On 21 July 2015, International Organization for Standardization (ISO) formally released ISO 18664:2015 Traditional Chinese Medicine -- Determination of heavy metals in herbal medicines used in Traditional Chinese Medicine, which is the second international standard for traditional Chinese medicine (TCM) following Traditional Chinese medicine -- Ginseng seeds and seedlings -- Part 1: Panax ginseng C.A. Meyer and the third one published by Technical Commission for Traditional Chinese Medicine of ISO (ISO/TC249).

At present, there is no universally acknowledged international standard to regulate the upper limits of heavy metals in TCM, resulting in disputes in the area. ISO 18664:2015 sets forth the testing methods and comparison among instruments for lead, arsenic and mercury content, also provides a reference for the upper limits of heavy metals in TCM in the Annex. The said reference also applies to international trade for non-fossil TCM and decoction pieces that serve as food supplements, functional foods or natural medicine. Furthermore, the standard also provides a reference for testing methods and danger assessment of heavy metals in TCM.

Supported by Standardization Administration of China (SAC) and State Administration of Traditional Chinese Medicine of the People’s Republic of China, Professor Guo Lanping, the Project Principal of Traditional Chinese Medicine Resource Center in China Academy of Chinese Medical Sciences, successfully completed demonstrations of ISO in various phases after three years’ struggle along with her team. The standard attaches great importance to promoting quality of TCM and industrial standardization, protecting consumers’ safety, as well as facilitating the TCM popularization by eliminating barriers in international trade on heavy metals in the field. As the first international standard after ISO/TC249 was named under “Traditional Chinese Medicine”, it predicts a sound opening for international standardization of TCM.