Presentation Transcript

1. Introduction to Chinese GHS Implementation from Japanese Point of View

   Hannah Zhuang Senior regulatory complianceconsultant REACH24H Consulting Group April 8, 2013 Osaka April 10, 2013 Tokyo
2. Content Global GHS Overview Background of GHS Global GHS Implementation China GHS Implementation Background of China GHS Regulation System Obligations & Case Study Advices for Japanese Companies on Compliance www.reach24h.com www.reach24h.com 2
3. Global GHS Overview Background of GHS What is GHS? Why GHS? Historical Development Global GHS Implementation www.reach24h.com www.reach24h.com 3
4. What is the GHS? The Globally Harmonized System of Classification and Labelling of Chemicals. (abbreviated as “GHS”) The GHS is a system for standardizing and harmonizing the classification and labelling of chemicals. It is a logical and comprehensive approach to: Defining health, physical and environmental hazards of chemicals; Creating classification processes that use available data on chemicals for comparison with the defined hazard criteria; and Communicating hazard information, as well as protective measures,  on labels and Safety Data Sheets (SDS). GHS Document (“purple Book”) www.reach24h.com
5. Why GHS? Example: Acute Oral Toxicity: LD50 = 257 mg/kg bw/day GHS Classification: Acute Tox Cat.3 Pictogram: Singnal word: danger Hazard statment: H301, Toxic if swallowed www.reach24h.com
6. Historical development of GHS Adopted at the United Nations Conference on Environment and Development (UNCED,1992). The first edition of the GHS was adopted in December 2002 and published in 2003. Updated every two years, the fourth revised edition of the GHS (GHS Rev.4) has been published in 2011. World Summit on Sustainable Development, Johannesburg, 2002, fully implement the system worldwide by 2008. http://www.unece.org/trans/danger/publi/ghs/ghs_rev04/04files_e.html www.reach24h.com
7. What does GHS indeed stand for? GHS? – Global Hopeless Situation www.reach24h.com www.reach24h.com 7
8. Global GHS Overview Background of GHS Global GHS Implementation www.reach24h.com www.reach24h.com 8
9. Global GHS Implementation Global overview: Implementation of UN GHS worldwide has started： http://www.unece.org/trans/danger/publi/ghs/implementation_e.html www.reach24h.com
10. Global GHS Implementation Chemicals Management Promotion Law Industrial Safety and Health Law Poisonous Substance Control Law www.reach24h.com
11. Global GHS Implementation www.reach24h.com
12. Question Why is it important to know China GHS? www.reach24h.com
13. Chinese Market for Chemicals Imports expected to increase to cope with domestic demand --- Overseas chemical companies will have big opportunities in Chinese chemical market. Ensure to fully comply with the chemical regulations of China, like China GHS and China REACH www.reach24h.com
14. China GHS Implementation Background of China GHS Regulation System Obligations & Case Study www.reach24h.com
15. The Timeline of China GHS Development The Standardization Administration of China initiated the “2003 National Standard Development Program” in order to compile China GHS Implementation China chose the Aye at the 48th Plenary Meeting of ECOSOC to approve the proposal of reconfigure and rename CETDG 1992 1999 2002 2003 2011 State Council of China announced the revised “ Regulation on Control Over Safety of Hazardous Chemicals” – Decree No. 591, which came into effect from 1 December 2011 China approved the plan of implementation from World Summit on Sustainable Development to implement GHS asap. The former Primer Minister LI Peng signed Agenda 21 of UNCED, and <Agenda 21 of China> was issued 2 years later. www.reach24h.com
16. Content Background of China GHS Regulation System Obligations & Case Study www.reach24h.com
17. Competent authorities for China GHS Over ten Departments/Ministries involved in China GHS implementation : Primary Coordinating Department/Ministry： Ministry of Industry and Information Technology ( MIIT ) Participating Departments/Ministries： National Registration Centre for Chemicals (NRCC) of SAWS are mainly responsible for implementing GHS. MEP are involved in new chemicals management, which can be referred to GHS issue. www.reach24h.com 17
18. Legal framework of China Level 1 Legislated by the People’s Congress e.g. Constitution Level 2 Legislated by the State Council e.g. Decree 591 Level 3 Legislated by each Ministry e.g. China NCSN Level 4 e.g. GB xxx or GB/T xxx * Compulsory Standards=”GB”; Recommended Standards= ”GB/T” www.reach24h.com
19. Regulatory System of hazardous chemicals management Administrative law: revised ”Regulations on the Control over Safety of Hazardous Chemicals” (Decree 591, replace Decree 344 since Dec. 1 2011) License system China GHS Registration system Measures on: Registration of Hazardous Chemicals Environmental Management of New Chemical Substance Measures for the Environmental management Registration of Hazardous Chemicals (Trial) National standards about: Classification Label SDS Packaging Inventory of Hazardous Chemicals (being revised) Other measures on : Manufacturing Importation Distribution Transportation Use www.reach24h.com
