Interpretation of The Catalog of Hazardous Chemicals (2015)

Transcription

1 Interpretation of The Catalog of Hazardous Chemicals (2015) Enabling Chemical Compliance for A Safer World Christine Chuang, Senior Regulatory Affairs Consultant, CIRS China 26 March Christine.chuang@cirs-group.com

2 About CIRS Main offices: China, Ireland; No. of Employees: ~120; IECSC 2013(~45612 ) Services: Product Registration & Regulatory Compliance Services for EU & Asia; Business Units: Industrial Chemicals, Cosmetics, Pesticides & Biocides, Food Contact & Food, Medical Devices

3 Content Background Introduction of Catalog of Hazardous Chemicals (2015) Comparison with previous version What you really need to be aware of? Case study

4 Chapter I: Background

5 China: An Overview of Chemical Lists Notification + Risk Assessment IECSC 2013(~45612 ) License New Substance Catalog of Hazardous Chemicals(~2828) List of toxic chemicals restricted from import/export(162) PHCs (84) Risk Assessment +PRTR Registrations( More like reporting) Phase-out List

6 An Overview of Hazardous Chemicals Control Laws

7 Timeline of Hazchem Regulations in China China Regulation on the safety administration of dangerous chemicals (Catalog of Hazardous Chemicals 2002) SAWS Order 41 came into force SAWS Order 55 came into force Draft version of Catalog of Hazardous chemicals was published 15/03/ /12/ /12/ /08/ /09/ /03/ /09/ /05/2015 Decree 591 came into force This regulation replaced the old version issued in Main law regulating existing chemicals Main law for implementing GHS in China SAWS Order 53 came into force MEP Order 22 came into force Catalog of Hazardous Chemicals 2015 come into force

8 Chapter II: Introduction of Catalog of Hazardous Chemicals (2015)

9 Introduction of Catalog of Hazardous Chemicals (2015) The definition and determining principle of Hazchem Clarify Hazard characteristics category Catalog of Hazardous Chemicals (2015) Instruction 2828 catalog The definition and decision boundaries of Toxic chemicals The meaning of each column Other matters Specify the data constraints Noun explanation

10 Introduction of Catalog of Hazardous Chemicals (2015) The upcoming Guidance Document Product Name Other Name Chemical Name CAS UN GHS Mark Warning Hazard description 盐酸 氢氯酸 Hydrochloric acid 腐蚀品危险盐酸 To do the hazard identification: (1)Contains one and above Hazardous components which included in Catalog, while the hazard property of whole product is unclear; (2)No any components included in Catalog, and the hazard property of whole product is unclear; (3)One included in Catalog, while come out some new hazard properties. Chemical Safety data sheet (SDS) Chemical Safety Label Hazardous Chemical Registration

11 Chapter III: Comparison with previous version

12 Comparison with previous version 2015 VS VS 2013 The concept more clearly The items slightly reduced ( ) No longer list the dangerous goods No. and UN No. Introducing GHS classification and building block principle more than 90% are pure substances Catalog of Hazchem 2013 draft The items slightly reduced ( ) Don't show "* items Pesticide items reduces about 80%

13 Chapter IV: What you really need to be aware of?

14 What you really need to be aware of? Hazardous Chemicals Management/Decree 591 Regulations on Safe Management of Hazardous Chemicals Entry into force: 1 Dec Implementing a licensing system for producers/operators/users of hazardous chemicals in the Catalog; Requiring hazardous chemicals registration; Requiring mandatory GHS SDS and labeling for hazardous chemicals; Chemical Registrations License Requirements GHS/SDSs/Labels

15 Definitions of Hazardous Chemicals Hazardous chemicals are defined as highly toxic chemicals and other chemicals which are toxic, corrosive, explosive, flammable and do harm to human body, facilities and environment. Chemicals meeting GHS hazard classification criteria(excluding certain categories such as flammable liquids 4) shall be regarded as hazardous chemicals under Decree 591; 15

16 Catalog of Hazardous Chemicals All Hazardous Chemicals (GHS) GHS SDSs & Labels; Registration with NRCC if a chemical is confirmed to be hazardous by authorities. Catalog of Hazardous Chemicals GHS SDSs & Labels; Requiring Licenses; Requiring Registrations; Extra requirements on packaging, storage, use and transport. Previous Catalog of Hazardous Chemicals (2002) Catalog of Hazardous Chemicals(2015) Previously 3,814 chemicals (2002) VS new 2015 Catalog with 2,828 chemicals 16

17 License Requirements Scope: Components in the Catalog of Hazardous Chemicals Production Use(*) Use hazardous chemicals to manufacture products Operation Import Wholesale/storage Warehouse/Storage Transportation(**) Note(*): This is a new requirement under decree 591, only applicable to some industry sectors **: also applicable to transportation of dangerous goods outside of the Catalog. Only Chinese domestic company needs to apply for license!

