Transcript CATEGORY 2

Scientific Institute of Public Health
TOXICOLOGY
Toxicology
GLOBALLY HARMONIZED SYSTEM OF CLASSIFICATION
& LABELLING OF CHEMICALS (GHS)
IN THE EU REGULATORY CONTEXT
Dr Thaly LAKHANISKY
Chef de section
Juliette Wytsman 16
B-1050 Brussels
Tel: + 32 2 642 5104
Fax: +32 2 642 5224
e-mail: [email protected]
http://www.iph.fgov.be/toxico/indextox.htm
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Background
The UN Conference on Environment and Development
(UNCED) in 1992 identified the harmonisation of
classification and labelling of chemicals as one of six
action programs in Chapter 19 of UNCED Agenda 21.
Its objective was:
"a globally harmonised hazard classification and
compatible labelling system (GHS) including material
safety data sheets and easily understandable symbols,
should be available, if feasible, by the year 2000."
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Objectives
 enhance the protection of mankind and the environment by
providing an internationally comprehensive system for
hazard communication;
 reduce the need for duplicative testing and evaluation of the
hazards chemicals;
 eliminate the barriers to international trade in chemicals
whose hazards have been properly assessed and identified
on an international basis;
 provide a recognised framework for those countries not
having an existing system.
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Principles
The GHS covers all hazardous chemicals.
Based on hazards - intrinsic properties
Available data will be applied to classification of
substances and mixtures
Target audiences for the GHS include consumers, workers,
transport workers and emergency responders.
“ building block ” - approach
classification as a basis for hazard communication
and other down-stream consequences
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The process
 Comparison of the major classification systems,
identification of similar or identical elements and, for the
elements which were dissimilar, development of a
consensus on a compromise;
 Examination of the scientific basis for the criteria which
define the end-point of concern, gaining expert consensus
on the test methods, data interpretation and level of concern,
and then seeking consensus on the criteria;
 Where there is a decision-tree approach (e.g. irritation) or
where there were dependent criteria in the classification
scheme (acute aquatic toxicity), development of consensus
on the process or the scheme for using the criteria.
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Endpoints
I. Endpoints covered in Existing Classification Systems










Hazardous to the Aquatic Environment
Acute Toxicity
Skin Irritation/Corrosion
Eye Irritation/Corrosion
Sensitisation
Germ Cell Mutagenesis
Reproduction Toxicity
Carcinogenesis
Specific Target Organ Systemic Toxicity
Chemical Mixtures
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Endpoints
II. Endpoints to be covered








Hazardous to the Terrestrial Environment
Neurotoxicity
Immunotoxicity
Aspiration Hazard
Local Dermal Effects after Repeated Exposure
Respiratory Irritation
Water-activated Toxicity Hazards
Narcotic Effects Hazards
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Acute Toxicity
LD50
ENDPOINT
ACUTE
TOXICITY
HAZARD CLASSES AND CRITERIA
Class 1 Class 2 Class 3 Class 4
Class 5
Criteria:
Oral
5
50
300
(mg/kg)
Dermal
50
Inhalation 100
Inhalation 0,5
50
1000
400
2000
* Indication of significant effect
2000 in human
2500
5000
0.5
2
2000
2
10
* Any mortality at Class 4
20
20
* Significant clinical signs at
vapour
Class 4
(mg/L)
mg/L/4h
Inhalation 0,05
dust/mist
(mg/L/4hrs)
2000 and 5000 mg/kg
200
500
gas (ppm)
mg/L/4h
* Anticipated oral LD50 between
25
200
(mg/kg)
2000
0.5
0,5
0.25
2
1
20
5
1
5
* Indication from other studies
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Dermal Irritation/Corrosion
TIERED TESTING AND EVALUATION OF DERMAL CORROSION AND IRRITATION POTENTIAL
Step
Parameter
1a
Existing human or animal
experience)

Not corrosive or no data

1b
Existing human or animal
experience)

