Introduction of GHS classification tool and GHS classification guidance for enterprises

Introduction of GHS classification tool and GHS classification guidance for enterprises Mutsuo Wada Japan Chemical Database Ltd. June 9, 2017 Copyright 2017 Japan Chemical Database All Rights Reserved. 1

Agenda 1.GHS classification(manual) 2.GHS classification Tool(METI) 3.GHS Model Classification(NITE) 4.GHS Classification Guidance for Enterprises(METI) Copyright 2017 Japan Chemical Database All Rights Reserved. 2

1.GHS classification(manual) Classification model of Mixture Model product: ABCD For detergent Pre-condition: 1.There are NITE classification data (National Institute of Technology and Evaluation in Japan) No CLP classification 2.Physical state : Liquid, Flash point : not flammable 3.classification : DIW GHS rule 4. Labeling : DIW GHS rule select pictogram/hazard statement/precautionary statements ( 6 phrases, if possible) Copyright 2017 Japan Chemical Database All Rights Reserved. 3

1.GHS classification(manual) Data collection 1. Not additional testing 2. Data gathering used echemportal 2-1Get available GHS classification from the point of global harmonization ex. CLP.NITE,JSIA, CESIO,EFFA etc. 2-2 Check the new data from OECD HPV or REACH and update the classification 3. Data selection 4. Do a classification in accordance with DIW GHS rule Fill classification result and reason in Classification sheet. Fill pictogram/signal word/hazard statement/precautionary statement in product information sheet 5. Make a product label in Label sheet according to DIW GHS rule select pictogram/hazard statement/precautionary statements( 6 phrases in case of EU/Malaysia/Singapore/Malaysia) Copyright 2017 Japan Chemical Database All Rights Reserved. 4

1.GHS classification(manual) ABCD(data source :NITE) Physical state : Liquid, Flash point : not flammable Model : Detergent Component CAS RN Conte nts Classification(NITE) Classification/category H code Remarks water 7732-18-5 52% - - Sodium Lauryl sulfate 151-21-3 20% Acute Tox. 4 - Oral Skin Irrit. 2 Eye Irrit. 2 STOT Single Exp. 2 (digestive system) Asp. Tox. 1 Aquatic Chronic 2 H302 H315 H319 H371 H304 H411 LD50=1200mg/kg(oral) LD50=580mg/kg(dermal) EC50(crustacea)=0.72mg/L Chronic : no data RD=85% LAS(liner alkyl benzene sulphfonate) 25155-30-0 18% Acute Tox. 4 - Oral Skin Irrit. 2 Eye Irrit. 2A Skin Sens. 1 STOT Single Exp. 3 Aquatic Acute 1 H302 H315 H318 H335 H336 H362 H373 LD50=438mg/kg(oral) EC50(algal)=0.9mg/L Chronic : no data RD=73% log Kow=1.96 Dodecyldimethyl amine oxide 1643-20-5 6% Skin Irrit. 2 Eye Irrit. 2A Aquatic Acute 1 H315 H319 H400 EC50(algal)=0.081mg/L 2-Ethylhexanoic Acid] 149-57-5 4% Acute Tox. 4 - Dermal Skin Corr. 1A BC Eye Irrit. 2 Repr. 1B STOT Single Exp. 2(respiratory system) H312 H314 H319 H360 H371 LD50=2043mg/kg(oral) LD50=1140mg/kg(dermal) EC50(crustacea)=85.4mg/L Copyright 2017 Japan Chemical Database All Rights Reserved. 5

1.GHS classification(manual) Classification physical ABCD (data source :NITE) Hazard class Classification Rationale for the classification Explosives Not applicable Containing no atom groups with explosive properties Flammable gases Not applicable Classified as "liquid" according to GHS definition Aerosols Not applicable Not aerosol products Oxidizing gases Not applicable Classified as "liquid" according to GHS definition Gases under pressure Not applicable Classified as "liquid" according to GHS definition Flammable liquids Not classified No flashing point Flammable solids Not applicable Classified as "liquid" according to GHS definition Self-reactive substances and mixtures Not applicable Containing no atom groups with explosive or self-reactive properties Pyrophoric liquids Classification not possible Not pyrophoric when in contact with air at ordinary temperatures: Pyrophoric solids Not applicable Classified as "liquid" according to GHS definition Self-heating substances and mixtures Substances and mixtures which, in contact with water, emit flammable gases Classification not possible Not applicable Test methods applicable to liquid substances are not available Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) Oxidizing liquids Not classified Organic compounds not containing oxygen, fluorine or chlorine Oxidizing solids Not applicable Classified as "liquid" according to GHS definition Organic peroxides Not applicable Organic compounds containing no "-O-O-" structure Corrosive to metals Classification not possible Only Classified into Class 3, not classified Class 8 Copyright 2017 Japan Chemical Database All Rights Reserved. 6

