Decree 46/2026 vs Decree 15/2018 — a structured comparison of Vietnam's food-safety reset

Decree 15/2018/NĐ-CP governed Vietnam's food-safety regulation for almost eight years, from February 2018 to April 2026. It was the instrument that institutionalised the self-declaration (tự công bố) regime — a major liberalisation that let companies bring food products to market by filing a one-page form with provincial authorities. Decree 46/2026/NĐ-CP, signed 26 January 2026 and (after a 75-day suspension under Resolution 09/2026/NQ-CP) effective again from 15 April 2026, rewrites every chapter of that framework. This article compares the two instruments, area by area, with article references where the public text supports them.

1) Self-declaration vs Conformity-declaration registration

Decree 15/2018: companies prepared a self-declaration of standards-compliance (tự công bố sản phẩm) and submitted a single copy to the local Department of Health or Department of Industry & Trade. Sales could begin the same day; no agency processing timeline was specified, and there was no central registry.

Decree 46/2026: the self-declaration perimeter is narrowed. Processed packaged food, food additives, processing aids, packaging materials and food-contact tools must now go through "đăng ký bản công bố hợp quy" — a true conformity-declaration registration with:

• Submission via the national public-service portal or registered post.
• Maximum agency processing of 10 working days.
• Validity not exceeding 3 years.
• Publication in the state-management database.

Transition: products self-declared before 26 January 2026 may continue to circulate for 12 months. After that, the new registration is the only valid market-entry instrument for the listed product categories.

2) Packaging and food-contact materials — newly in scope

Decree 15/2018: packaging was a peripheral concern, surfaced only as a sub-requirement of the underlying food product.

Decree 46/2026: for the first time, packaging and food-contact tools are an independent regulated object. Articles 4, 20 and 51 stand up three obligations:

• Article 4 — register a conformity declaration in the same regime as processed food.
• Article 20 — submit to state inspection at import or domestic placement.
• Article 51 — comply with local UBND safety oversight rules.

This pulls a long-overlooked tail of the supply chain (closures, films, multilayer laminates, contact utensils) into the same regulatory perimeter as the food they touch.

3) HACCP / GMP — from "recommended" to "mandatory by 31 December 2026"

Decree 15/2018: HACCP and equivalent quality-management systems were referenced as desirable practice and a precondition for certain product categories, but Decree 15 did not impose a date-certain mandate.

Decree 46/2026: a real deadline. Health-supplement (thực phẩm bảo vệ sức khỏe — TPBVSK) producers and food-additive manufacturers must complete and operate a HACCP, GMP, ISO 22000 or equivalent system no later than 31 December 2026. Two further personnel criteria are new:

• A designated professional in charge: university degree in medicine, pharmacy, nutrition, food safety or food technology, with a minimum of three years' relevant experience.
• Production and QC department heads must be permanent, full-time staff, and the two roles must be functionally independent.

Together, these turn TPBVSK manufacturing from a paperwork compliance activity into a real operational-system audit.

4) Import inspection — codified three-tier risk system

Decree 15/2018: contained a partial framework for state inspection at import, but mode classification and timelines were uneven and case-driven.

Decree 46/2026: Articles 19–28 codify a three-mode system, fully procedural:

• Strict inspection — applied where there are existing warnings, prior violations, or suspected fraud. Full file review plus laboratory testing.
• Standard inspection — file review with sampling at a defined frequency.
• Reduced inspection — applied to importers with good compliance history or under bilateral / multilateral recognition agreements.

A consignment maintaining good results for 12 months can be downgraded to reduced inspection — a structural incentive for sustained compliance. Crucially, the inspection perimeter now extends to packaging and food-contact materials, not only food and additives.

5) Advertising approval — Article 27 inheritor

Decree 15/2018 Article 27 was the foundation for advertising-content verification certificates for TPBVSK, and survived nearly intact until the parallel Resolution 21/2026/NQ-CP (29 April 2026) reassigned the issuing authority from the central VFA to provincial People's Committees with effect from 1 July 2026.

Decree 46/2026 preserves the substantive procedure (10-working-day approval, one revision allowed, 90-day expiry of unanswered files), and adds two notable refinements:

• A standardised mandatory warning for TPBVSK advertising — "This product is not a medicine and does not substitute for medicine" — formatted as audio, image or video as the channel requires.
• An express link to the state-management database for publication of issued certificates, ending the pre-2026 patchwork of provincial websites.

6) Labelling — GMO threshold, medical-food warning, exemption floors

Decree 15/2018: general label requirements with limited specifics on novel food categories.

