CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES FROM CURRENT EU LEGISLATION TO THE

1. 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

2. NOW FUTURE 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

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

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

6. NOW & FUTURE 1.1 PHYSICAL HAZARDS 1. HAZARD CLASSIFICATION 1.2 HAZARDS TO HUMAN HEALTH 1.3 HAZARDS TO ENVIRONMENT

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

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

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

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

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

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

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

14. NOW & FUTURE 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?

15. 2.1 HOW DOES IT LOOK LIKE? NOW LABELLING ELEMENTS: 1. SYMBOLS2. RISK PHRASES3. SAFETY PHRASES Very toxic to aquatic organisms This material and its container must be disposed as hazardous waste N

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

17. NOW SYMBOLS PHYSICAL CHEMICAL HAZARDS HAZARDS TO HUMAN HEALTH HAZARDS TO ENVIRONMENT

18. FUTURE SYMBOLS PHYSICAL HAZARDS HAZARDS TO HUMAN HEALTH HAZARDS TO ENVIRONMENT

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

20. FUTURE SIGNAL WORDS DANGER WARNING NO SYMBOL

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

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

23. 2.2 WHERE DO WE SEE THESE LABELS? WHERE WILL WE SEE THESE LABELS? +

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

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

26. 3.1 HARMONISED CLASSIFICATION & LABELLING vs SELF- CLASSIFICATION & LABELLING NOW FUTURE 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 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

27. 3.2 WHO IS RESPONSIBLE IN THE SUPPLY CHAIN FUTURE NOW 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 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.

28. 3.3 DOWNSTREAM LEGISLATION DOWNSTREAM LEGISLATION PLANT PROTECTION PRODUCTS (91/414/EEC) PREPARATIONS (1999/45/EC) RESTRICTIONS ON MARKETING AND USE (76/769/EEC) BIOCIDES(98/8/EC) ALL PROVISONS UNDER THIS DIRECTIVE ARE INCLUDED UNDER THE NEW REGULATION WORKPLACE PROTECTION (98/24/EC) SEVESO – MAJOR ACCIDENT HAZARDS (96/82/EC) EXPORT-IMPORT (304/2003) COSMETICS (2003/15/EC) HAZARDOUS WASTE (91/689/EC) … and others

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

30. 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

31. 4.1 PREPARATION OF DISCUSSIONS OF C&L UNDER DIRECTIVE 67/548 http://ecb.jrc.it/classification-labelling/MEETINGS/public.htm • SET UP AGENDA AND CALL FOR RELEVANT DOCUMENTATION • WRITTEN PROCEDURES AND PREPARATION OF DIUSCUSSION

32. 4.2 CHAIRING OF MEETINGS WITH EXPERTS • DIFFERENT TYPE OF EXPERTS’ MEETINGS: • THE TECHNICAL COMMITTEE OF CLASSIFICATION AND LABELLING (TC C&L) • AD-HOC MEETINGS, FOR EXAMPLE WITH THE EXPERTS ON PHYSICAL CHEMICAL EXPERTS • SPECIALISED EXPERTS MEETINGS ON CANCEROGENICITY, MUTAGENICITY OR REPRODUCTIVE TOXICITY

33. 4.3 FOLLOW-UP http://ecb.jrc.it/classification-labelling/MEETINGS/public.htm • FOLLOW-UP TO DISCUSSIONS AND CONCLUSIONS • DRAFTING DETAILED SUMMARY RECORDS OF DISCUSSIONS AT THE MEETINGS • PREPARE DRAFT PROPOSAL FOR AMENDMENT TO TECHNICAL PROGRESS TO DIRECTIVE 67/548/EEC AND FORWARD TO DG ENV

34. 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

35. 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

36. 4.6 PREPARING FOR HANDING OVER TO THE AGENCY 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

37. I TALKED ABOUT CLASSIFICATION AND LABELLING OF DANGEROUS SUBSTANCES FROM CURRENT EU LEGISLATION TO THE GLOBALLY HARMONISED SYSTEM 1. HAZARD CLASSIFICATION 4. TASKS OF THE ECB 2. LABELLING 3. WHO IS DOING CLASSIFICATION & LABELLING AND FOR WHOM THANK YOU FOR LISTENING In case of any additional questions after today, please contact: elisabet.berggren@jrc.it http://ecb.jrc.it/