Regulatory environment

General laws and regulations

As mentioned previously under Market Entry Considerations, Vietnam has specific import requirements for any given food product. It is critical for Canadian exporters to work with their importer(s) in foreign markets to confirm the official and detailed import requirements applicable to their product(s) and the necessary steps and documentation required. The Government of Canada strongly encourages exporting companies to contact their regional Canadian Food Inspection Agency (CFIA) office to confirm any certification requirements before exporting to Vietnam. Please refer to the following link to find the nearest CFIA office.

This section provides primary legal grounds for food safety in Vietnam and several regulations relevant to agri-food products, including product inspection, registration, labelling requirements, and announcement of conformity. The application dossier, procedures, timeline, and state agencies responsible for each process are also presented in this section.

Law on food safety

The primary legal framework for agricultural products and food imported to Vietnam is the Law on Food Safety (LFS 2010) No.55/2010/QH12 dated June 17, 2010 (the original text can be accessed in Vietnamese, and an unofficial English translation is also available). The LFS 2010 specifies the requirements and obligations for organizations and individuals in relation to the safety of food and food production, trade, transport, import and export; food advertisement and labelling; food testing; food safety risk analysis; prevention of food safety incidents; food safety information, education and communication.

Accordingly, imported processed food products, ingredients, additives, substances used in food processing, tools and materials for packing and containing imported food, and food supplements are subject to sanitary and phytosanitary measures, state inspection, and customs clearance before being they can be circulated in the local market.

Responsibility for food safety is divided among three ministries: the Ministry of Agriculture and Rural Development (MARD), Ministry of Health (MOH), and Ministry of Industry and Trade (MOIT). Responsibilities for the development of policies, guidelines and regulations and enforcing food safety requirements are divided among the three ministries.

The following are some examples of food products falling within the jurisdictions of the three ministries:

• Ministry of Industry and Trade (MOIT): Alcoholic drinks, such as wine and beer; soft drinks, excluding bottled and mineral water; processed milk products; vegetable oil; flour, starch; confectionary, such as bread, biscuits, cakes, candies, chocolate, jams, jellies, fruits, nuts, and other edible parts of plants treated or otherwise preserved and containing sugar, other sweeteners, wine
• Ministry of Agriculture and Rural Development (MARD): Cereals, including pre-processed, processed cereal but excluding flour, starch, and products thereof; meat and meat products; aquaculture and aquatic products; vegetables, tubers, fruits and their products; eggs and egg products; raw milk; honey and honey products; genetically engineered foods; salt; spices, including single and mixed spices, sauces and preparations for sauces; sugar, tea, coffee, cocoa, pepper; cashew; processed or unprocessed seeds, such as sunflower seeds, pumpkin seeds etc.; products derived from plants used as food, raw, pre-processed, or processed (bamboo shoots, black fungus, mushrooms; soy products, except for oil; edible bark, roots, leaves, stems, flowers of some plants, etc.); insect-derived foods, such as crickets (instruments and materials for packaging and containing these food items during manufacture, processing, sale of foods are also under the management of MARD)
• Ministry of Health (MOH): Functional foods (dietary supplements, medical foods, food for special dietary uses; dietary products for children up to 36 months); food additives, flavourings, food processing aids; bottled water, mineral water, consumable ice (food containers and packaging materials in direct contact with food are also regulated by MOH)

Sometimes in practice, multiple agencies might be involved in the approval processes for products. It is advisable for Canadian exporters to use the product HS code and check with the relevant authorities.

Please note that the local distribution or market entry consulting partner will typically take care of the approvals and product registration in Vietnam, with documentation support from the Canadian exporter.

Food inspection

LFS 2010 prescribes that food inspection is classified into three categories based on the nature and type of product: tightened inspection, normal inspection, and simplified inspection. Correspondingly, imported food inspection will be conducted by MOH and/or MOIT, depending on the product, as described in Section 6.1.1.

In 2018, the Vietnamese government issued Decree 15/2018/ND-CP (original text in Vietnamese and an unofficial English translation is available) prescribing the implementation of the Food Safety Law (FSL) 2010 to set up an import inspection regime to streamline and synchronize the import inspection methods applied by MOH, MARD, and MOIT.

This Decree provides the list of imported goods exempt from inspection and specifies regulations on the three methods of food safety inspection mentioned in LFS 2010. In addition, it employs simplified registration and inspection procedures for both domestic and imported food, besides switching to post-clearance inspection (from pre-inspection) and allowing enterprises to reduce the sampling frequency. The responsibility of food safety compliance is now placed on companies and importers through the process of self-declaration, thereby reducing administrative costs and labour expenses for both businesses and authorities.

A normal inspection involves the inspection of dossiers (contents described below) and taking representative samples for sensory inspection, an inspection of labelling, packaging status and the special preservation status if any. A normal inspection is applied to all shipments, except for products that qualify for an exemption, as listed in the table below. A simplified inspection means that only the dossiers submitted by the companies will be inspected.

Under tightened inspection, the competent agency shall either inspect dossiers and take samples for testing the group of indicators in the announced dossiers for goods failing to meet the requirements during previous inspections; or conduct inspection by normal methods and test the warning indicators. They may require the provision of a certificate of analysis for the warning indicators of laboratories accredited and recognized by competent agencies of the exporting country for goods, for which warmings have been issued by the competent agency of foreign countries or the manufacturer.

It should be noted that while customs authorities often conduct and implement simplified/reduced inspections, the inspection bodies under MOH, MARD and MOIT oversee tightened and normal inspections.

Application dossiers

The application dossier for simplified inspection of food safety upon entry includes:

• Product self-declaration Form No. 01 (Vietnamese; translateable) in Appendix I of Decree 15/2018/NC-CP
• Three satisfactory results of consecutive normal inspections or certified/legalized copies of either GMP, HACCP, ISO 22000, IFS, BRC, FSSC 22000 certificate or equivalent (must be valid at the time of submission)
• In the case of terrestrial or aquatic animals and products thereof, except for processed and pre-packaged products, there must be a certificate of compliance with food safety issued by the authorized agencies of the exporting country.

