Food Product Registration Process in Vietnam
End-to-end analysis of the đăng ký bản công bố hợp quy (conformity-declaration registration) and tự công bố sản phẩm (self-declaration) tracks for food in Vietnam — legal basis, the two-track perimeter under Decree 46/2026/NĐ-CP, dossier requirements, agency timelines, inter-ministerial allocation (MOH / MARD / MOIT), and the 2026 reform package.
Overview
Every prepackaged food placed on the Vietnamese market must have its product declaration on file with the competent authority before sale. Decree 46/2026/NĐ-CP, which replaced Decree 15/2018/NĐ-CP on 15 April 2026 after a 75-day Resolution 09/2026/NQ-CP suspension, runs a two-track system:
- Tự công bố sản phẩm (self-declaration) — the business prepares and posts the declaration itself, lodges a copy with the provincial Sở Y tế / Sở Công Thương / Sở Nông nghiệp & Môi trường, and may begin circulation the same day. Decree 46 has narrowed this perimeter sharply — many product categories that used to self-declare under Decree 15 now require pre-market registration.
- Đăng ký bản công bố hợp quy (conformity-declaration registration) — pre-market review against the applicable national technical regulation (QCVN) by the competent authority, culminating in a Giấy tiếp nhận đăng ký bản công bố hợp quy before sale. This is the new instrument introduced by Decree 46 for food additives, processing aids, packaging materials, food-contact tools, bottled water, and certain processed packaged food categories.
A third track — đăng ký bản công bố sản phẩm — sits parallel and covers TPBVSK (health-protection foods), medical-purpose nutrition foods, special-purpose dietary foods, and foods for infants and children under 36 months. That track is documented separately under /supplement/registration/ because the natural reader for it is a supplement company; this page focuses on the two general-food tracks.
Scope of this page:
- How to choose between tự công bố and đăng ký bản công bố hợp quy under Decree 46.
- Inter-ministerial allocation: which ministry takes which product category, and what changed when MOH absorbed packaging and food-contact materials under Decree 46 Article 51.
- Step-by-step process for each track, with dossier contents, agency timelines, and conformity-assessment-organisation (DCAO) involvement.
- The 2026 reform package: customs-clearance crisis of late January 2026, Resolution 09/2026/NQ-CP bridge period, and what changed when Decree 46 resumed on 15 April 2026.
- Practical pitfalls — wrong-ministry filings, QCVN mismatch, test-laboratory eligibility, transition-period traps.
How to read this page: "Key documents" is the legal stack in consultation order. "Recent updates" walks through the 2026 reform chronologically. "Resources & links" gives the operational portals. The FAQ closes recurring buyer/sponsor questions.
Validity of registration:
- Giấy tiếp nhận đăng ký bản công bố hợp quy — no fixed expiry; remains valid while product, formula, manufacturer, and label are unchanged.
- Tự công bố sản phẩm — no fixed expiry under Decree 46; the declarant is responsible for updating the declaration whenever the underlying product changes.
- Decree 15/2018 self-declarations made before 26 January 2026 remain valid for 12 months from that date; after 26 January 2027, only Decree 46 instruments are lawful for the affected product groups.
Key documents
Food-safety law (Luật An toàn thực phẩm):
- Law on Food Safety No. 55/2010/QH12 — foundational law; in force from 1 July 2011. Articles 38 and 39 set the product-declaration duty; Article 7 anchors the inter-ministerial allocation.
Implementing decrees (Nghị định) — currently in force:
- Decree 46/2026/NĐ-CP — signed 26 January 2026 to replace Decree 15/2018; effective from 26 January 2026 but immediately suspended by Resolution 09/2026/NQ-CP until 15 April 2026; operative again from 15 April 2026. Article 4 sets the new đăng ký bản công bố hợp quy regime; Article 6 governs tự công bố; Article 8 imposes mandatory HACCP / GMP / ISO 22000 by 31 December 2026 for TPBVSK and food-additive manufacturers; Article 51 reorganises inter-ministerial responsibility, transferring packaging and food-contact materials to MOH.
- Resolution 09/2026/NQ-CP — Government resolution dated 4 February 2026 suspending Decree 46 until 15 April 2026 and reinstating Decree 15/2018 plus its guidance during the bridge period.
Implementing decrees — historical context and transition:
- Decree 15/2018/NĐ-CP — operative from 2 February 2018 until 26 January 2026. Self-declarations made before that date remain valid for 12 months — the actual cut-over date is 26 January 2027.
- Decree 155/2018/NĐ-CP — amends Decree 15 (old regime); cited in earlier filings.
- Decree 38/2012/NĐ-CP — the pre-Decree-15 framework; relevant only for very old filings.
