Mixture Classification
2014
Importers
Formulators
Workers
2015
Consumers
What is Classification
•
Substance or Mixture meeting hazard criteria in parts 2-5 of
Annex I to CLP
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Physical:
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Human Health:
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Environment:
2
Physical Hazards
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Substance or Mixture meeting hazard criteria in parts 2 of Annex I
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Physical hazards:
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Gather all relevant and reliable information
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16 classes: Explosive, Flammable gases, Aerosols, Oxidising liquids , Oxidising solids,
Gases under Pressure, Flammable Liquids, Flammable solids, Self reactive, pyrophoric
liquids, pyrophoric solids, self-heating, organic peroxides, corrosive to metals
3
Health Hazards
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Substance or Mixture meeting hazard criteria in parts 3 of Annex I
•
Human Health:
•
Gather all relevant and reliable information
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9 classes: Acute toxicity, skin corrosion/irritation, serious eye
damage/eye irritation, respiratory sensitisation, skin sensitisation, germ
cell mutagenicity, carcinogenicity, reproductive toxicity, specific target
organ toxicity- single exposure, specific target organ toxicity- repeated
exposure, aspiration hazard, hazardous to the aquatic environment,
short term (Acute), Hazardous to the aquatic environment, long-term (
Chronic)
Environmental Hazards
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Substance or Mixture meeting hazard criteria in parts 4 -5 of
Annex I
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Environmental Hazards :
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Gather all relevant and reliable information
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3 classes: Hazardous to the aquatic environment, shortterm ( Acute), Hazardous to the aquatic environment, long
term ( Chronic), Hazardous to the ozone layer
5
What’s your role
Your role will define your duties
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Importer
Downstream user ( formulator)
Distributor
Retailer
Professional user
Consumer
What’s a Importer
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REACH and CLP define a…
Importer “means any natural or legal person
established within the Community who is responsible
for import”
Import “means the physical introduction into the
customs territory of the Community”
What’s a formulator
•
A formulator is not defined in CLP but it someone
who produces mixtures within the EU as distinct
from importing them. They are referred to as
‘Downstream Users’ in CLP but have full
responsibility for the classification, packaging and
labelling of mixtures they place on the market
What’s a Distributor
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•
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REACH and CLP define a…
Distributor “Any natural or legal person established
within the Community, including retailer, who only
stores and places on the market a substance, on its
own or in a mixture, for third parties;”
Supplier “Any manufacturer, importer, downstream
user or distributor placing on the market a substance,
on its own or in a mixture;“
What’s placing on the market
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•
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REACH and CLP define a…
Placing on the market “means supplying or making
available, whether in return for payment or free of
charge, to a third party. Import shall deemed to be
placing on the market”
ECHA CLP FAQ 0234 clarifies further regarding 1st
June 2017 derogation for already placed on the
market
Roles & Obligations
Classify
Manufacturer
Importer
Downstream User
Distributor
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*
**
Label
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Package
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Notify
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*If DU changes composition, must classify. If not, use classification
other actor
**Dist may use classification of another actor
Keep info 10
yrs
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What’s a Mixture
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Mixture means a solution or a mixture of two or
more substances
Known as Preparations previously under DPD
If you dilute a solid or liquid with water it is a
mixture
How to classify a mixture
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IMPORTER or FORMULATOR
Competent to classify
5 steps to classification
ECHA website
How to classify a mixture
5 steps to classification
1. Identify all the relevant information for ALL relevant hazard
2.
3.
4.
5.
classes/categories
Examine all the information for validity/relevance
Evaluate against the CLP criteria ( Annex I to CLP)
Decide on the classification- then label/package/prepare
SDS
Review when new information/change in criteria
Title II
Identify
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All information: pH ( ≤2 or ≥ 11.5 )
Composition: formula/recipe
Identity of components: CAS number, name
Concentration of components: % in mixture
Impurities or additives
Mixture in a mixture?
Up to date SDS for each component
Examine
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Is the data consistent: different suppliers with
different C&L in SDS
Listed in C&L inventory ( self- classified);
Listed in Annex VI (harmonised list)
Registered under REACH
SCL or GCL or M- factor apply
Is it relevant, reliable and sufficient
Evaluate
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Once data gathered and validated it can be checked
against the criteria hazard by hazard
CLP Annex I
• Part 1: General Principles & Bridging
Principles
• Part 2: Physical hazards
• Part 3:Health hazards
• Part 4&5:Environmental hazards
Decide
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Establish that mixture is hazardous against the
criteria for physical, health and environment
Need to decide on the appropriate hazard class
category or differentiation
Assign label elements as set out in Annex 1 Part 2-5
Check if any of the pictograms, signal words or
hazard statements overrule one another
Use the ECHA L&P guidance to assign Precautionary
statements
Review
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Review when there is NEW information
Update to Annex VI – harmonised list
Change in CLP criteria- e.g. ATP’s
New information from supplier. E.g SDS
Change in formulation of mixture
New information on substances e.g C&L inventory
or registerations.
Classification process
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Application of CLP criteria
Table 1.6.1 a ( page 67)
Applied for each hazard class
separately
Decision logic in each endpoint
Taking a closer look at health hazards
Classification of mixtures
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Human Health – 4 options
Gather existing data
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expert judgement/weight of evidence
Bridging principles
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read across/ interpolation
Estimate hazard from ingredient
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additivity/ non- additivity
concentration threshold method
calculation method
Translation Table - Annex VII
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already classified under DPD
Only where there is no data available
Limited use
NOTE: make sure that you choose the most appropriate method for your
mixture for each hazard class or category!
23
Gather existing data
Option 1
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Test data- good quality reports
Experience from use -occupational/accident database or weight of
evidence/expert judgement
New scientific information on the mixture or its ingredients
Any other information e.g. generated from international chemical
programmes e.g. US MSDS’s. e-ChemPortal
24
Bridging Principles
Option 2
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Can be used to classify untested mixtures where similar
mixtures are already tested
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Diluting
Batching
Concentration of highly toxic mixtures
Interpolation within one toxicity category
Substantially similar mixtures
Changes in composition of the mixture
Aerosols
NOTE :All bridging principles do not apply to every endpoint!
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Estimate hazard from ingredient
Option 3
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Classification is based on the concentration of individual
ingredients
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When data available for all components
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Calculations using formulas based on
additivity and non-addivity
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Generic cut off values
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Generic and Specific Concentration limits
Translation Table
Option 4
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Use of Translation table optional
Only used to translate existing classification if:
• Mixture classified according DPD before
June 2015 and
• No data available for hazard class
• If data available, DO NOT use Annex VII
Taking a closer look at option 3
Estimating hazards from ingredients
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Classification based on the concentration of individual
ingredients
When data available for all components
Calculations using formulas based on additivity and nonaddivity
Additivity
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Additivity applies to:
• Acute toxicity
• Skin corrosion/irritation
• Serious eye damage/ eye irritation
• STOT (SE) – respiratory tract irritation (Cat 3)
• STOT (SE)- narcotic effects (Cat 3)
There are some cases for skin corrosion/ irritation and serious eye
damage/eye irritation where addivity does not apply
Non-additivity
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Non-additivity applies to:
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Respiratory sensitisation
Skin sensitisation
Carcinogenicity (C)
germ cell mutagenicity (M)
reproductive toxicity (R)
specific target organ toxicity, single and repeated
exposure, cat. 1 and 2 (STOT)
• aspiration hazard (& consideration of viscosity of
mixture)
• And in special cases:
• skin corrosion/irritation
• serious eye damage/eye irritation
Rules for additivity
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Rules for using the conventional calculation
method (additivity)?
