Companies must understand the impact and changes that the GHS necessitates while pursuing an approach that accounts for the unprecedented level of complexity and change required for labeling in the chemical industry. Understanding the hazard information is critical to protect you and your employees.
Daniel Levine, CHMM
As a response to the multiple definitions of hazard and multiple ways of communicating these hazards, the United Nations adopted the Globally Harmonized System for Classification and Labeling of Chemicals (GHS) in 2003. OSHA鈥檚 revised Hazard Communication Standard has presented manufacturers, formulators and distributors with the challenge of revising their Safety Data Sheets (SDSs) and the product labels by June 1, 2015. These changes are based upon the third revision of the GHS. The GHS system is gradually being adopted on a worldwide basis. OSHA鈥檚 new standard will impact almost any and all manufacturing facilities and any businesses receiving shipments, which include hazardous materials. By June 15, 2015 all materials being housed, shipped or received must have proper labeling and abide by the ensuing GHS regulations. From raw materials to finished goods delivery, companies are facing more complexity in chemical labeling with risk of heavy penalties for non-compliance. Companies now will need to access multiple data systems and SDS applications, include HCS elements, fill in all pictograms, fulfill regional regulatory requirements, include customer requirements, multiple languages and more. This will also impact the waste management industry significantly considering the varied types of materials they ship and receive. This article will explore the background of the regulation, some of the issues raised in adopting it, and some of the challenges that chemical producers and shippers will encounter in complying with the GHS.
These challenges include the mandatory use of red color, the potential need for multiple languages if shipping to other countries, various U.S. state issues like New Jersey鈥檚 鈥淩ight to Know鈥� that go beyond OSHA鈥檚 requirements, and many other regional regulatory requirements for compliance in the global marketplace. The reality is that virtually every label for a hazardous chemical product is subject to change, and will in many cases require changes on an ongoing basis into the unforeseeable future.
Complicating the environment in which these regulations will go into effect, the chemicals industry is faced with a major challenge due to the fact that many large companies have decentralized their hazard communication work processes. In addition, many medium to smaller sized companies don鈥檛 have the internal resources to create their own Safety Data Sheets and must use outside resources. Because of the additional requirements in the 2012 OSHA and GHS regulations to be implemented starting June 1, 2015, regardless of how or where a Safety Data Sheet is created, automated systems will need to be capable of pulling the information from Section 2 of the SDS onto labels. In addition, the current complex nuances of labeling range from having many different products of various shapes and sizes, the need to respond to customer requirements, the need to access transactional data, languages, branding information and more.
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Why the GHS?
Before adoption of the GHS, multiple systems and definitions of hazard were the rule. Even here in the U.S. there have been鈥攁nd to some extent still are鈥攄ifferent definitions of various physical and health hazards presented by chemical substances. Looking at just two hazards such as flammability and oral toxicity, Charts 1 through 3 show the disparity in definitions, and how the GHS has created a common basis for these two frequently encountered hazards. These hazards were compared based upon 2009 regulations because many countries have already adopted, or are in the process of adopting, GHS definitions.
For instance, the European Union (EU) adopted GHS for substances in 2010 and the classification and labeling of mixtures is scheduled to become mandatory by June 1, 2015, which is the same day as OSHA鈥檚 mandatory implementation date. Canada is actively working on the institution of GHS, but will not be able to complete implementation for industrial products by 2015. Accordingly, they are trying for mandatory implementation by manufacturers by June 1, 2016, and a complete implementation by June 1, 2017 where stock on shelves can no longer be shipped with older formatted labels. Therefore, between June 1, 2015 and June 1, 2016, shippers in the U.S. may need to create a separate label for Canadian shipments.
This difference in implementation timelines is an example of why a single product might need two different labels depending upon its final destination. For the time being, industrial and consumer labels in the U.S. and Canada will continue to differ, while by next year, European industrial and consumer labels will follow the same classification and communication scheme.
