Latest Updates of Chemical Regulations in China & Taiwan

Transcription

1 Latest Updates of Chemical Regulations in China & Taiwan Enabling Chemical Compliance for A Safer World Yunbo Shi, Managing Director, CIRS Ireland 7-8 Oct 2013, Chemical Watch Regulatory Summit, Brussels yunbo.shi@cirs-reach.com

2 Key Updates for China China: An Overview China: Main Regulations HazChem Registrations & Updates Key Messages for China

3 China: An Overview Notification + Risk Assessment IECSC 2013(~45612 ) New Substance Registrations( More like reporting) Catalog of Hazardous Chemicals(~3800) PHCs List of toxic chemicals restricted from import/export(158) Risk Assessment +PRTR Phase-out List

4 China: Main Regulations 1) New Substance Management MEP order No. 7 Provisions on Environmental Administration of New Chemical Substances (2010) Entry into force 15 Oct 2010; 2) 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 Catalogue; Requiring hazardous chemicals registration; Requiring mandatory GHS SDS and labeling for hazardous chemicals;

5 China: Main Regulations 3) Supporting Regulations to Decree 591 The Measures for the Registration of Hazardous Chemicals SAWS Order 53; The Measures for the Environmental Administration Registration of Hazardous chemicals (2012) MEP Order 22; The Measures for the Administration of Operating Licenses for Hazardous Chemicals (2012) SAWS Order 55; The Measures for The Administration of Physical Hazard Identification and Classification of Chemicals(2013) SAWS Order 60;.

6 Registration of Hazardous Chemicals 1) SAWS Order 53 The measures for the administration of registration of hazardous chemicals in China: 1 Aug 2012 Scope Who? 24h emerg. number Hazardous Chemicals Highly Toxic Chemicals Not clearly defined Producer Storage Companies Not Specified GHS SDS/Label No Yes Catalog of Hazardous Chemicals Hazardous Chemicals If Confirmed by Authorities Domestic producer Importer (New!) Mandatory Supervision None Detailed procedure 6

7 Registration of Hazardous Chemicals 1) SAWS Order 53 - Current Situation & Updates New online registration system ready; Registration of non-listed chemicals is rare; More guidance required for non-listed chemicals; Exempt categories to be published; The Catalogue being revised: pesticides/mixtures removed; 7

8 Registration of Hazardous Chemicals 2) 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(158 chemicals) Catalog of Hazardous Chemicals Who? To: Foreign suppliers; Chinese importers/exporters; Chemical Registration Centre (CRC-MEP) Domestic manufacturers Producers who use hazardous chemicals; Local environmental Protection authorities. 8

9 Registration of Hazardous Chemicals 2) MEP Order 22- Current Situation & Updates Registration of restricted toxic chemicals implemented; Registration of chemicals in the Catalogue just starts; Guidance documents published; Priority Hazardous Chemicals for Environmental Management(PHCs): List being discussed. 9

10 Summary: Key Messages for China 1) New Substance Notifications Guidance being revised (internal discussions); 2) Catalog of Hazardous Chemicals An administrative Catalogue only/license Catalogue; Some pesticides & mixtures might be deleted from current Catalog; 3) HazChem Registrations More clarifications required for non-listed substances; 4) GHS in China Already implemented for both substance/mixture; To be aligned with GHS Rev. 4.

11 Key Updates for Taiwan Chemical Regulatory Framework Existing Substance Inventory Amendment to TCSCA(Draft) Amended OSHA in Taiwan GHS Updates for Taiwan Key Messages for Taiwan

12 Taiwan: Chemical Regulatory Framework Chemicals Ministries Regulations Industrial Chemicals Hazardous chemicals in workplaces Transported Dangerous Goods - Chemicals Medical Devices/Pharmaceuticals Narcotics/Cosmetics/Food additives/health food Agricultural Chemicals Environmental Protection Administration (EPA) Council of Labour Affairs (CLA) Ministry of Transportation and Communication (MOTC) Department of Health (DOH), Food and Drug Administration (TFDA) Council of Agriculture (COA) Toxic Chemical Substance Control Act -TCSCA(Being Revised) Occupational Safety and Health Act(OSHA) - New TDG Regulations Specific regulations & acts. Chemical consumer product, testing & inspection. Ministry of Economic Affairs (MOEA)

