin/English name
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3. ✅ CAS number
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4. ✅ EC number
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5. ✅ CLP Index number (if harmonised)
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6. ✅ REACH registration number
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7. ✅ Molecular formula
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8. ✅ Classification text (CLP)
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9. ✅ H-statements list
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10. ✅ EUH-statements (if applicable)
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11. ✅ P-statements (precautionary)
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12. ✅ UN number, Class, PG (transport)
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13. ✅ Pictogram codes
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14. ✅ Signal word
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15. ✅ Flash point
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16. ✅ Boiling point/range
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17. ✅ Density
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18. ✅ OEL (occupational exposure limit)
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19. ✅ ADR Kemler number
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20. ✅ ADR Tunnel code
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21. ✅ Transport category
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22. ✅ Limited quantities
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## Narrative text requirements
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All 16 sections must have **product-specific** narrative where applicable, not generic placeholders:
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- First aid measures: specific to the product's hazard profile
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- Firefighting: specific to the product's flammability
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- Toxicological: should reference the product's H-statements
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- Ecological: should reference the product's ecotoxicity classification
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