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CIRS
Your Compliance Expert
China Chemical Regulations Overview
Ethan Zheng
CIRS
ethan.zheng@cirs-group.com
1
Chemical
Substances
Chemical contained
in products with
certain function
Raw Material,
Intermediate
What to be Regulated?
Pesticide
Animal Medicine
Pharmaceutical
Food
Food Additive
Radioactive
Substance
Military
Product
Cigarette
Industrial Chemicals
2
New Chemical Substance Notification
Registration of Hazardous Chemicals
Environmental Administration Registration of Hazardous Chemicals
License System
GHS, SDS and Labeling
3
New Chemical Substance Notification
Who Should Notify?
Scientific Research
Record
Simplified
Notification
Typical
Notification
No Data
Requirement
Special Type:
No Data
Requirement
Basic Type:
Minimal Data
Requirement
Data Requirement
increases with the
tonnage level
1 – 10
10 – 100
100 – 1000
>1000
MEP Order 7
Domestic Manufacturers
and Importers
Oversea Manufacturers and
Exporters
4
New Chemical Substance Notification
Basic Procedure Substance
Exempted? End
IECSC Listed? End
Notification Type
Typical Notification Scientific Research RecordSimplified Notification
Basic Special
Domestic
Eco/toxicolo
gical Data
Special
Condition
Statement
Data Gap Analysis
Carry out Tests
Dossier Submission
Authority Review
R&D Activity Carried
out
Certificate Issued
Supervision
Yes
Yes
No
No
v
Dossier Submission
Dossier Submission
5
New Chemical Substance Notification
Entering IECSC
1. Complete Typical Notification
2. A 5-year period required after first business
activity of the notified chemical substance
CIRS Data
Typical NotificationScientific Research RecordSimplified Notification
85200+1000+
6
New Chemical Substance Notification
Registration of Hazardous Chemicals
Environmental Administration Registration of Hazardous Chemicals
License System
GHS, SDS and Labeling
7
Registration of Hazardous Chemicals
What Chemical Needs to be Registered?
Chemicals listed on
the Catalog of
Hazardous Chemical
2015
Chemicals that
classified as hazardous
chemicals according to
SAWS Order 60
SAWS Order 53
Who Should Register?
Domestic Manufacturers
and Importers
8
Registration of Hazardous Chemicals
What Chemicals are Recommended to
be Identified?
Contain substances listed in
the HazChem Catalog, with
unknown hazard
Contain substances not listed
in the HazChem Catalog, with
unknown hazard
SAWS Order 60
Used for R&D or PPORD with
annual tonnage > 1 t/y, with
unknown hazard
Contain substances listed in
the HazChem Catalog, with
new hazard discovered
9
Registration of Hazardous Chemicals
Basic Procedure
Enterprises
Provincial Registration
Office
National Registration
Center
Document Submission
Provincial Review
passed
National Center
Review passed
Certificate
issued
Certificate
issued
Provincial Review
not passed
Rejected
Rejected
National Center
Review not passed
10
Registration of Hazardous Chemicals
A Few Points
1. Catalog of Hazardous Chemicals published
and implemented since May 1st 2015
2. No low-volume/specific usage exemption
3. Self-Classification accepted
4. 24 Hour Emergency Number required
5. SDS and Label required
11
New Chemical Substance Notification
Registration of Hazardous Chemicals
Environmental Administration Registration of Hazardous Chemicals
License System
GHS, SDS and Labeling
12
Environmental Administration Registration of Hazardous Chemicals
What Chemical Needs to be Registered?
Chemicals listed on
the Inventory of Toxic
Chemicals Restricted
from Import/Export
Chemicals listed on
the Catalog of
Hazardous Chemicals
2015 and List of PHCs
MEP Order 22
Who Should Register?
Importers and Exporters Manufacturers and Users
13
Environmental Administration Registration of Hazardous Chemicals
A Few Points
1. Chemicals listed in the List of PHCs require Risk
Assessment Report, Pollutant Release & Transfer
Registration (PRTR) form and Environmental Risk
Management Plan
2. No low-volume/specific usage exemption
14
New Chemical Substance Notification
Registration of Hazardous Chemicals
Environmental Administration Registration of Hazardous Chemicals
License System
GHS, SDS and Labeling
15
License System
What Type of License?
