Taiwan FDA Revises Guidelines for Cosmetics Containing Nanomaterials to Enhance Safety and Regulation

On November 8, 2024, the Taiwan Food and Drug Administration (FDA) announced revised guidelines for Risk Assessment for Cosmetics Containing Nanomaterials. The updates aim to strengthen regulations, ensure product safety, and align with international standards. These guidelines provide guidance to manufacturers and importers in evaluating the safety and properties of nanomaterial-containing cosmetics.

Key Highlights of the Revised Guidelines

1. Definition of Nanomaterial-Containing Cosmetics

Nanomaterial-containing cosmetics are products formulated with intentionally manufactured nanomaterials that are insoluble or non-biodegradable. These materials have dimensions or internal structures in the nanoscale range (1-100 nanometers) and may have unique properties and risks compared to conventional ingredients.

2. Alignment with International Standards

The revised guidelines follow the definitions and practices of global organizations such as the International Cooperation on Cosmetics Regulation (ICCR) and the International Organization for Standardization (ISO). According to ISO/TS 80004-1:2023, nanomaterials are materials with at least one external or internal dimension in the nanoscale range.

3. Comprehensive Risk Assessment

The guidelines provide a two-step framework for assessing the physicochemical properties of nanomaterials (e.g., particle size, shape, surface chemistry) and conducting safety evaluations (e.g., exposure analysis, toxicological studies) to ensure the safety of cosmetics before market approval.

4. Product Information File (PIF)

Manufacturers are required to prepare a PIF to document the quality and safety of their products. This includes detailed data on the physicochemical and toxicological properties of nanomaterials, which must be reviewed by qualified personnel to confirm the safety of the product.

5. Industry Reference

The guidelines provide detailed risk assessment criteria and an appendix outlining key evaluation parameters. These resources are intended to assist manufacturers conduct thorough reviews during product development and ensure compliance.

Access to the Guidelines

The revised Guidelines for Risk Assessment of Cosmetics Containing Nanomaterials are available on the official website of the Taiwan FDA. Interested parties can find the document under the "Announcements" section and the "Cosmetics Business Area > Cosmetics Regulations Area > Guidelines" page.

For more details, visit the Taiwan FDA website here.