Introduction to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) August 2011
Course Objectives • Understand how and why the GHS was developed • Understand the purpose, objectives and benefits of the GHS • Understand the scope and application of the GHS • Become familiar with the basic elements of the GHS • Understand the GHS in relation to other international agreements and standards
Chapter 1 Background, Context, and Scope and Application of the GHS Lesson 1: Background on the GHS Lesson 2: Scope and Application of the GHS
Chapter 1: Objectives • Learn what the GHS is, and who is responsible for it • Understand why the GHS was developed, and how it relates to other international agreements and standards • Learn how the GHS was developed
Lesson 1: Background on the GHS This lesson will show: • What is the GHS • What is the “Purple Book” • Why and how the GHS was developed • What the role of the GHS is in chemical safety management • Who is responsible for the GHS • How GHS relates to other international agreements and standards on chemicals
The GHS • The Globally Harmonised System of Classification and Labelling of Chemicals (GHS) is: • An international system that harmonises the classification and labelling of hazardous chemicals • A logical and comprehensive approach for: • Defining health, physical, and environmental hazards of chemicals • Applying agreed hazard criteria to classify chemicals based on their hazardous effects • Communicating hazard information on labels and safety data sheets
The Purple Book • United Nations (UN) publication of the GHS • Outlines the provisions in four parts: • Introduction (scope, definitions, hazard communication) • Classification criteria for physical hazards • Classification criteria for health hazards • Classification of environmental hazards
Annexes • Annex 1 Allocation of label elements • Annex 2 Classification and labeling summary table • Annex 3 Codification of hazard statements, codification and use of • precautionary statements and examples of precautionary pictograms • Annex 4 Guidance on the preparation of Safety Data Sheets (SDS) • Annex 5 Consumer product labeling based on the likelihood of injury • Annex 6 Comprehensibility testing methodology • Annex 7 Examples of arrangements of the GHS label elements • Annex 8 An example of Classification in the Globally Harmonized System • Annex 9 Guidance on hazards to the aquatic environment • Annex 10 Guidance on transformation/dissolution of metals and • metal compounds in aqueous media
Why was the GHS developed • Chemicals contribute to improving the standard of living around the world: • Purifying water • Promoting growth of food • Improving hygiene • Producing essential goods • Use of these chemicals involves risks to safety and health
How extensive is chemical use? • The world’s largest substance data base is the Chemical Abstracts Service Registry: • Currently has over 60 million organic and inorganic substances recorded • Not all are produced on a regular basis • Potential for harm to people is great: • Chemicals cause a broad range of health effects and adverse effects on the environment • The International Labor Organization (ILO) estimates that 25% of workplace deaths worldwide are due to chemical exposures
Availability of chemical information • Many countries have tried to address protection from chemicals through laws that require dissemination of information about their hazards: • These laws are similar, but vary in definitions of hazards covered, information required on labels, and provisions for safety data sheets • The result is a disparity in the extent of information provided, the form it is provided in, and the coverage of chemicals and people • Other countries have no coverage
Results of conflicting requirements • Extensive international trade in chemicals results in exposed people seeing a wide variety of labels and safety data sheets • Differences in communication practices lead to differences in effectiveness • The broad range of provisions also leads to technical barriers to trade • Small companies in particular are effectively left out of international trade by the difficulties of complying with all these requirements
The GHS addresses these issues • Provides a chemical classification and labelling system that is updated and maintained internationally • Includes provisions for a common and coherent approach to classifying hazards and preparing labels and safety data sheets • Results in more effective communication worldwide • Facilitates trade in chemicals
Benefits of the GHS • Provides global benefits, as well as benefits to governments, industry, and chemical users (workers and consumers): • Enhances the protection of human health and the environment through the provision of harmonised chemical safety and health information • Reduces the need for duplicative testing of chemicals • Provides the informational infrastructure for chemical safety and health management programs • Increases efficiencies; reduces costs of compliance; lowers health care costs, etc.
