Chemical -related activities and the chemical industry in Vietnam

Chemical-related activities constitute a major industry, the chemical industry, that has a profound and extensive impact on Vietnam’s economy. Understanding this, Apolat Legal hereby provides our clients, other companies that are currently investing or planning to invest in the production and business of chemicals or conducting chemical-related activities in Vietnam, an overview of the law regulations related to chemical-related activities, chemical production and busines, and issues related to the production and use of chemicals in Vietnam. 

According to the Law on Chemicals:  

“Chemical means an element, a compound or a mixture which is exploited or created by humans from natural or artificial raw materials.”  

“Chemical-related activities means investing in, producing, bottling, packaging, selling and purchasing, importing, exporting, transporting, storing, preserving, using, researching into and testing chemicals, disposing of discarded chemicals and disposing of chemical waste.” 

According to the above two regulations, the scope of application is very broad and may affect many business operations in Vietnam that are related to the production, trading and use of chemicals. While operating in Vietnam, we have given consultation to many Vietnamese enterprises and foreign investors who are engaged in activities related to the production, trading and use of chemicals in their business operations. We have found that there are a number of difficulties and obstacles in understanding and applying the law in this field. Therefore, we would like to share with our readers important explanations and notes related to the production, trading and use of chemicals in Vietnam, which will be presented in three parts: 

Part 1: General issues regarding chemical-related activities in Vietnam;  

Part 2: Important notes on industrial chemical-related activities; 

Part 3: Important notes on chemical-related activities in other sectors such as medicine, agriculture, etc. 

Part 1: General issues regarding chemical-related activities in Vietnam

1. How are chemical-related activities regulated in Vietnam? 

As mentioned in the introduction, chemical-related activities are broadly defined under the Law on Chemicals. According to this, “chemical-related activities means investing in, producing, bottling, packaging, selling and purchasing, importing, exporting, transporting, storing, preserving, using, researching into and testing chemicals, disposing of discarded chemicals and disposing of chemical waste.” 

Based on this definition, chemical-related activities are regulated by the Law on Chemicals and encompass a wide range of activities that may affect various business sectors involved in the production, trading, and use of chemicals in their operations. However, in addition to the Law on Chemicals and its guiding documents, other specialized laws related to healthcare, pharmaceuticals, agriculture, and other fields may also contain provisions related to chemical-related activities in such fields. These include: 

• Chemicals in the industrial sector are regulated under Decree No. 113/2017/ND-CP and its guiding documents. 

• Pharmaceuticals, disinfectants, insecticides, food, and cosmetics are regulated under the Law on Pharmaceuticals and its guiding documents, as well as other legal documents related to products containing or using chemicals under the management of the Ministry of Health.  

• Pesticides and fertilizers, which contain chemicals, are managed by the Ministry of Agriculture and Rural Development under specific legal documents related to this field. 

• Gasoline, oil, condensate, and naphtha used in petroleum refining are under the specialized management of the Ministry of Industry and Trade and are regulated under specific legal documents related to this field.  

2. Which chemicals does Decree No. 113/2017/ND-CP apply to?  

Decree No. 113/2017/ND-CP (Decree No. 113) is one of the important legal documents regulating chemical-related activities in Vietnam. However, its scope is limited to industrial chemicals under the specialized management of the Ministry of Industry and Trade. Decree No. 113 does not regulate chemical-related activities with respect to the following product categories: 

• Pharmaceuticals, disinfectants, insecticides, food, and cosmetics; 

• Animal feed; veterinary drugs; pesticides; organic fertilizers, biological fertilizers, chemical fertilizers (mixed fertilizers, organic-mineral fertilizers, biological-mineral fertilizers); products for preserving and processing agricultural, forestry, aquatic products and food; 

• Radioactive substances; building materials; paints, printing inks; adhesives and cleaning products for household use; 

• Gasoline, oil; condensate, naphtha used in petroleum refining. 

Chemical-related activities related to these products are regulated by specialized laws and may be under the specialized management of different ministries and authorities according to the specific provisions of the law and the assignment of management tasks and functions.  