Not irritant or no data

1c
Existing human or animal
experience

No data

2a
Structure-activity
structure-property relationships b

Not corrosive or no data

2b
Structure-activity relationships or
Finding
Conclusion
 Corrosive
Classify as corrosive a
 irritant
Classify as irritant a
 Not corrosive or
irritant
No further testing
 corrosive
Classify as corrosive a
 Irritant
Classify as irritant a
structure-property relationships b

Not irritating or no data

./...
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Dermal Irritation/Corrosion
R38
Mean value of the score
of either erythema and
schar or oedema
formation ≥ 2 (min 2
animals)
R35
R34
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Target Organ Systemic Toxicity
CATEGORY 1:
SUBSTANCES THAT HAVE PRODUCED SIGNIFICANT TOXICITY IN
HUMANS, OR THAT, ON THE BASIS OF EVIDENCE FROM STUDIES IN
EXPERIMENTAL ANIMALS CAN BE PRESUMED TO HAVE THE
POTENTIAL TO PRODUCE SIGNIFICANT TOXICITY IN HUMANS
FOLLOWING SINGLE EXPOSURE
Placing a substance in Category 1 is done on the basis of:
 reliable and good quality evidence from human cases or epidemiological
studies;
or,
 observations from appropriate studies in experimental animals in which
significant and/or severe toxic effects of relevance to human health were
produced at generally low exposure concentrations. Guidance
dose/concentration values are provided below to be used as part of
weight-of-evidence evaluation.
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Target Organ Systemic Toxicity
CATEGORY 2:
SUBSTANCES THAT, ON THE BASIS OF EVIDENCE FROM STUDIES IN
EXPERIMENTAL ANIMALS CAN BE PRESUMED TO HAVE THE
POTENTIAL TO BE HARMFUL TO HUMAN HEALTH FOLLOWING SINGLE
EXPOSURE
Placing a substance in Category 2 is done on the basis of observations from
appropriate studies in experimental animals in which significant toxic effects, of
relevance to human health, were produced at generally moderate exposure
concentrations.
Guidance dose/concentration values are provided in order to help in
classification.
In exceptional cases, human evidence can also be used to place a substance in
Category 2.
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Target Organ Systemic Toxicity
GUIDANCE VALUE RANGES FOR SINGLE-DOSE EXPOSURES
Route of exposure
Oral (rat)
Dermal (rat or rabbit)
Inhalation (rat) gas
Inhalation (rat) vapour
Inhalation (rat)
dust/mist/fume
Units
mg/kg bw
mg/kg bw
ppm
mg/l
Category 1
c < 300
c < 1000
c < 2500
c<
10
mg/l/4h
c<
R39/… Very serious irrev. effects
LD50  25
 50
1.0

0.5 mg/l/4h

0.25
GUIDANCE VALUE RANGES FOR SINGLE-DOSE EXPOSURES
Route of exposure
Oral (rat)
Dermal (rat or rabbit)
Inhalation (rat) gas
Inhalation (rat) vapour
Inhalation (rat)
dust/mist/fume
Units
mg/kg bw
mg/kg bw
ppm
mg/l
mg/l/4h
Category 2
300 < c < 2000
1000 < c < 2000
2500 < c < 5000
10 < c < 20
1.0 < c < 5.0
R39/… Very serious irrev.effects
25 < LD50  200
50 < LD50  400
0.5 < LD50  2.0 mg/l/4h
0.25 < LD50  1.0
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Target Organ Systemic Toxicity
TOST following repeated exposure
GUIDANCE VALUE FOR REAPETED-DOSE EXPOSURES
Route of exposure
Oral (rat)
Dermal(rat or rabbit)
Inhalation (rat)gas
Inhalation (rat)vapour
Inhalation (rat)
dust/mist/fume
Units
mg/kg bw/d
mg/kg bw/d
ppm/6h/d
mg/litre/6h/d
mg/litre/6h/d
Category 1
10
20
50
0.2
0.02
R48/ Danger serious damage
 5
 10

