China's Chemical Regulation Regime Development on UN GHS Adoption Tommy Kong Deputy Manager, Dept. of Regulatory Compliance REACH24H Consulting Group 10.

China's Chemical Regulation Regime Development on UN GHS Adoption

Tommy KongDeputy Manager, Dept. of Regulatory Compliance

REACH24H Consulting Group10 Sep 2012

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Contents

• China’s Adoption of GHSBriefing of the milestones in the adoption

process of GHS;Primary obligations under China GHSAdvices on China GHS compliance

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Contents

• China’s Adoption of GHSBriefing of the milestone in the adoption process of

GHS;

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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.

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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.

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China file the Aye in the 48th 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 2008. Zhu Rongji, the former Premier, approved this document on behalf of China government in the plenary meeting hold in 4-Sep-2002.

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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.

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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 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: http://www.sac.gov.cn/sac_en/

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China’s GHS related GBIssue Date GB Number GHS-Dependent Content

24-Oct-2006 GB 20576~20599, 601~602 2006 (26 Standards)

1th Version Safety rules for classification, precautionary labelling and precautionary statements of chemicals

18-Jun-2008 GB/T 16483_2008

1th Version Safety data sheet for chemical products-content and order of sections

19-Jun-2008 GB/T 22234_2008

3th Version (Japan) Labelling of Chemical based on GHS

21-Jun-2009 GB 15258_2009 3th Version General rule for preparation of precautionary label for chemicals

21-Jun-2009 GB 13690_2009 3th Version General rule for classification and hazard communication of chemicals

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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.

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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,

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Decree No. 591 GHS-Related National Standards

Provision Content GB Number ContentArticle 15 Hazardous 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, 601~602 2006 (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_2009 General rule for preparation of precautionary label for chemicals

Article 78 Competent authority will impose of a fine of not more than 50,000 RMB to any companies violating Article 15.

GB 13690_2009 General 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;

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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

• China’s Adoption of GHS Briefing of the milestone in the adoption process of GHS; Primary obligations under China GHS

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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 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……

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“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.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 articlesSubstances itself , in mixtures and intended to be released from articles

Inclusion of Hazardous Chemical List (being revised)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.

Report the substance identifier to SAWS, which will pursue the expert judgment to determine whether the substance is potential hazardous or not.

China GHS

yesTesting by approved lab to assess the hazardous properties

Testing by approved lab to assess the hazardous properties

yes No

End

Inclusion of List of Highly Toxic substance

Inclusion of List of Highly Toxic substance

Highly toxic registrationHighly toxic registration

yesAvailable

hazardous data

Available hazardous

data

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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/T16483-2008)

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Section1: Chemical Product & Company Information

Section 9: Physical and Chemical Properties

Section 2: Hazards Identification Section 10: Stability and Reactivity

Section 3: Composition/Information on ingredients

Section 11: Toxicological Information

Section 4: First-Aid Measures Section 12: Ecological Information

Section 5: Fire Fighting Measures Section 13: Disposal Considerations

Section 6: Accidental Release Measures Section 14: Transport Information

Section 7: Handling and Storage Section 15: Regulatory information

Section 8: Exposure Controls and Personal Protection

Section 16: Other information

Only Simplified Chinese Applicable/SDS语言仅接受简体中文

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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/T16483-2008)

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 IdentificationSection 1: Company and product Identification

Section 2: Hazards IdentificationSection 2: Hazards Identification

Emergency number, important!!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/T16483-2008Indicating the SDS is compiled according to GB/T16483-2008

Section 3……16Section 3……1620WWW.REACH24H.COM

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2. Updating labels according to National Standard (GB15258-2009) 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, warningSignal word, warning

Hazard statementHazard statement

Precautionary statementPrecautionary statement

Product IdentifierProduct Identifier

Supplier informationSupplier information

Emergency telephone nr.Emergency telephone nr.

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3. Registration of dangerous chemicals (oversea and domestic companies )

Which legal entity is subject to registration?

Legal Entity type Previous Decree No. 344

Revised Decree NO.591

1 China-based manufacturer √ √

2 Importer X √

3 Storage 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)

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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)

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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.

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)

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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 16483 -2008

- Compile label according to ‘’General rules for precautionary label for chemicals’’ - GB 12528-2009

3. Find an appropriate Emergency Telephone Number

4. Follow up the developments of China GHS, eg. http://www.nrcc.com.cn/#.

Be proactive to dangerous chemicals registration. Find an responsible “Agent” to comply with the registration obligation if necessary.

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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 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 2010.

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Useful Link

• For China GHS On National Standards: http://www.sac.gov.cn/sac_en/ On Registration of hazardous chemicals: http://en.nrcc.com.cn/ On Latest Updating: http://www.reach24h.com/en/knowledge-base/china-

ghs.html

• For China REACH On General Information: http://www.crc-mep.org.cn/En/index.aspx On Latest Updating: http://www.reach24h.com/en/knowledge-base/china-

reach.html On IECSC: http://www.crc-mep.org.cn/en/M006/M006_C1.aspx On Professional Communication: Dedicated group of “China REACH Experts

Forum” in LinkedIn

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Workshop&Seminar

Workshop & Seminar

REACHworkshop Asia

Welcome to join in our International Chemical Regulation REACH Workshop Asia 2012 !

Thank you for your attention!Tommy Kong (孔德涛 )T: 0571 87007500E: [email protected] W: www.reach24h.com

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