3. State governance over chemical-related activities

a. The Government shall perform uniform State governance of chemical-related activities nationwide.  

b. The Ministry of Industry and Trade shall take responsibility before the Government for the performance of State governance of chemical-related activities:  

• To promulgate according to its competence or submit to the Government for promulgation legal documents, strategies, plannings and plans on development of the chemical industry and technical regulations on chemical safety; 

• To assume the prime responsibility for, and coordinate with ministries and branches in, formulating and submitting to the Government for promulgation a national chemical database, a list of chemicals subject to conditional production and trading, a list of chemicals restricted from production and trading, a list of banned chemicals; a list of chemicals subject to declaration and the list of chemicals requiring chemical incident prevention and response plans; 

• To manage chemicals for industrial use, chemicals which are pre-substances for industrial use and chemicals under the Convention on the Prohibition of the Development, Production, Stockpiling, Use of Chemical Weapons and on their Destruction; to manage chemicals used in consumer industrial products; to promulgate a list of chemicals banned from use in domestic products and consumer products, except those managed by the Ministry of Health and the Ministry of Agriculture and Rural Development; 

• To develop a national chemical database; 

• To perform the uniform management of the classification and labeling of hazardous chemicals; chemical registration and declaration and chemical safety information; 

• To synthesize and produce statistics on the chemical safety situation nationwide; 

• To guide the elaboration and organize the appraisal of chemical incident prevention and response plans; to coordinate with concerned authorities in preventing, responding to and remedying chemical incidents; 

• To enter into international cooperation in chemical-related activities and chemical safety; 

• To specify technical-material foundations and professional conditions on chemical facilities under its management; 

• To participate in the dissemination of and education about the law on chemicals; 

• To inspect chemical-related activities; to settle complaints and denunciations concerning chemical-related activities; 

• To perform other tasks concerning chemical-related activities as assigned by the Government. 

c. Ministries and ministerial-level authorities shall, within the scope of their task and powers, coordinate with the Ministry of Industry and Trade in performing the State governance of chemical-related activities under the Government’s assignment: 

• The Ministry of Natural Resources and Environment shall promulgate according to its competence or submit to competent authorities for promulgation regulations on environmental protection concerning chemical-related activities, the disposal and discard of residual toxic chemicals, residual toxic chemicals of the past wars, toxic chemicals of unclear origin and confiscated toxic chemicals.  

• The Ministry of Science and Technology shall promulgate and announce according to its competence standards and technical regulations on chemical safety; to submit to competent authorities for promulgation policies on research into, development and application of technologies suitable to the use of less hazardous chemicals.  

• The Ministry of Transport shall promulgate according to its competence to submit competent authorities for promulgation regulations on the transportation of hazardous chemicals by road, inland waterway, railway, airway or sea; and formulate additional technical regulations on transportation of hazardous chemicals.  

• The Ministry of Health shall manage chemicals used for preparation of pharmaceuticals for humans, germicidal and insecticidal substances for domestic and medical use; coordinate with ministries and branches in providing for labor safety and sanitation in chemical-related activities; coordinate with the Ministry of Industry and Trade in formulating a list of banned chemicals and a list of chemicals restricted from production or trading in the health domain for submission to the Government for promulgation; promulgate a list of chemicals banned from use, restricted from use or permitted for use in the health domain, and a list of germicidal and insecticidal substances for household and medical use, pharmaceuticals and food additives.  

• The Ministry of Agriculture and Rural Development shall manage chemicals used in cultivation, husbandry, aquaculture, animal health, plant protection and preservation and processing of agricultural, forest and aquatic products and food; coordinate with the Ministry of Industry and Trade and concerned ministries and branches in formulating a list of banned chemicals and a list of chemicals restricted from production and trading; promulgate a list of chemicals banned from use, restricted from use or permitted for use in the agricultural domain; guide the classification, labeling and making of chemical safety data sheets for plant protection drugs.  

• The Ministry of Public Security and the Ministry of Defense shall manage chemicals and chemical products in the defense and security domains.  

• The Ministry of Labor, Invalids and Social Affairs shall promulgate according to its competence or submit to competent authorities for promulgation regulations on labor safety and sanitation for laborers engaged in chemical-related activities; manage the use of chemicals in job-training establishments.  

• The Ministry of Education and Training shall manage the use of chemicals in schools and other educational establishments within the national educational system 

d. People’s Committees at all levels shall perform the State governance of chemical-related activities in their localities under the Government’s decentralization:

• People’s Committees at various levels shall, within the scope of their tasks and powers, manage, inspect and settle complaints and denunciations, and sanction administrative violations in chemical-related activities in their localities under the Government’s decentralization, this Law and other relevant law regulations.  

• Provincial-level People’s Committees have professional authorities assisting them the Committees in managing chemical-related activities in localities as prescribed by the Government. 

e. Management of activities related to inspection of chemical-related activities, handling of violations, settlement of disputes in chemical-related activities 

• The Ministry of Industry and Trade, concerned ministries and branches and People’s Committees at all levels shall inspect chemical-related activities within the management scope assigned or decentralized to them.  