Annex I of CLP:
Generic cut-off values
Generic concentration limits
Specific concentration limits
Not new (!) but there are some changes
Generic cut-off values
Minimum concentration values for substances to be taken into account for
classification (do NOT trigger classification of the mixture directly)
– if is concentration of subs. > generic cut-off value then contribute to the
classification
Table 1.1 (Annex I)
Hazard class
Acute Toxicity:
- Category 1 - 3
- Category 4
Skin corrosion/irritation
Serious damage to eyes/eye irritation
Generic cut-off values to be
taken into account
0.1 %
1%
1%
1%
Generic Concentration Limit
Minimum concentration of substance that triggers classification of mixture
given in CLP Annex I under each hazard class. Example: Table 3.3.3 Part 3 Annex I of
CLP Regulation for effects on the eye (Category 1 or 2)
Sum of ingredients classified as:
Concentration triggering classification
of a mixture as:
Eye Effects Category 1 or Skin Corrosive
Category 1A, 1B, 1C
Eye Effects Category 2
(10 x Eye Effects Category 1) + Eye effects
Category 2
Skin Corrosive Category 1A, 1B, 1C + Eye
effects Category 1
10 x (Skin Corrosive Category 1A, 1B, 1C +
Eye Effects Category 1) + Eye Effects
Category 2
Irreversible
Reversible
Eye Effects
Eye Effects
Category 1
Category 2
3%
 1 % but < 3 %
 10 %
 10 %
3%
 1 % but  3 %
 10 %
Specific Concentration Limits
•
Established for some substances
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•
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Only for human health ( but not for resp. sensitisation,
mutagenicity or aspiration hazard)
Included in Annex VI and C&L inventory
Must be used unless justification can be provided
Can be lower or higher than generic concentration limit
•
Specific Concentration Limits
From Annex VI of CLP Regulation (list of harmonised classifications):
How to reclassify your mixture
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There is an existing system (DPD) with GCLs and SCLs etc.
You have to reclassify your mixture by 1st June 2015
Practically how do you do it?
ADDITIVITY EXAMPLES
EXAMPLE 1
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•
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Substances classified for Skin corrosion/irritation
within a mixture
ADDITIVITY applies:
• Have information on all ingredients
• Generic conc. limits (GCLs) only
apply (no SCLs)
pH – neutral (no extreme pH)
Classification under DPD
Section 2 Hazard Identification:
Classification according to Directive 99/45/EC (DPD):
Label elements: None required
Other Hazards: There are no known other hazards
Not classified
Section 3 Information on Ingredients:
Name
EC No.
CAS No.
Content
Classification
Substance 1
211-952-3
719-96-0
10%
R38
Substance 2
123-789-0
1234-56-8
10%
None
Substance 3
204-485-1
121-60-8
2%
R34
Substance 4
789-123-0
1234-56-0
78%
None
Section 9:
pH 7.5MIXTURE A
Classification under DPD
Mixture with Subs 1 @ 10% R38 + Subs 3 @2% R34: not classified
How did we work C&L out?
Use Table 4.1 in Schedule 3 of the Preps Regulations:
Classification of the
substance
C with R35
Classification of the preparation
C with R35
C with R34
Xi with R41
Xi with R36, R37, R38
concentration > =
10% R35 obligatory
5% = <
concentration < 10%
R34 obligatory
(5%*)
1% = < concentration < 5% R36/38
obligatory
concentration > =
10% R34 obligatory
(10%*)
5% = < concentration < 10% R36/38
obligatory
concentration>=
10% R41 obligatory
5% = < concentration < 10% R36 obligatory
C with R34
Xi with R41
Xi with R36, R37,
R38
concentration >= 20% R36, R37, R38 are
obligatory in the light of the concentration
present if they apply to the substances
under consideration
And the formula: Ʃ(PCR35/LCR35 + PCR34/LCR34 + PCR38/LCR38)≥1 (in Schedule 3)
= 2/ 5 + 10/20
= 0.4 + 0.5 = 0.9 <1
Therefore NOT CLASSIFIED
Re-classification under CLP
Check the classification of each substance/ingredient:
Name
EC No.
CAS No.
Content
Classification
Substance 1
211-952-3
719-96-0
10%
R38
Substance 2
123-789-0
1234-56-8
10%
None
Substance 3
204-485-1
121-60-8
2%
R34
Substance 4
789-123-0
1234-56-0
78%
None
How?
• Supplier info e.g. data in sections 2 and 11 of SDS (NB date of SDS)
• C&L Inventory:
•
• Harmonised C&L or
• Self-classified
Other info source e.g. ECHA dissemination site, eChemPortal
Looking up C&L Inventory
ECHA website: http://echa.europa.eu/web/guest/information-on-chemicals/clinventory-database
• Substance 1 (EC No. 211-952-3)
Look up C&L Inventory
•
Substance 3 (EC No. 204-485-1)
Re-classification under CLP…

Established the C&L for each substance
Name
EC No.
CAS No.
Content
Classification
Substance 1
211-952-3
719-96-0
10%
H315
Substance 2
123-789-0
1234-56-8
10%
None
Substance 3
204-485-1
121-60-8
2%
H314
Substance 4
789-123-0
1234-56-0
78%
None
Note: pH is still 7.5
Look up concentration limits
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•
•
No Specific Concentration Limits (SCLs) apply
So use Generic concentration limits (found in Annex I of CLP)
Table 3.2.3:
Sum of ingredients
Concentration triggering classification of a mixture as:
classified as:
Skin Corrosive
Categories 1A, 1B, 1C
Skin irritant Category 2
Skin Corrosive
Skin Irritant
Category 1 (see note below)
Category 2
5%
 1 % but < 5 %
 10 %
(10 x Skin Corrosive
Category 1A, 1B, 1C) +
Skin irritant Category 2
 10 %
Look up tables for classification
Mixture with Subs 1 @ 10% H315 Skin Irrit. Cat. 2 + Subs 3 @2% H314 Skin
Corr. Cat. 1
How do you work out the CLP C&L?
Similar to before: Use Table 3.2.3 in in Part 3 of Annex I of the CLP Regulation:
Sum of ingredients
classified as:
Concentration triggering classification of a mixture as:
Skin Corrosive
Skin Irritant
Category 1
Category 2
Skin Corrosive
5%
Categories 1A, 1B, 1C
Skin irritant
Category 2
(10* x Skin Corrosive
Category 1A, 1B, 1C) +
Skin irritant Cat. 2
 1 % but < 5 %
 10 %
 10 %
And this formula: (10 x 2) + 10 = 30 ≥10%
* Weighting factor of 10 if Category 1 component ≥ 1% but ≤ 5% in a mixture
Classification: Skin Irritant Category 2 H315
Or is it?????
•
•
Look up tables for classification
Did you consider eye effects?
Substance 3 is a corrosive substance (@2%) therefore you must also look at Table
3.3.3 for eye effects
Sum of ingredients classified as:
Eye Effects Category 1 or Skin Corrosive
Category 1A, 1B, 1C
Concentration triggering classification
of a mixture as:
Irreversible
Reversible
Eye Effects
Eye Effects
Category 1
Category 2
3%
 1 % but < 3 %
Eye Effects Category 2
 10 %
(10 x Eye Effects Category 1) + Eye effects
Category 2
 10 %
Skin Corrosive Category 1A, 1B, 1C + Eye
effects Category 1
10 x (Skin Corrosive Category 1A, 1B, 1C +
Eye Effects Category 1) + Eye Effects
Category 2
3%
 1 % but  3 %
 10 %
Therefore Classification: Skin Irritant Category 2 H315; Eye Irrit. Cat. 2 H319
Look up tables for labelling
Use Table 3.2.5
Label elements for skin corrosion/irritation
Classification
Category 1 A/
Category 2
1 B/1 C
GHS Pictograms
Signal Word
Danger
H314: Causes
Hazard Statement
severe skin
Warning
H315: Causes
skin
burns and eye
damage
Precautionary
Statements………………………
irritation
Look up tables for labelling
And Table 3.3.5
Label elements for serious eye damage/eye irritation
Classification
Category 1
Category 2
GHS Pictograms
Signal Word
Hazard Statement
Precautionary
Statements………………
………
Danger
Warning
H318: Causes
H319: Causes serious
serious eye damage
eye irritation
The label on the 1st June…..
According to Tables 3.2.3 and 3.3.3 and Tables 3.2.5 and 3.3.5 (Annex I
of CLP) the result is: Skin irritant category 2, H315
Eye irritant category 2 H319
Labelling:
Warning
Causes skin irritation
Causes serious eye irritation
Keep out of the reach of children etc…….
