Taiwan Legislative Yuan Finally Approve Amendments to Statute for Control of Cosmetic Hygiene

Takehome:

"Taiwan Legislative Yuan" finally approved the amendments to "Statute for Control of Cosmetic Hygiene". The new Act stresses 8 key amendments aiming to align with international cosmetic management practices, facilitate global market access and also enhance the competitiveness of Taiwan's cosmetic industry.

Taiwan has been working on amending the original overarching cosmetic regulation "Statute for Control of Cosmetic Hygiene" which is now renamed as "Cosmetic Hygiene Safety Administration Act". The amendments to the statute were finally approved on Apr 10, 2018 by Taiwan's Legislative Yuan and after several administrative procedures are finalized the new Act will be officially published.

♦ 8 key amendments are as follows:

1. Modify cosmetic definitions to conform to international practice. The scope of cosmetics is extended to oral products. Non-medicated toothpastes and mouthwashes are classified as cosmetics.

2. Establish product notification system, which aligns with the systems implemented in the member states of ASEAN and EU. Pre-market approval system is replaced by a simplified notification. Manufacturer shall fill out records through an online platform before entering Taiwan's market. Product information will be transparent and open to public.

3. Establish a product information file (PIF) system to supplement the notification system. Manufacturers shall prepare and maintain scientific and complete files on product safety and function. Besides, all reports in the PIF shall be reviewed by designated professionals to confirm product safety.

4. Implement GMP for the production of cosmetics. Manufacturing sites shall comply with GMP to ensure the hygiene and safety of cosmetics. Manufacturers are required to build excellent quality control systems to stabilize product quality.

5. The registration of special use cosmetics.

• Cosmetics containing medicated, poisonous ingredients or potent drugs (medicated cosmetics) are renamed as special use cosmetics.
• Before the implementation of the new Act, a 5-year grace period will be granted to gradually replace the present system with notification and PIF.

6. Specify cosmetic enterprises' obligations:

• Voluntary disclosure of product safety information: Manufacturers are required to adopt appropriate measures to deal with the situation when severe adverse events occur or when products cause hygiene and safety problems.
• Strengthen supervision on cosmetic production and take steps to tighten border control for possible sampling inspections.
• Manufacturer who violates the regulations is required to recall or destroy unqualified products within stipulated time.

7. Abolish criminal liability and increase fines.

In line with current international decriminalization tendencies, enterprises in violation of hygiene and safety standards are subject to non-criminal punitive measures. Individuals reporting illegal activities will be rewarded while violators will be fined.

8. Abolish pre-market approval of advertisements

To align with Europe, America and Japan's regulatory frameworks, Taiwan's existing pre-market approval of advertisements has been invalidated according to explanation No. 744 of Grand Justice. If a product advertisement violates related regulations, the manufacturer will subject to fines. Severe violations of the regulations are subject to product recall and rectification of all future advertisements.

According to Wu Xiumei, director general of TFDA, the focus of this new Act will simplify administrative procedures and strengthen enterprises' self-management and product post-market surveillance. Next TFDA will commence formulation and enactment of subordinate regulations and other supporting measures to ensure completeness and comprehensiveness of "Cosmetic Hygiene Safety Administration Act".