• Authorities, organizations and individuals that violate the provisions of this Law and other legal provisions on chemical-related activities shall, depending on subject, nature and severity of their violations, be administratively sanctioned or examined for penal liability; if causing damage, they shall pay compensations in accordance with law regulations. 

• Disputes in chemical-related activities shall be resolved in accordance with Article 68 of the Law on Chemicals (including Negotiation; Conciliation; Referral to a Court or commercial arbitration).   

4. Noteworthy key points with respect to chemical use other than chemical production and trading

a. Organizations and individuals using chemicals for production of other products and goods may: 

• Request suppliers of hazardous chemicals to provide adequate and accurate information on their properties and characteristics, information on their classification and labeling and their chemical safety data sheets;

• Abide by regulations on chemical safety management;  

• Have persons in charge of chemical safety; to satisfy requirements on material – technical foundations and professional capacity regarding chemical safety suitable to the quantity and properties of chemicals;  

• Provide periodical training and re-training in chemical safety to their laborers;  

• Provide sufficient, accurate and timely information and guidance on chemical safety to laborers and managers;  

• Update and store information on used chemicals as prescribed in Article 53 of the Law on Chemicals;  

• Promptly notify chemical suppliers and chemical management authorities upon detection of signs of new hazardous properties of used chemicals;  

• Abide by inspection requests of competent state management authorities in the implementation of regulations on chemical safety. 

b. Organizations and individuals using hazardous chemicals for production of other products and goods shall: 

• Ensure safety conditions for humans and the environment in the process of using and preserving hazardous chemicals;  

• Abide by technical regulations on the contents and quality standards of hazardous chemicals in the production of other products and goods;  

• Not use toxic chemicals having specific properties (Causing cancer or posing threats of causing cancer; Causing genetic mutation; Reproductively toxic; Bio-accumulative) in food, cosmetics, food additives or food preservatives; 

• Install a signaling system in the places where hazardous chemicals are used or stored which is suitable to the hazard of chemicals; if the chemicals have different hazardous properties, the warning signs must fully display these properties;  

• Supply sufficient, accurate and timely information and guidance on chemical safety to persons who directly use, preserve or transport chemicals and persons who manage chemical production;  

• Observe legal provisions on disposal and discard of hazardous chemicals and their containers. 

c. Organizations and individuals using chemicals for consumption purposes: 

• May request suppliers to provide sufficient information on hazardous properties of chemicals and safety requirements and pay compensation for damage caused in the process of using chemicals due to incorrect information provided by suppliers. 

• Organizations and individuals using chemicals for consumption purposes are obliged to strictly comply with technical instructions accompanied with chemicals or displayed in chemical labels and ensure safety for themselves and the community.  

• Organizations and individuals using hazardous chemicals for production of products and goods shall abide by the provisions of Article 21 of the Law on Chemicals on storage and preservation of hazardous chemicals.  

• Organizations and individuals using hazardous chemicals for consumption purposes shall abide by manufacturer instructions which are displayed on labels or packages of, or in the use instruction sheets accompanied with, chemical products. 

d. Some general provisions applicable upon use of chemicals: 

• Organizations and individuals using chemicals for production of products and goods or using chemicals for scientific experimentation or research or consumption shall dispose of and discard residual chemicals and chemical wastes and containers according to the law on environmental protection.  

• Discarded chemicals must be disposed of by appropriate technologies up to environmental protection standards. 

• Chemicals consumed by households and individuals must be discarded according to manufacturer recommendations and legal provisions on environmental protection so as to ensure safety for humans and the environment.

Part 2: Important notes on industrial chemical-related activities

1. Legal documents governing industrial chemical-related activities

Industrial chemical-related activities are under the specialized management of the Ministry of Industry and Trade. The following are the legal documents currently applicable to entities engaged in industrial chemical-related activities: 

• Decree No. 113/2017/ND-CP providing detailed guidelines for the Law on Chemicals (“Decree No. 113”)  

• Circular No. 32/2017/TT-BCT providing detailed guidelines for Decree No. 113/2017/ND-CP (“Circular No. 32”) 

• Circular No. 17/2022/TT-BCT amending and supplementing Circular No. 32/2017/TT-BCT (“Circular No. 17”) 

2. Classification and management of industrial chemicals

The classification of chemicals under Decree No. 113 and Circular No. 32 is based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) from Revision 2, 2007 onwards and is specified in Appendix 7 to Circular No. 32. However, in this part, we will categorize chemicals based on the level of management and legal requirements for each group of chemicals: 

Group 1: Industrial chemicals subject to conditional production and trading  

• Substances or mixtures of substances listed in Appendix I and Appendix II other than those in the category of industrial chemicals restricted from production and trading, which require production licenses. 

