Vietnam Chemical Regulation -...

Vietnam Chemical Regulation

Webinar, 18 February 2014, 1pm GMT

Today’s webinar – aims

• To hear the status of the main laws on chemicals and related regulations in Vietnam including, hazard communication (GHS);

• To gain an overview of the roles, responsibilities and interface of the chemical management authorities in Vietnam;

• To hear examples of the practical implementation of the regulations with solutions to frequently asked questions.

Q&A session

If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar.

http://forum.chemicalwatch.com


Xunyao Fu, Asian Regulatory Compliance Specialist, ChemADVISOR, Inc.;

Doan Hong Anh, Environmental Specialist and Partner, Integrated Management Solution (iEMS);

Chair: Sarah Thompson, Hubs Editorial Content Manager, Chemical Watch.

Speakers

By Xunyao FU, Ph.D.

• Overview of chemical regulations in Vietnam

• Main chemical regulations: Law on Chemicals and the related regulations

• Hazard communication (GHS)• Other chemical regulations

©ChemADVISOR, Inc. 2014 2

• Laws – by the National Assembly• Ordinance – by the Standing

Committee of the National Assembly• Decree – by the Government• Circular – by Ministry• Decision – by the Director of

agency• Order – by the State President


• Vietnam Chemicals Agency –key agency responsible for chemical management

• Established in 2009 under the Ministry of Industry and Trade (MOIT)

• Main Chemical Regulations available in English (text only)

• http://www.vinachemia.gov.vn/


http://www.vinachemia.gov.vn/

• Ministry of Industry and Trade (MOIT) (http://www.moit.gov.vn/)

• Ministry of Natural Resource and Environment (MONRE) (http://www.monre.gov.vn/)

• Ministry of Health (MOH) (http://www.moh.gov.vn/)

• Ministry of Agriculture and Rural Development (MARD) (http://www.mard.gov.vn/)

• Ministry of Science and Technology (MOST) (http://www.most.gov.vn/)

• Ministry of Labour - Invalids and Social Affairs (MOLISA) (http://www.molisa.gov.vn/)

• Ministry of Defense (MOD) (http://mod.gov.vn/)


http://www.moit.gov.vn/

http://www.monre.gov.vn/

http://www.moh.gov.vn/

http://www.mard.gov.vn/

http://www.most.gov.vn/

http://www.molisa.gov.vn/

http://mod.gov.vn/

• Law No. 06/2007/QH12, issued on November 21, 2007

• Controlled by the Ministry of Industry and Trade and Vinachemia

• Objective: Chemical handlings (except radioactivity and radioactive waste)

• Vietnam's first comprehensive act to manage chemical activities and to ensure safety of the use of chemicals in the country


• Decree No. 108/2008/ND-CP: implementation of the Law on Chemicals

• Circular No. 28/2010/TT-BCT: clarification of the Law on Chemicals and the Decree No. 108/2008/ND-CP

• Decree No. 26/2011/ND-CP: amendment of Decree No. 108/2008/ND-CP

• Circular No. 40/2011/TT-BCT: regulations on chemicals declaration

• Circular No. 07/2013/TT-BCT: registration of using certain hazardous chemicals in industry


• Decree No. 90/2009/ND-CP: punishment (noncompliance with the requirements for chemical activities)

• Decree No. 15/2010/ND-CP: punishment (noncompliance with the requirements for fertilizers)

• Circular No. 04/2012/TT-BCT: GHS guidelines for classification and labeling of chemicals

• Circular No. 20/2013/TT-BCT: amendment of some articles of the Circular No. 28/2010/TT-BCT


• Law on Chemicals: proposed the issuance of the national list and database

• Decree No. 108: “…submit to the Prime Minister for approval before July 1, 2009.”

• Decree No. 26: “… build scheme of national chemical database, national list of chemicals and submit to the Prime Minister for consideration and approval.”

