Chemicals can pose a risk to human health and the environment during the various steps from their production to their handling, transport and use. Due to the extensive global trade in chemicals and the need to develop national programmes to ensure their safe use, transport and disposal, it was recognized that an internationally-harmonised approach to classification and labeling would be needed. Once countries have consistent and appropriate information on the chemicals they import or manufacture in their own countries, the infrastructure to manage chemical exposures and protect human health and the environment can be established in a comprehensive manner. The new system, which is called "Globally Harmonized System of Classification and Labeling of Chemicals (GHS)", addresses classification of chemicals by types of hazard and proposes harmonised hazard communication elements, including labels and safety data sheets (SDS). This paper provides a brief overview of the GHS system and the potential misconceptions as well as the challenges ahead.
Origins of GHS
The origins of GHS can be traced back to 1989 when the International Labor Organization (ILO) adopted a Resolution pertaining to the harmonization of systems of classification and labeling for the use of hazardous chemicals at work, which was followed a year later with a Convention (No.170) and a Recommendation (No.177) concerning safety in the use of chemicals at work (1). Countries adopting this convention were required to have a system in place for hazard classification and labeling. This international instrument laid the cornerstone for subsequent developments culminating in the UN Conference on the Environment and Development, Rio 1992, whereby GHS was endorsed as a priority for international cooperation (2). The first edition of GHS, which was intended to serve as the initial basis for the global implementation of the system, was approved by the Committee of Experts at its first session in 2002 and published in 2003 (3). Since then, GHS has been updated, revised and improved every two years as needs arise and experience is gained in its implementation.
Objective of GHS
The key objective of GHS is to facilitate protection of human health and the environment by providing chemical users and handlers with consistent information on chemical hazards via a single, globally harmonized system. This is to be achieved via standard elements (e.g. symbols or hazard pictograms) and statements on product labels and safety data sheets (SDS). It is anticipated that GHS will provide a consistent framework for classifying and simplifying hazard communication resulting in safer handling, transport, and use of chemicals. It will also potentially serve to promote safe and sound chemical management at the global level especially for countries currently without the pre-requisite regulatory framework. In terms of trade compliance, GHS can also facilitate trade by reducing the need to comply with multiple industry or geographic-specific hazard labeling systems. Last but not least, GHS will potentially reduce the need for testing and evaluation of chemicals via a global harmonised classification system.
Misconception of GHS
The very nature of GHS is to change the current status quo and bring about a new world order as far as chemical management is concerned. As with any such changes on a global scale, this will potentially result in some misconceptions about GHS especially among downstream players in the chemical value chain.
Global vs Country-Specific Implementation
A very common misconception about GHS is that it is a global regulation or standard that automatically applies to all countries. This is not the case. GHS is a system to classify chemicals according to their intrinsic properties or hazards. The system consists of a set of recommendations for chemical classification. No country is obligated to adopt all or even any part of the GHS system. Instead, countries can choose to voluntarily adopt all or pieces of the GHS system into their own regulations according to their own specific needs.
Such an approach can potentially lead to challenges that GHS is supposed to overcome. Even in a single country, different governmental agencies may implement GHS differently. For example, in South Korea, the Ministry of the Environment (MoE) revised the Toxic Chemicals Control Act in Nov 2007 to implement GHS for toxic chemicals. According to the revised regulation, toxic chemicals should be labeled according to GHS from July 2011 for single substance and from July 2013 for mixtures. However, the Ministry of Labor had previously revised the enforcement regulations in September 2006 to adopt the UN GHS for hazardous chemicals. The same transitional period was given for mixtures but not for single substance, which was enforced one year earlier (July 2010). Not only that, the building blocks were not harmonised resulting in the different regulations having slightly different building blocks for GHS. To further compound the complexity, the National Emergency Management Agency has prescribed a public notice in November 2008 to introduce GHS for dangerous materials (e.g. explosives, flammable substances etc.). However, the GHS classification here is not mandatory and both existing and GHS classification and labeling are allowed for use (4).
