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Vietnam's Ministry of Health (MoH) has notified the WTO of a revised draft decree regulating the management of cosmetics, with comments due by 1 November.
The latest text would classify cosmetics as high, medium or low risk, while dropping earlier criteria based on restricted substance concentrations, nanomaterials and other formulation triggers.
The draft decree, dated 17 September, would repeal Circular 06/2011/TT-BYT and Decree 93/2016/ND-CP that govern cosmetic products in Vietnam.
The ministry first announced a replacement decree in December 2023, followed by drafts in May 2025 and February and May this year.
The MoH's Drug Administration of Vietnam (DAV) expects to submit the draft to the government in November for entry into force on 1 January – six months later than in the February iteration.
The MoH Cosmetics Management System would go live on 1 July 2027.
Risk classification
The draft classifies product types as high risk (Group A), medium risk (Group B) or low risk (Group C) using the scoring method in Decree 37/2026/ND-CP, which implements the amended Law on Product and Goods Quality.
The scoring method combines impact, exposure and incident probability. Annex V of the draft assigns products to four impact tiers:
- highest – oxidative hair dyes and thioglycolate perm or straightening products;
- skin whiteners, eyelash growth products, hair-removal products, leave-on children's products and scalp or nasal aerosols;
- sunscreens, leave-on eye make-up and lip products such as lipsticks; and
- lowest – rinse-off products.
Leave-on products with special functions for children under three and products for the mucous membranes of the eyes, nose and mouth, would be Group A, whatever their score.
Group A notifiers would have to keep the manufacturer's batch test certificates on file, or upload the batch data to the MoH system, within ten working days of clearance or launch. They would also have to undergo annual sampling and testing, return product information file (PIF) extracts within ten working days and implement batch-chain traceability.
Group B would have 20 working days for PIF extracts and Group C 30 working days. Group C products would be sampled on a probabilistic basis.
Companies with two compulsory batch recalls due to substandard quality or safety violations within 12 months, or falsified data, could be placed on a "key control list" for three to 12 months. During this period, they could be required to have the following products tested at a state-designated laboratory before release:
- every product whose number was involved in the breach;
- half of their Group A products; and
- a tenth of their Group B products.
Industry objections
The May draft had classified products by formulation triggers, namely any product containing a restricted substance under Annex III of the ASEAN Cosmetic Directive (ACD) at ≥90% of its maximum permitted concentration, any nanomaterial or penetration enhancer, and pH ≤3.5 or ≥10.
Among the 291 comments from 57 bodies, the Vietnam Essential Oils, Aromas and Cosmetics Association (VOCA) said no country in the region or elsewhere classified cosmetics based on the concentration of a restricted substance relative to its Annex III limit, and that the approach lacked a scientific basis.
EuroCham objected to automatic high-risk placement of nanomaterials such as the nano-form UV filters titanium dioxide and zinc oxide, which the EU's Scientific Committee on Consumer Safety (SCCS) has assessed as safe and which appear in the ASEAN and EU permitted annexes.
The MoH accepted VOCA's point and revised the text, while the criteria EuroCham objected to are absent from the September draft.
On 11 September, Deputy Prime Minister Phạm Thị Thanh Trà told the MoH to keep to agreed ASEAN rules and set classification criteria in the decree, while leaving the detailed product list to a separate instrument.
Notification and import
Under the proposals, the notification receipt would be replaced by a 'management number' issued within three working days of a completed dossier and with no expiry date.
The number would be revoked after three consecutive years of no production, import or sale. It could also be revoked for a prohibited substance, a restricted substance above the ACD limit, a confirmed serious adverse event, or three or more compulsory batch recalls within 12 months.
Existing receipt numbers would be valid until 31 December 2028. From 1 January 2028, importers would file notification dossiers with provincial authorities rather than the MoH.
A certificate of free sale (CFS) would be needed only for imported products that the MoH and the Ministry of Finance would list publicly. Products made or notified in an ACD member state would be exempt.
Instructions for use, safety warnings and the notifier's details should be in Vietnamese; INCI names, country of manufacture or origin, and quantity could stay in English. Labels printed before entry into force could be used for 36 months.
ASEAN annex updates
Ingredient controls would stay anchored to the ACD lists of prohibited, restricted and permitted substances, colourants, preservatives and UV filters. Each updated annex would take effect 12 months after publication on the MoH portal.
At present, changes the ASEAN Cosmetic Committee makes to the annexes take effect in Vietnam according to the committee’s timetable, with DAV communicating the implementation dates by official letter – most recently for 4‑methylbenzylidene camphor (4-MBC), genistein and daidzein.
The September draft decree does not include the limits on heavy metals that were in the February version. Instead, the notifier would set its own specification and state laboratories would apply ACD safety parameters independently.
Traces of prohibited substances would remain acceptable and would go undeclared in notifications.
Formula changes – including changes to Annex III concentrations – could be made by updating the electronic record and PIF without a new notification or fee, unless the product name, form, function, notifier or domestic manufacturing site changes.