• No inventory published yet©ChemADVISOR, Inc. 2014 10


• Law on Chemicals: “substances not included in the national list and international lists”Ø Registration of New ChemicalsØ Annual Report on chemical safety within 5

yearsØ Added to the National List in 5 years

• Circular No. 28:Ø Registration dossier of New ChemicalsØ New Chemicals included on at least two

foreign inventories – less informationØ Submit to the Vinachemia at least 30 working

days prior to import or deliveryØ Annual Report form in Appendix 18

• Chemicals with one or more hazardous properties (GHS):a) Readily explosiveb) Strongly oxidizedc) Strongly corrosived) Readily flammablee) Acutely toxic f) Chronically toxicg) Allergenic to human germsh) Causing cancer or danger of cancer (carcinogenicity)i) Causing gene changes (germ cell mutagenicity)j) Toxic to reproductionk) Biological accumulationl) Organic pollution not readily biodegradablem) Toxic to the environment

• Chemical safety data sheet in Vietnamese (Appendix 17 of Circular No. 28)


• Hazardous substances having at least one of the properties ranging from e) to m)

• Decree No. 26: List of toxic chemicals for which sale and purchase control slips are required (Appendix VI)

• Trading control card (Appendix 16, Chapter VI of Circular No. 28)


• Dangerous chemicals under requirements of special control on safety techniques

• Decree No. 108: Appendix I (Categories)

• Circular No. 28: Appendix I – List of Industrial Chemicals Subject to Conditional Production or Trading (1076 substances)Ø Dossier (Section I of Chapter III)Ø Certificate issued within 20 daysØ Certificate valid for 5 years


• Dangerous chemicals under special control on safety techniques, entities’ scale, type, size and period of business

• Decree No. 108: Appendix II

• Decree No. 26: Amendment of Appendix II

• Circular No. 28: Ø Dossier (Section II of Chapter III)Ø License issued within 20 daysØ License valid for 3 years



• Decree No. 108: Appendix III – List of Banned Chemicals

• Circular No. 28: ØDossier (2 sets, Chapter IV)ØPermission to produce, import or use

banned chemicals issued within 20 working daysØReport on the production, import or use

of banned chemicals to the Vinachemia before January 31 every year


• Decree No. 108: Appendix IV

• Decree No. 26: Amendment of Appendix IV

• Circular No. 20: Ø Chemical incident prevention and

response plan (Chapter 2)Ø Dossier for approval of a plan (12 copies

of the plan)Ø Plan approved within 30 days


• Decree No. 108: Appendix V

• Decree No. 26: Amendment of Appendix V• Circular No. 40: Ø Declaration dossier:

o Chemical declaration form (Produce/Import)o Invoice/contract (I)o Chemical safety data sheet in Vietnamese (P/I) and

English version if any (I)Ø Declaration time:

o Producer: no later than January 30 every yearo Importer: before customs clearance

Ø Certificate issued within 7 working daysØ Online application available (Chemical bureau

http://cuchoachat.gov.vn/, in Vietnamese)

http://cuchoachat.gov.vn/


• Decree No. 26: Appendix VII• Circular No. 20: ØChemical incident prevention and

response measure (Chapter 3)ØDossier for a certification (5 copies of

the measure)ØMeasure certified within 20 working

days

• Decree No. 26: Registration of the use of chemicals

• Circular No. 07: Ø List of industrial hazardous chemicalsØRegistration form (Appendix 2)ØSubmit before 15 working days ahead

of the useØSix-month report submitted before

June 10, annual report submitted before December 10 (Appendix 3)


• Law No. 06/2007/QH12: Law on ChemicalsØ Hazardous chemicals classification

• Decree No. 108/2008/ND-CP: implementation of the Law on ChemicalsØ Hazard Class + Hazard CategoryØ Threshold Concentration for hazardous

substances in mixtures• Circular No. 04/2012/TT-BCT: GHS

guidelines for classification and labeling of chemicalsØ Based on the 3rd edition of GHSØ Substance: GHS classification and labeling from

March 20, 2014Ø Mixture: GHS classification and labeling from

March 20, 2016.©ChemADVISOR, Inc. 2014 22

• Chemicals with one or more hazardous properties (GHS)a) Readily explosiveb) Strongly oxidizedc) Strongly corrosived) Readily flammablee) Acutely toxic f) Chronically toxicg) Allergenic to humansh) Causing cancer or danger of cancer

(carcinogenicity)i) Causing gene changes (germ cell mutagenicity)j) Toxic to reproductionk) Biological accumulationl) Organic pollution not readily biodegradablem) Toxic to the environment.



