SG 001/25
Thailand updates standard ensuring safety and quality in cosmetics by specifying the container’s physical characteristics and supporting documents.
Thailand's Food and Drug Administration issued Guideline for Consideration of Notification of Cosmetics in Ampoule, Vial or Syringe Forms (Revised September 2024) in November 2024. The updated standard aims to ensure the safety and quality of cosmetics, prevent misuse and abuse of cosmetics, and provides clear guidance for businesses. It also includes provisions on container characteristics, notification application documents and labeling requirements.
Cosmetics in ampoule, vial or syringe form covered by this guideline must not be classified as a medicine or medical device. They must not be used with any medical devices or equipment (such as mesotherapy, iontophoresis, microneedle therapy system (MTS)) and are not to be intended for use after medical procedures such as laser or MTS.
Acceptable cosmetics that can be packaged in ampoule, vial or syringe form include leave-on products for nourishing the skin with application areas on the face, body skin, around the eyes or hair and scalp, as well as facial care products to be mixed with other cosmetics before use.
The guideline details the physical characteristics of ampoules, vials and syringes that can be used for cosmetics. Key elements are listed below:
| Packaging form | Required physical characteristics |
| Accessory parts must be provided to close the ampoule after opening for multiple uses. Ampoules and accessory parts must be neatly packed in the packaging box. | |
| Vials must be easy to open and close. Dropper cap must be provided to replace the rubber stopper after the vial is opened. All parts must be neatly packed in the packing box. | |
| Syringe cannot be pre-filled with any contents, and it cannot be connected to a needle or Luer lock tip or anything that can make it resemble a medical device. |
In addition, when submitting cosmetic notification for cosmetics in ampoule, vial or syringe, the following documents must be provided as supporting information:
- Certificate from the manufacturer that details instructions for use and explains how to use it with various devices, certifying that, “this product is for topical use only. It is not for injection or use with medical devices”
- A picture of the actual product/label/tube/bottle/box/insert ready for sale, enlarged to be clearly readable in all aspects, which must not exceed the scope of being a cosmetic. Documents must be translated into Thai by a reliable government language institute. Warnings: "Do not inject or use with medical devices. For external use only", or similar messages, must be labeled on both the box label and product bottle
- Real product samples
- A statement letter from the manufacturer or importer explaining the measures the company has taken to prevent misuse
- Certificate of free sale (CFS) from the country of origin indicating that this product is a cosmetic
- A statement from the manufacturer affirming whether the product is a sterile product or not. If so, please provide clarification
- In case the officer has any doubts, he/she may request additional supporting documents for consideration, such as a video showing how to use the product
Guideline for Consideration of Notification of Cosmetics in Ampoule, Vial or Syringe Forms (Revised September 2024)
With decades of experience, our global network of specialists provide expertise in all aspects of cosmetic, household care and hygiene testing and regulatory guidance. Our state-of-the-art facilities and technology will help you bring safe, effective and compliant products to market. Visit our website or contact us to learn more.
© SGS Société Générale de Surveillance SA. This publication or website is a property of SGS Société Générale de Surveillance SA. All contents including website designs, text, and graphics contained herein are owned by or licensed to SGS Société Générale de Surveillance SA. The information provided is for technical and general information purposes only and offers no legal advice. The information is no substitute for professional legal advice to ensure compliance with the applicable laws and regulations. All information is provided in good faith “as is”, and SGS Société Générale de Surveillance SA makes no representation or warranty of any kind, express or implied, and does not warrant that the information will be error-free or meet any particular criteria of performance or quality.
