Presentation on theme: "China's Chemical Regulation Regime Development on UN GHS Adoption"— Presentation transcript:
1 China's Chemical Regulation Regime Development on UN GHS Adoption Tommy KongDeputy Manager, Dept. of Regulatory ComplianceREACH24H Consulting Group10 Sep 2012
2 Contents China’s Adoption of GHS Briefing of the milestones in the adoption process of GHS;Primary obligations under China GHSAdvices on China GHS compliance
3 REACH24H Factsheet 3,000+ Clients mainly in China 400+ EU REACh Registrations3 EU Lead Registrations300+ EU CLP NotificationsEU SDS/eSDS300+ MEP Order No.7 – IECSC 700+ China GHS/SDS/Label11 HC Registration - SAWS200+ Workshops Worldwide
5 Contents China’s Adoption of GHS Briefing of the milestone in the adoption process of GHS;
6 Milestones (1)Rio, Jun 1992-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 <China’s Agenda 21> was issued by the State Council of China 2 years later.The Signing Ceremony of Agenda 21, Former Primer Li Peng (M), Rio 1992.
7 China file the Aye in the 48th Plenary Meeting of ECOSOC, 26-Oct-1999 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 48th Plenary Meeting of ECOSOC, 26-Oct-1999
8 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-2002.China Former Premier, Zhu Rongji, in the plenary meeting of WSSD, Johannesburg, 4-Sep-1999
9 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.
10 Interpretation of China National Standards Legal Base:Act on the Standardization of People's Republic of ChinaLegal 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 国标”.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:
11 China’s GHS related GBIssue DateGB NumberGHS-DependentContent24-Oct-2006GB 20576~20599, 601~ (26 Standards)1th VersionSafety rules for classification, precautionary labelling and precautionary statements of chemicals18-Jun-2008GB/T 16483_2008Safety data sheet for chemical products-content and order of sections19-Jun-2008GB/T 22234_20083th Version (Japan)Labelling of Chemical based on GHS21-Jun-2009GB 15258_20093th VersionGeneral rule for preparation of precautionary label for chemicalsGB 13690_2009General rule for classification and hazard communication of chemicalsCurrently, the 26 National Standards are subject to revision based on the 3th UN GHS and other necessary guidance in the process of draft.
12 Premier Wen Jiabao is holding one Decree of State Council 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
13 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 StandardsProvisionContentGB NumberArticle 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 chemicalsGB/T 16483_2008Safety data sheet for chemical products-content and order of sectionsGB 15258_2009General rule for preparation of precautionary label for chemicalsArticle 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
14 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;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.
15 Contents China’s Adoption of GHS Briefing of the milestone in the adoption process of GHS;Primary obligations under China GHS
16 “C&L” inventory of China GHS 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.The current ” Hazardous Chemicals List” is still being revised (expected to be available in Oct 2011.The revising C&L inventory (expected to around 7,000 substances)=“Hazardous chemicals list”(3,510 substances)+“Highly Toxic Chemicals list” (335 substances)+ more……C&L INVENTORY =Hazardous substance list~7,000Hazardous chemicals listHighly toxic chemicals listInformation of C&L from other regions (EU, Japan, US)
17 Substances subject to China GHS Substances itself , in mixtures and intended to be released from articlesInclusion of Hazardous Chemical List (being revised)Inclusion of List of Highly Toxic substanceNoImplement in parts of ProvincesyesyesReport the substance identifier to SAWS, which will pursue the expert judgment to determine whether the substance is potential hazardous or not.Available hazardous dataHighly toxic registrationyesNoChina GHSyesNoTesting by approved lab to assess the hazardous propertiesEnd
18 Primary obligations under China GHS 1. Immediately update the Safety Data Sheet (SDS) according to given National Standards (GB/T )Section1: Chemical Product & Company InformationSection 9: Physical and Chemical PropertiesSection 2: Hazards IdentificationSection 10: Stability and ReactivitySection 3: Composition/Information on ingredientsSection 11: Toxicological InformationSection 4: First-Aid MeasuresSection 12: Ecological InformationSection 5: Fire Fighting MeasuresSection 13: Disposal ConsiderationsSection 6: Accidental Release MeasuresSection 14: Transport InformationSection 7: Handling and StorageSection 15: Regulatory informationSection 8: Exposure Controls and Personal ProtectionSection 16: Other informationOnly Simplified Chinese Applicable/SDS语言仅接受简体中文
19 Primary obligations under China REACH Primary obligations under China REACH(MEP Order No.7)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 informationcertain special hazardous propertiesGHS hazard classes & categoriesmain symptomsemergency review
20 MSDS/SDS sampleThe layout is almost similar to that under CLP/UN GHS, however, there are still some differences.Indicating the SDS is compiled according to GB/TSection 1: Company and product IdentificationEmergency number, important!!Section 2: Hazards IdentificationSection 3……16
21 Primary obligations under China GHS 2. Updating labels according to National Standard (GB ) since 1 May 2011Label elements:- Product identifierHazard pictogramSignal wordHazard statementPrecautionary statementEmergency telephone numberSupplier informationReference to SDSConfidential ingredients are qualified not to be listed in the label, but the hazardous information should be indicated accordingly.
22 Label sample Product Identifier Signal word, warning Hazard statement Precautionary statementSupplier informationEmergency telephone nr.
23 Primary obligations under China REACH(MEP Order No.7) 3. Registration of dangerous chemicals (oversea and domestic companies )“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)Which legal entity is subject to registration?Legal Entity typePrevious Decree No. 344Revised Decree NO.5911China-based manufacturer√2ImporterX3Storage and use companies based in China
24 Primary obligations under China REACH(MEP Order No.7) Which substances need to be registered?Substances/mixtures listed in the on-going revised C&L inventorySubstances/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 informationPhysical and chemical property informationMain usesHazard class/category informationSafety management measures on storage, use and transportationEmergency disposal measures
25 Pro-activity is highly recommended! Primary obligations under China REACH(MEP Order No.7)How can the oversea companies apply for registration?1. Register the hazardous chemicals through your Chinese importer, or2. 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)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 2012.Pro-activity is highly recommended!
26 Primary obligations under China GHS 4. Emergency Telephone Number, which legally required in SDS, Label and RegistrationIt should be,24/7 availableThe number should be within the territory of ChinaProfessional work staff who can answer the emergency calling
27 How to comply with China GHS? Be familiar with the mentioned GHS-related GB/regulation/administrative provisions, and collect all the available hazardous data.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’’ - GB3. Find an appropriate Emergency Telephone Number4. 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.
28 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 can’t be synchronized with the updating of UN GHSNeed 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 SMEsGHS 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 2010.
29 Useful Link For China GHS For China REACH On National Standards:On Registration of hazardous chemicals:On Latest Updating:For China REACHOn General Information:On Latest Updating:On IECSC:On Professional Communication: Dedicated group of “China REACH Experts Forum” in LinkedIn
30 Workshop&SeminarWorkshop & SeminarREACHworkshop AsiaWelcome to join in our International Chemical Regulation REACH Workshop Asia 2012 !
31 Thank you for your attention! Tommy Kong (孔德涛)T:E:W: