Taiwan Introduces Supplements to PIF Guidelines, Alternatives to Animal Testing Included

As stipulated by the Cosmetic Hygiene and Safety Act, cosmetic enterprises shall prepare and maintain a Product Information File (PIF) for cosmetics, which contains scientific and complete files on product's safety and function. In March 2020, Taiwan Food and Drug Administration (TFDA) promulgated the Guidelines on the Establishment of PIF (the Guidelines) to guide enterprises on how to compile the PIF. To ensure its applicability to enterprises' practical need, TFDA updated the Guidelines on July 28, 2022, which entered into force upon its release.¹

Compared to the previous version, the main revisions made in the updated Guidelines are as follows:

1. Newly Including Six Test Methods for the Preservative Efficacy of Cosmetics

When compiling the PIF, enterprises are required to provide a testing report of cosmetic's preservative efficacy. In the updated Guidelines, six methods for testing cosmetic's preservative efficacy are newly included.

2. Newly Including Six Animal Testing Alternatives

Product's safety information is another required component of PIF. In terms of the methods chosen for the safety assessment, the Guidelines suggests the use of alternatives to animal testing announced by Organisation for Economic Co-operation and Development (OECD). In addition to the methods previously included, the updated Guidelines newly introduces the following six animal testing alternatives. Following a self-evaluation, enterprises are also allowed to adopt other alternative methods updated on OECD's official website.

3. Newly Providing Four PIF Templates

No templates were given in the previous Guidelines. To make up this deficiency, the updated Guidelines newly provides four PIF templates for both general cosmetics and specific purpose cosmetics. Enterprises can refer to these templates when preparing the PIF.

It is worth mentioning that, currently, preparing and maintaining a PIF is not a mandatory compliance requirement for cosmetics. The effective date of this requirement varies for different product categories, as shown in the table below: