Food businesses prepare product declaration dossiers ahead of Decree 46 taking effect

The Ministry of Health has asked food industry associations and businesses to urgently prepare product declaration dossiers and ensure readiness to implement Decree No. 46/2026/NĐ-CP and Resolution No. 66.13/2026/NQ-CP from 16 April 2026.

Deputy Minister of Health Do Xuan Tuyen has signed a document addressed to the Vietnam Chamber of Commerce and Industry and 18 food industry associations and organisations regarding the implementation of Decree No. 46/2026/NĐ-CP and Resolution No. 66.13/2026/NQ-CP.

According to the Ministry of Health, the Government issued Decree No. 46/2026/NĐ-CP on 26 January 2026, detailing certain provisions and measures for implementing the Food Safety Law. Resolution No. 66.13/2026/NQ-CP, issued on 27 January 2026, subsequently set out rules on food product declarations and registration.

To give organisations time to prepare, the Government issued Resolution No. 09/2026/NQ-CP on 4 February 2026, temporarily suspending the effect of the two instruments and adjusting their application date through 15 April 2026.

To ensure effective implementation of the new rules, the Ministry of Health has asked associations and organisations to notify food businesses and individuals to urgently prepare dossiers and register declarations of conformity for food products subject to technical regulations on quality and safety indicators under Article 4 of Decree No. 46/2026/NĐ-CP.

For pre-packaged processed foods, food additives, processing aids, and packaging and utensils in direct contact with food that are not covered by technical regulations, or for which there is no certification body for conformity with national technical regulations, businesses need to prepare dossiers declaring applicable standards under Article 6 of Resolution No. 66.13/2026/NQ-CP.

Businesses must also register product declarations for health supplements, foods for special medical purposes, foods for special dietary uses, supplementary foods—except products containing only vitamins and minerals without health claims—and nutritional products for children up to 36 months old, under Article 8 of Resolution No. 66.13/2026/NQ-CP.

Food manufacturing establishments must also apply for certificates of eligibility for food safety under Article 16 of Decree No. 46/2026/NĐ-CP. Domestic health supplement manufacturers must update their information and submit periodic reports on manufacturing activities as required.

For imported food, the Ministry of Health has asked organisations to proactively plan shipments and prepare dossiers for registration of state food safety inspections under Article 24 of Decree No. 46/2026/NĐ-CP.

Registration dossiers should be submitted before shipments reach the border crossing. Businesses should also provide the address of the consolidation warehouse so authorities can plan sampling and inspection and avoid congestion at the border.

Businesses must comply with food labelling requirements under Articles 31 and 32 of Decree No. 46/2026/NĐ-CP and other relevant legislation on goods labelling.

For advertising, products such as health supplements, foods for special medical purposes, foods for special dietary uses, supplementary foods and nutritional products for children up to 36 months old must have their advertising content registered before advertising, under Article 34 of Decree No. 46/2026/NĐ-CP.

The Ministry of Health has asked associations to widely inform their member businesses, organisations and individuals to prepare all necessary conditions for implementing Decree No. 46/2026/NĐ-CP and Resolution No. 66.13/2026/NQ-CP from 16 April 2026.

If difficulties arise during implementation, organisations may contact the Ministry of Health or other relevant ministries for specific guidance. The Ministry of Health’s focal point is the Vietnam Food Administration.

Regarding Decree 46, the Vietnam Chamber of Commerce and Industry (VCCI) has sent a document to the Prime Minister proposing that implementation be suspended pending the issuance of the Food Safety Law.

The proposal draws on comments from more than 200 in-person and over 1,000 online participants at a workshop on resolving difficulties in implementing food safety policies, together with feedback from numerous industry associations and food manufacturing and processing businesses.

The proposal, with detailed explanations, was also sent to Deputy Prime Minister Le Thanh Long and the Ministers of Health, Agriculture and Environment, and Industry and Trade.