• To produce and trade these chemicals, entities must apply for a certificate of qualification for production of and trading in chemicals, unless otherwise prescribed in Article 10a of Decree No. 113, such as:

• • Activities of chemical dilution and mixing without chemical reactions forming industrial chemicals subject to conditional production and trading to put into use and production of other products and goods of the organizations and individuals. 

• • Chemical composition in the mixtures of substances listed as industrial chemicals subject to conditional production and trading has the content in the mixtures of substances less than 0.1%. 

• Conditions that entities must meet include groups of conditions related to: qualification, facilities, and personnel standards;

• The authority responsible for granting the certificate of qualification for production of and trading in chemicals is the provincial-level Department of Industry and Trade in the locality where the enterprise’s head office is located; 

• This group also includes chemicals that are industrial precursors:

• • When enterprises export and import chemicals that are industrial precursors, they must also obtain licenses for import and export of industrial precursors and comply with the management and control regulations related to the production and trading of industrial precursors as prescribed in Section 3 of Decree No. 113. 

• • Industrial precursors mean chemicals used as materials, solvents or catalysts in production, scientific research, analysis and testing, which are also indispensable chemicals in the preparation and production of narcotics.

Group 2:  Industrial chemicals restricted from production and trading 

• Substances or mixtures containing substances listed in Appendix II to Decree No. 113 and having hazardous properties according to Clause 2, Article 14 of Decree No. 113. 

• Organizations and individuals may produce or trade in industrial chemicals restricted from production and trading only after being granted the licenses for production of or trading in industrial chemicals restricted from production and trading.

• The licensing conditions are similar to those for granting the Certificate of Qualification for Industrial Chemical Production and Trading.

• The licensing authority is the Vietnam Chemicals Agency. 

Group 3:  Banned chemicals 

• Banned chemicals are extremely hazardous chemicals listed in Appendix III to Decree No. 113; 

• Organizations and individuals may not produce, trade in, transport, store and use chemicals on the list of banned chemicals, unless otherwise in special cases for the purposes of scientific research, defense and security assurance or epidemic prevention and control, which must be permitted by the Government.

Group 4:  Toxic chemicals 

• Toxic chemical means a hazardous chemical having at least one of the hazardous properties defined from Points dd thru n, Clause 4, Article 4 of the Law on Chemicals; 

• Purchase and sale of toxic chemicals require toxic chemical purchase and sale control cards as prescribed in Article 23 of the Law on Chemicals; 

Group 5: Hazardous chemicals requiring a chemical incident prevention and response plan 

• The list of hazardous chemicals requiring a chemical incident prevention and response plan is provided in Appendix IV to Decree No. 113; 

• Owners of investment projects producing, trading, storing and using chemicals whose storage threshold during the business process is greater than the level specified in Appendix IV must develop measures to prevent and respond to chemical incidents before putting the projects into operation. 

Group 6: Chemicals subject to declaration 

• Chemical-importing organizations and individuals shall declare chemicals. Chemical-producing organizations and individuals shall declare chemicals to professional authorities managing chemical-related activities under provincial-level People’s Committees. 

• The list of chemicals subject to declaration is provided in Appendix V to this Decree. This Group covers chemicals subject to special control, which require due attention, including: dinitrogen monoxide, cyanide compounds, mercury and mercury compounds, which require a special procedure as prescribed at Point b, Clause 4a of Decree No. 82/2022/ND-CP. 

• Importers of chemicals subject to declaration shall declare imported chemicals before customs clearance via the Vietnam National Single Window portal.

• Producers of chemicals subject to declaration shall declare chemicals produced every year in annual reports prescribed in Article 36 of Decree No. 113.

Group 7: New chemicals 

• New chemical means a chemical not yet listed in the national chemical inventory or foreign chemical inventories recognized by Vietnamese competent state authorities. 

• New chemicals may be used or marketed only after they are registered with competent state authorities.  

• Organizations and individuals producing and importing new chemicals are obliged to register New Chemicals with the Vietnam Chemicals Agency.

Please note that when trading industrial chemicals, a chemical may belong to more than one group of chemicals and the conditions to be complied with are divided as above. Therefore, when producing chemicals, organizations and individuals should carefully study the issues that need to be complied with, the types of licenses and conditions that need to be met when producing and trading respective chemicals. 

