The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) was formally adopted in July 2003 by the United Nations Economic and Social Council and endorsed by the Intergovernmental Forum on Chemical Safety and the 2002 World Summit on Sustainable Development.
The objective of GHS is to promote consistent criteria for the classification and labeling of chemicals based on their health and environmental effects and physical hazards and to provide compatible safety data sheets and labeling to the general public, workers and employees. Additionally, GHS provides a structure that can be used by those countries that have not implemented a chemical management system.
As much as GHS is meant to drive global harmonization, individual countries are allowed to select the physical hazards, the health and environment classes and the associated categories within each class that they wish to adopt, and most countries that have implemented GHS have chosen to keep some of their existing hazard classification and communication that is not yet part of the GHS. As a result, there will be far less harmonization between countries and regulatory authorities within each country than originally anticipated.
Harmonization occurs at the category level where the category cutoff values or limits are defined. Countries can choose which classes and which categories within those classes they want to adopt, but once a category is selected, the cutoff values or limits must be accepted as stated and all the categories for higher hazard levels in that class also must be adopted. For example, a category 1 flammable liquid always will be defined as one where the flashpoint is <23 degrees C and the initial boiling point is less than or equal to 35 degrees C.
Regarding communication, GHS requires a 16-section safety data sheet (SDS) that will include more extensive information than what currently is required by OSHA and Canada's Workplace Hazardous Materials Information System (WHMIS). For example, a GHS label will consist of the following components: a pictogram, signal words, hazard statements, precautionary statements and related pictograms and product identifiers and supplier information.
The proposed OSHA revisions include revised criteria for the classification of hazardous chemicals, labeling provisions, a specified format for safety data sheets (SDS), changes to definitions and terms used in the standards, training requirements for employees on labels and SDS. OSHA also has proposed revisions on a number of other standards such as flammable and combustible liquids, process safety management and substance-specific health standards. They are requesting all public comments to be submitted by Dec. 29, 2009. At this time they are estimating a minimum of 18 months before the final rule is promulgated. Companies will be prohibited from implementing this regulation until the final rule is promulgated. Companies will have 3 years to come into compliance with the final rule and 2 years to implement training requirements on the final regulation. There are 26 states and territories with their own OSHA-approved plans. These states and territories will have 6 months to adopt comparable provisions of the final standard. In the meantime, individual state plans will remain in effect until they adopt the required revisions.
The proposed OSHA rule does not take over all the UN GHS hazard classes and categories and it also keeps some hazards that are not yet covered by the UN system (combustible dust is one example).
UNDERSTANDING THE IMPACT
GHS is challenging to implement, especially in countries such as the United States, Japan and Korea, where multiple regulatory authorities govern different aspects of the hazard communication requirements. In the United States, OSHA, EPA (Federal Insecticide, Fungicide and Rodenticide Act), the Consumer Products Safety Commission (CPSC) and the Department of Transportation (DOT) are working to implement GHS. Each agency has the right to adopt GHS in a way that best suits its purpose with no consideration given to a unified approach or timeline.
This especially is challenging when more than one government entity has authority related to the same requirement, as is the case with labels and SDS. Although OSHA primarily is responsible for defining SDS requirements, DOT is responsible for certain sections as well (i.e. the transport section).
Many Asian countries — including Japan, Taiwan, China, Korea, New Zealand and Russia — as well as Europe have implemented GHS, but not always in its entirety, which results in differences in how the classification results are presented on both the SDS and on the labels. In Europe, companies will be required to follow a harmonized (mandatory) classification of certain substances for certain endpoints. Korea and Japan also have official lists of recommended GHS classifications for substances.
One of the most significant shifts will be for companies accustomed to complying with OSHA's regulation in the United States. Those companies will need to shift from a risk-based classification approach to a hazard-based classification approach. Instead of considering the likelihood or probability of an event occurring, classification will be absolute under GHS. The introduction of symbols also is a relatively new concept in the United States.
CHOOSING THE RIGHT TOOLS
As GHS is adopted in countries and regions around the globe, many companies are realizing that implementing GHS compliance activities into their organizations is no easy task. Companies need to re-evaluate how their substances and mixtures are classified for each regulatory entity, country or region and likely will need to re-issue several SDS and labels. There are service providers who can help companies stay ahead of the GHS curve with solutions for identifying and managing the increasingly complex and changing global chemical regulatory obligations associated with GHS. These vendors can help address the new requirements and associated chemical regulatory information needed for compliance management as they arise.
Many companies choose to use reference tools that centralize all global chemical regulatory information into a robust, searchable, easy-to-use database. This provides quick access to official GHS classifications, including substance classifications published by the relevant authorities. Other features supporting GHS compliance include translated GHS classifications, GHS labels, GHS full text and GHS phrases.
Other content tools may be used to feed chemical regulatory data into corporate EH&S and SDS authoring systems. These integrated data tools provide efficient change management and regular updates as regulations change and new ones are released. These tools can help ensure correct, consistent GHS classification and labeling according to the UN purple book and also take into consideration the national deviations and other national regulations. Document templates for producing SDS, labels and other hazard communication documents and multi-lingual phrase libraries can complete the content suite for efficient production of accurate documents.
Companies also may choose to employ outsourced services for their GHS classification of substances and mixtures as a separate service or as part of outsourcing SDS and label authoring.
In-house SDS authoring staff may want to adopt an authoring platform that will help generate hazard communication documents to meet GHS-related international regulatory compliance and business requirements. Such a platform should provide full support of hazard communication, classification and labeling requirements to generate globally compliant SDS and label documents as well as business/user definable documents, such as technical data sheets, product data sheets, hazard summaries and product stewardship summaries. The system should use algorithms to accommodate the requirements outlined in the GHS. This consists of the classification of substances and mixtures according to their health, environmental and physical hazards and hazcom requirements for labeling and SDS.
For inbound vendor SDS management, users will want to search, print, view and email vendor and raw material SDS in a company-specific database via a Web browser interface. As GHS requirements increase the burden of vendor SDS management, a robust SDS management system can help reduce the time and resources necessary for effective compliance management.
Achieving compliance with GHS can be quite cumbersome. Strong processes, applications, systems and service providers are needed to support the various aspects of compliance management for GHS. Companies that are impacted by GHS can seek assistance from providers who are well versed in data and other content and information as it relates to global EHS regulations and who thoroughly understand the global regulatory environment. These providers will be able to assist in implementing GHS compliance activities into the organization, and can help facilitate compliance with these increasingly complex and changing global chemical regulatory obligations.
Jytte Syska has more than 20 years of experience as an EHS regulatory expert. She held the position of director of Occupational Health and Toxicology for the prestigious Danish Toxicology Centre (DTC) where she enjoyed scientific, financial and managerial responsibility for a department of 25 consultants. Syska spent several years as vice president of international operations at 3E Co. before taking on the role of president of Ariel operations, in charge of all the business units that support Ariel products and services for 3E Co. Europe. She is responsible for Ariel Global Product Development and Operations in Bethesda, Md.; the Ariel Authoring and Related Services Center in Kingsport, Tenn.; and the international operation in Copenhagen, Denmark.