Hazardous Chemical Licensing Consulting Services
Empowering Compliant Market Access for Enterprises

Types of Enterprises Required to Conduct Safety Assessments

·Mining enterprises: including coal mines and metal/non-metal mines, which under the Mine Safety Law must undergo assessment during the construction and production stages.

·Hazardous chemical related enterprises: enterprises that produce, store, transport or use hazardous chemicals must undergo assessment where major hazard sources are involved.

·Metal smelting enterprises: metallurgical and casting construction projects require safety pre-assessment and acceptance assessment.

·Fireworks and firecracker enterprises: construction projects for the production or storage of fireworks and firecrackers are mandatorily required to undergo safety pre-assessment.

·Construction enterprises: high-risk construction projects require safety assessment, particularly where major projects are involved.

Key Considerations for Safety Assessment

·Applicable mainly to production and business entities, including factories, mines, gas stations, etc.;

·The assessment covers the enterprise's existing production facilities, equipment, installations and safety management status;

·The purpose is to assess whether work safety conditions comply with national laws, regulations and standards, and to propose improvements based on the results;

·Typical application scenarios include Work Safety License renewal, compliance inspections and post-accident rectification.

Comprehensive Emergency Response Plan

A comprehensive work plan formulated by a production or business entity to respond to various work safety accidents; it serves as the overall framework of the entity's general work procedures, measures and emergency response plan system for work safety accidents, and applies to all accidents.

Special Emergency Response Plan

A dedicated work plan formulated by a production or business entity to respond to one or more specific types of work safety accidents, or to prevent work safety accidents in relation to major production facilities, major hazard sources or major events; it applies to accidents not yet concluded by on-site response.

On-Site Response Plan

Emergency response measures formulated by a production or business entity for specific premises, installations or facilities according to different types of work safety accidents; it applies to accidents in specific scenarios.

Definition: "Dual Control" refers to tiered risk management and control plus hidden hazard screening and remediation

1.Risk levels: classified by severity into four levels - red (major), orange (relatively large), yellow (general) and blue (low).

2.Laws and regulations:

·Shanghai Implementation Guidelines for Enterprise Safety Risk Tiered Management and Control, Section (VIII) Risk Classification.

·Based on the results of the risk assessment, different risks are ranked according to the degree of attention required.

·Risks are classified from high to low into four levels: Level A (major risk / red), Level B (relatively large risk / orange), Level C (general risk / yellow) and Level D (low risk / blue).

Hidden hazard screening: establish a list specifying corrective measures, responsible persons and deadlines

Legal basis: Article 41 of the Work Safety Law of the People's Republic of China provides that production and business entities shall establish a tiered safety risk management and control system and take corresponding control measures according to the level of safety risk.

Circumstances Requiring Changes to the Hazardous Chemical Registration Certificate

1.Changes to enterprise information: where the enterprise name, registered address, registered product varieties or emergency telephone number change, the enterprise must submit a change application to the registration office within 15 working days.

2.Where the properties of a chemical change and the hazardous chemicals produced or imported exhibit new hazardous characteristics, a change application must be submitted to the registration office within 15 working days.

3.The registration certificate is valid for 3 years; if the enterprise needs to continue importing hazardous chemicals, it must submit a renewal application to the registration office three months before expiry.

24-Hour Emergency Hotline

1.The SDS and safety label must indicate a 24-hour emergency advisory service telephone number.

2.A registration agency entrusted to provide agency emergency advisory services must maintain a domestic fixed service line staffed 24 hours a day by dedicated personnel, establish a comprehensive chemical emergency rescue database, be equipped with online digital recording equipment and at least 8 professional staff, be capable of handling 3 or more emergency inquiries simultaneously, and accurately provide information and advice on the emergency response to chemical leaks, fires, explosions, poisoning and other incidents.

The 16 Sections of an SDS

1. · Chemical Product and Company Identification

   · Hazards Identification

   · Composition / Information on Ingredients

   · Physical and Chemical Properties

   · First Aid Measures

2. · Firefighting Measures

   · Handling and Storage

   · Exposure Controls / Personal Protection

   · Stability and Reactivity

   · Disposal Considerations

3. · Transport Information

   · Toxicological Information

   · Ecological Information

   · Regulatory Information

   · Other Information

Label Validity

1.The validity of the label is consistent with that of the SDS; if the SDS changes, the label must be updated accordingly.

2.Label content: includes the chemical name, pictograms, signal word, hazard statements, precautionary statements, emergency telephone number, supplier identification and references to further information, all of which must be consistent with the SDS.

Non-pharmaceutical precursor chemicals are divided into three categories

1.Category I non-pharmaceutical precursor chemicals: primary raw materials that can be used to manufacture drugs, subject to a licensing system.

2.Category II and III non-pharmaceutical precursor chemicals: chemical reagents that can be used to manufacture drugs, subject to a record-filing system.

Types of Changes

1.Re-application: when the enterprise name, address or legal representative changes, the filing procedures must be completed anew within 30 working days after the Business License is updated, while the original validity period of the filing certificate remains unchanged.

2.Change of product varieties: where filed product varieties are added or the main distribution flow changes, the filing procedures must be completed anew within 30 working days after the change occurs.

3.Extension: the validity period is three years; an extension must be applied for with the approval authority 3 months before expiry.

4.Cancellation: enterprises that no longer operate non-pharmaceutical precursor chemicals or have had no business transactions for an extended period must complete cancellation procedures within 3 months of terminating the business.

Non-pharmaceutical precursor chemicals are divided into three categories

1.Category I non-pharmaceutical precursor chemicals: primary raw materials that can be used to manufacture drugs, subject to a licensing system.

2.Category II and III non-pharmaceutical precursor chemicals: chemical reagents that can be used to manufacture drugs, subject to a record-filing system.

Types of Changes

1.Re-application: when the enterprise name, address or legal representative changes, the filing procedures must be completed anew within 30 working days after the Business License is updated, while the original validity period of the filing certificate remains unchanged.

2.Change of product varieties: where filed product varieties are added or the main distribution flow changes, the filing procedures must be completed anew within 30 working days after the change occurs.

3.Extension: the validity period is three years; an extension must be applied for with the approval authority 3 months before expiry.

4.Cancellation: enterprises that no longer operate non-pharmaceutical precursor chemicals or have had no business transactions for an extended period must complete cancellation procedures within 3 months of terminating the business.

Key Considerations

·Licensing qualifications: when operating explosive precursor chemicals, precursor chemicals may be purchased with the Hazardous Chemical Business License, but a statement of legitimate purpose for the purchase must be provided.

·In actual operations, in addition to the above mandatory qualifications, an enterprise must also open an explosive precursor chemical account with the public security bureau in its jurisdiction, make the corresponding declarations, and truthfully register the relevant information.

Eligible Buyers

·Manufacturers: must hold a Work Safety License.

·End users: must hold an Explosive Precursor Chemical Purchase Voucher with the stated purpose of "experimental research."

·Trading companies: must hold a Hazardous Chemical Business License.

Prohibited Sales

·Sales to individuals (including self-employed industrial and commercial households) are prohibited.

·Sales to entities without a purchase voucher or filing certificate are prohibited, and sales must not exceed the varieties and quantities specified in the purchase voucher.

·Retail sales through e-commerce platforms are prohibited.

·Sales in broken or repackaged small quantities are prohibited.