The provision for authorities to adopt different building blocks and cut-offs can result in a certain amount of inconsistency in the adoption and adaptation of GHS. This is not only unique to South Korea but occurs in many other countries. For example, there are specific requirements for non-GHS elements in Australia (special combustible category) and New Zealand (unique hazard class numbering system) (5). In addition, some countries have reported that they won’t adopt GHS in certain sectors. In the case of Singapore, consumer goods are currently outside the scope of GHS (6). As such, these goods are not required to be labeled according to GHS although proper labeling including safe handling of the products still needs to be adhered to ensure adequate protection of consumer health. However, in Thailand where GHS was published into law on March 12, 2012, it is potentially applicable to consumer and household products as well (7). This may potentially create artificial barriers to trade once fully implemented. Consumer goods that are compliant to regulations in Singapore may need relabeling if exported to Thailand. This will add additional costs and uncertainty to inter-country trade. However, the trend seems to be moving towards GHS classification for consumer goods. In the Philippines, the Department of Health (DOH) in the Philippines has recently issued a draft administrative order to implement GHS for household hazardous chemicals and consumers products that are regulated by the DOH (8).
Another example of a potential country specific requirement may come from the US. On Jan 11, 2012, the US Chemical Safety and Hazard Investigation Board (CSB) recommended that “unclassified hazards” to remain in the final hazard communication rule that was subsequently released by OSHA on Mar 20, 2011 (9). The final rule pertains to the alignment of the Occupational Safety and Health Administration's (OSHA) hazard communication standard (29 C.F.R. 1910 Subpart Z) with GHS. Unclassified hazards is a hazard category included within OSHA's proposal but not in the latest revision of GHS and it would cover substances, which may pose risks to workers based on scientific evidence identified during the employer's classification process but not with GHS criteria. Combustible dust was cited as an example of an unclassified hazard in the proposal. The CSB noted that this hazard is very common in the industry but GHS would be unable to effectively provide information about its presence or prevention without an unclassified hazards' category. It is understandable that such country-specific requirements may be necessary and relevant but it does add another layer of complexity to a global harmonised system.
Risk vs Hazard
GHS is a hazard-based classification system. It has a harmonised criterion for defining physicochemical, health and environmental hazards. GHS provides guidance on how labels and SDS should be developed to convey information on chemical hazards and some basic instructions on handling the chemicals. It does not provide any information on the risk of handling such chemicals. In order to distinguish this point, there is a need to understand the difference between hazard and risk. Hazard is not equitable to risk. Hazard describes the intrinsic properties of a chemical. For example, corrosiveness is an intrinsic property of sodium hydroxide. It does not mean that sodium hydroxide has a high safety risk. Risk can be defined by the classic equation:
Risk = Hazard x Exposure
If the exposure to sodium hydroxide is minimized, there is minimal safety risk especially when proper precautions are taken (e.g. using PPE, following instructions for safe use etc.). Such instructions for safe use play a key part in ensuring workers‟ safety in an occupational setting and some components can be seen in the Safety (S-phrases) phrases incorporated in the MSDS (e.g. S:36 Wear suitable protective clothing). This will typically be replaced by the GHS precautionary statements (10). However, such instructions typically will not inform the worker of the magnitude of the risk in a specific exposure scenario nor the specific ways to minimize the risk (e.g. what kind of protective clothing/PPE should he/she be using). This has to come from proper chemical management/ product stewardship training that will be beyond the scope of the MSDS or label.
This needs to be clarified because there are still some misconceptions that the GHS SDS or label alone is sufficient to protect workers from chemical hazards. It is a key component in chemical management and product stewardship but it is not the only component.
However, it is important to note that GHS is not totally silent on chemical risk assessment. In the second revised edition of GHS (Annex 5), it is provided that if the risk of adverse chronic health effects in the consumer product use setting is insignificant, then the chronic health hazards do not need to be included on the product label for consumer use. It will be left to the individual countries to decide on whether to adopt such a risk-based approach for consumer products. In Asia, Japan has initiated such an approach in 2011 on a voluntary basis for certain consumer products (e.g. detergents and paints) (11). Such chemical risk assessment initiatives will play a significant role in chemical management and product stewardship. The development of such local expertise is to be encouraged.
