Globally Harmonized System

The Globally Harmonized System of Classification and Labeling of Chemicals or GHS is an internationally agreed upon system set to replace the various different classification and labeling standards used in different countries. The GHS will use consistent criteria for classification and labeling on a global level. Its development began at the United Nations Rio Conference in 1992, when the International Labour Organization (ILO), the Organisation for Economic Co-operation and Development (OECD), and various governments and stakeholders came together at the United Nations. It supersedes the relevant European Union and United States standards. Recently, the European Commission proposed to implement the United Nations' GHS into EU law as the European Union's Globally Harmonised System of the Classification and Labelling of Chemicals.

History
The Globally Harmonized System (GHS) for classification and labeling arose from the declaration at the 1992 Rio Conference on Environment and Development that “A globally harmonized hazard classification and compatible labeling system, including material safety data sheets and easily understandable symbols, should be available if feasible, by the year 2000”. The goals of the GHS are to enhance protection of mankind and the environment, by:
 * Providing an internationally comprehensible system for hazard communication.
 * Providing a recognized framework for those countries without an existing system.
 * Facilitating international trade in chemicals whose hazards have been properly assessed and identified on an international basis.
 * Reducing the need for animal testing and evaluation of chemicals.

What is it?
The GHS is a common and consistent approach to defining and classifying hazards, and communicating hazard information on labels and safety data sheets (SDS). The GHS will cover all hazardous chemicals, which includes substances, products, mixtures, preparations, etc. It will provide an internationally agreed upon system of hazard classification and labeling. The target audiences include workers, consumers, transport workers, and emergency responders. Under this system, chemical substances and mixtures will be classified according to their physical, health, and environmental hazards. The GHS is not a regulation or a standard. Compliance with the GHS is voluntary for each country but companies in countries that do not adopt the GHS will be at a disadvantage when doing business internationally. The GHS document, otherwise known as “The Purple Book”, is a guidance document that establishes criteria and methods for hazard classification and communication. The GHS document provides countries with the regulatory framework to develop or modify existing programs.

Why is GHS Needed?
Currently many different countries have their own standards for chemical hazard classification and communication. The GHS is intended to replace these multiple systems with one uniform system that all parties have adopted. These existing systems may be similar in content and approach, but their differences are significant enough to require multiple classifications, labels and MSDS’s for the same product when marketed in different countries. For example, a chemical may be considered toxic in one country, but not in another. These inconsistent systems impact both safety and business interests. Global businesses must comply with multiple regulations regarding hazard classification and labeling, which can be costly and time-consuming. Many underdeveloped countries have few, if any, requirements for communication of hazards. This system provides the infrastructure for these countries to implement a hazard classification and communication system. The United Nations Conference on the Environment and Development (UNCED) recognized that reliable management of chemicals is needed on a global basis to ensure the protection of all people. Given the extent of international trade in chemicals, and the potential impact on neighboring countries when controls are not implemented, it was determined that a worldwide approach was necessary.

Hazard Classification
The GHS classification system is complex. The data used for classification may be obtained from tests, literature, and practical experience. A full explanation of the classification for all physical, health, and environmental hazards can be found at the United Nations website for the GHS at http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html

The main elements of the hazard classification criteria are summarized below:

Physical Hazards
Physical hazards are largely based on those of the United Nations Dangerous Goods System. These regulations and UN test methods can be found at the United Nations website at. Some additions and changes were necessary since the scope of the GHS includes all target audiences.


