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This article introduces several important inventories of hazardous or toxic chemicals currently regulated by the Chinese government.
List of Toxic Chemicals Severely Restricted to be Imported in or Exported from P.R. China (2012)
List of First 60 Hazardous Chemicals for Priority Management
Name: The Catalogue of Hazardous Chemicals (2002)
The Catalogue of Hazardous Chemicals was first published in 2002 by SAWS, which contained over 3800 substances classified in 7 hazards categories (19 divisions). In essence, this list is similar to the C&L inventory under EU CLP regulation.
The revised Catalogue (also called "Chinese C&L Inventory") is formulated under the main implementing law of China GHS, Decree 591, as one of the most important justification to define "Hazardous Chemicals" in China.
The current Catalogue consists of three parts: 1) hazardous chemicals listed in China GB 12268-2005 (List of Dangerous Goods); 2) chemicals listed in the List of Highly-toxic chemicals; 3) other hazard chemicals not listed in GB 12268-2005 but identified and announced by relevant national authorities.
Company Duties:
If you are involved with the production, importation, operation, transport or storage of a substance included in the Catalogue, you need to make sure your substance is duly classified, labeled and supplied with a Safety Data Sheet in line with the Chinese national standard GB/T 16483-2008.
Recent Status:
With the establishment of Decree 591, China has made the decision to expand and revise the 2002 Catalogue. Stated in Article 3 of the Decree, new Catalogue will be compiled and adjusted by a group of ten departments led by SAWS, based on standards for hazard classification and identification of the inherent properties of substances. The new catalogue is planned to hold over 7000 substances classified with hazard category, precautionary Statement, pictogram and signal word in addition to the chemical name and CAS/EC number, which will substantially enhance the corporates' understanding and practice of a China GHS-based labeling and SDS preparation.
Name: Inventory of Chinese Highly-Toxic Chemicals (2003)
On June 24 2003, the amended 2002 Inventory of Hyper Toxic Chemicals (2003) was jointly released by eight Chinese ministries according to China’s framework legislation on hazardous chemicals, State Council Decree 344, which is also the predecessor of State Council Decree 591. The revised inventory currently contains 335 hyper toxic substances, including synthetic chemicals and their compounds (pesticides included) and natural toxins. Depending on the hazard identification and toxicological research of chemicals by relevant departments, the inventory might be under from time to time revision and update.
Restriction Scope
The column of “Restriction Scope” stands for the extent to which a corresponding chemical is restricted in China. Restriction Scope consists of three types:
“I” – hyper toxic chemicals definitely banned for use in China;
“II” – pesticides definitely banned for use in China;
“III” – pesticides prohibited to be used for vegetables, fruit trees, tea trees or Chinese herbal medicine plants in China.
Definition of the Toxicity Determination for Hyper-Toxic Chemicals
On rat: oral toxicity test LD50≤50 mg/kg;
dermal toxicity test LD50≤200 mg/kg;
inhalation toxicity test LC50≤500 ppm (gas) or 2.0 mg/L (vapour) or 0.5 mg/L (dust, mist);
test data of dermal toxicity LD50 can be referred to rabbit test.
The Inventory VS GB 6944 (classification and code dangerous goods)
This inventory is compiled based on the toxicity parameters of a chemical substance; it does not affect the classification of dangerous goods under China’s current regulation on hazardous chemicals. Competent Chinese authorities of transportation still follow the national standard GB 6944 (Classification and code of dangerous goods) in classifying and regulating dangerous goods for shipment.
Name: List of Toxic Chemicals Severely Restricted to be Imported in or Exported from China (2012)
The List of Toxic Chemicals Severely Restricted for Import and Export in China was drawn up in order to implement the MEP Order No. 140 issued in 1994 that governs chemicals imported to China for the first time and regulate the environmental management of imported and exported toxic chemicals. Since then the list has undergone several revisions. The latest update (2012 version) has been published on 28 December 2011 to align with the adjustment of annex III of the Rotterdam Convention on International Prior Informed Consent Procedure for Certain Trade Hazardous Chemicals and Pesticides in International Trade (hereinafter “Rotterdam Convention”) and the Customs Product Code of Chinese tariff items.
