How to Apply for Precursor Chemical Licenses in China
Introduction
To strengthen the control over precursor chemicals and prevent their misuse in illegal drug production, China has established a strict permitting and filing system. This article provides a comprehensive overview of China’s regulatory requirements for companies engaged in the production, operation, purchase, transport, and import/export of precursor chemicals. If your business handles such chemicals, understanding and complying with these rules is critical to ensuring legal operations and avoiding penalties.
Regulatory Background
The Regulations on the Administration of Precursor Chemicals form the legal foundation for managing precursor chemicals in China. These regulations categorize such substances and introduce a permit-based management system for their entire life cycle, including production, distribution, and cross-border activities.
Enterprises involved in these operations must not only comply with the precursor chemical regulations but also follow additional laws if their products fall under the scope of pharmaceuticals or hazardous chemicals. Illegal activities such as smuggling, unauthorized production, or unpermitted sale and transfer of precursor chemicals are strictly prohibited.
Scope of Regulation
All businesses involved in the following activities related to precursor chemicals must comply with the relevant permitting or filing requirements:
- Production
- Operation (sale/distribution)
- Purchase
- Transportation
- Import and Export
Special attention must be paid to substances also classified as pharmaceuticals or hazardous chemicals, which are subject to additional legal requirements.
Classification of Precursor Chemicals
China classifies precursor chemicals into three categories, as outlined in the Catalogue and Classification of Precursor Chemicals:
- Category I: Primary raw materials used for drug manufacturing
- Category II and III: Chemical auxiliary agents that can be used to produce drugs
Permitting and Filing Requirements by Category and Activity
| Activity | Category I (Non-Pharmaceutical) | Category II | Category III |
| Production | Production License (Provincial Emergency Dept., valid 3 years) | Filing Certificate (Municipal Emergency Dept., valid 3 years) | Filing Certificate (Municipal Emergency Dept., valid 3 years) |
| Operation | Operation License (Provincial Emergency Dept., valid 3 years) | Filing Certificate (Municipal Emergency Dept., valid 3 years) | Filing Certificate (County Emergency Dept., valid 3 years) |
| Purchase | Purchase License (Provincial Public Security, valid for 1 month per use) | Filing Certificate (County Public Security, valid 1 month single-use or 6 months multi-use) | Filing Certificate (County Public Security, same as Category II; individuals only allowed 1-time use) |
| Transport | Transport License (Municipal Public Security, 1 month per use) | Transport License (County Public Security, valid for 3 or 12 months multiple uses) | Filing Certificate (County Public Security, valid for 3 or 12 months multiple uses) |
| Import/Export | Dual-use Items and Technology Import/Export License (issued by the Ministry/Provincial Commerce Dept., valid 6 months) | Same as Category I | Same as Category I |
Legal Sources:
- Emergency Management Order No. 5
- Ministry of Public Security Order No. 87
- Ministry of Commerce Orders No. 7 & 8, Customs & Commerce Order No. 29
Special Compliance Notes
- Production Enterprises Selling Products: Manufacturers may sell directly. However, if they set up external sales offices, they must obtain an operation license or filing certificate.
- Sales Record Filing: Distributors must file records with public security authorities after sales:
- Category I: within 5 days
- Category II & III: within 30 days
- Pharmaceutical Precursor Chemicals: Licenses must be obtained from the Medical Products Administration.
Precursor Chemicals in Mixtures: What You Need to Know
According to the Provision on the Management of Import and Export of Precursor Chemicals, mixtures containing certain levels of precursor substances must be treated as regulated items.
Regulated Mixtures
Mixtures containing any of the following above threshold levels require licenses:
- Toluene, Acetone, MEK, or Sulfuric Acid > 40%
- Hydrochloric Acid > 10%
- Any other precursor chemical listed in the import/export directory
Exemptions
- Mixtures below these thresholds are exempt.
- Certain product types containing γ-butyrolactone (GBL)are also exempt:
- GBL ≤ 60% in photolithographic resists, PI alignment solutions, developers, anti-reflective coatings → no import, purchase, or transport filing required
- GBL ≤ 20% in printer ink and related supplies → exempt from all permitting
Step-by-Step Permitting Procedures
For Purchase/Transport
- Register on the Precursor Chemical Service Platform
- Enter chemical information and upload qualifications
- Wait for the Public Security review
- Download the certificate upon approval
For Production/Operation
- Register on the Integrated Management System for Non-Pharmaceutical Precursor Chemicals
- Select permit type and upload required documentation
- Await Emergency Department review
- Receive the official permit
For Import/Export
- Determine if your product qualifies as a regulated precursor
- Apply for a Dual-Use Item e-Key
- Register on the Ministry of Commerce system and apply for an approval slip
- Obtain the final import/export license
- Download the electronic certificates of the licenses
Our Compliance Services
Handling precursor chemicals in China requires rigorous compliance. REACH24H offers expert support for the following:
- Operation License/ Filing Certificate
- Purchase License/ Filing Certificate
- Transport License/ Filing Certificate
- Dual-use Items Import/Export License
Our team ensures your documentation is accurate, submitted correctly, and approved efficiently, helping you navigate regulatory complexities with confidence.
