the globally harmonized system (ghs)fcmavoice.com/ghswhitepaper2011.pdf · 2013-10-08 · the...

© 2011 Safetec Compliance Systems, Inc. www.safetec.net White Paper – Globally Harmonized Classification System – Overview of “Purple Book” of 10

The Globally Harmonized System (GHS) of Classification and Labeling of Chemicals

A n O v e r v i e w o f t h e G H S “ P u r p l e B o o k ”

2011

JeanMarie Calvillo, Ph.D. Safetec Regulatory Specialist


INTRODUCTION The Globally Harmonized Classification System (GHS) provides standards for classifying chemicals to create smooth-flowing and environmentally conscious international trade. In the “Purple Book”, the details needed to use the Globally Harmonized System of Classification and Labeling of Chemicals are comprehensively outlined. The full five hundred and fifty-five (555) pages of this text are online, provided by the United Nations Economic Commission for Europe (UNECE): (http://www.unece.org/ trans/danger/publi/ghs/ghs_rev03/03files_e.html).

At Safetec, we recognize that busy environmental professionals are being asked to do more with fewer resources. Not everyone has time to read this large, albeit useful, compilation and quickly glean the applications that are relevant to their particular industry. For this reason, we are providing you with this quick, snapshot view of the GHS document, so that you can more easily identify the points of the “Purple Book” that are most relevant to you and your business.

WHAT IS THE GHS? The GHS is an international plan that will make how we classify, label and communicate chemical hazards easier across the board. Harmonized means standardized, so that your consumers in Thailand will understand the same information about your chemicals and products as those in Germany, with less confusion and more safety. The main ways that your present system of chemical risk management will change includes the following areas:

1. How chemicals are classified 2. How chemicals are labeled 3. How mixtures of chemicals are classified 4. How mixtures of chemicals are labeled 5. Material Safety Data Sheets 6. Hazard Communication Diagrams

GHS Classification of Chemicals The basic elements involved in classification of substances using the GHS system apply three types of classification criteria: physical hazards, health hazards, and environmental hazards. OSHA has proposed to adopt all of the physical and health hazard classes in the GHS. Because OSHA’s authority does not extend to environmental concerns, this agency will not adopt GHS criteria related to aquatic toxicity or hazards to the ozone layer.


Hazard Classification If you have hazardous substances at your worksite, you are more than likely familiar with OSHA’s hazard communication standard (HCS), a “performance-oriented” regulation. This means that OSHA has required employers to inform their employees about any physical or health hazards associated with hazardous substances that are used at the work place. Although OSHA has given fairly clear guidance on what constitutes a physical or health hazard in the US, many other countries have vastly different guidelines. On December 29, 2009, OSHA proposed to update the current HCS to require manufacturers, importers and employers in the chemical industry to follow the GHS “specification-oriented” system (i.e. every chemical and mixture is assigned a certain hazard/danger category or class using defined criteria). OSHA made this decision in an effort to promote global worker safety, as it relates to hazards associated with chemicals. Hazard Communication The way GHS handles hazard communication requirements is by directly linking them to these specified hazard classes. Each class and category of hazard is given one of two harmonized signal words: Warning or Danger. The “Purple Book” Annexes I - III illustrate the harmonized pictograms (e.g., skull and crossbones), and hazard statements (e.g., Fatal if Swallowed) are specified for each classification of hazard. These specified elements are the core information for the hazardous chemical. The core information that is given to each category indicates the degree of severity of the hazard. Precautionary statements are also required on GHS labels (“Purple Book,” Annexes VII and VIII). The most recent revision to the GHS has codified these statements (meaning they have assigned numbers) as well as aligned them with the hazard classes and categories. Codification allows one to reference to them in a shorthand form, and makes it easier for authorities to organize them in a regulatory text. In addition, there are provisions to allow supplementary information, so that chemical manufacturers can provide data to buttress the specified core information. GHS Style Labeling The approach GHS uses to classify a hazardous chemical is first to identify its intrinsic hazard. Intrinsic means that by its very nature, a chemical is hazardous. For example, concentrated hydrochloric acid (38% g HCL/ml) has a pH of 1.1, making it an extremely potent acid. Therefore it is intrinsically hazardous to the skin upon contact. In contrast, municipal tap water, by its nature, has a neutral pH at room temperature and pressure. This means it is intrinsically not hazardous to the skin.

GHS pictograms have a red frame with a black, simple diagram. Here, the flammable hazard pictogram is shown (black flame over a bar) with an exclamation point, citing danger. Alongside the pictogram, the GHS label will require a single word, either “Danger” or “Warning,” and a hazard statement. The hazard statements for our hydrochloric acid example are: “highly flammable liquid and vapor,” “may be harmful if swallowed,” “causes mild skin irritation,” and “causes serious eye irritation.”

HOW IS THE GHS PURPLE BOOK ORGANIZED? There are four main parts to the GHS Purple Book. Part 1 is the introduction to GHS and it covers the purpose, scope and application of the standard. Part 2 discusses physical hazards; Part 3 covers health hazards; and Part 4 goes over environmental hazards.


“A globally harmonized hazard classification and compatible labeling system, including material safety data sheets and easily understandable symbols (that) should be available, if feasible, by the year 2000.”

The GHS document also contains Annexes 1 through 10, which are as follows:

1. Allocation of label elements 2. Classification and labeling summary tables 3. Codification of hazardous statements 4. Guidance to preparation of standards 5. Consumer product labeling 6. Testing methodology 7. Examples of GHS label elements 8. Example of GHS classification 9. Hazardous to aquatic environment 10. Metals and metal compounds guidance

WHO ESTABLISHED THE GHS? The GHS was created from the contributions of devoted and industrious groups of experts from stakeholders and countries around the world, including the USA. Some key contributors to the GHS are the United Nations Economic Social Council (UNESC) and the United Nations Economic Commission for Europe (UNECE). Harmonization concepts were derived from organizations that already had such concepts in place, such as the UNESC’s Committee of Experts on the Transport of Dangerous Goods.

The United Nations Conference on Environment and Development (UNCED, 1992), provided the mandate to create the GHS. The mandate (adopted in 1992) states its ultimate goal as:

In September of 2002, the World Summit on Sustainable Development (WSSD) encouraged world-wide implementation of GHS, with hopes for a fully operational system by 2008. The first version of GHS was adopted in December 15, 2002 by the aforementioned committees. In 2010, the third revision of the GHS guidance document, published in 2009 by the UNECE, is available for world-wide application.

Definition of “Harmonized” In music, something is harmonized if a mathematically determined set of notes (chords) produces a melodious sound when played in unison. Applied to the GHS, a harmonized approach to hazard classification accomplishes an analogous result; when hazard communication elements converge via a scientifically valid set of guidelines, the result is global synchrony in chemical compliance to protect human health and the environment.

WHAT DOES THE GHS MEAN TO MY BUSINESS? Chemicals support our quality of life in a multitude of visible and unseen ways. Whether as life-saving oxygen in the medical realm, pesticides and emulsifiers in the food/beverage sector, surfactants in sanitation engineering, or solvents in electronics manufacturing, chemical


products are an ingrained constituent of our 21st century matrix. This means that the production and use of chemicals is fundamental to all economies, with the global chemical business totaling $1.7 trillion per year. In the US, this industry is a $450 billion business with yearly exports representing a significant percentage of these earnings. With such a universally ubiquitous use of chemicals, regulations have arisen to cover the spectrum of transport, production, workplace, agriculture, trade and consumer products.

The European Union and Canada have already incorporated the GHS into their established regulatory bodies. The US is in the process of evaluating how GHS can be effective within our own agencies, namely: OSHA, EPA & DOT. Currently, OSHA is leading the way with its proposed changes to the HazCom standard. The EPA & DOT are both planning to adopt elements of the GHS at some point in the future.

Your own company can benefit in numerous ways. Some of these include: reduced costs due to fewer accidents, a decrease in hazard-induced illness, improved relations with employees, and an improved corporate image. When the GHS is implemented globally, the information will be communicated on labels and SDSs to complement or augment that which is already in place as ANSI, OSHA, NFPA and NIOSH styles of MSDSs and HazCom tags. Any business that currently conducts or envisions international trade will benefit from having the appropriate electronic compliance tools at hand to prepare for this anticipated transition. All US companies will be given ample time to comply with the new GHS standards as they are incorporated into US policy.

