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Thailand Proposes Revisions to the Labeling Requirements for Fluoridated Toothpaste

Thailand is seeking public feedback on proposed updates to warning statements for products containing 20 fluoride compounds and new labeling requirements for fluoride-containing toothpaste.

On February 28, 2025, Thailand’s Cosmetics Committee issued two draft announcements for public consultation, proposing updates to the labeling requirements for fluoride-containing cosmetics. These drafts specifically revise the warning statements for products containing certain fluoride compounds and introduce new labeling requirements for fluoride toothpaste.

The public consultation period is open until March 14, 2025. Once finalized, the new regulations will take effect the day after their publication in the Government Gazette, imposing new compliance obligations on cosmetic manufacturers, importers, and distributors.

1. Draft Announcement on Warning Labels for Specific Fluoride Ingredients

The first draft revises the warning statements for 20 fluoride compounds (Items 23–40, Item 44, and Item 52) listed in the List of Warnings on Labels for Cosmetic Containing Restricted Ingredient. These compounds, including Sodium Fluoride, Ammonium Fluoride, and Potassium Fluoride, are restricted for use in toothpaste, mouthwash, and other oral care products at a maximum concentration of 0.15%.

The primary change concerns toothpaste labels, introducing more precise fluoride usage guidance based on age groups. The current warning statement "Children under six years old should use a pea-sized amount of toothpaste and be supervised by an adult while brushing" will be replaced with the following:

  • Children under 3 years old: Use an amount equivalent to a moistened brush tip or a grain of rice.

  • Children aged 3 to under 6 years: Use an amount equivalent to a corn kernel or a pea and be supervised by an adult while brushing.

The warning requirements for mouthwash and other oral care products remain unchanged.

Below is a detailed comparison of the warning requirements before and after the revisions. Once approved, stakeholders with toothpaste products containing the listed ingredients and compliant with current labeling regulations will have one year from the effective date of the official notification to update their labels.

fluoride-ingredients.png

2. Draft Announcement on Fluoride Toothpaste Labeling

The second draft establishes new mandatory labeling requirements for fluoride-containing toothpaste. Under the proposal, manufacturers, importers, and contract manufacturers must ensure that toothpaste labels clearly display:

  • The statement “Fluoride Toothpaste” or similar wording.

  • The total concentration of fluoride, calculated as fluoride ions and expressed in parts per million (ppm). For example, the fluoride content shall be stated as “… ppm Fluoride” or “Total Fluoride: … ppm”, or similar wording.

These new requirements are in addition to those stipulated in the existing Notification of the Cosmetics Committee Re: Label of Cosmetic B.E. 2562 (2019).

Once the announcement is enacted, manufacturers, importers, and contract manufacturers of fluoride-containing toothpaste who have obtained notification certificates and labeled their products before the enforcement of this regulation must update their labels accordingly. They may continue using their remaining stock of existing labels for up to one year from the effective date of the final announcement.

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