International Standard for Chemical Safety Globally Harmonized System of Classification and Labelling of Chemicals (GHS) UNITAR PAG (United Nations Institute.

International Standard for Chemical Safety Globally Harmonized System of Classification and Labelling of Chemicals (GHS) UNITAR PAG (United Nations Institute for Training and Research Programme Advisory Group) Edited by Hiroshi JONAI Expert of UNSCGHS

GHS Welcome to the GHS learning module. My name is Chemi. I will be your guide as you tour the different sections of this module. Let me start by telling you what the letters G H S stand for. The acronym means Globally Harmonized System of Classification and Labeling of Chemicals.

Contents of the CD Introduction to the GHS What is the GHS?
Objective History of GHS Classification Criteria Hazard Communication Factors to Consider in the GHS Implementation Other Issues Q & A Classification Examples Pictograms for downloading What can this learning module on the GHS offer to its audience? The CD covers the basic information on how the system works. The introduction to the GHS will provide an understanding of the key concepts of the GHS including a short history on how it was developed and more importantly how significant the system is to everyone. The different topics of the introduction are “What is the GHS?” pointing out its definition, objectives and history. “Classification Criteria”, “Hazard Communication” “ Factors to consider in the GHS Implementation” and “Other Issues” will also be discussed. A “Q and A” portion will tackle the frequently asked questions. Examples of chemical classification will be given and pictograms are provided for you to download. You can start the learning session by clicking the topic of your choice. You can stop at any time during session and may resume where you last left off at a more convenient time. My voice will be heard only in the introductory portion. You can proceed at your own pace for the rest of the topics. Now, let’s get started. Click on your topic of choice.

1. Introduction Welcome to the Introduction to the GHS!

Objective Historical Background
What is the GHS? Objective Historical Background What is the GHS?

What is the GHS? A common and coherent approach
To define and classify hazards To communicate information on labels and safety data sheets (SDS) A simple and transparent method guided by Classification criteria Label requirements SDS requirements The Globally Harmonized System (GHS) is a common and coherent use of a method of classifying and labeling chemicals. The aim is to have an internationally shared criteria for categorizing chemicals in terms of their health, physical and environmental hazards. The GHS also refers to a consistent way of communicating hazard information on labels and safety data sheets. As such, classification criteria and requirements for labelling and SDS were meant to be simple and transparent to allow the users to “self classify” chemicals.

What is the objective of the GHS?
To enhance the protection of human health and the environment The primary objective of the GHS is to provide information on chemical hazards to protect health and the environment.

Benefits of GHS Adoption
Protection of humans and environment around the world will be enhanced. International trade in chemicals will be facilitated. An internationally maintained system will be made available to all nations. Avoidance of duplication of testing and evaluation of chemicals to determine their hazardous effects will be ensured. There are several benefits in adopting the GHS. With the application of the GHS, it is expected that protection of human health and the environment will be enhanced by providing an internationally comprehensible system. Another benefit is likely to be seen in the international trade of chemicals. The GHS will facilitate international trade of chemicals whose hazards have been properly assessed and identified. With regards formulation of local regulation, countries who have no existing system will have the GHS, an internationally maintained system, for the taking, without needing to develop from the beginning the infrastructure necessary to formulate or maintain such a system themselves. Taking into consideration the global shift towards resource maximization, the GHS will ensure that duplication of testing and evaluation of chemicals to determine their hazardous effects will avoided.

Situation analysis of chemical Use
Why is there a need for the GHS to address the issues of chemical safety? Why is there a need for a globally harmonized system to address the issues of chemical safety?

(Insert pictures of modernized society or utilizing chemicals.)
Chemicals – We see them everywhere from the manufacturing stage to their transport, distribution until they reach their intended users. Chemicals are essential in responding to the needs of modern society and for economic development.

(Insert pictures of disasters by chemicals.)
But chemicals also carry risks to humans and the environment. Chemically-related accidents, disasters and diseases may arise at any stage in the lifecycle of a chemical substance – anywhere from its creation to its disposal.

Magnitude of Chemical Use
More than 27 million chemicals in the world （CAS 2005） 1.1 million work-related deaths every year （ILO） 1/4 caused by chemicals According to Chemical Abstract Service, more than 25 million organic and inorganic chemicals were registered in 2005. But as the number of chemicals continues to increase, the possibility of adverse effects due to chemical exposure likewise increases. The International Labour Organization estimates that out of the 1.1 million work-related deaths every year, one fourth of them have been caused by chemicals.

Issues in Hazard information
No one country has the ability to identify and regulate ALL hazardous chemicals and chemical products. Requirements for hazard definition, label or safety data sheet may differ from country to country. Among the most basic means of chemical management is the promulgation and enforcement of legislations. Most countries have in place certain provisions of the law that would ensure some amount of protection to those exposed to chemicals. However, even in the most developed countries, there is a recognized limitation to regulatory capabilities to deal with all hazardous chemicals and chemical products. This limitation may be magnified several times over in the case of the developing countries. Disseminating hazard information has been recognized by many countries to be a very potent instrument in addressing chemical hazards. However, the discrepancies among countries may hinder economic trade and transport of chemicals that would entails crossing of political borders and boundaries. The effort to comply with the requirements of multiple agencies or with requirements of multiple trade partners may be too tedious or too costly. In other words, these differences impact both protection from chemical exposure and trade

Example of differences: Acute toxicity (oral LD50)
Dose [mg/kg] 5　　25　　　50　　 200　300　500　　　　　2,000　　　　5,000 GHS　 1 2 3 4 5　__ EU R-phrase R28 T+ Very toxic R25 T Toxic R22 Xn Harmful USA Harm-ful UN RTDG 6.1　Toxic substances Very serious risk PG　Ⅰ Serious Risk PG　Ⅱ Low Risk PG Ⅲ (Liquid) Low PG Ⅲ (Solid) Let us then take Acute Toxicity as an example. This table shows the classification differences between regulations of the United States and the European Union. The United Nations Recommendations on the Transport of Dangerous Goods is also shown. If you focus your attention on cut off values for the categories of acute toxicity as indicated by the dose in milligrams of the chemical per kilogram body weight. You would notice the discrepancies in the 3 systems. The cut-off value for the most dangerous category is 25 mg/kg in EU, 50 in the USA and 5 for United Nations Recommendations on the Transport of Dangerous Goods. These discrepancies are not exclusive for the classification for acute toxicity. Differences in classification are also present in other categories of health hazards. With the worldwide implementation of GHS, the cut off values will be harmonized into one and trade is facilitated as requirements of different entities become easier to comply with.