The 2012 version contains 158 substances to be severely restricted for import and export. The new version only makes three small changes to the 2011 version: it combines the original seven tributyl tin compounds into one category entry; it divides the original “organic or inorganic compounds of mercury other than amalgam” into two category entries based on if the existing chemical definition is available; and it adds a supplementary explanation to the original “organic surface-active agents containing nonylphenol ethoxylates”.
The list plays an important role in preventing illegal import and export of toxic chemicals and the effective fulfillment of China’s obligation in the Rotterdam Convention and the Stockholm Convention on Persistent Organic Pollutants.
Industry Regulatory Compliance
Companies importing or exporting the listed substances are obliged to register with the Chemical Registration Center (CRC) of MEP and apply for a Registration Certificate for the Environmental Management on the Import of Toxic Chemicals (for non-Chinese exporters or domestic importers) or an Import/Export Clearance Notification (for domestic exporters).
Roles and Obligations
Different actors in the supply chain have different obligations, which are listed in the table below:
Roles | Definitions | Obligations |
Non-Chinese exporter | Non-Chinese companies exporting toxic chemicals to China | Apply for Registration Certificate for the Environmental Management on the Import of Toxic Chemicals |
Domestic importer | Domestic companies importing toxic chemicals to China | Apply for Import Clearance Notification |
Domestic exporter | Domestic companies exporting toxic chemicals from China | Apply for Export Clearance Notification |
One Registration Certificate is issued for only one type of toxic chemical, to only one non-Chinese company with only one Chinese domestic company as its trader; and each Registration Certificate is issued with a quantity limit and with a valid period of two years.
For every batch of goods introduced to China, the importer (Chinese domestic company) shall apply for an Import Clearance Notification by providing a copy of the Registration Certificate obtained from its contract partner, i.e. a non-Chinese company which exports goods to China.
Domestic companies shall apply for Export Clearance Notification for every batch of toxic chemicals before exporting those goods to other countries.
Name: List of Dangerous Goods (GB 12268-2012)
The List of Dangerous Goods (GB 12268-2012) applies to the transport, storage, production, management, usage and handling of dangerous goods. It was first published in 1990 and updated in 2005. In October 2011, China SAC notified to the World Trade Organization the 3rd revision of GB 12268. The latest version is due to be adopted on 10 January 2012 to replace the previous GB 12268-2005. New GB 12268 is technically consistent with Part 3 (Dangerous goods list, special provisions and exceptions) of UN Recommendations on the Transport of Dangerous Goods - Model Regulations (16th revised edition).Chapter 4 (except 4.2 and 4.6) and chapter 6 (except the column of special provisions in Table 1) are compulsory; the remainder is recommended.
The List of Dangerous Goods concerns most common dangerous goods during the process of transportation, storage, sale or other related commercial chains, but it does not include those so dangerous goods that are prohibited for transportation, storage or sale if not officially approved. The list is also subject to continuous refinement and update. Please note that chemicals not listed in may not be exempt from any restriction regarding transportation, storage, sale or other related activities.
The list mainly regulates the hazard categorization of dangerous goods (including mixtures), based on GB 6944 and it classifies the listed chemicals into 9 categories and 16 divisions.
Name: Catalog of Entry & Exit Goods under Inspection and Quarantine of China’s Entry-Exit Inspection and Quarantine Bureaus (2012)
The Chinese Catalog of Entry-Exit Commodities under Inspection and Quarantine of China’s Entry-Exit Inspection & Quarantine Bureaus (CIQ) was first drawn up to comply with the United Nations’ Harmonized Commodity Description and Coding Systems (HS). This Catalogue is based on multiple provisions regarding the China Import and Export Commodity Inspection Law, the Food Safety Law of China and the State Council Decree 591, and it shall embody the annual tariff and/or tariff category adjustment of the Customs Tariff Commission Office under State Council and the General Administration of Customs (GAC).