For example: a chemical may need to be declared upon import, require a certificate of qualification for trading in, and also require an industrial precursor import license. 

3. Cases where the conditions do not apply to industrial chemical-related activities in the industrial sector

Some chemical activities are not subject to the specific chemical management regulations in the industrial sector. These cases include: 

Category 1: Cases not subject to the grant of certificates of qualification for production of and trading in industrial chemicals subject to conditional production and trading 

• Activities of chemical dilution and mixing without chemical reactions forming industrial chemicals subject to conditional production and trading to put into use and production of other products and goods of the organizations and individuals. 

• Chemical composition in the mixtures of substances listed as industrial chemicals subject to conditional production and trading has the content in the mixtures of substances less than 0.1%. 

Category 2: Cases of exemption from chemical declaration 

• Chemicals produced or imported for the purposes of national defense and security and emergency response to natural disasters and epidemics.  

• Chemicals that are precursors of narcotics, precursors of explosives, industrial explosives and chemicals on the chemical schedules already licensed for production or import.

• Chemicals imported with an amount of under 10 kg per import shipment. This exemption does not apply to industrial chemicals restricted from production and trading. 

• Chemicals that are drug materials with certificates of registration for sale of drugs in Vietnam, drug materials that are pharmaceuticals for production of drugs with certificates of registration for sale in Vietnam under drug registration dossiers.

• Chemicals that are materials for production of pesticides with certificates of registration in Vietnam.

• Chemical composition in the mixtures of substances listed as chemicals subject to declaration has the content in the mixtures of substances less than 0.1%.

Category 3: Cases where owners of investment projects on production, trading, storage and use of chemicals shall not make chemical incident prevention and response plans 

If the maximum storage volume at a point of time is less than the volume limit specified in Appendix IV to Decree No. 113. 

4. National chemical database

The national list of chemicals and national chemical database shall be used for the management of chemical safety and provision of information for the system of responding to inquiries and providing information about hazardous chemicals in cases of emergency. 

Link to the national chemical database: https://chemicaldata.gov.vn/ 

5. Classification and labeling of chemicals  

• Organizations and individuals producing or importing chemicals are obliged to classify and label chemicals before using or marketing these chemicals are used or marketed. 

• Chemicals are classified in accordance with technical principles and guidance of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). 

• Chemicals are labeled in accordance with the law on goods labeling.

• Hazardous chemicals are labeled in accordance with the law on goods labeling and guidance of the Globally Harmonized System of Classification and Labeling of Chemicals.

6. Material safety data sheets, provision of training in chemical safety, reporting responsibility

• Hazardous chemicals include hazardous substances or mixtures with the content of hazardous substances exceeding the limit (prescribed in Article 24 of Decree No. 113). For hazardous chemicals, material safety data sheets must be made.

• Organizations and individuals producing or importing hazardous chemicals, before using or marketing these chemicals, shall make material safety data sheets (“MSDS” or “SDS”).

• Hazardous chemical producers and traders shall provide material safety data sheets for organizations and individuals engaged in chemical-related activities.

• Material safety data sheets shall be made in Vietnamese.

• Organizations and individuals engaged in chemical-related activities shall provide training in chemical safety or appoint the persons specified in Decree No. 113 to participate in training courses organized by chemical safety training centers in accordance with Appendix VI to Decree No. 113. 

• Before February 15 every year, organizations and individuals engaged in chemical-related activities shall make general reports on chemical-related activities in the previous year on the national chemical database.

• Organizations and individuals engaged in chemical-related activities shall make ad-hoc reports upon the occurrence of incidents in chemical-related activities or termination of chemical-related activities and upon request by a competent authority. 

Part 3: Important notes on chemical-related activities in other sectors such as medicine, agriculture, etc

Group 1: Chemical Activities in the fields of: Pharmaceuticals; antibacterial and insecticidal preparations; food; and cosmetics

a. Chemical Activities in the field of Pharmaceutical:  

According to the definition, Pharmaceuticals are drugs and drug materials. Accordingly, the key legal document regulating business activities and related to pharmaceuticals in Vietnam is the Law on Pharmacy and its guiding documents. The scope and subjects of application of the Law on Pharmacy are as follows: 

• The Law on Pharmacy regulates the State’s policies on pharmacy and the development of the pharmaceutical industry; the practice of pharmacy; pharmaceutical business; registration, circulation, and recall of drugs and drug materials; medicinal materials and traditional drugs; medical prescriptions and use of drugs; drug information, pharmacovigilance, and drug advertisement; clinical pharmacy; management of drugs at medical examination and treatment establishments; clinical trial and bioequivalence trial of drugs; management of the quality of drugs and drug materials and management of drug prices. 