Oral toxicity is even more complicated, and the scope of this article does not have the space to show all the conflicting definitions that existed in 2009, but here is the unified definition developed under GHS. There are different GHS tables for dermal toxicity and three for inhalation, one each for gases, vapors, and dusts and mists. All would have to be examined in creating a new label.
Also, the various shapes of symbols and graphics used for hazard communications are being unified into a single shape and graphic that will be used for both transport and for workplace notification. This will require a change for all EU labels for mixtures鈥攂oth industrial and consumer鈥攂eginning June 1, 2015, and will change Canadian industrial labels by June 1, 2016. The new graphic will be mandatory (see Figure 1).
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Some Things Change While Others Don鈥檛
Labels will now have more information on them, and will have to be revised to include symbols, standard signal words and standard phrases. Other text, such as contact phone numbers and statements about ingredients with unknown toxicity will also be required. Because of the regional challenges presented by a widening global supply chain, signal words and phrases must be translated into multiple languages, making labels more efficient instruments for global hazard communication (see Chart 4).
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And Some Things Are Changing a Lot
Before 2015, as a performance standard, manufacturers could meet the OSHA requirements by methods of their own choosing. Now as a specification standard, manufacturers must follow methods of compliance outlined by OSHA (see Chart 5). From 2015 onward, manufacturers will have to examine all available information and make a scientifically based determination where conflicting toxicity information is found. Also, formulators will now have a greater degree of responsibility for determining the correct hazards associated with ingredients supplied by others where the identity of the ingredient is known. Definitions have expanded, especially for physical hazards. OSHA used to talk about flammability, pressure, explosively and reactivity. It is now more finely defined by GHS into these categories:
- Explosives
- Flammable gases
- Oxidizing gases
- Pressurized gases
- Compressed gases
- Liquefied gases
- Refrigerated liquefied gases
- Dissolved gases
- Flammable liquids
- Flammable solids
- Self-reactive substances
- Pyrophoric liquids
- Pyrophoric solids
- Self-heating substances
- Water Reactive producing flammable gases
- Oxidizing liquids
- Oxidizing solids
- Organic peroxides
- Corrosive to metals
- Explosive dusts
OSHA regulates all of these hazards, including some others like 鈥渆xplosive听dusts.鈥� Likewise, health hazards have been more finely defined, but the听change is not as dramatic as with physical hazards. The increased number of听physical hazards is more in line with worldwide definitions already existing听for the transport of dangerous goods. The changes to health hazards had to听accommodate the various international systems with the guiding principle that听no country would reduce the level of protection that previously existed. This听will impact both Safety Data Sheets and labels. The older definitions of health听hazards include:
- Irritants
- Corrosives
- Toxins
- Sensitizers
- Effects on target organs (i.e. liver, kidney, nervous system, blood, lungs,mucous membranes, reproductive system, skin, eyes, etc.).
The newer definitions include:
- Acute toxicity, oral
- Acute toxicity, dermal
- Acute toxicity, inhalation
- Aspiration hazard
- Skin corrosion/irritation
- Eye corrosion/irritation
- Respiratory sensitization
- Skin sensitization
- Germ cell mutagenicity
- Carcinogenicity
- Reproductive toxicity, fertility
- Reproductive toxicity, development
- Specific target organ toxicity (STOT)
- Single Dose
- Repeat Dose
Most of these categories had been regulated previously, but now all categories of these hazards are being regulated. It is important to clarify that OSHA will not regulate materials of lower toxicity that would be in the home where children are present; this is because The Consumer Product Safety Commission regulates consumer labels, and that organization has yet to propose adoption of the GHS system.
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So Where Do You Start? And What Do You Do?
First, manufacturers need to begin by classifying their products. If dealing with pure substances, this will be an easier task than if classifying mixtures. But either way, the criteria from the GHS is the rule. Classification will take longer than the old methods, and organizations need to begin this process now. The challenge is to work with accurate data. GHS does not require 鈥渢esting,鈥� but it does require obtaining whatever information is available to accurately assess products.