For normal and tightened goods inspection, the application dossier comprises:

• Registration for imported products inspection Form No. 04 (Vietnamese; can be translated) attached in Appendix I of Decree 15/2018/ND-CP
• Product self-declaration Form No. 01 (Vietnamese; can be translated)
• Three satisfactory results of consecutive tightened inspections for shipments, commodities subject to switching over from tightened inspection to normal inspection
• Packing list (List of goods)
• In the case of terrestrial or aquatic animals and products thereof, except for processed and pre-packaged products, it is required to submit a certificate of compliance with food safety issued by the authorized agencies of the exporting country, except for fish caught and processed by foreign vessels and then sold directly in Vietnamese market (if any).

For goods under simplified inspection, at the point of entry, Vietnam Customs will receive the complete dossier and shall check the documents and clear the shipments within three working days. If additional documents are required, the reason and legal grounds must be clearly stated. Customs shall randomly select and inspect 5% of total imported shipments eligible for reduced inspection within one year for the document examination.

For regular/normal and tightened inspections, preceding the day of arrival of the imported goods at Vietnam's port of entry, the owners shall submit the inspection registration dossiers directly to the inspecting authorities, such as MOH, MARD, or the MOIT (as applicable) or via the Vietnam National Single Window (VNSW; https://vnsw.gov.vn/) information portal. The VNSW portal is available only in Vietnamese, and a local entity is required to register and submit documents through the platform.

Within three working days of the application for the normal inspection method and seven working days for the tightened one, the competent authorities shall examine and issue a result notice (Form No.05 in Appendix I of Decree 15/2018/ND-CP; in Vietnamese; can be translated). The owners shall then submit the result and other documents listed above to the Customs Office at the port of entry for customs clearance. If additional documents are needed, the authorities must present the reasons and legal grounds.

It should be noted that plants, animals, and products thereof must be subject to additional import quarantine and other phytosanitary measures before seeking customs clearance. The procedure of import quarantine for such products is detailed in Sections 6.2.1, 6.2.2, 6.2.3 and 6.2.4.

Banned products

Before selling foods and agricultural products to Vietnam, Canadian firms are advised to check the list of goods prohibited from being imported into the country, presented in Appendix I (Vietnamese; can be translated) of Decree 69/2018/ND-CP. Although most food items and common goods are not specified in this list, foreign companies should be aware of the following products that are banned:

• Plant protection drugs that are banned by ARD
• Specimens of endangered, precious and rare wild fauna and flora listed in Appendix I of CITES (the Convention on International Trade in Endangered Species of Wild Fauna and Flora) that are of natural origin and imported for commercial purposes
• Specimens and manufactured products of the species: white rhinoceros (Ceratotherium simum), black rhinoceros (Diceros bicomis), African elephant (Loxodonta Africana)

Product registration

According to Decree No. 15/2018/ND-CP, registration is compulsory for imported processed/pre-packed food products. All organizations and individuals must conduct self-declaration of products (a form of product registration) to confirm quality specifications, labelling information, product shelf-life and other technical information before importing and distributing products in the market. The Vietnamese government has assigned the rights of self-declaration on food product quality and origins to companies and individuals. As a result, entities can reduce registration processing time but simultaneously must take full responsibility for the safety and hygiene of their goods.

Several food products are entitled to self-declaration, including food additives, food containers, primary packages, food processing aids, and pre-packaged processed foods (for other categories, please refer to the declaration procedure in the corresponding sections). Generally, the application dossier for self-declaration includes:

• Self-declaration Form No. 01 in Appendix I of Decree 15 (Vietnamese; can be translated)
• Certificate of Free Sale or Health Certificate
• Certificate of Analysis (including microbial, chemical, heavy metal analysis) or Food testing result issued within 12 months before the date of submission by a designated laboratory or a laboratory complying with ISO 17025
• Certificate of Good Manufacturing Practice (GMP), HACCP Certificate, ISO 22000 Certificate or equivalent
• Importer's business registration certificate including Enterprise Registration Certificate (ERC) and Investment Registration Certificate (IRC)
• Product label
• Product samples

The steps in the process of product self-declaration are undertaken in the following order by businesses and individuals (importers):

• Send product samples to a testing centre designated by the MOH to get a food testing result
• Conduct and publish the self-declaration on mass media or the company's website, or the premises in Vietnam (note that immediately after the self-declaration process, businesses and individuals are entitled to import, produce and trade products and are responsible for the safety and hygiene of such products)
• Submit one hard copy of all required documents to the competent state agencies designated by the People's Committee of the province or city where the business was registered
• The receiving authority posts the product names and self-declaration of those products on its official website
• In some cases, imported products may be randomly inspected by the Ministry of Health before being circulated in the market

The estimated timeline for the registration process is up to four weeks. In case of refusal, the applicant company will be given two months to complete the dossier as requested; otherwise, the dossier will be cancelled. After self-declaration, if there are any changes in product name, origin, or ingredients, the organizations and individuals responsible must re-conduct the self-declaration procedure and notify the competent state agencies in writing of the adjusted contents.

Depending on the type of products, MOH, MARD or MOIT are responsible for food products' registration, depending on the food type, as described in Section 6.1.1.

Canadian companies should note that any addition of a nutrient mineral or additive is enough to consider the product as nutritional food, and subsequently, the responsibility of food safety rules implementation shift from MARD and MOIT to MOH, where their products might be subject to stricter assessment.

Labelling requirements

Vietnamese law imposes strict requirements on the labelling of goods, and most imported products must be labelled with mandatory information related to the products. Required information described on the labels can be different depending on the types of products. Decree No. 43/2017/ND-CP and No. 111/2021/ND-CP are the primary legal frameworks for labelling all categories of food, beverages, and agricultural inputs, regardless of whether they are domestically produced or imported goods. The labelling requirements stipulated in this Decree are not applicable to raw materials (agricultural products, fisheries, minerals, etc.) and unpacked raw or fresh food (for example, live animals) that are sold directly to consumers.

