EducationㆍConsulting > New Chemical Registration > China
New chemicals imported or manufactured in China, in accordance with related laws and rules (Harmful Chemical Substances Control Law), require registration with the State Environmental Policy Act (SEPA), prior to their designated date of import and manufacture.
- KTR Chemical Notification Process
- · Check CAS No. and chemical substance name
· Verify international registration
· Classify type of notification - · Collect existing data on chemical properties and toxicity
· Prepare data on exposure routes and quantity
· Create data on GLP Toxicity, if necessary - · Submit New Chemical Substances Examination to the Ministry of Labor
· Submit a request for data protection (if required)
- Required Data for New Chinese Chemical Notification
| Basic Level Q < 10 ton |
Level 1 10 ton ≤ Q < 1000 ton |
Level 2 1000 ton ≤ Q |
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| Physico-chemical properties | - Solid : Density, Flash Point, Spontaneous Combustion Temperature, Explosive Limit, Particle Size, Water Solubility, Kow - Liquid : Density, Oxidative/Causticity, Vapor Pressure, Kow, pH - Gas : Explosive Limit, Oxidative |
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| Toxicity Test | - Acute Toxicity : Acute Oral Toxicity, Acute Inhalation Toxicity, Acute Dermal Toxicity, Acute Dermal Irritation, Acute Ocular Toxicity, Acute Ocular Irritation, Dermal Hypersensitivity - Short-term Repeated Overdose Toxicity: Oral Toxicity, Dermal Toxicity, Inhalation Toxicity - Mutagenicity : Ames Test and Chromosome Aberration Test |
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| - QSAR result - Mutagenicity - Reproduction/Development Toxicity - 90-day Repeated Overdose Toxicity |
- Request additional data, according to expert decision | ||
| Eco-Toxicity Test | - Algae Growth Inhibition Test, 24-hour Daphnia Acute Immobilization Test, Fishery Acute Toxicity Test, Activated Sludge Respiration Inhibition Test, Biodegradability Test or Non- Biodegradability Test, Absorption/Desorption Screening Test | ||
| Bio-concentration Test for Non-degradability | |||
- KTR Services
- - Register in conjunction with KTR China
- Examine the IECSC registration status of subject substances within and outside China
- Verify registration type and provide consulting on registration process (Notification types: Generic, Simplified, Joint and Polymer)
- Keep test scheduling and monitoring conducted by Chinese institutes