Hazard Class Hazard CatExplosives Unstable

explosiveDiv 1.1 Div 1.2 Div 1.3 Div

1.4Div 1.5 Div

1.6

Flammable gases Cat 1 Cat 2 A (Chemically unstable gases)

B (Chemically unstable gases)

Aerosols Cat 1 Cat 2 Cat 3Oxidizing gases Cat 1

Gases under pressure Compressed gas

Liquefied gas Refrigerated liquefied gas

Dissolved gas

Flammable liquids Cat 1 Cat 2 Cat 3 Cat 4Flammable solids Cat 1 Cat 2Self-reactive substances and mixtures

Type A Type B Type C&D Type E&F Type G

Pyrophoric liquids Cat 1Pyrophoric solid Cat 1Self-heating substances and mixtures

Cat 1 Cat 2

Substances and mixtures, which in contact with water, emit flammable gases

Cat 1 Cat 2 Cat 3

Oxidizing liquids Cat 1 Cat 2 Cat 3Oxidizing solids Cat 1 Cat 2 Cat 3Organic peroxides Type A Type B Type C&D Type E&F Type

GCorrosives to metals Cat 1


Hazard Class Hazard CatAcute toxicity Cat 1 Cat 2 Cat 3 Cat 4 Cat 5Skin corrosion/irritation Cat 1A Cat 1B Cat 1C Cat 2 Cat 3Serious eye damage/eye irritation

Cat 1 Cat 2A Cat 2B Cat 2

Respiratory sensitization Cat 1 Cat 1A Cat 1BSkin sensitization Cat 1 Cat 1A Cat 1BGerm cell mutagenicity Cat 1A Cat 1B Cat 2Carcinogenicity Cat 1A Cat 1B Cat 2

Reproductive toxicity Cat 1A Cat 1B Cat 2 Additional category for effects on or via lactation

Specific target organ toxicity -single exposure

Cat 1 Cat 2 Cat 3

Specific target organ toxicity -repeated exposure

Cat 1 Cat 2

Hazardous to the aquatic environment - Acute toxicity

Cat 1 Cat 2 Cat 3

Hazardous to the aquatic environment - Chronic toxicity

Cat 1 Cat 2 Cat 3 Cat 4

No classification for aspiration hazard and hazard to the ozone layer

• Chemical nameØ International non-proprietary names are acceptable

• Chemical identityØ Acute toxicity, skin corrosion or serious eye damage,

germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory sensitivity → disclose all chemical ingredients that can cause these risks on the label

• Pictogram, signal words, risk warning• Precautions• QuantityØ Use “,” for decimal

• Ingredients or ingredient quantities


• Date of manufactureØ Start with “NSX” followed by the date in the order of

day, month and year, e.g., NSX 18022014 or NSX 180214

Ø NSX is the abbreviation of “Ngày Sản Xuất” (date of manufacture)

• Expiry dateØ Start with “HSD” (“Hạn Sử Dụng”, expiry date)

• Information of manufacturer, importer and distributor

• Origin of goodsØ Imported goods – marked with “made in” or “origin”

together with the country’s nameØ Produced in Vietnam – not required

• Manuals, maintenance instructions.©ChemADVISOR, Inc. 2014 27

• Safety data sheet in Vietnamese (Appendix 17 of Circular No. 28)

• Hazardous chemicals• Mixtures containing hazardous substances

• Ingredients can be listed in exact concentration or concentration range


No. Hazardous property Concentration1 Acute toxicity ≥ 1.0%2 Skin corrosion/irritation ≥ 1.0%3 Serious eye damage/eye irritation ≥ 1.0%4 Germ cell muta-genecity, category I ≥ 0.1%5 Carcinogenecity ≥ 0.1%6 Reproductive toxicity ≥ 0.1%7 Specific target organ (single exposure) ≥ 1.0%8 Aquatic toxicity ≥ 1.0%

• 1. Identification• 2. Composition/information on ingredients• 3. Hazard(s) identification• 4. First-aid measures• 5. Fire-fighting measures• 6. Accidental release measures• 7. Handling and Storage• 8. Exposure controls/personal protection• 9. Physical and chemical properties• 10. Stability and reactivity• 11. Toxicological information• 12. Ecological information• 13. Disposal considerations• 14. Transport information• 15. Regulatory information• 16. Other information


• Decision No.3733/2002/QD-BYT on labor hygiene standardsØ Occupational exposure limits

• Circular No. 27/2012/TT-BYT on guidance on the management of food additives

• Circular No. 46/2007/QD-BYT on maximum permitted biological and chemical residue in foodØ Requirements on food packagingsØ Pesticide residues in food

• Decision No. 05/2006/QD-BCN on chemicals banned for import and export

• Circular No. 03/2013/TT-BNNPTNT on the management of plant protection drugs

• Circular No. 22/2009/TT-BYT on drug registration• Decision No. 134/2003/QD-BCN on chemical

precursors.



