[Updated] Vietnam Revises, Supplements and Annuls Several Important Food Safety Provisions

As revealed by an official Circular on September 25, 2023, Vietnam Ministry of Health amends, supplements and annuls a number of legal documents on food safety. The Circular will come into effect on November 9, 2023.

Keynotes to Several Important Regulations

1. Circular No. 24/2019/TT-BYT Guiding the Management and Use of Food Additives

• The definition of compound food additive with new effect is detailed as “Compound food additive with new effect is a food additive that contains two (02) or more additives and has at least one (01) function different from all the functions already specified for each of those additives.”

• Permitted flavorings used in foods are with expanded scope, including:

a) Flavorings that have been evaluated by JECFA and are determined to be safe at expected intakes or acceptable daily intakes (ADI);

b) [New] Fragrances that are recognized as safe (GRAS) by the Flavor and Extract Manufacturers Association of the United States (FEMA);

c) [New] Flavorings for use in foods issued by the Parliament and of the Council of the European Union

• To automatically align Vietnamese requirements on food additives to the international standard, the Circular adds Clause 5 and 6 to Article 5. It stipulates that the maximum use of food additives in food product specified in Appendix 2A & 3, as well as the classification and description of food groups in Appendix 4 are updated according to the latest CAC standards—CODEX STAN 192-1995 General Standard for Food Additives.

• As for the revision on Appendix 2B, which lists the use of food additives that are not included in the Codex standard but are approved by Vietnam itself, this Circular adds 18 food additives to Appendix 2B [Can be found at Appendix 1 of this Circular]. Moreover, the Circular stipulates that for maximum use levels of food additives in Appendix 2B that are different from CODEX STAN 192-1995, CODEX STAN 192-1995 shall prevail.

2. Decision 46/2007/QD-BYT Regulation on Maximum Limit of Biological and Chemical Contamination in Food

This Circular revises the list of processing aids allowed for food production [Can be found at Appendix 2 of this Circular] and adds the requirement that processing aids shall be used as per the National Standard TCVN 11429: 2016 (CAC/GL 75:2010) Guidelines on substances used as processing aids.

3. Circular No. 18/2019/TT-BYT of the Minister of Health Guiding Good Manufacturing Practices (GMP) in the Production and Trading of Health Supplements

The key revision is about acknowledged certificates equivalent to GMP certificate. As per Circular No, 18/2019, imported health supplements must be with GMP certificate or other equivalent certificates. The Circular issued this time (Circular No. 17/2023/TT-BYT) amends Article 4 and clarifies that the competent authority of the manufacturing country shall grant one if the following certificates:

a) Certificate of GMP for facilities producing health supplement

b) Certificate or assessment meeting GMP requirements for pharmaceutical or food manufacturing facilities

c) For countries and areas that do not issue the certificates specified in Points a) and b), organizations and individuals must submit a certificate that contains one of the following contents:

- Compliant with Hazard Analysis and Critical Control Point (HACCP) standards;

- Compliant with International Organization for Standardization 22000 (ISO 22000 standard);

- Compliant with international food standards (IFS - International Food Standard);

- Compliant with global food safety standards of the British Retail Consortium (BRC);

- Compliant with food safety system standards (FSSC 22000 - Food Safety System Certification 22000).

d) For countries and areas that do not issue the certificates specified in Points a), b) and c), a certificate or written confirmation must be provided stating that the manufacturing facility complies with the legal requirements of that country or area.

4. Circular No. 43/2014/TT-BYT Regulating the Management of Functional Foods

• The name of Article 3 is revised from “Announcement of regulation conformity or conformity with food safety regulations” into “Self-declaration of products and registration of product declaration”. Besides, the draft also cites the legal basis for enterprises to finish the self-declaration and the registration of declaration. Read Decree No. 15/2018/ND-CP and Decree No. 155/2018/ND-CP for more details of self-declaration and registration of declaration.

• The requirement for conducting efficacy testing is specified that efficacy testing on human health must be carried out according to biomedical research related to humans specified in the Circular No. 04/2020/TT-BYT dated March 5, 2020, of the Ministry of Health.

• Regarding the requirements on nutrient content claims and health claims for supplemented food specified in Article 8, this Circular introduced the usage amount of the ingredient as another criteria for substances without Recommended Nutrient Intakes (RNI). Please note that supplemented food refers to ordinary food with micronutrients, other elements such as vitamins, etc.

• Requirements on the content claims and health claims for health supplements are revised.

  [Content claims] The content of vitamins and minerals in food calculated according to the manufacturer's recommended daily dose must reach at least 15% RNI specified in Appendix 1 issued with Circular No. 43/2014, or at least 15% of the use amount of that ingredient stated in the scientific certificate. In case Vietnam does not have the RNI level and maximum tolerance threshold, CODEX and the regulations of relevant international organizations shall apply.

  [Health claims] When the daily dosage of vitamins and minerals in the product reaches a minimum of 15% of the RNI or a minimum of 15% of the specified usage level of that ingredient as stated in scientific evidence, the product's beneficial effects can be claimed, but its appropriate target groups and dosage must be indicated. For ingredients without specified RNI levels, when the daily dosage reaches a minimum of 15% of the specified usage level of that ingredient as stated in scientific evidence, the product's beneficial effects can be claimed, but its appropriate target groups and dosage must be indicated.

Read this Circular for more provisions that are amended or partially annulled. For further translation service, please email [email protected].