1. Definition

Infant formula in this pedia refers to breast milk substitutes for infants under 24 months old. As per Decree No. 100/2014/ND-CP on the Trading in and Use of Nutritious Products for Infants, Feeding Bottles, Teats, breast milk substitutes for infants under 24 months include:

• Liquid or powdered infant formula used to substitute breast milk for infants under 12 months, which is made from milk of cows or other animals and contains appropriate ingredients;

• Liquid or powdered follow-up formulas used for infants aged 6-24 months during the complementary feeding period, which is made from milk of cows or other animals, and contains appropriate ingredients or animal- or plant-derived ingredients;

• Other liquid or powdered follow-up formulas presented or introduced as suitable to infants under 24 months but not included in complementary foods in the nutritional structure for infants aged over 6 months, which is made from milk of cows or other animals and contains appropriate ingredients or animal- or plant-derived ingredients.

2. Competent authority

3. Market access approval

3.1 Overall import conditions

Infant formula products to be exported to Vietnam must comply with relevant regulations established by the Vietnamese authorities before its importation to Vietnam being permitted. One of the primary regulations entails obtaining a registration conformity declaration from the MOH before importation into the country. (Read details in Point 3.2 Product registration: Registration of product conformity declaration)

Please note:

• Overseas manufacturers producing infant formula products and their exporting countries are not required to get registered or listed with Vietnam authorities.

• Different from some food categories, infant formula traders are not required to obtain the Certificate of Satisfaction of Food Safety Condition since infant formula are pre-packaged foods.

3.2 Product registration: Registration of product conformity declaration

Food traders should finish the product registration of infant formula before entering the Vietnamese market by submitting a registration dossier to the MOH. If the submitted materials meet the requirements, the authority will verify the application and issue a Certificate of Registered Product Conformity Declaration afterwards.

Submitted materials should include:

• Declaration form;

• A legalized Certificate of Free Sale/Certificate of Exportation/Health Certificate issued by the authority of the exporting country;

• The testing results, completed within 12 months before the document submission, issued by recognized laboratories or ISO 17025 accredited laboratories;

• A documentation of scientific evidence of the effects of the product or ingredients;

• Original Label (in color) and sub-label (in Vietnamese).

3.4 Inspection and quarantine

Unless there is an alert, infant formula products are exempted from import inspection since such products are with Certificate of Registered Product Declaration. Please note that the quarantine requirements for dairy products for children under 36 months old has been removed since 2022. However, there are no amendment or decision officially issued relating to this requirement removal. The authority may apply the requirement again based on their actual consideration.

4. Product compliance

Manufacturers of infant formula shall satisfy general food safety conditions specified in:

• Food Safety Law 2010;

• Decree No. 15/2018/ND-CP of the Government: Detailing the Implementation of a Number of Articles of the Law on Food Safety (partly amended by Decree No. 155/2018/ND-CP); and

• Decree No. 100/2014/ND-CP on the Trading in and Use of Nutritious Products for Infants, Feeding Bottles, Teats.

Besides the Food Safety Law and its subordinate regulation, it is important to follow specific regulations for infant formula products as well as some safety and hygiene requirements.

5. Label

Food Safety Law and its implementation rules specify some requirements for labelling:

• Food Safety Law 2010

• Decree No. 100/2014/ND-CP on the Trading in and Use of Nutritious Products for Infants, Feeding Bottles, Teats

• Decree No. 15/2018/ND-CP of the Government: Detailing the Implementation of a Number of Articles of the Law on Food Safety (partly amended by Decree No. 155/2018/ND-CP Amendments to Some Articles Related to Business Conditions Under State Management of the Ministry of Health). Besides the Food Safety Law and its implementation rules mentioned above, Decree No. 43/2017/ND-CP on Goods Labels is the most important regulation for stakeholders to learn, since it is a specialized regulation for product label. In 2021, some articles of Decree No. 43/2017 were amended and supplemented by Decree No. 111/2021/ND-CP. Circular No. 05/2019/TT-BKHCN also provides details for a number of articles of Decree No. 43/2017.

At last, stakeholders also need to check the labeling requirements raised in the National Technical Regulations (QCVN) listed in Point 4. Product compliance.

Recommended materials:

• Focus on Southeast Asia, Japan, and South Korea: Food Compliance and Import Procedure Interpretation

• Vietnam's Legislation Framework on Food Labeling

*Global Food Compliance Service

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