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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

**Important — current status (mid-2026):** Decree 46/2026/NĐ-CP is suspended indefinitely under Resolution 15/2026/NQ-CP (6 April 2026), until the revised Food Safety Law and its implementing decrees take effect. Decree 15/2018/NĐ-CP and its existing implementing documents therefore continue to apply. Dossiers filed before NQ 15/2026 are handled under NĐ 15/2018. The framework described below is the NĐ 46 framework as written — it does not currently operate as live regulation. The revised Food Safety Law is expected at the September 2026 UBTVQH session (NQ 119/2026/UBTVQH15).

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 was signed on 26 January 2026 to replace Decree 15/2018/NĐ-CP but never entered operational force (suspended four days later by NQ 09/2026/NQ-CP, then indefinitely by NQ 15/2026/NQ-CP) — would have run 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. The NĐ 46 design would have narrowed this perimeter sharply — many product categories that self-declare under Decree 15 would require pre-market registration under the suspended NĐ 46 text; until NĐ 46 enters force the NĐ 15/2018 self-declaration perimeter continues to apply.
  • 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 instrument NĐ 46 would introduce for food additives, processing aids, packaging materials, food-contact tools, bottled water, and certain processed packaged food categories; because NĐ 46 is suspended, these products remain on the NĐ 15/2018 regime in the meantime.

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 as drafted in NĐ 46 (suspended) — and how the choice maps back onto the operative NĐ 15/2018 perimeter.
  • Inter-ministerial allocation: which ministry takes which product category under NĐ 15/2018, and what NĐ 46 Article 51 would change (MOH absorbing packaging and food-contact materials) — currently not in force.
  • 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 the indefinite suspension of NĐ 46 under Resolution 15/2026/NQ-CP.
  • 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; the declarant is responsible for updating the declaration whenever the underlying product changes.
  • Decree 15/2018 self-declarations remain operative because NĐ 15/2018 itself remains operative; the 12-month transition + 26 January 2027 cut-over date drafted in NĐ 46 cannot take effect until NĐ 46 (or a successor decree) is operative.

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) — current status:

  • Decree 15/2018/NĐ-CP — in force from 2 February 2018 and still the operative implementing decree for food safety in mid-2026. Its replacement by Decree 46 has been suspended indefinitely (see below), so NĐ 15/2018 and its existing guidance documents continue to govern both tự công bố sản phẩm and đăng ký bản công bố hợp quy.
  • Decree 46/2026/NĐ-CP — signed 26 January 2026 to replace Decree 15/2018; effective on the day of signing but immediately suspended by Resolution 09/2026/NQ-CP; the suspension was then extended indefinitely by Resolution 15/2026/NQ-CP (see below). NĐ 46 is therefore not in operational force as of mid-2026. As drafted: Article 4 sets the 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. These provisions are pending until NĐ 46 is brought into force (or superseded by the revised Food Safety Law and its successor decrees).

Suspending and ancillary resolutions:

  • Resolution 09/2026/NQ-CP — Government resolution dated 4 February 2026; initial 75-day suspension of NĐ 46, reinstating NĐ 15/2018 and its guidance for what was expected to be a bridge period to 15 April 2026.
  • Resolution 15/2026/NQ-CP — Government resolution dated 6 April 2026; extended the NĐ 46 suspension indefinitely until the revised Food Safety Law and its implementing decrees take effect. This is the resolution that keeps NĐ 15/2018 as the operative regime. NQ 119/2026/UBTVQH15 schedules the revised Food Safety Law for the September 2026 UBTVQH session.

Implementing decrees — historical context and transition:

  • Decree 15/2018/NĐ-CP transition framework: under the suspended NĐ 46 text, self-declarations made before 26 January 2026 would remain valid for 12 months with a cut-over date of 26 January 2027. Because NĐ 46 is suspended, those self-declarations continue under NĐ 15/2018 itself; the cut-over cannot take effect until NĐ 46 (or a successor decree) is operative.
  • Decree 155/2018/NĐ-CP — amends Decree 15; cited in current 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, with the NĐ 46 revisions noted but suspended):

  • Ministry of Health (MOH) / VFA — food additives, processing aids, micronutrient products, bottled water, TPBVSK and related. NĐ 46 would also move packaging materials and food-contact tools to MOH under Article 51; because NĐ 46 is suspended, these remain on the NĐ 15/2018 split.
  • 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 NĐ 15/2018, carried into NĐ 46 Article 12 unchanged).

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 initial 75-day bridge period under NQ 09, and the indefinite suspension under NQ 15/2026 — and then sets out the practical pitfalls. NĐ 15/2018 remains the operative implementing decree.

1) Choosing the track — tự công bố vs đăng ký bản công bố hợp quy (NĐ 46 design — currently suspended):

  • Would stay in tự công bố under NĐ 46 (narrower than under NĐ 15/2018): 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.
  • Would move to đăng ký bản công bố hợp quy under NĐ 46 (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 NĐ 46 Annexes. Because NĐ 46 is suspended, these products remain on the NĐ 15/2018 perimeter for the time being.
  • 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 would introduce a real agency processing window — typical targets in the published drafts are 7–15 working days depending on the product category; because NĐ 46 is suspended, the operative timeline today is the NĐ 15/2018 window.
  • 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; under the suspended NĐ 46 Articles 20–24 this would become a full → reduced → exempted ladder, but until NĐ 46 is in force the operative inspection regime is the NĐ 15/2018 one. Re-registration upon material change.

