Business • Food & Cosmetics

Product DeclarationFood, Health Supplements & Cosmetics

LTV Law advises on and executes the entire procedure for product self-declaration or declaration registration under Decree No. 15/2018/ND-CP for food, health-protection food, cosmetics, and medical products.

Quick facts

  • Scope of application
    Food, health supplements, cosmetics, medical devices
  • Competent authority
    Food Safety Authority (MOH); Drug Administration
  • Processing time
    Immediate (self-declaration) / 45 days (health supplements)
  • Legal basis
    Decree 15/2018/ND-CP
Overview

What is product declaration? Who must complete it?

Under Decree 15/2018/ND-CP, before placing food, health-protection food (health supplements), or cosmetics on the Vietnamese market, businesses are required to complete a product declaration procedure. Depending on the product type, there are two pathways:

2 pathways for product declaration

Pathway 1
PRODUCT SELF-DECLARATION
Article 4, Decree 15/2018
Applies to
  • Ordinary food (confectionery, beverages, spices, etc.)
  • Ordinary food additives
  • Food-contact packaging tools/materials
Timeline: Immediate
Posted on the local Department of Health web portal; the business bears full responsibility; subject to post-market inspection by the authorities.
Pathway 2
DECLARATION REGISTRATION
Article 5, Decree 15/2018
Applies to
  • Health-protection food (health supplements/functional food)
  • Special dietary food (infant formula, food for diabetics, etc.)
  • Food additives not yet on the approved list
Authority: Food Safety Authority (Ministry of Health)
Timeline: 45 working days
Fee: 1,000,000 VND/dossier
Receipt Certificate valid for 3 years; renewal required thereafter
COSMETICS
Circular 06/2011/TT-BYT; Decree 93/2016
  • Cosmetic Product Notification must be accepted by the Drug Administration (MOH) AT LEAST 30 days before market circulation
  • Fee: 500,000 VND/product
  • Accompanying dossier: GMP/ISO 22000; Certificate of Free Sale from the exporting country (if imported); product formula; Vietnamese label; test results

Reference testing costs

Ordinary food
3,000,000 – 8,000,000 VND
At a designated facility
Health supplements (more parameters)
10,000,000 – 30,000,000 VND
At a designated facility
Cosmetics
5,000,000 – 15,000,000 VND
At a designated facility

Mandatory product labeling under Decree 43/2017

Product name
Name/address of the manufacturer/importer
Origin of goods
Ingredients
Instructions for use
Expiry date
Storage conditions
Safety warnings
Procedure

Product declaration procedure in Vietnam

6 steps under Decree 15/2018/ND-CP and Circular 06/2011/TT-BYT (cosmetics).

1
Classify the product & choose the pathway
Determine whether the product falls under self-declaration or declaration registration; identify the competent authority (Food Safety Authority, Drug Administration, or local Department of Health).
Same day
2
Testing at a designated facility
Send product samples to a testing laboratory designated by the Food Safety Authority/Ministry of Health; obtain the Test Result Certificate.
2–6 weeks (depending on product type)
3
Prepare the declaration dossier
Declaration statement; test results; product label; manufacturing process; technical documentation; corporate legal records.
3–5 days
4
Submit the dossier to the competent authority
Food Safety Authority (health supplements/imported products); Drug Administration (cosmetics); local Department of Health portal (self-declaration of ordinary food).
1 day
5
Review & issuance of the Receipt Certificate
Self-declaration: effective immediately upon posting. Registered health supplements: 45 working days. The authority may request supplementary documents.
Immediate or 45 days
6
Market circulation & post-declaration monitoring
Release the product to the market; conduct periodic testing; re-declare upon changes; renew registration after 3 years (applicable to health supplements).
Annually
Required documents

Declaration registration dossier (health supplements)

Declaration registration dossier for health supplements / imported products
  • Application for the Receipt Certificate (form under Appendix I of Decree 15/2018)
  • Product declaration statement
  • Food safety test result certificate (from a designated facility)
  • Product label (including a supplementary Vietnamese label if imported)
  • Manufacturing process / in-house standard (TCCS)
  • GMP, HACCP, ISO 22000 certificates (if any)
  • Certificate of Free Sale (CFS) from the exporting country (if imported)
  • Business registration certificate

Note: The self-declaration dossier for ordinary food is simpler — it mainly consists of the declaration statement, test results, and the product label. LTV Law will prepare the specific document checklist once the product has been classified.

Reference fees

Reference costs for product declaration

Actual costs depend on the product type, the number of testing parameters, and the declaration method applied.

Fee typeAmount
Declaration registration fee (health supplements)1,000,000 VND/dossier
Cosmetic declaration fee500,000 VND/product
Testing of ordinary food3–8 million VND
Testing of health supplements10–30 million VND
Testing of cosmetics5–15 million VND
LTV Law service feeContact for a quote

Actual testing costs may be higher depending on the number of parameters required and the type of laboratory used. LTV Law advises on an optimal testing pathway to help control costs.

LTV Law service packages

LTV Law product declaration services

We offer 2 flexible service packages suited to each business's needs and budget.

Advisory & Dossier Package

  • Product classification & determination of the declaration pathway
  • Advice on the appropriate competent authority
  • Drafting the entire declaration dossier
  • Detailed guidance on filing the dossier
  • Labeling advice under Decree 43/2017
Contact us for advice
Most popular

Full-Service Package

  • Product classification & determination of the declaration pathway
  • Connection to a designated testing facility
  • Drafting the entire declaration dossier
  • Filing on your behalf and follow-up with the competent authority
  • Handling supplementary requests from state agencies
  • Support for re-declaration upon changes
  • Reminders for renewal before expiry (health supplements)
Contact us for advice
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product declaration procedure

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Free product classification
Advice on the optimal declaration pathway
Cost estimate before you proceed
No obligation, no consultation fee

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FAQ

Frequently asked questions about product declaration

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