Production Safe Use Operation Transportation
What Should be Done?
SAWS Order 41 SAWS Order 57 SAWS Order 55
State Council
Decree 591
-Check the relevant chemical inventories
-Identify the activities: Production, Use, Operation,
Transportation
16
License System
Production
SAWS Order 41
Safe Production Licence
Before production initiated
Catalog of Hazardous Chemicals
Measures of Safe Production Licence
Industrial Goods Production Licence
Manufacturing enterprises
Catalog of Industrial Goods
Measures of Industrial Goods Production Licence
17
License System
Safe Use
SAWS Order 57
Safe Use Licence
Companies using hazardous chemicals for production
Catalog of Hazardous Chemicals
Exemption
Companies using hazardous chemicals as fuel
18
License System
Operation
SAWS Order 55
Operation Licence
Scope: Hazardous chemical operation and storage
Exemption
Companies selling hazardous chemical manufactured by
the same companies with the range of the factory
Companies with Port Operation Licence that runing
hazardous chemical storage
19
License System
Transportation
State Council
Decree 591
Transportation Licence
Road, Air and Waterway Transportation Licence
Related staffs with qualifications
Full time safety management staff for road air
and waterway transportation
Obligations
Compliant packaging, SDS and labels
Stabilizers and inhibitors disclosed
Appoint qualified transportation units
20
New Chemical Substance Notification
Registration of Hazardous Chemicals
Environmental Administration Registration of Hazardous Chemicals
License System
GHS, SDS and Labeling
21
GHS, SDS and Labeling
What Should be Provided?
Classification SDS Label
UN GHS Rev 4
16 Physical Hazards
10 Health Hazards
2 Environmental
Hazards
16 Sections
Language in
Simplified Chinese
24H Emergency
Telephone Number
All the required
label elements
Size requirement
GB 30000
GB/T 16483-2008
GB/T 17519-2013
GB 15258-2009
GB 190-2009
22
GHS, SDS and Labeling
A Few Points
1. CBI protection in SDS: components can be kept
confidential but hazards must be disclosed
2. Precautionary statement can be removed in
the simplified labels
CIRS Data
SDS of major countries
3000+ per year
23
Summary
24
Summary
Your Role in the Supply Chain
and Your Obligations
First Step: Check all the inventories
Inventory of Existing
Chemical Substance (IECSC)
Catalog of Hazardous
Chemical Substance (2015)
Priority Hazardous
Chemicals for Environmental
Management (PHCs)
List of Toxic Chemicals
Restricted to be
Imported/Exported
CCISS Inventory Search System by CIRS
cciss.cirs-group.com
25
Summary
Summary
Summary
Summary
Your Role in the Supply Chain
and Your Obligations
For chemicals NOT listed in IECSC
Roles in the supply Chain Obligations
Domestic Manufacturer New substance registration by MEP
Domestic Users
Implement proper precautionary measures when
using new chemicals after they are registered.