GHS as a basis for Chemical management
Safe Use of Chemicals Risk Management system Through the GHS, a mechanism was created to produce harmonized criteria for classifying substances and mixtures according to physical, health and environmental hazards and harmonized hazard communication elements, including requirements for labelling and safety data sheets. These factors are the basis of risk management system. These factors will lead to safe use of chemicals. Appropriate and effective exposure control measures cannot be developed without adequate hazard information. Hazard Communication (GHS Labels and SDS) GHS Classification

Historical Background
The Past That Defined GHS The history of GHS spans almost 2 decades.

A Chronology of Initiatives in Developing the GHS
1950’s - United Nations issued Recommendations on the Transport of Dangerous Goods (UNRTDG). The GHS criteria for physical hazards based on UNRTDG. The concepts of classification and labelling of chemicals are already being practiced by the transport sector guided by the United Nations Recommendations on the Transport of Dangerous Goods (UNRTDG). The GHS physical hazards criteria were largely based on the existing criteria of the UNRTDG.

UNRTDG ILO adopted a Resolution concerning a Convention on safety in the use of chemicals at work ILO Convention 170 and Recommendation 177 on safety in the use of chemicals at work These instruments require countries to adopt a system for hazard classification and labelling. At the 76th Session of the International Labor Organization in June 1989, a Resolution presented to the assembly for the drafting of a Convention on safety in the use of chemicals at work. This Resolution was followed by the adoption by the ILO of the Chemicals Convention (N0. 170) and its accompanying Recommendation in 1990.

UNRTDG ILO Resolution ILO Convention 170 and Recommendation 177 United Nations Conference on the Environment and Development (UNCED) in Brazil: Established 6 programme areas in Chapter 19, Agenda 21 Chapter 19, Agenda 21, seeks to strengthen national and international efforts related to the environmentally sound management of chemicals. The goal of a globally harmonized chemical classification and labelling was further endorsed by the 1992 UN Conference on Environment and Development and included it as one of the six programme areas for action identified in Chapter 19 of Agenda 21 on environmentally sound management of chemicals.

UNRTDG ILO Resolution ILO Convention 170 and Recommendation 177 United Nations Conference on the Environment and Development (UNCED) in Brazil: Established 6 programme areas in Chapter 19, Agenda 21 Chapter 19, Agenda 21 Risk assessment Harmonization of classification and labelling of chemicals Information exchange Risk reduction programmes Strengthening of national chemical management capabilities and capacities Prevention of illegal international traffic in toxic and dangerous products Harmonization of classification and labelling of chemicals appeared as Programme B in Chapter 19, Agenda 21. The other programmes include A for Risk Assessment C for Information Exchange D for Risk Reduction Programmes E for Strengthening of national chemical management capabilities and capacities AND F for Prevention of illegal international traffic in toxic and dangerous products

Chapter 19, Agenda 21 Programme B: Harmonization of classification and labelling of chemicals
Specific Mandate: “A globally-harmonised hazard classification and compatible labelling system, including material safety data sheets and easily understandable symbols, should be available, if feasible, by the year 2000.” The specific mandate of Programme B is to ensure that “a globally harmonized hazard classification and compatible labelling system, including material safety data sheets and easily understandable symbols, should be available, if feasible, by the year 2000“.

Technical Focal Point IFCS IOMC/CG/HCCS UN CETDG OECD/AG/HCL ILO/HC
Intergovernmental Forum on Chemical Safety Interorganization Programme for the Sound Management of Chemicals Coordinating Group for Harmonization Of Chemical Classification Systems UN CETDG OECD/AG/HCL ILO/HC Advisory Group on Harmonization of Classification and labelling Working Group on Harmonization of Chemical Hazard Communication Committee of Experts on Transport of Dangerous Goods (Since 1952) UNRTDG: Unique International Standard for Chemical Safety After Agenda 21, it took long time to finalize the GHS draft. The different international organizations that worked towards the drafting of the GHS are shown on this slide. The first pillar of the GHS is the Intergovernmental Forum on Chemical Safety (IFCS), created in The IFCS provides the mechanism for international cooperation in the promotion of sound chemical management. In 1995, under the umbrella of the Interorganization Programme for the Sound Management of Chemicals (IOMC), the Coordinating Group for Harmonization of Chemical Classification Systems (CG/HCCS), coordinated the efforts of international and intergovernmental organizations in assessing and managing chemicals. Technical and scientific work was shared by international focal points. Harmonization of classification criteria of physical hazards was led by the Committee on Transport of Dangerous Good. Established in 1950s, UNRTDG had in place the criteria for classification of physical hazards and acute toxicity . The committee to set up the health and environmental hazard criteria was led by Advisory Group of Organization for Economic Cooperation and Development (OECD). OECD had established the test guidelines for chemicals. Discussion about hazard communication elements was led by the International Labour Organization. Health and Environmental Hazard Criteria Hazard Communication Elements Physical Hazards

Major Basis for GHS UN Transport Recommendations
European Union (EU) Directives on Substances and Preparations Canadian Requirements for Workplace, Consumers and Pesticides US Requirements for Workplace, Consumers and Pesticide The work of the technical focal points started by examining existing systems and finding ways to adopt the best aspects of each system into the GHS. The following four (4) systems were deemed to be the “major” existing systems and were used as the primary basis for the elaboration of the GHS. United Nations Recommendations on the Transport of Dangerous Goods European Union (EU) Directives on Substances and Preparations Canadian Requirements for Workplace, Consumers and Pesticides US Requirements for Workplace, Consumers and Pesticides

Scope of GHS The scope of the GHS has been defined in terms of the chemicals covered, requirements for labels and safety data sheet, and sectors that will be affected.

What chemicals are covered by the GHS?
Covers ALL hazardous chemical substances, dilute solutions and mixtures The GHS covers all hazardous chemical substances, dilute solutions and mixtures.

