Taiwan Consults on the Amendment to Cosmetics Categories and Scope

Takehome:

On Sep 17, 2018, Taiwan FDA released a draft of Cosmetics Categories and Scope. Under the proposed adjustments, non-medicated toothpaste and non-medicated mouthwash are re-designated as cosmetics and subject to cosmetic regulatory compliance requirements. 

The amendment to Cosmetics Categories and Scope has been realized to align with the new cosmetic definition articulated within Cosmetic Hygiene Safety Administration Act released on May 2, 2018. Regulatory scope has been expanded to include non-medicated toothpaste and mouthwash which will be subject to cosmetic regulatory compliance one year after the implementation of Cosmetic Hygiene Safety Administration Act. The one-year grace period is designed to give stakeholders time to adjust their product label or formula to comply with cosmetic regulations and mitigate the impact on the oral product industry.

Once the new requirements become legally enforceable, non-medicated toothpaste and mouthwash will need to be labeled with a comprehensive list of all ingredients on the outer packaging. Violations involving failure to include a comprehensive and accurate ingredients list on the label will be subject to fines ranging from a minimum of NT$10,000 to NT$1 million. Violations involving the usage of inaccurate product labels or usage of false claims/advertisements will be subject to fines ranging from NT$40,000 to NT$200,000.

Problems may occur

In the past, the main regulatory compliance problems associated with toothpastes were: preservatives exceeding limitations, label efficacy claims did not correspond to the functional ingredients used, etc.

As toothpaste directly contact with the oral mucosa, improper usage or the addition of non-compliant ingredients or excessive use of certain ingredients has the potential to negatively impact health. Changing the categorization of non-medicated toothpastes and designating them as cosmetics will mean more stringent regulatory requirements and will likely reduce the incidence of adverse reactions associated with usage. It is still unknown whether or not the prohibited and restricted ingredients standard in cosmetics, such as Standard for Usage and Maximum Concentration of Permitted Preservatives in Cosmetics, are applicable to non-medicated toothpastes. 

Taiwan’s oral product industry has proposed that the technical specifications and ingredient standards for non-medicated toothpaste and mouthwash should align with Taiwan's major trade partners, such as the United States, the European Union and Japan, a move which would greatly facilitate multilateral trade.

Public consultation will last until Nov 16, 2018. Any suggestions can be submitted on Taiwan Public Policy Participation Platform or mailed [email protected].

Note:

• Medicated toothpaste with a fluorine content of more than 1500ppm is managed according to Pharmaceutical Affairs Law.
• Whitening toothpaste has been classified as cosmetics.