Hazard class Acute toxicity (Oral) Acute toxicity (Dermal) Acute toxicity(inhalation) Skin corrosion/irritati on Serious eye damage/eye irritation Respiratory sensitization Classification / Hazard statement Category 4 H302 Harmful if swallowed Category 5 H303 May be harmful in contact with skin Not classified Category 2 H314 Causes severe skin burns and eye damage Category 1 H318 Causes serious eye damage Classification not possible Rationale for the classification Category 4:Na Lauryl sulphate 1200mg/kg 20%, LAS 438mg/kg 18% 2-Ethylhexanoic Acid 2043mg/kg, 4%, ATEmix = 100 / ((20% / 1200mg/kg ) + (18% / 438mg/kg ) + (4% /2043mg/kg )) =1647mg/kg <2000mg/kg Category 4 Category 3:Na Lauryl sulphate 580mg/kg 20%, 2-Ethylhexanoic Acid 1140mg/kg 6% Classification not possible: LAS, amine oxide ATEmix = (100-24)/((20%/580mg/kg) + (4%/1140mg/kg))=2001mg/kg >2000mg/kg Category 5 All ingredients are not classified or Classification not possible Category 1 :2-Ethylhexanoic Acid 4% Category 2 :Na lauryl sulphate 20%, LAS 18% amine oxide 6% Category 1( 4% ) <=5% Category 2 Category 2: Na lauryl sulphate 20% 2-Ethylhexanoic Acid 4% Category2A LAS 18% amine oxide 6% skin category 1 4% >=3% Category 1 All ingredients are not classified or Classification not possible Skin sensitization Classification not possible All ingredients are not classified or Classification not possible Germ cell mutagenicity Classification health 1.GHS classification(manual) Classification not possible ABCD (data source :NITE) All ingredients are not classified or Classification not possible 100 ATEmix = Ci n ATEi Copyright 2017 Japan Chemical Database All Rights Reserved. 7

Hazard class Classification /Hazard statement Rationale for the classification Carcinogenicity Classification not possible All ingredients are not classified or Classification not possible Reproductive toxicity Classification Health 1.GHS classification(manual) Categroy 1B H360 May damage fertility or the unborn child ABCD (data source :NITE) Category 1B:2-Ethylhexanoic Acid 4% >0.3% Category 1B STOT SE Category 3 H335:May cause respiratory irritation Category 2: 2-Ethylhexanoic Acid 4% (Respiratory system), <10% Category 3:Na lauryl sulphate 20% (Respiratory tract irritancy LAS 18% (Respiratory tract irritancy) 20%+18%=38%>20% Category 3 STOT RE Category 2 H373:May cause damage to organs through prolonged or repeated exposure Kidneys Cat.3 >=20% Category 2:Na lauryl sulphate 20%( Kidneys) >=10% Category 2 Aspiration hazard Classification not possible All ingredients are not classified or Classification not possible Copyright 2017 Japan Chemical Database All Rights Reserved. 8

