Freedom of Information · 5 steps to classification 1. Identify all the relevant information for...

Mixture Classification

2014 2015 Importers Consumers Formulators Workers

What is Classification

• Substance or Mixture meeting hazard criteria in parts 2-5 of Annex I to CLP

• Physical:

• Human Health:

• Environment:

2

http://www.hsa.ie/clp

Physical Hazards • Substance or Mixture meeting hazard criteria in parts 2 of Annex I

• Physical hazards:

• Gather all relevant and reliable information

• 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

• Substance or Mixture meeting hazard criteria in parts 3 of Annex I • Human Health:


• 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

• Substance or Mixture meeting hazard criteria in parts 4 -5 of Annex I

• Environmental Hazards :


• 3 classes: Hazardous to the aquatic environment, short- term ( 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

• Importer

• Downstream user ( formulator)

• Distributor

• Retailer

• Professional user

• Consumer

What’s a Importer

• 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


• 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


• 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

http://www.echa.europa.eu/web/guest/support/qas-support/search-qas?p_p_id=qahelpdesk_WAR_qahelpdeskportlet&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&p_p_col_id=column-2&p_p_col_count=1&_qahelpdesk_WAR_qahelpdeskportlet_searchUniqueIds=&_qahelpdesk_WAR_qahelpdeskportlet_searchTopic=19968986&_qahelpdesk_WAR_qahelpdeskportlet_searchScope=empty&_qahelpdesk_WAR_qahelpdeskportlet_searchKeywords=placing&_qahelpdesk_WAR_qahelpdeskportlet_searchStatusFlag=1&_qahelpdesk_WAR_qahelpdeskportlet_searchDeletedFlag=0&_qahelpdesk_WAR_qahelpdeskportlet_searchFaqFlag=-1&_qahelpdesk_WAR_qahelpdeskportlet_searchFromDate=&_qahelpdesk_WAR_qahelpdeskportlet_searchToDate=&_qahelpdesk_WAR_qahelpdeskportlet_searchTags=&_qahelpdesk_WAR_qahelpdeskportlet_searchChapter=0&_qahelpdesk_WAR_qahelpdeskportlet_cur=&_qahelpdesk_WAR_qahelpdeskportlet_delta=&_qahelpdesk_WAR_qahelpdeskportlet_qaId=1783&_qahelpdesk_WAR_qahelpdeskportlet_jspPage=/html/administration_portlet/view_qa.jsp




Roles & Obligations

Classify Label Package Notify Keep info 10 yrs

Manufacturer

Importer

Downstream User *

Distributor **

*If DU changes composition, must classify. If not, use classification other actor **Dist may use classification of another actor

What’s a Mixture

• 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

• 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 classes/categories

2. Examine all the information for validity/relevance

3. Evaluate against the CLP criteria ( Annex I to CLP)

4. Decide on the classification- then label/package/prepare SDS

5. Review when new information/change in criteria

Title II

Identify

• 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

• 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

• 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

• 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

• 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

• 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

Human Health – 4 options • Gather existing data

• expert judgement/weight of evidence

• Bridging principles • read across/ interpolation

• Estimate hazard from ingredient • additivity/ non- additivity • concentration threshold method • calculation method

• Translation Table - Annex VII

• already classified under DPD • Only where there is no data available • Limited use

23

NOTE: make sure that you choose the most appropriate method for your

mixture for each hazard class or category!

Gather existing data

Option 1

• 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

http://www.echemportal.org/echemportal/index?pageID=0&request_locale=en



25

Bridging Principles

Option 2

• Can be used to classify untested mixtures where similar

mixtures are already tested

• 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!

Estimate hazard from ingredient

Option 3

• Classification is based on the concentration of individual ingredients

• When data available for all components

• Calculations using formulas based on additivity and non-addivity

• Generic cut off values

• Generic and Specific Concentration limits

Translation Table

Option 4

• 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

• Classification based on the concentration of individual ingredients

• When data available for all components

• Calculations using formulas based on additivity and non-

addivity

Additivity

• 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

• Non-additivity applies to:

• 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

• 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

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 %

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)

Generic Concentration Limit

Sum of ingredients classified as: Concentration triggering classification

of a mixture as:

Irreversible

Eye Effects

Reversible

Eye Effects

Category 1 Category 2

Eye Effects Category 1 or Skin Corrosive

Category 1A, 1B, 1C 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 3 % 1 % but 3 %

10 x (Skin Corrosive Category 1A, 1B, 1C +

Eye Effects Category 1) + Eye Effects

Category 2

10 %

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)

Specific Concentration Limits

• Established for some substances

• 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

• 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

• 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): Not classified Label elements: None required

Other Hazards: There are no known other hazards

Section 3 Information on Ingredients:

Section 9:

pH 7.5MIXTURE A

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

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:

And the formula: Ʃ(PCR35/LCR35 + PCR34/LCR34 + PCR38/LCR38)≥1 (in Schedule 3)

Classification of the substance

Classification of the preparation

C with R35 C with R34 Xi with R41 Xi with R36, R37, R38

C with R35 concentration > = 10% R35 obligatory

5% = < concentration < 10%

R34 obligatory

(5%*) 1% = < concentration < 5% R36/38 obligatory

C with R34 concentration > = 10% R34 obligatory

(10%*) 5% = < concentration < 10% R36/38 obligatory

Xi with R41 concentration>= 10% R41 obligatory

5% = < concentration < 10% R36 obligatory

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

= 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:

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


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

Looking up C&L Inventory ECHA website: http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database

• Substance 1 (EC No. 211-952-3)

http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database










Look up C&L Inventory • Substance 3 (EC No. 204-485-1)

Re-classification under CLP…

Established the C&L for each substance

Note: pH is still 7.5


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

Look up concentration limits • No Specific Concentration Limits (SCLs) apply

• So use Generic concentration limits (found in Annex I of CLP)

• Table 3.2.3:

Sum of ingredients

classified as:

Concentration triggering classification of a mixture as:

Skin Corrosive Skin Irritant

Category 1 (see note below) Category 2

Skin Corrosive

Categories 1A, 1B, 1C

5 % 1 % but < 5 %

Skin irritant Category 2 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:


Skin Corrosive Skin Irritant Category 1 Category 2

Skin Corrosive Categories 1A, 1B, 1C

5 % 1 % but < 5 %


10 %

(10* x Skin Corrosive Category 1A, 1B, 1C) + Skin irritant Cat. 2

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

Therefore Classification: Skin Irritant Category 2 H315; Eye Irrit. Cat. 2 H319

Sum of ingredients classified as: Concentration triggering classification of a mixture as:

Irreversible Eye Effects

Reversible Eye Effects


Eye Effects Category 1 or Skin Corrosive Category 1A, 1B, 1C 3 % 1 % but < 3 %


(10 x Eye Effects Category 1) + Eye effects Category 2

10 %

Skin Corrosive Category 1A, 1B, 1C + Eye effects Category 1 3 % 1 % but 3 %

10 x (Skin Corrosive Category 1A, 1B, 1C + Eye Effects Category 1) + Eye Effects Category 2

10 %

Look up tables for labelling

Classification Category 1 A/

1 B/1 C Category 2

GHS Pictograms

Signal Word Danger Warning

Hazard Statement

H314: Causes

severe skin

burns and eye

damage

H315: Causes

skin

irritation

Precautionary

Statements………………………

Use Table 3.2.5 Label elements for skin corrosion/irritation


Classification Category 1 Category 2

GHS Pictograms


Hazard Statement H318: Causes

serious eye damage

H319: Causes serious

eye irritation

Precautionary

Statements………………

………

And Table 3.3.5 Label elements for 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: A


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

EXAMPLE 2

• Mixture with substances classified for Skin corrosion/irritation

• ADDITIVITY applies

• This time Specific Conc. Limits (SCLs) assigned

• pH - neutral



Classification according to Directive 99/45/EC (DPD): Not classified

Label elements: None required



Section 9:

pH 7.5MIXTURE A

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 C; R34: C ≥ 25 % Xi; R36/38: 10 % ≤ C < 25 %

Substance 4 789-123-0 1234-56-0 78% None -

Check C&L Inventory • Substance 1 (as before – no SCLs)

• Substance 3: SCLs apply


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…..

