The main chemical law in Vietnam is the Law on Chemicals 06/2007/QH12 issued in Nov. 2007. The Chemical Law provides regulations on chemical handling, safety in chemical handling, right and obligations of organizations and individuals engaged in chemical handling, and state management of chemical handling. The main authority in charge of chemical management is the Ministry of Industry and Trade (MOIT). The chemical law in Vietnam is supported by various decrees. The Decree No. 113/2017/ND-CP Specifying and providing guidelines for implementation of certain articles of the law on chemicalsin which updated on 2017 provides detailed regulations on chemical lists on licenses, classification, plans/measures for chemical incident, safety training, declaration, etc. The Circular 32/2017/TT-BCT provides forms and guidelines of labeling, MSDS, declaration, reports, license application, plans/measures, etc.
National Chemical Inventory (NCI)
Vietnam began to compile the national chemical inventory (NCI) in 2012. Substances that are not listed on the inventory will be considered as new substances and require registration before they can be used, imported, or produced in Vietnam. So far, there are 5 times where companies can nominate substances to the inventory. The inventory contains about 40,000 substances. The new deadline for substance submission is April 15th, 2021. The final draft of the inventory is expected to be released by the end of this year.
Nominating Substance to the NCI
Nominating Substances to the NCI requires the following information:
Chemical Name (IUPAC)
Safety Data Sheet (SDS) - as per Vietnamese Decree No. 113/2017/ND-CP and Circular no. 04/2012/TT-BCT in Vietnamese language
Document that showing the chemicals are being used in Vietnam (such as purchase contract, invoices, etc)
The Vietnamese authority will evaluate the substances and decide if they should be included in the inventory.
GPC through its Vietnamese affiliates can help you with the NCI nomination for Vietnam regulatory compliance.
Chemical Lists and Compliance Strategies
Conditional industrial chemicals
Certificates for production and trading of conditional
Restricted industrial chemicals
Licenses for production and trading of restricted industrial chemicals
Management of invoices related to sale and purchase of restricted industrial chemicals
Licenses from Prime Minister for some special purpose (authorized to minister of MOIT)
Hazardous chemicals requiring
incident prevention and
Licenses for Plan from MOIT
Self-approved Measure by company
Declaration on National Single Window before custom clearance
Purchasing control paper
License for import/export from Minister of MOIT
Logbook for recording the industrial precursor chemical production
Vietnam has been working on a draft National Chemical Inventory (NCI) and so far the inventory has been opened 5 times for industry to nominate substances. Currently, the inventory contains about 40,000 substances. The new deadline for substance submission is April 15th, 2021.
The final draft of the inventory is expected to be released by the end of this year. It's therefore important that all chemical manufacturers, importers, traders in Vietnam as well as non-Vietnamese manufacturers nominate their substances to the inventory to ensure their access to the market.
It's expected that the Inventory would be published by end of 2021. Its therefore important that all chemical manufacturers, importers, traders in Vietnam and from outside Vietnam nominate their substances to the inventory.
Once registered online, companies will be able to search the site for chemical substances. The search results will provide the status of the chemicals, which are divided into four groups:
nominated and verified – for this group, no further action is required. The chemicals have been included on the draft inventory;
nominated with some documentation – chemical substances which have been nominated, but have not yet been verified. In this case, companies can choose to attach further evidence or documentation. Companies are encouraged to submit additional evidence if feasible. If a company declines to submit additional evidence, and the information previously submitted by another company is deemed insufficient at a later point, the substance will not be added to the draft list of chemicals;
nominated – chemical substances which have been nominated but no documentation has been submitted. If no evidence is submitted for these chemicals, they will not be added to the draft inventory; and
not nominated – if not listed, then these chemical substances have not yet been nominated. Companies can nominate the substances and submit the required evidence.
The pesticide legislation and regulations in the countries share the following basic concepts:
* Submission of application to register for pesticide use, with required data and other information, and a draft of a label;
* Formation of a Technical Advisory Committee to assist in the evaluation of scientific data submitted for registration;
* Appointment of inspectors or officers to monitor and enforce the law; and " Control of imports and restrictions on availabiliy.
The agricultural sector in Vietnam has played the leading role in the transition to a market economy. Economic liberalization began with the realization that, with a population growing faster than food production and national income, Vietnam would soon be in a position where it could not guarantee its own food supply. Learning from the experiences of other countries, Vietnam immediately revised its plant protection policy and adopted IPM as its main program for plant protection. Where pesticides are to be used, the Ministry of Agriculture and Food Industries conducts research and training to guide the farmers on their pest management practices.
Domestic and foreign entities and individuals (with representative offices, companies, company branches trading in plant protection drugs licensed for operation in Vietnam) that manufacture plant protection drug active ingredients.
plant protection drugs of technical grade or finished plant protection products from the technicalgrade drugs may register under their own names PPD which they manufacture.