18 HazChem Registrations Requirement-1 1) SAWS Order 53 The measures for the administration of registration of hazardous chemicals in China: 1 Aug 2012 focus on products Scope Who? 24h emerg. number GHS SDS/Label Supervision Catalog of Hazardous Chemicals determination principle Hazardous Chemicals If Confirmed by Authorities(*) Domestic producer Importer Mandatory Yes Detailed procedure *Note: Eventually all hazardous chemicals(falling into catalog 2015 GHS classification) require registration. Authority: National Registration Centre of Chemicals(NRCC) of SAWS 18

19 HazChem Registrations Requirement-2 1) MEP Order 22 The Measures for Environmental Administration Registration of Hazardous Chemicals(2012): 1 March 2013 Toxic chemicals severely restricted to be imported into or exported from China(162 chemicals) Catalog of Hazardous Chemicals Who? To: Foreign suppliers; Chinese importers/exporters; Chinese Solid Waste and Chemical Management Center (SCC-MEP) Domestic manufacturers Producers who use hazardous chemicals; Local environmental Protection authorities. Authority: Ministry of Environmental Protection (MEP) 19

20 HazChem Registrations Requirement-2 2) MEP Order 22: Risk Assessment Report and Pollutant Release & Transfer Register(PRTR) for PHCs Scope: Priority Hazardous Chemicals for Environmental Management(PHCs); 84 substances (firstly batch); Risk assessment report: environmental risk assessment report created by designated institutions shall be provided to authorities when applying for a registration certificate pollutant release & transfer register(prtr) form and environmental risk management plans shall be submitted before 31 Jan of each year; 20

21 China GHS and Updates-National Standards 1) Classification Standards GB ~ (effect on Nov 1, 2014) Fully adopt UN GHS Rev. 4, 28 hazard classes, including Aspiration hazards and Hazards to the ozone layer 2) SDS GB/T , Safety data sheet for chemical products content and order of sections (effect on Feb 1, 2009) GB/T , Guidance on the compilation of safety data sheet for chemical products (effect on Jan 31, 2014) 3) Labelling GB , General rules for preparation of precautionary label for chemicals (effect on May 1, 2010) GB , Packaging labels for dangerous goods (effect on May 1, 2010) 21

22 China GHS and Updates-SDS 1. Identification 9. Physical and Chemical Properties 2. Hazard overview 10. Stability and reactivity 3. Composition/information on ingredients 11. Toxicological information 4. First-aid measures 12. Ecological information 5. Fire-fighting measures 13. Disposal 6. Accidental release measures 14. Transport Information 7. Handling and storage 15. Regulatory information 8. Exposure controls/personal protection 16. Other information

23 China GHS and Updates-SDS

24 China GHS and Updates-Label Product identifier Signal Word Pictogram Hazard Statement Precautionary Statement Please refer to Safety Data Sheet Supplier Information

25 China GHS and Updates-Label Simplified label For chemical packages of 100ml or less; Precautionary statements can be omitted;

26 Chapter V: Case study

27 Case study Inventory Listing Status Chemical Substance Name CAS No. Catalog of Hazardous Chemicals(2015) List of Toxic Chemicals Restricted to be Imported/Exported Copper monoxide Yes Yes Yes 1,4-dioxane Yes Yes No Ethanol Yes No No Priority Hazardous Chemicals for Environment Management(PHCs) Sodium decyl sulfate No No No Copper sulfate No No No

28 Case study Products Compliance Analysis Main obligations for chemicals listed in the Catalog of Hazardous Chemicals(2015) Roles in the supply Chain Domestic Manufacturer Obligations Production License by SAWS; Hazardous Chemical registration by NRCC-SAWS; Environmental Administration Registration by MEP; SDS/Label under China GHS Domestic Users Domestic Operators Domestic importers (users and traders) Foreign Manufacturers/ Suppliers Environmental Administration Registration by MEP Operation License by SAWS Hazardous Chemical registration by NRCC-SAWS; SDS/Label under China GHS

29 Case study Products Compliance Analysis Main obligations for chemicals Listed in List of Toxic Chemicals Restricted to be Imported/Exported Roles in the supply Chain Obligations Foreign exporter Domestic importer Domestic exporter Apply for Registration Certificate for the Environmental Management on the Import of Toxic Chemicals Apply for Import Clearance Notification Apply for Export Clearance Notification

30 Case study Products Compliance Analysis Main obligations for chemicals Listed in Priority Hazardous Chemicals for Environment Management(PHCs) Roles in the supply Chain Obligations Domestic Manufacturer Domestic Users Environmental Administration Registration by MEP; Risk assessment report and PRTR Environmental Administration Registration by MEP; Risk assessment report and PRTR

31 Case study Products Compliance Analysis Chemicals which are not listed in the Catalog of Hazardous Chemicals(2015) while with severe GHS classifications Roles in the supply Chain Obligations Domestic Manufacturer Domestic importers (users and traders) Foreign Manufacturers/ Suppliers Hazardous Chemical registration by NRCC-SAWS; SDS/Label under China GHS Hazardous Chemical registration by NRCC-SAWS; SDS/Label under China GHS

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