0.025
GUIDANCE VALUE RANGES FOR REAPETED-DOSE EXPOSURE
Route of exposure
Oral (rat)
Dermal (rat or rabbit)
Inhalation (rat) gas
Inhalation (rat)vapour
Inhalation (rat)
dust/mist/fume
Units
mg/kg bw/d
mg/kg bw/d
ppm/6h/d
mg/litre/6h/d
mg/litre/6h/d
Category 1
10-100
20-200
50-250
0.2-1.0
R48/ Danger serious damage



50
100
0.25
0.02-0.2
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Carcinogenicity
Category 1:
May cause cancer
known to be carcinogenic
to man based on causal
association


Sufficient evidence on
basis of appropriate
long-term animal
studies,
other relevant
information.
Class 1:
Known or presumed carcinogen
Sub Class 1A:
known human
carcinogen based on
human evidence
Category 3:
Limited evidence of a
carcinogenic effect
Category 2:
May cause cancer
Sub Class 1B:
presumed human
carcinogen based on
demonstrated animal
carcinogenicity
Insufficient evidence for
cat 2


Insufficiently investigated
Class 2:
Suspected human carcinogen

suspected carcinogen

limited evidence of
human or animal
carcinogenicity
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Germ Cell Mutagenicity
Class 2:
May induce heritable mutation in
human germ cells
Class 1:
Known to produce heritable mutation in human germ cells
Sub Class 1A:
positive evidence from
epidemiological studies
Category 1:
May cause inheritable genetic
damage
known to be mutagenic to man
based on causal association
Sub Class 1B:
positive results in:
 in vivo heritable germ cell
tests in mammals
 human germ cell tests
 in vivo somatic mutagenicity
tests, combined with some
evidence of germ cell
mutagenicity.
Category 2:
May cause inheritable genetic
damage
Sufficient evidence on basis
of appropriate long-term
animal studies ,
other relevant information.


positive evidence from tests in
mammals and somatic cell tests
in vivo somatic genotoxicity
supported by in vitro
mutagenicity
Category 3:
Possible risk of irreversible
effects
Evidence from appropriate
mutagenicity studies* but
insufficient for cat 2
* Positive results in assays (in vivo
somatic cell mutagenicity; in vivo
somatic cell DNA interaction assays
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Reproductive Toxicity
Categorie 1:
Categorie 3:
Categorie 2:
May impair fertility
May cause harm to the
unborn child
May impair fertility
May cause harm to the
unborn child
based on causal
association


Possible risk of
impaired fertility
Possible risk of harm to
unborn child
Clear evidence in
animal studies in
absence of toxic
effects,
 Evidence from
other relevant
information.

appropriate animal
studies but insufficient
for cat2
Known or presumed human reproductive or
developmental toxicant
Sub Class 1A:
Sub Class 1B:
Known
Presumed
May cause
harm to
breastfed
babies
other relevant
information
Class 2:
Class 1:
R64
Suspected human
reproductive
or developmental toxicant
Suspected human
reproductive toxicant
Additional
Class :
Effect on or
via lactation
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Aquatic Toxicity
CATEGORY:
96 hr LC50
(for fish)
48 hr EC50
(for crustacea)
72 or 96 hr ErC50
(for algae or other
aquatic plants)
Chronic I
≤ 1 mg/L
Chronic II
>10 to ≤100 mg/L
>1 to ≤10 mg/L
and/or
≤ 1 mg/L
and/or
and/or
The substance is not
rapidly degradable
and/or the log Kow>4
(unless the
experimentally
determined BCF<500.)
and/or
and/or
>1 to ≤10 mg/L
≤ 1 mg/L
Chronic III
>10 to ≤100 mg/L
and/or
>1 to ≤10 mg/L
and/or
>10 to ≤100 mg/L
and/or
The substance is not
rapidly degradable
and/or the log Kow>4
(unless the
experimentally
determined BCF<500.),
unless the chronic
toxicity NOECs> 1mg/L
and/or
The substance is not
rapidly degradable
and/or the log Kow>4
(unless the
experimentally
determined BCF<500.),
unless the chronic
toxicity NOECs> 1mg/L
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Mixtures
CLASSIFICATION OF CHEMICAL MIXTURES

