Thai FDA Cosmetic Notification (จดแจ้ง) Thailand

Thailand does not pre-license cosmetics. Manufacturers for sale, importers for sale and contract manufacturers notify on form จ.ค.1 before manufacturing or importing, and may manufacture or import only after the notification certificate (ใบรับจดแจ้ง) is issued. The assumption that "it is only a notification, so we can ship first and file later" is the most common reason a first shipment stops at customs.

Review runs on two tracks. Ordinary products that meet the conditions of the review criteria (B.E. 2564, 2021 revision) receive a notification number immediately from the automatic review system. Product groups for which the criteria require a label, or products the officer has questions about, are reviewed on the label and supporting documents submitted, and products that do not fit the criteria go to the cosmetics control working group for deliberation. The formula and claims usually show which track applies, so this is decided before filing.

The certificate has a validity period and needs renewal (จ.ค.2); changes to the particulars are filed on a separate form (จ.ค.4). For a reformulation that keeps the existing product name, the FDA has issued relaxed guidance that reduces the burden of re-notifying.

The notifier is a Thai national or a Thai company. A foreign brand headquarters cannot be the notifier; instead, the manufacturer issues a letter of authorization giving the Thai notifier the right to act. The letter must be endorsed by the FDA before it can serve as the basis for later administrative work and system access.

A notification is tied not only to the operator but to the premises. Setting up or moving import or storage premises for sale requires on-site inspection, and manufacturers for sale and contract manufacturers must meet the requirements for the production site, equipment, containers, manufacturing methods and storage set in Annex Kor (ภาคผนวก ก) of the Ministry of Public Health announcement. Until the business details have been submitted through the system and the operator confirmed, the cosmetics system itself cannot be used.

For a brand, this comes down to one thing: whose name the notification is filed in decides who holds the product's regulatory asset. Brands that intend to work with several distribution partners look at license holding under Doosigan's Thai entity before notifying.

Based on the ASEAN Cosmetic Directive annexes, Thailand sets prohibited substances, restricted substances, preservatives, colorants and UV filters through Ministry of Public Health announcements. The prohibited list saw a fourth round of additions recently, and conditions of use have been revised even for widely used ingredients such as titanium dioxide. A formula is not assumed to pass because it has been notified elsewhere; each one is checked — substance, concentration and application site — against the announcements in force.

New substances not listed in cosmetic ingredient references such as COSING or CTFA must first go through an assessment of academic evidence. For a product built around a novel material, this gate is where the timeline starts.

Cannabis and hemp ingredients follow separate criteria. They are classified as high-risk products: only manufacturing and contract manufacturing notifications are accepted, notification for import for sale is not, and the raw material must be of Thai origin. This is the first point checked when a foreign brand asks about importing CBD cosmetics.

Words that cannot be used in product names and trademarks fall into five types. The main one is wording that suggests treating, relieving or preventing disease or bodily abnormality; screening names at the naming stage is what avoids rejection. "Anti-bacterial" is allowed only for rinse-off cleansing products, and only on the basis of the cleansing effect of washing and the use of permitted ingredients.

Where the boundary is unclear, a product classification ruling can be requested from the FDA. It is the official channel for confirming whether a product is a cosmetic, a drug or a medical device, and it is faster than notifying in doubt and being rejected.

Cosmetic advertising is not subject to pre-review the way food advertising is. Instead there is a procedure for requesting the FDA's opinion on advertising copy, and enforcement in practice centres on efficacy claims that go beyond the scope of a cosmetic. Expressions such as whitening, anti-ageing and sensitive skin are examined differently depending on the sentence and its evidence, and wording that implies treating disease affects whether the product counts as a cosmetic at all.

Brand tip: Review the English copy and the Thai draft together before packaging goes to print. The same principles apply to product detail pages and e-commerce advertising.

The certificate is not the end. Cosmetic operators are required to assemble and keep a Product Information File (PIF), which is called for at post-market inspection. Gathering the safety and quality evidence at the time of notification avoids having to collect it again later.

For products notified in Thailand and exported to other countries, a certificate of free sale (CFS), a CFS with the formula attached and a certificate of origin can be obtained through e-Submission, and there is a route for an English-language notification certificate. Brands using Thailand as an ASEAN hub plan for this at the notification stage.

• Shipping before notifying. Import is possible only after the certificate is issued. Samples use the separate exemption and one-time import routes.
• Trying to notify in the brand headquarters' name. The notifier is a Thai national or a Thai company. The letter of authorization takes effect only with FDA endorsement.
• Filing an overseas formula as it is. Announcements on prohibited and restricted substances keep being added and revised. Check against the current ones.
• Reading the rules after the product name is fixed. A name that falls under a banned word type has to change before anything else.
• Planning to import CBD cosmetics. Notification for import for sale is not accepted.
• Leaving the PIF until after notification. Bundling the safety and quality evidence at notification is far less work.

Product documents and notification work that each importer used to manage separately are organised into an SKU master. Formula, brand, manufacturer, notification number and label version are linked, and when a partner is added, the scope in which existing material can be reused is separated from the scope that needs a new or amended notification.

This is not a scheme in which one notification number is automatically shared by every independent importer. Actual notification and import responsibility is tied to the lawful holder and premises, and brand rights, access to documents, distribution rights and what happens at contract termination are agreed.

Discuss a cosmetic SKU and multi-vendor structure · See Thailand license holding

For this product category, we coordinate overseas manufacturer documents with the Thai applicant's existing notifications, product scope and distribution plan. We review new SKUs, label changes and renewal or amendment needs before filing. The notifier and notification scope are assessed for each project.

Where needed, explore Thailand license holding or Importer of Record services alongside your product requirements.