In Vietnam, self-declaration of product quality is a regulatory process that allows businesses to declare that their products comply with relevant food safety and quality standards without needing prior approval from the authorities. This procedure is governed by Decree 15/2018/ND-CP, which provides detailed guidelines on the food safety law in Vietnam. Self-declaration is an important mechanism for speeding up the product registration process, particularly for non-high-risk food products. Here’s an overview of how the self-declaration process works and its requirements.
1. Who Needs to File Self-Declaration?
Non-high-risk food products: Most general food items such as snacks, beverages, bottled water, nutritional supplements, and food additives fall under the self-declaration system.
Domestic and imported products: Both local manufacturers and importers of food products must complete the self-declaration process before distributing their products in Vietnam.
2. Exemptions from Self-Declaration
High-risk products such as dietary supplements, medical foods, foods for special dietary uses, and products used for disease prevention must undergo a separate process known as Product Registration with the Vietnam Food Administration (VFA). These products are not eligible for self-declaration.
3. Process of Self-Declaration
The self-declaration process involves the following steps:
Preparation of Documents: The company must prepare a self-declaration document that includes detailed information about the product. This typically includes:
- Product name and type.
- Ingredients and composition.
- Production methods.
- Shelf life and storage conditions.
- Product label (in compliance with Vietnamese labeling regulations).
- Test results showing that the product meets Vietnamese safety and quality standards (these tests must be conducted by an accredited laboratory in Vietnam or recognized international labs).
Submission of Documents: The business submits the self-declaration dossier to the local Department of Health (DOH) or the Food Safety Management Authority, depending on the type of product and the location of the business.
Publication on Website: After submitting the documents, the company must publish the self-declaration on its website or the portal of the Department of Health for transparency and public access. No prior approval from the government is needed for self-declared products to enter the market.
Distribution of Products: Once the self-declaration document is published, the company is free to distribute the product on the market. This is a significant departure from earlier regulations, where businesses needed to wait for approval from the relevant authorities.
4. Post-Market Surveillance
After the product is on the market, regulatory authorities conduct inspections and audits to ensure that the self-declared products comply with the declared safety and quality standards. If a product is found to be non-compliant, it can be subject to penalties, recalls, or bans from the market.
5. Required Documents for Self-Declaration
- Completed self-declaration form.
- Product testing results from an accredited laboratory.
- Product labels in Vietnamese.
- Certificate of Good Manufacturing Practice (GMP), if applicable.
- Certification for imported products, showing compliance with standards in the country of origin.
6. Validity and Updates
The self-declaration is generally valid indefinitely for as long as the product remains unchanged in terms of its composition, production process, or safety profile. If there are any changes to the product, such as modifications to ingredients or packaging, the company must re-submit the self-declaration or update the information with the relevant authorities.
7. Benefits of Self-Declaration
Faster Market Access: Companies can bring their products to the market without having to wait for prior approval, significantly reducing the time-to-market.
Streamlined Process: Self-declaration eliminates bureaucratic bottlenecks, making it easier for companies to comply with food safety regulations.
Transparency: Publishing the self-declaration online allows consumers and regulatory bodies to verify the safety and compliance of products more easily.
Conclusion
The self-declaration process in Vietnam provides a streamlined and efficient approach for businesses to bring non-high-risk food products to market. By allowing companies to declare their own compliance with safety standards, the system enhances market transparency and reduces regulatory delays. However, businesses must ensure they comply fully with the requirements, as authorities conduct regular checks to maintain food safety standards in Vietnam.
Vietnam’s regulatory environment, however, is dynamic and can change quickly. With this in mind, to keep abreast of changes to said regulations, foreign firms operating in Vietnam should make sure to subscribe to the-shiv.