What chemicals are NOT covered by the GHS?
“Articles”, as defined in the United States OSHA Standard 29 CFR Pharmaceuticals, food additives, cosmetics and pesticide residues in food will not be covered but will be covered where workers may be exposed and in transport However, there are some exemptions from the scope of the GHS. The GHS will not apply to "Articles" as defined in the OSHA Hazard Communication Standard (HCS) (29 CFR ) of the United States. If you want to see the definition of “Article”, click “Article”. The medicines prescribed by a doctor for a patient or cosmetics for consumers are not covered by the GHS because of the concept of “intentional intake”. But workers exposed to chemicals during the manufacture and transport of medicine or cosmetics fall within the scope of the GHS.

What will be changed by GHS?
Methyl Alcohol CH3OH=32.04 CAS No UN No. 1230 ＤＡＮＧＥＲ Hazard statements: ・Highly flammable liquid and vapor ・May be harmful if swallowed ・Cause serious eye irritation ・May damage fertility or the unborn child ・Causes damage to organs (central nervous system, visual organ, systemic toxicity) ・May cause respiratory irritation ・May cause drowsiness and dizziness ・Cause damage to organs (central nervous system, visual organ) through prolonged or repeated exposure Precautionary statements: ・Do not handle until all safety precautions have been read and 　　understood. ・Keep container tightly closed. ・Keep away from heat/sparks/open flame – No smoking. ・Wear protective gloves and eye/face protection. ・Do not eat, drink or smoke when using this product. ・Use only outdoors or in well ventilated area. ・Wash thoroughly after handling. United Nations Co., Ltd. 1-1, Peace Ave., Geneva Switzerland Tel 　　　　　　Fax Methanol 14kg Methanol Methyl Alcohol CH3OH=32.04 99.5% kg Flammable Toxic Provide Personal Protective Equipment . Install local ventilation system. Wash well when touched. Fraud Co., Ltd. 1-1, Error Ave., Hidden city Imaginary country X Among the changes that will take effect with the GHS implementation is the content and appearance of labels. The labelling requirements under the GHS may be compared with the disharmonized requirements in this slide. The label on the left side is a prototype of pre-GHS labels. Please pay close attention to the information displayed on the labels. Compare the old label on the left with that on the right. This label on the right was developed using the requirements set by the GHS. The most prominent differences are the following: First, the old methanol label contained very little information on the hazards and precautionary measures. Under the GHS, the labels developed must have signal word, hazard statements and the precautionary statements assigned. Second, pictograms are voluntarily used by the company before the GHS implementation. On the other hand, the GHS requires the display of harmonized pictograms. The third difference is the incomplete supplier information on the old label. You may note the absence of telephone number that may be used to contact the supplier. With the implementation of the GHS, the supplier information that must appear on labels have also been standardized and have been defined to include the supplier’s name, address and telephone number. OLD NEW

Target Audience of GHS Employers Workers Transport workers Consumers
Emergency responders Target populations of the GHS include employers, workers, transport workers, consumers and emergency responders. That means everybody who may have a chance to be exposed to chemicals and be responsible for measures against accidents.

Roles and Responsibilities of Major Stakeholders
Many sectors and populations of the society can contribute to implement the GHS.

Stakeholders Roles and Responsibilities
Manufacturer or Supplier To classify chemicals and make labels and SDSs Employer To provide opportunities to educate and train workers on GHS To ensure successful implementation of GHS in the workplace Worker To understand value and implication of information on label and SDS and to improve attitudes and practices towards chemical management Sharing responsibility entails active participation in the GHS implementation. The manufacturer or supplier of chemicals has the primary responsibility of classifying chemicals and in producing labels and safety data sheets. Periodical review and timely updating of information are among the responsibilities of manufacturers and suppliers. The employers are expected to provide education and training on the GHS to all workers involved in the use of chemicals and to ensure that the GHS is being implemented properly in the workplace. Workers, on the other hand, must actively pursue avenues that will lead to a better understanding of the information contained in labels and Safety Data Sheets. This heightened understanding should be translated to an improvement in compliance to safe practices, proper waste disposal procedures, among others.

Stakeholders Roles and Responsibilities
Consumer To understand the meaning of contents of a label Government To harmonize the domestic regulations in order to implement GHS Academe, Scientific Institutions, Professional Organizations, etc. To do hazard assessment, information dissemination, education and information campaign, etc. Consumers as end-users of chemical products are expected to understand the meaning of the information on consumer product labels. Their responsibility does not end with the selection of the products based on the chemical hazard information. Consumers are also expected to take to heart the recommended safe practices to ensure that chemical products are managed soundly in the homes in terms of proper use, storage, and disposal. The government must act to harmonize existing domestic regulations and to align the harmonized form with the GHS. And in the absence of a system, the government is responsible for the promulgation of regulations on sound chemical management that are likewise in consonance with the GHS. The community of experts in the academe, institutions and professional organizations must put in their share by contributing in hazard assessment, information dissemination, education program to support the GHS implementation.

Classification Criteria
Now let us go to the core of GHS – the classification criteria for chemicals.

Principles of Harmonized Classification System
Classification is based on the hazards resulting from intrinsic properties of chemicals. Classification is based on currently acceptable and available data. no test requirement in GHS The harmonized classification system is anchored on several principles. One is that classification must be based on the hazards that come from the intrinsic properties of the chemical substances and mixtures. The GHS does not include establishment of uniform test methods or promotion of further testing to address hazards. As such, classification of chemicals is hinged on the existing and acceptable data about the hazardous chemical.

Classification Criteria for Hazards
Physical Hazard Health Hazard Environmental Hazard The GHS has set criteria for classification of chemicals according to 3 major hazards - physical, health and environmental hazards. Each hazard will be explained in detail in the following slides.

Physical Hazards First, the physical hazards.