DATA ARE AVAILABLE FOR THE COMPLETE MIXTURE.
Classification of mixtures will be based on the available test data
on the individual constituents of the mixture using cut-off
values/concentration limits for the components of the mixture.
The classification may be modified on a case-by case basis
based on the available test data for the mixture as a whole.
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Mixtures

DATA ARE NOT AVAILABLE FOR THE COMPLETE MIXTURE.
Bridging Principles
There are sufficient data on the individual ingredients and similar tested mixtures to
adequately characterise the hazards of the mixture, these data will be used in
accordance with the following agreed bridging rules:

Dilution: If a mixture is diluted with a diluent which is not expected to affect the
carcinogenicity of other ingredients, then the new mixture may be classified as
equivalent to the original mixture.

Batching: The carcinogenic potential of one production batch of a complex
mixture can be assumed to be substantially equivalent to that of another
production batch of the same commercial product.

Substantially similar mixtures: Given 2 mixtures:
i.) A + B (carcinogen)
ii.) C + B
 If mixture (i) is already classified by testing, mixture (ii) can be assigned the
same category.
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Mixtures

DATA ARE AVAILABLE FOR ALL COMPONENTS OR ONLY FOR
SOME COMPONENTS OF THE MIXTURE.
The mixture will be classified as a carcinogen when at least one ingredient has
been classified as a Category 1 or Category 2 carcinogen and is present at or
above the appropriate cut-off value/concentration limit:
Ingredient
classified as:
Cut-off/concentration limits for a mixture as:
Class 1 Carcinogen
Class 1
Carcinogen
Class 2
Carcinogen
Class 2 Carcinogen
 0.1 %
 0.1 % (note 1)
 1.0 % (note 2)
Note 1: If a Category 2 carcinogen ingredient is present in the mixture at a
concentration between 0.1% and 1%, every regulatory authority would require
information on the SDS for a product. However, a label warning would be
optional. Some authorities will choose to label when the ingredient is present
in the mixture between 0.1% and 1%, whereas others would normally not
require a label in this case.
Note 2: If a Category 2 carcinogen ingredient is present in the mixture at a
concentration of > 1%, both an SDS and a label would generally be expected.Thal akhanisky
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Hazard Communication
EFFECT
Mutagenicity
Carcinogenicity
CATEGORY
SIGNAL WORD
SYMBOL
1A
Danger
New symbol
May cause genetic defects
1B
Danger
New symbol
May cause genetic defects
2
Warning
New symbol
Suspected of causing
genetic defects
1A
Danger
New symbol
May cause cancer
1B
Danger
New symbol
May cause cancer
2
Mixtures 0.1%
Warning
New symbol
Suspected of causing cancer
Mixtures 1.0%
Reprotox
1A
mixtures  0.3%

Danger
New symbol
Mixtures  0.1%
1B
Mixtures  0.3%
MSDS
New symbol
Mixtures  0.1 %
Warning
New symbol
Effects on or via
lactation
?
?
May damage fertility or the
unborn child
May damage fertility or the
unborn child

2+
Mixtures  3.0%
Suspected of causing cancer
May damage fertility or the
unborn child

