Presentation on theme: "China's Chemical Regulation Regime Development on UN GHS Adoption Tommy Kong Deputy Manager, Dept. of Regulatory Compliance REACH24H Consulting Group 10."— Presentation transcript:
China's Chemical Regulation Regime Development on UN GHS Adoption Tommy Kong Deputy Manager, Dept. of Regulatory Compliance REACH24H Consulting Group 10 Sep 2012
Contents Chinas Adoption of GHS Briefing of the milestones in the adoption process of GHS; Primary obligations under China GHS Advices on China GHS compliance
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Contents Chinas Adoption of GHS Briefing of the milestone in the adoption process of GHS;
Milestones (1) Rio, Jun The UN Conference on Environment and Development (UNCED) established 6 program areas to strengthen national and international efforts regarding the environmental sound management of chemical set out within Chapter 19 of Agenda 21, and Li Peng, the former Primer, signed and approved this document on behalf of Chinese government and the was issued by the State Council of China 2 years later. The Signing Ceremony of Agenda 21, Former Primer Li Peng (M), Rio 1992.
Milestones (2) Geneva, 26 Oct 1999 – By resolution 1999/65 United Nations Economic and Social council decided to reconfigure and rename the Committee of Experts on Transport of Dangerous Goods to include the Globally Harmonized System of Classification and Labeling of Chemicals (CETDGGHS), and to create a new Sub- Committee of Experts on the GHS. China as the Member Government chose the Aye in the 48th Plenary Meeting to approve this resolution. China file the Aye in the 48 th Plenary Meeting of ECOSOC, 26-Oct-1999
Milestones (3) Johannesburg, 6 Sep 2002 – A plan of Implementation was adopted in the World Summit on Sustainable Development (WSSD) encouraged countries to implement the GHS as soon as possible, with a view to having the system fully operational by Zhu Rongji, the former Premier, approved this document on behalf of China government in the plenary meeting hold in 4-Sep China Former Premier, Zhu Rongji, in the plenary meeting of WSSD, Johannesburg, 4-Sep-1999
Milestones (4) Beijing, 16 May 2003-The Standardization Administration of China (SAC) initiated the 2003 National Standard Development Program in order to compile the National Standard system according to the GHS (1th Version) and establish the basic of GHS implementation in the following days.
Interpretation of China National Standards Legal Base: Act on the Standardization of People's Republic of China Legal Power: Art 14: The mandatory standards should be implemented and any given products without complying with the related mandatory standards should be prohibited from manufacturing, distribution and importing. As to the voluntary standards, government encourage any related companies or institutes to adopt. Abbreviation: GB, based on Chinese pronounce, Guo Biao. Logo: Types/Code: (1) Mandatory Standards/GB, (2) Voluntary Standards/GB/T, (3) Guiding Documents/GB/Z Standards concerning protection of human health, personal property and safety and those enforced by laws and administrative regulations are mandatory standards, others are voluntary standards. Useful Link:
Chinas GHS related GB Issue DateGB NumberGHS-DependentContent 24-Oct-2006GB 20576~20599, 601~ (26 Standards) 1th VersionSafety rules for classification, precautionary labelling and precautionary statements of chemicals 18-Jun-2008GB/T 16483_2008 1th VersionSafety data sheet for chemical products- content and order of sections 19-Jun-2008GB/T 22234_2008 3th Version (Japan)Labelling of Chemical based on GHS 21-Jun-2009GB 15258_20093th VersionGeneral rule for preparation of precautionary label for chemicals 21-Jun-2009GB 13690_20093th VersionGeneral rule for classification and hazard communication of chemicals Currently, the 26 National Standards are subject to revision based on the 3th UN GHS and other necessary guidance in the process of draft.