Foreign Manufacturers/ Suppliers
Appoint Chinese agent to register new substance
by MEP, or rely on Chinese importers to register
Domestic importers New substance registration by MEP
29
Summary
Your Role in the Supply Chain
and Your Obligations
For chemicals listed in Catalog of Hazardous Chemicals (2015)
Roles in the supply Chain Obligations
Domestic Manufacturer
Production License by SAWS;
Hazardous Chemical registration by NRCC-SWAS;
Environmental Administration Registration by MEP;
SDS/Label under China GHS
Domestic Users Environmental Administration Registration by MEP
Domestic Operators Operation License by SAWS
Domestic importers (users and traders) Hazardous Chemical registration by NRCC-SWAS;
Foreign Manufacturers/ Suppliers SDS/Label under China GHS
* If listed in PHCs, PRTR and Risk assessment report will be required 30
Summary
Your Role in the Supply Chain
and Your Obligations
For chemicals listed in List of Toxic Chemicals Restricted to be I/E
Roles in the supply Chain Obligations
Foreign exporter
Apply for Registration Certificate for the
Environmental Management on the Import of Toxic
Chemicals
Domestic importer Apply for Import Clearance Notification
Domestic exporter Apply for Export Clearance Notification
31
Summary
Your Role in the Supply Chain
and Your Obligations
For chemicals not listed in the Catalog (2015)
but with hazardous classifications
Roles in the supply Chain Obligations
Domestic Manufacturer
Hazardous Chemical registration by NRCC-SWAS;
SDS/Label under China GHS
Domestic importers (users and traders) Hazardous Chemical registration by NRCC-SWAS;
Foreign Manufacturers/ Suppliers SDS/Label under China GHS
32
Useful Links
33
Useful Links
1. Search Engine for Chemical Inventory in China:
http://cciss.cirs-group.com/
2. Regulatory Related Materials Download:
http://freedoc.cirs-group.com/en/
3. Regulatory News Updates:
http://www.cirs-reach.com
Find us on LinkedIn: https://www.linkedin.com/company/chemical-
inspection-and-regulation-service-limited?trk=biz-companies-cym
34
Our Services
Taiwan
- (Late) Pre-registration
- Existing substance registration
- New substance registration
- CCIP application
- Taiwan GHS
- Regulatory training
EU REACH
- Lead Registrant service
- Late Pre-registration
- REACH full registration
- EU CLP, SDS and Label
- CSR authoring
- Regulatory training
Korea
- Existing substance registration
- New substance registration
- Annual reporting
- Korean GHS
- Regulatory training
Global GHS
- EU CLP
- China, Japan, Korea, Taiwan
- US, Canada
- Malaysia, Thailand, Indonesia
- Others like Turkey, Brazil, Mexico, Russia,
Australia, New Zealand, etc.
35
Food and Food Related Products
- FCM Migration Tests
- Dietary Supplement Registration
- Diary Products Registration
- Ingredient and Package Review
- Dairy Product Label
- Genetically Modified Product Detection
Cosmetic
- SFDA Registration of Cosmetic
- New Cosmetic Ingredient Registration
- Toxicology Safety Assessment
- Product Formula and Label Review
- Cosmetic Notification in EU
- Customs Clearance Assistance
Thank You!
CIRS will be ready to help!
My email: ethan.zheng@cirs-group.com
36

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China Chemical Regulations Overview

  • 1. CIRS Your Compliance Expert China Chemical Regulations Overview Ethan Zheng CIRS ethan.zheng@cirs-group.com 1
  • 2. Chemical Substances Chemical contained in products with certain function Raw Material, Intermediate What to be Regulated? Pesticide Animal Medicine Pharmaceutical Food Food Additive Radioactive Substance Military Product Cigarette Industrial Chemicals 2
  • 3. New Chemical Substance Notification Registration of Hazardous Chemicals Environmental Administration Registration of Hazardous Chemicals License System GHS, SDS and Labeling 3
  • 4. New Chemical Substance Notification Who Should Notify? Scientific Research Record Simplified Notification Typical Notification No Data Requirement Special Type: No Data Requirement Basic Type: Minimal Data Requirement Data Requirement increases with the tonnage level 1 – 10 10 – 100 100 – 1000 >1000 MEP Order 7 Domestic Manufacturers and Importers Oversea Manufacturers and Exporters 4
  • 5. New Chemical Substance Notification Basic Procedure Substance Exempted? End IECSC Listed? End Notification Type Typical Notification Scientific Research RecordSimplified Notification Basic Special Domestic Eco/toxicolo gical Data Special Condition Statement Data Gap Analysis Carry out Tests Dossier Submission Authority Review R&D Activity Carried out Certificate Issued Supervision Yes Yes No No v Dossier Submission Dossier Submission 5