Decree 46/2026 codifies:

• Medical nutritional foods must state "Use for patients under medical supervision".
• GMO labelling is mandatory when GMO content exceeds 5%.
• Labelling exemptions: free samples, gifts, souvenirs, and pack surfaces smaller than 10 cm².

7) Traceability and recall — separate chapters, database integration

Decree 15/2018: traceability and testing sat under combined chapters; trigger moments for recall were vague.

Decree 46/2026: Chapter VIII (testing) and Chapter IX (traceability) are separate. The recall trigger (Articles 42–43) is the "moment of detection or notice of risk." Required traceability data is enumerated — batch codes, manufacturing and expiry dates, packaging, additives, supplier information — and producers must connect their records to the state-management database to enable rapid alerts.

Designated testing laboratories must hold ISO/IEC 17025 accreditation and a quality-management system — a tightening that meaningfully reduces the eligible Vietnamese laboratory pool.

8) E-commerce platform liability — entirely new

Decree 15/2018: e-commerce was outside the scope; platform operators bore no specific food-safety duty under the food law.

Decree 46/2026 Article 52 §6: marketplace operators (Shopee, Lazada, TikTok Shop, Tiki, Sendo) bear direct primary obligations to (a) operate content-moderation workflows, (b) require sellers to disclose product legal documents, (c) take down infringing products on regulator request, and (d) carry joint liability for safety incidents that result from a failure of the above. Administrative penalties continue to flow through Decree 38/2021/NĐ-CP.

9) Ministerial division of labour — preserved, products reassigned

Both decrees keep the "one-door" assignment per product category, but the perimeter shifts:

• Ministry of Health — food additives, bottled water, health-supplements (TPBVSK), AND packaging materials.
• Ministry of Agriculture and Environment — cereals, meat, seafood, vegetables, and GMO foods.
• Ministry of Industry and Trade — alcohol, beverages, processed milk, and supermarket / e-commerce surveillance.

Packaging moving into MoH's perimeter is significant — it concentrates the new conformity-declaration workflow at a single ministry.

10) Transition and grandfathering

• Decree 15/2018 self-declarations are valid for 12 months from 26 January 2026.
• Marketing-authorisation certificates issued under Decree 15 remain valid through their original expiry.
• Advertising-content certificates issued by the central VFA continue to be valid; new applications from 1 July 2026 go to the provincial UBND (per Resolution 21/2026/NQ-CP).
• HACCP / GMP for TPBVSK and additive manufacturers must be operational by 31 December 2026 with no further extension signalled.

Implications for foreign sponsors and importers

The combined effect is a shift in regulatory posture: from light-touch pre-market filing with intensive enforcement-after-the-fact, to a heavier pre-market registration regime with a structured post-market risk-based inspection ladder. The cost of carrying a non-compliant product across the border is now higher; the reward for maintaining a clean compliance record (downgrade to reduced inspection after 12 months) is also higher.

Three concrete preparations are now standard practice for multinational sponsors entering Vietnam:

• Re-classify the product portfolio against the new categories (self-declared vs conformity-declared) before the 26 January 2027 grandfathering expiry.
• Map every food-contact packaging SKU into the new registration workflow; suppliers based outside Vietnam need to provide updated test data and origin certification.
• Lock in the HACCP / GMP / ISO 22000 work-stream against the 31 December 2026 deadline. The previous practice of certifying only the parent food product is no longer sufficient — system-level certification of the manufacturing site is now required for TPBVSK and additive plants.

The 75-day suspension episode in February 2026 demonstrated that Vietnam will not back down from the structural design of Decree 46. The implementing-circular layer is still under construction at the Ministry of Health and the Ministry of Agriculture and Environment; expect further specifications across H2 2026.

Sources

• Decree 46/2026/NĐ-CP full text — Vietnam Government policy-build portal (xaydungchinhsach.chinhphu.vn).
• Decree 15/2018/NĐ-CP full text — Vietnam legal portal (thuvienphapluat.vn).
• "Nghị định 46/2026/NĐ-CP: Những thay đổi so với Nghị định 15/2018/NĐ-CP" — SNI Vietnam (snivietnam.vn).
• "6 điểm mới tại Nghị định 46/2026/NĐ-CP về quản lý an toàn thực phẩm" — LuatVietnam.
• Resolution 09/2026/NQ-CP (4 February 2026, suspending Decree 46) — Government Office.
• Resolution 21/2026/NQ-CP (29 April 2026, decentralising advertising approval) — Government Office.