According to the business community, Decree No. 46/2026/NĐ-CP introduces fundamental changes to food safety management, particularly product declaration procedures and state inspections of imported food. However, implementation has shown that many provisions lack the practical conditions needed for enforcement.

One major difficulty is the requirement for most food products—including ingredients, additives, and packaging and utensils in direct contact with food—to undergo declaration procedures before circulation or use in production. This removes many exemptions available under Decree No. 15/2018/NĐ-CP and requires additional procedures for materials used only in internal production.

Food manufacturers report that the rules require two declaration procedures for the same product: registration of a declaration of conformity for its packaging and a separate declaration for the product contained in that packaging.

“This is an overlapping and unnecessary requirement, as manufacturers already bear full legal responsibility for the final products placed on the market,” VCCI stated, conveying businesses’ views in its submission to the Government.

Some dossier requirements currently cannot be met. For example, the rules require conformity certification from an accredited certification body, but no body has yet been accredited to provide such certification for food products.

In addition, 90% of imported food products currently on the market would be unable to meet the requirement for a direct letter of authorisation from the overseas manufacturer when registering a declaration of conformity. In practice, most food and ingredient imports into Vietnam pass through global distribution networks or trading intermediaries rather than being purchased directly from manufacturers. Overseas manufacturers, particularly in Japan, Europe and the United States, do not customarily issue authorisation letters in the form required by Decree 46 and do not accept legal liability under Vietnamese law.

These circumstances prevent businesses from completing dossiers even when they wish to comply. Under the new rules, all imported food ingredients used in production, including those not sold directly on the market, must undergo state food safety inspections.

Meanwhile, inspection authority has been delegated to provincial governments. Businesses report that many localities lack sufficient personnel, procedures and dossier reception systems. Some local specialist agencies have temporarily stopped accepting dossiers in the absence of implementation guidance, causing prolonged cargo congestion.

The new inspection process also involves multiple stages, from deciding the inspection method to sampling, testing and confirmation of results. Standard inspections take 10 working days and tightened inspections take 12 working days, excluding laboratory testing time, so actual clearance times may be longer. This creates substantial warehousing and storage costs and can cause spoilage, especially for fresh ingredients.

Businesses also report that some technical concepts in the new policy remain unclear, including “biologically active substances” and “declaration of health claims”. The lack of clear legal definitions may lead to differing interpretations and applications across localities, creating significant business risks.

Many new provisions also require results from designated testing laboratories, but the domestic testing system currently lacks sufficient capacity and methods to meet the new requirements.

At some laboratories, results can take 40–45 days, while samples may also be refused because of concerns about legal liability. If Decree 46 is fully implemented from 15 April 2026, testing demand will rise sharply beyond the current system’s capacity, forcing many businesses to send samples overseas at substantial cost.

In this context, the business community considers the temporary suspension of certain provisions of Decree No. 46/2026/NĐ-CP under Resolution No. 09/2026/NQ-CP a timely decision that has helped resolve congestion at border crossings and seaports.

However, the suspension currently lasts only through 15 April 2026. If the underlying difficulties are not resolved before then, procedural bottlenecks and supply chain disruption could recur.

Many industry associations and businesses therefore recommend extending the suspension of Decree No. 46/2026/NĐ-CP and Resolution No. 66.13/2026/NQ-CP until the amended Food Safety Law is passed by the National Assembly and takes effect, while continuing to apply Decree No. 15/2018/NĐ-CP during the transition.

Beyond implementation concerns, the proposal reflects the fact that Decree 46 and Resolution 66.13 were issued and took immediate effect while the Food Safety Law was being revised. Applying these rules briefly and then replacing them with new guidance for the amended law would create legal instability, substantial compliance costs and disruption to production and business.

Businesses believe this approach would ensure legal stability, avoid large compliance costs over a short period, and allow a more coordinated and workable regulatory system to be developed.