  • 6. New Chemical Substance Notification Entering IECSC 1. Complete Typical Notification 2. A 5-year period required after first business activity of the notified chemical substance CIRS Data Typical NotificationScientific Research RecordSimplified Notification 85200+1000+ 6
  • 7. New Chemical Substance Notification Registration of Hazardous Chemicals Environmental Administration Registration of Hazardous Chemicals License System GHS, SDS and Labeling 7
  • 8. Registration of Hazardous Chemicals What Chemical Needs to be Registered? Chemicals listed on the Catalog of Hazardous Chemical 2015 Chemicals that classified as hazardous chemicals according to SAWS Order 60 SAWS Order 53 Who Should Register? Domestic Manufacturers and Importers 8
  • 9. Registration of Hazardous Chemicals What Chemicals are Recommended to be Identified? Contain substances listed in the HazChem Catalog, with unknown hazard Contain substances not listed in the HazChem Catalog, with unknown hazard SAWS Order 60 Used for R&D or PPORD with annual tonnage > 1 t/y, with unknown hazard Contain substances listed in the HazChem Catalog, with new hazard discovered 9
  • 10. Registration of Hazardous Chemicals Basic Procedure Enterprises Provincial Registration Office National Registration Center Document Submission Provincial Review passed National Center Review passed Certificate issued Certificate issued Provincial Review not passed Rejected Rejected National Center Review not passed 10
  • 11. Registration of Hazardous Chemicals A Few Points 1. Catalog of Hazardous Chemicals published and implemented since May 1st 2015 2. No low-volume/specific usage exemption 3. Self-Classification accepted 4. 24 Hour Emergency Number required 5. SDS and Label required 11
  • 12. New Chemical Substance Notification Registration of Hazardous Chemicals Environmental Administration Registration of Hazardous Chemicals License System GHS, SDS and Labeling 12
  • 13. Environmental Administration Registration of Hazardous Chemicals What Chemical Needs to be Registered? Chemicals listed on the Inventory of Toxic Chemicals Restricted from Import/Export Chemicals listed on the Catalog of Hazardous Chemicals 2015 and List of PHCs MEP Order 22 Who Should Register? Importers and Exporters Manufacturers and Users 13
  • 14. Environmental Administration Registration of Hazardous Chemicals A Few Points 1. Chemicals listed in the List of PHCs require Risk Assessment Report, Pollutant Release & Transfer Registration (PRTR) form and Environmental Risk Management Plan 2. No low-volume/specific usage exemption 14
  • 15. New Chemical Substance Notification Registration of Hazardous Chemicals Environmental Administration Registration of Hazardous Chemicals License System GHS, SDS and Labeling 15
  • 16. License System What Type of License? Production Safe Use Operation Transportation What Should be Done? SAWS Order 41 SAWS Order 57 SAWS Order 55 State Council Decree 591 -Check the relevant chemical inventories -Identify the activities: Production, Use, Operation, Transportation 16
  • 17. License System Production SAWS Order 41 Safe Production Licence Before production initiated Catalog of Hazardous Chemicals Measures of Safe Production Licence Industrial Goods Production Licence Manufacturing enterprises Catalog of Industrial Goods Measures of Industrial Goods Production Licence 17
  • 18. License System Safe Use SAWS Order 57 Safe Use Licence Companies using hazardous chemicals for production Catalog of Hazardous Chemicals Exemption Companies using hazardous chemicals as fuel 18
  • 19. License System Operation SAWS Order 55 Operation Licence Scope: Hazardous chemical operation and storage Exemption Companies selling hazardous chemical manufactured by the same companies with the range of the factory Companies with Port Operation Licence that runing hazardous chemical storage 19
  • 20. License System Transportation State Council Decree 591 Transportation Licence Road, Air and Waterway Transportation Licence Related staffs with qualifications Full time safety management staff for road air and waterway transportation Obligations Compliant packaging, SDS and labels Stabilizers and inhibitors disclosed Appoint qualified transportation units 20
  • 21. New Chemical Substance Notification Registration of Hazardous Chemicals Environmental Administration Registration of Hazardous Chemicals License System GHS, SDS and Labeling 21
