Offical Dispatch No. 2792/ATTP-SP dated November 04, 2024 on guidelines on classification of self-declared products and registration of product disclosure

According to Article 65 of the Law on Food Safety 2010, People’s Committees at all levels shall manage food safety in their localities; disseminate and communicate information on and raise awareness of food safety of food manufacturers and food traders; conduct inspection and examination, and impose penalties for violations against the law on food safety in their localities.

According to clauses 8 and 9 Article 40 of the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some Articles of the Law on Food Safety, each provincial People’s Committee shall organize the receipt and management of dossiers on self-declaration of pre-packaged processed foods, food additives, food processing aids, food implements and containers, packaging in direct contact with food; issue certificates of registered product disclosure to medical foods, foods for special dietary uses; dietary products for children up to 36 months.

Recently, the Vietnam Food Administration has received multiple feedback and concerns from organizations and individuals in relation to self-declaration and registration of disclosure of products under local management such as:

- Classification of a product into supplemented food or dietary supplement;

- Procedures for food self-declaration and registration of food disclosure;

- Translation of documents enclosed with declaration dossiers;

- Contents of Certificate of Free Sale (CFS)/Health Certificate (HC)/Certificate of Exportation (CE);

- Time limit for submission of product declaration dossiers;

- Periodic testing;

- Testing of quality indicators upon product declaration.

- Intake levels for vitamins and minerals.

Accordingly, with a view to strengthening the management of self-declaration of products under local management, the Vietnam Food Administration hereby requests Departments of Health, Food Safety Departments, Food Safety Management Boards and Sub-departments of Food Safety and Hygiene of provinces/cities (hereinafter referred to as “Units”) to perform several tasks below:

1. Speed up the classification of products, receipt of self-declarations and registration of disclosure of products under local management as prescribed in Articles 4, 5, 7 and 8 of the Government's Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some Articles of the Law on Food Safety for organizations and individuals in areas under their management:

- Regarding product grouping: rely on Article 3 of the Government’s Decree No. 15/2018/ND-CP , Article 2 of the Circular No. 43/2014/TT-BYT dated November 24, 2014 of the Ministry of Health on management of functional foods, label contents, ingredients, instructions for use, etc. to carry out classification.

- Regarding procedures for product self-declaration and registration of product disclosure: comply with Article 5 (Self-declaration) and Article 7 (Registration of disclosure) in the Decree No. 15/2018/ND-CP .

- Regarding translation of documents enclosed with declaration dossiers: translate documents into Vietnamese and notarize translations as prescribed in clause 3 Article 7 of the Decree No. 15/2018/ND-CP .

- Regarding contents of CFS/HC/CE: conform to the regulations set forth in point b clause 1 Article 7 of the Decree No. 15/2018/ND-CP , for CFS: conform to the regulations under clause 3 Article 10 of the Decree No. 69/2018/ND-CP dated May 15, 2018

- Regarding effective period of the Certificate of receipt of product declaration dossier and time of periodic testing: the Decree No. 15/2018/ND-CP does not stipulate the effective period of the Certificate of receipt of product declaration dossier and time of periodic testing.

- The Decree No. 15/2018/ND-CP only requires the testing of food safety indicators and does not stipulate testing of quality indicators, however, for dietary supplements, it is required to specify main quality indicators in section II of the product disclosure prescribed in Form No. 02 in the Appendix I to the Decree No. 15/2018/ND-CP. The food safety data sheet must be issued by a designated laboratory or a laboratory complying with ISO 17025 within 12 months before the declaration dossier is submitted.

- Regarding intake levels of vitamins and minerals: comply with regulations of the Circular No. 43/2014/TT-BYT: for supplemented foods, it is required to reach 10% RNI as specified in Appendix No. 1 to the Circular No. 43/2014/TT-BYT and the maximum intake levels as specified in Appendix No. 2 to the Circular No. 43/2014/TT-BYT must not be exceeded.

2. Strengthen the post-inspection after organizations and individuals make self-declaration and register product disclosure in order to prevent incorrect categorization in self-declarations such as self-declarations of dietary supplements, etc. Focus on inspecting, examining and reviewing e-commerce floors, e-commerce applications, e-commerce websites and functional food malls on the said applications that have not been granted a certificate of registered product disclosure or have not submitted self-declarations to competent state authorities as prescribed.

3. Organize propaganda, train and instruct organizations and individuals to classify self-declared products and register disclosure of products under local management in accordance with applicable regulations. Pursuant to clause 2 Article 8 of the Law on Food Safety 2010, food traders are obliged to inspect origin of goods, food labels and documents relating to food safety, and comply with regulations of law on food safety. Food traders must gain a profound knowledge of food safety and regulations of law on food safety, and clear understanding of their products so as to classify products in accordance with regulations.

4. Promptly resolve difficulties facing organizations and individuals in the course of classifying self-declared products and registering product disclosure as per applicable regulations of law in order to prevent them from bypassing the hierarchy of management when submitting documents.

5. Build a management database in the field of self-declaration and registration of disclosure of products under local management and connect it with the national database.

6. Units are requested to report any difficulties that arise during the implementation directly to the Food Management Division - Vietnam Food Administration for timely resolution to meet the prescribed time limit for processing dossiers on registration of product disclosure. Contact phone number: 0438463702, ext. 2020.

In order to intensify the product self-declaration and registration of product disclosure in the localities, the Vietnam Food Administration requests the Units to expedite the application of the abovementioned guidelines and ensure the consistency during the application.

Best regards./.