Inter-ministerial scope (Annex IV of Decree 15, restated and revised in Decree 46):
- Ministry of Health (MOH) / VFA — food additives, processing aids, micronutrient products, bottled water, TPBVSK and related, AND (new under Decree 46) packaging materials and food-contact tools.
- Ministry of Agriculture & Environment (MAE) — fresh and processed agricultural products, meat, fish, dairy raw material, vegetable oils at source, etc. (Note: the former MARD merged with MONRE into MAE in early 2025.)
- Ministry of Industry & Trade (MOIT) — general processed foods, milk and dairy products, oils, alcoholic beverages, soft drinks, confectionery, instant noodles.
Technical regulations and standards:
- QCVN (national technical regulations) — mandatory; each product category falls under one or more QCVNs that set the safety ceilings. The QCVN identifier appears in the conformity-declaration dossier.
- TCVN (Vietnamese standards) — voluntary; cited where no QCVN applies.
- Codex Alimentarius — accepted as reference where no QCVN or TCVN applies (per Decree 46 Article 12).
Labelling, claims, and inspection:
- Decree 43/2017/NĐ-CP — labelling of goods, general framework; mandatory Vietnamese language.
- Decree 111/2021/NĐ-CP — amends Decree 43 on labelling.
- Decree 38/2021/NĐ-CP — administrative penalties for advertising and labelling violations.
Note on numbering: Decree, Resolution, and Circular numbers and effective dates should be verified against the official publication on baochinhphu.vn, xaydungchinhsach.chinhphu.vn, or the Official Gazette (Công báo) before relying on them.
Recent updates
This section walks chronologically through the 2026 reform package — the Decree 46 customs-clearance crisis, the 75-day bridge period, and the regime that has been operative since 15 April 2026 — and then sets out the practical pitfalls.
1) Choosing the track — tự công bố vs đăng ký bản công bố hợp quy under Decree 46:
- Stays in tự công bố (narrower than under Decree 15): most prepackaged processed foods sold direct to consumers that do not fall into the new registration perimeter; raw ingredients used by the same business in further processing; small-volume artisan products that meet Article 6 thresholds.
- Moves to đăng ký bản công bố hợp quy (the new pre-market registration): food additives, processing aids, packaging materials, food-contact tools, bottled water, fortified foods with added micronutrients above QCVN ceilings, and certain processed packaged foods listed in Decree 46 Annexes.
- Separate đăng ký bản công bố sản phẩm: TPBVSK, medical-purpose nutrition foods, special-purpose dietary foods, foods for children under 36 months. Covered under /supplement/registration/.
2) Step-by-step process — đăng ký bản công bố hợp quy:
- Step 0 — Pre-submission. Identify the applicable QCVN (or TCVN/Codex fallback). Identify the competent ministry per Decree 46 Article 51. Confirm the manufacturing site holds the relevant ATTP certificate (Cơ sở đủ điều kiện an toàn thực phẩm) under Decree 67/2016/NĐ-CP. For TPBVSK and food-additive sites, confirm the HACCP / GMP / ISO 22000 roadmap against the 31 December 2026 deadline.
- Step 1 — Conformity assessment. Engage a designated conformity-assessment organisation (DCAO) — a state-designated body that issues the Conformity Assessment Certificate (Giấy chứng nhận hợp quy) after laboratory testing against the QCVN.
- Step 2 — Prepare dossier. Includes (i) the conformity-declaration form, (ii) the Conformity Assessment Certificate from the DCAO, (iii) test results from a designated laboratory accredited under ISO/IEC 17025 in the relevant scope, (iv) the proposed Vietnamese-language label, (v) ATTP certificate of the manufacturing site, (vi) registrant business registration, and (vii) for imports a CFS consularised where required.
- Step 3 — Online submission. Via the National Single Window (vnsw.gov.vn) for goods crossing customs, or the relevant ministry portal (dichvucong.moh.gov.vn for MOH-scope, dichvucong.mae.gov.vn for MAE-scope, dichvucong.moit.gov.vn for MOIT-scope).
- Step 4 — Completeness review and substantive evaluation. Decree 46 introduces a real agency processing window — typical targets in the published drafts are 7–15 working days depending on the product category.
- Step 5 — Question rounds (yêu cầu bổ sung). Applicant cures within the period set in the request; two rounds is typical.
- Step 6 — Issuance of Giấy tiếp nhận đăng ký bản công bố hợp quy; the registration is published on the issuing-ministry register and the product may circulate.
- Step 7 — Post-issuance: import-shipment inspection regime (full → reduced → exempted) under Decree 46 Articles 20–24; re-registration upon material change.
3) Step-by-step process — tự công bố sản phẩm:
- Step 0 — Confirm the product is inside the narrowed Decree 46 self-declaration perimeter. If in doubt, file đăng ký bản công bố hợp quy.
