Biosafety Regulations

Biosafety Regulations in Asia-Pacific (selected countries in alphabetical order)

Click on the country for more information about its biosafety regulations

BANGLADESH (People's Republic of)

LAWS, REGULATIONS, RULES

• DRAFT Biosafety Act (2004)
• DRAFT Biodiversity Act (2004)
• Biosafety Guidelines (2000)

 COMMITTEES (and other bodies)

• National Biodiversity Authority (NBA)
• Bangladesh Biosafety Monitoring and Control Authority (BMCA)
• National Committee on Biosafety of Bangladesh (NCBB)

BHUTAN (Kingdom of)

LAWS, REGULATIONS, AND RULES

• Biodiversity Act (2003)
• Environmental Assessment Act (2000)
• Forest and Nature Conservation Act (1995)
• Plant Quarantine Act (1993)

CAMBODIA (Kingdom of)

LAWS, REGULATIONS, AND RULES

• DRAFT Law on Biosafety (2004) - Annex 3 of Cambodian National Biosafety Framework
• DRAFT Sub-decree on LMOs Management (2004) - Annex 7 of Cambodian National Biosafety Framework
• Law on Environmental Protection and Natural Resource Management (1996)
  
• DRAFT Fishery Law (2004)
• DRAFT Protected Areas Management Law (2003) - Annex 6 of Cambodian National Biosafety Framework
• Phyto-Sanitary Inspection Sub-Decree (2003) - Annex 5 of Cambodian National Biosafety Framework
• Food Sanitary for Humans Sub-Decree (2003)
• Law on Marks, TradeNamesand Acts of Unfair Competitions (2002)
• Law on Copyright and Related Rights (2002)
• Forestry Law (2002)
• Law on the Management of Quality and Safety of Products and Services (2000) - Annex 10 of Cambodian National Biosafety Framework
• Environmental Impact Assessment Sub-Decree (1999) - Annex 9 of Cambodian National Biosafety Framework
• Public Health Law (1998) - Annex 8 of Cambodian National Biosafety Framework
• Sub-DecreeonProductionofImport,ExportandCommerceofTraditionalMedicine in Public Sector (1998)

COMMITTEES (and other bodies)

• Scientific Advisory Committee (SAC)

CHINA (People's Republic of)

LAWS, REGULATIONS, AND RULES

• Administrative Meaures of Inspection and Quarantine on Entry-Exit GM Products, Decree 62 (2004)
  
• Implementation Regulations on the Safety of Import of Agricultural GMOs (2001)
  
• Implementation Regulations on Safety Assessment of Agricultural GMOs (2001)
  
• Implementation Regulations on Labeling of Agricultural GMOs (2001)
  
• Regulation on Safety of Agricultural GMOs (2001)
  
• Safety Administration Implementation Regulation on Agricultural Biological Genetic Engineering (1996)
  
• Safety Administration Regulation on Genetic Engineering (1993)
  

COMMITTEES (and other bodies)

• Genetic Engineering Safety Committee
• Safety Committee for Agricultural Biological Genetic Engineering
• National Agricultural GMO Biosafety Committee/National Biosafety Committee

INDIA (Republic of)

LAWS, REGULATIONS AND RULES

• Guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics and other biologicals (1999)
• Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts (1998)
• Revised Guidelines for Safety in Biotechnology (1994)
• Recombinant DNA Safety Guidelines and Regulations (1990)
• Rules for the Manufacture, use, import, export and storage of hazardous microorganisms, genetically engineered organisms or cells (1989)
• Environment Protection Act (1986)

COMMITTEES

• Review Committee on Genetic Manipulation (RCGM)
• Genetic Engineering Approval Committee (GEAC)
• State Biotechnology Coordination Committee (SBCC)
• District Level Committee (DLC)
• Institutional Biosafety Committees (IBSC)

INDONESIA (Republic of)

LAWS, REGULATIONS, AND RULES

• DRAFT Law for the Management of Genetic Resources (2005)
• DRAFT Government Regulation on Biosafety for Genetically Engineered Products (2005) Annex IV of National Biosafety Framework of the Republic of Indonesia
  
• DRAFT Safety of Living Organisms of Biotechnological Products Produced through Genetic Engineering (2001)
  
• DRAFT Safety of Living Organisms and Foods of Biotechnological Products Produced through Genetic Engineering (2001)
  
• Biosafety and Food Safety of Genetically Engineered Agricultural Products (1999)
• Food Safety Decree (1999)
• Provisions on Biosafety of Genetically Engineered Agricultural Biotechnology (1997)
  
