CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES FROM CURRENT

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

CLASSIFICATION & LABELLING OF DANGEROUS SUBSTANCES IN ACCORDANCE WITH DIRECTIVE 67/548/EEC 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 AND LABELLING OF DANGEROUS SUBSTANCES FROM CURRENT EU LEGISLATION TO THE GLOBALLY HARMONISED SYSTEM 1. HAZARD CLASSIFICATION 4. TASKS OF THE ECB 3. WHO IS 2. LABELLING 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. 1 PHYSICAL HAZARDS 1. HAZARD CLASSIFICATION 1. 2 HAZARDS TO HUMAN HEALTH 1. 3 HAZARDS TO ENVIRONMENT

EXPLOSIVES 1. 1 PHYSICAL HAZARDS OXIDISING SUBSTANCES/ PREPARATIONS EXTREMELY FLAMMABLE SUBSTANCES / HIGHLY PREPARATIONS FLAMMABLE WITH OTHER PHYSICALPREPARATIONS SUBSTANCES / PROPERTIES PREPARATIONS REACTS VIOLENTLY WITH WATER MAY FORM EXPLOSIVE PEROXIDES

1. 1 PHYSICAL HAZARDS EXPLOSIVES OXIDISING GASES FLAMMABLE GASES OXIDISING SOLIDS OXIDISING GASES UNDER LIQUIDS PRESSURE ORGANIC FLAMMABLE LIQUIDS PEROXIDES SELF-REACTIVES FLAMMABLE CORROSIVE TO SOLIDS METALS FLAMMABLE SELF-HEATING AEROSOLS SUBSTANCES PYROPHORIC SUBSTANCES WHICH IN PYROPHORIC LIQUIDS CONTACT WITH WATER SOLIDS EMIT FLAMMABLE GASES

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

ACUTE TOXICITY 1. 2 HAZARDS TO HUMAN HEALTH SPECIFIC TARGET ORGAN TOXICITY – SINGLE EXPOSURE CORROSION/ IRRITATION SERIOUS EYE DAMAGE/ EYE IRRITATION RESPIRATORY OR SKIN SENSITISATION SPECIFIC TARGET ORGAN TOXICITY – REPEATED EXPOSURE ASPIRATION HAZARD CANCEROGENICITY GERM CELL MUTAGENICITY REPRODUCTION TOXICITY

LONG-TERM ADVERSE EFFECT 1. 3 HAZARDS TO ENVIRONMENT TOXICITY TO AQUATIC ENVIRONMENT VERY TOXIC DANGEROUS FOR THE OZONE LAYER VERY TOXIC & LONG-TERM ADVERSE EFFECT HARMFUL & LONG-TERM ADVERSE EFFECT TOXIC & LONG-TERM ADVERSE EFFECT

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

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

2. 1 HOW DOES IT LOOK LIKE? 2. LABELLING WHAT WILL IT LOOK LIKE? 2. 2 WHERE DO WE SEE THESE LABELS? WHERE WILL WE SEE THESE LABELS?

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

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

SYMBOLS PHYSICAL CHEMICAL HAZARDS TO HUMAN HEALTH HAZARDS TO ENVIRONMENT

SYMBOLS PHYSICAL HAZARDS TO HUMAN HEALTH HAZARDS TO ENVIRONMENT

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

SIGNAL WORDS DANGER WARNING NO SYMBOL

RISK PHRASES – HAZARD STATEMENTS ACUTE TOXIC VERY TOXIC ORAL R 28: Very toxic if swallowed ACUTE TOXIC CATEGORY 1 ORAL H 300: Fatal if swallowed EXPLOSIVES R 2: Risk of explosion by shock, friction, fire other sources of ignition EXPLOSIVES DIVISION 1. 2 H 202: Explosive, severe projection hazard

SAFETY PHRASES – PRECAUTIONARY STATEMENTS ACUTE TOXIC EXPLOSIVES VERY TOXIC S 2: Keep out of reach of children ORAL S 36/37: Wear suitable protective clothes and gloves ACUTE TOXIC CATEGORY 1 ORAL EXPLOSIVES DIVISION 1. 2 P 370+P 380: In case of fire: evacuate area P 264: Wash…thoroughly

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 4. TASKS OF THE ECB 3. WHO IS 2. LABELLING DOING CLASSIFICATION & LABELLING AND FOR WHOM

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

SUBSTANCES: 3. 1 HARMONISED CLASSIFICATION & LABELLING vs SELF- CLASSIFICATION & LABELLING 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 ‘SELFCLASSIFICATION’ IN ACCORDANCE TO THE SAME CRITERIA 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 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 MIXTURES: ALL MIXTURES ARE SUBJECT TO ‘SELFCLASSIFICATION’ IN ACCORDANCE TO THE CRITERIA IN THE NEW REGULATION

3. 2 WHO IS RESPONSIBLE IN THE SUPPLY CHAIN 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. 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

3. 3 DOWNSTREAM LEGISLATION PLANT PROTECTION PREPARATIONS RESTRICTIONS ON PRODUCTS (1999/45/EC) MARKETING AND USE (91/414/EEC) (76/769/EEC) ALL BIOCIDES PROVISONS SEVESO – UNDER THIS WORKPLACE (98/8/EC) DIRECTIVE ARE MAJOR ACCIDENT PROTECTION INCLUDED HAZARDS UNDER THE (98/24/EC) NEW REGULATION (96/82/EC) EXPORT-IMPORT COSMETICS HAZARDOUS (304/2003) (2003/15/EC) WASTE (91/689/EC) … and others

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

4. 1 PREPARATION OF DISCUSSIONS OF C&L UNDER DIRECTIVE 67/548 4. TASKS OF THE ECB 4. 2 CHAIRING OF MEETINGS WITH EXPERTS 4. 3 FOLLOW-UP 4. 4 ASSISTING IN DRAFTING THE NEW REGULATIUON 4. 5 RIP 3. 6 4. 6 PREPARING FOR HANDING OVER TO THE AGENCY

4. 1 PREPARATION OF DISCUSSIONS OF C&L UNDER DIRECTIVE 67/548 http: //ecb. jrc. it/classification-labelling/MEETINGS/public. htm 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 14 -15 November 2006

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 http: //ecb. jrc. it/classification-labelling/MEETINGS/public. htm 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

4. 4 ASSISTING IN DRAFTING THE NEW REGULATIUON 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: 2008

4. 5 RIP 3. 6 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

FROM OCTOBER 2006: 4. 6 PREPARING FOR HANDING OVER TO THE AGENCY 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

1. HAZARD 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 In case of any additional questions after today, please contact: elisabet. berggren@jrc. it http: //ecb. jrc. it/