3) Step-by-step process — tự công bố sản phẩm:

  • Step 0 — Confirm the product is inside the operative NĐ 15/2018 self-declaration perimeter (the NĐ 46 narrowing is suspended). 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 NĐ 15/2018 (with NĐ 46 Article 51 revisions noted but suspended):

  • MOH / VFA — food additives, processing aids, micronutrient products, bottled water, TPBVSK and related. NĐ 46 would also move packaging materials and food-contact tools to MOH; because NĐ 46 is suspended, these remain split across MOIT and MAE per the NĐ 15/2018 Annex IV.
  • MAE (Ministry of Agriculture & Environment) — 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 of the NĐ 46 design (suspended): a product team currently maintaining three parallel channels would consolidate packaging registrations into a single MOH channel once NĐ 46 enters force.

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.
  • On 6 April 2026, before the 75-day NQ 09 window expired, the Government issued Resolution 15/2026/NQ-CP, extending the NĐ 46 suspension indefinitely until the revised Food Safety Law and its implementing decrees take effect. NĐ 46 has not since resumed; NĐ 15/2018 and its existing guidance documents remain operative. NQ 119/2026/UBTVQH15 schedules the revised Food Safety Law for the September 2026 UBTVQH session.

6) 2026 reform package — what the NĐ 46 design would change (currently suspended; not in force):

  • Self-declaration perimeter narrowed (Article 4): processed packaged food, food additives, processing aids, packaging materials and food-contact tools would move 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 would have to 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.
  • Inter-ministerial reorganisation (Article 51): MOH/VFA would absorb packaging materials and food-contact tools in addition to food additives, bottled water, and TPBVSK.
  • Transition (suspended along with NĐ 46): the 12-month window and 26 January 2027 cut-over date drafted in NĐ 46 cannot take effect until NĐ 46 (or a successor decree) is operative. Until then, NĐ 15/2018 self-declarations remain valid under NĐ 15/2018.

7) Practical pitfalls (where most rejection cycles come from):

  • Wrong-ministry filing: because NĐ 46 Article 51 is suspended, the operative allocation is still the NĐ 15/2018 Annex IV split. Verify against NĐ 15/2018 Annex IV before submission; assuming the NĐ 46 reshuffle has happened is the opposite mistake.
  • 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: although the NĐ 46 12-month transition is suspended along with NĐ 46 itself, an NĐ 15/2018 self-declaration cannot legally be amended, extended, or re-purposed without a fresh filing under the operative regime. The familiar "expires 26 January 2027" framing only matters once NĐ 46 (or a successor decree) is in force.
  • 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 self-declare and which require đăng ký bản công bố hợp quy in mid-2026?

NĐ 15/2018 is the operative implementing decree (NĐ 46 is suspended indefinitely by NQ 15/2026/NQ-CP), so the operative perimeter is the NĐ 15/2018 one. Under the suspended NĐ 46 design, 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 would move into đăng ký bản công bố hợp quy; this narrowing is currently not in force. 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?

NĐ 46 was drafted to introduce a real agency processing window for the first time, with published targets of 7–15 working days depending on the product category. Because NĐ 46 is suspended, the operative window today is the NĐ 15/2018 one — typically longer in practice, driven by question rounds. The NĐ 46 timing data will not exist until NĐ 46 (or a successor decree) enters force.

Do my old Decree 15/2018 self-declarations still work?

Yes — they continue to operate under NĐ 15/2018 itself, which is still the operative implementing decree. The 12-month transition window and 26 January 2027 cut-over date drafted in NĐ 46 are suspended along with NĐ 46 (NQ 15/2026/NQ-CP). Whenever NĐ 46 (or a successor decree) enters force, the transition clock will need to be re-set by that decree.

Which ministry takes my dossier?

NĐ 15/2018 Annex IV is the operative allocation. Rule of thumb: MOH/VFA for additives, processing aids, micronutrient products, bottled water, and TPBVSK; MAE for fresh and processed agricultural products; MOIT for general processed foods, milk and dairy, oils, alcoholic and soft drinks, confectionery, instant noodles, AND packaging materials and food-contact tools (which NĐ 46 Article 51 would move to MOH when in force, but is currently suspended). Mis-allocation is one of the most common dossier-rejection causes; do not assume the NĐ 46 reshuffle has happened.

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 NĐ 46 risk-based inspection ladder mean for importers?

NĐ 46 Articles 20–24 would 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). Because NĐ 46 is suspended by NQ 15/2026/NQ-CP, this ladder is not currently in force; the operative regime is still the NĐ 15/2018 inspection one. Prudent importers are nevertheless building the audit trail in anticipation.

What about the 31 December 2026 HACCP / ISO 22000 / GMP deadline for TPBVSK and food-additive sites?

Article 8 of NĐ 46 would require a manufacturing-system certificate by 31 December 2026 for TPBVSK and food-additive sites. Because NĐ 46 is suspended indefinitely by NQ 15/2026/NQ-CP, this Article 8 deadline is not currently in operational force; under NĐ 15/2018 the existing requirement is GMP-TPBVSK per Circular 18/2019/TT-BYT (TPBVSK sites already need this), without the broader system-level HACCP / ISO 22000 obligation. The system-level obligation will apply if and when NĐ 46 (or a successor decree) enters force.

My product's formula will change next year — variation or new registration?

New filing under the operative regime. Any material change to formula, manufacturer, claim, dose, or label that affects mandatory disclosures triggers a fresh declaration / registration (currently under NĐ 15/2018; under NĐ 46 it would be a fresh đăng ký bản công bố hợp quy or tự công bố depending on the perimeter). There is no "variation" instrument equivalent to medicine-side Type IA/IB/II under the food framework.

Page updated:
2026-06-29

Reference information only; not legal or medical advice.