Harmonized Criteria for Physical Hazards
Explosives Flammable gases Flammable aerosols Oxidizing gases Gases under pressure Flammable liquids Flammable solids Self-reactive substances and mixtures Pyrophoric liquids Pyrophoric solids Self-heating substances and mixtures Substances and mixtures which, in contact with water, emit flammable gases Oxidizing liquids Oxidizing solids Organic peroxide Compressed gas Corrosive to metal The harmonized criteria for physical hazards will apply to chemicals that can be considered as any of the following: explosive, flammable gas or flammable aerosol, oxidizing gas, or gas under pressure, Other physical hazards include flammable liquids, flammable solids, self-reactive substances and mixtures, pyrophoric liquids or pyrophoric solids. Self-heating substances and mixtures; Substances and mixtures which, in contact with water, emit flammable gases; Oxidizing liquids; Oxidizing solids; Organic peroxide; Compressed gas; and Corrosive to metal. The classification criteria of each hazard can bee seen by clicking the hazard.

Flammable Liquids Category Criteria 1
Flash point < 23oC and initial boiling point  35oC 2 Flash point < 23oC and initial boiling point > 35oC 3 Flash point  23oC and  60oC 4 Flash point > 60oC and  93oC This is an example of physical hazard criteria for flammable liquids. There are four categories based on the flash point and boiling point. Category 1 includes liquids with flash point lower than 23 degree Celsius and boiling point more than or equal to 35 degree Celsius. As the flash point and boiling point become higher, the category number becomes bigger. Liquids with flash points higher than 93 degree Celsius are not flammable liquid in the GHS criteria. The lower the category number is, the more severe the hazard becomes. The other hazard classes have their own criteria which you can pore over at a later time.

Health Hazards Now let us turn our attention to the health hazards

Harmonized Criteria for Health Hazards
Acute toxicity Skin corrosion/ irritation Serious eye damage/ eye irritation Respiratory or skin sensitization Germ cell mutagenicity Reproductive toxicity Carcinogenicity Specific target organ toxicity (single exposure) Specific target organ toxicity (repeated exposure) Aspiration hazard Classification criteria for health hazards include acute toxicity, skin corrosion or irritation, serious eye damage or irritation, respiratory or skin sensitization, germ cell mutagenicity, reproductive toxicity, carcinogenicity, specific target organ toxicity (single exposure) and (multiple exposure) and aspiration hazard. Specific target organ toxicity is applied to substances or mixtures that produce specific, non lethal target organ toxicity arising from a single or repeated exposure. All significant health effects that can impair function, both reversible and irreversible, immediate and/or delayed and not specifically addressed in the other health hazard class are included. The criteria of each hazard can be seen by clicking the hazard.

Dusts and Mists (mg/l/4h)
Classification criteria for acute toxicity Acute toxicity estimate: LD50/LC50 Category 　　1 Category 　　2 Category 　　3 Category 　　4 Category 5 Oral (mg/kg) 50 300 2000 5000 See detailed criteria Dermal (mg/kg) 200 1000 Gases (ppm/4h) 100 500 2500 20000 Vapours (mg/l/4h) 0.5 2.0 10 20 Dusts and Mists (mg/l/4h) 0.05 1.0 This is an example of health hazard classification criteria for acute toxicity. Acute toxicity estimate or value represents lethal dose or concentration which causes the death of 50% of a group of test animals. In Category 1 for chemicals that enter the body of test animals through the mouth or oral route, the value 5 means that 50% of the test animals were killed by the dose equal to or less than 5 mg per kilogram body weight. The lower the number of the category a chemical is assigned to, the greater is the toxic potency. Criteria for Category 5 are not discussed here but these will facilitate the identification of substances which are of relatively low toxicity hazard but which under certain circumstances may present danger to vulnerable populations. Please refer to the GHS text in detail when you classify chemicals. (LD50/LC50: lethal dose/lethal concentration causing death of 50% of test animals)

Classification Criteria for Carcinogens
Category 1 Known or presumed carcinogen Category 2 Suspected carcinogen Limited evidence of human or animal carcinogenicity Subcategory 1A Known human carcinogen based on human evidence Subcategory 1B Presumed human carcinogen based on demonstrated animal carcinogenicity Another example of health hazard classification shown here is for carcinogens. For the purpose of classification for carcinogenicity, chemical substances are allocated to one of two categories based on strength of evidence and additional considerations such as weight of evidence. Criteria for Category 1 is for “Known or presumed carcinogen” and may be divided into 1A or 1B depending on the evidence from human or animal studies. A chemical assigned to Category 2 and classified as a suspected carcinogen when evidence of human or animal carcinogenicity is limited.

Environmental Hazards
The last hazards harmonized by the GHS affect the environment.

Harmonized Criteria for Environmental Hazards
Hazardous to the aquatic environment Unlike the physical and health hazards, the harmonized criteria for environmental hazards have been developed only for aquatic toxicity.

Classification Criteria for Substances Hazardous to Aquatic Environment
Acute Category 1 Acute toxicity ≦ 1 mg/l Acute Category 2 ＞ 1 but ≦ 10 mg/l Acute Category 3 ＞ 10　but ≦ 100 mg/l Chronic Category 1 <1mg/l 　 and ・ lack of rapid 　　 degradability and/or ・ BCF > 500 (or, log Kow > 4) Category 2 > 1 but < 10 mg/l degradability and ● unless chronic toxicity > 1 mg/l Category 3 > 10 but < 100 mg/l Category 4 No acute toxicity 　 and ● unless chronic toxicity >1 mg/l Acute aquatic toxicity refers to the intrinsic property of a substance to be injurious to an organism following short-term exposure. It would normally be determined using a fish 96 hour LC50, a crustacea species 48 hour effective concentration EC50 and/or an algal species 72 or 96 hour EC50. These species are considered as surrogate for all aquatic organisms Chronic toxicity data are less available than acute data. Chronic categories combined two types of information: acute toxicity data and environmental fate data that consider degradability and bioaccumulation data. BCF: Bioconcentration Factor Kow: octanol/water partition coefficient

Classification of Mixtures
Most of the chemical products are mixtures. It is for this reason why the GHS has defined the classification mechanism for mixtures.

Classification of Mixtures
Where test data are available for the complete mixture, the classification of the mixture will always be based on that data. Physical hazards: For physical hazards, test results of mixtures should be used for classification. However classification of Flammable Gases, Flammable Aerosols, Flammable Liquids and Oxidizing Gases may be determined by calculations in a specific cases. Classification of mixtures is a key element of the GHS implementation. The system recommends that classification of mixtures be based on available test data for the complete mixture. Especially for physical hazards, testing results for the mixture should be used for classification. However classification of Flammable Gases, Flammable Aerosols, Flammable Liquids and Oxidizing Gases may be determined by calculations in a specific cases.