• The Law on Pharmacy applies to domestic agencies, organizations, and individuals, as well as foreign organizations and individuals involved in pharmaceutical activities in Vietnam.   

• The Ministry of Health is the agency primarily responsible for managing business activities and other activities related to pharmaceuticals. 

Notes:

• Regarding conditions related to entities: in order to engage in the pharmaceutical business (including finished products and raw materials) across all stages of the pharmaceutical business process, entities shall meet the conditions (facilities, personnel, techniques) as prescribed by law for pharmaceutical business establishments. This is required to obtain a Certificate of Eligibility for Pharmaceutical Business Activities (Certificate of Eligibility for Production, Distribution, Retail, and Storage of Pharmaceuticals).   

• One of the important conditions for engaging in the pharmaceutical business is that the establishments must obtain a good practice certification in the specific pharmaceutical field to be eligible for the certificate of eligibility for pharmaceutical business activities as mentioned above. Specifically, production activities require GMP, distribution activities require GDP, retail requires GPP, and drug storage requires GSP. 

• Pharmaceutical products, including imported and domestically produced products, are strictly regulated by the Ministry of Health, specifically the Drug Administration of Vietnam. Accordingly, finished pharmaceutical products and pharmaceutical raw materials must be registered for circulation before being allowed to be imported, traded, and circulated in Vietnam.  

b. Chemical activities related to chemical products, insecticidal and antibacterial preparations used in household and healthcare fields:

• Decree 91/2016/ND-CP is the document regulating activities related to the production, bottling and packaging (hereinafter referred to as production), testing, field trials, circulation, purchase and sale, transportation, export and import of chemicals, insecticidal and antibacterial preparations used in household and healthcare fields. 

• Circular No. 09/2018/TT-BYT promulgates the list of chemicals, insecticidal and antibacterial preparations used in healthcare and household fields under the management of the Ministry of Health.

• Chemicals and antibacterial preparations for food (regulated by food safety regulations) and chemicals and preparations used solely for disinfecting medical equipment (regulated by medical equipment regulations) are not within the scope of this Decree.  

• The Ministry of Health is the agency primarily responsible for managing business activities and other activities related to Chemicals in this activity. 

Notes:

In addition to the general conditions stipulated in the Law on Chemicals, the production and business of Chemicals and preparations in this category require important attention to the following: 

• When producing chemicals, insecticidal and antibacterial preparations in the household and healthcare fields, it is necessary to meet the conditions on personnel, facilities, and equipment as prescribed in Decree 91/2016/ND-CP, as amended and supplemented by Decree 155/2018/ND-CP, and to declare the eligibility for production. 

• To be circulated in Vietnam, chemicals and preparations in this category must be notified for circulation in Vietnam. 

c. Chemical Activities in food business: 

• The Law on Food Safety and its guiding documents regulate the use of chemicals and food additives permitted for use in food business activities. 

• Circular No. 27/2012/TT-BYT regulates the management of food additives, with an appendix specifying the additives permitted for use in food production, processing, and business, along with maximum allowable limits for these additives in food products. 

• The Ministry of Health is the agency primarily responsible for managing business activities and other activities related to chemicals in this activity. 

Notes: 

As presented above, chemicals and food additives used in food must meet food safety conditions, specifically: 

• Establishments producing and trading chemicals and food additives must meet the conditions on facilities, personnel, etc., to be eligible for the Certificate of Eligibility for Food Safety. 

• Among the cases not subject to the issuance of a Certificate of Eligibility for Food Safety are prescribed in Article 12 of Decree 15/2019/ND-CP, there is specific provision stating that if an establishment has already been issued certain types of certifications, it is not required to apply for the Certificate of Eligibility for Food Safety. These certifications include: Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), ISO 22000 Food Safety Management System, International Food Standard (IFS), British Retail Consortium Global Standard for Food Safety (BRC), Food Safety System Certification (FSSC 22000) or equivalent, which are still valid. 

• Depending on the type of product, these chemical products, food additives, and food processing aids must undergo one of the following two procedures before being circulated in the market: (1) Self-declaration of the product; (2) Registration of the product declaration. 

d. Chemical Activities in cosmetics business: 

• Decree No. 93/2016/ND-CP and Circular No. 06/2011/TT-BYT are the two important documents related to cosmetics production activities in Vietnam. 

• The Ministry of Health is the agency primarily responsible for managing business activities and other activities related to the use of chemicals in the cosmetics business in Vietnam. 

