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Guidance for the Implementation of China 2015 Inventory of Hazardous Chemicals (Trial)
Mandatory classification
The Classification Information Sheet of Hazardous Chemicals annexed to the Implementation Guidance looks similar to the Inventory but has two additional columns namely the “English Name” and “Hazard Category”, for example:
SN | Chinese Chemical Name | Chinese Alias | English Name | CAS No. | Hazard Category | Remark |
|---|---|---|---|---|---|---|
1 | 阿片 | 鸦片 | opium | 8008-60-4 | Specific target organ toxicity-Repeated exposure, Cat.2 | |
2 | 氨 | 液氨；氨气 | ammonia;liquid ammonia | 7664-41-7 | Flammable gases, Cat.2 Gases under pressure Acute toxicity-Inhalation, Cat.3* Skin corrosion/irritation, Cat.1B Serious eye damage/eye irritation, Cat.1 Hazardous to the aquatic environment-Acute hazard, Cat.1 |
Compliance with these classification results is generally a mandatory requirement although the "lowest classification" and "incomplete classification" principles allow the industry to make their own decisions to a certain extent.
Lowest Classification: Only the lowest applicable hazard classification results are specified for the listed chemicals; Companies can assign higher sub-categories under the same hazard category based on the available and reliable data. (Annotation 5 (3), Information Sheet)
E.g. Entry No. 498 “1,3-dichloro-2-propanol” is classified to “acute toxicity – Oral, Cat.3*”. Based on sufficient evidence, it can be classified to a stricter category such as “acute toxicity – Oral, Cat.2
Incomplete Classification: The guidance does NOT include the complete hazard categories of the chemicals; companies should supplement other hazard categories by consulting the data of their own, without changing the hazard categories listed in the guidance. (Annotation 5 (1) (2) (4), Information Sheet)
This principle is further addressed in the following section “hazardous chemical determination principle”.
Hazardous chemical determination principle
The Implementation Guidance and the Information Sheet have repeatedly mentioned the “hazardous chemical determination principle”. For example -
Annotation 5(2): The provided hazard classifications of the listed chemicals are limited to those hazards and hazard categories specified in the hazardous chemical determination principle. The chemicals may have other hazards and hazard categories.
Previously set forth in the Inventory (2015), the hazchem determination principle indicates if a chemical is classified to any of the 81 hazard categories adopted by the Inventory and regarded as a hazardous chemical. According to GB 30000 series standards, China adopts all the 95 hazard categories (also known as the “building blocks”) under UN GHS Rev.4. So there are 14 hazard categories regarded as not applicable to the hazchem determination principle. For the comparison of hazard categories adopted by China and those adopted by the Inventory, please refer to Interpretation of China Inventory of Hazardous Chemicals (2015).
Take Entry No. 308 as an example:
SN | Chinese Chemical Name | Chinese Alias | English Name | CAS No. | Hazard Category | Remark |
308 | 2,6-二氨基甲苯 | 甲苯-2,6-二胺；2,6-甲苯二胺 | 2,6-toluenediamine;2-methyl-m-phenylenediamine | 823-40-5 | Skin sensitizer, Cat.1 Reproductive toxicity, Cat.2 Hazardous to the aquatic environment-Acute hazard, Cat.2 Hazardous to the aquatic environment-Long-term hazard, Cat.2 |
|
According to HSDB database, LD50 of 2,6-toluenediamine is 1000 mg/kg bw, so it should be classified to acute toxicity (oral), category 4, which is a hazard category not adopted by the Inventory. So in practice, companies can add this classification information in SDS, hazchem registration system, internal classification record, etc.
If a chemical is assigned with hazard categories limited to the 14 categories not adopted by the Inventory, it is not referred to as a “hazardous chemical” but a “chemical with certain hazard properties”.
Comparison with other classifications
According to our information source officials referenced the harmonized classification results of EU, Japan, South Korea, New Zealand, etc. when formulating the Implementation Guidance although China’s classification results are not identical to that of any other country/region.
In case there is any disagreement with the official classification and which is not applicable to the "lowest classification" and "incomplete classification" principles stated above, companies can submit the opinions and source data to NRCC for expert review.
About the Author
Mr. Sun is a senior regualtory consultant of REACH24H Consulting Group China. He is extremely experienced in chemical classification, labeling and compiling SDS in accordance with the requirements of China GHS. He regularly runs training programs on China GHS and hazardous chemical regulations for the international companies such as Würth Group, Vaillant GmbH, Coloplast A/S, Cardolite Corporation. Currently his focus is on hazardous chemical regulations in China, mainly the Regulations on the Control over Safety of Hazardous Chemicals" (Decree 591).