Exemptions from GHS
It has already been mentioned above that in Singapore, consumer goods are currently not within the scope of GHS whereas in Thailand and the Philippines, this may not be the case. Indeed, in many countries, specific goods e.g. cosmetics, therapeutic goods, food and agricultural chemicals are not within the scope of GHS. In ASEAN, cosmetics are regulated by the ASEAN Cosmetic Directive and are not required by law to be labeled according to GHS requirements (12). In agriculture, the regulations are linked to UN WHO and FAO standards with their own regulatory requirements. However, due to country specific implementations, there may be confusion over a globally harmonised approach. For example, in Australia, under the National Model Code of Practice for the Labeling of Workplace Hazardous Chemicals, products that are exempted from hazard labeling such as cosmetics, therapeutic goods or food that are packed and sold as end-use product will be subject to hazard labeling if it is related to work activity (13). This can potentially be confusing to the end-users and the decision to apply such hazard labeling should take into consideration the end-user’s understanding of hazard and risk.
Conclusion
The objective of GHS is such that it will confer a significant advantage to countries that choose to adopt this system in terms of protection of human health and the environment as well as facilitating trade between countries. Theoretically, with the implementation of GHS, hazard classification of chemicals will be harmonised and workers globally will be accorded the same protection. Ideally, this system will do away with multiple interpretations of chemical hazards whereby for example, one country considering a specific chemical as toxic while another country consider it as non-dangerous.
However, with such a massive international initiative, there are bound to be misconceptions due to various factors especially at the local levels (cultural, historical, different levels of technical expertise etc.). Such misconceptions need to be overcome before GHS can truly become a globally harmonised system. Country-specific differences can potentially be resolved via greater efforts by international organizations to align with GHS. Chemical risk assessments should complement GHS in chemical management and product stewardship. In this regard, capacity building for such expertise should go hand in hand with GHS implementation especially in the developing countries.
Also, the jury is still out on the ramifications of GHS in consumer products. Typically for such products, unless the consumer or end-user is familiar with the GHS elements on the label, such hazard-based labeling may potentially result in further confusion. In developing countries, cleaning workers in hotels or restaurants handling detergents or cleaners typically will not be conversant with hazard labeling or GHS elements. There needs to be a program instituted to ensure that these workers and the consumers at large are adequately trained to benefit from GHS labeling before GHS is implemented in consumer products. This in itself may potentially be a huge undertaking that requires substantial planning and investment.
At the end of the day, the foremost consideration of any regulation pertaining to chemical classification should ensure that human health and the environment are adequately protected. The speed and manner of implementation may vary between countries but the end-goal should remain the same. That in essence, will fulfill the objective of GHS irrespective of the instruments used to implement it. The GHS for the first time has provided global guidance for a broad base of hazard classes and classification criteria that will serve as a strong foundation for subsequent risk assessments of chemicals. This bodes well for chemical risk management in the coming years ahead.
Author Profile
Keng-Meng Khoo, PhD (Biochemistry), LLM (Commercial Law)
Arch Chemicals Singapore Pte Ltd (subsidiary of Lonza)
10 Science Park Road, #02-12, The Alpha,
Singapore Science Park II, Singapore 117684.
Notes:
South Korea has several classification and labelling systems for chemicals. Among the most important ones include the Toxic Chemicals Control Act (TCCA) issued by the Ministry of Environment, the Industrial Safety and Health Law (ISHL) issued by the Ministry of Labour and the Hazardous Material Safety Act issued by the National Emergency Management Agency. The TTCA regulates the manufacture, import and use of industrial chemicals whereas the ISHL regulates workers’ health and safety aspects in the workplace. The MSDS for hazardous chemicals are covered by the ISHL.
S-phrases are originally defined in Annex IV of European Union Directive 67/548/EEC: Safety advice concerning dangerous substances and preparations. The list was subsequently updated in Directive 2006/102/EC and eventually will be replaced by the Classification, Labeling and Packaging of Hazardous Substances and Mixtures (CLP) regulations.