 * Explosives, which are assigned to one of six subcategories depending on the type of hazard they present, as used in the UN Dangerous Goods System.
 * A Flammable Gas is one that has a flammable range in air at 20 °C and a standard pressure of 101.3 kPa. Substances and mixtures of this hazard class are assigned to one of two hazard categories on the basis of the outcome of the test or calculation method.
 * Flammable Aerosols should be considered for classification as Category 1 or Category 2 if they contain any component, which is classified as flammable according to the GHS criteria, that is, flammable liquids, flammable gases or flammable solids.
 * Oxidizing Gases are any gas that may, generally by providing oxygen, cause or contribute to the combustion of other material more than air does. Substances and mixtures of this hazard class are assigned to a single hazard category on the basis that, generally by providing oxygen, they cause or contribute to the combustion of other material more than air does.
 * Gases Under Pressure are gases contained in a receptacle at a pressure not less than 280 Pa at 20 °C or as a refrigerated liquid. This endpoint covers four types of gases or gaseous mixtures to address the effects of sudden release of pressure or freezing which may lead to serious damage to people, property, or the environment independent of other hazards the gases may pose.
 * A Flammable Liquid is a liquid with a flash point of not more than 93 °C. Substances and mixtures of this hazard class are assigned to one of four hazard categories on the basis of the flash point and boiling point.
 * A Flammable Solid is one that is readily combustible or may cause or contribute to fire through friction. Readily combustible solids are powdered, granular, or pasty substances which are dangerous if they can be easily ignited by brief contact with an ignition source, such as a burning match, and if the flame spreads rapidly.
 * Self-Reactive Substances are thermally unstable liquids or solids liable to undergo a strongly exothermic thermal decomposition even without participation of oxygen (air). This definition excludes materials classified under the GHS as explosive, organic peroxides or as oxidizing.
 * A Pyrophoric Liquid is a liquid that, even in small quantities, is liable to ignite within five minutes after coming into contact with air. Substances and mixtures of this hazard class are assigned to a single hazard category on the basis of the outcome of the UN Test N.3.
 * A Pyrophoric Solid is a solid that, even in small quantities, is liable to ignite within five minutes after coming into contact with air. Substances and mixtures of this hazard class are assigned to a single hazard category on the basis of the outcome of the UN Test N.2.
 * Self-Heating Substances are solids or liquids, other than a pyrophoric substance, which, by reaction with air and without energy supply, is liable to self-heat. Substances and mixtures of this hazard class are assigned to one of two hazard categories on the basis of the outcome of the UN Test N.4.
 * Substances which on Contact with Water Emit Flammable Gases are substances that, in contact with water, emit flammable gases are solids or liquids which, by interaction with water, are liable to become spontaneously flammable or to give off flammable gases in dangerous quantities. Substances and mixtures of this hazard class are assigned to one of three hazard categories on the basis of the outcome of UN Test N.5, which measures gas evolution and speed of evolution.
 * Oxidizing Liquids are liquids that, while in it is not necessarily combustible, may, generally by yielding oxygen, cause or contribute to the combustion of other material. Substances and mixtures of this hazard class are assigned to one of three hazard categories on the basis of the outcome of UN Test O.2.
 * Oxidizing Solids are solids that, while it is not necessarily combustible, may, generally by yielding oxygen, cause or contribute to the combustion of other material. Substances and mixtures of this hazard class are assigned to one of three hazard categories on the basis of the outcome of UN Test O.1.
 * Organic Peroxides are organic liquids or solids that contain the bivalent -0-0- structure and may be considered a derivative of hydrogen peroxide, where one or both of the hydrogen atoms have been replaced by organic radicals. The term also includes organic peroxide formulations (mixtures). Substances and mixtures of this hazard class are assigned to one of seven 'Types', A to G, on the basis of the outcome of the UN Test Series A to H.
 * Substances Corrosive to Metal are substances or a mixtures that by chemical action will materially damage, or even destroy metals. These substances or mixtures are classified in a single hazard category on the basis of tests (Steel: ISO 9328 (II): 1991 - Steel type P235; Aluminum: ASTM G31-72 (1990) - non-clad types 7075-T6 or AZ5GU-T66). The GHS criteria are a corrosion rate on steel or aluminum surfaces exceeding 6.25 mm per year at a test temperature of 55 °C.