Classification environ. 1.GHS classification(manual) ABCD (data source :NITE) Hazard class Hazardous to the aquatic environment (Acute) Classification /Hazard statement Category 1 H400 Very toxic to aquatic life Category 1: Na lauryl sulphate 20%, LAS 18%, Amine oxide 6%, Category 3:2-Ethylhexanoic Acid 4%, Rationale for the classification toxicity value fish = No data, crustacea = 0.72mg/l, algal = No data toxicity value fish = No data, crustacea = No data, algal = 0.9mg/kg toxicity value fish = No data, crustacea = No data, algal = 0.081mg/l toxicity value fish = No data, crustacea = 85.4mg/l, algal = No data Method 1(each species) Additivity formula Crustacea species:24 / ((20% / 0.72mg/l) + (4% / 85.4mg/l))=0.86mg/l, Category 1, toxicity M factor= 1 Algal species:24 / ((18% / 0.9mg/l) + (6% / 0.081mg/l))= 0.255mg/l, Category 1, toxicity M factor= 1 Summation method Crustacea (M x 10 x category 1) + category 2 = 240% >=25% category 2. Algal (M x 10 x category 1) + category 2=240% >=25% category 2. Method 2( severe data) Additivity formula 48 / ((20% / 0.72mg/l) + (18% / 0.9mg/l) + (6% / 0.081mg/l) + (4% / 85.4mg/l))=0.39mg/l, Category 1, toxicity M factor= 1 Summation method category 1 x M=48% >=25% category 1. Method 3: Summation method category 1 x M = 1x20%+1x18%+10x6%=98% >=25% category 1. Result Method 1 : Category 1 Method 2 : Category 1 Method 3 : Category 1 -- Category 1 Copyright 2017 Japan Chemical Database All Rights Reserved. 9

1.GHS classification(manual) Classification environ. ABCD (data source :NITE) Hazard class Hazardous to the aquatic environment (Long-term) Hazardous to the ozone layer Classification /Hazard statement Category 2 H411 Toxic to aquatic life with long lasting effects Classification not possible Rationale for the classification Category 2: Na POE(3) lauryl ether sulphate 20%, toxicity value fish = No data, crustacea = No data, algal = No data, RD = Unknown, Na stearate 12%, toxicity value fish = No data, crustacea = No data, algal = No data, RD= Unknown Category 3:2-Haxanoic acid 4%, toxicity value fish = No data, crustacea = No data, algal species = No data, RD= Unknown, Method 3: Summation method (M x 10 x category 1) + category 2=0%+20%+12%=32% >=25% applicable to category 2. Result Method 1 : No data Method 2 : No data Method 3 : Category 2 -- Category 2 All ingredients are not classified or Classification not possible Copyright 2017 Japan Chemical Database All Rights Reserved. 10

Classification Aquatic toxicity criteria for mixtures Step 1: Aquatic toxicity data available for the mixture as a whole No Step 2 : Sufficient data available on similar mixtures to estimate hazards No Step 3.: Either aquatic toxicity or classification data available for all relevant ingredients Step 4: Use available hazard data of known ingredients Yes Yes Classify Apply Bridging Principles Classify Apply Additivity formula Yes No Classify Yes Apply Summation Method Classify Copyright 2017 Japan Chemical Database All Rights Reserved. 11

1.GHS classification(manual) Product information sheet ABCD (data source :NITE) GHS elements Symbol Signal word Hazard statement Precautionary statement Danger H302:Harmful if swallowed H303 May be harmful in contact with skin H315:Causes skin irritation H318:Causes serious eye damage H335: May cause respiratory irritation H360:May damage fertility or the unborn child H373:May cause damage to organs through prolonged or repeated exposure Cardiovascular system, Kidneys H400:toxic to aquatic life Prevention P201:Obtain special instructions before use. P202:Do not handle until all safety precautions have been read and understood. P260:Do not breathe dust/fume/gas/mist/vapours/spray. P264:Wash... thoroughly after handling. P270:Do not eat, drink or smoke when using this product. P271:Use only outodoors or in a well-ventilated area. P273:Avoid release to the environment. P280:Wear protective gloves/protective clothing/eye protection/face protection. Response P301+P312:IF SWALLOWED: Call a POISON CENTER/doctor/ /if you feel unwell. P302+P352:IF ON SKIN: Wash with plenty of water/... P304+P340:IF INHALED, Remove person to fresh air and comfortable for breathing. P305+P351+P338:IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P308+P313:IF exposed or concerned: Get medical advice/attention. P310:Immediately call a POISON CENTER/doctor/ P312:Call a POISON CENTER/doctor/ /if you feel unwell. P314:Get medical advice/attention if you feel unwell. P321:Specific treatment (see... on this label). P330:Rinse mouth. P332+P313:If skin irritation occurs: Get medical advice/attention. P362+P364:Take off contaminated clothing and wash it before reuse. P391:Collect spillage. Storage P403+O233:Store in a wellventilated place. Keep container tightly closed. P405:Store locked up. Disposal P501:Dispose of contents/container to... Copyright 2017 Japan Chemical Database All Rights Reserved. 12

