China Chemical Regulations Overview

CIRS

Your Compliance Expert

China Chemical Regulations Overview

Ethan Zheng

CIRS

[email protected]

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mailto:[email protected]



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

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New Chemical Substance Notification

Registration of Hazardous Chemicals

Environmental Administration Registration of Hazardous Chemicals

License System

GHS, SDS and Labeling

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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 level1 – 10

10 – 100100 – 1000

>1000MEP Order 7

Domestic Manufacturers and Importers

Oversea Manufacturers and Exporters

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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

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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+

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License System


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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

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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

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Basic Procedure

Enterprises

Provincial Registration Office

National Registration Center

Document Submission

Provincial Review passed

National Center Review passed

Certificateissued

Certificateissued

Provincial Reviewnot passed

Rejected

Rejected

National Center Review not passed

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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

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License System


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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

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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

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License System


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License System

What Type of License?

Production Safe Use Operation Transportation

What Should be Done?

SAWS Order 41 SAWS Order 57 SAWS Order 55State Council

Decree 591

-Check the relevant chemical inventories-Identify the activities: Production, Use, Operation, Transportation

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License System

Production

SAWS Order 41

Safe Production Licence

Before production initiatedCatalog of Hazardous ChemicalsMeasures of Safe Production Licence

Industrial Goods Production Licence

Manufacturing enterprisesCatalog of Industrial GoodsMeasures of Industrial Goods Production Licence

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License System

Safe Use

SAWS Order 57

Safe Use Licence

Companies using hazardous chemicals for productionCatalog of Hazardous Chemicals

Exemption

Companies using hazardous chemicals as fuel

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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 runinghazardous chemical storage

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License System

Transportation

State Council

Decree 591

Transportation Licence

Road, Air and Waterway Transportation LicenceRelated staffs with qualificationsFull time safety management staff for road air and waterway transportation

Obligations

Compliant packaging, SDS and labelsStabilizers and inhibitors disclosedAppoint qualified transportation units

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License System


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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 30000GB/T 16483-2008

GB/T 17519-2013

GB 15258-2009

GB 190-2009

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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

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Summary

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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 CIRScciss.cirs-group.com

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cciss.cirs-group.com



Summary

Summary

Summary

Summary


For chemicals NOT listed in IECSC

Roles in the supply Chain Obligations

Domestic Manufacturer New substance registration by MEP

Domestic UsersImplement proper precautionary measures whenusing new chemicals after they are registered.

Foreign Manufacturers/ SuppliersAppoint Chinese agent to register new substanceby MEP, or rely on Chinese importers to register

Domestic importers New substance registration by MEP

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Summary


For chemicals listed in Catalog of Hazardous Chemicals (2015)


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


For chemicals listed in List of Toxic Chemicals Restricted to be I/E


Foreign exporterApply 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

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Summary


For chemicals not listed in the Catalog (2015) but with hazardous classifications


Domestic ManufacturerHazardous 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

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Useful Links

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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

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http://www.cirs-reach.com/



https://www.linkedin.com/company/chemical-inspection-and-regulation-service-limited?trk=biz-companies-cym















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.

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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: [email protected]

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