Danger
HAZARD STATEMENT
May damage fertility or the
unborn child
Suspected of damaging
fertility or the newboen child
May cause harm to breastfed children
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Hazard Communication
EFFECT
Aquatic
environment :
acute
Aquatic
environment :
chronic
CATEGORY
1
SIGNAL WORD
SYMBOL
Warning
Fish & Tree
MSDS
HAZARD STATEMENT
Very toxic to aquatic life
2
Toxic to aquatic life
3
Harmful to aquatic life
1
2
Warning
Fish & Tree
Very toxic to aquatic life with
long lasting effects
Fish & Tree
Toxic to aquatic life with
long lasting effects
3
Harmful to aquatic life with
long lasting effects
4
May cause long lasting
harmful effects to aquatic life
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Pictograms For Supply & Use
EXPLOSIVE
FLAMMABLE
OXIDISING
MILDER
HEALTH
EFFECTS
ACUTELY
TOXIC
DANGEROUS
TO THE
ENVIRONMENT
CORROSIVE
SERIOUS
HEALTH
EFFECTS
!
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Pictograms For TDG
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Hazard Communication
ACUTE TOXICITY: ORAL
Category 1
Category 2
Category 3
Category 4
Category 5
No symbol
Danger
Fatal if swallowed
Danger
Fatal if swallowed
Danger
Toxic if swallowed
Warning
Harmful if
swallowed
Warning
May be harmful if
swallowed
Not required under the UN
Recommendations on the Transport of
Dangerous Goods, Model Regulations
Note:
For gases under the UN Model Regulations,
replace the number 6 in the bottom corner
of the pictogram by 2.
UN Model Regulations pictogram colours:
Symbol and figure: black, Background:
white
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Current EU Labelling
Artikelbezeichnung:
Chargen-Nr. / Partie-Nr. / Lot-Nr.:
Desmodur N 75 MPA/X
0215,00 kg B01
(SAP)-Lieferungs- und Positionsnummer Abgeber:
Auftrags-Nummer Abgeber:
2006004567/ 012
00546872
Netto-Gewicht (kg):
Bayer AG
215,00 kg
Geb. D 604, LS LEV SCM SIS
D-51368 Leverkusen
Brutto-Gewicht (kg):
Adresse Empfänger:
Bestell-Nr. Kunde:
Sumitomo Bayer Urethane Co. Ltd.
13-26, Kukuchi, 3 Chome
Amagasaki, Hyogo Pref. 661; Japan
Artikel-Nr. Empfänger:
Yokohama
Made in Germany
2010004158
Artikel-Nr. Abgeber:
Adresse Abgeber:
via
LL 01-1234
Warenursprung:
230,50 kg
1234567890
1234567890
Packmittelbezeichnung:
Rollsickenfass
Bayer Material-Nummer (02) / Chargen-Nummer (10) / Gewicht (3102) :
WGK
LGK
1
8a
Lfd. Gebinde-Nr.: Stapelbarkeit:
01
3
Gefahrenhinweise / UN-Nr.:
UN 1866
Proper-Shipping-Name:
123456789012345678901234578901234567890
Resin-Solution
Resin-Solution
Resin-Solution
Resin-Solution
Zusatzinformationen / freies Textfeld:
Handle with care !
Do not throw !
1234567890123456789012345678901234567890
c/o Mr. Takeo Misushima
Telephone: 1234-56789-31
gesundheitsschädlich
harmful
nocif
leicht entzündlich
flammable
D
enthält Xylol / 2-Methoxy-1-methyl-ethylacetat
Entzündlich, gesundheitsschädlich beim Einatmen und Berührung
mit der Haut. Reizt die Augen und die Haut.
Bei Berührungen mit den Augen sofort gründlich mit Wasser
abspülen und Arzt konsultieren. Nur in gut gelüfteten Bereichen
verwenden.
contains xylene / 2-methoxy-1-methylethyl acetate
GB
Flammable. Harmful by inhalation and in contact with skin. Irritating
to eyes and skin.
In cases of contact with eyes, rinse immediately with plenty of
water and seek medical advice. Use only in well ventilated areas.
contient xylène / acétate de 2-méthoxy-1-méthyléthyl
NVE (Nummer der Versandeinheit)
F
Inflammable. Nocif par inhalation et par la contact avec la peau.
Irritant pour les yeux et la peau.
En cas de contact avec les yeux, lavez immédiatement et
abondamment avec l‘eau et consulter un spécialiste. Utilizer
seulement dans des zones bien ventilées.
Bayer AG, D-51368 Leverkusen, Tel. + 49 (0) 214-30-99300
FLAMMABLE LIQUID
3
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GHS Labelling
Company/Branding
Information
GHS Label
§1.4.10.5.4.1
Transport Information
§1.4.10.5.2(d)(i)
Commercial
Information
PRODUCT ABC
Manufactured by
Company XYZ
Product Information/Use
Instructions
XXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXX
XXXXXXXX
Other Information
GHS Product Identifier (§1.4.10.5.2(d)(i))
[GHS Chemical Identities
(§1.4.10.5.2(d)(ii))]
GHS Signal Word (§1.4.10.5.2(a))
GHS Hazard Statement (§1.4.10.5.2(b))
GHS Hazard Statement (§1.4.10.5.2(b))
GHS Precautionary Statement
(§1.4.10.5.2(c))
GHS Precautionary Statement
(§1.4.10.5.2(c))
GHS Precautionary Statement
(§1.4.10.5.2(c))
GHS Supplier Identifier (§1.4.10.5.2(e))
GHS Supplemental Information
(§1.4.6.3)
XXXXXXXXXXXXXXXXXXXXXXXXXXXX
GHS Supplemental Information
§1.4.10.5.4.2
UNXXXX &
Proper Shipping
Name
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Safety Data Sheet
(M)SDS Content