• Law on Food (1996)
• Laboratory Guidelines for Genetic Engineering Research (1993)
• Law on Environment
• Law on Conservation of Biological Resources and its Ecosystem
• Law on Health
• Law on Systems for Plant Cultivation
• Law on Animal Husbandry and Animal Health
• Law on Fishery
• Law on Plant, Animal and Fish Quarantine
• Law on Systems for Reseasrch, Development and Application of Science and Technology
• For others, see Annex IV of Indonesian National Biosafety Framework
  

COMMITTEES (and other bodies)

• Biosafety Committee (BC) / Biosafety and Food Safety Committee (BFSC) / National Commission for Safety of Living Organisms and Foods (KNKHKP)
• Biosafety Technical Team (BTT) / Biosafety and Food Safety Technical Team (BFSTT) / Technical team for Safety of Living Organisms and Foods (TTKHKP)

LAO (People's Democratic Republic)

LAWS, REGULATIONS, AND RULES

• DRAFT Biosafety Law (2004) pp. 23-31 of Lao National Biosafety Frameworks
  
• Food Law (2004)
• Woman Protection Law (2004)
• Land Law (2003)
• Law on Hygiene, Prevention and Health Promotion (2001)
• Penal Code Law (2001)
• Medicine and Medical Law (2000)
• Education Law (2000)
• Processing Industry Law (1999)
• Environmental Protection Law (1999)
  
• Agriculture Law (1998)
• Water and Water Resources Law (1996)
• Forestry Law (1996)
• Road Transport Law (1997)
• Promotion of Domestic Investment Law (1995)
• Law on Promotion and Management of Foreign Investment (1994)
• Business Law (1994)
• Custom Law (1994)
• Secured Transaction Law (1994)
• Contract Law (1990)
• Tort Law (1990)

COMMITTEES (and other bodies)

• National Biosafety Committee (NBC)

MALAYSIA

LAWS, REGULATIONS AND RULES

• DRAFT Regulation on Genetically Modified Foods (2005)
• DRAFT Biosafety Bill (2003)
• Guideline for the Release of GMOs into the Environment (1997)
  
• Food Act (1983) and Food Regulations (1985)
• Poisons Act (1979)
• Plant Quarantine Act (1976) and Agricultural Pests Regulations (1981)
• Pesticide Control Act (1974)
• Fisheries Act (1963; revised in 1978)

COMMITTEES (and other bodies)

• Genetic Modification Advisory Committee (GMAC)

MYANMAR (Union of)

LAWS, REGULATIONS AND RULES

• Animal Health and Development Law (1993)
• Freshwater Fisheries Law (1991)
• Pesticide Law (1990)
• Marine Fisheries Law (1990)
• Aquaculture Law (1989)
• The Plant Pest Quarantine Law

NEPAL (Kingdom of)

LAWS, REGULATIONS, AND RULES

• Seed Act (1998)
• Livestock Health and Services Act (1998)
• Medicine Act (1978)
• Export Import (Control) Act (1956)
• Other international agreements, including:
• Plant Protection Agreement for the South East Asia and Pacific Region (1956)
• Convention on Wetlands of International Importance Especially as Waterfowl Habitat (1971)
• Convention for the Protection of the World Cultural and Natural Heritage (1972)
• Convention on International Trade in Endangered Species of Wild Fauna and Flora (1973)
• World Conservation Strategy (1980)
• World Charter for Nature (1982)
• International Tropical Timber Agreement (1983)
• Agreement on Network of Aquaculture Centres in Asia and the Pacific (1988)

PHILIPPINES (Republic of)

LAWS, REGULATIONS, AND RULES

• Rules and regulations for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology (2002)
  
• Guidelines for Planned Release of Genetically Manipulated Organisms (GMOs) and Potentially Harmful Exotic Species (PHES) (1998)
  
• Biosafety Guidelines for Small-Scale Laboratory Work (1998)
• BIosafety Guidelines for Large-Scale Contained Work and Glasshouse Trials (1998)
• Biosafety Guidelines (1991)
  