20. China GHS related national standards Classification: Clarify the classification of hazard chemicals according to GB 13690-2009 and “26 National Standards” under China GHS www.reach24h.com
21. China GHS related national standards SDS GBT16483-2008 “Safety Data Sheet for Chemical Products Content and Order of Sections” promulgated on 18th June, 2008, and implemented from 1st Feb, 2009. Label GB 15258-2009 “General rules for preparation of label for chemicals” promulgated on 21st June, 2009, and implemented from 1st May, 2010. Transition period: May 1st, 2010 -- May 1st, 2011 The core standard for labeling, which specifies: - Sequence of hazard information: 1. Physical; 2. Human Health; 3. Environment. - For simplified labeling, precautionary measures could be left out on the container ≤100ml - Label Size - Printing requirements of the label - Usage of the label Packaging GB190-2009 “Packing symbol of dangerous goods” promulgated on 21st June, 2009, and implemented from 1st May, 2010 www.reach24h.com
22. Content Background of China GHS Regulation System Obligations & Case Study www.reach24h.com
23. Obligations under China GHS Obligation 1 – Classification Obligation 2 – SDS Obligation 3 – Label Obligation 4 – Registration Obligation 5 – Emergency Telephone Number Other Obligations www.reach24h.com
24. Obligation 1 - Hazard Identification (classification) Substances itself, or in mixtures and intended to be released from articles 3815 substances Check the revised Catalogue of Hazardous Chemicals Catalogue of Hazardous Chemicals Catalogue of Hazardous Chemicals - Chinese C&L inventory - Around 7000 substances are expected to be included Inventory of Chinese Highly Toxic chemicals Being revised C&L inventory of EU, Japan and New Zealand etc. 335substances www.reach24h.com
25. Sample of Catalogue of Hazardous chemicals (Chinese C&L inventory) precautionary statements Hazard Classes and Categories Signal word UN No. Chinese name English name CAS No. www.reach24h.com
26. A tiered approach for hazard identification Listed in the upcoming C&L inventory? NO Yes Published sources of information or internal company testing available?  Mandatory to apply the harmonised classification. Yes Decision on classification against the classification criteria under 26 national standards. NO Classification results from other regions or countries available? Self-classification Yes Reclassified according to the classification criteria under 26 national standards. Pay attention to the differences. NO Not classified. Update the classification when you have new data. www.reach24h.com
27. Obligation 2 - SDS compilation Prepare/update Safety Data Sheet (SDS) according to China GHS standard GB/T 16483-2008 after 1st Feb. 2009 Section1: Chemical Product & Company Information Section 2: Hazards Identification Section 3: Composition/Information on ingredients Section 4: First-Aid Measures Section 5: Fire Fighting Measures Section 6: Accidental Release Measures Section 7: Handling and Storage Section 8: Exposure Controls and Personal Protection Section 9: Physical and Chemical Properties Section 10: Stability and Reactivity Section 11: Toxicological Information Section 12: Ecological Information Section 13: Disposal Considerations Section 14: Transport Information Section 15: Regulatory information Section 16: Other information Hazards Identification main physical and chemical hazard information certain special hazardous properties GHS hazard classes & categories main symptoms emergency review www.reach24h.com
28. Obligation 2 - SDS compilation - case study 1 In our case, happened to one of our clients, the subsection of ecological toxicity in section 12 is removed due to the information is not available, this subsection missing SDS was finally identified as unqualified by the authority. Tips: China GHS require an entry for every data field listed on an SDS. If information is not available or not applicable for a listed field, the preparer should indicate it on the SDS accordingly www.reach24h.com
29. Obligation 2 - SDS compilation – case study 2 Consistency of SDS must be verified. Classified as Flammable liquid cat.4 under China GHS. Not classified under EU CLP regulation. Criteria for flammable liquids under UN & China GHS Category 4 is not adopted by EU CLP!!! www.reach24h.com
30. Obligation 3 - Label compilation - elements Prepare/update label according to China GHS standard GB15258‐2009 Label elements  Product identifier  hazard pictogram  signal word  hazard statement  precautionary statement  emergency telephone number  supplier information  reference to SDS www.reach24h.com
31. Obligation 3 - Label compilation - sample Product Identifier Signal word, warning Hazard statement hazard pictogram Precautionary statement Prompt users to refer to SDS Supplier information Emergency telephone nr. www.reach24h.com
32. Obligation 3 - Label compilation - Special requirements Special requirements according to GB15258-2009 layout sequence of Hazard statements: 1. Physical; 2. human health; 3. Environment. Precedence of the pictograms Label size Simplified labeling (container ≤ 100 ml ) (precautionary statement could be left out) Prompt users to refer to SDS Printing requirements of the label Emergency telephone number Keep in mind to update your SDS/label authoring software www.reach24h.com
33. Obligation 3 - Label compilation - Case study Q&A 1: For confidential reasons, many companies don’t want to disclose all the constituents of the chemical mixtures on the label. How to solve the issue of CBI (confidential business information) when prepare the SDS and label? Answer Main ingredients contributing to the hazardous classification and their concentration or concentration ranges should be indicated. Ingredients which are considered confidential business information do not have to be indicated, however, their hazards should be listed. Case 1: On February 8 2012, a Thailand exporter reported that their synthetic rubber products were detained by the custom because they “forgot to attach GHS label for shipments to China”. Solutions Prepare the China GHS label before your exports arrive at China Customs; Supply a compliant China GHS label ASAP; Make proper explanations to the officials at the Customs with certain justification statement. www.reach24h.com
34. Obligation 3 - Label compilation – Case study Background: Chinese entry-exit inspection and quarantine bureau strengthening inspection on imported hazardous chemicals from 1 February 2012. The bureau will identify whether a China GHS SDS has been provided along with the goods, whether a Chinese label has been affixed on the packaging of goods; whether the contents in SDS and label meet the requirements of relevant standards and are consistent with the goods. Case 2: According to inspection and quarantine bureau of Huizhou, an important port in Guangzhou, a batch of imported ink was investigated and rejected for illegal labeling of the contained hazardous chemicals. The bureau found the declared hazardous chemicals were labeled only in English other than Chinese, and no domestic emergency call was marked on the packages, non-compliances in formation and content with Chinese standards were investigated as well. Solutions Provide the label written in Chinese. A multilingual label is also permitted, but the font size of the foreign language shall be smaller than the Chinese. Provide the qualified Emergency telephone number. The content and the format of the label shall be consistent with the national standard GB 15258-2009 www.reach24h.com
35. Obligation 4 - Registration of hazardous chemicals Registration of hazardous chemicals (non-Chinese and Chinese companies ) ‘Measures on registration of hazardous chemicals – SAWS order No. 53’ requires all hazardous substances/mixtures be registered to National Chemical Registration Center (NRCC) Which legal entity is subject to registration? www.reach24h.com 35
36. Obligation 4 - Registration of hazardous chemicals Which substances need to be registered? Listed in the coming C&L inventory Not listed, but classified as hazardous after hazard identification 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 www.reach24h.com WWW.REACH24H.COM 36
37. Sample of the registration certificate - The effective period of certificate will be 3 years - 25000+ companies have completed the registration in 2011 www.reach24h.com
38. Obligation 5 - Emergency Telephone Number Legally required in SDS, Label and Registration It should be, 24/7 available The number should be within the territory of China Professional work staff who can answer the emergency calling NRCC will organize inspection of the compliance of emergency telephone number. During the year 2011, approx. 5,000 emergency tel. number were inspected. Use of Emergency telephone number provided by NRCC: TEL: (+86) 0532 8388 9090 http://er.nrcc.com.cn/ It‘s not free. Contact REACH24H GROUP for the quotation. www.reach24h.com
39. Other Obligations Other obligations under China GHS Apply for the “License” Companies involved in the hazardous chemicals industry should apply for the license corresponding to their role in the supply chain, i.e.safe manufacturing license, safe operation license, dangerous goods license and safe use license. Register new chemical substances ---”China REACH” Registration of Import/Export of Toxic Chemicals www.reach24h.com
40. Advices for Japanese Companies on Compliance Clarify the classification of the hazardous chemicals correctly under China GHS Update your SDS/label authoring software - Compile the SDS according to “Safety data sheet for chemical products: Content and order of sections’’- GB/T 16483-2008 - Compile label according to ‘’General rules for precautionary label for chemicals’’ - GB 12528-2009 Label the product before entering into the boundary of China Be proactive in hazardous chemicals registration Provide an appropriate Emergency Telephone Number Pay close attention to the further updates by various Ministries/Authorities/Bureaus that provide specific detail citing Decree 591 as the implementing legislation www.reach24h.com

41. Thank you for your attention!

    HannahZhuang T: +86(571)-87007541 Fax: +86(571)-87007566 E-mail: hannah.zhuang@cn.reach24h.com Website: www.reach24h.com