The SDS on the 1st June…..
Section 2 Hazard Identification:
Classification according to CLP Regulation:
Skin Irritant Category 2 H315 Causes skin irritation
Eye Irritant Category 2 H319 Causes serious eye irritation
Label elements:
Pictogram:
Signal Word: Warning
Hazard statements: H315 Causes skin irritation
H319 Causes serious eye irritation
Precautionary statements: Keep out of reach of children etc…………
Other Hazards: There are no known other hazards
Section 3 Information on Ingredients:
Name
EC No.
CAS No.
Content
Classification
Substance 1
211-952-3
719-96-0
10%
H315
Substance 2
123-789-0
1234-56-8
10%
None
Substance 3
A
204-485-1
121-60-8
2%
H314
Substance 4
789-123-0
1234-56-0
78%
None
EXAMPLE 2
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•
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Mixture with substances classified for Skin
corrosion/irritation
ADDITIVITY applies
This time Specific Conc. Limits (SCLs) assigned
pH - neutral
Classification under DPD
Section 2 Hazard Identification:
Classification according to Directive 99/45/EC (DPD):
Label elements: None required
Other Hazards: There are no known other hazards
Not classified
Section 3 Information on Ingredients:
Name
EC No.
CAS No.
Content
Classification
SCL
Substance 1
211-952-3
719-96-0
10%
R38
-
Substance 2
123-789-0
1234-56-8
10%
None
-
Substance 3
240-898-3
16872-11-0
2%
R34
Substance 4
789-123-0
1234-56-0
78%
None
C; R34: C ≥ 25 %
Xi; R36/38: 10 %
≤ C < 25 %
-
Section 9:
pH 7.5MIXTURE A
•
•
Check C&L Inventory
Substance 1 (as before – no SCLs)
Substance 3: SCLs apply
Re-classification under CLP
We have Mixture with:
• Subs 1 @ 10% H315 Skin Irrit. Cat. 2 (GCL) and
• Subs 3 @2% H314 Skin Corr. Cat. 1 (with SCL)
SCL for Subs 3 as per C&L Inventory:
Skin Corr. 1B; H314: C ≥ 25 %
Skin Irrit. 2; H315 & Eye Irrit. 2 H319: 10 % ≤ C < 25 %
As subs 3 is present at <25% (SCL), the mixture is not classified as Skin Corr.
Cat. 1
However, could it be classified as an irritant?
When SCLs apply…..
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•
•
•
•
Where additivity applies for skin corrosion/irritation to a mixture with
substances with SCLs assigned, use formula:
Sum of (ConcA / clA) + (ConcB / clB) + …. + (ConcZ / clZ) is ≥ 1
ConcA = concentration of substance A in mixture
clA = concentration limit (either specific or generic) for substance A
ConcB = concentration of substance B in mixture;
clB = concentration limit (either specific or generic) for substance B etc.
For this mixture: (% substance 1/GCL) + (% subs 3/SCL)
You know the SCL for Subs 3 (10-25% for Skin Irrit.), where do you find GCL
for Subs 1?
Look up tables for re-classification
GCL for skin irrit. Cat. 2 is found in Table 3.2.3 (Annex I of CLP):
Sum of ingredients
classified as:
Concentration triggering classification of a mixture as:
Skin Corrosive
Skin Irritant
Category 1
Category 2
Skin Corrosive
5%
Categories 1A, 1B, 1C
Skin irritant
Category 2
(10* x Skin Corrosive
Category 1A, 1B, 1C) +
Skin irritant Cat. 2
 1 % but < 5 %
 10 %
 10 %
We have subs. 1 @10% (GCL) and Subs 3 @ 2% (SCL)
Ʃ(ConcA / clA) + (ConcB / clB) is ≥ 1
= (10 /10) + (2 /10) = 1.2 ≥ 1
Mixture is classified Skin Irrit. Cat. 2
Note: In this example, you do not need to take eye irritation into account as you are
calculating only for skin irritation. The SCL for Skin Corr. took account of eye irrit. but
you were below the limit.
Look up tables for re-labelling
And Table 3.2.5
Label elements for skin corrosion/irritation
Classification
Category 1 A/
Category 2
1 B/1 C
GHS Pictograms
Signal Word
Danger
H314: Causes severe
Hazard Statement
H315: Causes skin
skin burns and eye
damage
Precautionary
Statements………………
………
Warning
irritation
The label on the 1st June…..
According to table 3.2.3 and Table 3.2.5 (Annex I of CLP) the result is:
Skin irritant category 2, H315
Labelling:
Warning
Causes skin irritation
Keep out of the reach of children etc…….
The SDS on the 1st June…..
Section 2 Hazard Identification:
Classification according to CLP Regulation:
Skin Irritant Category 2 H315 Causes skin irritation
Label elements:
Pictogram:
Signal Word: Warning
Hazard statement: H315 Causes skin irritation
Precautionary statements: Keep out of reach of children etc…………
Other Hazards: There are no known other hazards
Section 3 Information on Ingredients:
Name
EC No.
CAS No.
Content
Classification
SCL
Substance 1
211-952-3
719-96-0
10%
H315
-
Substance 2
123-789-0
1234-56-8
10%
None
-
Substance 3
240-898-3
16872-11-0
2%
H314
Skin Corr. 1B; H314: C
≥ 25 % Skin Irrit. 2;
H315 & Eye Irrit. 2
H319: 10 % ≤ C < 25 %
789-123-0
1234-56-0
78%
None
-
A
Substance 4
EXAMPLE 3
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•
Mixture with substances classified for ACUTE TOXICITY ORAL
Additivity applies
Classification under DPD
Section 2 Hazard Identification:
Classification according to Directive 99/45/EC (DPD):R22 Xn Harmful if swallowed
Label elements: Xn Harmful if Swallowed
S2 Keep out of the reach of children etc.
Other Hazards: There are no known other hazards
Section 3 Information on Ingredients:
MIXTURE A
Identifier
Concentration
LD50 oral
Classification
Substance 1
123-456-7
1%
225 mg/kg
Xn R22
Substance 2
456-789-0
3%
100 mg/kg
T R25
ASubstance 3
123-789-0
10%
?
T R25
000-000-0
76%
Water
Classification under DPD
•
Look at Table I of Schedule 3 in Preps Regs:
Classification of the
substance
T+ with R26, R27,
R28
T with R23, R24,
R25
Xn with R20, R21,
R22
•
Classification of the preparation
T+
concentration > =
7%
T
Xn
1% = <
concentration < 7%
0.1% = <
concentration < 1%
concentration > =
25%
3% = <
concentration <
25%
concentration > =
25%
Use formula Ʃ(PT+/LT+ + PT/LT + PXn/LXn)≥1 (in point 3 of Schedule 3)
We have 3% of R25 + 10% of R25 + 1% of R22
= 3 /3 + 10 /3 + 1/25 = >1
Classification = Xn Harmful if swallowed
Re-classification under CLP
How is mixture classified under CLP?
MIXTURE A
Identifier
Concentration
LD50 oral
Substance 1
123-456-7
1%
225 mg/kg
Substance 2
456-789-0
3%
100 mg/kg
Substance 3
123-789-0
10%
?
Water
000-000-0
76%
Classification
Acute tox. 3 oral
H301
We need to use a formula to calculate the acute toxicity of this mixture
but we don’t have the LD50 for substance 3.
How do we find the LD50 (ATE)?
