Thailand Consults on Labeling Regulations for Ampoule, Vial, and Syringe Cosmetics

Cosmetics packaged in ampoules, vials, and syringes will be required to bear the warning “Injection is prohibited. Cosmetics are for external use only” in red on both primary and secondary packaging.

From October 11 to 27, 2023, the Thai Food and Drug Administration (Thai FDA) conducted a public consultation to gather feedback on proposed labeling regulations for ampoule, vial, and syringe cosmetics. This draft spells out essential requirements for labeling, including the necessary content, position, language, and other pertinent details.

Highlights of the Draft

1. Scope

Cosmetics contained in ampoules, vials, and syringes in this draft refer to cosmetics intended for external application on the human body, excluding those used for hair.

2. Labeling Content

When sold in Thailand, these products shall bear a Thai label with the following information in a prominent position on the product container or outer packaging:

No.	Labeling Items	Requirements
1	Cosmetics name or trade name	It shall correspond to the cosmetic notification receipt and its font size shall be larger than other texts.
2	Cosmetic category or type	/
3	Full ingredients list	The ingredients shall be listed in descending order by amount. Permitted colorants and ingredients with a concentration of less than 1% are exempt from sorting but should be placed after substances with concentration exceeding 1%. Ingredient names can be presented in Thai, Thai translated into English, or in English. If nanoparticles are used in the production of cosmetics, the term "(nano)" shall be indicated in brackets after the product name.
4	Directions for use	As specified by the manufacturer or importer. Prohibited for injection.
5	Domestic cosmetics: Manufacturer’s name and address; Imported cosmetics: importer’s name and address, manufacturer’s name, and country of origin	/
6	Net content	/
7	Batch number	/
8	Manufacture date	It can be expressed in either "month, year" or "year, month" format.
9	Expiry date	It applies only to cosmetics with a shelf life of less than 30 months. It can be expressed in either "month, year" or "year, month" format.
10	Warnings or precautions (if any)	/
11	Notification receipt number	/
12	The message “Injection is prohibited. Cosmetics are for external use only."	The message shall be marked in red on both primary and secondary packaging of the product.
*Note:* For small-sized containers or products with label display space of less than 20 square centimeters, the label must at least contain item 1, 7, 8, 9, 11 and 12.

3. Labeling Standards

The draft stresses that all information on labels including text, images, designs, trademarks, etc., irrespective of language, shall not be false, be exaggerated, cause misunderstanding, contravene public morals or national customs and culture, or create dissension or disunity among the public, etc.

4. Imported Products

Imported ampoule, vial, and syringe cosmetics will be temporarily exempted from affixing a Thai-language label upon arrival at cosmetic inspection points. However, a Thai label must be added within 30 days after customs inspection and release.

5. Grace Period

Once officially adopted, labels created before the announcement shall be modified within one year to ensure compliance with the new regulation.

ChemLinked Comments

The Thai FDA's initiative follows the introduction of the revised criteria for reviewing notifications of ampoule, vial, and syringe cosmetics in May 2023, enhancing the regulatory framework for such products in Thailand. The proposed labeling requirements mirror Thailand’s general cosmetic labeling regulations but underscore the need for explicit warnings about the prohibition of injection and external use only.