Notes: 

• In order to engage in cosmetic production, the establishment must meet the conditions on personnel, facilities, techniques, etc., and be issued a certificate of eligibility for cosmetics production; 

• Cosmetic products must meet the conditions on ingredients as prescribed in Circular 06/2011/TT-BYT and undergo the procedure for Cosmetic Product Declaration before being circulated in Vietnam. 

Group 2: Chemical activities in the fields of animal feed; veterinary drugs; pesticides; organic fertilizers, bio-fertilizers, chemical fertilizers that are compound fertilizers, organic-mineral fertilizers, bio-mineral fertilizers; products for preservation and processing of agricultural, forestry, aquatic and food products

a. Chemical activities in the field of animal feed:

• According to the definition in the Law on Animal Husbandry, Animal feed means products which domestic animals eat or drink in fresh, live, or processed form, including complete compound feed, concentrate feed, supplementary feed and traditional feed. 

• The basic legal documents regulating chemical activities in the field of animal feed include the Law on Animal Husbandry and guiding documents of the Law on Animal Husbandry.  

• The specialized regulatory authority for the field of animal feed is the Ministry of Agriculture and Rural Development, in which the Department of Livestock Production under the Ministry is the unit in charge of managing activities related to animal feed nationwide. 

Notes: 

• Animal feed must have its applied standards and conformity declared in accordance with the law on standards, technical regulations, product and goods quality. 

• Animal feed production facilities must meet requirements for location, infrastructure, position, personnel, etc., and possess a Certificate of Eligibility for Animal Feed Production issued by a competent state authority. 

• Information on animal feed products must be disclosed on the portal of the Ministry of Agriculture and Rural Development. 

• Labels or accompanying documents for animal feed must comply with Article 46 of the Law on Animal Husbandry. 

b. Chemical activities in the field of Veterinary Drugs 

• According to the definition in the Law on Animal Health, Veterinary Drugs means a single substance or a mixture of substances including pharmaceuticals, vaccines, biological products, microorganisms, chemicals approved for use in animals to prevent, treat, diagnose diseases, or regulate, rehabilitate growth and reproductive function of animals.  

• The primary legal documents regulating chemical activities in the field of veterinary drugs include: the Law on Animal Health and guiding documents of the Law on Animal Health. 

• The specialized regulatory authority for the field of veterinary drugs is the Ministry of Agriculture and Rural Development in which the Department of Animal Health under the Ministry is the unit in charge of managing activities related to Veterinary Drugs nationwide.  

Notes: 

• Veterinary drugs must meet quality standards according to technical regulations and be granted a Certificate of Circulation for Veterinary Drugs in Vietnam. 

• Veterinary drugs must be registered for circulation before being used in Vietnam, except in cases of importation under import license regulations. 

• Organizations and individuals importing veterinary drugs as prescribed in Clauses 1, 2, and 3, Article 100 of the Law on Veterinary Drugs must obtain an import license and use the drugs for the purposes stated in the import license issued by the Department of Animal Health. 

• Facilities involved in the production, wholesale, or import of veterinary drugs must meet requirements for infrastructure, personnel, location, and equipment as prescribed by the Law on Veterinary Drugs and be granted corresponding certificates:  

• • Certificate of Eligibility for Veterinary Drug Import.

• • Certificate of Eligibility for Veterinary Drug Production.

• • Certificate of Eligibility for Veterinary Drug Wholesale.

c. Chemical activities in the field of pesticides 

• According to the definition in the Law on Plant Protection and Quarantine, Pesticides means substances or mixtures of substances or preparations of microorganisms which have the effect of preventing, deterring, repelling, attracting, destroying or controlling organisms harmful to vegetation; regulating the growth of plants or insects; preserving plants; increasing safety and effectiveness when using drugs. 

• The primary legal documents regulating chemical activities in the field of Pesticides include: the Law on Plant Protection and Quarantine and guiding documents of the Law on Plant Protection and Quarantine. 

• The specialized regulatory authority for the field of Pesticides is the Ministry of Agriculture and Rural Development, in which the Plant Protection Department under the Ministry is the unit in charge of managing activities related to Plant Protection Drugs nationwide. 

Notes:

• Pesticides are conditional business goods and must be managed according to the List. 

• Organizations and individuals are allowed to import, produce, trade, and use products listed in the List of pesticides permitted for use in Vietnam.  

• Organizations and individuals are allowed to import, produce, trade, and use products listed in the List of pesticides permitted for use in Vietnam. Pesticides must be granted a Certificate of Registration for pesticides before circulation in Vietnam, except in cases of importation under import license. 