Summary of GHS Parts One to Four and the Ten Annexes

GHS PART ONE Part One covers the purpose, scope and application of the standards, definitions and abbreviations. The mid-section of this part describes the classification of hazardous substances and mixtures. It also describes hazard communication as it pertains to labeling. The final portion of Part One describes Hazard Communication as it pertains to Safety Data Sheets (SDS).

Purpose The GHS provides an international standard for the identities and hazards of chemicals used for improved quality of life worldwide. It also supplies guidance for the development and application of globally harmonized measures, in order to protect people and the environment when these chemicals are manufactured, transported and consumed.

The motivating force behind the development of the GHS was propelled by several drivers. Among these were the enhancement and protection of human health and our environment by making hazard communication less obscure and more intuitive visually. Another impetus was to facilitate international trade. A globally harmonized approach to tracking chemicals will ensure safer transport and disposal across borders and seas.

Scope The scope of the GHS is based on the aforementioned 1992 mandate from the UNCED. The GHS is focused on covering all hazardous chemicals, without micromanaging specific regulations, risk assessment and test methods.


The GHS includes two elements:

1. Harmonized criteria for classifying substances and mixtures according to their health, environmental and physical hazards.

2. Harmonized hazard communication elements, including requirements for labeling and safety data sheets.

Application The goal of GHS is to identify intrinsic hazards in chemical substances and their mixtures and to communicate these effectively to cover every level of literacy and user contact. The existing hazard communications elements in the transport, workplace, consumer and pesticide sectors can be converged, according to GHS guidelines.

Building Block Approach The GHS was designed to be flexible and uses the so-called “building block” approach, so that countries with existing hazard communication regulations can choose particular “blocks” of GHS to either juxtapose, superimpose or connect to existing regulations. Additionally, countries brand new to this endeavor can apply all available GHS guidance “blocks” to the foundation of their health, safety, environmental, transportation and/or security regulations.

Classification The classification process is fundamental to GHS and there are several guidance documents available to assist with this process. Essentially, there are three basic steps to this process which are as follows:

1. Identify relevant data about hazards of a substance or mixture. For example, the levels of toxicity caused by lead-based paint would not apply to lead metal alloys, making exposure limit determinations vastly different for this chemical and its mixture.

2. Review this data to determine hazards associated with substance or mixture. For example, in the US, regulatory bodies such as OSHA and FIRFA have well-documented end points and limits for a wide range of toxic and xenobiotic (foreign to organisms) compounds.

3. Decide on substances or their mixtures to determine if they 1) are hazardous, 2) the degree of hazard, and 3) to compare data with established criteria used for classification. This decision can be made by in-house or contracted experts who are familiar with the body of knowledge collected on regulated compounds used in a specific business.

Once a chemical is given a classification, the substance/mixture must be properly labeled.

Labeling The GHS standard definition for labeling is as follows:

“Label means an appropriate group of written, printed, or graphic information elements concerning a hazardous product, selected as relevant to the target sector(s), that is affixed to, printed on, or attached to immediate container of a hazardous product, or to the outside packaging of a hazardous product.” (The Purple Book, Glossary)


1 Product & Company ID

2 Hazards Iden8fica8on

3 Composi8on/Ingredients

4 First-‐Aid Measures

5 Fire Figh8ng Measures

6 Accidental Release Measures

7 Handling & Storage

8 Physical & Chemical Proper8es

9 Exposure & Personal Protec8on

10 Stability & Reac8vity

11 Toxicological Informa8on

12 Ecological Informa8on

13 Disposal Considera8ons

14 Transport Informa8on

15 Regulatory Informa8on

16 Other Informa8on

The definition itself calls for the use of graphic information elements known as “pictograms.” There are several different pictograms that are used to convey various types of hazards. Labels under GHS will also need to include standard phrasing (referred to as signal words), hazard and precautionary statements. In addition, chemical supplies and other supplemental information must be included on the label (see Annexes 1,2,3,5,& 7 of the “Purple Book” for additional information on proper GHS labeling requirements).

