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2019-01-03
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1Korea Chemicals Management Association
Registration evaluation
SoonKwang KWON
Consumer Chemical Products
and Biocides Safety Act
Korea Chemicals Management Association
Introduction
1. Law
-Seven chapters and sixty articles (five articles under ADDENDA)
2. Decree
- Seven chapters and thirty nine articles (two articles under Addenda)
- Required documents for approval of active substances and biocidal products, grace period for approval of existing active substances, approval of changed information on active substances and biocidal products, etc.
3. Rule
- Six chapters and fifty seven articles (two articles under ADDENDA)
- Types of biocidal products, procedure for approval of biocidal substances and products, registration of changed information on active substances and biocidal products, etc
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Korea Chemicals Management Association3
Introduction
Korea Chemicals Management Association4
1. Purpose
2. Principle
Introduction
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Korea Chemicals Management Association5
3. Definition
Introduction
Korea Chemicals Management Association6
4. K-BPR is not applicable to followings
Introduction
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Korea Chemicals Management Association
Consumer chemical products management system
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1. Status Survey & Risk assessment
2. Products subject to safety confirmation & safety standards
3. Self safety check & submission of product information
4. Placing on the market
Korea Chemicals Management Association
Household product management scheme
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ME
Status investigation
(fine when refusing investigation)
Risk assessment
(periodical reassessment on safety
standard
Meet labelling standard(ingredient, cautious
and etc.)
(manufacturer∙importer try to sell product)
Designate household product subject to
safety confirmation(enlarged to house
office and public)
Notify safety and labelling
standard
Confirm safety standard adequacy(every
3years)
(manufacturer∙importer → evaluating agency)
Product information(evaluation result,
ingredient, labelling ) report
(manufacturer∙importer→ ME)
Market distribution (renew every 3 years)
Companies
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Korea Chemicals Management Association
Active substance approval
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1. Active substance approval
Manufacturer/importers of active substance contained in biocide product that were distributed
domestically before December 31st 2018, should report by June 30th 2019 (grace period max 10
yrs)
2. Registration of existing AS in distribution and grace period
Korea Chemicals Management Association
Active substance approval
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3. BP Types
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Korea Chemicals Management Association
Active substance approval
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4. Existing grace period for AS approval
Korea Chemicals Management Association
Active substance approval
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5. Data Requirements for AS Approval
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Korea Chemicals Management Association
Active substance approval
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1. Active substance approval
Korea Chemicals Management Association
Active substance approval
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2. Grace period for FP authorization
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Korea Chemicals Management Association
Active substance approval
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3. Data requirement for BP authorization
Korea Chemicals Management Association
Approval or Relieve standard
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1. Biocide active substance and biocidal product approval or relieve standard
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Korea Chemicals Management Association
Treated articles
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1. Safety Standard for Treated articles
2Labeling standard for treated article
3. Biocidal product
Korea Chemicals Management Association
Biocide management flowchart
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살생물물질 살생물제품살생물처리제
품
살생물제
Active substance Biocidal product Treated article
Biocide
신고Apply for grace
period (existing) 신고Apply for
approval(new)
신고Data preparation
(Toxicology, effect, effectiveness, exposure)
신고Apply for
approval 신고Approval
exemption
신고 신고Submit data
(grace period max. 10yrs)
신고Examination(ME)
신고approval 신고disapproval
신고Renew every 10
yrs 신고Manufacture
/import prohibition
신고
Data preparation(risk, effect,
How to use )
신고Submit data
(when applying for approval)
신고Draft evaluation(ME)
(safety, labelling)
신고approval 신고disapproval
신고Renew every 10
yrs 신고Manufacture
/import
prohibition
신고
Meet safety standard(only use approved biocidal
product)
Meet labelling standard(when advertising effect on
removing harmful organisms)
신고
No concern,
nano, Yes
product
effect
satisfactory unsatisfactory
Use only approved
substanceUse only approved
products
Submit data(applying for approval)
satisfactory unsatisfactory
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Korea Chemicals Management Association
Dangerous products management
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1. Illegal product
2. Notification of New risk
Korea Chemicals Management Association
Penalty Surcharge
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1. Subject
2. Amount
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Korea Chemicals Management Association
Addena(Transitional provisions)
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Korea Chemicals Management Association
List of ME public Notices to be ussued
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Thank you
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Korea Chemicals Management Association