vDeclaration form for hazardous chemicalsvIn Vietnamese,

no English versionvNot updated

frequently

• ChemADVISOR – Global Chemical Regulatory Report (GCRR)


• Inventories• Substance registrations• Product registrations• Notifications• Hazard communication

43 countries covered currentlyAsia-Pacific North AmericaEurope South AmericaMiddle East Customer specific request

• ChemADVISOR (http://www.chemadvisor.com/)Email: [email protected]

• Xunyao Fu, Ph.D.Email: [email protected]: +1 412-847-2008


http://www.chemadvisor.com/

mailto:[email protected]



Presentation design by

Implementation of Chemical Regulations in Vietnam

By Anh Doan, M.Sc.

HCMC, Feb 2014

Content

• Chemical Regulations Review• Key Topics vs Related Regulations • Chemical Management Authorities• Implementation of Chemical Regulations in Vietnam• Challenges

Chemical Law 06/2007/QH12

Decree108/2008/NĐ-CP

Decree 26/2011/NĐ-CP

Decree163/2013/ND-CP

Circular 07/2013/TT-BCTCircular 28/2010/TT-BCT

Circular 18/2011/TT-BCT

Circular 04/2012/TT-BCT Circular 20/2013/TT-BCT


Circular 50/2012/TT-BCTQCVN 11:2012/BCT


Decrees/Circulars on import/ export chemical

Circular 52/2013/TT-BTNMT

Chemical Regulations Review

Note:QH: National AssemblyND-CP: Government BCT: Ministry of Industry and TradeBNTMT: Ministry of Natural Resources and Environment

Chemical Regulations ReviewChemical Law

Key Contents• General provisions• Developing the Chemical Industry• Chemical Production and Trading• Classification, Labeling, Packaging, and Chemical Safety Data Sheet• Chemical use• Accident prevention and mitigation• Declaration, registration and provision of chemical information• Environmental protection and safety for community• State management responsibility and chemical handling• Implementation provisions

The Decree No. 108/2008/ND-CP

Key Contents• General provisions;• Chemicals lists; • Production and trade conditions of chemicals with limited production and trade and conditional production and trade; • Safety distance; • Threshold content of dangerous substance in mixture required the chemical safety data sheet; •Chemical information; •Organization of implementation and implementation provisions.Noted: Decree No. 26/2011/ND-CP dated 08 April 2011: Revision, addition to some articles of the Government Decree 108/2008/ND-CP

Content• Chemical Regulations Review• Key Topics vs Related Regulations • Chemical Management Authorities• Implementation of Chemical Regulations in Vietnam• Challenges

Q&A

Key Topics vs Related Regulations1. Chemicals subject to conditional production and trading (Article 14.1 of Chemical Law, detailed list is provided in

Appendix I of Decree No.108/2008/ND-CP)

2. Chemicals restricted from production and trading (Article 15 of Chemical Law, detailed list is provided in Appendix II of

Decree No. 26/2011/ND-CP)

3. Banned chemicals (Article 19.1 of Chemical Law, detailed list is provided in in Appendix III of Decree No.108/2008/ND-

CP)

4. Chemicals subject to declaration (Article 43.1 and 2 of Chemical Law, detailed list is provided in Appendix V of Decree

No. 26/2011/ND-CP)

5. Toxic chemicals for which sale and purchase control slips are required (Article 23, detailed list is provided in Appendix VI of

Decree No. 26/2011/ND-CP)

6. Chemicals which are required to elaborate chemical-related incident prevention and response plans (Article 38 of

Law on Chemicals, detailed list is provided in Appendix IV of Decree No. 26/2011/ND-CP)

7. Chemicals which are required to elaborate chemical-related incident prevention and response measures (Article 1.3

of Decree No. 26/2011/ND-CP, detailed list is provided in Appendix VII of this Decree)

8. New chemicals (Article 44, 45 of Chemical Law)

9. Hazardous chemicals required to be registered is provided in Appendix 1 of Circular No. 07/2013/TT-BCT

10. GHS guidelines for classification and labeling of chemicals - Circular No. 04/2012/TT-BCT

Content

• Chemical Regulations Review• Key topics vs Related Regulations • Chemical Management Authorities• Implementation of Chemical Regulations in Vietnam• Challenges

Chemical Management Authorities

Government MONRE

MOST

MOLISA

MOD

MARD

MOH

MoIT

•MOIT: Ministry of Industry and Trade; •MARD: Ministry of Agriculture and Rural Development; •MOH: Ministry of Health; •MOST: Ministry of Science and Technology;•MONRE: Ministry of Natural Resource