How was the GHS developed? • International mandate was adopted in the 1992 United Nations Conference on Environment and Development: “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.”
Development of the GHS • Agenda 21 of the UNCED agreements included the mandate, and instructed the developers to build on existing systems • The process ultimately included numerous countries, multiple international organizations, and many stakeholder representatives • The GHS was developed based on consensus among the participants
What is the GHS based on? • A meeting of experts convened by the ILO identified the following existing systems as the primary basis for the GHS: • Requirements of systems in the United States for the workplace, consumers and pesticides • Requirements of Canada for the workplace, consumers and pesticides • European Union directives for classification and labelling of substances and preparations • The United Nations Recommendations on the Transport of Dangerous Goods
Basis Principles of Harmonisation • In order to guide the discussions, the participants agreed to a set of basic principles • Key among these was an agreement that the level of protection offered by existing systems would not be reduced as a result of harmonising the provisions • This allowed countries to participate in negotiations on the basis that the protection of their current systems would be maintained or enhanced as a result of harmonisation
Other principles • The GHS would be based on the classification of hazards (i.e., intrinsic properties) • Sectors would be able to choose those parts of the GHS relevant to them • Hazard communication would be addressed in addition to classification • Comprehensibility (communicating information in an understandable manner) is key • Validated data can continue to be used • Confidential business information needs to be addressed
Who developed the GHS? • The Interorganization Programme for the Sound Management of Chemicals’ Coordinating Group for the Harmonisation of Chemical Classification Systems managed the process of harmonisation • The Coordinating Group included representatives of interested countries, international organizations, and stakeholders • The technical work was completed by technical focal points with expertise in the area involved
International organization responsibilities • International Labor Organization (ILO): Secretariat for the Coordinating Group and the hazard communication work group • Organization for Economic Cooperation and Development (OECD): Secretariat for health and environmental hazard criteria, including mixtures • United Nations’ Subcommittee of Experts on the Transport of Dangerous Goods: Secretariat for physical hazard criteria
Who is responsible for implementing the GHS? • The type of international legal instrument the GHS is considered to be is a “non-mandatory recommendation” • The GHS provisions become mandatory in countries or regions that adopt the GHS • Overseeing national or regional implementation is the responsibility of the competent authorities that adopt the GHS provisions. There is no international body that monitors implementation for compliance
Who is responsible • Internationally, the UN Subcommittee of Experts on the GHS is responsible for the maintenance, updating and promotion of the GHS: • Over 30 countries have jointed the S/C • Observer countries and stakeholders also participate
GHS/Other international instruments • Strategic Approach to International Chemicals Management (SAICM) • Rotterdam Convention/Prior Informed Consent (PIC) • Stockholm Convention/Persistent Organic Pollutants (POPs) • Basel Convention/Hazardous Waste • ILO Instruments re: chemicals • International Chemical Control Toolkit (Control Banding)
Lesson 2: Scope and application of the GHS • This lesson will show: • What chemicals are covered in the GHS • Sectors affected by the GHS • How the hazard communication components are applied • The Building Block approach • Principles of hazard vs. risk • Principles of consumer product labelling based on likelihood of injury
What chemicals are covered? • All hazardous chemicals are covered: • Includes substances, products, mixtures, preparations, formulations, and solutions.
Application of the hazard communication components • The need for labels and safety data sheets varies by the product and the stage of the life cycle: • Pharmaceuticals, food additives, cosmetics, and pesticide residues in food will not be covered at the point of consumption (e.g., where a patient is taking a pharmaceutical), but will be covered in the workplace and in transport • These types of products are generally regulated based on risk where the consumer is exposed so are not subject to hazard communication
Sectors affected by the GHS • The GHS is intended to cover any place where people are exposed to hazardous chemicals • Considering coverage of chemicals by sector is a convenient way to indicate different ways they may be covered due to differing exposures • However, countries may identify the sectors in any way that is appropriate to their regulatory system, as long as they consider all types of exposures
Sectors that may be considered • Industrial workplace: Workers are a key sector to be considered. Chemicals are often present in all types of workplaces, from manufacturing facilities to construction, retail services to health care. • Agriculture (pesticides): Involves both workplace and consumer exposures, and is often regulated separately by countries.