  • 22. GHS, SDS and Labeling What Should be Provided? Classification SDS Label UN GHS Rev 4 16 Physical Hazards 10 Health Hazards 2 Environmental Hazards 16 Sections Language in Simplified Chinese 24H Emergency Telephone Number All the required label elements Size requirement GB 30000 GB/T 16483-2008 GB/T 17519-2013 GB 15258-2009 GB 190-2009 22
  • 23. GHS, SDS and Labeling A Few Points 1. CBI protection in SDS: components can be kept confidential but hazards must be disclosed 2. Precautionary statement can be removed in the simplified labels CIRS Data SDS of major countries 3000+ per year 23
  • 25. Summary Your Role in the Supply Chain and Your Obligations First Step: Check all the inventories Inventory of Existing Chemical Substance (IECSC) Catalog of Hazardous Chemical Substance (2015) Priority Hazardous Chemicals for Environmental Management (PHCs) List of Toxic Chemicals Restricted to be Imported/Exported CCISS Inventory Search System by CIRS cciss.cirs-group.com 25
  • 29. Summary Your Role in the Supply Chain and Your Obligations For chemicals NOT listed in IECSC Roles in the supply Chain Obligations Domestic Manufacturer New substance registration by MEP Domestic Users Implement proper precautionary measures when using new chemicals after they are registered. Foreign Manufacturers/ Suppliers Appoint Chinese agent to register new substance by MEP, or rely on Chinese importers to register Domestic importers New substance registration by MEP 29
  • 30. Summary Your Role in the Supply Chain and Your Obligations For chemicals listed in Catalog of Hazardous Chemicals (2015) Roles in the supply Chain Obligations Domestic Manufacturer Production License by SAWS; Hazardous Chemical registration by NRCC-SWAS; Environmental Administration Registration by MEP; SDS/Label under China GHS Domestic Users Environmental Administration Registration by MEP Domestic Operators Operation License by SAWS Domestic importers (users and traders) Hazardous Chemical registration by NRCC-SWAS; Foreign Manufacturers/ Suppliers SDS/Label under China GHS * If listed in PHCs, PRTR and Risk assessment report will be required 30
  • 31. Summary Your Role in the Supply Chain and Your Obligations For chemicals listed in List of Toxic Chemicals Restricted to be I/E Roles in the supply Chain Obligations Foreign exporter Apply for Registration Certificate for the Environmental Management on the Import of Toxic Chemicals Domestic importer Apply for Import Clearance Notification Domestic exporter Apply for Export Clearance Notification 31
  • 32. Summary Your Role in the Supply Chain and Your Obligations For chemicals not listed in the Catalog (2015) but with hazardous classifications Roles in the supply Chain Obligations Domestic Manufacturer Hazardous Chemical registration by NRCC-SWAS; SDS/Label under China GHS Domestic importers (users and traders) Hazardous Chemical registration by NRCC-SWAS; Foreign Manufacturers/ Suppliers SDS/Label under China GHS 32
  • 34. Useful Links 1. Search Engine for Chemical Inventory in China: http://cciss.cirs-group.com/ 2. Regulatory Related Materials Download: http://freedoc.cirs-group.com/en/ 3. Regulatory News Updates: http://www.cirs-reach.com Find us on LinkedIn: https://www.linkedin.com/company/chemical- inspection-and-regulation-service-limited?trk=biz-companies-cym 34
  • 35. Our Services Taiwan - (Late) Pre-registration - Existing substance registration - New substance registration - CCIP application - Taiwan GHS - Regulatory training EU REACH - Lead Registrant service - Late Pre-registration - REACH full registration - EU CLP, SDS and Label - CSR authoring - Regulatory training Korea - Existing substance registration - New substance registration - Annual reporting - Korean GHS - Regulatory training Global GHS - EU CLP - China, Japan, Korea, Taiwan - US, Canada - Malaysia, Thailand, Indonesia - Others like Turkey, Brazil, Mexico, Russia, Australia, New Zealand, etc. 35 Food and Food Related Products - FCM Migration Tests - Dietary Supplement Registration - Diary Products Registration - Ingredient and Package Review - Dairy Product Label - Genetically Modified Product Detection Cosmetic - SFDA Registration of Cosmetic - New Cosmetic Ingredient Registration - Toxicology Safety Assessment - Product Formula and Label Review - Cosmetic Notification in EU - Customs Clearance Assistance
  • 36. Thank You! CIRS will be ready to help! My email: ethan.zheng@cirs-group.com 36