Chemicals Digital Product Passport

REACH + CLP + ESPR Comprehensive Compliance Guide

71 Mandatory Fields 18 Optional Fields GHS Labeling

⚖️ Critical Legal Requirements

🚨 Mandatory Compliance Deadlines

  • Active Now: REACH Registration for >1 tonne/year production
  • Active Now: CLP Classification & Labeling (GHS) mandatory
  • Active Now: Safety Data Sheet (SDS) for hazardous substances/mixtures
  • Active Now: SCIP notification within 6 months (if SVHC in articles)
  • July 2026: Full Digital Product Passport integration (ESPR)
  • Penalty: Fines up to €50,000 per substance + imprisonment for severe violations

🔐 Insolvency Protection (ESPR Article 9 + REACH Article 36)

Régris Continuity Guarantee: If your company declares insolvency with official documentation, Régris ensures:

✅ REACH dossier data: 10 years after last supply to EU

✅ Safety Data Sheets: Indefinite availability

✅ 99% uptime maintained per EU requirements

✅ Emergency contact information preserved

✅ GHS labeling data always accessible

Legal basis: ESPR Article 9 + REACH Article 36 (information retention)

📋 Applicable EU Regulations

REACH Regulation (EC) 1907/2006

Registration, Evaluation, Authorization of Chemicals

Covers: Substance registration, safety data, downstream user obligations

CLP Regulation (EC) 1272/2008

Classification, Labeling, Packaging (GHS implementation)

Mandatory pictograms, hazard statements, precautionary statements

Biocidal Products Regulation (EU) 528/2012

If product has biocidal function (disinfectants, preservatives, etc.)

Regulation (EU) 2024/1781 (ESPR)

Ecodesign requirements + Digital Product Passport obligations

Full lifecycle traceability from July 2026

1. Product Identification

Basic substance/mixture identification requirements

Product Name / Trade Name

MANDATORY

Commercial product name exactly as appears on label

REACH Article 18 - Must be consistent across all documentation

Product Type

MANDATORY

Classification: "Substance" or "Mixture"

Substance = single chemical, Mixture = blend of chemicals

CAS Number (if substance)

MANDATORY for substances

Chemical Abstracts Service registry number

Unique identifier - Example: "7732-18-5" (water)

EC Number

MANDATORY for REACH-registered substances

European Community number (EINECS/ELINCS)

Format: XXX-XXX-X - Links to REACH registration

REACH Registration Number

MANDATORY if >1 tonne/year

Unique REACH registration identifier from ECHA

Format: "01-XXXXXXXXXXX-XX-XXXX"

UFI Code (Unique Formula Identifier)

MANDATORY for hazardous mixtures (from 2025)

16-character code for poison center notification

Format: "XXXX-XXXX-XXXX-XXXX" - Generated via ECHA UFI generator

Batch/Lot Number

MANDATORY

Production batch identifier for traceability

Manufacturer/Supplier Details

MANDATORY

Company name, full address, telephone, email

Must include emergency contact number (24/7)

2. CLP Classification & GHS Labeling

Mandatory hazard classification per CLP Regulation

Hazard Classification

MANDATORY

Complete list of hazard classes and categories

Examples: "Flam. Liq. 2", "Acute Tox. 3", "Skin Corr. 1A"

CLP Categories: Physical hazards (16), Health hazards (10), Environmental hazards (3)

GHS Pictograms

MANDATORY

Required pictogram codes (GHS01-GHS09)

Examples: GHS02 (Flame), GHS06 (Skull/crossbones), GHS07 (Exclamation mark)

Signal Word

MANDATORY

"Danger" or "Warning" based on most severe hazard

Danger = Categories 1-2, Warning = Categories 3-4

Hazard Statements (H-phrases)

MANDATORY

Complete list of H-codes and full text

Example: "H225 - Highly flammable liquid and vapor"

Label Requirement: H-codes AND full text must appear on label

Precautionary Statements (P-phrases)

MANDATORY

Required P-codes (max 6 on label)

Example: "P210 - Keep away from heat/sparks/open flames"

Supplemental Hazard Information (EUH-phrases)

OPTIONAL

Additional EU-specific hazard statements

Example: "EUH066 - Repeated exposure may cause skin dryness"