The mandatory details that must be included in labels on imported food generally include the following:

• Name of product
• Name and address of the enterprise or individual responsible for the product
• Name and address of the manufacturer
• Country of origin
• Additional details in conformity with the nature of the goods specified in Appendix I of Decree 111/2021 (Vietnamese; can be translated) and other relevant legal documents (presented in the table below)
• Expiration dates can be represented as “hạn sử dụng” (expiration date), “sử dụng đến ngày” (use-by date), or “sử dụng tốt nhất trước ngày” (best before date), depending on the category of products

Other information such as quantity, manufacturing date, technical specifications, sanitary and safety warnings, instructions, recommendations, and preservation should be included depending on the product's nature. Specific additional labelling requirements (over and above the mandatory labelling requirements listed above) for selected product categories in accordance with Decree 111/2021/ND-CP are presented in the table below. As regulations vary and are subject to change, Canadian firms should verify with government officials or legal specialists before exporting products to Vietnam.

Product Category	Compulsory Contents	Legal Grounds
Food and beverages (except alcohol)	Quantity Manufacturing date Expiry date Composition or ingredient quantity, nutritional value and composition (if any) Warning information Instruction for use and preservation	Decree No. 111/2021/ND-CP
Alcohol	Quantity Ethanol content Expiry date (if any) Preservation instructions (for wine) Warning information (if any) Lot identification code (if any)	Decree No. 111/2021/ND-CP
Food additives, food processing aids	Quantity Manufacturing date Number code of Certificate of Conformity Expiry date Composition or ingredient quantity Instruction for use and preservation Mention the corresponding phrase: “Food additives” or “Food processing aids” Warning information (if any)	Decree No. 111/2021/ND-CP Circular 34/2014/TTLT-BYT-BNNPTNT-BCT
Food ingredients	Name of the ingredient Quantity Manufacturing date Expiry date Instruction for use and storage	Decree No. 111/2021/ND-CP
Animal feed	Quantity Manufacturing date Expiry date Ingredient quantity Instruction for use and preservation Warning information (if any) Name, address, and phone number of the organization or individual registering	Decree No. 111/2021/ND-CP Circular No. 21/2019/TT-BNNPTNT
Plant protection products	Type of product (e.g., pesticides, fungicides, etc.) Finished product form Quantity Manufacturing date Registration number issued by the Plant Protection Department Country of origin Expiry date Composition or ingredient quantity Instruction for use and preservation Information of registered organization or individual Warning information (if any)	Decree No. 111/2021/ND-CP Circular No. 21/2015/TT-BNNPTNT
Functional food	Quantity Manufacturing date Expiry date Composition or ingredient quantity Instruction for use and preservation, including targeted consumers Warning information (if any) Write the corresponding phrases: “health food/supplement”, “supplementary food”, “food for special medical purposes or medical food”, or “food for special dietary use” Write the phrase: “Caution: This product is not a medicine, nor effective to replace medicine” Other contents as prescribed in relevant regulations (if any)	Decree No. 111/2021/ND-CP Circular No. 43/2014/TT-BYT
Irradiated food	Quantity Manufacturing date Expiry date Composition or ingredient quantity Warning information Write the phrase: “Irradiated food”	Decree No. 111/2021/ND-CP
Genetically modified food (GM food)	Quantity Manufacturing date Expiry date Composition or ingredient quantity Warning information Write the phrase: “Genetically modified food” or “genetically modified” next to the name of the genetically modified ingredient and its content.	Decree No. 111/2021/ND-CP

Source: Library of Law

If labels of imported goods do not comply sufficiently with such mandatory information in Vietnamese, there must be auxiliary labels that show mandatory contents in Vietnamese. This secondary label is exempted for food ingredients, food additives, and food processing aids imported for internal production only and not for resale in the market.

Under Decree 43, it is compulsory to display the origin of goods on the labels, which can cause difficulty for entities who cannot determine the origin of the goods. However, Decree 111 has resolved this issue by adding a clause whereby, if the origin of goods cannot be determined, it is required to clearly state the place where the final production stage is conducted to produce the finished product. The following statements should be used to present the final production stage: “assembled at”, “bottled at”, “mixed at”, “finished at”, “packed at”, or “labelled at”, followed by the country name or the territory where the final completion process takes place.

Notably, Circular No. 05/2019/TT-BKHCN allows for labelling to indicate “no presence” or “not containing” or “no addition” of an ingredient” only if: (1) the ingredient does not exist in the product nor in the materials used to produce the product; or (2) the product does not contain ingredients of the same group with similar properties or uses unless the nature of the substitution is clearly stated. However, Circular 5 accepts labelling as per Codex's guidance in certain situations; for instance, goods are labelled “No sugar” if the sugar content is less than or equal to 0.5g/100g (solid) or 0.5g/100ml (liquid). Some industries in Vietnam complain that the “no presence” and “no addition” provisions are not in line with international practices and are requesting the Ministry of Science and Technology (MOST) and MOH to make revisions.

There are some cases where imported goods are exempt from mandatory labelling, such as products used as samples (e.g., for fairs, exhibitions, and experiments), or when products and raw materials are used for processing of goods for export or for internal uses at organizations without circulating in the market (e.g., for research purpose). Product labels must be ensured for long-term existence and must not affect the product's quality. Organizations and individuals are encouraged to label nutritional information according to the Codex guidelines (Codex General Standard for the Labelling of Pre-packaged Foods).

Announcement of conformity

According to LFS 2010, organizations and individuals are required to conduct an Announcement on Conformity to obtain the Certificate of Conformity Declaration (CCD). The products subject to this regulation are prescribed by several ministries under different circulars. The table below provides details for products that are obliged to obtain a CCD.