13 Update of Taiwan s Existing Substance Inventory Draft inventory launched in April 2012; Updated inventory (after supplementary nomination) launched in Dec 2012; ~79,000 substances, 40%>=1t/y; ~19,000 substances meeting GHS hazard criteria. Advanced Search: By CAS or serial No.. By Chinese Name By English Name

14 TCSCA Amendment: History 1) The Toxic Chemical Substance Control Act(TCSCA) Firstly issued on 26 Nov 1986; Latest revision: 2007 (after 5 amendments); Control of toxic chemical substances; Requiring handling permits for toxic chemicals substances; 2) Latest Draft Amendment to TCSCA Issued: 9 Nov 2012

15 Amended TCSCA(Draft): Background 1) Reasons for Amendment No regulatory registration scheme in place; Risk of making Taiwan as a test ground for new substances; 2) Goals To establish a registration mechanism; To strengthen the management of class 4 toxic chemicals; To enhance transparency by developing data dissemination platform;

16 Amended TCSCA(Draft): Definitions 1) New substances Substances other than those listed in the Inventory of Existing Chemical Substances published by central competent authority; 2) Handling Referring to activities such as manufacture, import, export, sale, transport, use, storage or disposal of chemical substances; 3) Toxic chemical substances Chemical substances that are intentionally produced or unintentionally derived from production processes and that have been officially announced by the central competent authority as having toxicity. 4 Classes: Class 1, 2, 3 4;

17 Amended TCSCA(Draft): Definitions 3) Toxic chemical substances Class 1 Class 2 Chemical substances that do not readily decompose in the environment or that pollute the environment or endanger human health due to bioaccumulation, bioconcentration or biotransformation. Chemical substances that cause tumors, infertility, teratogenesis, genetic mutations(cmrs) or other chronic diseases. Class 3 Class 4 Chemical substances that endanger human health or the lives of biological organisms immediately upon exposure. Chemical substances for which there is concern of pollution of the environment or the endangerment of human health

18 Amended TCSCA(Draft): Main Revisions 1) Establishment of a registration scheme in Taiwan Article 7-1 P1, Domestic enterprises manufacturing or importing a given quantity of chemical substances designated by the central competent authority shall register the manufacturing or importing details, the physical, chemical, and toxicology data, and the exposure and hazard assessment data prior to commencing manufacturing or import. Article 7-1 P3, Companies which jointly apply for registration of the same chemical substance shall reach an agreement to share the information required for registration..

19 Amended TCSCA(Draft): Main Revisions 2) Strengthening the management of Class 4 toxic substances Article 7 P4, Prior to handling, toxicological information concerning the toxic chemical substances at issue should be submitted to authorities, and approval obtained; Article 17, The handler shall mark matters related to toxicity and pollution control on Class 1 to Class 4 toxic substance containers, packaging, handling sites, and facilities, and shall keep SDSs; Article 23, Handlers of Class 1 to Class 4 toxic chemical substances may not sell or transfer the toxic chemical substances to those that have not obtained a permit, registration or approval

20 Amended TCSCA(Draft): Proposed Scheme New Substance National Existing Chemical Inventory Registration at a given tonnage Registration for Desinated Substance Toxic Chemical Screening Process Proclamation and Management Handling record notification Banned Restricted Handling Permits Green Chemistry Source: Adapted from Dr Jowit Li s presentation, SATECH, SMCR 2012

21 Amended TCSCA(Draft): Types of Registration Type Standard Registration Simplified Registration Tonnage bands and purpose of use Designated existing substances >= XXXX tons/y New substances >= X XXX tons/y New substances for R&D >= XXXX tons/y New substances of high concern Polymer of low concern >= XXXX tons/y New substance < XXXX tons/y New substance for R&D < XXXX tons/y Notice New substances < XXXX tons/y Small volume R&D Trade show purpose Annual reporting of volume Designated existing substances Existing substance > = XXXX tons/y New substance registration certificate holder Exemptions Source: Presentation at SMCR 2012, Shanghai, Dr Jowitt Li, SATECH,

22 Amended TCSCA(Draft): Data Requirements Required Information Notice Simplified Standard Legal entity info Substance Identification Appearance, colour, odour Safe use information (handling storage transportation etc) GHS classification & labeling Characterisation / Identification data Analytical methods Physico chemical properties Manufacture, use & exposure information Toxicological information Ecotoxicological information Environmental fate & pathway Assessment reports Results of literature search Source:

23 Amended TCSCA(Draft): Handling of Toxic Substance Type Management Measures Class 1, 2, 3 & 4 Compulsory marking, labeling and SDSs; Pollution control; May not sell to companies without handling permits; Class 1, 2 & 3 Application of handling permits; May face restriction or ban; Industry may submit an appeal; Class 1, 2 Total release quantity control; Class 4 Application of approval by submitting toxicological information.