A manufacturer of active ingredients, technical-grade drugs or finished products that does not register them under its/his/her own name may authorize only one organization or individual that fully satisfies the conditions prescribed in Clause 3, Article 50 of the Law on Plant Protection and Quarantine to register each plant protection drug under its/his/her name.
An entity or individual may be authorized by only one manufacturer of active ingredients, technical-grade drugs or finished products to register each of those active ingredients, technical-grade drugs or finished products.
Register one trade name for each active ingredient, technical-grade drug or finished product for pest prevention and control or crop growth regulation. In case such active ingredient, technical-grade drug or finished product is used for disinfection of warehouses; preservation of plants; killing of termites harmful to construction works or dikes; or treatment of seeds, one more trade name shall be registered.
Register only one active ingredient content for each formulation of a plant protection drug; c/ Transfer trade names under Clauses 2, 3 and 4, and Points a and b, Clause 5, of this Article; d/ Not change trade names of plant protection drugs on the list, unless the state management agency in charge of intellectual property or a court makes written conclusions that they infringe upon trademarks of trade names on the list.
Change the manufacturer named in the plant protection drug registration certificate in case the manufacturer ceases supply of products or there is a written agreement on termination of authorization between the manufacturer and the authorized organization or individual.
Only five years after the organization or individual that first registers a plant protection drug containing active ingredients not yet on the list is granted a full registration certificate for such drug, may others file dossiers for supplementary registration of new trade names for plant protection drugs containing such active ingredients.
Plant protection drugs containing active ingredients being mixtures of chemicals and biologicals shall be managed like chemical drugs.
Plant protection drugs containing active ingredients not yet included in the list or plant protection drugs with new contents and compositions of active ingredients on the list which are invented and registered for use abroad.
Plant protection drugs containing active ingredients not yet included in the list or plant protection drugs with new contents and compositions of active ingredients on the list which are invented at home and proposed by scientific councils formed by the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam to the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam for recognition as plant protection drugs.
In case of Supplementary registration, Plant protection drugs having their trade names on the list but having their use scope broadened, or their dosage, usage, formulation type or active ingredient content changed.
Plant protection drugs containing active ingredients on the list but registered with other trade names.
A plant protection drug shall be removed from the list in the following cases:
It falls into one of the cases specified in Clause 2, Article 49; Points b and c, Clause 1, Article 54 of the Law on Plant Protection and Quarantine;
It is specified in Annex III to the Rotterdam Convention or warned by the United Nations Food and Agriculture Organization (FAO), United Nations Environmental Program (UNEP) or World Health Organization (WHO).
Procedures for removing a plant protection drug from the list:
In the case specified at Point b, Clause 1 of this Article, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall report to and propose in writing the Minister of Agriculture and Rural Development to remove such plant protection drug from the list.
In the case specified at Point a or b, Clause 2, Article 49 of the Law on Plant Protection and Quarantine, the Plant Protection Department - Ministry of Agriculture and Rural Development of Vietnam shall summarize information and form a scientific council to consider and advise on the removal of such plant protection drug from the list, and report to and propose the Minister of Agriculture and Rural Development to remove such plant protection drug from the list.
The labeling requirements of the countries implementing a registration system are almost completely harmonized based on Relevant FAO guidelines:
All countries require the printing of labels in both the national language and the dialect of the locality where the material is used.
Legibility of the print is a common problem.
To facilitate monitoring of compliance, all countries operating a registration system print the registration number of the product prominently.
Many have imposed the use of color codes, based on the hazard classification system recommended by the World Health Association. Some countries have also incorporated the use of pictograms, as suggested by FAO
The Regulations for Pesticide Registration were promulgated in 1992 by the Ministry of Agriculture and Food Industries; the Plant Production and Protection Department (PPPD) became the implementing authority.
Efficacy protocols have been incorporated into the Vietnamese system. Efficacy trials must be performed at the Plant Production and Protection Stations located in the provinces. Cost and efficacy are the most important factors considered in reaching a regulatory decision.
Because most of Vietnam's pesticide imports are those that have been in use for years throughout the world, Vietnamese authorities believe there is information widely available on these products and that there is no need for the registrant to submit it- information on regulatory decisions abroad is considered more useful.
Recently, a new labeling system has been implemented in accordance with FAO guidelines. Color coding is now used on pesticide labels. In addition, labeling must be in Vietnamese. Because the Ministry of Agriculture and Food Industries is the major formulator, repackager, and retailer of pesticides in Vietnam, the labeling revisions were done uniformly and quickly.
Vietnam has two monitoring laboratories, which check product quality and, on occasion, residues on crops.
Global Product Compliance (GPC) specializes in Global Regulatory Compliance Solutions across sectors
globally. SSS Europe, a familiar name in chemical regulatory and compliance services now formally belongs
under the umbrella of GPC Holding Sweden.
Since 2008, we have emerged as one of the leading names among Global Regulatory Compliance Service
Providers with Representation services in Europe, Asia and Middle East for respective chemical