- Step 1 — Prepare the self-declaration form against the applicable QCVN, TCVN, or Codex reference. Test the product at a designated laboratory; obtain results.
- Step 2 — Publish the self-declaration on the business website or on a designated public information channel.
- Step 3 — Lodge a copy with the provincial Sở Y tế / Sở Công Thương / Sở Nông nghiệp & Môi trường depending on the product category. Circulation may begin immediately.
- Step 4 — Maintain records, including a current copy of the self-declaration accessible to inspectors within 72 hours of a request.
4) Inter-ministerial allocation under Decree 46 Article 51:
- MOH / VFA — food additives, processing aids, micronutrient products, bottled water, TPBVSK and related, AND (new) packaging materials and food-contact tools previously split across MOIT and MARD.
- MAE — fresh and processed agricultural products, meat, fish, dairy raw materials, vegetable oils at source.
- MOIT — general processed foods, milk and dairy products, oils, alcoholic beverages, soft drinks, confectionery, instant noodles.
- The practical effect: a product team previously maintaining three parallel channels (one per ministry) now consolidates its packaging registrations into a single MOH channel.
5) The Decree 46 customs-clearance crisis of late January 2026:
- Decree 46 took effect the day it was signed (26 January 2026), on the eve of Lunar New Year, with no transition period for goods already in transit.
- Within four to five days, more than 700 shipments and approximately 300,000 tonnes of food and agricultural product were stuck at land, sea, and air borders.
- On 4 February 2026, the Prime Minister issued a directive instructing eight ministries to "urgently remove difficulties" in inspecting food and import-export goods. The Government issued Resolution 09/2026/NQ-CP the same day, suspending Decree 46 until 15 April 2026 and reinstating Decree 15/2018 plus its guidance for the bridge period.
- Detained shipments began clearing customs on the evening of 5 February 2026.
- Decree 46 resumed on 16 April 2026. Companies should now operate on the assumption that the substantive design is permanent.
6) 2026 reform package — what changed when Decree 46 resumed:
- Self-declaration perimeter narrowed (Article 4): processed packaged food, food additives, processing aids, packaging materials and food-contact tools moved out of tự công bố into đăng ký bản công bố hợp quy.
- Mandatory HACCP / GMP / ISO 22000 (Article 8): TPBVSK and food-additive manufacturers must operate a manufacturing-system certificate no later than 31 December 2026.
- Risk-based post-market inspection ladder (Articles 20–24): full → reduced → exempted inspection for imports based on the importer's compliance record. After 12 months of clean compliance, an importer can be downgraded to reduced inspection.
- Inter-ministerial reorganisation (Article 51): MOH/VFA now covers food additives, bottled water, TPBVSK, AND packaging materials and food-contact tools.
- Transition: products self-declared under Decree 15/2018 before 26 January 2026 remain valid for 12 months. After 26 January 2027, only Decree 46 instruments are valid for the affected product groups.
7) Practical pitfalls (where most rejection cycles come from):
- Wrong-ministry filing: with the Decree 46 reshuffle, lodging the dossier with the prior-Decree-15 ministry is a frequent error. Verify against Article 51 before submission.
- QCVN mismatch: identifying the wrong technical regulation as the conformity reference invalidates the Conformity Assessment Certificate. Cross-check against the QCVN library maintained at vbpl.vn before engaging the DCAO.
- Designated laboratory eligibility: test results must come from a laboratory designated by the relevant ministry and accredited under ISO/IEC 17025 by BoA in a scope covering the QCVN. Results from a non-recognised lab have no value.
- Transition-period trap: a product circulating under a Decree 15/2018 self-declaration may legally still be on the market through 26 January 2027 — but cannot be amended, extended, or re-purposed under that old declaration. Any change requires a Decree 46 filing.
- Vietnamese-language labelling: the label must be ready and attached to the dossier at submission; "to be finalised" placeholders are routinely rejected at completeness review.
- Importer record-keeping: under the new risk-based inspection ladder, the path to reduced inspection requires 12 months of clean compliance with a complete audit trail — missing records reset the clock.
Resources & links
Operational portals (for submission and lookup):
- National Single Window — https://vnsw.gov.vn — primary channel for dossiers tied to import-export goods.
- MOH public-service portal — https://dichvucong.moh.gov.vn — for MOH/VFA-scope products (additives, bottled water, packaging materials, food-contact tools).
- Ministry of Industry & Trade public-service portal — https://dichvucong.moit.gov.vn — for MOIT-scope products.
- Ministry of Agriculture & Environment public-service portal — https://dichvucong.mae.gov.vn — for MAE-scope agricultural and processed-agricultural products.
- VFA — https://vfa.gov.vn — circulars, notices, and VFA-issued acceptance certificates.
Government & primary legal sources:
- Decree 46/2026 full text — https://xaydungchinhsach.chinhphu.vn — Government Office policy-tracking portal.
- Official Gazette (Công báo) — https://congbao.chinhphu.vn — authoritative publication of laws, decrees, resolutions, and circulars.
- National legal database — https://vbpl.vn — QCVN library and consolidated full-text retrieval.
Designated laboratories and conformity-assessment bodies:
- National Institute for Food Control (NIFC) — https://nifc.gov.vn — flagship MOH food laboratory.
- MAE-designated laboratories list — published on the MAE website; periodically refreshed.
- Bureau of Accreditation (BoA) — https://boa.gov.vn — ISO/IEC 17025 accreditation.
- List of designated conformity-assessment organisations (DCAOs) — issued by MOH, MAE, and MOIT respectively for each ministry's scope.
Medibase internal cross-references:
- /food/self-declaration/ — the broader tự công bố regime and its narrowed Decree 46 perimeter.
- /food/technical-standards/ — QCVN and TCVN tier; required to identify the conformity reference for the dossier.
- /food/specialized-management/ — inter-ministerial allocation in greater depth.
- /food/safety-certificates/ — the manufacturer ATTP certificate that the dossier must reference.
- /food/labeling/ — the Vietnamese-language label that must be attached at submission.
- /supplement/registration/ — the parallel đăng ký bản công bố sản phẩm regime for TPBVSK and similar.
Frequently asked questions
- Which products still self-declare under Decree 46, and which now require đăng ký bản công bố hợp quy?
After 15 April 2026, food additives, processing aids, packaging materials, food-contact tools, bottled water, fortified foods with added micronutrients above QCVN ceilings, and certain processed packaged foods listed in the Decree 46 annexes require đăng ký bản công bố hợp quy. Most other prepackaged processed foods remain in tự công bố sản phẩm, but the perimeter is materially narrower than it was under Decree 15/2018. If a product's classification is unclear, filing the registration is the safer choice — a self-declaration filed in the wrong perimeter is voidable and exposes the business to recall and administrative penalty.
- How long does đăng ký bản công bố hợp quy actually take?
Decree 46 introduced a real agency processing window for the first time. The published targets are 7–15 working days depending on the product category, measured from formal acceptance of a complete dossier. The real-world data is still being collected — the first systematic timing report is expected in late 2026 from VFA and the equivalent MAE / MOIT inspectorates.
- Do my old Decree 15/2018 self-declarations still work?
Yes, but on a clock. Self-declarations made before 26 January 2026 remain valid for 12 months from that date — i.e., until 26 January 2027. After that, the only valid instrument for the affected product groups is the Decree 46 instrument (đăng ký bản công bố hợp quy for the new registration perimeter, tự công bố under Decree 46 Article 6 for the narrower remaining perimeter).
- Which ministry takes my dossier?
Decree 46 Article 51 is the authoritative allocation. Rule of thumb: MOH/VFA for additives, processing aids, micronutrient products, bottled water, and now packaging and food-contact materials; MAE for fresh and processed agricultural products; MOIT for general processed foods, milk and dairy, oils, alcoholic and soft drinks, confectionery, and instant noodles. Cross-check Annex IV of Decree 46 for borderline cases. Mis-allocation is one of the most common dossier-rejection causes.
- Can the laboratory I currently use produce the test results in the dossier?
Only if it is (i) designated by the relevant ministry for the product scope, AND (ii) accredited under ISO/IEC 17025 by BoA in a scope covering the applicable QCVN. Test results from a non-designated or out-of-scope lab have no value at completeness review. Each ministry publishes its designated-laboratory list; verify the current version before booking the analysis.
- What does the new risk-based inspection ladder mean for importers?
Decree 46 Articles 20–24 replace the prior uniform inspection regime with a three-tier ladder: full inspection (default), reduced inspection (after 12 months of clean compliance with complete records), and exempted inspection (for products on a specific list). Missing or incomplete records reset the clock — the path to reduced inspection requires not only no violations but also a complete audit trail for the entire 12-month window.
- What happens after 31 December 2026 if my TPBVSK or food-additive manufacturing site lacks HACCP / ISO 22000 / GMP?
Article 8 of Decree 46 makes a manufacturing-system certificate mandatory by 31 December 2026 for TPBVSK and food-additive sites. No further extension has been signalled. After that date, registrations relying on a non-certified site become liable to suspension and the products are exposed to recall and administrative penalty under Decree 38/2021/NĐ-CP.
- My product's formula will change next year — variation or new registration?
New registration. Any material change to formula, manufacturer, claim, dose, or label that affects mandatory disclosures triggers a fresh đăng ký bản công bố hợp quy. There is no "variation" instrument equivalent to medicine-side Type IA/IB/II under the food framework.
Last updated: 2026-05-19