• 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):

We have subs. 1 @10% (GCL) and Subs 3 @ 2% (SCL)

Sum of ingredients

classified as:

Concentration triggering classification of a mixture as: Skin Corrosive Skin Irritant Category 1 Category 2


5 % 1 % but < 5 %


10 %


10 %

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


1 B/1 C Category 2

GHS Pictograms


Hazard Statement

H314: Causes severe

skin burns and eye

damage

H315: Causes skin

irritation

Precautionary


………

And Table 3.2.5 Label elements for skin corrosion/irritation


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





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…………



A

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 %

Substance 4 789-123-0 1234-56-0 78% None -

EXAMPLE 3

• 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.



A

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

Substance 3 123-789-0 10% ? T R25

Water 000-000-0 76%


• Look at Table I of Schedule 3 in Preps Regs:

• 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

Classification of the substance

Classification of the preparation

T+ T Xn

T+ with R26, R27, R28

concentration > = 7%


0.1% = < concentration < 1%

T with R23, R24, R25



Xn with R20, R21, R22


= 3 /3 + 10 /3 + 1 /25 = >1

Classification = Xn Harmful if swallowed


How is mixture classified under CLP?


Substance 1 123-456-7 1% 225 mg/kg

Substance 2 456-789-0 3% 100 mg/kg

Substance 3 123-789-0 10% ? Acute tox. 3 oral

H301

Water 000-000-0 76%

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)?


• Find the LD50 (ATE) for Substance 3

• In Table 3.1.2 (Annex I of CLP):

Exposure routes Classification Category or experimentally obtained acute

toxicity range estimate

Converted acute toxicity point estimate

(see Note 1) Oral

(mg/kg bodyweight)

0 < Category 1 5

5 < Category 2 50

50 < Category 3 300

300 < Category 4 2000

0,5

5

100

500 Dermal

(mg/kg bodyweight)

0 < Category 1 50

50 < Category 2 200

200 < Category 3 1000

1000 < Category 4 2000

5

50

300

1100 Gases

(ppmV)

0 < Category 1 100

100 < Category 2 500

500 < Category 3 2500

2500 < Category 4 20000

10

100

700

4500 Vapours

(mg/l)

0 < Category 1 0,5

0,5 < Category 2 2,0

2,0 < Category 3 10,0

10,0 < Category 4 20,0

0,05

0,5

3

11 Dust/mist

(mg/l)

0< Category 1 0,05

0,05 < Category 2 0,5



0,005

0,05

0,5

1,5


Put in your converted ATE


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 Acute tox. 3 oral

H301

Water 000-000-0 76%

68

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)

Ci = concentration of ingredient i

i = the individual ingredient from 1 to n

n = the number of ingredients

ATEi = Acute Toxicity Estimate of ingredient

i = n i mix ATE

C

ATE

100

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 classification category


100

ATEmixture

=∑ Ci

ATEi n

MIXTURE A Identifier Concentration LD50 oral Classificati

on

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 Acute tox. 3

oral H301

Water 000-000-0 76%

100

ATEmixture

1

225

+ 3

100

+ 10

100

ATEmixture = 0.1344

100/0.1344 = 744 mg/kg

=

ATE: 100

Look up tables for re-classification • ATEmix = 744 mg/kg b.w.

• What’s the classification?


• Classification: Acute Tox. 4.

Exposure Route Category 1 Category 2 Category 3 Category 4

Oral (mg/kg bodyweight)

See Note (a)

ATE ≤ 5 5 < ATE ≤ 50 50 < ATE ≤ 300 300 < ATE ≤ 2000

Dermal (mg/kg

bodyweight)

See Note (a)

ATE ≤ 50 50 < ATE ≤ 200 200 < ATE ≤ 1000 1000 < ATE ≤ 2000

Gases (ppmV)

see: Note (a)

Note (b)

ATE ≤ 100 100 < ATE ≤ 500 500 < ATE ≤ 2500 2500 < ATE ≤ 20000

Vapours (mg/l) ATE ≤ 0,5 0,5 < ATE ≤ 2,0 2,0 < ATE ≤ 10,0 10,0 < ATE ≤ 20,0

Dusts and Mists (mg/l) ATE ≤ 0,05 0,05 < ATE ≤ 0,5 0,5 < ATE ≤ 1,0 1,0 < ATE ≤ 5,0

744 mg/kg

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

Hazard Statement:

- Oral

H300:

Fatal if swallowed

H300:

Fatal if swallowed

H301:

Toxic if swallowed

H302:

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

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




Acute oral tox. 4, H302 Harmful if swallowed



Hazard statement: H302 Harmful if swallowed




A

MIXTURE A Identifier Concentration LD50 oral Classificati

on

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 Acute tox. 3

oral H301

Water 000-000-0 76%

Example 4

• Classify and Label this mixture with correct pictogram(s), signal

word and hazard statement(s)

• 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)

Product/

Ingredient Name

CAS No. Weight % Classification

67/548/EEC

Regulation (EC)

No 1272/2008

[CLP]

Ingredient 1 1234-56-7 1-5 C: R34 Skin Corr. 1B:

H314

Ingredient 2 4567-58-9 1 - 5 Xi R36 Eye Irrit. 2; H319

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:

At a conc. of 3.5%, this substance will contribute to the classification of the mixture.

Sum of ingredients

classified as:


Skin Corrosive Skin Irritant Category 1 Category 2


5 % 1 % but < 5 %


10 %


10 %

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):

• Skin Corrosion Cat. 1B @ 3.5%

• Eye irritant Cat. 2 @ 2.5%





Eye Effects Category 1 or Skin Corrosive Category 1A, 1B, 1C

3 % 1 % but < 3 %



10 %

Skin Corrosive Category 1A, 1B, 1C + Eye effects Category 1

3 % 1 % but 3 %


10 %

Addivitity: (10 x 3.5) + 2.5 = 37.5 >1

Therefore Classification: Serious eye irritation Cat.2



1 B/1 C Category 2

GHS Pictograms


Hazard Statement

H314: Causes

severe skin

burns and eye

damage

H315: Causes

skin

irritation

Precautionary

Statements………………………

Use Table 3.2.5 Label elements for skin corrosion/irritation



GHS Pictograms



serious eye damage


eye irritation

Precautionary


………



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


Labelling:

Warning





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: A


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

EXAMPLE 5

• Mixture with substance classified for ACUTE TOXICITY - DERMAL



How will this mixture be classified under CLP?

Substance CAS No. % in mixture Classification

Ingredient A

123-456-0

3

Acute Tox. 1 H310

Ingredient B

(water)

456-789-0 97 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)?


• Find the LD50 (ATE) for Substance


Exposure routes Classification Category or experimentally obtained acute

toxicity range estimate

Converted acute toxicity point estimate

(see Note 1) Oral

(mg/kg bodyweight)

0 < Category 1 5

5 < Category 2 50

50 < Category 3 300

300 < Category 4 2000

0,5

5

100

500 Dermal

(mg/kg bodyweight)

0 < Category 1 50

50 < Category 2 200

200 < Category 3 1000

1000 < Category 4 2000

5

50

300

1100 Gases

(ppmV)

0 < Category 1 100

100 < Category 2 500

500 < Category 3 2500

2500 < Category 4 20000

10

100

700

4500 Vapours

(mg/l)

0 < Category 1 0,5


2,0 < Category 3 10,0

10,0 < Category 4 20,0

0,05

0,5

3

11 Dust/mist

(mg/l)

0< Category 1 0,05

0,05 < Category 2 0,5



0,005

0,05

0,5

1,5

Input data for re-classification under CLP

Put in your converted ATE

Substance CAS No. % in mixture Classification ATE

Ingredient A

123-456-0

3

Acute Tox. 1

H310

5

Ingredient B

(water)

456-789-0 97 None

85

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)

Ci = concentration of ingredient i

i = the individual ingredient from 1 to n

n = the number of ingredients

ATEi = Acute Toxicity Estimate of ingredient

i = n i mix ATE

C

ATE

100

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 classification category

Re-classification under CLP ( ATE)

100

ATEmixture

=∑ Ci

ATEi n

100

ATEmixture

3

5

ATEmixture = 0.6

100/0.6 = 167 mg/kg

=

Substance CAS No. % in mixture Classification ATE

Ingredient A

123-456-0

3

Acute Tox. 1

H310

5

Ingredient B

(water)

456-789-0 97 None

ATE = 5

Look up table for re-classification • ATEmix = 167 mg/kg b.w.

• What’s the classification?