Milestones (5) Beijing, 2 March 2011-State Council of China Announces revised Regulation on Control Over Safety of Dangerous Chemicals through Decree No. 591 signed by Premier Wen Jiabao, which will be effective on 1-Dec-2011, by then the UN GHS will be legally implemented in industrial chemical sector, but agrichemical and pharmaceutical sector temporarily. Premier Wen Jiabao is holding one Decree of State Council
Decree No. 591 v.s. National Standards GHS-related National Standards are legally required to be implemented in accordance with Decree No. 591 since 1-Dec- 2011, as below, Decree No. 591GHS-Related National Standards ProvisionContentGB NumberContent Article 15Hazardous chemical manufacturers should provide corresponding material safety data sheets (SDS) for hazardous chemicals it produces, and paste or tie safety labeling for corresponding hazardous chemicals inside the package. All content stated in the material safety data sheet (SDS) and the safety labeling for chemicals should meet the requirements in the national standards. GB 20576~20599, 601~ (26 Standards) Safety rules for classification, precautionary labelling and precautionary statements of chemicals GB/T 16483_2008 Safety data sheet for chemical products-content and order of sections GB 15258_2009General rule for preparation of precautionary label for chemicals Article 78Competent authority will impose of a fine of not more than 50,000 RMB to any companies violating Article 15. GB 13690_2009General rule for classification and hazard communication of chemicals
Competent authorities for China GHS Ten Ministries/Administration involved in China GHS implementation : Lead Authority: Ministry of Industry and Information Technology (MIIT), the lead representative of China delegation of GHS Sub-committee. Participating Authority: State Administration of Work Safety(SAWS),Ministry of Environmental Protection (MEP), Ministry of Transport, Ministry of Railway, Ministry of Agriculture, Ministry of Health, State Administration for Industry and Commerce, General Administration of Quality Supervision, Inspection and Quarantine, Ministry of Public Security (MPS), Civil Aviation Administration of China (CAAC), State Post Bureau; 14WWW.REACH24H.COM National Registration Centre for Chemicals (NRCC) of SAWS is mainly responsible for implementing GHS technically. MEP is involved in new chemicals management, and responsible for the classification, labeling and SDS of new chemicals.
Contents Chinas Adoption of GHS Briefing of the milestone in the adoption process of GHS; Primary obligations under China GHS
C&L INVENTORY =Hazardous substance list ~7,000 Hazardous chemicals list Highly toxic chemicals list The current Hazardous Chemicals List is still being revised (expected to be available in Oct The revising C&L inventory (expected to around 7,000 substances)= Hazardous chemicals list(3,510 substances)+ Highly Toxic Chemicals list (335 substances)+ more…… 16WWW.REACH24H.COM C&L inventory of China GHS Information of C&L from other regions (EU, Japan, US) China Government is updating the C&L Inventory to which substance involved should be legally re-classified and re-labeled based on the step-by-step GHS implement strategy.
Substances subject to China GHS Substances itself, in mixtures and intended to be released from articles Inclusion of Hazardous Chemical List (being revised) yes No Report the substance identifier to SAWS, which will pursue the expert judgment to determine whether the substance is potential hazardous or not. China GHS yes Testing by approved lab to assess the hazardous properties yes No End Inclusion of List of Highly Toxic substance Highly toxic registration yes Available hazardous data 17WWW.REACH24H.COM Implement in parts of Provinces No
Primary obligations under China GHS 1. Immediately update the Safety Data Sheet (SDS) according to given National Standards (GB/T ) Section1: Chemical Product & Company Information Section 9: Physical and Chemical Properties Section 2: Hazards IdentificationSection 10: Stability and Reactivity Section 3: Composition/Information on ingredients Section 11: Toxicological Information Section 4: First-Aid MeasuresSection 12: Ecological Information Section 5: Fire Fighting MeasuresSection 13: Disposal Considerations Section 6: Accidental Release MeasuresSection 14: Transport Information Section 7: Handling and StorageSection 15: Regulatory information Section 8: Exposure Controls and Personal Protection Section 16: Other information Only Simplified Chinese Applicable/SDS
19WWW.REACH24H.COM The content of each sections can be further broken down into sub-section, but the sub-section should not be numbered. When using titles for sub-sections, it was suggested to be sequenced according to the order specified in Appendix A of SDS National Standard (GB/T ) For example: Section 2 Hazardous identification can be broken into the following sub-sections: main physical and chemical hazard information certain special hazardous properties GHS hazard classes & categories main symptoms emergency review Primary obligations under China REACHPrimary obligations under China REACH(MEP Order No.7)