Look up tables for re-classification
•
•
Find the LD50 (ATE) for Substance 3
In Table 3.1.2 (Annex I of CLP):
Exposure routes
Oral
(mg/kg
bodyweight)
Classification Category or
experimentally obtained acute
toxicity range estimate
0 < Category 1  5
5 < Category 2  50
Converted acute toxicity point
estimate
(see Note 1)
0,5
5
50 < Category 3  300
100
300 < Category 4  2000
0 < Category 1  50
500
5
50 < Category 2  200
50
200 < Category 3  1000
300
Gases
1000 < Category 4  2000
0 < Category 1  100
1100
10
(ppmV)
100 < Category 2  500
100
500 < Category 3  2500
700
Vapours
2500 < Category 4  20000
0 < Category 1  0,5
4500
0,05
(mg/l)
0,5 < Category 2  2,0
0,5
2,0 < Category 3  10,0
3
Dermal
(mg/kg
bodyweight)
Re-classification under CLP
Put in your converted ATE
MIXTURE A
Identifier
Concentration
LD50 oral
Substance 1
123-456-7
1%
225 mg/kg
Substance 2
456-789-0
3%
100 mg/kg
Substance 3
123-789-0
10%
100
Water
000-000-0
76%
Classification
Acute tox. 3 oral
H301
Look up formula for re-classification
•
Calculations using formulas (acute toxicity) based on additivity
Additivity formula (found in 3.1.3 of Annex I of CLP)
The ATE of the mixture is determined by calculation from the ATE values for the relevant
ingredients (for all three routes of exposure)
100
ATE mix
= 
n
Ci = concentration of ingredient i
i = the individual ingredient from 1 to n
n = the number of ingredients
ATEi = Acute Toxicity Estimate of ingredient
Ci
ATE i
ATE:
- LD50 or LC50-value, or
- Converted value (point estimate) for
acute toxicity from Table 3.1.2 in Annex I,
relating to a value from a range test or to
a classification68
category
Re-classification under CLP
MIXTURE A
Identifier
Concentration
LD50 oral
Substance 1
123-456-7
1%
225 mg/kg
Substance 2
456-789-0
3%
100 mg/kg
Substance 3
123-789-0
10%
100
Water
000-000-0
76%
100
ATEmixture
100
ATEmixture
1
=
225
Ci
=∑ ATE
n
3
+
100
Classificati
on
Acute tox. 3
oral H301
ATE: 100
i
10
+
100
ATEmixture = 0.1344
100/0.1344 = 744 mg/kg
•
•
•
Look up tables for re-classification
ATEmix = 744 mg/kg b.w.
What’s the classification?
In Table 3.1.1 (Annex I of CLP):
Exposure Route
Oral (mg/kg
bodyweight)
744 mg/kg
Category 1
Category 2
Category 3
Category 4
ATE ≤ 5
5 < ATE ≤ 50
50 < ATE ≤ 300
300 < ATE ≤ 2000
ATE ≤ 50
50 < ATE ≤ 200
200 < ATE ≤ 1000
1000 < ATE ≤ 2000
ATE ≤ 100
100 < ATE ≤ 500
500 < ATE ≤ 2500
2500 < ATE ≤ 20000
ATE ≤ 0,5
0,5 < ATE ≤ 2,0
2,0 < ATE ≤ 10,0
10,0 < ATE ≤ 20,0
ATE ≤ 0,05
0,05 < ATE ≤ 0,5
0,5 < ATE ≤ 1,0
1,0 < ATE ≤ 5,0
See Note (a)
Dermal (mg/kg
bodyweight)
See Note (a)
Gases (ppmV)
see:
Note (a)
Note (b)
Vapours (mg/l)
Dusts and Mists
(mg/l)
•
Classification: Acute Tox. 4.
Look up tables to for re-labelling
•
Table 3.1.3:
Classification
Category 1
Category 2
Category 3
Category 4
GHS Pictograms
Signal Word
Danger
Danger
Danger
Warning
H300:
H300:
H301:
H302:
Fatal if
swallowed
Fatal if
swallowed
Toxic if
swallowed
Harmful if
swallowed
- Dermal
H310:Fatal in
contact with
skin
H310:Fatal in
contact with
skin
H311: Toxic in
contact with
skin
H312: Harmful
in contact with
skin
- Inhalation
(see Note 1)
H330:Fatal if
inhaled
H330: Fatal if
inhaled
H331: Toxic if
inhaled
H332: Harmful if
inhaled
Hazard Statement:
- Oral
Precautionary
Statements
……………………………………
………………………..
The label on 1st June 2015
According to Tables 3.1.1 and Table 3.1.3 (Annex I of CLP):
Acute oral tox. 4, H302
Labelling:
Warning
H302 Harmful if swallowed
The SDS on the 1st June…..
Section 2 Hazard Identification:
Classification according to CLP Regulation:
Acute oral tox. 4, H302 Harmful if swallowed
Label elements:
Pictogram:
Signal Word: Warning
Hazard statement: H302 Harmful if swallowed
Precautionary statements: Keep out of reach of children etc…………
Other Hazards: There are no known other hazards
Section 3 Information on Ingredients:
MIXTURE A
Identifier
Concentration
LD50 oral
Substance 1
123-456-7
1%
225 mg/kg
A
Substance
2
456-789-0
3%
100 mg/kg
Substance 3
123-789-0
10%
100
Classificati
on
Acute tox. 3
oral H301
Example 4
•
Classify and Label this mixture with correct pictogram(s), signal
word and hazard statement(s)
Product/
CAS No.
Ingredient Name
Weight %
Classification
67/548/EEC
Ingredient 1
1234-56-7
1-5
C: R34
Ingredient 2
4567-58-9
1-5
Xi R36
•
•
Regulation (EC)
No 1272/2008
[CLP]
Skin Corr. 1B:
H314
Eye Irrit. 2; H319
You are a formulator, you know that concentration of Ingredient 1 is
3.5% and conc. of Ingredient 2 is 2.5%
If you were an importer, you would not be aware of exact formulation
(so you would have to use the “worst case” concentration i.e. 5% in your
calculations for both substances)
Look up tables for re-classification
Mixture with Subs 1 @ 3.5% H314 Skin Corr. Cat. 1
How do you work out the CLP C&L?
Similar to before: Use Table 3.2.3 in in Part 3 of Annex I of the CLP Regulation:
Sum of ingredients
classified as:
Concentration triggering classification of a mixture as:
Skin Corrosive
Skin Irritant
Category 1
Category 2
Skin Corrosive
5%
Categories 1A, 1B, 1C
Skin irritant
Category 2
(10* x Skin Corrosive
Category 1A, 1B, 1C) +
Skin irritant Cat. 2
 1 % but < 5 %
 10 %
 10 %
At a conc. of 3.5%, this substance will contribute to the classification of the mixture.
Classification: Skin Irritant Category 2 H315
Look up tables for re-classification
•
For eye effects, use generic concentration limits in Table 3.3.3 (Annex I of CLP):
Sum of ingredients classified as:
Eye Effects Category 1 or Skin Corrosive
Category 1A, 1B, 1C
Eye Effects Category 2
(10 x Eye Effects Category 1) + Eye effects
Category 2
Skin Corrosive Category 1A, 1B, 1C + Eye
effects Category 1
10 x (Skin Corrosive Category 1A, 1B, 1C +
Eye Effects Category 1) + Eye Effects
Category 2
•
•
Concentration triggering classification
of a mixture as:
Irreversible
Reversible
Eye Effects
Eye Effects
Category 1
Category 2
3%
 1 % but < 3 %
 10 %
 10 %
3%
Skin Corrosion Cat. 1B @ 3.5%
Eye irritant Cat. 2 @ 2.5%
Addivitity: (10 x 3.5) + 2.5 = 37.5 >1
Therefore Classification: Serious eye irritation Cat.2
 1 % but  3 %
 10 %
Look up tables for re-labelling
Use Table 3.2.5
Label elements for skin corrosion/irritation
Classification
Category 1 A/
Category 2
1 B/1 C
GHS Pictograms
Signal Word
Danger
H314: Causes
Hazard Statement
severe skin
Warning
H315: Causes
skin
burns and eye
damage
Precautionary
Statements………………………
irritation
Look up tables for re-labelling
And Table 3.3.5
Label elements for serious eye damage/eye irritation
Classification
Category 1
Category 2
GHS Pictograms
Signal Word
Hazard Statement
Precautionary
Statements………………
………
Danger
Warning
H318: Causes
H319: Causes serious
serious eye damage
eye irritation
The label on the 1st June…..