Health Hazards

 * Acute Toxicity includes five GHS categories from which the appropriate elements relevant to transport, consumer, worker and environment protection can be selected. Substances are assigned to one of the five toxicity categories on the basis of LD50 (oral, dermal) or LC50 (inhalation).
 * Skin Corrosion means the production of irreversible damage to the skin following the application of a test substance for up to 4 hours. Substances and mixtures in this hazard class are assigned to a single harmonized corrosion category.
 * Skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours. Substances and mixtures in this hazard class are assigned to a single irritant category. For those authorities, such as pesticide regulators, wanting more than one designation for skin irritation, an additional mild irritant category is provided.
 * Serious Eye Damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the front surface of the eye, which is not fully reversible within 21 days of application. Substances and mixtures in this hazard class are assigned to a single harmonized category.
 * Eye Irritation means changes in the eye following the application of a test substance to the front surface of the eye, which are fully reversible within 21 days of application. Substances and mixtures in this hazard class are assigned to a single harmonized hazard category. For authorities, such as pesticide regulators, wanting more than one designation for eye irritation, one of two subcategories can be selected, depending on whether the effects are reversible in 21 or 7 days.
 * Respiratory Sensitizer means a substance that induces hypersensitivity of the airways following inhalation of the substance. Substances and mixtures in this hazard class are assigned to one hazard category.
 * Skin Sensitizer means a substance that will induce an allergic response following skin contact. The definition for "skin sensitizer" is equivalent to "contact sensitizer". Substances and mixtures in this hazard class are assigned to one hazard category.
 * Germ Cell Mutagenicity means an agent giving rise to an increased occurrence of mutations in populations of cells and/or organisms. Substances and mixtures in this hazard class are assigned to one of two hazard categories. Category 1 has two subcategories.
 * Carcinogenicity means a chemical substance or a mixture of chemical substances that induce cancer or increase its incidence. Substances and mixtures in this hazard class are assigned to one of two hazard categories. Category 1 has two subcategories.
 * Reproductive Toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in offspring. Substances and mixtures with reproductive and/or developmental effects are assigned to one of two hazard categories, 'known or presumed' and 'suspected'. Category 1 has two subcategories for reproductive and developmental effects. Materials, which cause concern for the health of breastfed children, have a separate category, Effects on or Via Lactation.
 * Target Organ Systemic Toxicity (TOST)  category distinguishes between single and repeated exposure for Target Organ Effects. All significant health effects, not otherwise specifically included in the GHS, that can impair function, both reversible and irreversible, immediate and/or delayed are included in the non-lethal target organ/systemic toxicity class (TOST). Narcotic effects and respiratory tract irritation are considered to be target organ systemic effects following a single exposure.  Substances and mixtures of the single exposure target organ toxicity hazard class are assigned to one of three hazard categories.  Substances and mixtures of the repeated exposure target organ toxicity hazard class are assigned to one of two hazard categories.
 * Aspiration Hazard includes severe acute effects such as chemical pneumonia, varying degrees of pulmonary injury or death following aspiration. Aspiration is the entry of a liquid or solid directly through the oral or nasal cavity, or indirectly from vomiting, into the trachea and lower respiratory system. Substances and mixtures of this hazard class are assigned to one of two hazard categories this hazard class on the basis of viscosity.

Environmental Hazards

 * Acute Aquatic Toxicity means the intrinsic property of a material to cause injury to an aquatic organism in a short-term exposure. Substances and mixtures of this hazard class are assigned to one of three toxicity categories on the basis of acute toxicity data: LC50 (fish) or EC50 (crustacean) or ErC50 (for algae or other aquatic plants). In some regulatory systems these acute toxicity categories may be subdivided or extended for certain sectors.
 * Chronic Aquatic Toxicity means the potential or actual properties of a material to cause adverse effects to aquatic organisms during exposures that are determined in relation to the lifecycle of the organism. Substances and mixtures in this hazard class are assigned to one of four toxicity categories on the basis of acute data and environmental fate data: LC50 (fish) or EC50 (crustacea) or ErC50 (for algae or other aquatic plants) and degradation or bioaccumulation.

Classification of Mixtures
The GHS approach to the classification of mixtures for health and environmental hazards is also complex. It uses a tiered approach and is dependent upon the amount of information available for the mixture itself and for its components. Principles that have been developed for the classification of mixtures, drawing on existing systems such as the European Union (EU) system for classification of preparations laid down in Directive 1999/45/EC. The process for the classification of mixtures is based on the following steps:


 * 1) Where toxicological or ecotoxicological test data are available for the mixture itself, the classification of the mixture will be based on that data;
 * 2) Where test data are not available for the mixture itself, then the appropriate bridging principles should be applied, which uses test data for components and/or similar mixtures;
 * 3) If (1) test data are not available for the mixture itself, and (2) the bridging principles cannot be applied, then use the calculation or cutoff values described in the specific endpoint to classify the mixture.

