CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES FROM CURRENT EU LEGISLATION TO THE GLOBALLY HARMONISED SYSTEM Zagreb, 12 December 2006 Dr. Elisabet Berggren European Chemicals Bureau Institute for Health and Consumer Protection Directorate-General Joint Research Centre European Commission

A NEW REGULATION IMPLEMENTING THE GLOBALLY HARMONISED SYSTEM (GHS) OF CLASSIFICATION & LABELLING OF CHEMICALS - DRAFT DEVELOPED BY DG ENTR IN COLLABORATION WITH DG ENV AND DG JRC (ECB) - COMMISSION PROPOSAL: DECEMBER 2006 (HOPEFULLY) - POSSIBLE TIMING FOR ENTERING INTO FORCE: 2008 CLASSIFICATION & LABELLING OF DANGEROUS SUBSTANCES IN ACCORDANCE WITH DIRECTIVE 67/548/EEC

CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES FROM CURRENT EU LEGISLATION TO THE GLOBALLY HARMONISED SYSTEM 4. TASKS OF THE ECB 1. HAZARD CLASSIFICATION 2. LABELLING 3. WHO IS DOING CLASSIFICATION & LABELLING AND FOR WHOM

CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES FROM CURRENT EU LEGISLATION TO THE GLOBALLY HARMONISED SYSTEM 1. HAZARD CLASSIFICATION 2. LABELLING 4. TASKS OF THE ECB 3. WHO IS DOING CLASSIFICATION & LABELLING AND FOR WHOM

1. HAZARD CLASSIFICATION 1.1 PHYSICAL HAZARDS 1.2 HAZARDS TO HUMAN HEALTH 1.3 HAZARDS TO ENVIRONMENT

1.1 PHYSICAL HAZARDS EXPLOSIVES OXIDISING SUBSTANCES/ PREPARATIONS EXTREMELY FLAMMABLE SUBSTANCES / PREPARATIONS HIGHLY FLAMMABLE SUBSTANCES / PREPARATIONS REACTS VIOLENTLY WITH WATER SUBSTANCES / PREPARATIONS WITH OTHER PHYSICAL PROPERTIES MAY FORM EXPLOSIVE PEROXIDES FLAMMABLE SUBSTANCES / PREPARATIONS

1.1 PHYSICAL HAZARDS EXPLOSIVES OXIDISING GASES FLAMMABLE GASES FLAMMABLE AEROSOLS FLAMMABLE LIQUIDS FLAMMABLE SOLIDS OXIDISING LIQUIDS OXIDISING SOLIDS GASES UNDER PRESSURE SELF-REACTIVES PYROPHORIC LIQUIDS PYROPHORIC SOLIDS SELF-HEATING SUBSTANCES SUBSTANCES WHICH IN CONTACT WITH WATER EMIT FLAMMABLE GASES ORGANIC PEROXIDES CORROSIVE TO METALS

1. 2 HAZARDS TO HUMAN HEALTH CANCEROGENICITY LONG-TERM TOXICITY IRRITATION CORROSION SENSITISATION MUTAGENICITY TOXICITY TO REPRODUCTION ACUTE TOXICITY OTHER TOXIC PROPERTIES TOXICITY VIA LACTATION NARCOTIC EFFECTS

1.2 HAZARDS TO HUMAN HEALTH CANCEROGENICITY RESPIRATORY OR SKIN SENSITISATION SERIOUS EYE DAMAGE/ EYE IRRITATION CORROSION/ IRRITATION SPECIFIC TARGET ORGAN TOXICITY – SINGLE EXPOSURE GERM CELL MUTAGENICITY REPRODUCTION TOXICITY ACUTE TOXICITY SPECIFIC TARGET ORGAN TOXICITY – REPEATED EXPOSURE ASPIRATION HAZARD

1.3 HAZARDS TO ENVIRONMENT TOXICITY TO AQUATIC ENVIRONMENT DANGEROUS FOR THE OZONE LAYER VERY TOXIC & LONG-TERM ADVERSE EFFECT TOXIC & LONG-TERM ADVERSE EFFECT HARMFUL & LONG-TERM ADVERSE EFFECT LONG-TERM ADVERSE EFFECT

1.3 HAZARDS TO ENVIRONMENT HAZARDOUS TO THE AQUATIC ENVIRONMENT HAZARDOUS TO THE OZONE LAYER AQUATIC ACUTE AQUATIC CHRONIC CATEGORY 1 CATEGORY 2 CATEGORY 3 CATEGORY 4 ADDITIONAL EU HAZARD CLASS

CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES FROM CURRENT EU LEGISLATION TO THE GLOBALLY HARMONISED SYSTEM 1. HAZARD CLASSIFICATION 2. LABELLING 4. TASKS OF THE ECB 3. WHO IS DOING CLASSIFICATION & LABELLING AND FOR WHOM

2. LABELLING 2.2 WHERE DO WE SEE THESE LABELS? 2.1 HOW DOES IT LOOK LIKE? WHAT WILL IT LOOK LIKE? WHERE WILL WE SEE THESE LABELS?