Classification of mixtures (cont.)
Health and Environmental Hazards: Where test data are not available for the mixture itself, then bridging principles included and explained in each specific chapter should be considered to see whether they permit classification of the mixture. When classifying an untested mixture based on the hazards of its ingredients, generic cut-off values or concentration limits for the classified ingredients of the mixture are used for several hazard classes in the GHS. In the case of health and environmental hazards, the classification of mixtures follow a tier approach. Where test data are not available for the mixture itself, then bridging principles included and explained in each specific chapter should be considered to see whether they permit classification of the mixture. When classifying an untested mixture based on the hazards of its ingredients, generic cut-off values or concentration limits for the classified ingredients of the mixture are used for several hazard classes in the GHS. These principles will be elaborated further in the section on “Classification Examples”.

Hazard Communication Hazard Communication is the next logical step after classification chemicals has been accomplished. For hazard information to become useful, these information must be conveyed to the intended audience.

The sequence of chemical lifecycle
The importance of hazard communication is best appreciated after understanding the lifecycle of chemicals. Indeed, chemicals have their own lifecycle from its manufacture, transport, storage, use, and disposal. At each stage of lifecycle, hazards to humans or environment may be produced. As such, chemicals should be managed properly at every phase of the lifecycle. Chemical hazard communication thereby aims to inform its audience what hazards are present and how these hazards can be controlled. These information are fundamental in sound management of chemicals.

What is harmonized? Labels Safety Data Sheets (SDS)
The harmonized system for hazard communication entails the development of labels and safety data sheets. These communication tools must be based on the criteria set by the GHS.

Target Groups & Sectors
Workplace including pesticides and pharmaceuticals labels and safety data sheets Consumers labels Transport labels, placards, transport documents Emergency responders Under the GHS, labels and safety data sheets must be developed for all hazardous chemicals. In the process of development, consideration must be given to the needs of the target audience that include consumers, workers, transport workers and emergency responders. The mode of application of labels or safety data sheets may vary by product category or stage in the lifecycle. In the workplace the label and the SDS are used for chemical management. However, the label in most cases is likely to be the sole source of information available to the consumer.

Labels How do labels made following the GHS look like?

Labels The Essential Tools Symbols, Pictograms and colour Signal words
Hazard statements Precautionary statements and pictograms Product identifiers/declaration of ingredients Supplier identification The requirements for making GHS-based label include symbols or pictograms, signal words, hazard statements, precautionary statements, product identifiers/declaration of ingredients and supplier identification.

GHS Symbols Flame Flame over circle Exploding bomb Corrosion
Gas cylinder Skull & crossbones Exclamation Mark Health Hazard Environmental Hazard These 9 hazard symbols are used in the GHS: flame, flame over circle, exploding bomb, corrosion, gas cylinder, skull and cross bones, exclamation mark, health hazard and environmental hazard. With the exception of the symbols depicting exclamation mark, health hazard and environmental hazard, all are part of the standard symbols set used in the UNRTDG.

GHS Pictogram Flammable substance Self-reactive substance
Pyrophoric and self- heating substance Organic peroxides Oxidizing substance Explosives Self-reactive subst. Organic peroxide Environmental hazard Compressed gas Skin corr./irrit. Eye damage/irrit. Corrosive to metal There are 9 pictograms in the GHS. Each pictogram is assigned to the hazard or its category or division. All pictograms should be in the shape of a square set at a point. For labels of products being supplied or distributed to clients, the pictograms have a black symbol on a white background with a red frame. A competent authority may choose to give suppliers and employers discretion to use a black border for domestic use. Sensitization (Respiratory) Mutagenicity Carcinogenicity Reproductive toxicity Target organ toxicity Aspiration hazard Acute toxicity Skin corr./irrit. Eye corr./irrit. Sensitization (Dermal) Target organ toxicity Acute toxicity

UNRTDG Pictograms This slide shows the pictograms established by the UNRTDG. The background and symbol colour are very important and have special meanings. The UNRTDG will still cover the system of labelling for transport sector as in the past. It is worthy to take note that the symbols of the UNRTDG are the basis for symbols use in the GHS symbols as mentioned earlier.

Precedence of pictograms
＞＞ Skin/Eye irritation ＞ Respiratory sensitization Skin sensitization, Skin/Eye irritation The labelling system of the GHS applies the principle of precedence of hazard information. Where a substance or mixture presents more than one GHS hazard, the following principles of precedence apply for heath hazard: If the symbol skull and cross bones applies, the exclamation mark should not appear. If the corrosive symbol applies, the exclamation mark should not appear where it is used for skin or eye irritation. If the health hazard symbol appears respiratory sensitization, the exclamation mark should not appear for skin sensitization or for skin or eye irritation.

＞ Signal Word “Danger” or “Warning”
Used to emphasis hazard and to discriminate between hazard categories (level of hazard) Example: Acute toxicity Category 1, 2, “Danger”, Category “Warning” “Danger” “Warning” Another item that must appear in the labels is the signal word. A signal word refers to a word used to indicate the relative level of severity of hazard and alert the reader to a potential hazard on the label. “Danger” is used for the more severe hazard categories. For example, “Danger” is used for Acute toxicity Category 1, 2 and 3, while “Warning” is used for Category 4. The precedence also applies for signal word. If the signal word “Danger” applies, the signal word “Warning” should not appear. ＞

Hazard Statements A single harmonised hazard statement for each hazard category within each hazard class e.g. Flammable liquid Category 1 “ Extremely flammable liquid and vapour “ Category 2 “Highly flammable liquid and vapour” Category 3 “ Flammable liquid and vapour” Category 4 “Combustible liquid” Hazard statements A hazard statement is a phrase assigned to a hazard class and category. A single harmonised hazard statement is assigned for each hazard category within each hazard class For Flammable liquid: Category 1 “ Extremely flammable liquid and vapour “ Category 2 “Highly flammable liquid and vapour” Category 3 “ Flammable liquid and vapour” Category 4 “Combustible liquid”

Hazard Statements (cont.)
e.g. Acute toxicity Category 1 “ Fatal if swallowed “ Category 2 “Fatal if swallowed ” Category 3 “ Toxic if swallowed” Category 4 “Harmful if swallowed” Category 5 “Maybe harmful if swallowed” These are the hazard statements for Acute toxicity: Category 1 “ Fatal if swallowed “ Category 2 “Fatal if swallowed ” Category 3 “ Toxic if swallowed” Category 4 “Harmful if swallowed” Category 5 “Maybe harmful if swallowed”

Precautionary Statements
A precautionary statement means a phrase that describes recommended measures that should be taken to minimize or prevent adverse effects resulting from exposure to hazardous product, or improper storage or handling of a hazardous product. What is a precautionary statement? It is a phrase that describes recommended measures that should be taken to minimize or prevent adverse effects resulting from exposure to hazardous product, or improper storage or handling of a hazardous product.

