Self-Declaring Food Made at Two Factories in Different Localities

1. How to self-declare a self-declarable food product manufactured at two factories in two different localities?
Pursuant to Clause 2, Article 5 of Decree 15/2018/ND-CP (as amended and supplemented by Clause 2, Article 1 and Clause 1, Article 3 of Decree 155/2018/ND-CP), the self-declaration of products by a food business enterprise with 02 or more factories manufacturing the same product in 02 different localities is carried out in the following order:

(i) The enterprise self-declares the product on mass media or its own website, or publicly posts it at its head office, and publishes it on the food safety data information system.

Where there is no food safety data information system yet, the enterprise submits 01 copy by post or in person to the competent state management agency designated by the People’s Committee of the province or centrally-run city for dossier storage and for posting the names of the declaring organizations, individuals and self-declared products on the receiving agency’s website.

Note: The enterprise files the dossier at only one state management agency in the locality with a production facility of its choice. Once a state management agency has been chosen for filing, subsequent self-declarations must be filed at the previously chosen agency.

(ii) Immediately after self-declaring the product, the enterprise may manufacture and trade the product and bears full responsibility for the product’s safety.

In addition, where the product has changes in product name, origin or composition, the enterprise must re-self-declare the product. For other changes, the enterprise notifies in writing the changed contents to the competent state management agency and may manufacture and trade the product immediately after sending the notification (Under Clause 4, Article 5 of Decree 15/2018/ND-CP).

2. In which cases does a food business enterprise self-declare products?
Pursuant to Article 4 of Decree 15/2018/ND-CP, an enterprise self-declares products in the following cases:

(i) A food business enterprise self-declares pre-packaged processed foods, food additives, food processing aids, food containers, and packaging materials in direct contact with food (collectively referred to as products), except for the products specified in clause (ii) of this Section and the following products:

– Health protection foods, medical nutrition foods, foods for special dietary uses.

– Nutritional products for children up to 36 months of age.

– Mixed food additives with new functions, food additives not on the list of additives permitted for use in food, or not used for the intended subjects as prescribed by the Ministry of Health.

(ii) Products and raw materials for production or import used only for manufacturing or processing export goods, or for the internal production of organizations or individuals not consumed on the domestic market, are exempt from product self-declaration procedures.

3. What documents does the self-declaration dossier include?
Pursuant to Clause 1, Article 5 of Decree 15/2018/ND-CP, the product self-declaration dossier includes:

(i) The product self-declaration in Form No. 01, Appendix I issued with Decree 15/2018/ND-CP.

(ii) The food safety testing result sheet of the product within 12 months up to the filing date, issued by a designated testing laboratory or an ISO 17025-accredited testing laboratory, covering safety indicators issued by the Ministry of Health under risk management principles consistent with international regulations, or safety indicators under corresponding regulations and standards published by the declaring organization or individual where the Ministry of Health has no regulations (original or certified copy).

Note: Documents in the self-declaration dossier must be presented in Vietnamese. Foreign-language documents must be translated into Vietnamese and notarized. Documents must be valid at the time of self-declaration (Under Clause 3, Article 5 of Decree 15/2018/ND-CP).

Frequently asked questions

Must each factory self-declare separately? Self-declaration is performed by the responsible organization or individual; where manufacturing at multiple locations, the self-declaration dossier must fully reflect information on all production facilities.
In which locality should the self-declaration be filed? File at the competent agency where the organization or individual is headquartered, or under the current food safety management decentralization.