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Comparison of GHS Concentration Limits for Mutagenicity and Carcinogenicity

Little Pro on 2018-12-03

GHS concentration limit is the minimum concentration for a hazardous substance to trigger the classification of a mixture as hazardous. However, UN GHS allows each jurisdiction to choose their concentration limits for germ cell mutagenicity or carcinogenicity: 0.1% or 1%. This has created big challenges for companies trying to prepare one global classification or SDSs for1 product. In this article, we have summarized global GHS classification concentration limits for mutagenicity or carcinogenicity covering EU, USA, Canada, China, Japan, Korea, Malaysia, Taiwan, Vietnam, Thailand, Australia, Singapore and Brazil.

UN GHS Purple Book

The table below summarizes GHS concentration limits for carcinogenicity classification in UN GHS purple book. There is no fixed concentration limit given for category 1 or category 2 carcinogents. 

GHS Concentration Limits Carcinogen

For the meaning of note 1 and 2, please refer to UN GHS purple book. Usually the labelling of a category 1 carcinogen is required if its concentration is >=0.1% and the labelling of category 2 carcinogen is required if its content is >=1%. However, all category 1 and category 2 carcinogents must be shown in SDSs if their concentration exceeds 0.1% depite whether the mixture containing them will be classified as carcinogens or not .

GHS Concentration Limits for Mutagenicity

Jurisdiction Category 1(1A/1B) Category 2
UN  >=0.1% >=1%
USA >=0.1% >=1%
Canada >=0.1% >=1%
Brazil >=0.1% >=1%
China >=0.1% >=1% 
Taiwan >=0.1% >=1%
Vietnam >=0.1% >=1% 
EU >=0.1% >=1%
Japan >=0.1%  >=1% 
Korea >=0.1%  >=1% 
Malaysia >=0.1%  >=1% 
Thailand >=0.1%  >=1% 
Singapore >=0.1%  >=1% 
Australia >=0.1%  >=1% 

GHS Concentration Limits for Carcinogenicity

Jurisdiction Category 1(1A/1B) Category 2
UN  >=0.1% >=0.1% or >=1%
USA >=0.1% >=0.1%
Canada >=0.1% >=0.1%
Brazil >=0.1% >=0.1%
China >=0.1% >=0.1% or >=1%
Taiwan >=0.1% >=0.1% or >=1%
Vietnam >=0.1% >=0.1% or >=1%
EU >=0.1% >=1%
Japan >=0.1%  >=1% 
Korea >=0.1%  >=1% 
Malaysia >=0.1%  >=1% 
Thailand >=0.1%  >=1% 
Singapore >=0.1%  >=1% 
Australia >=0.1%  >=1% 

Summary

US, Canada and Brazil's concentration limit for category 2 carcinogen (0.1%) is stricter than other countries (1%). Most of APAC countries have followed EU's concentration limits for mutagenicity and carcinogenicity. China, Taiwan and Vietnam are quite unique since they let companies to choose which concentration limit to use.

References

List of free GHS regulations and resources

Advanced GHS Readings

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