Testing Requirements
The GHS document does not include testing requirements for substances or mixtures. In fact, one of the main goals of the GHS is to reduce the need for animal testing. The GHS criteria for determining health and environmental hazards are test method neutral, allowing different approaches as long as they are scientifically sound and validated according to international procedures and criteria already referred to in existing systems. Test data already generated for the classification of chemicals under existing systems should be accepted when classifying these chemicals under the GHS, thereby avoiding duplicative testing and the unnecessary use of test animals. The GHS physical hazard criteria are linked to specific UN test methods. It is assumed that mixtures will be tested for physical hazards.

Hazard Communication
After the substance or mixture has been classified according to the GHS criteria, the hazards need to be communicated. As with many existing systems, the communication methods incorporated in GHS include labels and MSDS’s. The GHS attempts to standardize hazard communication so that the intended audience can better understand the hazards of the chemicals in use. The GHS has established guiding principles:
 * The problem of trade secret or confidential business information has not been addressed within the GHS, except in general terms. For example, non-disclosure of confidential business information should not compromise the health and safety of users.
 * Hazard communication should be available in more than one form (for example, placards, labels or MSDS’s).
 * Hazard communication should include hazard statements and precautionary statements.
 * Hazard communication information should be easy to understand and standardized.
 * Hazard communication phrases should be consistent with each other to reduce confusion.
 * Hazard communication should take into account all existing research and any new evidence.

Comprehensibility is challenging for a single culture and language. Global harmonization has numerous complexities. Some factors that affected the work include: These factors were considered in developing the GHS communication tools. The GHS Purple Book includes a comprehensibility-testing instrument in Annex 6.
 * Different philosophies in existing systems on how and what should be communicated;
 * Language differences around the world;
 * Ability to translate phrases meaningfully;
 * Ability to understand and appropriately respond to symbols/pictograms.

GHS Label Elements
The standardized label elements included in the GHS are:
 * Symbols (hazard pictograms): Convey health, physical and environmental hazard information, assigned to a GHS hazard class and category. Pictograms include the harmonized hazard symbols plus other graphic elements, such as borders, background patterns or colors that are intended to convey specific information. The symbols are similar to current EU symbols, with a few exceptions.  A new hazard symbol featuring a white sprawling mass within a bust of a human is introduced. It is used for carcinogens, mutagens, reproductive toxicity, aspiration hazards, respiratory sensitizers and substances which have target organ toxicity. Also, harmful chemicals and irritants are marked with an exclamation mark, replacing the European saltire. Pictograms will have a black symbol on a white background with a red diamond frame.  For transport, pictograms will have the background, symbol and colors currently used in the UN Recommendations on the Transport of Dangerous Goods Model Regulations. Where a transport pictogram appears, the GHS pictogram for the same hazard should not appear.  Examples of all the pictograms and downloadable files can be accessed on the UN website for the GHS at http://www.unece.org/trans/danger/publi/ghs/pictograms.html
 * Signal Words: "Danger" or "Warning" will be used to emphasize hazards and indicate the relative level of severity of the hazard, assigned to a GHS hazard class and category.  Some lower level hazard categories do not use signal words. Only one signal word corresponding to the class of the most severe hazard should be used on a label.
 * Hazard Statements: Standard phrases assigned to a hazard class and category that describe the nature of the hazard. An appropriate statement for each GHS hazard should be included on the label for products possessing more than one hazard.