1.GHS classification(manual) Label ABCD (data source :NITE) ABCD-2 water (52%),Sodium Lauryl sulfate (20%),LAS (18%),Dodecyldimethyl amine oxide (6%).2-Hexanoic acid (4%) Harmful if swallowed May be harmful in contact with skin Causes skin irritation Causes serious eye damage May damage fertility or the unborn child May cause damage to organs Digestive system May cause damage to organs through prolonged or repeated exposure Cardiovascular system, Kidneys toxic to aquatic life Toxic to aquatic life with long lasting effects prevention Do not breathe dust/fume/gas/mist/vapours/spray. Wear protective gloves/protective clothing/eye protection/face protection. Response IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. IF exposed or concerned: Get medical advice/attention. Immediately call a POISON CENTER/doctor/ If skin irritation occurs: Get medical advice/attention. Company name Company address Tel,, Emergency Tel 6 phrases of precautionary statements have to be selected in case of Singapore/Indonesia/EU. Copyright 2017 Japan Chemical Database All Rights Reserved. 13

Merit 2.GHS classification Tool(METI) Automatic classification that conform to the GHS 4th revised edition and JIS Z 7252:2014 (Japanese Industry Standard for GHS Classification) Is equipped GHS classification results by Japanese Government which are published on NITE(National Institute of Technology and Evaluation) website. Can be output the classification result as a label element http://www.meti.go.jp/policy/chemical_management/int/ghs_auto_clas sification_tool_ver4_eg.html Copyright 2017 Japan Chemical Database All Rights Reserved. 15

2.GHS Classification Tool(METI) Operating Environment 1 CPU: Pentium 1GHz or higher 2 RAM:1GB or more 3 Disk Space: 10GB or more List of Required Components 1 Microsoft SQL Server 2008 Express 2 Microsoft.NET Framework 3.5 SP1 3 Microsoft Excel 2007 or 2010 *The required components 1and 2 will be downloaded during the required component installation process. List of Supported Operating Systems 1 Microsoft Windows Vista 2 Microsoft Windows 7 3 Microsoft Windows 8(8.1) The system can be installed on either the 32-bit or the 64-bit version. Caution) This system is designed to work stand-alone. Please do not install and use on network drives etc. Copyright 2017 Japan Chemical Database All Rights Reserved. 16

Downloads Please refer to " The GHS Mixture Classification System Install Manual " and " GHS Mixture Classification System Operating Manual " when downloading and using the system. Software * The Full Package Edition provides the installer and all required components. Internet connection is required only if Windows 8 or 8.1 is used. *Since some components required by the system must be downloaded and installed individually via internet during the installation process, internet environment is required. Either downloading, installing or using of the System shall automatically constitute full acceptance of " Term of Use " and disclaimer of liability above. The GHS Mixture Classification System - Full Package Edition - ( Ver.2.0 )(ZIP 形式 :412,529KB) (New!) The GHS Mixture classification System - Downloadable Edition -( Ver.2.0 ) (ZIP 形式 :11,927KB) (New!) The GHS Mixture classification System - update -( Ver.2.0 Ver.2.1 )(ZIP 形式 :193KB) (New!) Refinement of Substance list Refinement of Substance list (PDF 形式 :165KB) (New!) Manual The GHS Mixture Classification System Install Manual - Full Package Edition - ( Ver.2.0 ) (PDF 形式 :1,115KB) (New!) The GHS Mixture Classification System Install Manual - Downloadable Edition - ( Ver.2.0 ) (PDF 形式 :1,126KB) (New!) GHS Classification System Operating Manual ( Ver.1.2 )(PDF 形式 :1,102KB) The attached sheet About the Precautionary statement narrowing down (PDF 形式 :138KB) GHS Classification System Import Export Operating Manual ( Ver.1.2 ) (PDF 形式 :1,167KB) Supplementary document for GHS classification system (PDF 形式 :224KB) Copyright 2017 Japan Chemical Database All Rights Reserved. 19