MSDS/SDS sample Section 1: Company and product Identification Section 2: Hazards Identification Emergency number, important!! The layout is almost similar to that under CLP/UN GHS, however, there are still some differences. Indicating the SDS is compiled according to GB/T Section 3……16 20WWW.REACH24H.COM
21WWW.REACH24H.COM 2. Updating labels according to National Standard (GB ) since 1 May 2011 Label elements: - Product identifier - Hazard pictogram - Signal word - Hazard statement - Precautionary statement - Emergency telephone number - Supplier information - Reference to SDS Confidential ingredients are qualified not to be listed in the label, but the hazardous information should be indicated accordingly. Primary obligations under China GHS
Label sample Signal word, warning Hazard statement Precautionary statement Product Identifier Supplier information Emergency telephone nr. 22WWW.REACH24H.COM
23WWW.REACH24H.COM 3. Registration of dangerous chemicals (oversea and domestic companies ) Which legal entity is subject to registration? Legal Entity typePrevious Decree No. 344 Revised Decree NO.591 1China-based manufacturer 2ImporterX 3Storage and use companies based in China X Measures on registration of hazardous chemicals (Promulgated by State Economic and Trade Commission in 2002, and being revised by SAWS according to Decree No. 591) requires all hazardous substances/mixtures should be registered to National Chemical Registration Center (NRCC) Primary obligations under China REACH(MEP Order No.7)
24WWW.REACH24H.COM Which substances need to be registered? -Substances/mixtures listed in the on-going revised C&L inventory -Substances/mixtures classified as hazardous according to classification criteria set out within the 26 national standards. What kinds of information are required for registration? -Classification and labelling information -Physical and chemical property information -Main uses -Hazard class/category information -Safety management measures on storage, use and transportation -Emergency disposal measures Primary obligations under China REACH(MEP Order No.7)
25WWW.REACH24H.COM As the revised administrative provision on registration was expected to be promulgated by the end of 2011, then the registration work would be highly likely to start in the middle of How can the oversea companies apply for registration? 1. Register the hazardous chemicals through your Chinese importer, or 2. Appoint an China-based OR to comply with the registration obligation as to protect confidential business information---(this proposed option still on the table of SASW, which mainly responsible to promulgate and revise the administrative provision regarding registration) Pro-activity is highly recommended! Primary obligations under China REACH(MEP Order No.7)
26WWW.REACH24H.COM It should be, 24/7 available The number should be within the territory of China Professional work staff who can answer the emergency calling It should be, 24/7 available The number should be within the territory of China Professional work staff who can answer the emergency calling 4. Emergency Telephone Number, which legally required in SDS, Label and Registration Primary obligations under China GHS
How to comply with China GHS? 1.Be familiar with the mentioned GHS-related GB/regulation/administrative provisions, and collect all the available hazardous data. 2.Update your SDS/label authoring software - Compile the SDS according to Safety data sheet for chemical products: Content and order of sections- GB/T Compile label according to General rules for precautionary label for chemicals - GB Find an appropriate Emergency Telephone Number 4. Follow up the developments of China GHS, eg. Be proactive to dangerous chemicals registration. Find an responsible Agent to comply with the registration obligation if necessary. 27WWW.REACH24H.COM
Challenges to fully implement GHS in China Need to amend or draft GHS-related acts or regulations, and it seems not applicable to enact a new act/regulation solely for GHS implement. The revision of national standards cant be synchronized with the updating of UN GHS Need a long transition period, as highly regulatory compliance costs to the Chinese industrial chemical sector which consists of 400,000 companies of which 90% are SMEs GHS implementation involves various Ministries/Administrations, which lead to the need to establish the inter-ministry coordination mechanisms and national implement program. Few society awareness of GHS adoption/implement, and lack of human resources for GHS implement and training. The cooperation between MIIT and UNITAR has been established in WWW.REACH24H.COM
Useful Link For China GHS On National Standards: On Registration of hazardous chemicals: On Latest Updating: ghs.htmlhttp://www.reach24h.com/en/knowledge-base/china- ghs.html For China REACH On General Information: On Latest Updating: reach.htmlhttp://www.reach24h.com/en/knowledge-base/china- reach.html On IECSC: On Professional Communication: Dedicated group of China REACH Experts Forum in LinkedInDedicated group of China REACH Experts Forum in LinkedIn
30 Workshop&Seminar REACHworkshop Asia Welcome to join in our International Chemical Regulation REACH Workshop Asia 2012 !
Thank you for your attention! Tommy Kong ( ) T: E: W: