Taiwan Clarifies the Scope of Cosmetic False, Exaggerated and Medical Efficacy Claims

On Jan. 10 and Jan. 19, 2019, TFDA released 2 cosmetic regulation drafts, “Particulars of Specific Purpose Cosmetics that May Be Voluntarily Modified” and “Regulations Governing of Criteria for the Label, Promotion and Advertisement of Cosmetic Products Identify False, Exaggerated or Medical Efficacy”. Cosmetic stakeholders with any suggestions or comments can send to us (cosmetic@chemlinked.com) before Mar 5, 2019. We will sort your suggestion, submit them to TFDA and send back the reply to you.

Regulations Governing Criteria for the Labeling, Promotion and Advertisement of Cosmetic Products Identified as Using False, Exaggerated or Medical Efficacy Claims

Cosmetic Hygiene Safety Administration Act released on May 2, 2018, stipulated that the labels, claims and advertisements of cosmetics shall not be false, exaggerated or indicate medical efficacy. The draft clarifies the scope of false, exaggerated or medical efficacy claims, as well as acceptable claims/labels/advertisements.

Scope of false or exaggerated claims:

1. Inconsistent with the facts
2. No evidence or insufficient evidence to substantiate the claims
3. Exceed the scope of cosmetic definitions and categories
4. Affect physiological functions or change body structure

Scope of medical efficacy claims:
1. Prevent, alleviate or cure disease
2. Indicate any terminology associated with pharmaceutical effect or stipulate utility as a medical devices

The draft also includes detailed examples of claims affecting physiological functions or changing body structure, acceptable claims/labels/advertisements according to product categories or ingredients and medical efficacy claims. Stakeholders can refer to Coslist (will be updated recently) for details. If other claims outside the example list are used, they will be determined case by case.

Particulars of Specific Purpose Cosmetics that May Be Voluntarily Modified

5 years after the implementation of Cosmetic Hygiene Safety Administration Act, specific purpose cosmetics (sunscreen, hair dyes, hair perms, deodorants, teeth whitening and other cosmetics stipulated by TFDA) still need to be registered with TFDA.

The draft stipulated the information on cosmetics label, instruction or packaging that can be changed by manufacturers without TFDA’s approval, including changes on textual content, packaging materials, shapes, etc.