According to Tables 3.2.3 and 3.3.3 and Tables 3.2.5 and 3.3.5 (Annex I
of CLP) the result is: Skin irritant category 2, H315
Eye irritant category 2 H319
Labelling:
Warning
Causes skin irritation
Causes serious eye irritation
Keep out of the reach of children etc…….
The SDS on the 1st June…..
Section 2 Hazard Identification:
Classification according to CLP Regulation:
Skin Irritant Category 2 H315 Causes skin irritation
Eye Irritant Category 2 H319 Causes serious eye irritation
Label elements:
Pictogram:
Signal Word: Warning
Hazard statements: H315 Causes skin irritation
H319 Causes serious eye irritation
Precautionary statements: Keep out of reach of children etc…………
Other Hazards: There are no known other hazards
Section 3 Information on Ingredients:
Name
EC No.
CAS No.
Content
Classification
Substance 1
211-952-3
719-96-0
10%
H315
Substance 2
123-789-0
1234-56-8
10%
None
Substance 3
A
204-485-1
121-60-8
2%
H314
Substance 4
789-123-0
1234-56-0
78%
None
EXAMPLE 5
•
•
Mixture with substance classified for ACUTE TOXICITY DERMAL
Additivity applies
Re-classification under CLP
How will this mixture be classified under CLP?
Substance
Ingredient A
Ingredient B
(water)
CAS No.
% in mixture
123-456-0
456-789-0
3
97
Classification
Acute Tox. 1 H310
None
We need to use a formula to calculate the acute toxicity of this mixture
but we don’t have the LD50 for substance A.
How do we find the LD50 (ATE)?
Look up tables for re-classification
•
•
Find the LD50 (ATE) for Substance
In Table 3.1.2 (Annex I of CLP):
Exposure routes
Oral
(mg/kg
bodyweight)
Classification Category or
experimentally obtained acute
toxicity range estimate
0 < Category 1  5
5 < Category 2  50
Converted acute toxicity point
estimate
(see Note 1)
0,5
5
50 < Category 3  300
100
300 < Category 4  2000
0 < Category 1  50
500
5
50 < Category 2  200
50
200 < Category 3  1000
300
Gases
1000 < Category 4  2000
0 < Category 1  100
1100
10
(ppmV)
100 < Category 2  500
100
500 < Category 3  2500
700
Vapours
2500 < Category 4  20000
0 < Category 1  0,5
4500
0,05
(mg/l)
0,5 < Category 2  2,0
0,5
2,0 < Category 3  10,0
3
Dermal
(mg/kg
bodyweight)
Input data for re-classification under CLP
Put in your converted ATE
Substance
CAS No.
% in mixture
Ingredient A
123-456-0
3
Ingredient B
(water)
456-789-0
97
Classification
Acute Tox. 1
H310
None
ATE
5
Look up ATE formula for re-classification
•
Calculations using formulas (acute toxicity) based on additivity
Additivity formula (found in 3.1.3 of Annex I of CLP)
The ATE of the mixture is determined by calculation from the ATE values for the relevant
ingredients (for all three routes of exposure)
100
ATE mix
= 
n
Ci = concentration of ingredient i
i = the individual ingredient from 1 to n
n = the number of ingredients
ATEi = Acute Toxicity Estimate of ingredient
Ci
ATE i
ATE:
- LD50 or LC50-value, or
- Converted value (point estimate) for
acute toxicity from Table 3.1.2 in Annex I,
relating to a value from a range test or to
a classification85
category
Re-classification under CLP ( ATE)
Substance
CAS No.
% in mixture
Ingredient A
123-456-0
3
Ingredient B
(water)
456-789-0
97
ATEmixture
ATEmixture
Acute Tox. 1
H310
None
ATE
5
ATE = 5
100
100
Classification
Ci
=∑ ATE
n
i
3
=
5
ATEmixture = 0.6
100/0.6 = 167 mg/kg
•
•
•
Look up table for re-classification
ATEmix = 167 mg/kg b.w.
What’s the classification?
In Table 3.1.1 (Annex I of CLP):
Exposure Route
Oral (mg/kg
bodyweight)
ATE = 167 mg/kg
Category 1
Category 2
Category 3
Category 4
ATE ≤ 5
5 < ATE ≤ 50
50 < ATE ≤ 300
300 < ATE ≤ 2000
ATE ≤ 50
50 < ATE ≤ 200
200 < ATE ≤ 1000
1000 < ATE ≤ 2000
ATE ≤ 100
100 < ATE ≤ 500
500 < ATE ≤ 2500
2500 < ATE ≤ 20000
ATE ≤ 0,5
0,5 < ATE ≤ 2,0
2,0 < ATE ≤ 10,0
10,0 < ATE ≤ 20,0
ATE ≤ 0,05
0,05 < ATE ≤ 0,5
0,5 < ATE ≤ 1,0
1,0 < ATE ≤ 5,0
See Note (a)
Dermal (mg/kg
bodyweight)
See Note (a)
Gases (ppmV)
see:
Note (a)
Note (b)
Vapours (mg/l)
Dusts and Mists
(mg/l)
•
Classification: Acute Tox. 2 dermal
Look up table for re-labelling
•
Table 3.1.3:
Classification
Category 1
Category 2
Category 3
Category 4
GHS Pictograms
Signal Word
Danger
Danger
Danger
Warning
H300:
H300:
H301:
H302:
Fatal if
swallowed
Fatal if
swallowed
Toxic if
swallowed
Harmful if
swallowed
- Dermal
H310:Fatal in
contact with
skin
H310:Fatal in
contact with
skin
H311: Toxic in
contact with
skin
H312: Harmful
in contact with
skin
- Inhalation
(see Note 1)
H330:Fatal if
inhaled
H330: Fatal if
inhaled
H331: Toxic if
inhaled
H332: Harmful if
inhaled
Hazard Statement:
- Oral
Precautionary
Statements
……………………………………
………………………..
The label on 1st June 2015
According to Tables 3.1.1 and Table 3.1.3 (Annex I of CLP):
Acute dermal tox. 2, H310
Labelling:
Danger
H310 Fatal in contact with skin
The SDS on the 1st June
Section 2 Hazard Identification:
Classification according to CLP Regulation:
Acute dermal tox 2, H310
Label elements:
Pictogram:
Signal Word: Danger
Hazard statements: H310 Fatal in contact with skin
Precautionary statements: Keep out of reach of children etc…………
Other Hazards: There are no known other hazards
Section 3 Information on Ingredients:
Substance
CAS No.
% in mixture
Ingredient A
123-456-0
3
Ingredient B
(water)
456-789-0
97
Classification
Acute Tox. 1
H310
None
AT
E
5
EXAMPLE 6
•
•
•
•
Mixture with substances classified for Eye
Damage/irritation
Additivity applies
Generic concentration limits (GCLs) apply
pH 5.5
Classification under CLP
Mixture with substances classified for eye damage/irritation:
Name
EC No.
CAS No.
Content
Classification
Substance 1
123-456-0
456-789-0
91%
None
Substance 2
123-789-0
1234-56-8
5%
Eye Cat. 2
Substance 3
111-222-3
1234-56-0
3%
None
Substance 4
222-333-4
555-666-7
0.9%
Eye Cat. 1
Substance 5
123-123-0
321-321-0
0.1%
None
Classification under CLP
•
•
Check supplier SDS
Check the substances Inventory on ECHA website:
http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventorydatabase
•
If harmonised C&L … use it & check for SCLs
•
If self-classified… check your data (section 11, dissemination site etc.)
•
Check pH of mixture
•
Check the generic cut-off values (Table 1.1 Annex I CLP)
Classification under CLP




Established the C&L for each substance
No Specific Concentration Limits (SCLs) applied
The generic cut off value for eye damage/irrit. is 1%
Disregard Substance 4
Name
EC No.
CAS No.