Precautionary Statements (cont.)
Precautionary statements consist of four types: Prevention, Response, Storage and Disposal. This table shows examples of precautionary statements for Acute toxicity as seen in the Annex of the GHS text. All precautionary statements assigned to the hazards of a product may not be described in a label due to space constraint. Consideration should be given to select precautionary statements for each target audience, worker, commercial user or consumer.

Examples of Precautionary Pictograms
From European Union (COUNCIL DIRECTIVE 92/58/EEC of 24 June 1992) Precautionary pictograms can be used where allowed by the competent authority. The GHS has no harmonized precautionary pictograms. These are examples from European Union.

Product Identifier Substances Mixtures
chemical identity (name as determined by IUPAC, ISO, CAS or technical name) Mixtures chemical identities of all ingredients contributing to acute toxicity, skin or eye corrosion, mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory sensitisation or Target Organ Toxicity UN proper shipping name also to be used on the package when substance or mixture covered by the UN RTDG The label for a substance should include the chemical identity of the substance. For mixtures or alloys, the label should include the chemical identities of all ingredients or alloying elements that contribute to health hazards. United Nations proper shipping name also to be used on the package when substance or mixture covered by the UNRTDG

Other Points to Consider

Declaration of Ingredients
Competent authorities should establish appropriate mechanisms for CBI (Confidential Business Information) protection. CBI will not be harmonized under the GHS. CBI claims should be limited to the names of chemicals and their concentrations in mixtures. Mechanisms should be established for disclosure in emergency and non-emergency situations. Competent authorities should establish the appropriate mechanism for Confidential Business Information (CBI) protection. CBI will not be harmonized under the GHS. CBI claims should be limited to the names of chemicals and their concentrations in mixtures. All other information should be disclosed. Mechanisms should be established for disclosure in emergency and non-emergency situations.

Supplementary Information
Information on labels not harmonized under the GHS but are important may be placed on labels. Competent authorities determines if additional information are needed. Suppliers may choose to add supplementary information on their own initiative. There are many other label elements which may appear on a label which have not been standardized in the harmonized system. Some of these information clearly need to be included on the labels. For example, the type of gloves to be used as exposure control measures has not been standardized in the GHS but this information is essential and must be included in the precautionary statements. Competent authorities may require additional information, or suppliers may choose to add supplementary information on their own initiative.

Allocation of Label Elements
Example : Acute Toxicity (Oral) Category 1 Category 2 Category 3 Category 4 Category 5 Danger Fatal if swallowed Toxic if swallowed Warning Harmful if Swallowed No Symbol May be harmful if swallowed For the GHS, the assigned pictogram, signal word and hazard statement are given in that order for each category of the hazard class. This slide is one example of allocation of label elements for acute toxicity. Pictogram “Skull and cross bones” is assigned to Category 1, 2 and3, “Exclamation mark” Category 4, none for Category 5. Signal Word “Danger” is assigned to Category 1, 2 and 3, “Warning” Category 4 to Category 5. Hazard statement “Fatal if swallowed” is used for Category 1 and 2. Precautionary statements are not described in this table.

Example of label elements
Methyl Alcohol CH3OH=32.04 CAS No UN No. 1230 Product identifier Pictogram ＤＡＮＧＥＲ Signal word Hazard statements: ・Highly flammable liquid and vapor ・May be harmful if swallowed ・Cause serious eye irritation ・May damage fertility or the unborn child ・Causes damage to organs (central nervous system, visual organ, systemic toxicity) ・May cause respiratory irritation ・May cause drowsiness and dizziness ・Cause damage to organs (central nervous system, visual organ) through prolonged or repeated exposure Hazard statements Precautionary statements: ・Do not handle until all safety precautions have been read and 　　understood. ・Keep container tightly closed. ・Keep away from heat/sparks/open flame – No smoking. ・Wear protective gloves and eye/face protection. ・Do not eat, drink or smoke when using this product. ・Use only outdoors or in well ventilated area. ・Wash thoroughly after handling. Precautionary statements United Nations Co., Ltd. 1-1, Peace Ave., Geneva Switzerland Tel Fax Supplier identification Example of 　　label elements Methanol 14 kg In the GHS, once the classification is done, label elements like pictogram, signal word, hazard statements and precautionary statements are followed automatically. Precautionary statements can be chosen taking into account the needs of its target audiences.

Safety Data Sheet (SDS)

Safety Data Sheet (SDS)
Primarily workplace use Criteria for SDS production For all substances and mixtures which meet the harmonized criteria for physical, health or environmental hazards under the GHS. The Safety Data Sheet (SDS) is another hazard communication tool. It should provide comprehensive information about a chemical substance or mixture for use in the workplace chemical control program. In addition, the SDS provides an important source of information for other target audiences in the GHS. Which chemicals need to have SDS? An SDS should be produced for all substances and mixtures which meet the harmonized criteria for physical, health or environmental hazards under the GHS.

Cut-off value /Concentration limit
Cut off values/Concentration limits for health and environmental hazard class Hazard class Cut-off value /Concentration limit Acute toxicity 　　　　　　 ≥ 1.0％ Skin Corrosion/Irritation Serious damage to eyes/eye irritation Respiratory/Skin sensitization Mutagenicity: Category1 　　　　　　 ≥ 0.1％ Mutagenicity: Category2 Carcinogenicity Reproductive toxicity Specific target organ toxicity (single Exp.) Specific target organ toxicity (repeat Exp.) Hazardous to the aquatic environment A few words about limits or cut off values in hazard classification. An SDS should be provided based on the generic cut-off values/concentration limits indicated in this table. Cut-off values or concentration limits for Mutagenicity Category 1 and Carcinogenicity and Reproductive toxicity are 0.1% and for the other hazard 1%. There is no cut-off value like this for physical hazards.