The process to obtain the announcement of conformity and the corresponding documentation requirements are detailed below:

• Documentation for an announcement of conformity based on certification by the appropriate body (the third party):
  • Conformity Declaration Form No.02.CBHC/HQ (Vietnamese; can be translated) attached in Appendix III of Circular No. 28/2012/TT-BKHCN
  • Product specifications following Form No. 3a or No. 3c (Vietnamese; can be translated) in Circular 38
• Certificate of conformity issued by a third party (a notarized copy or a copy accompanied by the original for verification)
• Certificate of conformity to HACCP standards, ISO 22000, or equivalent where the organizations or individuals manufacturing the product(s) have a quality control system that has been certified to conform to HACCP standards, ISO 22000, or equivalent (a notarized copy or a copy accompanied by the original for verification)
• Documentation for an announcement of conformity based on an appropriate self-assessment by organizations and individuals that manufacture and trade foods (the first party):
  • Conformity Declaration Form No.02.CBHC/HQ (Vietnamese; can be translated) attached in Appendix III of Circular No. 28/2012/TT-BKHCN
  • Product specifications following Form No. 3a or No. 3c (Vietnamese; can be translated) in Circular 38
• Product testing results in the most recent 12 months, including the criteria required by relevant regulated technical standards; issued by a testing lab designated by an authorized government agency or a recognized independent testing lab, or a testing lab recognized by an authorized agency in Vietnam (the original, a notarized copy, or a consular legalized copy)
• Quality control plan
• Periodic monitoring plan (the first party's authentication)
• Report of Conformity Assessment (the first party's authentication)
• Certificate of conformity to HACCP standards, ISO 22000, or equivalent where the organizations or individuals manufacturing the product(s) have a quality control system that has been certified to conform to HACCP standards, ISO 22000, or equivalent (a notarized copy, or a copy accompanied with the original for verification)
• Documentation for an announcement of conformity with food safety regulations for imported products whose regulated technical standards have not yet been provided (except for functional foods and foods enriched with micro-nutrients, for which details are covered in Section 6.2.6):
  • Conformity Declaration Form No.02.CBHC/HQ (Vietnamese; can be translated) attached in Appendix III of Circular No. 28/2012/TT-BKHCN
  • Product specifications following Form No. 3a or No. 3c (Vietnamese; can be translated) in Circular 38
  • Product testing results from the 12 most recent months, including the major quality and safety criteria; issued by a testing lab designated by an authorized government agency or a recognized independent testing lab (the original or a notarized copy); or a testing lab recognized by an authorized agency in Vietnam (the original, a notarized copy, or a consular legalized copy). As of April 2017, National Agro-Forestry-Fisheries Quality Assurance Department (NAFIQAD), Plant Protection Department (PPD), and MARD's Department of Science and Technology have approved some laboratories to perform food safety testing.
  • Periodic monitoring plan (authenticated by the organization or individual)
  • Sample of the product label as circulated in the country of origin and the supplementary label in Vietnamese (authenticated by the organization or individual)
  • Sample of the finished product for goods that are imported into Vietnam for the first time for verification when the application is filed
  • Business registration certificate with a licence in the food business or a certificate of legal entity for food importers (copies authenticated by the organization or individual)
  • Certificate of satisfaction of food safety requirements for the importers that are legally required to be certified to satisfy food safety requirements (copies authenticated by the organization or individual)
  • Certificate of conformity to HACCP standards, ISO 22000, or equivalent where the organizations or individuals manufacturing the product(s) have a quality control system that has been certified to conform to HACCP standards, ISO 22000, or equivalent (a notarized copy, or a copy accompanied with the original for verification)

There are several different lists of testing labs recognized by the different competent agencies in Vietnam:

1. List of laboratories accredited by the Bureau of Accreditation (BoA), under the General Department of Standards - Metrology - Quality (STAMEQ) the Ministry of Science and Technology (The options ‘biological' and ‘chemical' from the dropdown menu in field can be combined with keywords such as ‘food' and ‘agro' within the ‘Key word' field to filter relevant testing labs. This source includes laboratories for food as well as animal feed.)
2. List of designated food safety testing laboratories from Vietnam Food Administration (VFA) under the Ministry of Health
3. List of designated laboratories from the National Agro-Forestry-Fisheries Quality Assurance Department under the Ministry of Agriculture and Rural Development (NAFIQAD also runs its own network of labs across the country which can be seen in this list.)
4. List of quality testing laboratories for livestock and poultry feed from the Department of Livestock Production under the Ministry of Agriculture and Rural Development

Below we highlight some leading agri-food testing laboratories in the country which Canadian companies can consider for product testing:

1. Eurofins Sac Ky Hai Dang
2. Bureau Veritas Vietnam
3. TÜV SÜD Vietnam
4. SGS Vietnam
5. QUATEST (this is under the General Department of Standards, Metrology and Quality (STAMEQ) – Ministry of Science and Technology)
6. Vinacontrol Group Corporation

The receiving state agencies shall be the Vietnam Food Administration (VFA) or the Provincial Department of Agriculture and Rural Development, depending on the types of goods. Within five working days from the filing date, the specialized state bodies will examine the documents and issue the CCD. In case of a rejection, the dossier-receiving agency will issue a written statement clearly stating the reason and request for an amendment and/or supplementary documents. The CCD remains valid for three years, and the organizations and individuals shall take responsibility for continuously maintaining the quality of the products in accordance with the granted CCD.

Compliance requirements specific to product categories

Quarantine of plants and products thereof

The legislation for the quarantine of imported plants and products thereof is Law No. 41/2013/QH13 on Plant Protection and Quarantine (LPPQ). This Law assures the early detection, prompt and accurate conclusion with respect to harmful organisms, and comprehensive treatment and prevention of the entry and spread of detrimental organisms in accordance with international integration treaties. In addition, the Law on Plant Protection and Quarantine mandates the plant owners to conduct phytosanitary procedures at the first point of entry where the plants are brought into Vietnam or at another location eligible for isolation.