Content
Classification
Substance 1
123-456-0
456-789-0
91%
None
Substance 2
123-789-0
1234-56-8
5%
Eye Cat. 2
Substance 3
111-222-3
1234-56-0
3%
None
Substance 4
222-333-4
555-666-7
0.9%
Eye Cat. 1
Substance 5
123-123-0
321-321-0
0.1%
None
Note: pH is still 5.5
Look up tables for classification
•
Use generic concentration limits in Table 3.3.3 (Annex I of CLP) for Subs 2 @ 5%:
Sum of ingredients classified as:
Eye Effects Category 1 or Skin Corrosive
Category 1A, 1B, 1C
Eye Effects Category 2
(10 x Eye Effects Category 1) + Eye effects
Category 2
Skin Corrosive Category 1A, 1B, 1C + Eye
effects Category 1
10 x (Skin Corrosive Category 1A, 1B, 1C +
Eye Effects Category 1) + Eye Effects
Category 2
Concentration triggering classification
of a mixture as:
Irreversible
Reversible
Eye Effects
Eye Effects
Category 1
Category 2
3%
 1 % but < 3 %
 10 %
 10 %
3%
We have Subs 2 which is Eye Cat. 2 @ 5%
Which is <10%
Therefore Classification: Not classified (below GCL)
 1 % but  3 %
 10 %
Check the hazards of ingredients
Mixture with substances classified for eye damage/irritation:
Name
EC No.
CAS No.
Content
Classification
Substance 1
123-456-0
456-789-0
91%
89%
None
Substance 2
123-789-0
1234-56-8
5%
Eye Cat. 2
Substance 3
111-222-3
1234-56-0
3%
None
Substance 4
222-333-4
555-666-7
0.9%
2.9%
Eye Cat. 1
Substance 5
123-123-0
321-321-0
0.1%
None
Validate the classification of ingredients
Again…………..
•
•
Check supplier SDS
Check the substances Inventory on ECHA website:
http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventorydatabase
•
If harmonised C&L … use it & check for SCLs
•
If self-classified… check your data (section 11, dissemination site etc.)
•
Check pH of mixture
•
Check the generic cut-off values (Table 1.1 Annex I CLP)
Classification under CLP



Established the C&L for each substance
No Specific Concentration Limits (SCLs) applied
The generic cut off value for eye damage/irrit. is 1% (subs 4 @2.9%>1%)
Name
EC No.
CAS No.
Content
Classification
Substance 1
123-456-0
456-789-0
89%
None
Substance 2
123-789-0
1234-56-8
5%
Eye Cat. 2
Substance 3
111-222-3
1234-56-0
3%
None
Substance 4
222-333-4
555-666-7
2.9%
Eye Cat. 1
Substance 5
123-123-0
321-321-0
0.1%
None
Note: pH is still 5.5
Look up table for classification
•
•
We have 2.9% of Cat. 1 subs and 5% of Cat. 2 subs
Use generic concentration limits in Table 3.3.3 (Annex I of CLP):
Sum of ingredients classified as:
Eye Effects Category 1 or Skin Corrosive
Category 1A, 1B, 1C
Eye Effects Category 2
(10 x Eye Effects Category 1) + Eye effects
Category 2
Skin Corrosive Category 1A, 1B, 1C + Eye
effects Category 1
10 x (Skin Corrosive Category 1A, 1B, 1C +
Eye Effects Category 1) + Eye Effects
Category 2
Concentration triggering classification
of a mixture as:
Irreversible
Reversible
Eye Effects
Eye Effects
Category 1
Category 2
3%
 1 % but < 3 %
 10 %
 10 %
3%
Additivity: (10 x 2.9) + 5 = 34 >10%
Therefore Classification: Serious eye irritation Cat.2
 1 % but  3 %
 10 %
Look up tables for labelling
And Table 3.3.5
Label elements for serious eye damage/eye irritation
Classification
Category 1
Category 2
GHS Pictograms
Signal Word
Hazard Statement
Precautionary
Statements………………
………
Danger
Warning
H318: Causes
H319: Causes serious
serious eye damage
eye irritation
The label on the 1st June…..
According to Tables 3.2.5 and 3.3.5 (Annex I of CLP) the result is:
Eye irritant category 2 H319
Labelling:
Warning
Causes serious eye irritation
Keep out of the reach of children etc…….
The SDS on the 1st June…..
Section 2 Hazard Identification:
Classification according to CLP Regulation:
Eye Irritant Category 2 H319 Causes serious eye irritation
Label elements:
Pictogram:
Signal Word: Warning
Hazard statements: H319 Causes serious eye irritation
Precautionary statements: Keep out of reach of children etc…………
Other Hazards: There are no known other hazards
Section 3 Information on Ingredients:
Name
EC No.
CAS No.
Content
Classification
Substance 1
123-456-0
456-789-0
89%
None
Substance 2
123-789-0
1234-56-8
5%
Eye Cat. 2
Substance 3
111-222-3
1234-56-0
3%
None
Substance 4
A
222-333-4
555-666-7
2.9%
Eye Cat. 1
Substance 5
123-123-0
321-321-0
0.1%
None
Non-additivity examples
•
Non- additivity applies to:
•
•
•
•
•
•
Skin and respiratory sensitisers
Germ cell mutagenicity
Carcinogenicity
Reproductive toxicity
STOT SE and RE, Cat 1 & 2
Aspiration hazard – viscosity also taken into account
Example 7 – Non-additivity
Mixture
%
STOT-RE
mutagenicity
carcinogenicity
reprotoxicity
substance 1
9
STOT-RE Cat
2; H373
NC
Carc. 2; H351
NC
substance 2
4
STOT-RE Cat.
2; H373
NC
NC
Repr. 2 ; H361
Substance 3
0.4
NC
Muta. 1B; H340
Carc. 1B ; H350
NC
substance 4
86.6
NC
NC
NC
NC
To classify for STOT-RE:
Look at Table 3.9.4 (Annex I):
Generic concentration limits triggering classification of the mixture as:
Ingredient classified as:
Category 1
Category 2
Category 1
Specific Target Organ Toxicant
Concentration  10 %
1.0 %  concentration  10 %
Category 2
Specific Target Organ Toxicant
Concentration  10 % [(Note 1)]
The 2 substances classified as STOT-RE Cat. 2 in this mixture are present
at 9% and 4%.
Therefore, none of the substances are above 10%, therefore no
classification of the mixture for STOT-RE required (Non- additivity).
For mutagenicity:
Look at Table 3.5.2 (Annex I):
Concentration limits triggering classification of a mixture as:
Ingredient classified as:
Category 1A mutagen
 0,1 %
Category 1A mutagen
Category 1B mutagen
–
Category 2 mutagen
–
Category 1B mutagen
Category 2mutagen
–
 0,1 %
–
Substance 3 is Mut. Cat. 1B: present at 0.4% (>0.1%) of the mixture
therefore mixture is classified as Mutagen. 1B.
–
–
 1,0 %
For carcinogenicity:
Look at Table 3.6.2:
Ingredient classified as:
Generic concentration limits triggering classification of a mixture as:
Category 1A carcinogen
 0,1 %
Category 1A carcinogen
Category 1B carcinogen
-
Category 2 carcinogen
-
Category 1B carcinogen
Category 2 carcinogen
-
-
 0,1 %
-
-
 1,0 % [Note 1]
Substance 3 is Carc. Cat. 1B: present in the mixture at 0.4% (>0.1%)
therefore mixture is classified as Carc. 1B
Note: there is also a Carc. Cat. 2 in the mixture but Cat. 1B takes precedence
For Reproductive toxicity:
Look at Table 3.7.2:
Ingredient
classified as:
Repro cat. 1A
Repro cat. 1B
Repro cat. 2
Concentration triggering classification of a mixture as:
Repro cat. 1A
Repro cat. 1B
Repro cat.2
Effects on or via
lactation
 0,3 %
 0,3 %
 3,0 %
Effects on or via
lactation
Substance 2 is Repro. Cat. 2: present at 4% (>3%) of the mixture
therefore classification of the mixture as Rep. 2 is required.
 0,3 %
Classification of the mixture:
•
•
•
•
•
Mutagen. 1B, H340 May cause genetic effects;
Carc. 1B H350 May cause cancer, and
Repr. 2, H361 Suspected of damaging fertility or the unborn child
To Label:
Look up Tables 3.9.5 (STOT-RE), 3.5.3 (Mut.), 3.6.3 (Carc.) and 3.7.3 (Repro.)