2.1 HOW DOES IT LOOK LIKE? LABELLING ELEMENTS: 1.SYMBOLS 2.RISK PHRASES 3.SAFETY PHRASES Very toxic to aquatic organisms This material and its container must be disposed as hazardous waste N

WHAT WILL IT LOOK LIKE? LABELLING ELEMENTS: 1.PICTOGRAMS 2.SIGNAL WORDS 3.HAZARD STATEMENTS 4.PRECAUTIONARY STATEMENTS Very toxic to aquatic life Avoid release to the environment. Collect spillage. Dispose of contents/container to… WARNING

PHYSICAL CHEMICAL HAZARDS HAZARDS TO HUMAN HEALTH HAZARDS TO ENVIRONMENT SYMBOLS

PHYSICAL HAZARDS HAZARDS TO HUMAN HEALTH HAZARDS TO ENVIRONMENT SYMBOLS

PHYSICAL HAZARDS HAZARDS TO HUMAN HEALTH HAZARDS TO ENVIRONMENT SYMBOLS – TRANSPORT SYMBOLS ON SINGLE PACKAGES

SIGNAL WORDS DANGER WARNING NO SYMBOL

RISK PHRASES – HAZARD STATEMENTS EXPLOSIVES ACUTE TOXIC VERY TOXIC ORAL R2: Risk of explosion by shock, friction, fire other sources of ignition R28: Very toxic if swallowed EXPLOSIVES ACUTE TOXIC CATEGORY 1 ORAL H202: Explosive, severe projection hazard H300: Fatal if swallowed DIVISION 1.2

SAFETY PHRASES – PRECAUTIONARY STATEMENTS EXPLOSIVES ACUTE TOXIC VERY TOXIC ORAL S2: Keep out of reach of children S36/37: Wear suitable protective clothes and gloves ACUTE TOXIC CATEGORY 1 ORAL P264: Wash…thoroughly EXPLOSIVES P370+P380: In case of fire: evacuate area DIVISION 1.2

2.2 WHERE DO WE SEE THESE LABELS? WHERE WILL WE SEE THESE LABELS? +

CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES FROM CURRENT EU LEGISLATION TO THE GLOBALLY HARMONISED SYSTEM 1. HAZARD CLASSIFICATION 2. LABELLING 4. TASKS OF THE ECB 3. WHO IS DOING CLASSIFICATION & LABELLING AND FOR WHOM

3.1 HARMONISED CLASSIFICATION & LABELLING vs SELF- CLASSIFICATION & LABELLING 3.2 WHO IS RESPONSIBLE IN THE SUPPLY CHAIN 3.3 DOWNSTREAM LEGISLATION 3. WHO IS DOING CLASSIFICATION & LABELLING AND FOR WHOM

SUBSTANCES: SOME SUBSTANCES HAVE A COMPLETELY HARMONISED AND LEGALLY BINDING CLASSIFICATION THROUGH ANNEX I TO DIRECTIVE 67/548 SUBSTANCES NOT LISTED IN ANNEX I ARE SUBJECT TO ‘SELF- CLASSIFICATION’ IN ACCORDANCE TO THE SAME CRITERIA 3.1 HARMONISED CLASSIFICATION & LABELLING vs SELF- CLASSIFICATION & LABELLING SUBSTANCES: SOME SUBSTANCES HAVE A COMPLETETLY OR PARTIALLY HARMONISED AND LEGALLY BINDING CLASSIFICATION THROUGH ANNEX VI TO THE NEW REGULATION SUBSTANCES NOT LISTED IN ANNEX VI ARE SUBJECT TO ‘SELF-CLASSIFICATION’ IN ACCORDANCE TO THE SAME CRITERIA AND THESE CLASSIFICATIONS MUST BE REGISTERED IN THE C&L INVENTORY PREPARATIONS: ALL PREPARATIONS ARE SUBJECT TO ‘SELF-CLASSIFICATION’ IN ACCORDANCE TO THE CRITERIA IN DIRECTIVE 67/548 AND ADDITIONAL PROVISIONS FOR PREPARATIONS IN DIRECTIVE 1999/45 MIXTURES: ALL MIXTURES ARE SUBJECT TO ‘SELF- CLASSIFICATION’ IN ACCORDANCE TO THE CRITERIA IN THE NEW REGULATION

THE ONE PLACING THE SUBSTANCE OR MIXTURE ON THE MARKET MUST CLASSIFY AND LABEL IN ACCORDANCE WITH DIRECTIVE 67/548 ‘PLACING ON THE MARKET’ MEANS MAKING AVAILABLE TO THIRD PARTIES. IMPORTATION INTO THE COMMUNITY CUSTOMS TERRITORY SHALL BE DEEMED TO BE PLACING ON THE MARKET FOR THE PURPOSES OF THIS DIRECTIVE. 3.2 WHO IS RESPONSIBLE IN THE SUPPLY CHAIN THE MANUFACTURER, IMPORTER OR DOWNSTREAM USER PLACING THE SUBSTANCE OR MIXTURE ON THE MARKET MUST CLASSIFY AND LABEL IN ACCORDANCE WITH THE NEW REGULATION THE DISTRIBUTOR MUST ENSURE THAT THE LABEL IS CORRECT AND UNCHANGED ON THE FINAL PACKAGE THE DEFINITIONS OF MANUFACTURER, IMPORTER, DOWNSTREAM USER AND DISTRIBUTOR ARE THE SAME AS IN REACH