SDS 16 Headings Physical and chemical properties
Stability and reactivity Toxicological information Ecological information Disposal considerations Transport information Regulatory information Other information including information on preparation and revision of the SDS Identification of the substance or mixture and of the supplier Hazard(s) identification Composition/information on ingredients First-aid measures Fire-fighting measures Accidental release measures Handling and storage Exposure controls/ personal protection The information in the SDS should be presented using the 16 headings. Please note that the appearance of the headings must follow strictly the order given in the slides. In chronological order, the 16 headings are: Identification of the substance or mixture and of the supplier Hazard(s) identification. Under this, GHS label elements should be described. Composition/information on ingredients. First-aid measures. Fire-fighting measures. Accidental release measures. Handling and storage. Exposure controls/personal protection. Physical and chemical properties. Stability and reactivity. Toxicological information. Ecological information. Disposal considerations. Transport information. Regulatory information. Other information including information on preparation and revision of the SDS Minimum additional information is specified, where applicable or available, under the relevant headings Items under each heading can be seen by double click the heading.

Factors to Consider in the GHS Implementation
There are some more points to consider in the implementation of the GHS.

Points to implement GHS
Harmonization Building Block Approach Translation into the local language Comprehensibility test Risk-based labelling Harmonization, Building Block Approach, Translation into the local language, Comprehensibility test and Risk-based labelling are described.

Harmonization Harmonization means establishing a common and coherent basis for chemical hazard classification and communication, from which the appropriate elements relevant to means of transport, consumer, worker and environment protection can be selected. Harmonization means establishing a common and coherent basis for chemical hazard classification and communication, from which the appropriate elements relevant to means of transport, consumer, worker and environment protection can be selected. Competent authorities will decide how to apply the various elements of the GHS based on the needs of the competent authority and the target audience.

Building Block Approach
Transport Workplace Consumers Pesticides Label requirement Safety data sheet Explosives Skin corrosion/irritation Self reactive substances Carcinogen Oxidizing gases Mutagenicity Pyrophoric solids Aquatic toxicity Corrosive to metals Acute toxicity Flammable liquids Sensitization Reproductive toxicity Consistent with the building block approach, countries are free to determine which of the building blocks will be applied in different parts of their systems. As long as the hazards covered by a sector or system are covered consistently with the GHS criteria and requirements, it will be considered appropriate implementation of the GHS. Not withstanding the fact that an exporter needs to comply with importing countries' requirements for GHS implementation, it is hoped that the application of the GHS worldwide will eventually lead to a fully harmonized situation. Coverage of hazards may vary by the perceived needs of the target audience for information. In particular, the transport sector focuses on acute health effects and physical hazards, but has not to date covered chronic effects due to the types of exposures expected to be encountered in that setting. Self heating substances Physical hazard Health hazard Environmental hazard

May be harmful if swallowed
Building Block Approach Example : Acute Toxicity (Oral) Category 1 Category 2 Category 3 Category 4 Category 5 Danger Fatal if swallowed Toxic if swallowed Warning Harmful if Swallowed No Symbol May be harmful if swallowed Not required under the UNRTDG This is an example of the Building Block Approach for “Acute toxicity”. For the transport, Category 4 are 5 of Acute toxicity are not required. Furthermore signal word, hazard statements and precautionary statements on a label are also not necessary.

Translation The GHS will be the basis for chemical management in the country or region. Without the GHS document in the local language, without GHS implementation. Translation should be harmonized in different sectors. The GHS will be the basis for chemical management in a country or a region. Translation of the GHS document into the local language is very important for successful implementation. Translation of terminologies, however, should be harmonized, because technical terminologies are sometimes different between sectors.

Comprehensibility Test
Some information, like pictograms, on a GHS label may be very new to the public. Comprehensibility test on the GHS label or SDS can be recommended before implementing the GHS. Some information, like pictograms, on the GHS label may be very new to the people. Comprehensibility test on GHS label or SDS is recommended before implementing the GHS. Guidelines for comprehensibility test are found in the Annex of GHS documents.

Risk-based Labelling All systems should use the GHS classification criteria based on hazard. However, competent authorities may authorize consumer labelling systems to provide information based on the likelihood of harm (risk-based labelling). Risk-based labelling maybe done only on chronic health effects (e.g. Specific Target Organ Toxicity following repeated exposure, reproductive toxicity and carcinogenicity). All systems should use the GHS classification criteria based on hazard, however competent authorities may authorize consumer labelling systems providing information based on the likelihood of harm (risk-based labelling). Risk-based labelling may be done only on chronic health effects (e.g. Specific Target Organ Toxicity following repeated exposure, reproductive toxicity and carcinogenicity).

Other Issues And still some other issues

Plans for International Implementation
The GHS: will be a non-mandatory recommendation available to countries to implement, but once implemented in the local regulations, it will be mandatory. will be operational in every country before 2008. The GHS will be a non-mandatory recommendation available to countries to implement, but once implemented in the local regulations, it will be mandatory. The GHS will be operational in every country before 2008, though the transient periods may be set up to full implementation.

ECOSOC GHS Structure UN ECOSOC Committee of Expert on TDG/GHS
Sub-Committee of Experts on TDG Sub-Committee of Experts on GHS The permanent “home” for the GHS is the United Nations Economic and Social Council (UN ECOSOC). The Sub-Committee of Experts on GHS (UNSCEGHS) and the Sub-Committee of Experts on TDG (UNSCETDG), both operate under the parent committee with responsibility for these two areas. The GHS Subcommittee is responsible for implementation issues, and maintenance/update of the technical work. The participants of GHS Subcommittee include experts from countries, representatives of the United Nations Organizations, intergovernmental organizations and representatives of the non-governmental organizations.

