INTRODUCTION
Understanding Vietnamese laws and regulations concerning food can be a challenge. The government relies on general laws to regulate the quality of goods, including food. There are also specific regulations which apply to food products. This means that there are two sets of rules--one covering goods in general and another covering food products--and they often overlap.
The major laws on the subject are the Law on the Quality of Products and Goods1 ("LoQPG") and the Law on Food Safety2 ("LoFS"). The former states that "the State shall implement a uniform system to control the quality of goods."3 However, "in cases where international treaties, to which the Socialist Republic of Vietnam is a party, contain provisions which differ from the Law, the international treaties shall prevail."4
The LoQPG came into effect on 1 July 2008 and replaced the Ordinance on the Quality of Goods. It provides that manufacturers and traders must take responsibility for the quality of the goods or products that they manufacture or trade, in order to ensure safety for humans, animals, plants, property, and the environment, and to enhance the productivity, quality, and competitiveness of Vietnamese goods and products.5 It further defines 'goods' and 'products', which essentially cover food.
The LoFS, with effect from 1 July 2011, replaced the Ordinance on the Hygiene and Safety of Foods. Mainly, it describes the rights and obligations of organizations and individuals with respect to food safety; conditions to ensure the safety of food for manufacturing, doing business in food, and importing or exporting food; advertising and labelling food; testing food; analyzing threats to food safety; and protecting, preventing, and overcoming breakdowns in food safety.6
The LoQPG gives the Ministry of Science and Technology ("MOST") overall responsibility for the quality of goods, including foods, while the LoFS assigns responsibility for the safety of food to the Ministry of Health ("MOH"), Ministry of Agriculture and Rural Development ("MARD"), and the Ministry of Industry and Trade ("MOIT").
WHAT IS FOOD?
The LoFS defines "foods" as follows: "Foods are products which human beings eat and drink in their fresh, raw, processed or preserved forms. Foods do not include cosmetics, tobacco, and medicinal products."7 There are sub-definitions of different types of food, including fresh and raw food, micronutrient-fortified food, functional food, genetically modified food, irradiated food, street food, and packaged food.
These categories are defined further as follows:
"Fresh and raw food" is unprocessed food including fresh meat, eggs, fish, aquatic products, vegetables, tubers, fruits, and other unprocessed foods.8
"Micronutrient-fortified food" is food supplemented with vitamins, mineral substances, and serum antioxidant micro-minerals in order to prevent the community or a particular group in the community from a shortage of vitamins, substances, and microminerals.9
"Functional food" is food used to support the operation of body organs, creates comfort for the body, increases resistance, and reduces pathogenic dangers. It consists of food supplements, health protective food, and medically nutritious food.10 Detailed regulations on functional foods are provided in the MOH's Circular 43/2014/TT-BYT dated 24 November 2014.
"Genetically modified food" is food which consists of one or more materials which have been genetically modified.11
"Irradiated food" is food radiated by a form of radioactivity to preserve and prevent food from degenerating.12 Detailed regulations on irradiated foods are provided in the MOH's Decision 3616/2004/QD-BYT dated 14 October 2004.
"Street food" is a ready-to-eat food or beverage. It is obtained from a vendor, sold on street sides, in public, or in similar places.13
"Packaged food" is completely packaged and labeled food, which may be eaten or processed further.14
FOOD SAFETY
All individuals and entities that want to produce and to trade foods must assure that their foods are safe. In other words, the foods must conform to the relevant technical specifications and meet limit requirements for pathogenic microorganisms, residues of plant protection drugs or veterinary drugs, heavy metals, contaminants, and other substances in food that may cause harm to human life and health. In addition, subject to the type of food, food must comply with one or more of the regulations on (i) use of food additives and processing aids in food production and trading; (ii) food packaging and labeling; and (iii) food preservation.15
The quality of goods and products is managed on the basis of applicable announcement standards and technical specifications.16 The system of Vietnamese standards includes national standards ("TCVN") and standards applied voluntarily by businesses and individuals ("TCCS").17 Vietnamese standards are based on international, regional, and foreign standards. Also included are the outcomes of scientific and technological research projects, technical progress, factual experience, and the results of evaluations, tests, experiments, inspections, and appraisals.18
At one time, all goods were subject to quality "registration". That is, the State required individuals and organizations that produced and traded goods to follow certain quality standards. Foods were no exception. Foods had to be registered with the MOH. The registration included information such as: a list of standards with which the food products must comply; a chart showing the stages of food product processing from storage of raw materials through the processing stage and ultimately to storage and delivery of the finished product; a final or draft version of the label; instructions and warranties; test results for the food product issued by an authorized government test centre; and a list of all raw materials used to process a food product, including additives and packing materials. The MOH had the power to reject an application for registration.
However, under the LoQPG, individuals and organizations that produce and trade in goods, including foods, are required only to "announce", rather than "register", their own quality standards. Under the LoFS, producers and traders must decide and announce the standards of their foods. That is, they are able, themselves, to decide the standard of their goods.19 Of course, such standards must satisfy applicable Vietnamese standards or industry standards. Accordingly, the prior authoritarian role of the State regarding the quality standards of goods, including food, has been changed into voluntary commitments by entities to set and to comply with their own standards.
Producers and traders of packaged food, additives, food process supporting substances, packing materials, and food containers ("Products" for short) are required to announce that their Products conform to relevant technical specifications. Previously, under Decree 3820, the announcement had to be registered with a competent authority, ie, the MOH or the DOH before production and trade of the Products could be initiated. While this may seem like a reasonable approach in terms of food safety, this regulation usually hindered producers and traders from getting their Products into the market as it could take up to four weeks before their announcement was approved.