In 2014, the MARD issued Circular No. 30/2014/TT-BNNPTNT promulgating a list of pests considered to present risk of causing serious damage to plants (Vietnamese; can be translated), for which the plants have to be tested before importing them into Vietnam. While the information on such plants and plant products is presented in the table below, the detailed List of regulated articles subject to plant quarantine based on an 8-digit HS code is specified in Appendix 3 (Vietnamese; can be translated) of Circular 24/2017/TT-BNNPTNT and Section 9 (Vietnamese; can be translated) of Circular 11/2021/TT-BNNPTNT.

List of plants and plant products subject to quarantine and pest risk analysis

Plant Quarantine

• Plant: Living plants and living part(s) of plants
• Plant products: (1) Tubers/bulbs, fruits, seeds, flowers, leaves, stems, branches, roots, stumps, barks; (2) Broken rice, bran, dried plant meal, raw natural fibre, plant fibre; (3) Starch, powder with plant origin (except dough and modified starch); (4) Tobacco stem, tobacco fibre, makhorka fibre (Nicotiana rustica), feed yeast, raw cotton, cotton by-products, straw, rice straw, and aquatic plants; (5) Log, sawn timber, wood pallets, sawdust, coconut dust; (6) Feedstuff of plant origin or materials of plant origin for feedstuff production; (7) Growing media made from plant materials;
• Mushrooms (except all salted, frozen and canned mushrooms, yeast)
• Silkworm cocoon, silk waste
• Insects, spiders/mites, fungi, nematodes, bacteria, viruses, phytoplasma, viroids, weeds for inspection, training, biological control and scientific research
• Transportation means and facilities used for shipment or storage of regulated articles
• Other objects capable of harbouring quarantine pests as determined by the Plant Protection Department and reported to the Minister of Agriculture and Rural Development for decision
• In case of export of objects that are not on the list specified above, plant quarantine will be carried out at the request of the importing country and international treaties to which Vietnam has signed or acceded

Source: Library of Law (Circular No. 30/2014/TT-BNNPTNT)

Pest Risk Analysis

• Living plants and living part(s) of the plants
• Fresh tubers/bulbs, fresh fruits
• Grass and grass seeds
• Beneficial organisms used in the field of plant protection
• Detected imported plants that are subject to plant quarantine in Vietnam
• Articles with high risks of carrying any regulated pests of Vietnam as determined by the Plant Protection Department and reported to the Minster of Agriculture and Rural Development for decision

Source: Library of Law (Circular No. 30/2014/TT-BNNPTNT)

According to the Circular 33/2014/TT-BNNPTNT providing guidance on quarantine procedures for import, export, and in-transit for consignments of plant origin, the application dossier for plant quarantine includes:

• An application form for plant quarantine, as attached in Appendix I (Vietnamese; can be translated) of this Circular
• An original or notified copy of the Phytosanitary Certificate issued by competent authorities of exporting countries
• A phytosanitary licence for import of objects mentioned on the list of objects, subject to plant quarantine and pest risk analysis (if any). To obtain this licence, the object owner or importer needs to submit the following documents to the Plant Protection Department, and the result will be announced in 10 working days:
  • An application form for an import phytosanitary licence Form No. 04/BVTV Appendix IV enclosed with Circular No. 43/2018/TT-BNNPTNT (Vietnamese; can be translated)
  • 1 Copy of the Commercial contract
  • 1 Copy of Trader's Investment Certificate or Business Registration Certificate

The object owner shall directly submit the complete dossier to the nearest Plant Protection Department/Office for inspection. If there are no harmful organisms detected, the phytosanitary certificate will be issued within one working day from the inspection date; otherwise, the time for inspection would be longer, and the competent agency shall clearly state the reason in written form.

Quarantine of terrestrial animals and products thereof

Law No. 79/2015/QH13 on Animal Health dated June 19, 2015, is the main legal background for the quarantine of terrestrial animals and products thereof. Additionally, this law provides provisions on the quarantine and hygiene inspection for food of animal origin. MARD is responsible for issuing the list of terrestrial animals and food of animal origin subject to quarantine and the list of terrestrial animals and food of animal origin exempted from quarantine, as provided in Appendix 1 of Circular No. 25/2016/TT-BNNPTNT. The detail of regulated articles subject to animal quarantine based on an 8-digit HS code is specified in Section 1 of Appendix I of Circular No. 11/2021/TT-BNNPTNT (Vietnamese; can be translated).

List of terrestrial animals and animal products subject to quarantine in accordance with Circular 25

Animals

• Cattle: Buffalos, cows, donkeys, horses, mules, goats, sheep, pigs, rabbits, dogs, cats and other domestic cattle species
• Poultry: chickens, ducks, geese, turkeys, ostriches, pigeons, quails, ornamental bird species and other bird species
• Laboratory animals: guinea pigs, white mice, rabbits and other laboratory animal species
• Wild animals: elephants, tigers, leopards, bears, deer, gibbons, orangutans, monkeys, pangolins, lorises, squirrels, raccoons, monitor lizards, geckos, pythons, snakes, jungle fowls, pheasants, peacocks and other wild animal species
• Other animal species: bees, silkworms, and other insects

Source: Library of Law (Circular 25/2016/TT-BNNPTNT)