IDENTIFICATION
COMPOSITION/INFORMATION ON INGREDIENTS
HAZARDS IDENTIFICATION
FIRST-AID MEASURES
FIRE-FIGHTING MEASURES
ACCIDENTAL RELEASE MEASURES
HANDLING AND STORAGE
EXPOSURE CONTROLS/ PERSONAL PROTECTION
PHYSICAL AND CHEMICAL PROPERTIES
TOXICOLOGICAL INFORMATION
ECOLOGICAL INFORMATION
DISPOSAL CONSIDERATIONS
TRANSPORT INFORMATION
REGULATORY INFORMATION
OTHER INFORMATION
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Downstream consequences
At EU level :

CLASSIFICATION, PACKAGING AND LABELING OF DANGEROUS SUBSTANCES AND
PREPARATIONS :
Dir 67/548/EC (92/32/EC= 7th amendt)

CLASSIFICATION, PACKAGING AND LABELING OF DANGEROUS PREPARATIONS :
Dir 1999/45/EC



RESTRICTION ON MARKETING AND USE OF CHEMICALS:
Dir 76/769/EC
EXPORT OF DANGEROUS CHEMICALS :
Dir 1734/88/EC
WORKER PROTECTION :
Dir 80/1107/EC & 89/391/EC
2nd Framework Directive : 89/391/EC & 90/394/EC: carcinogens at work
PESTICIDES : Use restrictions & labelling:
Dir 79/117/EC + 78/631/EC
Authorisation & Marketing :
Dir 91/414/EC
MAJOR ACCIDENT HAZARDS : « Seveso Directive »
Dir 82/501/EC


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Downstream consequences
At REACH level :
REACH Classification Related Objectives
Classification and Labelling Inventory
Harmonised Substance Classifications
Title X, Articles 109-113
Title X, Article 110
REACH Classification Related Provisions
Pre-Registration
Title III, Article 26
No Requirement to provide Classification
Registration
Title II, Article 9
Requirement to provide Classification
Classification and Labelling Inventory
Title X, Articles 110
Requirement to notify Classification for the Inventory
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Globally Harmonised System
GHS provides common basis for classification for all
systems
GHS provides single Hazard Communication for
supply/transport
Initially differences will be seen in the hazard
communication
GHS will not be “harmonised” at first
GHS will have optionality to facilitate countries with
existing systems to make the transition to the GHS
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Competent Authority Options
GHS Chapter 1.1 – Purpose Scope and Application
§22 Competent authorities will decide how to apply the various
elements of the GHS based on the needs of the competent
authority and the target audience.
§26 Countries are free to determine which of the building blocks will
be applied in different parts of their systems.
§27 Countries (can) choose not to cover all of the effects addressed
by the GHS in each use setting
§28 The full range (of the harmonised elements of the GHS) does
not have to be adopted
§28 As long as the hazards covered by a sector or system are
covered consistently with the GHS criteria and requirements, it
will be considered appropriate implementation of the GHS
lakhanisky
Tha y
FEDICHEM Nov 2004
Competent Authority Options
IMPACT ON THE HAZARD COMMUNICATION MESSAGE
Labels
§19
§39
§39
§41
§42
§46
§51
§53
§54
§59
Supplemental Information, CA to specify additional Information
Precautionary Statements, CA may specify what to use
Precautionary Statements, CA may allow use of Pictograms
Product Identifier, CA may require all Chemical Identities
Product Identifier, Chemical identity on SDS and not on label
Precedence of Symbols, to require all Phys-Chem. Pictograms
Supplemental Information, CA may allow additional information
CMRs, CA may allow certain information either on label or SDS
Labelling Metals &Alloys, CA may allow information on SDS only
Consumer Risk Based Labelling, CA may allow Risk based labels
Safety Data Sheets
§12
CA may require additional information in SDS
GHS Chapter 1.3 – Labels and GHS Chapter 1.4 - SDS
lakhanisky
Tha y
FEDICHEM Nov 2004
Competent Authority Options
HEALTH HAZARD ENDPOINTS
Acute Toxicity, Oral
Acute Toxicity, Dermal
Acute Toxicity, Inhalation
Skin Corrosion/Irritation
Eye Damage/Irritation
Respiratory Sensitisation
Skin Sensitisation
Germ Cell Mutagenicity
Carcinogenicity
Reproductive Toxicity-Fertility
Reproductive Toxicity-Development
Target Organ ST – Single Dose
Target Organ ST – Repeat Dose
HAZARD CATEGORY
1
1
1
1
1
1
1
1
1
1
1
1
1
2
3
2
3
2
3
1A/B/C 2
2A
2
1A/B
1A/B
1A/B
1A/B
2
2
2
2
2
2
4
4
4
5
5
5
3
Lactation



GHS core element
Optional
not clear
lakhanisky
Tha y
FEDICHEM Nov 2004
Competent Authority Options
HAZARD CLASSES
SUPPLY&USE TGD
Aquatic Environment
Physico-Chemical Hazards
Acute Toxicity
Corrosion - Skin and Eyes
Irritation - Skin and Eyes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Sensitisation
CMRs
Target Organ Toxicity
Yes
Yes
Yes
No
No
No
ACUTE ORAL TOXICITY
Transport
Supply&Use
Cat. 1
Cat. 2
Cat. 3
Cat. 4
Cat. 5
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
No
No
lakhanisky
Tha y
FEDICHEM Nov 2004
Conclusions
The GHS will provide all countries with a structure to classify and
label hazardous chemicals. It will help ensure that coherent
information is provided on all imported and exported chemicals
worldwide.
This information will form the basis of systems for the sound
management of chemicals worldwide.
Implementation will require a long-term effort and cooperation among
countries, international organizations, and stakeholders, including
industry and labor representatives.
Hopefully, the system will be widely applied, and significant benefits
to human health and the environment will be the result of that
application.
lakhanisky
Tha y
FEDICHEM Nov 2004
Scientific Institute of Public Health
TOXICOLOGY
Toxicology
... And my thanks to Bill MACHIN (Cefic) for
allowing me to use some of his presentation material.
lakhanisky
Tha y
FEDICHEM Nov 2004