PREPARATIONS (1999/45/EC) RESTRICTIONS ON MARKETING AND USE (76/769/EEC) WORKPLACE PROTECTION (98/24/EC) SEVESO – MAJOR ACCIDENT HAZARDS (96/82/EC) COSMETICS (2003/15/EC) HAZARDOUS WASTE (91/689/EC) EXPORT-IMPORT (304/2003) PLANT PROTECTION PRODUCTS (91/414/EEC) BIOCIDES (98/8/EC) … and others 3.3 DOWNSTREAM LEGISLATION ALL PROVISONS UNDER THIS DIRECTIVE ARE INCLUDED UNDER THE NEW REGULATION

CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES FROM CURRENT EU LEGISLATION TO THE GLOBALLY HARMONISED SYSTEM 4. TASKS OF THE ECB 1. HAZARD CLASSIFICATION 2. LABELLING 3. WHO IS DOING CLASSIFICATION & LABELLING AND FOR WHOM

4. TASKS OF THE ECB 4.1 PREPARATION OF DISCUSSIONS OF C&L UNDER DIRECTIVE 67/ CHAIRING OF MEETINGS WITH EXPERTS 4.3 FOLLOW-UP 4.4 ASSISTING IN DRAFTING THE NEW REGULATIUON 4.5 RIP PREPARING FOR HANDING OVER TO THE AGENCY

1.SET UP AGENDA AND CALL FOR RELEVANT DOCUMENTATION 2.WRITTEN PROCEDURES AND PREPARATION OF DIUSCUSSION Draft AGENDA Technical Committee on Classification and Labelling of Dangerous Substances Meeting on Health Effects of Plant Protection Products and Biocides Hotel Concorde, Arona November PREPARATION OF DISCUSSIONS OF C&L UNDER DIRECTIVE 67/548

4.2 CHAIRING OF MEETINGS WITH EXPERTS DIFFERENT TYPE OF EXPERTS’ MEETINGS: 1.THE TECHNICAL COMMITTEE OF CLASSIFICATION AND LABELLING (TC C&L) 2.AD-HOC MEETINGS, FOR EXAMPLE WITH THE EXPERTS ON PHYSICAL CHEMICAL EXPERTS 3.SPECIALISED EXPERTS MEETINGS ON CANCEROGENICITY, MUTAGENICITY OR REPRODUCTIVE TOXICITY

4.3 FOLLOW-UP 1.FOLLOW-UP TO DISCUSSIONS AND CONCLUSIONS 2.DRAFTING DETAILED SUMMARY RECORDS OF DISCUSSIONS AT THE MEETINGS 3.PREPARE DRAFT PROPOSAL FOR AMENDMENT TO TECHNICAL PROGRESS TO DIRECTIVE 67/548/EEC AND FORWARD TO DG ENV

DRAFT DEVELOPED BY DG ENTR IN COLLABORATION WITH DG ENV AND DG JRC (ECB), WORK STARTED SEPTEMBER 2005 PUBLIC INTERNET CONSULTATION (21 AUGUST-21 OCTOBER 2006) FINALCOMMISSION PROPOSAL: DECEMBER 2006 (HOPEFULLY) POSSIBLE TIMING FOR ENTERING INTO FORCE: ASSISTING IN DRAFTING THE NEW REGULATIUON

GUIDANCE FOR INDUSTRY TO BE DEVELOPPED DURING 2007 BASED ON THE NEW REGULATION WITH HELP OF THE EXISTING NET OF EXPERTS CONNECTED TO TC C&L 4.5 RIP 3.6

FROM OCTOBER 2006: NEW CLASSIFICATION PROPOSALS PREPARED BY MEMBER STATES SHALL BE PRESENTED IN ANNEX VI (TO REACH) FORMAT CLASSIFICATION PROPOSALS SHALL BE UPDATED WITH THE TC C&L DISCUSSION AND THEREBY READDY TO HAND OVER TO THE AGENCY TC C&L RECOMMENDATIONS FOR CLASSIFICATION AND LABELLING ARE MADE BOTH IN THE CURRENT AND THE GHS SYSTEM 4.6 PREPARING FOR HANDING OVER TO THE AGENCY

CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES FROM CURRENT EU LEGISLATION TO THE GLOBALLY HARMONISED SYSTEM 4. TASKS OF THE ECB 2. LABELLING 3. WHO IS DOING CLASSIFICATION & LABELLING AND FOR WHOM 1. HAZARD CLASSIFICATION In case of any additional questions after today, please contact: