GHS Implementation in European Union

Classification, Labelling and Packaging (CLP) Regulation Framework

Overview

The European Union implemented GHS through the CLP Regulation (EC) No 1272/2008, which ensures the protection of human health and the environment while facilitating free movement of chemical substances and mixtures. The regulation applies to all EU Member States and EEA countries.

Implementation Timeline

Regulatory Authorities

European Chemicals Agency (ECHA)

  • CLP Regulation implementation
  • Classification and Labelling Inventory
  • Harmonised classification proposals
  • Guidance development and support

European Commission

  • Regulatory development and updates
  • International harmonization
  • Policy coordination
  • Enforcement oversight

Member State Competent Authorities

  • National enforcement
  • Market surveillance
  • Inspection and compliance
  • Penalty application

Regulatory Framework

Key Legislation

The EU's GHS implementation is primarily governed by the CLP Regulation, supported by various technical guidance documents and implementing regulations.

CLP Regulation (EC) No 1272/2008

  • Title I: General provisions and scope
  • Title II: Classification of substances and mixtures
  • Title III: Labelling and packaging requirements
  • Title IV: Harmonised classification and labelling
  • Title V: Classification and labelling inventory

Supporting Regulations

  • Commission Regulation (EU) 2018/669: Technical updates
  • Commission Regulation (EU) 2019/521: Poison centres notifications
  • Various ATP Regulations: Adaptations to Technical Progress
  • REACH Regulation: Complementary chemical safety framework

Classification and Labelling Requirements

Mandatory Classification

All substances and mixtures placed on the EU market must be classified, labelled and packaged according to CLP requirements.

Hazard Classes

  • Physical Hazards: 16 classes including explosives, flammables, oxidizers
  • Health Hazards: 10 classes covering acute and chronic effects
  • Environmental Hazards: 2 classes for aquatic environment and ozone layer
  • Additional EU Classes: Hazardous to the ozone layer

Labelling Elements

  • Product Identifiers: Chemical name and identifiers
  • Hazard Pictograms: Standardized GHS symbols
  • Signal Words: "Danger" or "Warning"
  • Hazard Statements: H-codes describing hazards
  • Precautionary Statements: P-codes for safe use
  • Supplier Information: Company name and contact details
  • Nominal Quantity: For consumer products

Language Requirements

  • Official Languages: Language(s) of the Member State
  • Multilingual Labels: Permitted with space constraints
  • Translation Quality: Accurate and appropriate translations
  • Supplementary Languages: Additional languages allowed

Harmonised Classification and Labelling

EU-wide Harmonisation

Certain substances have legally binding harmonised classification and labelling that must be used by all suppliers in the EU.

Harmonised Classification Process

  • Proposal Submission: Member States or ECHA submit proposals
  • Scientific Evaluation: Risk Assessment Committee (RAC) opinion
  • Regulatory Decision: European Commission adoption
  • Legal Implementation: Annex VI to CLP Regulation

Priority Substances

  • CMR Substances: Carcinogens, mutagens, reproductive toxicants
  • Respiratory Sensitizers: Substances causing respiratory sensitization
  • Other Serious Hazards: Case-by-case evaluation
  • Pesticide Active Substances: Systematic harmonisation

Classification and Labelling Inventory

C&L Inventory

Companies must notify ECHA of the classification and labelling of substances placed on the EU market, creating a public inventory.

Notification Requirements

  • Scope: Substances in quantities ≥1 tonne/year
  • Deadline: Within one month of placing on market
  • Content: Classification, labelling, and tonnage band
  • Updates: When classification changes

Joint Submissions

  • Same Substance: Coordination among notifiers
  • Agreed Classification: Joint entry preferred
  • Divergent Views: Individual entries with justification
  • Data Sharing: Encouraged for consistency

Poison Centres Notifications

UFI and PCN Requirements

Hazardous mixtures for consumer or professional use must be notified to poison centres with Unique Formula Identifiers (UFI).

Notification Requirements

  • Scope: Hazardous mixtures for consumers/professionals
  • UFI Code: 16-character unique identifier on label
  • Submission Format: IUCLID format to ECHA
  • Timeline: Before placing on market

Information Requirements

  • Product Information: Name, UFI, category, pH
  • Hazard Information: Classification and toxicological data
  • Composition: Concentration ranges of components
  • Packaging: Size, type, and closure information

Compliance and Enforcement

Enforcement Framework

Member States enforce CLP requirements through national competent authorities with harmonised penalty frameworks.

Enforcement Measures

  • Market Surveillance: Product compliance monitoring
  • Inspections: Company and facility audits
  • Corrective Actions: Mandatory compliance measures
  • Product Recalls: Non-compliant product removal
  • Administrative Penalties: Fines and sanctions

Penalty Framework

  • Effective Penalties: Proportionate and dissuasive
  • Criminal Sanctions: For serious violations
  • Administrative Fines: Up to €1.5 million in some Member States
  • Repeat Offenses: Enhanced penalties

Resources and Support