• Classification: Acute Tox. 2 dermal

Exposure Route Category 1 Category 2 Category 3 Category 4

Oral (mg/kg bodyweight)

See Note (a)

ATE ≤ 5 5 < ATE ≤ 50 50 < ATE ≤ 300 300 < ATE ≤ 2000

Dermal (mg/kg

bodyweight)

See Note (a)

ATE ≤ 50 50 < ATE ≤ 200 200 < ATE ≤ 1000 1000 < ATE ≤ 2000

Gases (ppmV)

see: Note (a)

Note (b)

ATE ≤ 100 100 < ATE ≤ 500 500 < ATE ≤ 2500 2500 < ATE ≤ 20000

Vapours (mg/l) ATE ≤ 0,5 0,5 < ATE ≤ 2,0 2,0 < ATE ≤ 10,0 10,0 < ATE ≤ 20,0

Dusts and Mists (mg/l) ATE ≤ 0,05 0,05 < ATE ≤ 0,5 0,5 < ATE ≤ 1,0 1,0 < ATE ≤ 5,0

ATE = 167 mg/kg

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

Hazard Statement:

- Oral

H300:

Fatal if swallowed

H300:

Fatal if swallowed

H301:

Toxic if swallowed

H302:

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

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

Substance CAS No. % in mixture Classification AT

E

Ingredient A

123-456-0

3

Acute Tox. 1

H310

5

Ingredient B

(water)

456-789-0 97 None

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:

EXAMPLE 6

• Mixture with substances classified for Eye Damage/irritation


• Generic concentration limits (GCLs) apply

• pH 5.5

Classification under CLP


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

Mixture with substances classified for eye damage/irritation:


• Check supplier SDS

• Check the substances Inventory on ECHA website: http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database

• 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)













No Specific Concentration Limits (SCLs) applied

The generic cut off value for eye damage/irrit. is 1%

Disregard Substance 4



Substance 1 123-456-0 456-789-0 91% None


Substance 3 111-222-3 1234-56-0 3% None


Substance 5 123-123-0 321-321-0 0.1% None

Look up tables for classification • Use generic concentration limits in Table 3.3.3 (Annex I of CLP) for Subs 2 @ 5%:

We have Subs 2 which is Eye Cat. 2 @ 5%

Which is <10%

Therefore Classification: Not classified (below GCL)






3 % 1 % but < 3 %



10 %


3 % 1 % but 3 %


10 %

Check the hazards of ingredients


Substance 1 123-456-0 456-789-0 91% None


Substance 3 111-222-3 1234-56-0 3% None


Substance 5 123-123-0 321-321-0 0.1% None

Mixture with substances classified for eye damage/irritation:


Substance 1 123-456-0 456-789-0 89% None


Substance 3 111-222-3 1234-56-0 3% None


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-inventory-database

• 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)













No Specific Concentration Limits (SCLs) applied

The generic cut off value for eye damage/irrit. is 1% (subs 4 @2.9%>1%)



Substance 1 123-456-0 456-789-0 89% None


Substance 3 111-222-3 1234-56-0 3% None


Substance 5 123-123-0 321-321-0 0.1% None

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):






3 % 1 % but < 3 %



10 %


3 % 1 % but 3 %


10 %

Additivity: (10 x 2.9) + 5 = 34 >10%

Therefore Classification: Serious eye irritation Cat.2



GHS Pictograms



serious eye damage


eye irritation

Precautionary


………



According to Tables 3.2.5 and 3.3.5 (Annex I of CLP) the result is:


Labelling:

Warning






Eye Irritant Category 2 H319 Causes serious eye irritation



Hazard statements: H319 Causes serious eye irritation




A


Substance 1 123-456-0 456-789-0 89% None


Substance 3 111-222-3 1234-56-0 3% None


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:

Ingredient classified as:

Generic concentration limits triggering classification of the mixture as:


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).

Look at Table 3.9.4 (Annex I):

For mutagenicity:

Ingredient classified as:

Concentration limits triggering classification of a mixture as:

Category 1A mutagen Category 1B mutagen Category 2mutagen

Category 1A mutagen 0,1 % – –

Category 1B mutagen – 0,1 % –

Category 2 mutagen – – 1,0 %

Substance 3 is Mut. Cat. 1B: present at 0.4% (>0.1%) of the mixture therefore mixture is classified as Mutagen. 1B.