With the replacement of Decree 38 by Decree 1521, procedures to announce Products have been greatly streamlined. Producers and traders of Products22 are now only required to self-announce their Products on public media and with the appropriate authority under the local People's Committee. Self-announcement of Products in Decree 15 is significantly different from the announcement of the Products under Decree 38. Whereas Decree 38 required approval from the authorities, Decree 15 does not. After Products are self-announced, they can be immediately produced and/or circulated into the market. Producers and traders are totally responsible for the safety of self-announced Products23. Some products, however, do require an additional registration step, called Registration of the Self-announcement of Products24. Decree 15 has significantly decreased the gap between announcement and production/trade of a Product while it still holds producers and traders responsible for dealing in Products that conform with technical specifications and food safety regulations. As a result, Decree 15 has considerably decreased the administrative registration process when compared with Decree 38.
Self-Announcement of Products
The dossier to self-announce Products includes one self-announcement using Form 01 provided in Annex I of Decree 15 and a valid food safety evaluation report ("Evaluation Report"). The report must be no more than 12 months old and have been issued by an ISO 17025 accredited laboratory. The report must test either (i) the criteria provided by the MOH in accordance with internationally compatible risk management principles or (ii) safety criteria in accordance with equivalent standards, specifications provided by an organization or individual, in case there are no regulations from the MOH. This Evaluation Report is also required for Registration of the Self-announcement of Products mentioned below.
The dossier must be published on public media or on the website of the producer or trader, which website announces the product. Then, the dossier is made public by the competent authorities' food safety data system. If there is no food safety data system at that moment, the dossier must be submitted to the authority designated by the provincial People's Committee.25 The name of the traders, producers and their products must be published on the website of the receiving authority.
Registration of Self-announcement of Products
The registration of self-announced of products is required for products in one of the following categories:
- health protective foods26;
- medical nutrition foods27, foods for special dietary use28;
- nutritious products for children under-36-months; and
- mixed food additives29 with new functions, and food additives which are not on a list of allowed food additives30 or are not regulated by the MOH.
Producers and traders of products in categories (i) and (iv) must register their self-announcement with the MOH. Producers and traders of products in categories (ii) and (iii) must register their self-announcement with the authority designated by the provincial People's Committee. A complete dossier to self-announce a product includes the following documents:
- Announcement of products following Form 02 Annex I of Decree 15;
- Certificate of Free Sale or Certificate of Exportation or Health Certificate issued by a competent authority of the country of origin/exporting country, which assures the safety of users or permits free sale of the products in the country of origin/exporting country;
- An Evaluation Report;
- Published scientific evidence proving the effects or the ingredients of the products;
- Certificate of satisfaction of food safety conditions as required by Good Manufacturing Practices ("GMP"). An equivalent certificate may be substituted if the product is an imported health protective food. This requirement took effect on 1 July 2019; and
- Certificate of satisfaction of food safety conditions, if the product is manufactured domestically.
Within 21 days of submission of the dossier for health protective foods and 7 days for certain mixed food additives, the authorities will examine the dossier and issue the appropriate receipt.
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Footnotes
* This book has been written and updated by lawyers from Russin & Vecchi. It is current though June 2022.
1. Law No. 05/2007/QH12 adopted by the National Assembly on 21 November 2007 on the quality of products and goods.
2. Law No. 55/2010/QH12 adopted by the National Assembly on 17 June 2010 on food safety
3. LoQPG, art 68.1
4. Id, art 4.3.
5. Id, art 5.2.
6. LoFS, art 1.
7. LoFS, art 2.20.
8. Id, art 2.21.
9. Id, art 2.22.
10. Id, art 2.23.
11. Id, art 2.24.
12. Id, art 2.25.
13. Id, art 2.26.
14. Id, art 2.27.
15. LoFS, art 10.
16. LoQPG, art 5.1.
17. Law on Standards and Technical Specifications 68/2006/QH11 dated 29 June 2006 ("LoSTS"), art 10.
18. Id, art 13.
19. LoFS, art. 7
20.Government Decree 38/2012/ND-CP dated 25 April 2012, providing detailed regulations implementing some articles of the LoFS ("Decree 38"), as replaced by Decree 15 on 2 February 2018.
21.Government Decree 15/2018/ND-CP dated 2 February 2018, providing detailed regulations implementing some articles of the LoFS ("Decree 15"), art 4.
22. Except for products, ingredients, which are produced or imported especially for the production, processing of for goods export or for internal production by an organization or individuals without entering the market.
23. Decree 15, art 5.2.b.
24. See "Registration of the Self-announcement of Products" on page 5.
25. Government Decree 155/2018/ND-CP dated 12 November 2018, amending some articles related to business conditions under state management of the Ministry of Health ("Decree 155"), art 3.
26. Article 3.1 of Decree 15 defines "health protective food" as a supplement to the daily diet to improve the user's health and immunity.
27. Article 3.2 of Decree 15 defines "medical nutrition food" as a food item which can be consumed orally or by tube feeding, prescribed to regulate the patient's diet, the use of which has to be supervised by medical personnel.
28. Article 3.3. of Decree 15 defines "food for special diet" as food for people on a diet, elderly people and other users defined by the Codex Alimentarius, processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition and/or specific disease and disorder of the user, as defined.
29. The LoFS defines a "food additive" as a substance with or without nutritious value, which is intentionally added to food in the process of production in order to retain or improve particular characteristics of food.
30. The list of allowed food additives is provided in the MOH's Circular 28/2021/TT-BYT dated 20 December 2021.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.