PRODUCT ABC
Danger
May cause genetic effects
May cause cancer
Suspected of damaging fertility or the unborn child
Alphabet ltd
O Connell Street
Dublin 1
Telephone 123456789
Session 3
Hazard Communication
Caroline Walsh
Hazard Communication
Tools for
using
chemicals
safely
CLP Label
DO YOU READ THE LABEL?
Label elements
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Name, address & telephone number of supplier
Nominal quantity
Product identifier
Hazard Pictogram(s)
Signal word
Hazard (H) Statements
Precautionary (P) Statements
Supplemental information
Official language = English
Article 17
Label elements
Product
Identifier
PRODUCT ABC
Hazard
Pictogram
Danger
Signal Word
Company X Y Z
Alphabet Street
Number Town
Code ABCD
Phone: +353 1 0000000
Supplier
Information
Highly flammable liquid and vapour. May be fatal if swallowed and enters airways. Causes skin
irritation. May cause drowsiness or dizziness. Very toxic to aquatic life with long lasting effects.
Keep away from heat/sparks/open flames/hot surfaces. – No smoking. Avoid breathing
dust/fume/gas/mist/vapours/spray. Wear protective gloves/protective clothing/eye protection/face
protection. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. IF ON
SKIN: Wash with plenty of soap and water. IF INHALED: Remove victim to fresh air and keep at
rest in a position comfortable for breathing. Avoid release to the environment.
Hazard &
Precautionary
Statements
Contains substance XYZ
Nominal
quantity
200 L*
Space for
Supplemental
information
Label elements
Product
Identifier
PRODUCT ABC
Hazard
Pictogram
Danger
Signal Word
Company X Y Z
Alphabet Street
Number Town
Code ABCD
Phone: +353 1 0000000
Supplier
Information
Highly flammable liquid and vapour. May be fatal if swallowed and enters airways. Causes skin
irritation. May cause drowsiness or dizziness. Very toxic to aquatic life with long lasting effects.
Keep away from heat/sparks/open flames/hot surfaces. – No smoking. Avoid breathing
dust/fume/gas/mist/vapours/spray. Wear protective gloves/protective clothing/eye protection/face
protection. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. IF ON
SKIN: Wash with plenty of soap and water. IF INHALED: Remove victim to fresh air and keep at
rest in a position comfortable for breathing. Avoid release to the environment.
Hazard &
Precautionary
Statements
Contains substance XYZ
Nominal
quantity
200 L
Space for
Supplemental
information
Product Identifier
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Product Identifier for substance or mixture on the
label must be the same as that used on the SDS
Product Identifier for a mixture consists of Trade
name or designation of the mixture
The identity of the substances contribute to the
classification of mixture if:
Acute toxicity, skin corrosion, serious eye damage, CMR’s, STOT,
skin or respiratory sensitisation, aspiration Hazards
Max of 4 names required unless more needed to reflect severity of hazards
Article 18
Hazard Pictograms
Product
Identifier
PRODUCT ABC
Hazard
Pictogram
Danger
Signal Word
Company X Y Z
Alphabet Street
Number Town
Code ABCD
Phone: +353 1 0000000
Supplier
Information
Highly flammable liquid and vapour. May be fatal if swallowed and enters airways. Causes skin
irritation. May cause drowsiness or dizziness. Very toxic to aquatic life with long lasting effects.
Keep away from heat/sparks/open flames/hot surfaces. – No smoking. Avoid breathing
dust/fume/gas/mist/vapours/spray. Wear protective gloves/protective clothing/eye protection/face
protection. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. IF ON
SKIN: Wash with plenty of soap and water. IF INHALED: Remove victim to fresh air and keep at
rest in a position comfortable for breathing. Avoid release to the environment.
Hazard &
Precautionary
Statements
Contains substance XYZ
Nominal
quantity
200 L*
Space for
Supplemental
information
Hazard Pictograms
GHS 01
Principles
of
precedence
Only applies if for skin
or eye irritant
Only applies if GHS 08
for respiratory
sensitisation then GHS
07 not to appear for skin
sensitisation or skin &
eye irritant
Article 19 & Annex V
Signal Word
Product
Identifier
Hazard
Pictogram
Signal Word
PRODUCT ABC
Danger
Company X Y Z
Alphabet Street
Number Town
Code ABCD
Phone: +353 1 0000000
Supplier
Information
Highly flammable liquid and vapour. May be fatal if swallowed and enters airways. Causes skin
irritation. May cause drowsiness or dizziness. Very toxic to aquatic life with long lasting effects.
Keep away from heat/sparks/open flames/hot surfaces. – No smoking. Avoid breathing
dust/fume/gas/mist/vapours/spray. Wear protective gloves/protective clothing/eye protection/face
protection. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. IF ON
SKIN: Wash with plenty of soap and water. IF INHALED: Remove victim to fresh air and keep at
rest in a position comfortable for breathing. Avoid release to the environment.
Hazard &
Precautionary
Statements
Contains substance XYZ
Nominal
quantity
200 L
Space for
Supplemental
information
Signal Word
DANGER or WARNING
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Replaces the Indication of Danger used in DSD/DPD
Use will depend on the classification of the
substance or mixture
If Danger is used Warning shall not appear on the
label
Clear and simple language to indicate the degree of
hazard
Article 20
Hazard Statements
Product
Identifier
PRODUCT ABC
Hazard
Pictogram
Danger
Signal Word
Company X Y Z
Alphabet Street
Number Town
Code ABCD
Phone: +353 1 0000000
Supplier
Information
Highly flammable liquid and vapour. May be fatal if swallowed and enters airways. Causes skin
irritation. May cause drowsiness or dizziness. Very toxic to aquatic life with long lasting effects.
Keep away from heat/sparks/open flames/hot surfaces. – No smoking. Avoid breathing
dust/fume/gas/mist/vapours/spray. Wear protective gloves/protective clothing/eye protection/face
protection. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. IF ON
SKIN: Wash with plenty of soap and water. IF INHALED: Remove victim to fresh air and keep at
rest in a position comfortable for breathing. Avoid release to the environment.
Hazard &
Precautionary
Statements
Contains substance XYZ
Nominal
quantity
200 L
Space for
Supplemental
information
Hazard Statements
Hazard
Code
Example
Text
Physical
H200-299
H241
Heating may
cause fire or
explosion
Health
H300-399
H311
Toxic in contact
with skin
Environment
H400-499
H412
Harmful to
aquatic life with
long lasting
effects.
Article 21 & Annex III
Precautionary Statements
Product
Identifier
PRODUCT ABC
Hazard
Pictogram
Danger
Signal Word
Company X Y Z
Alphabet Street
Number Town
Code ABCD
Phone: +353 1 0000000
Highly flammable liquid and vapour. May be fatal if swallowed and enters airways. Causes skin
irritation. May cause drowsiness or dizziness. Very toxic to aquatic life with long lasting effects.
Keep away from heat/sparks/open flames/hot surfaces. – No smoking. Avoid breathing
dust/fume/gas/mist/vapours/spray. Wear protective gloves/protective clothing/eye protection/face
protection. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. IF ON
SKIN: Wash with plenty of soap and water. IF INHALED: Remove victim to fresh air and keep at
rest in a position comfortable for breathing. Avoid release to the environment.
Contains substance XYZ
Nominal
quantity
Supplier
Information
200 L
Hazard &
Precautionary
Statements
Space for
Supplemental
information
Precautionary Statements
Code
Purpose
Example
Text
100
General
P102
Keep out of reach of
children
200
Prevention
P201
Obtain special
instructions before
use
300
Response
P310
Call a poison centre
400
Storage
P410
Store in a well
ventilated place
500
Disposal
P501
Dispose of
container…
Article 22 & Annex IV
P Statement Assignment
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Double amount of P Statements to S Phrases
Very limited ‘conditions of use’, none obligatory
P Statement assignment a new challenge
Omit only if clearly redundant/unnecessary
P Statement on disposal required for general public
No more than 6 P Statements on label
P Statement Assignment
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ECHA Guidance being developed using S Phrase
‘conditions of use’ to assist in
P Statement selection
Will include a ‘traffic light’ system of
Highly Recommended
Recommended
Optional
Available on ECHA website
Supplemental Information
Product
Identifier
PRODUCT ABC
Hazard
Pictogram
Danger
Signal Word
Company X Y Z
Alphabet Street
Number Town
Code ABCD
Phone: +353 1 0000000
Supplier
Information
Highly flammable liquid and vapour. May be fatal if swallowed and enters airways. Causes skin
irritation. May cause drowsiness or dizziness. Very toxic to aquatic life with long lasting effects.