Look at Table 3.5.2 (Annex I):

For carcinogenicity:

Ingredient classified as: Generic concentration limits triggering classification of a mixture as:

Category 1A carcinogen Category 1B carcinogen Category 2 carcinogen

Category 1A carcinogen 0,1 % - -

Category 1B carcinogen - 0,1 % -

Category 2 carcinogen - - 1,0 % [Note 1]

Look at Table 3.6.2:

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

Ingredient

classified as:


Repro cat. 1A Repro cat. 1B Repro cat.2

Effects on or via

lactation

Repro cat. 1A 0,3 %

Repro cat. 1B 0,3 %

Repro cat. 2 3,0 %

Effects on or via

lactation

0,3 %

For Reproductive toxicity:

Look at Table 3.7.2:

Substance 2 is Repro. Cat. 2: present at 4% (>3%) of the mixture therefore classification of the mixture as Rep. 2 is required.

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?

http://vimeo.com/52916029

Label elements

• 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

PRODUCT ABC

Danger 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

200 L*

Company X Y Z Alphabet Street Number Town Code ABCD Phone: +353 1 0000000

Product Identifier

Signal Word

Hazard & Precautionary

Statements

Supplier Information

Space for Supplemental information

Label elements

Nominal quantity

Hazard Pictogram

PRODUCT ABC









200 L


Product Identifier

Signal Word


Statements



Label elements

Nominal quantity

Hazard Pictogram

Product Identifier

• 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

PRODUCT ABC









200 L*


Product Identifier

Signal Word


Statements



Hazard Pictograms

Nominal quantity

Hazard Pictogram

Hazard Pictograms

GHS 01

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

Principles of

precedence

Article 19 & Annex V

PRODUCT ABC Danger Highly flammable liquid and vapour. May be fatal if swallowed and enters airways. Causes skin








200 L


Product Identifier

Signal Word


Statements



Signal Word

Nominal quantity

Hazard Pictogram

Signal Word

DANGER or WARNING

• 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

PRODUCT ABC









200 L


Product Identifier

Signal Word


Statements



Hazard Statements

Nominal quantity

Hazard Pictogram

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

PRODUCT ABC









200 L


Product Identifier

Signal Word


Statements



Precautionary Statements

Nominal quantity

Hazard Pictogram

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

• 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

• 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

http://www.google.ie/imgres?imgurl=https://www.crowdirect.co.uk/case/images/traffic_light_-_caution.gif&imgrefurl=https://www.crowdirect.co.uk/case/replist.aspx&h=588&w=467&sz=13&tbnid=FDtVP-7qzYxjYM:&tbnh=252&tbnw=200&prev=/images?q%3Dtraffic%2Blight%2Bpictures&hl=en&usg=__YylUxIBrliFOuv6u4thwt-tgKmk=&ei=ZxLoS5eQEcmNsAbCtOCYBA&sa=X&oi=image_result&resnum=1&ct=image&ved=0CB4Q9QEwAA

PRODUCT ABC









???????????????????????????????????? 200 L


Product Identifier

Signal Word


Statements



Supplemental Information

Nominal quantity

Hazard Pictogram

Article 25 & Annex II


• 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


• Obligatory

• 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

.


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

• 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

Product identifier

Signal word

Hazard statements

Precautionary

statements

Contact details

Labelling & Article 33 (1)

Product identifier

Signal word

Hazard statements

Precautionary

statements

Contact details

Classified for

transport &

supply

Outer & Inner packaging

Product identifier

Signal word

Hazard statements

Precautionary

statements

Contact details


Product identiifier

Signal wordHazard

statements

Precautionary

statements

Contact details

Product identifier

Signal word

Hazard statements

Precautionary

statements

Contact details

Classified

for supply

only

Outer & Inner packaging


Product identifier

Signal w ord

Hazard statements

Precautionary

statements

Contact details

Classified for supply & transport

Single packaging

TOXIFLAM

Manufactured by

Compa ,


9

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.