On 29 December 2011, the 2012 adjustment notice on this Catalogue was jointly published by China’s General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and the General Administration of Customs (GAC). The latest version has modified the “regulatory conditions” of 160 hazardous chemicals listed. In all 252 commodities including melamine, sodium silicate and rare earth, etc. shall apply to their new regulatory conditions and/or inspection & quarantine types since 1 February 2012.
Detailed modifications are shown as below:
13 HS codes (products defined in HS code) regarding food additives shift in terms of “regulatory condition” from empty to A&B and the “inspection & quarantine type” of R&S;
9 HS codes that are banned for food additives shift in terms of “regulatory condition” from empty to A and the “inspection & quarantine type” of M. When imported, product in this category must be marked with a warning statement like “Prohibited for Food Processing” on its outer package.
160 HS codes regarding hazardous chemicals are updated in the areas of “regulatory condition” and “inspection & quarantine type”: sulfurs and 133 other chemicals shift from empty to A&B and M&N; phthalic anhydride from A to A&B and M&N; antimony powder and 3 other chemicals from B to A&B and M&N; hydrofluoric acid and 18 other chemicals shift from empty to A and M; potassium chlorate and non cleaning agent carbon tetrachloride shift from empty to B and N.
70 HS codes regarding primary products of rare earth shift in the areas of “regulatory condition” and “inspection & quarantine type” from empty to B and N.
Regulatory Conditions
A: to impose entry inspection and quarantine on the concerned goods
B: to impose exit inspection and quarantine on the concerned goods
Inspection & Quarantine Type
M: for imported general goods
N: for exported general goods
R: for imported food products
S: for exported food products
Industry Regulatory Compliance
Since the new inspection measures have taken effect as of 1 February 2012, we advise all importers and exporters keep up with the adjustment of the Catalog and take time to check whether your products have been affected. If they are indeed listed on the 2012 Catalog adjustment, you just need to provide the due documentation required of the new entry-exit inspection ruling and get prepared for the corresponding inspection & quarantine. Then you will be allowed to apply for a Clearance Notification Certificate for imports/exports before your goods pass through the other Customs formalities smoothly.
If your products fall into the category of 9 chemicals that are banned to be used as food additives, the local entry-exit inspection & quarantine authorities will only check whether your product outer packaging are attached with a warning markup reading “Prohibited for Food Processing”. Your Import or export will be stopped if you fail to prepare for the warning markup. But there shall be neither more other inspection & quarantine items nor corresponding administrative fees.
The Entry-Exit Inspection & Quarantine on Imported Hazardous Chemicals
Imported hazardous chemicals and their packaging shall apply to relevant Chinese standards and industry standards for the entry-exit inspection and quarantine. If the product contract or Letter of Credit (LOC) has indicated an inspection & quarantine requirement higher than the equivalent Chinese standard, relevant authorities shall adopt the inspection requirements/standard indicated in the contract or LOC. If there should be still some preferential trade agreement signed between governments, the concerned trade agreement shall apply too.
If the imported products fall into the category of the 160 hazardous chemicals listed on the 2012 Catalog, the following documentation should be submitted to the relevant entry-exit inspection & quarantine authorities:
Declaration of conformity supplied by the importer
Information on inhibitors and stabilizers (names and quantities)
China GHS-compliant Safety Data Sheets and Precautionary Labels
Other documents required for customs declaration according to the regulations on entry-exit inspection and quarantine.
The following are important points of entry-exit inspection and quarantine imposed by relevant authorities on imported hazardous chemicals and their packaging:
Identify whether the composition/constituent information of goods, physical and chemical properties, hazard class, packaging category meet the requirements of relevant standards, and whether they are consistent with the hazard identification and classification report, SDS and precautionary label provided when applying for an inspection;
Identify whether a China GHS SDS has been provided along with the goods, whether a Chinese label has been affixed on the packaging of goods; whether the contents in SDS and label meet the requirements of relevant standards and are consistent with the goods;
Identify whether the models, category, specification, unit quantity and mark of packaging meet the standard requirements and whether the packaging has been adapted to the properties and uses of the inspected goods;
Identify whether the packing method meets standard requirement and whether the use of packaging is appropriate, whether the packaging is sealed tightly and whether the goods inside the package have leaked.
