As we all know, Supplemented Food (“SP”) means ordinary food supplemented with micronutrients and other elements conducive to health such as vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics and other biologically active substances. This content is clearly mentioned in Article 2.1 of Circular 43/2014/TT-BYT dated November 24, 2014 of the Minister of Health regulating the management of functional foods (“Circular 43”). This is a group of products belonging to the functional food line as prescribed in Article 2.28 of the Law1 on Food Safety 2010 (“FS Law”).
According to the current law, specifically Decree 15/2018/ND-CP dated February 2, 2018 of the Government detailing the implementation of a number of articles of the Law on Food Safety (“Decree 15”), SP belongs to the group of products subject to self-declaration procedures as prescribed in Article 4, Article 5 of Decree 15.
Accordingly, organizations or individuals shall announce the product declaration through mass media or post it on their websites or publicly post it up at their offices and make public through the food safety data system (if such system has not been established, organizations or individuals shall send 01 application by post or in person to the regulatory agency assigned by the People’s Committees of provinces and central-affiliated cities (hereinafter referred to as “receiving authority”), in order for it to retain the application documents and post the self-declaration, including names of organizations or individuals and product information, on its website. If the organizations or individuals have more than 02 facilities which manufacture the same product, they shall only submit the application at the regulatory agency in their locality where the manufacturing facility is selected by them. After selecting the regulatory agency for submitting the application, the next self-declared documents must be submitted at the previously selected agency). These contents are provided in Article 5.2(a) Decree 15.
Right after self-declaration of products, organizations and individuals are entitled to produce, trade products and take full responsibility for the safety of such products (Article 5.2(b) of Decree 15).
Obviously, according to current regulations, it can be seen that the procedures for management at the pre-inspection stage for SF are quite simple, open, and quick in terms of forms, required documents and processing timeline.
However, with the latest Draft of Decree amending Decree 15 (“Draft of Amended Decree”) that Apolat Legal is aware of, the SF group is being proposed to be applied according to the product registration procedures. In case the content of this amendment is approved and passed, the regulations and requirements related to forms and required documents of registration dossiers are also stricter, much more difficult. The time for appraisal of dossiers and issuance of product certificates according to this procedure is also much longer.
Perhaps, the proposed amendment comes from the fact that businesses circumvent regulations related to the grouping of food products to bring some products that are Health Supplements to the SF group. The application of self-declaration procedures by traders in this case leads to product quality not really being closely managed. This also greatly affects the health and interests of consumers when using the product.
Facing the content of the drafted amendment as above, the traders need to actively review and have a plan to prepare the necessary documents for the registration for SF products, accordingly, in case the amended draft content is approved and passed, the traders can register as soon as possible, minimizing the interruption of their business activities.
Relating posts
- What traders need to do when QCVN 20-1:2024/BYT applies to health supplements/dietary supplements/food supplements takes effect
- Detailed contents to comply with NTR no. 20-1:2024/BYT for health supplement/dietary supplement groups
- Decree No. 17/2022/ND-CP amends and supplements decrees on administrative penalties in the fields of chemicals, electricity, commercial activities, and petroleum
