China

• Overview
• New Chemical Substance
• Hazardous Chemical
• Classification, Labeling and SDS (China GHS)
• Toxic Chemicals Restricted To Be Imported/Exported
• Narcotic Drugs and Drug Precursors
• Prohibited Chemicals
• Food Additives
• Pesticides
• Cosmetics and Cosmetic Ingredient
• Occupational Exposure Limits & Protection
• Regulations on Administration of Veterinary Drugs

Narcotic Drugs and Drug Precursors

In China, the main legislation regulating precursor chemicals is the Regulations for The Administration of Precursors and Chemicals Used in Production of Narcotic Drugs and Psychotropic Substances, which came into force in Nov 2005.

The purpose of the legislation is to strengthen the administration of precursor chemicals, regulating the production, distribution, purchase, transportation and import and export of precursor chemicals, preventing precursor chemicals from being used in manufacturing drugs and psychotropic substances.

Catalog and Classification of Precursor Chemicals

The precursor chemicals are classified into three categories. Category I includes the major materials that can be used for producing drugs. Categories II and III include the chemical agents that can be used for producing drugs. The detailed classification and types of precursor chemicals are shown as below:

Category I

1. 1-phenyl-2-propanone

2. 3,4-Methylenedioxyphenyl-2-propanone

3. piperonal

4. safrole

5. sassafras oil

6. iso-safrole

7. n-acetyl o-amino benzoic acid

8. o-amino benzoic acid

9. ergotic acid*

10. ergotamine*

11. ergobasine*

12. ephedrine, pseudo ephedrine, mesoephedrine, phenylpropanolamine, methylephedrine, ephedrine extractum, ephedrine extractum powder and other ephedrine substances

13. 2-Chlorophenyl cyclopentyl ketone(new in 2012)

Category II

1. phenyl acetic acid

2. acetic oxide

3. chloroform

4. aether

5. piperidine

Category III

1. toluene

2. acetic oxide acetone

3. methyl ether ketone

4. polsassium permanganate

5. sulphuric acid

6. hydrochloric acid

Notes:

　　1. The saline chemicals that may exist in the substances as listed in Category I or II shall be brought into control.

　　2. The types marked with "*" are precursor chemicals under the item of pharmaceuticals in Category I, which include the pharmaceutical raw materials and the single preparation thereof

How to Comply

To comply with this legislation, you need to find out what your roles are and which category your product belongs to:

Category	Regulation(updated in Oct 2011)
Category I	Producers or sellers need to obtain production license or operation license from state food and drug administration(SFDA) or administrative department of work safety at provincial level; Sellers need to keep all sales records for at least 2 years; Buyers need to obtain purchase license from the administrative department of food and drug at provincial level or public security office at city level; Transporters need to obtain transport permit from public security office at city level; Importers/Exporters need to obtain a license from department of commerce; Importers need to obtain a license from state food and drug administration(SFDA);
Category II	Producers need to report product name, category and quantity to administrative department of work safety at city level within 30 days since the date of manufacturing; Sellers need to report product name, category, quantity and buyer's information to administrative department of work safety at city level within 30 days since the date of operation; Buyers need to report product name, category, quantity to public security office at county level within 30 days since the date of operation; Transporters need to obtain transport permit from public security office at county level; Importers/Exporters need to obtain a license from department of commerce;
Category III	Producers need to report product name, category and quantity to administrative department of work safety at city level within 30 days since the date of manufacturing; Sellers need to report product name, category, quantity and buyer's information to administrative department of work safety at county level within 30 days since the date of operation; Buyers need to report product name, category, quantity to public security office at county level within 30 days since the date of operation; Transporters need to report transport information to public security office at county level; Importers/Exporters need to obtain a license from department of commerce;

 

About Us

Initially set up by China Inspection and Quarantine(CIQ) Bureau in 2007 to provide REACH compliance services to Chinese chemical industry, CIRS has grown to be a leading provider of comprehensive chemical compliance services for companies doing businesses in/with China.

Our services cover new substance notification, registration of the import and export of toxic chemicals, registration of hazardous chemicals, classification and labeling in according to China GHS, Chinese SDS, risk assessment of industrial chemicals, food additives and cosmetic ingredients. We provide one-stop solutions to your regulatory issues in China.We also deliver the most up-to-date regulatory information about chemical control laws in China.

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• Mr. Eric Xiong, China Office
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