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Registration of Hazardous Chemicals in China
Neso Zhao
Jan 25, 2024
China

To strengthen the safety management of hazardous chemicals, to prevent and reduce accidents involving hazardous chemicals, and to protect people's health,  China formulates the Measures for Administration of Hazardous Chemicals Registration (SAWS's Order 53) to standardize the registration of hazardous chemicals.

I. Definition of Hazardous Chemicals 

Hazardous chemicals refer to highly toxic chemicals and other chemicals that possess properties such as toxicity, corrosion, explosiveness, and flammability, and pose risks to human health, facilities, and the environment. 

II. Registration Entities

Under the SAWS's Order 53, domestic manufacturers and importers are required to register hazardous chemicals prior to manufacture or importation. Chemical products (including both substances and mixtures) listed in the Catalog of Hazardous Chemicals (2015) or chemicals that meet the determinative principle are subject to registration.

Enterprises can be divided into the following types: enterprises manufacturing hazardous chemicals; enterprises operating hazardous chemicals; enterprises using hazardous chemicals (use permission license); enterprises involving chemicals (no use permission license); enterprises involving pharmaceuticals; and other enterprises. Each of these enterprises can be divided into 2 types: enterprises importing hazardous chemicals; and enterprises not importing hazardous chemicals. Details can be seen in the following table.

Serial No. Enterprise Type Specification Hazardous Chemicals
Import of hazardous chemicals Not involving the import of hazardous chemicals
1 Enterprises manufacturing hazardous chemicals Enterprises with hazardous chemicals safety production licenses; enterprises manufacturing chemicals meet the determinative principle Products, intermediate products, imported chemicals and raw materials Products, intermediate products, raw materials
2 Enterprises operating hazardous chemicals Enterprises with hazardous chemicals business licenses Operation and importing of chemicals Operation
3 Enterprises using hazardous chemicals (usage permit) Enterprises with use permit of hazardous chemicals Import of chemicals and raw materials Raw materials
4

Chemical enterprises (without use permit)

Enterprises manufacturing chemicals that meet the registration scope of the chemical and pharmaceutical industries, but do not meet the conditions for use licenses of hazardous chemicals Imported chemicals, raw materials Raw materials
5 Pharmaceutical companies Enterprises manufacturing pharmaceuticals that meet the registration scope of chemical and pharmaceuticals Imported chemicals, raw materials Raw materials
6 Other companies Other enterprises such as enterprises involving mining and other industries Imported chemicals, raw materials Determined by emergency management department at the provincial level

III. Competent Authority 

The National Registration Center for Chemicals (NRCC) under the Ministry of Emergency Management of China (known as the State Administration of Work Safety (SAWS)) is in charge of registration work of hazardous chemicals in the Chinese mainland. The local registration offices at the provincial and municipal levels, and autonomous regions are in charge of the registration work within their respective administrative areas.

IV. Registration Time, Scope and Procedure

4.1 Registration time

New manufacturers of hazardous chemicals are required to complete the registration work prior to the final acceptance of construction. An enterprise importing hazardous chemicals is required to register before its first import of hazardous chemicals. An enterprise manufacturing and importing the same hazardous chemical shall be registered as a manufacturing enterprise by submitting the information of imported hazardous chemicals. An enterprise importing the same type of hazardous chemicals from different manufacturers shall register the chemical firstly imported from the manufacturer, but the information of such chemicals from other manufacturers shall also be submitted. Manufacturers and importers importing the same type of hazardous chemicals from the same manufacturer for many times are only required to register once.

4.2 Registration scope

  • Classification and labeling, including hazard category, pictogram, warnings, hazard statements, precautionary statements of hazardous chemicals;
  • Physical properties (appearance, solubility, melting point, boiling point, etc.) and chemical properties (flashing point, explosion limit, ignition temperature, decomposition temperature);
  • Major uses, including recommended legal uses, prohibited or restricted uses;
  • Hazard properties, including physical hazard, environmental hazard, and toxicological property;
  • Safety requirements for storage, utilization and transportation, including requirements on buildings, warehouses, security conditions, environment, sanitation, temperature and humidity; safety use requirements on operation conditions, protective measures for operators, and hazard control measures for operation areas; safe transportation requirements on delivery methods, approaches for disclosure of hazard information to deliverymen, and protective measures for loading, unloading and transportation;
  • Emergency response measures, including measures against and consultation line for fire, explosion, leakage, poisoning, suffocation, burns and other chemicals-related accidents.

4.3 Registration procedure

 

V. Materials Required

When making registration, a production entity shall submit the following materials:

  • Hazardous chemical Registration Form;
  • The business license, the registration form for foreign trade manager, the import and export license in China, the certificate of approval for establishment of enterprises with foreign investment (in the People’s Republic of China) or the certificate of approval for establishment with investment from Taiwan, Hong Kong, Macao;
  • Chemical safety technical specification (SDS) and chemical safety label, three pieces and one electronic version of each;
  • Emergency telephone number or an electronic copy of emergency consultation service; and
  • Product standards of hazardous chemicals to be registered (the standard number shall be provided if national standards or industrial standards are adopted).

VI. Certificate Renewal

If there are changes in the enterprise name, registered address, registered varieties, or emergency consulting service telephone number within the validity period of the certificate of hazardous chemical registration, or if new hazards of the hazardous chemicals produced or imported are identified, the Applicant shall, within 15 working days, apply for a certificate renewal to the Registration Office and follow relevant procedures.

VII. Certificate Validity and Review

The validity of hazardous chemical registration certificate is 3 years. Enterprises are required to apply for the renewal and review of registration certificates 3 months before its expiration if they intend to remain the manufacture or import of hazardous chemicals.

VIII. Responsibilities of Registration Enterprises

Registered enterprises are responsible to examine all of their hazardous chemicals and establish a portfolio covers its name, quantity, hazard identification, hazard classification, SDS and label of hazardous chemicals.

Registered enterprises shall complete the registration of hazardous chemicals under the Measures and fill in the registration forms based on the facts, and accept the supervision and inspection by the competent administration authorities.

Registered enterprises shall designate personnels to take charge of hazardous chemicals registration and to assist on the review of hazardous chemical registrations when necessary. It should be noted that personnels should be equipped with professional abilities in the registration of hazardous chemicals.

For chemicals whose hazard characteristic is unidentified (not listed in the Catalog of Hazardous Chemicals), the Applicants shall entrust the qualified institutes to identify chemical hazards in accordance with the specifications on chemical hazard identification. If a chemical is identified as a hazardous chemical, the applicants shall complete registrations in accordance with this Measures.

Neso Zhao
ChemRadar Regulatory Analyst
CONTENTS
1. Definition of Hazardous Chemicals
2. Registration Entities
3. Competent Authority
4. Registration Time, Scope and Procedure
5. Materials Required
6. Certificate Renewal
7. Certificate Validity and Review
8. Responsibilities of Registration Enterprises
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