Some things may calculate out to be more toxic as OSHA has expanded the definition of 鈥渢oxic鈥� from a toxicity of 500 mg/ kg out to 2,000 mg/kg in order to be consistent with the GHS. On the other hand, removal of the old 1 percent bright line means that you have 1 percent or more of a material with a certain health hazard, and mixtures will not automatically inherit that hazard. For example, some things formerly labeled as irritants may no longer be classified as irritants. So the classification and sub-classification, known as 鈥渃ategories,鈥� must be dealt with first. Next, the GHS criteria will lead to the selection of symbols, signal words such as Danger or Warning, statements of hazard, and statements of precautions. These all have to go into Section 2 of the 16-section format of the Safety Data Sheet.
And following these considerations, here comes an important issue鈥攁s label content will appear on the SDS, both the SDS and the label need to be deployed together. SDSs are documents and can be sent out both in paper or as electronic files, but labels need to be applied to the actual package, which is not as easily accomplished. Key challenges of label production that must be accounted for include accommodating for color printing, dealing with different size products, accommodating multiple languages and transactional data.
Regarding color, OSHA requires a red border on all symbols used to communicate hazard categories. Black will just not do. For many, using preprinted label stock with red diamonds has become less practical, as the number of possible variations of pictograms needed varies and also requires manual oversight to make sure the correct label stock is being used.
Package size is also an important consideration in labeling as chemicals can be transported through supply in containers that vary in size from drums to small vials. The label needs to address both OSHA regulations and the size restrictions of the container, so for small packages it is a challenge to effectively use the limited real estate on a label.
Then there is the issue of dealing with languages on a label. In the U.S., English is mandatory while other languages can be added optionally. For most other countries, e.g. European countries, the label must be produced in that country鈥檚 language but may also require other languages if you sell and transport in other countries.
Extending the challenge of GHS labeling is a common requirement to apply transactional data such as batch numbers, lot numbers or packing dates. This data, in conjunction with the variables of color, size and language, introduce complexity on the label that make pre-printing labels impractical.
Real-time, data-driven labeling is one of the primary pathways of dealing with these issues to ensure that the correct symbols, languages and transactional data appear on labels of any size or shape. This approach also enables manufacturers to leverage the same regulatory content to ensure that the SDS and label agree with each other. The last thing they want is for the SDS to say one thing, and the label to say something else.
Ongoing regulatory changes in the chemical industry, successful GHS compliance and regional regulatory adherence all require rapid labeling changes to be deployed quickly throughout the organization. The ultimate goal is meeting the requirements presented by the GHS at the same time you deal with the complexity of labeling hazardous materials to protect all participants in the global supply chain. To achieve this goal, companies must first understand the impact and changes that the GHS necessitates while pursuing an approach that accounts for the unprecedented level of complexity and change required for labeling in the chemical industry. Understanding the hazard information is critical to protect you and your employees.
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Daniel Levine, CHMM, is President of Product Safety Solutions, a consulting firm providing services in product hazard communication, TSCA compliance, and other regulatory areas affecting both manufacturing activities and finished products. Daniel鈥檚 past positions include Director of Product Safety and Integrity for Allied Signal Inc. and President of the Society for Chemical Hazardous Communication (SCHC). Due to his extensive experience in chemical industry safety, he received SCHC鈥檚 鈥楲ifetime Achievement Award鈥� in 2003 and was elected a 鈥楩ellow鈥� for the Institute of Hazardous Materials Management in 2010. Daniel can be reached at [email protected].
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If you鈥檙e interested in more detailed information about GHS and want to hear firsthand from Mr. Levine you can download a recording from our recent webinar 鈥淗ow to Manage Labeling Changes fro GHS Compliance鈥�<> or visit Loftware鈥檚 GHS Labeling Solutions web site page at .