Click Click the system icon created during the installation process to launch the application. 2.1 Selecting the Language When the application is launched for the first time, a dialog box asking you to select the language to use with the system will be displayed. If you wish to change the language setting later, you can do so from the Change Language menu on the system screen. Language Settings Screen Displayed at System Launch Copyright 2017 Japan Chemical Database All Rights Reserved. 20

2.2. Reviewing Disclaimers When the application is launched, a dialog box containing disclaimers applicable to use of the system will be displayed. Click the Agree button to proceed to the system menu. Clicking the Do Not Agree button will exit the system. Click Copyright 2017 Japan Chemical Database All Rights Reserved. 21

4. Overview of Compound Classification and Label Element Output Process with This System 1. Registration of company information Register the company information to output to label elements with the Configure Settings button. 2. Registration of chemical substance information Register information about the chemical substances that are to be registered as part of the product composition with the Manage Chemical Substance Information button. 3. Registration of products Register information (composition, etc.) about the products for which you wish to create label elements and perform GHS classification with the Manage Product Information button. Label elements will be saved at the same time. 4. Generation of label element output Output label elements created based on GHS classification results from step 3, Registration of products, as Excel or text (TSV) files with the Output Label Elements button. Copyright 2017 Japan Chemical Database All Rights Reserved. 23

5.1 Managing Product Information The Manage Product Information button provides access to functionality for registering, changing, and deleting product information, GHS classification results, and label elements. Click the Manage Product Information button on the menu to use this functionality. Click Copyright 2017 Japan Chemical Database All Rights Reserved. 24

2) Enter the product information.(user control number(optional),product name(required), UN number(optional),physical state(select),flash point(optional),initial boiling point(optional),kinematic viscosity(optional)) * This system, can not classification of physical hazards. Classification of physical hazards will be required to enter in manually. Sample_Paint 12.0 20.5 Click If you know the UN number for the product being registered, click the Search button 40.0 Copyright 2017 Japan Chemical Database All Rights Reserved. 26

to classify physiochemical hazards [Classified based on the flash point] Flammable liquids [Classified based on the UN number] Explosives etc. Copyright 2017 Japan Chemical Database All Rights Reserved. 34

1. Strong recommendation (for industrial/professional users) 2. Strong recommendation (in consideration of applications other than [1] above) 3. Recommendation 4. Voluntary Copyright 2017 Japan Chemical Database All Rights Reserved. 43

Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008 The P-statements assignment follows a traffic light system. highly recommended, recommended, optional and not to be used for the hazard label; Copyright 2017 Japan Chemical Database All Rights Reserved. 44

Level 2 : 14 P code Precautionary statements Level 1 : 5 P code Precautionary statements Level 3 : 27 P code Level 4 : 35 P code Precautionary statements Precautionary statements Copyright 2017 Japan Chemical Database All Rights Reserved. 53

Agenda 1.GHS classification by manual 2.GHS classification Tool(METI) 3.GHS Model Classification(NITE) 4.GHS Classification Guidance for Enterprises(METI) Copyright 2017 Japan Chemical Database All Rights Reserved. 56

3.GHS Model Classification(NITE) http://www.nite.go.jp/en/chem/chrip/chrip_search/intsrhspclst?slidxnm=&slscnm=ci_01_001&slscctnm=&slscrgnm=&ltcatfl=& slmddplt=0&ltpgct=500&stmd=&cnglngmd=1 Method 1 :List Stage ONE Decree number :3636 Same CAS No : different chemical name Copyright 2017 Japan Chemical Database All Rights Reserved. 57

3.GHS Model Classification(NITE) http://www.safe.nite.go.jp/english/db.html Method 3 :CHRIP Click NITE : National Institute of Technology and Evaluation Copyright 2017 Japan Chemical Database All Rights Reserved. 59

4.GHS Classification Guidance for Enterprises(METI) GHS Classification Guidance for Enterprises 2013 Revised Edition (P306) http://www.meti.go.jp/policy/chemical_management/int/files/ghs/h25jenter_en.pdf Copyright 2017 Japan Chemical Database All Rights Reserved. 66