Roles and Responsibilities• Laws – by the National Assembly• Ordinance – by the Standing Committee of the National Assembly• Decree – by the Government• Circular – by Ministry• Decision – by the Director of Agency/People’s Committee of Province • Order – by the State President

•Ministry of Industry and Trade (MOIT) (http://www.moit.gov.vn/)•Ministry of Natural Resource and Environment (MONRE) (http://www.monre.gov.vn/)•Ministry of Health (MOH) (http://www.moh.gov.vn/)•Ministry of Agriculture and Rural Development (MARD) (http://www.mard.gov.vn/)•Ministry of Science and Technology (MOST) (http://www.most.gov.vn/)•Ministry of Labour - Invalids and Social Affairs (MOLISA) (http://www.molisa.gov.vn/)•Ministry of Defense (MOD) (http://mod.gov.vn/)

http://www.moit.gov.vn/

http://www.monre.gov.vn/

http://www.moh.gov.vn/

http://www.mard.gov.vn/

http://www.most.gov.vn/

http://www.molisa.gov.vn/

http://mod.gov.vn/

Content

• Chemical Regulations Review• Key topics vs Related Regulations • Chemical Management Authorities• Implementation of Chemical Regulations in Vietnam• Challenges

Main products of Vietnam Chemical Industry

• Fertilizers & Agrochemicals;• Plastics;• Basic Chemicals;• Rubber Products;• Household & Personal Care Products;• Cells & Batteries;• Industry Gases &Welding Electrodes;• Paints & Pigments;• Chemical Minerals;• Petrochemicals;• Pharmaceutical Chemistry.

Challenges• Lack of information relevant to updated chemical regulations• Project owners have not yet played an active role in inspection as conducted by local authorities due to:

• lack of competent staffs• lack of communication and coordination

Frequently Asked Questions –Proposed Solutions

• how the project owner/the person in charge can be updated on chemical regulations - how often should it be done?;

• Assign a person in charge/ a consultancy company to conduct/provide a legal review to ensure related chemical regulations will be updated; • Updated regulations can be obtained through

• Public source – government’s website• Depending on requirements and budget – legal review should be done quarterly / bi-annual/ annual

• how to built an implementation framework (action, timeframe, cost, etc)• Specific actions can be referenced to Circular 28/2010/TT-BCT clarification of the Law on Chemicals and the Decree No. 108/2008/ND-CP

• what chemicals are requested to be declared• Chemicals subject to declaration (Article 43.1 and 2 of Chemical Law, detailed list is provided in Appendix V of Decree No. 26/2011/ND-CP)

Frequently Asked Questions –Proposed Solutions

• what level of local authorities should the project owner need to report to (• MoNRE• DoNRE• Reference should also be made to

•Circular 40/2011/TT-BCT regulations on chemicals declaration•Circular 28/2010/TT-BCT clarification of the Law on Chemicals and the Decree No. 108/2008/ND-CP

• what are the requested reports and how often it need to be submitted to who - key content of the reports

• Environmental Management Plan• Hazardous chemical required to be registered is provided in Appendix 1 of Circular No. 07/2013/TT-BCT•Emergency Response Measures – DoNRE •Emergency Response Plan – Vietnam Chemical Agency - MoIT Q&A

References

•GHS Implementation in Vietnam, Vietnam Chemicals Agency, May 2013•Viet Nam Update on Chemical Legislation and Regulations, APEC Chemical Regulators’ Forum, March 2012 • Chemical Regulations in Vietnam, Xunyao FU, Febuary 2014• Websites

• http://cuchoachat.gov.vn/Trangchủ.aspx• http://www.vinachem.com.vn/Desktop.aspx/Homepage

http://cuchoachat.gov.vn/Trangch

http://www.vinachem.com.vn/Desktop.aspx/Homepage

Thanks!

Contact

Integrated Environment ManagementSolutions (iEMS)8th Floor Vietnam Business Center 57-59 Ho Tung Mau Str. Dist 1Ho Chi Minh City Viet Nam

Core Services:

• Legal Review and Training• Environmental Due Diligence• Environmental Site Assessments• Environmental, Health & Safety Audits• Environmental Compliance Audit • Environmental and Social Impact Assessment (ESIA)

Anh DoanEnvironmental AdvisorPhone: + 84 (0) 908 921 779Email: [email protected]


Q&A session

If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar.



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