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Chemical Substance Registration
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China REACH

New chemicals imported or manufactured in China are required to be approved by the State Environmental Protection Administration of China (SEPA) for their registration prior to the date of importation or the manufacturing date.

Visit the KTR Chemical Regulatory Compliance Center site (EN) Visit the KTR Chemical Regulatory Compliance Center site (JP)

KTR Chemical Substance Work Procedures

KTR 화학물질 업무절차 확대

  • 화학물질 등록 상담 및 접수

    • · 대상 화학물질명, CAS No. 확인
    • · 국내외등재 현황확인
    • · 신고유형 분류

  • 기초자료 접수 및 견적 제공

    • · 기존 물성 및 독성자료 수집
    • · 환경 중 배출경로 및 배출량에 관한 자료준비
    • · GLP 동석 Data 생성 (필요 자료 필요 시)

  • 등록 필요 서류 준비 및 제출

    • · 신규화학물질 신고서 작성,제출
    • · 자료보호 신청서 제출(요청시)

  • 신청결과 보고 및 사후관리

Required Data for Registration of New Chemical Substance in China

중국 신규화학물질 등록 필요 자료
  Basic Level
(Q < 10ton)		 Level 1
(10ton ≤ Q < 1000ton)		 Level 2
(1000ton ≤ Q)
Physico-chemical properties
  • - Solid : Density, Flash Point, Spontaneous Combustion Temperature, Explosive Limit, Particle Size, Water Solubility, Kow
  • - Liquid : Density, Oxidization/Corrosion Properties, Vapor Pressure, Kow, pH
  • - Gas : Explosive Limit, Oxidazation properties
Toxicity Test
  • - Acute Toxicity : Acute Oral Toxicity, Acute Inhalation Toxicity, Acute Dermal Toxicity, Skin Irritation, Eye Irritation, Skin Sensitization
  • - Short-term Repeat Dose Toxicity: Oral, Dermal, Inhalation
  • - Mutagenicity : Ames Test, In vitro chromosome aberration assay
 
  • - QSAR result
  • - Mutagenicity
  • - Reproduction/Development Toxicity
  • - Repeat Dose Toxicity - 90 days

- Request additional data, according to expert decision
Eco-Toxicity Test

- Algae Growth Inhibition Test, 24-hour Daphnia Acute Immobilization Test, Acute Toxicity Test to Fish, Activated Sludge Respiration Inhibition Test, Biodegradability Test or Non- Biodegradability Test, Absorption/Desorption Screening Test
  Bio-accumulation test for non-biodegradable substances  

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: General, Simplified, Joint and Polymer)
  • - Test scheduling and monitoring tests conducted by Chinese institutes