The additional label elements included in the GHS are:
 * Precautionary Statements: Measures to minimize or prevent adverse effects. There are four types of precautionary statements covering: prevention,  response in cases of accidental spillage or exposure, storage, and disposal. The precautionary statements have been linked to each GHS hazard statement and type of hazard.
 * Product Identifier (ingredient disclosure): Name or number used for a hazardous product on a label or in the MSDS. The GHS label for a substance should include the chemical identity of the substance.  For mixtures, the label should include the chemical identities of all ingredients that contribute to acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory sensitization, or Target Organ Systemic Toxicity (TOST), when these hazards appear on the label.
 * Supplier identification: The name, address and telephone number should be provided on the label.
 * Supplemental information: Non-harmonized information on the container of a hazardous product that is not required or specified under the GHS. Supplemental information may be used to provide further detail that does not contradict or cast doubt on the validity of the standardized hazard information.

GHS Label Format
The GHS includes directions for application of the hazard communication elements on the label. In particular, it specifies for each hazard, and for each class within the hazard, what signal word, pictogram, and hazard statement should be used. The GHS hazard pictograms, signal words and hazard statements should be located together on the label. The actual label format or layout is not specified in the GHS. National authorities may choose to specify where information should appear on the label or allow supplier discretion. There has been discussion about the size of GHS pictograms and that a GHS pictogram might be confused with a transport pictogram or "diamond". Transport pictograms are different in appearance than the GHS pictograms. Annex 7 of the Purple Book explains how the GHS pictograms are expected to be proportional to the size of the label text. So that generally the GHS pictograms would be smaller than the transport pictograms.

GHS Material Safety Data Sheet or Safety Data Sheet
The safety data sheet (The GHS has dropped the word “material” from material safety data sheet. It will now be called the safety data sheet or SDS) is specifically aimed at use in the workplace. It should provide comprehensive information about the chemical product that allows employers and workers to obtain concise, relevant and accurate information that can be put in perspective with regard to the hazards, uses and risk management of the chemical product in the workplace. The SDS should contain 16 sections. While there were some differences in existing industry recommendations, and requirements of countries, there was widespread agreement on a 16 section SDS that includes the following headings in the order specified:


 * 1) Identification
 * 2) Hazard(s) identification
 * 3) Composition/ information on ingredients
 * 4) First-aid measures
 * 5) Fire-fighting measures
 * 6)  Accidental release measures
 * 7) Handling and storage
 * 8) Exposure control/ personal protection
 * 9) Physical and chemical properties
 * 10) Stability and reactivity
 * 11) Toxicological information
 * 12) Ecological information
 * 13) Disposal considerations
 * 14) Transport information
 * 15) Regulatory information
 * 16) Other information.

The primary difference between the GHS requirements in terms of headings and sections and the international industry recommendations is that sections 2 and 3 have been reversed in order. The GHS SDS headings, sequence and content are similar to the ISO, EU and ANSI MSDS/SDS requirements. The SDS should provide a clear description of the data used to identify the hazards. There is a table comparing the content and format of a current MSDS/SDS versus the GHS SDS provided in Appendix A of the OSHA GHS guidance document available at this website http://www.osha.gov/dsg/hazcom/ghs.html#3.0

Training
Current training procedures for Hazard Communication in the United States are more detailed than the GHS training recommendations. Therefore, educating employees on the updated chemical and product classifications and related pictograms, signal words, hazard statements and precautionary measures will represent the greatest training challenge. Training will be a key component of the overall GHS approach and should incorporate information as it is introduced into the workplace. Employees and emergency responders will need to be trained on all new program elements, from hazard statements to pictograms. Bear in mind, if products are imported from countries that implement GHS prior to the United States and Canada, employee training may need to begin earlier than expected.

Implementation
There is no set international implementation schedule for the GHS. The goal of the United Nations is broad international adoption by 2008. Different countries will require different time frames to update current regulations or implement new ones. In countries like the United States, for example, there are many facets of the regulatory system that will have to be modified in order to adopt and implement the GHS. Japan's Industrial Safety and Health Law has already been amended to reflect the GHS. In the United States, an Advanced Notice of Proposed Rulemaking was published in the Federal Register on September 12, 2006. This notice began a public comment period that ended on November 13, 2006. The adoption of the GHS is expected to facilitate international trade by increasing consistency between the laws in different countries that currently have different hazard communication requirements. The UN monitors international implementation status of the GHS. This summary is available at http://www.unece.org/trans/danger/publi/ghs/implementation_e.html