Transcript No Slide Title

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
FLAMMABLE
SUBSTANCES /
SUBSTANCES /
SUBSTANCES
/
HIGHLY
PREPARATIONS
PREPARATIONS
FLAMMABLE
WITH OTHER PHYSICAL PREPARATIONS
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
HAZARDOUS TO
THE AQUATIC
ENVIRONMENT
1.3 HAZARDS TO
ENVIRONMENT
HAZARDOUS
TO THE OZONE
LAYER
AQUATIC ACUTE
AQUATIC CHRONIC
CATEGORY 1
ADDITIONAL
EU HAZARD CLASS
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
HAZARDS TO
HUMAN HEALTH
HAZARDS TO
ENVIRONMENT
SYMBOLS
PHYSICAL
HAZARDS
HAZARDS TO
HUMAN HEALTH
HAZARDS TO
ENVIRONMENT
SYMBOLS – TRANSPORT SYMBOLS ON
SINGLE PACKAGES
PHYSICAL
HAZARDS
HAZARDS TO
HUMAN HEALTH
HAZARDS TO
ENVIRONMENT
SIGNAL WORDS
DANGER
WARNING
NO
SYMBOL
RISK PHRASES – HAZARD STATEMENTS
ACUTE TOXIC
VERY TOXIC
ORAL
R28: Very toxic if swallowed
ACUTE TOXIC
CATEGORY 1
ORAL
H300: Fatal if swallowed
EXPLOSIVES
R2: Risk of explosion by shock, friction,
fire other sources of ignition
EXPLOSIVES
DIVISION 1.2
H202: Explosive, severe projection hazard
SAFETY PHRASES – PRECAUTIONARY STATEMENTS
ACUTE TOXIC
EXPLOSIVES
VERY TOXIC
S2: Keep out of reach of children
ORAL
S36/37: Wear suitable protective
clothes and gloves
ACUTE TOXIC
CATEGORY 1
ORAL
EXPLOSIVES
DIVISION 1.2
P370+P380: In case of fire: evacuate area
P264: 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
PREPARATIONS
(1999/45/EC)
PLANT
PROTECTION
PRODUCTS
(91/414/EEC)
RESTRICTIONS ON
MARKETING AND USE
(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
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: [email protected]
http://ecb.jrc.it/