Sectors, cont. • Transport (emergency response): Another subset of occupational exposures that is often regulated separately. Involves many provisions beyond classification and labelling (e.g., packaging). These are addressed in the UN Recommendations on the Transport of Dangerous Goods. Also impacts public exposures. • Consumer Products (public): Involves products sold to the general public, and exposures of vulnerable populations (e.g., children).
Building block approach • The GHS includes all of the regulatory tools needed to cover any of the sectors, hazards, or chemicals present: • Competent authorities can choose their own scope of coverage from the comprehensive choices presented in the GHS • Coverage may vary among sectors in the same country • The GHS provides the building blocks to construct an appropriate regulatory system
Expected sector application • Transport: similar to current transport system covering physical hazards, acute toxicity, corrosivity, and aquatic toxicity; pictograms used to convey hazards • Workplace: all types of health and physical hazards; labels and safety data sheets, supplemented by training • Consumers: labels primary focus
Differentiating hazard vs. risk • GHS is based primarily on the identification of the intrinsic properties of chemicals (hazards) that may cause harm • Risk is the likelihood of the harm, and is characterized by relating the expected exposure to the hazard identified Hazard x Exposure = Risk
GHS Hazard Classification • The purpose of the GHS is to provide information about the hazards of a chemical in order to help people determine the appropriate protections. This involves identifying the hazard; assessing the severity of the effect; and communicating the information to users. • When chemical users have information about the hazards, they can relate it to the exposure where it is used, and thus determine the risk. This is referred to as risk assessment. Determining the way to protect people is risk mitigation. Risk assessment and risk mitigation are uses of the GHS hazard classifications.
Optional consumer product labels • Some systems provide information on consumer labels regarding chronic health hazards only after considering risk (not based on hazards alone) • Since labels are the only means to provide information to consumers, these systems consider it important to consider the likelihood of injury before providing information on chronic effects • Annex 5 of the GHS outlines general principles for this process while not addressing harmonisation of risk-based labelling for consumer products
Chapter 2 Lesson 1 ClassificationLesson 2 Hazard Communication Technical Overview of the GHS
Chapter 2 Objectives • Be familiar with the main elements of the GHS • Understand who is responsible for development of the elements • Learn what hazards are covered by the GHS • Learn what the GHS hazard communication tools include and how the information is obtained by users
Lesson 1: Classification • This lesson will show: • How classification is done under the GHS, and who is responsible for it • What physical, health, and environmental hazards are covered under the GHS
What is hazard classification? • The GHS describes the process as follows: • Identification of relevant data regarding the specific hazard of the substance or mixture. • Subsequent review and quality check of those data to ascertain the hazards associated with the substance or mixture. • A decision on whether the substance or mixture will be classified as a hazardous substance or mixture and the degree of hazard, where appropriate, by comparison of the data with agreed hazard classification criteria.
Key definitions • “Hazard class” means the nature of the physical, health or environmental hazard, e.g., flammable solid, carcinogen, oral acute toxicity • “Hazard category” means the division of criteria within each hazard class, e.g. oral acute toxicity includes five hazard categories and flammable liquids include four hazard categories
Who classifies hazards? • The GHS is designed to be a “self” classification system, i.e., chemical manufacturers classify their products based on evaluation of data and expert judgment • Some competent authorities may choose to classify chemicals, and provide lists of classifications • Chemical users do not have to undertake the classification process, but can rely on the information provided by their suppliers with the products when they purchase them
How were the criteria developed? • Physical hazard criteria were based on the existing definitions in the UN transport system, revised to address other sectors • Health and environmental hazard criteria in existing systems were compared and analyzed • The most current scientific information was reviewed (and will be updated as necessary by the Subcommittee) • Negotiators agreed to harmonised approaches based on the information assembled