China Chemical Regulations Overview

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1 China Chemical Regulations Overview CIRS Your Compliance Expert Ethan Zheng CIRS 1

2 What to be Regulated? Pesticide Food Food Additive Chemical Substances Raw Material, Intermediate Chemical contained in products with certain function Animal Medicine Radioactive Substance Cigarette Pharmaceutical Industrial Chemicals Military Product 2

3 New Chemical Substance Notification Registration of Hazardous Chemicals Environmental Administration Registration of Hazardous Chemicals License System GHS, SDS and Label 3

4 New Chemical Substance Notification Who Should Notify? Domestic Manufacturers and Importers Oversea Manufacturers and Exporters Scientific Research Record No Data Requirement MEP Order 7 Simplified Notification Special Type: No Data Requirement Basic Type: Minimal Data Requirement Typical Notification Data Requirement increases with the tonnage level >1000 4

5 New Chemical Substance Notification Basic Procedure Substance Exempted? No IECSC Listed? No Notification Type Yes Yes End End Simplified Notification Basic Special Typical Notification Data Gap Analysis Scientific Research Record v Dossier Submission Domestic Eco/toxicolo gical Data Special Condition Statement Carry out Tests Dossier Submission R&D Activity Carried out Dossier Submission Authority Review Certificate Issued Supervision 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 Notification 100 6

7 New Chemical Substance Notification Registration of Hazardous Chemicals Environmental Administration Registration of Hazardous Chemicals License System GHS, SDS and Label 7

8 Registration of Hazardous Chemicals Who Should Register? Domestic Manufacturers and Importers What 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 8

9 Registration of Hazardous Chemicals Basic Procedure Enterprises Rejected Provincial Review not passed Document Submission Provincial Registration Office Certificate issued Rejected Provincial Review passed Certificate issued National Center Review not passed National Registration Center National Center Review passed 9

10 Registration of Hazardous Chemicals A Few Points 1. Catalog of Hazardous Chemicals published and implemented since May 1 st No low-volume/specific usage exemption 3. Self-Classification accepted Hour Emergency Number required 5. SDS and Label required 10

11 New Chemical Substance Notification Registration of Hazardous Chemicals Environmental Administration Registration of Hazardous Chemicals License System GHS, SDS and Label 11

12 Environmental Administration Registration of Hazardous Chemicals Who Should Register? Importers and Exporters Manufacturers and Users 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 12

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 13

14 New Chemical Substance Notification Registration of Hazardous Chemicals Environmental Administration Registration of Hazardous Chemicals License System GHS, SDS and Label 14

15 License System What Type of License? SAWS Order 41 SAWS Order 57 SAWS Order 55 State Council Decree 591 Production Safe Use Operation Transportation What Should be Done? -Check the relevant chemical inventories -Identify the activities: Production, Use, Operation, Transportation 15

16 License System SAWS Order 41 Production Safe Production Licence Before production initiated Catalog of Hazardous Chemicals Industrial Goods Production Licence Manufacturing enterprises Catalog of Industrial Goods 16

17 License System SAWS Order 57 Safe Use Safe Use Licence Companies using hazardous chemicals for production Catalog of Hazardous Chemicals Exemption Companies using hazardous chemicals as fuel 17

18 License System SAWS Order 55 Operation Operation Licence Scope: Hazardous chemical operation and storage Exemption Company is selling hazardous chemical manufactured by the same company within the range of the factory Companies with Port Operation Licence that running hazardous chemical storage 18

19 License System State Council Decree 591 Transportation 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 19

20 New Chemical Substance Notification Registration of Hazardous Chemicals Environmental Administration Registration of Hazardous Chemicals License System GHS, SDS and Label 20

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 GB/T GB/T GB GB

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

23 Summary 23

24 Summary Your Role in the Supply Chain and Your Obligations First Step: Check all the inventories Inventory of Existing Chemical Substance (IECSC) List of Toxic Chemicals Restricted to be Imported/Exported Catalog of Hazardous Chemical Substance (2015) Priority Hazardous Chemicals for Environmental Management (PHCs) APCISS Inventory Search System by CIRS apciss.cirs-group.com 24

25 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 25

26 Summary Your Role in the Supply Chain and Your Obligations For chemicals listed in Catalog of Hazardous Chemicals (2015) Roles in the supply Chain Domestic Manufacturer Domestic Users Domestic Operators Domestic importers Foreign Manufacturers/ Suppliers Obligations Production License by SAWS; Hazardous Chemical registration by NRCC-SAWS; Environmental Administration Registration by MEP; SDS/Label under China GHS Environmental Administration Registration by MEP Operation License by SAWS Hazardous Chemical registration by NRCC-SAWS; SDS/Label under China GHS 26

27 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 Foreign exporter Domestic importer Domestic exporter Obligations Apply for Registration Certificate for the Environmental Management on the Import of Toxic Chemicals Apply for Import Clearance Notification Apply for Export Clearance Notification 27

28 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-SAWS; SDS/Label under China GHS Domestic importers (users and traders) Hazardous Chemical registration by NRCC-SAWS; Foreign Manufacturers/ Suppliers SDS/Label under China GHS 28

29 Useful Links 29

30 Useful Links 1. Asia-Pacific Chemical Inventory Search System: 2. Regulatory Related Materials Download: 3. Regulatory News Updates: Find us on LinkedIn: 30

31 Our Services EU REACH - Lead Registrant service - Late Pre-registration - REACH full registration - EU CLP, SDS and Label - CSR authoring - Regulatory training Global GHS - EU CLP - China, Japan, Korea, Taiwan - US, Canada - Malaysia, Thailand, Indonesia - Others like Turkey, Brazil, Australia, New Zealand, etc. Taiwan - (Late) Pre-registration - Existing substance registration - New substance registration - CCIP application - Taiwan GHS - Regulatory training Korea - Existing substance registration - New substance registration - Annual reporting - Korean GHS - Regulatory training 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 31

32 CIRS will be ready to help! My Thank You! 32

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