Safety Data Sheets (SDSs) Most likely your business has been using the traditional MSDS (Materials Safety Data Sheet) for hazardous substances that are accounted for in your chemical inventory. The GHS uses something similar, with a few additional sections. The last section of the GHS Part 1 describes what components are needed to create a GHS-style Safety Data Sheet (SDS). Below is a diagram that compares and contrasts the traditional MSDS with the GHS-style SDS.

As can be seen in this figure, the MSDS is a 12-section format (Sections 1-11, 16). Also, traditional MSDSs are not required to follow a specific style. The GHS on the other hand, is in a standardized 16-section format. One of the most convoluted issues in chemical risk management has been the lack of standardization for MSDSs. The development of the GHS-style SDS was done to respond to the need to provide a consistent format for a Safety Data Sheet, so that exposed employees and emergency responders have easier access to important, need-to-know information on hazardous chemicals. The GHS SDS format matches the style used in the voluntary industry consensus standard for safety data sheets (ANSI Z400.1). If you are a chemical manufacturer and/or importer who already uses the ANSI Z400.1 standard, then your safety data sheets should already have the appropriate format and the modifications needed to transition to GHS format will be minimal.


GHS PART TWO Part Two of the “Purple Book” addresses the physical hazards that require guidance for transport, manufacturing, distribution, production and consumption.

These hazards are defined in 16 sections and begin with “Explosives” (section 2.1.1) and end with “Substances and Mixtures Corrosive to Metals” (section 2.1.16). Each section has the definition for the physical hazard, the criteria used to classify the hazards into categories, hazard communication, and a decision logic flow chart based on the results of evaluative tests. The evaluative tests can be conducted using three main resources, which are: the UN Recommendations on the Transport of Dangerous Goods, the Manual of Tests and Criteria (also known as “The Orange Book,” International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM).

GHS PART THREE Part Three of the Purple book addresses the health hazards that require guidance for transport, manufacturing, distribution, production and consumption. These hazards are defined in 10 sections and begin with “Acute Toxicity” (section 3.1.1) and end with “Aspiration Hazard” (section 3.1.16). Each section has the definition for the health hazard, the criteria used to classify the hazards into categories, hazard communication, and a decision logic flow chart. The decision logic flow chart is based on the results of evaluative tests that can be conducted using guidelines from globally recognized research and development agencies.

In Part Three, a large portion of the decision logic, hazard communication and tests for classification of health hazards are derived from the test guideline programs set forth by the Organization for Economic Cooperation and Development (OECD). In the sections on germ cell mutagenicity (section 3.5), cancer (section 3.6), and organ toxicity, (section 3.8 and 3.9), the International Agency for Research on Cancer (IARC) provides other test methods to classify health hazards that result in these issues. References to animal testing involve predominantly bred-for-research white rats, with most albino rat lines derived from the Wistar rat, Sprague Dawley, Fischer 344 and Holtzman strains. Other animal tests reference rabbit and bovine subjects. Data from human medical research represent clinical trial study results and statistical analysis of data gathered from anonymous hospital patients world-wide. Some results in human studies may be derived from volunteers in prisons and mental health institutions.

GHS PART FOUR There are two sections that make up Part 4 of the “Purple Book”, both of which deal with hazardous impacts to the environment. They are referred to as “Hazardous to Aquatic Environment” (Section 4.1.1) and “Hazardous to the Ozone Layer (Section 4.2.1).

Section 4.1.1 was developed based on the scientific consensus that chemical contaminants ultimately end up in the larger water bodies, where the most vulnerable organisms reside. Development of criteria to classify and identify chemical hazards to the environment directed the authors to center on toxicity testing of aquatic species. This was deemed to grant the most sensitive evaluation of chemicals that might impact the other two sectors of the environment. Additionally, there are four subsections. These consist of general considerations (4.1.1), classification criteria for substances and mixtures (4.1.2, 4.1.3), hazard communication (4.1.4) and decision logic for both substances and mixtures (4.1.5).


Section 4.2.1 was developed due to a growing concern over chemicals that impact air quality; specifically, the depletion of the ozone layer which is believed to be a primary contributor to the effects of climate change. This section consists of definitions (4.2.1), classification criteria (4.2.2), hazard communication and (4.2.3) decision logic for substances and mixtures (4.2.4).