• Prescribing Guidelines and Establishing a Regulatory Framework for the Prospecting of Biological and Genetic Resources, Their By-Products and Derivatives, For Scientific and Commercial Purposes, and For Other Purposes (1995)
• Public Health and Safety:
• Traditional and Alternative Medicine Act (1977)
• Code on Sanitation (1975)
• Consumer Act of the Philippines (1975)
• Food and Drug Law (1963)
• Food Security/Poverty Alleviation:
• Plant Variety Protection Act (2002)
• Intellectual Property Code (1998)
• Agricultural and Fisheries Modernization Act (1998)
• Fisheries Code (1998)
• High Valued Crops Development Act (1995)
• Seed Industry Development Act (1992)
• Plant Quarantine Law (1978)
• Fertilizer and Pesticide Authority (1977)
• Environmental Protection
• Wildlife Resources Conservation and Protection Act (2001)
• Animal Welfare Act (1998)
• Indigenous Peoples Rights Act (1997)
• NIPAS Act (1992)
• Local Government Code (1991)
• The Revised Forestry Code (1975, amended in 1991)
• Administrative Code (1987)
• Environmental Impact Statement System (1978)
• Environmentally Critical Areas and Projects (1978)
• Philippine Environmental Policy (1977)
• Philippine Environmental Code (1977)

COMMITTEES (and other bodies)

• National Committee on Biosafety of the Philippines (NCBP)

SINGAPORE (Republic of)

LAWS, REGULATIONS, AND RULES

• Biological Agents and Toxins Act (2005) - draft version
  
• Guidelines for Research on GMOs (last updated in 2004)
  
• Guidelines on the Care & Use of Animals for Scientific Purposes (2004)
  
• Guidelines on the Release of Agriculture-Related GMOs (1999)
  
• Occupation Health and Safety Guideliens for Laboratories and Production facilities in the Biomedical Sciences (2003) - Appendix 1 of OSH Guidelines for Laboratories and Production Facilities
  
• WHO Laboratory Biosafety manual (2003)
  
• Sale of Food Act (1973) and Food Regulation (1974)
• The Environmental and Public Health Act (1970)

COMMITTEES (and other bodies)

• Genetic Modification Advisory Committee (GMAC)
  

SRI LANKA (Democratic Socialist Republic of)

LAWS, REGULATIONS, AND RULES

• Consumer Affairs and Authority Act (2003)
• Plant Protection Act (1999)
• Fisheries and Aquatic Resouces Act (1996)
  
• Forest (amendment) Act (1995)
• Science and Technology Development Act (1994)
• Fauna and Flora Protection Act (1993)
  
• Animal Diseases Act (1992)
  
• National Heritage Wilderness Areas Act (1988)
• Animal Feed Act (1986)
• National Environmental Act (1980)
• Control of Pesticides Act (1980)
• Animals Act (1958)
• State Lands Ordinance (1947)
• Water Hyacinth Ordinance (1909)
• Forests Chapter 283 (1907)
• Fauna and Flora Protection Ordinance (1937)
  
• Quarantine and Prevention of Diseases Ordinance (1897)

THAILAND (Kingdom of)

LAWS, REGULATIONS, AND RULES

• Biosafety Guidelines For Work Related to Modern Biotechnology or Genetic Engineering (2004) - Available at UNESCO SHS (Thai only
• DRAFT Guidelines on Contained Uses of GMOs (2004)
  
• Biosafety Guidelines in Genetic Engineering and Biotechnology for Field Work and Planned Release (1992)
  
• Biosafety Guidelines in Genetic Engineering and Biotechnology for Laboratory Work (1992)
  
• Intellectual Property Rights Act (1993)
• Enhancement and Conservation of National Environmental Quality Act (1992)
• Hazardous Substance Act (1992)
• Disease and Animal Toxin Act (1982)
• Animal Pathogen and Toxin Act (1982)
• Patent Law (1979)
• Copyright Law (1978)
• Fertilizer Act (1975)
• Plant Variety Act (1975)
• Plant Quarantine Act (1964, amended in 1999)
• Animal Disease Control Act (1962)
• Food Act

COMMITTEES (and other bodies)

• National Biosafety Committee (NBC)

VIETNAM (Socialist Republic of)

 LAWS, REGULATIONS, AND RULES

• DRAFT Biosafety Management regulation for GMOs and their Products (2004) Annex III of The National Action Plan to 2010
  
• Ordinance on Crop Varieties (2004)
• Veterinary Ordinance (2004)
• Ordinance on Livestock Breeds (2004)
• Fishery Law (2003)
• Ordinance on Plant Protection and Quarantine (2003)
• Science and Technology Law (2000)
• Law on Environmental Protection (1993)
• Law on the People's Health Protection (1989)







NOTE: In many cases, we have been unable to obtain GMO/LMO legislation. The reasons for this vary: it may not be translated, it may still be under examination by that country's national legislature, or other reasons.



Still to gather information (please submit if you have) on:

BRUNEI (Negara Brunei Darussalam)

TIMOR LESTE / EAST TIMOR (Democratic Republic of)