Animal Products

• Meat, viscera, by-products and products [made] from meat, viscera, animal by-products stipulated in Section I of Appendix 1 attached in Circular 25 in the forms of fresh, smoked, dried, salted or frozen, and canned
• Sausage, pate, ham, fat and other animal products in the form of simply-prepared or processed
• Fresh milk, yogurt, butter, cheese, canned milk, powdered milk, bread, and dairy products
• Fresh eggs, salted eggs, egg powder, and egg products
• Breeding poultry eggs, silkworm eggs; embryos, and animal sperm
• Meat meal, bone meal, blood meal, feather meal and other animal products in the form of raw materials; animal and poultry feed, aquatic animal feed that contain ingredients derived from animals
• Fish meal, fish oil, fish fat, shrimp powder, oyster powder and other aquatic animal products used as raw materials for processing cattle, poultry and aquaculture feed
• Pharmaceutical materials originating from animals: snake venom, bee venom, pangolin scales, bear gall, animal extract, digestive enzymes and other pharmaceutical materials originating from animals
• Animal skins in the forms: fresh, dried, and salted
• Fur, skin, stuffed animals of animal species: tigers, leopards, civets, rabbits, otters and from other animal species
• Cilia: hairs of horse tails, hairs of cow tails, pig hair, fleece, and hairs of other animal species
• Feathers: chicken feathers, duck feathers, goose feathers, peacock feathers, and feathers of other bird species
• Teeth, horns, nails, tusks, and animal bone
• Edible bird nests and products thereof
• Honey, royal jelly, beeswax
• Silkworm cocoons
• Pathological materials
• Other animal and animal products that are subject to quarantine as required by the importing country or the provisions of the international treaties to which Vietnam has signed or acceded to

Source: Library of Law (Circular 25/2016/TT-BNNPTNT)

Pre-export approval

Article 22 of Decree No. 15/2018/ND-CP requires countries, territories, and foreign business establishments producing food products of terrestrial or aquatic animals to register for pre-export approval before exporting to Vietnam.

The application dossier shall include:

• Registration Form No.08 in Appendix I of Decree 15 (Vietnamese; can be translated)
• A list of establishments producing and trading food of animal and aquatic origin that have registered to export to Vietnam in Form No.07 of Decree 15 (Vietnamese; can be translated)
• Information on food hygiene and safety of these establishments in Form No.09 of Decree 15 (Vietnamese; can be translated)

It should be noted that this process shall be conducted by the competent authorities of the exporting countries. The application dossiers shall be checked and approved by the competent authorities of the exporting countries (e.g., the Canadian Food Inspection Agency) before being sent to the Vietnamese competent authorities (e.g., the Department of Animal Health).

Within 30 days from the filing date, the Vietnamese stage agencies shall collaborate with the competent counterparts of the exporting countries to carry out the inspection in accordance with Decree 15. The inspection can cover the exporting country's legal system on food safety management, the capacity of the food safety management agency, and conditions for ensuring food safety of the establishments registering to export to Vietnam. However, in practice, Vietnamese authorities rarely conduct inspection on a national system and/or individual establishments in the exporting countries.

Registration for quarantine

The registration and declaration for the quarantine of terrestrial animals and terrestrial animal products shall be conducted in accordance with the Law on Animal Health and Circular 25/2016/TT-BNNPTNT. Before the importation, the shipment owner shall send the Department of Animal Health (DAH) a registration dossier for animal quarantine, which shall include:

• An application for Animal Quarantine Form 19 (Vietnamese; can be translated) in Appendix V of Circular 25
• Additional documents if the imported animals or animal products are subject to the management of other ministries

Within 5 working days after receiving the completed registration dossier, DAH will issue an official letter guiding the shipment owner and relevant veterinary agency conducting the animal quarantine. In cases where DAH does not accept a quarantine registration, the DAH shall provide the consignment owner with a written response indicating the reasons for rejection. After being approved by the DAH, the shipment owner shall declare the quarantine to the veterinary agency at the border gate by using Form 03 in Appendix V of Circular 25 (Vietnamese; can be translated) and the imported shipment shall be subject to quarantine as regulated under the Law on Animal Health.

It should be noted that as a normal practice, DAH does not consider applications for animal quarantine of specific imported animals and animal products for which the model export health certificates have not been pre-negotiated with exporting countries. The exporting countries and/or business establishments shall obtain pre-export approval from the Vietnamese competent authorities, before exporting animals and products thereof to Vietnam.

Quarantine of aquatic animals and products thereof

The primary legislations for the quarantine of aquatic animals and products thereof are the Law on Animal Health, Circular No. 26/2016/TT-BNNPTNT, Circular No. 36/2018/TT-BNNPTNT, and Circular No. 07/VBHN-BNNPTNT (Consolidated document). Accordingly, the list of objects subject to quarantine and risk analysis are provided in Appendix I and II of Circular 26. Additionally, the details of regulated articles subject to aquatic animal quarantine based on an 8-digit HS code are stipulated in Section 5 of Appendix I (Vietnamese; can be translated) of Circular No. 11/2021/TT-BNNPTNT.

List of aquatic animals and products thereof subject to quarantine in accordance with Circular 26

Aquatic Animals

• Fish: species of scaled fish, catfish, and other fish species
• Crustaceans: shrimp, crab and snow crab, and other species of crustaceans living in water
• Mollusks: squid, octopus, snails, mussels, clams, ark clams, oyster and other mollusk species living in water
• Amphibians: frogs, hylidae, and other species of amphibians
• Reptiles: turtles, trionychidae, hawksbill sea turtles, crocodiles, aquatic species of reptiles, and other species of amphibian reptiles
• Coelenterata: jellyfish, hydra, and coral
• Echinoderm: sea cucumbers and sea urchins
• Sponges
• Mammals living in water: whales, seals, otters, and other species of mammals that live in water
• Other aquatic animals
• Other aquatic animals subject to quarantine as required by the importing country or the provisions of the international treaties to which Vietnam has signed or acceded to

Source: Library of Law (Circular No. 26/2016/TT-BNNPTNT)

Aquatic Animals Aquatic Animal Products

• Embryos, eggs, sperm, and larvae of aquatic animal species
• Aquatic animal products in the forms of fresh, simply-prepared, frozen, chilled (including aquatic animals dried in the form of the whole animal)
• Aquatic animal products which are salted or processed (dried, smoked)
• Products in the forms of processed, canned, fish oil
• Fresh eggs, salted eggs, and products from aquatic animal eggs
• Aquatic animal skin, fur, fins, scales, shells in the forms of fresh, dried or salted
• Other aquatic animal products that are subject to quarantine as required by the importing country or the provisions of the international treaties to which Vietnam has signed or acceded to

Source: Library of Law (Circular No. 26/2016/TT-BNNPTNT)

The pre-export approval for business establishments producing and trading products of aquatic animals shall be conducted following steps listed in Section 6.2.2.

