Decree 15 on product declaration – Update the latest declaration information!
Decree 15 on product declaration (Decree 15/2018/ND-CP) clearly stipulates issues related to product declaration, including:
- Product line
- File
- Legal procedures
Making specific requirements will help to strictly control the quality of products before putting them on the market. In this article, NanoFrance will summarize all the information that businesses need to know according to the latest regulations. Don't forget to refer to it now!
Refer and download the full version of Decree 15/2018 HERE .
I. Overview of the contents of Decree 15 on product declaration
Decree 15 2018 on product declaration consists of 44 articles and is divided into 13 chapters with the following general content:
Chapter I - General provisions, including 3 articles: Article 1 - Scope of regulation, Article 2 - Subjects of application, Article 3 - Interpretation of terms in the decree.
Chapter II & III: Procedures for self-declaration of products and Procedures for registration of product declarations. Contents from Article 4 to Article 8.
Chapter IV: Ensuring the safety of genetically modified foods
Chapter V: Granting certificates of food safety qualified facilities
Chapter VI: State inspection of imported and exported food safety.
Chapter VII: Regulations on food labeling, including 2 articles: Mandatory labeling content and Exemption from certain mandatory labeling content.
Chapter VIII: Food advertising, including 2 articles: Foods must register content before advertising and Registration of food advertising content.
Chapter IX: Conditions for ensuring food safety in the production of health protection foods.
Chapter X: Conditions for ensuring food safety in production, trading and use of food additives.
Chapter XI: Food traceability.
Chapter XII: Assignment of state management responsibilities for food safety.
Chapter XIII: Implementation provisions.
Decree 15 provides general regulations for many product groups that are in the list of products that need to be declared. Therefore, each enterprise that produces and distributes products does not necessarily need to pay attention to all the provisions in the decree.
In the following part of this article, NanoFrance will emphasize some key information that businesses MUST know in Circular 15 on product declaration. Let's find out now!
II. Basic information that businesses need to know in Decree 15 on product declaration
1. Regulations on products: MANDATORY - VOLUNTARY - EXEMPTED from product declaration
a. Product groups that must be declared
In Article 6, it is stipulated that organizations and individuals producing and trading food must register product declarations for the following product groups:
- Health protection food, Medical nutrition food, Food for special diets.
- Nutritional products for children up to 36 months old.
- Mixed food additives with new uses, food additives not on the list of additives permitted for use in food or not for the right users as prescribed by the Ministry of Health
b. Product groups performing self-declaration procedures
Food production and trading enterprises must self-declare the following products:
- Prepackaged processed foods
- Food Additives – Food Processing Aids
- Food containers – Packaging materials in direct contact with food
c. Which product groups are EXEMPTED from self-declaration?
Clause 2, Article 4 clearly states: “Products and raw materials produced and imported for use only in the production and processing of export goods or for internal production of organizations and individuals and not for consumption in the domestic market are exempted from self-declaration procedures.
Product declaration certificate for functional foods
2. Decree 15 on product declaration: Documents, processes and procedures
Articles 7 and 8 fully stipulate the issue of "Product declaration registration procedures" as follows:
a. About product declaration registration dossier
| Imported products | Domestically produced products |
| 1. Product declaration as prescribed | 1. Product declaration as prescribed |
| 2. Certificate of Free Sale | 2. Food safety test results of the product within 12 months |
| 3. Food safety test results of the product within 12 months | 3. Original or copy of scientific evidence proving the effectiveness of the product or ingredients that create the declared effectiveness |
| 4. Original or copy of scientific evidence proving the effectiveness of the product or ingredients that create the declared effectiveness | 4. Certificate of food safety qualified facility in case the facility is subject to issuance of a certificate of food safety qualified facility according to regulations |
| 5. Certificate of food safety qualified facility according to GMP requirements or equivalent certificate. | 5. Certificate of food safety facility meeting GMP requirements |
| 6. Documents in the product declaration registration dossier must be presented in Vietnamese. |
b. Procedure for registering product declaration
Step 1: Organizations and individuals engaged in production and business activities submit product declaration registration dossiers via the online service system or by post or submit directly to the dossier receiving agency.
Step 2: The competent authority processes the application. The time for processing the application after the application meets the requirements is as follows:
- 21-30 days for Health Food
- 7 days for Medical Nutritional Foods, Foods for Special Diets
Step 3: Pay the fee for product declaration dossier appraisal according to the provisions of law on fees and charges.
Step 4: Receive product declaration confirmation.
On Decree 15 of the Food Safety Department (Ministry of Health), businesses are now allowed to register to declare Functional Foods Online.
Note: In case of disagreement with the product declaration dossier of the organization or individual or request for amendment or supplementation, the dossier receiving agency must have a document stating the reason and legal basis for the request. The dossier receiving agency is only allowed to request amendment or supplementation once.
Within 07 (seven) working days from the date of receipt of the revised and supplemented dossier, the dossier receiving agency shall appraise the dossier and issue a written response. After 90 working days from the date of the official dispatch requesting revision and supplementation, if the organization or individual fails to revise and supplement, the dossier shall no longer be valid.
3. Six important notes that businesses need to know when making product announcements
During the product announcement process, individuals and businesses need to pay attention to the following 6 important points:
Firstly , the test certificate must be valid for 12 months and meet all safety criteria, showing the correct name of the facility and address of the business.
Second , documents in the file must be presented in Vietnamese. In case the documents are in a foreign language, they must be translated into Vietnamese or notarized.
Third , when a product has a change in product name, origin, or composition, the enterprise must re-declare the product.
Fourth , for enterprises with 2 or more production facilities and producing the same product, the enterprise only needs to submit the application to a state management agency in the locality where the production facility is located, chosen by the enterprise.
Fifth , in case the enterprise has a Business Registration Certificate at this location, but has a contract with a production facility at another location (in case of renting a production facility or outsourcing production), the Enterprise shall submit the dossier to the competent state management agency where the enterprise is headquartered.
Sixth , for self-declared products: The name and address of the company on the product's test results must match the name of the company that self-declared the product. Do not use the product test results of the company that is the manufacturer or importer.
Above is the information about product declaration according to Decree 15 that businesses need to know. For more detailed advice on common difficulties in the declaration process or advice on professional product declaration services, do not forget to contact NanoFrance immediately!