3. Safety Data Sheet (SDS) - 16 Sections

REACH Annex II - Mandatory SDS information for hazardous products

SDS Date & Version Number

MANDATORY

Date of compilation/revision and version identifier

SDS must be updated within 6 months of new safety info

Composition/Ingredient Information

MANDATORY

Substances: Chemical identity, CAS, EC, concentration

Mixtures: All hazardous components + concentration ranges

First Aid Measures

MANDATORY

Emergency procedures per exposure route

Inhalation, skin contact, eye contact, ingestion

Firefighting Measures

MANDATORY

Suitable extinguishing media, special hazards, protective equipment

Accidental Release Measures

MANDATORY

Spill cleanup procedures, containment, disposal

Handling & Storage

MANDATORY

Safe handling precautions, storage conditions, incompatibilities

Temperature limits, ventilation requirements, packaging materials

Exposure Controls / PPE

MANDATORY

Occupational exposure limits (OELs), engineering controls, PPE requirements

Must specify: Gloves, eye protection, respiratory protection

DNEL Values: Derived No-Effect Levels for workers/consumers (if available)

Physical & Chemical Properties

MANDATORY

Appearance, odor, pH, flash point, boiling point, density, solubility, etc.

Minimum 20 properties required per REACH Annex II

Stability & Reactivity

MANDATORY

Chemical stability, hazardous reactions, conditions to avoid

Incompatible materials, hazardous decomposition products

Toxicological Information

MANDATORY

Acute toxicity, skin/eye irritation, sensitization, mutagenicity, carcinogenicity

LD50/LC50 values if available

Ecological Information

MANDATORY

Aquatic toxicity, persistence, bioaccumulation, soil/terrestrial effects

PNEC values (Predicted No-Effect Concentration) if available

Environmental Classification: Must state if Aquatic Acute/Chronic toxicity present

Disposal Considerations

MANDATORY

Waste treatment methods, disposal codes (EWC)

European Waste Catalogue codes, local regulations

Transport Information (ADR/RID/IMDG/IATA)

MANDATORY for hazardous goods

UN number, proper shipping name, hazard class, packing group

Separate info for road (ADR), rail (RID), sea (IMDG), air (IATA)

4. REACH-Specific Requirements

Additional REACH obligations and data

Exposure Scenario (if applicable)

MANDATORY for registered substances >10 tonnes/year

Annex to SDS describing conditions of use

Required if substance classified as hazardous or PBT/vPvB

Use Descriptor System Codes

MANDATORY

SU (Sector of Use), PC (Product Category), PROC (Process Category) codes

Example: "SU3 (Industrial uses), PC9a (Coatings), PROC7 (Spraying)"

Authorization List Status

MANDATORY if substance in Annex XIV

Declaration if substance requires REACH authorization

Sunset date, authorization number if granted

Restriction List Status

MANDATORY if Annex XVII applies

Restrictions on manufacture, use, or placing on market

Example: "Restricted for consumer use per Annex XVII Entry 28"

PBT/vPvB Assessment

MANDATORY if substance >10 tonnes/year

Assessment if substance is Persistent, Bioaccumulative, Toxic

Part of Chemical Safety Assessment (CSA)

5. Sustainability & Circularity (ESPR)

Environmental impact and lifecycle data

Carbon Footprint (kg CO₂e per kg)

MANDATORY (from July 2026)

Cradle-to-gate greenhouse gas emissions

Includes: Raw material extraction, energy use, transport

Renewable Content Percentage

OPTIONAL (encouraged by ESPR)

% of bio-based or renewable raw materials

Recyclability/Recovery Rate

MANDATORY (ESPR)

Feasibility of chemical recycling or recovery

Many solvents: >90% recyclable, Polymers: variable

Alternative Substances (Green Chemistry)

OPTIONAL

Safer alternatives if available (REACH substitution principle)

🎯 Compliance Summary

Mandatory Deadlines:

  • Active Now: REACH registration + CLP classification/labeling
  • Active Now: SDS for hazardous products (update within 6 months of new info)
  • ⏱️ July 2026: Full DPP integration (ESPR 2024/1781)

Data Retention:

  • 📋 Manufacturer: REACH dossier 10 years after last supply
  • 📋 SDS: Indefinite availability requirement
  • 🔒 Régris DPP: 10+ years minimum (chemical-dependent)
  • Insolvency Protected: Safety data survives bankruptcy