Keep away from heat/sparks/open flames/hot surfaces. – No smoking. Avoid breathing
dust/fume/gas/mist/vapours/spray. Wear protective gloves/protective clothing/eye protection/face
protection. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. IF ON
SKIN: Wash with plenty of soap and water. IF INHALED: Remove victim to fresh air and keep at
rest in a position comfortable for breathing. Avoid release to the environment.
Hazard &
Precautionary
Statements
Contains substance XYZ
Nominal
quantity
????????????????????????????????????
200 L
Article 25 & Annex II
Space for
Supplemental
information
Supplemental Information
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New concept introduced with CLP
To incorporate labelling ‘EU leftovers’
Allowed because of UNGHS ‘Building Block
Approach’
New Codes to distinguish from H statements e.g.
EUH001
Obligatory & Non-Obligatory
Applicable in EU & EEA countries only
Supplemental Information
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Obligatory
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From CPL- substances e.g. EUH001, EUH059
From CPL- preparations e.g. EUH201
From other Community laws e.g. EUH401 (PPP)
Shall be placed alongside other label elements
.
Supplemental Information
CLP code
CPL R phrase
Text
EUH001
R1
‘Explosive when dry’
EUH066
R66
‘Repeated exposure may
cause skin dryness or
cracking’
EUH059*
R59
‘Hazardous to ozone layer’
Supplemental information
CLP Code
CPL Special Provisons
EUH201/201A
Contains lead. Should not be used on surfaces liable to be
chewed or sucked by children . Warning contains lead.
EUH202
Cyanoacrylate. Danger. Bonds eyes and skin in seconds.
Keep out of reach of children.
EUH204
Contains Isocyanates. May produce an allergic reaction
EUH210
Safety data sheets available on request.
Supplemental information
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Non-Obligatory
Content up to the supplier, e.g. specific product
information or instructions for use.
May be placed alongside other label elements
Not distract from nor contradict obligatory
labelling elements.
Example
Labelling & Article 33 (1)
Classified for
transport &
supply
Outer & Inner packaging
Product identifier
Signal word
Hazard statements
Precautionary
statements
Contact details
Product identifier
Signal word
Hazard statements
Precautionary
statements
Contact details
Labelling & Article 33 (2)
Classified
for supply
only
Outer & Inner packaging
Product identiifier
Signal wordHazard
statements
Precautionary
statements
Contact details
Product identifier
Signal word
Product
identifier
Hazard
statements
Signal
word
Precautionary
Hazard
statements
statements
Precautionary
Contact details
statements
Contact details
Labelling & Article 33 (3)
Single packaging
Classified
for supply &
transport
Product identifier
Signal w ord
Hazard statements
Precautionary
statements
Contact details
Example- single packaging
TOXIFLAM
Product
Identifier
Manufactured by
Compa ,
Supplier
Details
Company X Y Z
Alphabet Street
Number Town
Code ABCD
Phone: +353 1 0000000
9
Signal word
Space for
supplemental
information
GHS
pictogram
Danger
Highly
Flammable
liquid.
Causes skin irritation. May
cause respiratory irritation May
cause damage to liver, testis
through prolonged or repeated
exposure May be fatal if
swallowed and enters airways.
Very toxic to aquatic life Very
toxic to aquatic life with long
lasting effects.
Transport
Information
Keep out of reach of children. Keep
away
from
heat/sparks/open
flames/hot surfaces. No smoking. Wash
hands thoroughly after handling. Use
only outdoors or in a well-ventilated
area.
Wear
protective
gloves/protective
clothing/eye
protection/face protection
UN9999 &
Proper Shipping Name
Label Derogations
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Derogations : Article 23 & Annex 1.3
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Transportable gas cylinders
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Gas containers for propane, butane & LPG
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Aerosols with fitted seal spray
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Metals in massive form, alloys, polymer mixtures
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Explosives – for pyrotechnic effect
General label rules
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Firmly affixed to immediate packaging
Readable horizontally when set down
Hazard pictogram stands out clearly
Text easy to read
“Non-Toxic” “Non-Harmful” “Non-polluting” or other
misleading statements NOT to be used on Label
Must be in English
Label and pictogram size
Capacity of the package
Dimensions of the label (in
Dimensions of each
millimetres) for the
pictogram (in millimetres)
information required by
Article 17
Not exceeding 3 litres:
If possible, at least 52 x 74
Not smaller than 10 x 10
If possible, at least 16 x 16
Greater than 3 litres but,
At least 74 x 105
At least 23 x 23
At least 105 x 148
At least 32 x 32
At least 148 x 210
At least 46 x 46
not exceeding 50 litres:
Greater than 50 litres but
not exceeding 500 litres:
Greater than 500 litres:
Table 1.3 Minimum dimensions of labels and pictogram
Exemptions from L&P
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New Provisions
Labelling of soluble packaging for single use <25ml
(excludes PPP/Biocides)
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Labelling for R&D and QC analysis ( <10ml)
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Label to accompany delivery of ‘Ready mix cement
& concrete in wet state’ to general public without
packaging
Updating Label
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New requirement under CLP
Supplier to ensure label is updated without undue delay if a
more severe C&L required
Other changes within 18 months
PPP and Biocides label update in accordance with their
Directives.
Labelling transition
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Chemicals ‘on the shelf’ on 1st June 2015 do not need to be
relabelled and repackaged until 1st June 2017..as this is a
supplier derogation.
Long life chemicals in the workplace do not need to be
relabelled unless a workplace risk assessment warrants it as
they are not in the ‘supply chain’.
Decanted laboratory chemicals labelling requirements are based
on risk assessment and where appropriate workplace signs may
apply.
Packaging
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Come from DSD/DPD
Designed so its contents don’t
damage it or react with contents & fastening remain intact
during normal use
Designed not to arouse curiosity of children/mislead
consumers or have similar presentation or design that looks
like food.
Safety Data Sheets
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SDS format and content in transition with CLP deadlines
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ECHA e-guide/video’s available
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HSA SDS information sheet
Further information
HSA Chemicals Helpdesk
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All chemical related queries
[email protected]
1890 289 389
Scope
www.hsa.ie/chemicals
Health and Safety Authority
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Publications
European Chemicals Agency
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Support for SME’s classifying mixtures
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AWARENESS RAISING
Website for mixtures
Targeted at SME’s
ECHA CLP guidance & FAQ’s
National Helpdesks
Webinar 5th November
http://echa.europa.eu/web/guest/clp-2015
European Commission
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DG Environment and DG Enterprise
Responsible for CLP Regulation
CLP legislation/archives
Hosted workshop on safe use of chemicals on 16th
September ( recorded) (link) ( info)
European Commission
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DG Employment
Responsible for OSH Directives
Worker awareness on CLP
Chemical Handling Directive 2014/27/EU
Publish series of leaflets, posters ,guidance .
Go to link
EU- OSHA
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Worker awareness on CLP
NAPO man short videos
see link..
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NAPO man poster see link
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Use existing HSA publications
CLP Guidance
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HSA website on CLP: www.hsa.ie/clp
ECHA website on mixture classification: http://echa.europa.eu/web/guest/clp2015
ECHA guidance : http://echa.europa.eu/web/guest/guidancedocuments/guidance-on-clp
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ECHA CLP FAQ’s: http://http://echa.europa.eu/support/qas-
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GHS guidance: http://www.unece.org/trans/danger/publi/ghs/guidance.html