classification and labelling of dangerous substances from current eu legislation to the

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 ProtectionDirectorate-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 ECB1. HAZARD

CLASSIFICATION

2. LABELLING3. WHO IS

DOING CLASSIFICATION & LABELLING

AND FOR WHOM

CLASSIFICATION AND LABELLING OF

DANGEROUS SUBSTANCES FROM CURRENT EU

LEGISLATION TO THE GLOBALLY HARMONISED SYSTEM

1. HAZARDCLASSIFICATION

2. LABELLING

4. TASKS OF THE ECB

3. WHO IS DOING CLASSIFICATION

& LABELLING AND FOR WHOM

1. HAZARDCLASSIFICATION

1.1 PHYSICAL HAZARDS

1.2 HAZARDS TO HUMAN HEALTH

1.3 HAZARDS TO ENVIRONMENT

1.1 PHYSICAL HAZARDS

EXPLOSIVES

OXIDISINGSUBSTANCES/

PREPARATIONSEXTREMELYFLAMMABLE

SUBSTANCES /PREPARATIONS

HIGHLYFLAMMABLE

SUBSTANCES /PREPARATIONS

REACTS VIOLENTLY

WITH WATER

SUBSTANCES /PREPARATIONS

WITH OTHER PHYSICALPROPERTIES

MAY FORM EXPLOSIVE PEROXIDES

FLAMMABLESUBSTANCES /

PREPARATIONS

1.1 PHYSICAL HAZARDS

EXPLOSIVES

OXIDISING GASESFLAMMABLE

GASES

FLAMMABLEAEROSOLS

FLAMMABLE LIQUIDS

FLAMMABLESOLIDS

OXIDISING LIQUIDS

OXIDISING SOLIDS

GASES UNDERPRESSURE

SELF-REACTIVES

PYROPHORIC LIQUIDSPYROPHORIC

SOLIDS

SELF-HEATING SUBSTANCES

SUBSTANCES WHICH IN CONTACT WITH WATER

EMIT FLAMMABLE GASES

ORGANIC PEROXIDES

CORROSIVE TOMETALS

1. 2 HAZARDS TO HUMAN HEALTH

CANCEROGENICITY

LONG-TERM TOXICITY

IRRITATION

CORROSION

SENSITISATION

MUTAGENICITYTOXICITY 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 CELLMUTAGENICITY

REPRODUCTIONTOXICITY

ACUTE TOXICITY

SPECIFIC TARGET ORGAN TOXICITY

– REPEATED EXPOSURE

ASPIRATIONHAZARD

1.3 HAZARDS TO ENVIRONMENT

TOXICITY TO AQUATIC ENVIRONMENT

DANGEROUS FOR THE OZONE

LAYER

VERY TOXIC

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

HAZARDOUSTO THE OZONE

LAYERAQUATIC ACUTE

AQUATIC CHRONICCATEGORY 1

CATEGORY 1

CATEGORY 2CATEGORY 3

CATEGORY 4ADDITIONAL EU HAZARD CLASS

CLASSIFICATION AND LABELLING OF

DANGEROUS SUBSTANCES FROM CURRENT EU

LEGISLATION TO THE GLOBALLY HARMONISED SYSTEM

1. HAZARDCLASSIFICATION

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. SYMBOLS2. RISK PHRASES3. 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. PICTOGRAMS2. SIGNAL WORDS3. HAZARD STATEMENTS4. 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

DANGERDANGER

WARNINGWARNING

NO SYMBOL

RISK PHRASES – HAZARD STATEMENTS

EXPLOSIVESACUTE TOXIC

VERY TOXIC

ORAL R2: Risk of explosion by shock, friction, fire other sources of ignition

R28: Very toxic if swallowed

EXPLOSIVESACUTE TOXIC

CATEGORY 1ORAL H202: Explosive, severe projection hazard

H300: Fatal if swallowed

DIVISION 1.2

SAFETY PHRASES – PRECAUTIONARY STATEMENTS

EXPLOSIVESACUTE 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. HAZARDCLASSIFICATION

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 67/548SUBSTANCES 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 REGULATIONSUBSTANCES 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 INVENTORYPREPARATIONS:

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 REGULATIONTHE 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 ECB1. HAZARD

CLASSIFICATION

2. LABELLING3. WHO IS

DOING CLASSIFICATION & LABELLING

AND FOR WHOM

4. TASKS OF THE ECB

4.1 PREPARATION OF DISCUSSIONS OF C&L

UNDER DIRECTIVE 67/548

4.2 CHAIRING OF MEETINGS WITH

EXPERTS 4.3 FOLLOW-UP

4.4 ASSISTING IN DRAFTING

THE NEW REGULATIUON4.5 RIP 3.6 4.6 PREPARING FOR

HANDING OVER TO THE AGENCY

1. SET UP AGENDA AND CALL FOR RELEVANT DOCUMENTATION

2. WRITTEN PROCEDURES AND PREPARATION OF DIUSCUSSION

DraftAGENDA

Technical Committee onClassification and Labelling of Dangerous

Substances  

Meeting on Health Effects of Plant Protection Products and Biocides

Hotel Concorde, Arona14-15 November 2006

4.1 PREPARATION OF DISCUSSIONS OF C&L UNDER

DIRECTIVE 67/548http://ecb.jrc.it/classification-labelling/MEETINGS/public.htm

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

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

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

4.4 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. LABELLING3. WHO IS

DOING CLASSIFICATION & LABELLING

AND FOR WHOM

1. HAZARDCLASSIFICATION

In case of any additional questions after today, please contact: elisabet.berggren@jrc.it

http://ecb.jrc.it/