Technical work concerning GHS
Classification Physical hazards TDG Health hazard OECD Environmental hazards OECD Supports to implement GHS in developing countries or countries with economy in transition UNITAR The GHS Subcommittee has some focal points for technical works; concerning classification, TDG is on physical hazards, OECD on health and environmental hazards. United Nations Institute for Training and Research (UNITAR) is running some projects to support implementation of GHS in developing countries or countries with economy in transition,

Revision of GHS document
The GHS document is regularly revised and updated to reflect national, regional and international experiences in implementing requirements into national, regional and international laws, as well as experiences of those doing the classification and labelling. The GHS document is regularly revised and updated to reflect national, regional and international experiences in implementing requirements into national, regional and international laws, as well as experiences of those doing the classification and labelling.

Updating of information
Suppliers should respond to “new and significant” information they receive about a chemical hazard by updating the label and safety data sheet for that chemical. Suppliers should respond to “new and significant” information they receive about a chemical hazard by updating the label and safety data sheet for that chemical.

Other International Programs synchronized with GHS
Basel Convention (Wastes) Montreal Protocol (Ozone depleting substances) REACH (Registration, Evaluation, Authorization of Chemicals) Control Banding (Chemical management) The GHS will be synchronized with other international programs: Basel Convention, Montreal Protocol, REACH, Control Banding etc..

Information source 21, Chapter 19） homepage） (EU REACH) (US OSHA) (UNITAR) You can get some more information on GHS from these site.

Hidden slides The slides after this one should be hidden, but appear by double clicking the item concerned.

“Article” US OSHA 29 CFR A manufactured item other than a fluid or particle: which is formed to a specific shape or design during manufacture; which has end use function(s) dependent in whole or in part upon its shape or design during end use; and which under normal conditions of use does not release more than very small quantities, e.g., minute or trace amounts of a hazardous chemical, and does not pose a physical hazard or health risk to employees. (This slide is hidden. It will come out by double-clicking “Article”.) Articles excluded from GHS can be referred to United States regulations in this slide. The sentence under number three is very important point; “does not release more than very small quantities and does not pose a physical hazard or health risk”

Items under each headings
1. Identification of the substance or mixture and of the supplier • GHS product identifier. • Other means of identification. • Recommended use of the chemical and restrictions on use. • Supplier’s details (including name, address, phone number etc). • Emergency phone number. 2. Hazards identification • GHS classification of the substance/mixture and any national or regional information. • GHS label elements, including precautionary statements. (Hazard symbols may be provided as a graphical reproduction of the symbols in black and white or the name of the symbol e.g. flame, skull and crossbones.) • Other hazards which do not result in classification (e.g. dust explosion hazard) or are not covered by the GHS. The following slides will come out by double-clicking the headline of SDS.

3. Composition/information on ingredients Substance
• Chemical identity. • Common name, synonyms, etc. • CAS number and other unique identifiers. • Impurities and stabilizing additives which are themselves classified and which contribute to the classification of the substance. Mixture • The chemical identity and concentration or concentration ranges of all ingredients which are hazardous within the meaning of the GHS and are present above their cut-off levels. NOTE: For information on ingredients, the competent authority rules for CBI take priority over the rules for product identification.

5. Fire-fighting measures
4. First aid measures • Description of necessary measures, subdivided according to the different routes of exposure, i.e. inhalation, skin and eye contact and ingestion. • Most important symptoms/effects, acute and delayed. • Indication of immediate medical attention and special treatment needed, if necessary. 5. Fire-fighting measures • Suitable (and unsuitable) extinguishing media. • Specific hazards arising from the chemical (e.g. nature of any hazardous combustion products). • Special protective equipment and precautions for firefighters. 6. Accidental release measures • Personal precautions, protective equipment and emergency procedures. • Environmental precautions. • Methods and materials for containment and cleaning up.

8. Exposure controls/personal protection.
7. Handling and storage • Precautions for safe handling • Conditions for safe storage, including any incompatibilities. 8. Exposure controls/personal protection. • Control parameters e.g. occupational exposure limit values or biological limit values. • Appropriate engineering controls. • Individual protection measures, such as personal protective equipment. 9. Physical and chemical properties • Appearance (physical state, colour etc). • Odour. • Odour threshold. • PH. • Melting point/freezing point. • Initial boiling point and boiling range. • Flash point. • Evaporation rate. • Flammability (solid, gas). • Upper/lower flammability or explosive limits. • Vapour pressure. • Vapour density. • Relative density. • Solubility(ies). • Partition coefficient: n-octanol/water. • Auto-ignition temperature. • Decomposition temperature.

10. Stability and reactivity
• Chemical stability. • Possibility of hazardous reactions. • Conditions to avoid (e.g. static discharge, shock or vibration). • Incompatible materials. • Hazardous decomposition products. 11. Toxicological information • Concise but complete and comprehensible description of the various toxicological (health) effects and the available data used to identify those effects, including: • information on the likely routes of exposure (inhalation, ingestion, skin and eye contact); • Symptoms related to the physical, chemical and toxicological characteristics; • Delayed and immediate effects and also chronic effects from short- and long-term exposure; • Numerical measures of toxicity (such as acute toxicity estimates). 12. Ecological information • Ecotoxicity (aquatic and terrestrial, where available). • Persistence and degradability. • Bioaccumulative potential. • Mobility in soil. • Other adverse effects.

13. Disposal considerations
• Description of waste residues and information on their safe handling and methods of disposal, including the disposal of any contaminated packaging. 14. Transport information • UN number. • UN Proper shipping name. • Transport hazard class(es). • Packing group, if applicable. • Marine pollutant (Yes/No). • Special precautions which a user needs to be aware of or needs to comply with in connection with transport or conveyance either within or outside their premises. 15. Regulatory information • Safety, health and environmental regulations specific for the product in question. 16. Other information including information on preparation and revision of the SDS

International Standard for Chemical Safety Globally Harmonized System of Classification and Labelling of Chemicals (GHS) UNITAR PAG (United Nations Institute.

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International Standard for Chemical Safety Globally Harmonized System of Classification and Labelling of Chemicals (GHS) UNITAR PAG (United Nations Institute.

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Presentation on theme: "International Standard for Chemical Safety Globally Harmonized System of Classification and Labelling of Chemicals (GHS) UNITAR PAG (United Nations Institute."— Presentation transcript:

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