Following Circular 07, the quarantine registration dossier for the aquatic animals and animal products imported into Vietnam is promulgated as follows:

• A request for quarantine instructions Form 02 TS in Appendix V of Circular 07 (Vietnamese; can be translated)
• A copy of the certificate of export quarantine issued by the competent authority of the exporting country (for aquatic animals and aquatic animal products originating from countries and territories that do not have agreements on quarantine certificates with Vietnam)
• A copy of the CITES permit (if applicable)
• A copy of Import Permit issued by the Directorate of Fisheries (for breeding aquatic animals not included in the List of breeding aquatic animals permitted for trade and production; and aquatic animals for food-use not included in the list of live aquatic animals for food-use permitted for import), according to Circular No: 24/2017/TT-BNNPTNT

Within 5 working days from the filing date, the DAH shall examine and issue the written consent and quarantine instructions to the goods owner and the animal quarantine agency at the border gate via email or the Vietnam National Single Window e-portal. The shipment owner shall subsequently prepare the following documents to conduct a quarantine declaration:

• A quarantine declaration Form 03 TS (Vietnamese; can be translated) in Appendix V of Circular 07
• Copy bearing the certification by the enterprise or the original quarantine certificate of the exporting country

At the time of inspection, the animal quarantine agency at the point of entry shall take samples of the imported aquatic animal products for testing microorganisms, physical and chemical indicators, and monitoring of toxic residues (such as antibiotics, heavy metals, veterinary drugs, and pesticides) as per the provisions of Appendix IV (Vietnamese; can be translated) prescribed in conjunction with Circular 26. The border-gate animal quarantine agency shall issue a Quarantine Certificate for imported aquatic animal products meeting requirements within 5 working days from the commencement of quarantine.

Businesses shall obtain an import permit for live aquatic animals that have not been specified in the List of live aquatic animals for food-use permitted for import (Appendix 14 (Vietnamese; can be translated) of Circular No. 24/2017/TT-BNNPTNT and Circular No. 04/2015/TT-BNNPTNT). The importation process shall be conducted in accordance with Circular No. 25/2018/TT-BNNPTNT. The application dossier includes:

• Application Form No.01 (Vietnamese; can be translated) in Appendix 1 of Decree 25
• A description of the biological characteristics of the aquatic animals applying for the import permit Form 02 (Vietnamese; can be translated) in Appendix 1 of Decree 25
• A plan for the management and observation of live aquatic Form No.03 (Vietnamese; can be translated) in Appendix 1 of Decree 25

Within 30 working days of the receipt of sufficient documents, the Directorate of Fisheries (DOF) of MARD shall conduct a risk assessment (only for the initial import consignment) in order to consider granting the permit and approve the risk management plan of the imported live aquatic animals.

Quarantine and quality inspection of imported animal feed and aquaculture feed originating from animals

According to Decree No. 13/2020/ND-CP guiding the Law on Animal Husbandry, animal feed is divided into 3 types:

• A single raw material product used for animal feed production
• Completed animal feeds
• Feed additives (supplementary feeds)

Currently, all imported animal and aquaculture feed made from animals are subject to quarantine and specialized quality inspection. Prior to shipment arrival to Vietnam, the owner shall submit the application dossier to the DAH, which includes:

• The registration form for quarantine and quality inspection Form 12.TACN (Vietnamese; can be translated) attached in Circular 13
• An application for Animal Quarantine Form 19 (Vietnamese; can be translated) in Appendix V enclosed with Circular 25/2016/TT-BNNPTNT
• Additional documents if imported animals or animal products are subject to the management of other ministries
• Packing list
• Invoice
• Certificate of Analysis
• Certificate of Free Sale or equivalent
• Original product label
• Certification of standard or technical regulation conformity of the importing unit (importer)

The animal quarantine agency shall conduct quarantine, inspect, and certify the quality in accordance with Decree No.74/2018/ND-CP. For imports of formulated animal feed and aquaculture feed of both animal and plant origins, the DAH will coordinate with the Plant Protection Department on the implementation of quarantine and quality inspection. The whole process may take up to 10 working days and subject to be longer in cases where the products are imported from a country or territory at high risk of animal diseases.

Following Decree 39/2017/ND-CP, imported animal and aquaculture feeds must be registered for circulation with the MARD. The registration dossier includes:

• Registration Form No. 05 (Vietnamese; can be translated) attached in Decree 39/2017
• Certificate of Free Sale or equivalent
• A notarized copy of one of the following certificates: ISO, GMP, HACCP or equivalent
• The product information sheet provided by the manufacturer, including names of ingredients, quality criteria, safety criteria, uses, instructions for use
• Announcement of applicable standards of organizations and individuals registering imported animal and aquaculture feeds for circulation in Vietnam; product sub-label in the Vietnamese language in accordance with current regulations
• Test results on quality and product safety indicators issued by laboratories appointed by the competent authorities of exporting countries or laboratories recognized by the regional or international organizations of quality certification or appointed, accepted by MARD
• Product labels (certified by suppliers or importers)

Within 5 working days, the MARD shall examine the documents and announce in written form if there are any documents that need to be amended or complemented. Upon receipt of a valid dossier, the MARD shall assess the contents of the application and issue a decision on the certification of animal and aquaculture feeds permitted for circulation in Vietnam.

Processed food products

As previously mentioned, Decree 15/2018 requires organizations and individuals to register (self-declare) for all imported processed foods before they can be circulated in the market. Normally, a Vietnamese importer/distributor will assist an exporter in completing this process and registering the product with the Vietnam Food Administration (VFA) so that it can be imported. In addition, Decree 15 permits goods and raw materials imported for processing for re-export or for internal production and that are not meant for domestic sale to be exempt from self-declaration. For registration (self-declaration) documents and procedures, please refer to Section 6.1.3.