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

Product Identifier

Supplier Details

Space for supplemental information

Transport Information

Example- single packaging

GHS pictogram

Signal word

Label Derogations

• Derogations : Article 23 & Annex 1.3

• Transportable gas cylinders

• Gas containers for propane, butane & LPG

• Aerosols with fitted seal spray

• Metals in massive form, alloys, polymer mixtures

• Explosives – for pyrotechnic effect

General label rules

• 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

millimetres) for the

information required by

Article 17

Dimensions of each

pictogram (in millimetres)

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,

not exceeding 50 litres:

At least 74 x 105 At least 23 x 23

Greater than 50 litres but

not exceeding 500 litres:

At least 105 x 148 At least 32 x 32

Greater than 500 litres: At least 148 x 210 At least 46 x 46

Table 1.3 Minimum dimensions of labels and pictogram

Exemptions from L&P

New Provisions

• Labelling of soluble packaging for single use <25ml (excludes PPP/Biocides)

• Labelling for R&D and QC analysis ( <10ml)

• Label to accompany delivery of ‘Ready mix cement & concrete in wet state’ to general public without packaging

Updating Label

• 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

• 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.

http://www.hsa.ie/eng/Publications_and_Forms/Publications/General_Application_Regulations/Safety_Signs_at_a_Place_Work_2010.html

Packaging

• 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

• SDS format and content in transition with CLP deadlines

• ECHA e-guide/video’s available

• HSA SDS information sheet

http://www.hsa.ie/eng/Your_Industry/Chemicals/Classification_and_Labelling/Countdown_to_CLP_compliance/poison_centre_and_sds_information_.pdf

http://www.hsa.ie/eng/Publications_and_Forms/Publications/Information_Sheets/SDS_hazchem_info_sheet.pdf

http://www.hsa.ie/eng/Publications_and_Forms/Publications/Information_Sheets/SDS_hazchem_info_sheet.pdf

Further information

HSA Chemicals Helpdesk

• All chemical related queries

• [email protected]

• 1890 289 389

• Scope

• www.hsa.ie/chemicals

mailto:[email protected]

http://www.hsa.ie/eng/Your_Industry/Chemicals/REACH/Chemicals_Helpdesk-Scope_Functions.pdf

http://www.hsa.ie/chemicals

Health and Safety Authority

• Publications

http://www.hsa.ie/eng/Publications_and_Forms/Publications/Chemical_and_Hazardous_Substances/?pageNumber=2

European Chemicals Agency

• Support for SME’s classifying mixtures

• 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

•

https://echa.webex.com/mw0401l/mywebex/default.do?nomenu=true&siteurl=echa&service=6&rnd=0.3080440356307411&main_url=https://echa.webex.com/ec0701l/eventcenter/event/eventAction.do?theAction%3Ddetail%26confViewID%3D1888401405%26%26EMK%3D4832534b00000001f938dea05d918686eceb087b802d548ba896095ab28e62a98a4dafc5a36b2273%26%26%26siteurl%3Decha

http://echa.europa.eu/web/guest/clp-2015




European Commission

• 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)

http://ec.europa.eu/enterprise/sectors/chemicals/documents/classification/index_en.htm

https://scic.ec.europa.eu/streaming/index.php?es=2&sessionno=049671e28a386427e432b3370a22aae4

http://ec.europa.eu/enterprise/newsroom/cf/itemdetail.cfm?item_id=7500&lang=en&title=Workshop-on-the-safe-use-of-chemicals-by-SMEs

European Commission

• 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

http://ec.europa.eu/social/main.jsp?catId=148&furtherPubs=yes&langId=en

EU- OSHA

• Worker awareness on CLP

• NAPO man short videos

see link..

• NAPO man poster see link

• Use existing HSA publications

http://www.napofilm.net/en/napos-films/multimedia-film-episodes-listing-view?set_language=en&filmid=napo-012-danger-chemicals

http://www.hsa.ie/eng/Publications_and_Forms/Publications/Chemical_and_Hazardous_Substances/

CLP Guidance

• HSA website on CLP: www.hsa.ie/clp

• ECHA website on mixture classification: http://echa.europa.eu/web/guest/clp-2015

• ECHA guidance : http://echa.europa.eu/web/guest/guidance-documents/guidance-on-clp

• ECHA CLP FAQ’s: http://http://echa.europa.eu/support/qas-

• GHS guidance: http://www.unece.org/trans/danger/publi/ghs/guidance.html

http://www.hsa.ie/clp





http://echa.europa.eu/web/guest/guidance-documents/guidance-on-clp








http://http/echa.europa.eu/support/qas-



http://www.unece.org/trans/danger/publi/ghs/guidance.html

http://www.unece.org/trans/danger/publi/ghs/guidance.html

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