• Pesticide production and trading facilities must obtain a Certificate of Eligibility for Pesticide Production and Trading upon meeting the prescribed requirements. 

• The import of pesticides is only permitted after a Certificate of Registration for pesticides has been granted, except in cases of importation under import license as prescribed in Clause 2, Article 67 of the Law on Plant Protection and Quarantine. 

• The transportation, storage, advertising, packaging, labelling, and use of pesticides must comply with Section 3 of the Law on Plant Protection and Quarantine and its guiding documents. 

d. Chemical activities in the field of fertilizers 

• According to the definition in the Law on Crop Production, Fertilizer means a product that provides nutrients or improves the soil to increase crop yield and quality. 

• The primary legal documents regulating chemical activities in the field of fertilizers include: the Law on Crop Production and documents guiding the implementation of the Law on Crop Production. 

• The specialized regulatory authority for the field of fertilizers is the Ministry of Agriculture and Rural Development, in which the Plant Protection Department under the Ministry is the unit in charge of managing activities related to fertilizers nationwide. 

Notes:

• Fertilizers are conditional business goods and must be granted a Decision on Recognition of Fertilizer Circulation in Vietnam, except for organic fertilizers produced for non-commercial purposes and fertilizers imported under a Fertilizer Import Permit as prescribed in Clause 2, Article 44 of the Law on Crop Production.   

• The Decision on Recognition of Fertilizers in Circulation in Vietnam is valid for 05 years and may be extended. 

• Domestic organizations and individuals or foreign organizations and individuals with representative offices or branches operating in the field of fertilizer in Vietnam are eligible to register for recognition of fertilizer circulation. 

• Organizations and individuals producing fertilizers must obtain a Certificate of Eligibility for Fertilizer Production. Specifically, the requirements for location, factory area, machinery and equipment, testing laboratories, quality management systems, etc., as prescribed by the Law on Crop Production and its guiding documents must be satisfied. 

• Organizations and individuals trading fertilizers must obtain a Certificate of Eligibility for Fertilizer Trading; except cases where they only sell fertilizers they produce. 

• The labelling and advertising of fertilizers must comply with the Law on Crop Production and related legal documents regarding labelling and advertising. 

d. Chemical activities in the field of products for preservation and processing of agricultural, forestry, aquatic and food products 

• Chemical activities in this field must comply with the Law on Food Safety and guiding documents such as Decree 15/2018/ND-CP guiding the Law on Food Safety. 

• The regulatory authorities in this field include the Ministry of Agriculture and Rural Development, the Ministry of Health and the Ministry of Industry and Trade. The division of management scope among these 03 authorities shall comply with the Law on Food Safety and Decree 15/2018/ND-CP regarding the list of products prescribed and assigned to each Ministry. 

• In principle, the management responsibilities for products under the authority of the Ministry of Agriculture and Rural Development, the Ministry of Health, and the Ministry of Industry and Trade are organized correspondingly at local levels (province/city, district, and commune/ward) in alignment with the structure of each Ministry from the central to local levels.  However, in some cases where there are general or specific law regulations, that local authority may establish a specialized agency under its authority to manage all food safety matters, without separating responsibilities by product type or category.  

Specifically, as of 2024, applying the mechanism prescribed in Resolution 98 regarding piloting a number of specific mechanisms and policies for the development of Ho Chi Minh City, Ho Chi Minh City establishes the Department of Food Safety for management of all food safety matters in the city. 

Notes:

• The production and trade of products for preservation and processing agricultural, forestry, aquatic, and food products are applied to corresponding regulations depending on the product type, characteristics, and intended use, such as: 

• • For the protection of agricultural products during the seed stage, cultivation, crop protection in the field, and the preservation of agricultural products to prevent, deter, repel, attract, destroy, or control harmful organisms (such as fungi, insects, weeds, nematodes, bacteria, viruses, etc.), and for the preservation of agricultural and forest products after harvest (but before food processing), the pesticides fall under the category of pesticides managed by the Ministry of Agriculture and Rural Development and regulated by the Law on Plant Protection and Quarantine. 

• • Chemicals used to wash vegetables, fruits, agricultural products, seafood, and food during the preliminary processing stage fall under the category of food additives regulated by the Law on Food Safety and, in my opinion, are managed by the Ministry of Health; 

• Organizations and individuals engaging in the production and trade of these products must identify which category their product falls into and which regulatory authority is responsible for managing them to ensure compliance with regulations. This identification can sometimes be challenging, and it may be necessary to seek advice from specialized and experienced units or consult with specialized regulatory authorities.