Name: Catalogue and Classification of Precursor Chemicals (2005)
In China, precursor chemicals refer to the precursors, ingredients, accessories and other substances that can be used in the manufacture of narcotic and psychotropic drugs under the state control. 26 August 2005, the Regulation on the Control of Precursor Chemicals was signed by Chinese State Council Premier and came into force since 1 November of the same year.
The appendix of this Regulation, the Catalogue and Classification of Precursor Chemicals, included altogether 23 types of precursor chemicals in 3 categories currently under the state surveillance. The first category contains 12 types of substances which mainly are ingredients of narcotic drugs; the second (5 substances) and third (6 substances) categories mainly concern accessories of narcotic drugs. The appendix list indicates that category 1 and 2 chemicals in the salt form are also brought into the regulatory orbit. Substances marked with * are precursor chemicals of medical uses in the first category; the precursor chemicals of medical uses in category 1 include APIs (active pharmaceutical ingredients) and the associated prescribed preparations.
On 21 September 2006, in order to further clarify and implement Article 29 of the 2005 Regulation, Chinese Ministry of Commerce (MOC) and Ministry of Public Security (MPS) jointly issued the Provisions on Management of Import and Export of Precursor Chemicals which also attached a list highlighting the international inspection over Chinese precursor chemicals, i.e. Catalogue of the Import and Export Management of Precursor Chemicals. This Catalogue refines the 2005 State Council list and includes in all 33 precursor chemicals in 2 categories. Chemicals in the MOC Catalogue are collected by product name and HS code.
Industry Compliance Obligations
If you are importing or exporting a precursor chemical substance listed on the 2005 Catalogue, you should have a sound understanding of the Chinese provisions on its manufacture/production, operation (distribution and purchasing) and transportation as well as import and export.
China adopts a licensing system for the import and export of precursor chemicals. Relevant importers and exporters must apply to the local MOC authorities for an Import/Export Permit.
Your product package and instruction manuals must indicate clearly the product name (include chemical name and generic name), molecular formula and its compositions.
For any social entity that is engaged in either activity of the manufacture/production, sale, use, transportation or import/export of the listed chemicals, if your substance still meets the state definition of medicine drugs or hazardous chemicals, you must also comply with the relevant Chinese regulations on drugs (i.e. 2007 Provisions for Drug Registration, SFDA Order 28) or hazardous chemicals (i.e. State Council Decree 591).
List of First 60 Hazardous Chemicals under Priority Management
Considering the nation’s chemical accidents over the past 40 years and the variety of chemical hazards subject to priority control at home and abroad, the SAWS carried out the hazard screening on the 3823 substances listed in 2002 Catalogue of Hazardous Chemicals and issued in June 2011 a first list of 60 hazardous chemicals to which priority environmental management should be applied.
The first batch contains hazardous chemicals that are listed on 2002 HC Catalogue and meet the following conditions at the temperature of 20 ℃ and normal atmosphere pressure of 101.3 kPa:
a. Flammable gases, Category 1 (lower explosive limit ≤ 13% or explosion limit range ≥ 12%);
b. Flammable liquids, Category 1 (Flash point < 23 ℃ and initial boiling point ≤ 35 ℃);
c. Liquids liable to spontaneous combustion, Category 1 (liable to combustion when in contact with gas for no more than 5 minutes);
d. Solids liable to spontaneous combustion, Category 1 (liable to combustion when in contact with gas for no more than 5 minutes);
e. Substances when in contact with water emit flammable gases, Category 1 (When reacting violently with water at ambient temperature, the produced gas is usually susceptible to spontaneous combustion, Release of flammable gas is equal to or greater than the rate per kilogram of substance release within 1 minute in any 10 liters of any substance or mixture);
f. Phosgene derivatives like triphosgene, etc.