Other processed foods under the management of the MARD, such as processed meat and poultry, dairy products, egg products, animal feed, processed aquatic animal products, processed plant products, etc., are subject to quarantine and quality inspection. Specifically, products listed in Section 1, Section 6, Section 11 (based on HS codes) of Circular No. 15/2018/TT-BNNPTNT must be accompanied by either a health or phytosanitary certificate. For more details, please refer to Sections 6.2.1, 6.2.2, 6.2.3, and 6.2.4.

In addition to product registration, certain processed foods must undergo the Declaration of Conformity. A notarised copy of the Certificate of Conformity Declaration (CCD) is required for the application for a food safety inspection at the port of entry. For more details, please refer to Section 6.1.5.

Besides, processed food products must comply with several national technical regulations, which prescribe the limits of technical characteristics and management requirements for many product categories in order to ensure safety, hygiene and human health. In accordance with Vietnamese laws, technical regulations are applied compulsorily in production, business, and other socio-economic activities, and they are also used as the basis for conformity assessment activities. The table below provides some links to national technical regulations for processed foods.

Food additives

In 2019, MOH issued Circular No. 24/2019/TT-BYT promulgating the management and use of food additives, which includes some key points as follows (links are in Vietnamese):

• Appendix 1 of the circular provides the List of 400 food additives coded by the International Numbering System (INS) that are permitted for use in food
• Appendix 2A lists the additives permitted for use in food and their maximum levels
• Appendix 2B comprises food additives and their maximum levels that are not specified in Codex General Standard for Food Additives (GSFA)

The List of Harmonized Schedule (HS) Codes for food additives and food processing aids (Vietnamese; can be translated) was promulgated in conjunction with Circular No. 05/2018/TT-BYT. In addition, pursuant to the LFS 2010 and Decree 15/2018/ND-CP, MOH enacted Circular No. 31/2020/TT-BYT on the issuance of National technical regulations for food additives (from QCVN 4-24:2020/BYT to QCVN 4-33:2020/BYT), which took effect from 1 September 2021.

In addition, the MOH also issued several other National Technical Regulations managing the use of food additives (from QCVN 4-1:2010/BYT to QCVN 4-22:2010/BYT). Canadian firms are recommended to consult local legal offices for the complete list of regulations that may apply to food additives before exporting products to Vietnam.

For the inspection, registration, and labelling requirements of food additives and food processing aids, please refer to Sections 6.2.1, 6.2.2, 6.2.3, and 6.2.4.

Food supplements

According to Decree No.15/2018/NC-CP, food supplements, dietary supplements, and any foods containing micronutrients, minerals, or additives that are enough to be considered as nutritional foods (or fortified foods) are subject to the management of the MOH. Subsequently, the following products must undergo product declaration procedures:

• Dietary supplements, medical foods, food for special dietary uses
• Dietary products for children up to 36 months
• Mixed food additives with new uses, food additives that are not on the list of permitted food additives prescribed by the MOH

The application dossier for product declaration shall include:

• The Declaration Form No. 02 (Vietnamese; can be translated) in Appendix I of Decree 15
• A notarized copy of the Certificate of Free Sale, Export Certificate, or Health Certificate issued by the competent authority of the country of origin/exporting country
• Certificate of Analysis (issued within 12 months before the date of application by a designated laboratory or a laboratory accredited in accordance with ISO 17025)
• Scientific evidence proving the effects of products or ingredients. When using scientific evidence of ingredients' effects, the daily dose must be at least equal to or greater than 15% of the content of such ingredients mentioned in the document.
• Certificate of Good Manufacturing Practices (GMP) or equivalent certificate

In addition, Circular No. 43/2014/TT-BYT prescribing regulations on management of functional food also requires organizations and individuals to register with the Vietnam Food Administration (VFA) – an agency of the MOH – to obtain a Certificate of Conformity Declaration (CCD) before being imported into and/or circulated in the market. Accordingly, the application shall include:

• Conformity Declaration Form No.02.CBHC/HQ (Vietnamese; can be translated) attached in Appendix III of Circular No. 28/2012/TT-BKHCN
• Product specifications following Form No. 3b (Vietnamese; can be translated) in Circular 38
• Certificate of Free Sale, Health Certificate, or equivalent certificate issued by an authorized competent agency from the country of origin verifying that the product is safe and wholesome for consumers and complies with food safety laws
• Certificate of Analysis (issued within 12 months before the date of application by a designated laboratory or a laboratory accredited in accordance with ISO 17025)
• The certificate of Good Manufacturing Practice (GMP) or an equivalent certificate if the imports are dietary supplements, applicable from July 01, 2019.
• Periodic supervision plan
• Product sample
• Product label
• Business Registration Certificate with a food business licence or legal certificates for organizations and individuals importing food (copies authenticated by the organization or individual)
• Certificate of satisfaction of food safety requirements for importers that are legally required to be certified to satisfy food safety requirements
• Certificate of conformity to HACCP standards, ISO 22000, or equivalent where the organizations or individuals manufacturing the product(s) have a certified quality management system in accordance with HACCP or ISO 22000 or equivalent
• Documents about scientific evidence of the effects of the product or ingredients (original or authenticated copy). If scientific evidence is used to convey the effects of the ingredients, then the daily dose must be at least equal to or greater than 15% of the content of such ingredients mentioned in the document.

The registration can be completed via the e-portal of VFA. It should be noted that all documents in the application must be in Vietnamese and still be valid at the time of submission. In case there are any documents in foreign languages, they must be translated into Vietnamese and notarized. The time for evaluation is 21 working days from the date the authority receives the complete application dossier. The CCD remains valid for three years. In case of refusal, the dossier-receiving agency will issue a written statement clearly stating the reason and request for amendment and supplemental information. If the applicant fails to supplement the application within 90 working days from the day on which a written request is made, the application will be deemed invalid.

Apart from the above-listed regulations, Canadian companies exporting supplemental foods to Vietnam should be aware of several National Technical Regulations, as shown in the table below.

Export certificates required by the Vietnamese government