ANNEXES 1-10 Annex 1. Allocation of Label Elements - Label elements allocated by the GHS are displayed on an array of tables covering physical, environmental and health hazards, ranging from explosives to aquatic toxicity. If the same hazard classes are covered by the UN Recommendations on the Transport of Dangerous Goods, then this pictogram is displayed below the one required by GHS.

Annex 2. Classification and Labeling Summary Tables - Summary tables to classify and label physical, health and environmental hazards are presented in Annex 2. Within each table, subdivisions are shown as well as the criteria used for their categorization. These tables range from explosives to chronic hazards to the aquatic environment.

Annex 3. Codification of Hazard Statements, Codification and Use of Precautionary Pictograms - Hazard statements and examples of precautionary pictograms are presented in Annex 3. The recommended codes assigned to each of the hazard statements in the GHS hazard categories are given. In this section, five types of precautionary statements are delineated.

Annex 4. Guide to Preparation of the SDS - This annex provides detailed, step-by-step guidance on how to prepare a safety data sheet (SDS). Safety Data Sheets are required for all substances and mixtures which meet the GHS criteria for hazards. Some competent authorities (CA) may require an SDS even for non-hazardous classes of substances and mixtures. Besides provided hazard information, the SDS can also be used as a standardized method to convey useful information about materials across global markets.

Annex 5. Consumer Product Labeling - Consumer product labeling based on the likelihood of injury is the guidance provided in this Annex. Exposure assessments for consumer products based on customary use or foreseeable misuse are done to decide what to include on the product label.

Annex 6. Comprehensibility Testing Methodology - This Annex provides a method to assess the comprehensibility of labels and Safety Data Sheets. The focus of this tool is on the needs of workers and consumers in developing countries, and takes into account varied levels of literacy and differences in cultural experience.

Annex 7. Examples of GHS Label Elements - This annex provides detailed examples of how GHS labels can be displayed on packages for hazardous substances.

Examples of Annex 7 GHS Label Elements:


Annex 8. Examples of GHS Classification - This annex contains brief statements about the proposal for each hazard class and the details of all the available scientific evidence.

Annex 9. Hazardous to Aquatic Environment - This annex provides detailed guidance through the most difficult of interpretational problems, especially when it comes to common and not so common obstacles in classifying substances and mixtures that are hazardous to the aquatic environment.

Annex 10. Metals and Metal Compounds Guidance - The guidance provided in this annex describes the tools that apply to determining the rate and extent to which metals and sparingly soluble metal compounds (SSIMs) can produce soluble, available ionic and other metal-bearing species in water.

LEVERAGING TECHNOLOGY FOR GHS COMPLIANCE Keeping up with the intricate and dynamic flux of global chemical compliance can seem a Herculean task. However, identifying the elements in what might seem a tangled conglomeration of guidance rules can be managed, especially when armed with the cutting-edge, compliance and risk management tools offered by Safetec. As the leader in chemical, risk and EHS compliance solutions, Safetec has a simple, cost-effective solution for every step of your GHS transition, whether you are a small company or fortune-500 organization. Safetec’s complete GHS transition solution includes: on-site chemical inventory audit services; SDS authoring; SDS acquisition, monitoring and management; and container labeling.

• With our robust chemical management system, CCM8, Safetec is poised to provide your company with the means to smoothly transition into new compliance requirements.

• With Safetec’s proprietary classification features, chemicals can be classified using GHS or any other custom classification methodology.

• Safetec’s International Regulatory Information Database (IRID) will make in-depth searching and reporting analysis powerful and intuitive, to ensure that current chemical use can be easily parlayed for GHS.

Contact Safetec today for a complimentary GHS Analysis which will assess your current level of chemical compliance and provide recommendations on how to leverage technology to better prepare for GHS.

888-745-8943 - in fo rmat ion@safe tec .ne t - www.sa fe tec .net

A Safetec Chemical Inventory Specialist taking inventory for one of our many satisfied clients.

the globally harmonized system (ghs)fcmavoice.com/ghswhitepaper2011.pdf · 2013-10-08 · the...

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