24 Amended TCSCA(Draft): Entry into Force Provisions regarding chemical registration mechanism and the strengthening of Class 4 toxic chemical substances control: -> one year after promulgation. Other provisions : the date of promulgation. FAQ: Can we now export new substances to Taiwan without registration? Yes.

25 Comparing Draft TCSCA with EU & P.R. China Items Taiwan(Draft TCSCA) EU REACH P.R. China(Order No. 7) Registration Object New substance; Designated existing substance>=xx t/y; New substance>=1t/y; Existing substance>=1t/y; New substance; Who? M/I M/I/OR M/I/OR Type of Registration Polymer Risk Assessment Joint submission Notice/Simplified/ Standard Registration of polymer itself PPORD, Intermediate, Full Registration of monomer & reactant(>=2%) R&D; Simplified; Regular Registration of polymer itself To be announced >=10t/y 1-10t: qualitative; >=10t: quantitative Mandatory Mandatory Not mandatory

26 Occupational Health and Safety Act(OSHA) 1) Overview & Summary Promulgated and published on 3 July 2013; Previous called Labor Safety and Health Act(LSHA); To stipulate obligations of hazardous chemicals operators to label, provide SDS, register, evaluate and obtain permit of hazardous chemical substances.

27 Occupational Health and Safety Act(OSHA) 2) Main Provisions Related to Chemicals Article 10, employers shall label hazardous chemicals,., and prepare safety data sheets ; Article 13, manufacturers or importers shall not manufacture or import new substances that are not listed in the chemical inventory before obtaining approval of registrations ; Article 14-1, manufacturer, importer, supplier or employer shall apply for permit for operating the designated controlled chemical substances by the central competent authority; Article 14-2, The manufacturer, importer, supplier or employer shall submit relevant operation data of priority management chemical substances designated by competent authority.

28 GHS Implementation in Taiwan 1) Summary Implemented from 30 Dec 2008; Mandatory compliance is currently required for two lists ( substances) by CLA, toxic chemical substances by EPA, and their mixtures. 1 st List by CLA: 1062 substances, required since Jan 1, nd List by CLA: 1089 substances, required since Jan 1, rd List to be released later this year. Full implementation is scheduled by the end of 2015;

29 Taiwan GHS: Classification 1) Self classification Criteria; National Standard CNS 15030; Currently based on the 2nd revised edition of UN GHS; To be aligned with the 4 th revised edition of UN GHS; 2) CLA GHS Classification List, July 2011 Advisory; Link: SDS Example Label Example

30 Taiwan GHS: SDS & Labeling 1) SDS Standard 16-section format; Requiring traditional Chinese, other languages as supplementary; Requiring 24h emergency telephone number; 2) Labelling Standard GHS labeling elements; Both Chinese and English chemical names should be indicated; For small package(<=100ml): h & p statements can be omitted.

31 How to Comply with TCSCA & OSHA Item What to do - Draw up a list of substances exported to Taiwan & volume; Registration - Check Taiwan s national existing chemical inventory; - Monitor the update of TCSCA amendment; - Generate some data in advance if you are already exporting new substances to Taiwan in high volumes; Handling of Toxic Chemicals - Identify if your company or your customer handles any class 1, 2, 3 & 4 toxic substances in Taiwan; - Yes, comply with relevant management measures. Safety Data Sheet & Labelling - Prepare GHS SDSs & labels immediately if your products contain any substance on CLA s two lists or any class 1, 2, 3 & 4 toxic substance; - Prepare for full GHS implementation.

32 Summary: Key Messages for Taiwan 1) Taiwan s Existing Substance Inventory Finalized and available for online search since Dec 2012; 2) New Substance Notifications Required by OHSA, newly published on 3 July 2013; Implemented 1 year after the of promulgation of amended TCSCA; No need to do new substance notifications at the moment; 3) GHS in Taiwan Full implementation scheduled at 2015; To be aligned with the 4 th revised edition of UN GHS.

33 Thank You! Thank you! 谢谢! Welcome to Hangzhou! 33