Harmonized or not harmonized, that is the question!
In 2005 the United Nations published the first version of the Globally Harmonized System. The intention was the global unification of evaluation and labeling of hazardous substances and mixtures. Today a multitude of countries have implemented GHS. This article is intended to “scan” to what extent a global harmonization has actually been realized.
The GHS concept
In general GHS consists of two parts: On the one hand, rules for the hazard determination of substances and mixtures have been defined. On the other hand, standards have been set for the respective labeling of hazardous substances. Basically, GHS distinguishes between 28 different hazard classes existing under GHS: 16 physical hazards (e.g. flammability), 10 health hazards (e.g. skin irritant), and 3 environmental hazards (e.g. chronic aquatic toxicity). The intensity of a hazard is expressed by the hazard category between 1 and 5; the lower the number, the stronger the hazard.
The hazard determination rules for substances differ from those for mixtures (like metal working fluids). In compliance to GHS, substances have to be evaluated by standardized tests. In the EU for example this process is regulated by REACh. In contrast, the hazards of a mixture are in general determined in standardized procedures based on the hazards of its contained substances.
Example “Skin irritation category 2”: A mixture has to be classified as skin irritant, when 10% or more of the ingredients are classified as skin irritant category 2. In this case, 10% is the classification limit value (CLV) for the respective hazard.
Besides the manufacturers or importers, which have to classify and label any hazardous substance, authorities can also set mandatory lists with GHS classifications for specific substances. In the EU, the European Parliament determines these “legal classifications”, which are published as appendix to the CLP regulation. In many cases, these “legal classifications” match minimum classifications.
Similar classification lists also exist in China, Korea and Malaysia and it seems that more countries will implement individual lists in future.
After the classification of a hazardous substance or mixture, it has to be labeled respectively. The GHS label elements are
- Hazard pictograms (see figure on the right)
- Signal words: “Warning” or “Danger”
- Hazard statements (H-statements)
- Precautionary statements (P-statements)
Example: A substance or mixture, which is classified as skin irritant category 2, has to be labeled as follows:
- Hazard pictogram: GHS07
- Signal word: Warning
- Hazard statement: Causes skin irritation. (H315)
- Precautionary statement example: Wear protective gloves. (P280)
There are several possibilities why GHS can vary in different countries/regions:
- Status of implementation: In some countries GHS is implemented as a mandatory standard, in others it is voluntary or not implemented at all.
- GHS revisions: In 2015 the 6th GHS revision was published. But most countries have currently implemented the 3rd, 4th or 5th revision. Amongst others, one difference is the application and wording of the precautionary statements.
- Hazard classes: Differences to the GHS specified hazard classes can be found in Canada and the USA: The application of environmental hazard classes is voluntary. Further, so-called “hazards not otherwise classified“ were created to account for the prior national classifications systems.
- Hazard categories: The biggest differentiation potential can be found here. Each country may decide individually about the implementation of the hazard categories. Countries with an established classification and labeling system tried to implement GHS with the intention to conserve the former rules and conditions as much as possible. Other countries like China and Mexico implemented GHS without any deviation from the GHS model of the United Nations. Example: The category 3 of the hazard “Skin irritation” exists in these countries, but not the EU, Canada, Singapore or the USA.
- Concentration limit value (CLV): The CLVs for most of the hazard classes are fixed by the GHS standard of the UN. However, for a group of specific hazard classes an agreement for CLVs didn’t seem to be possible. Thus, the UN allowed implementation of different CLVs for the following hazards: respiratory and skin sensitization, carcinogenicity, reproduction toxicity, and specific target organ toxicity.
Due to this difference, there may be mixtures which have to be classified as skin sensitizing in China, Canada or the USA, but not in the EU or Singapore.
- “Legal classifications”: In this context, the European Union is the most active authority. Even in the former system (DPD), a list with legally binding classifications for chosen substances existed. Moreover, China, Korea and Malaysia have similar lists. Other countries may follow in future.
- EUH-statements: The EU has implemented so-called EUH-statements in addition to the standard GHS hazard statements.
Example: EUH208 - Contains a sensitizing substance. May produce an allergic reaction.
These aspects are related only to differences in classification and in labeling elements. There are products that have five different classifications in five different countries because of the described variation possibilities. Moreover, there are many regulatory differences in the content and layout of safety data sheets as well as labels.
In summary, the creation of the Global Harmonized System can be described as the generation of a unified “language”. Each GHS authority uses the same pictograms, the same hazard statements and almost the same precautionary statements. But in particular for mixtures, there is no guarantee that this “language” is used to “say” the same thing. A mixture, which is not hazardous in the EU, might be classified as hazardous in China, the USA, or another country, or vice versa.
With a highly qualified staff, modern software tools, and chemical databases, Oemeta Chemische Werke GmbH is able to deliver worldwide products, which are classified and labeled in compliance with global and local regulations. In cooperation with the Oemeta subsidiaries and our international distributors, and through regular training, auditing, and software and database updates, we always stay up to date on national and international chemical regulatory affairs.