Taiwan Implements Cosmetic Hygiene and Safety Act

Taiwan’s newly implemented overarching Cosmetic regulation “Cosmetic Hygiene and Safety Act” makes significant changes to administration of Taiwan’s cosmetic sector including:

• Modification of cosmetic definition to align with international best practices.

• Establish product notification system and product information filing system.

• The registration of specific purpose cosmetics.

• Implement GMP for the production of cosmetics.

• Specify cosmetic enterprises' obligations.

• Abolish criminal liability and increase fines.

• Abolish pre-market approval of advertisements.

On July 1^st, 2019, Taiwan implemented the new cosmetic overarching regulations, Cosmetic Hygiene and Safety Act ^[1].

Source: TFDA

8 Key Amendments

1. Modify cosmetic definitions to conform to international practice.

The scope of cosmetics is extended to oral products. From Jul. 1st, 2021, non-medicated toothpastes and mouthwashes will be regulated as cosmetics.

2. Establish a product notification system, which aligns with the systems implemented in the member states of ASEAN and EU.

Notification system is applied to general cosmetics and specific purpose cosmetics. Manufacturer shall fill out records through an online platform before entering Taiwan's market. The validity period for product notification is 3 years.
 

FAQs for product notification can be referred to CL News ^[3].

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. The files shall be maintained at least 5 years in electronic or paper format. Besides, all reports in the PIF shall be reviewed by designated professionals to confirm product safety. 

4. The registration of specific purpose cosmetics.

Cosmetics containing medicated, poisonous ingredients or potent drugs (medicated cosmetics) are renamed as specific purpose cosmetics. Specific purpose cosmetics are specified as sunscreen, hair dyes, hair perms, deodorants, teeth whitening and other cosmetics stipulated by TFDA.

Specific purpose cosmetics still need to register with TFDA until Jul. 1^st, 2024.

5. 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.
 

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.

• Manufacturer violating 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

Taiwan's existing pre-market approval of advertisements has been invalidated according to explanation No. 744 of Grand Justice. Cosmetics advertisements, labels or claims shall not be exaggerated, fake or related to medical efficacy.

If a product advertisement violates related regulations, the manufacturer will be subject to fines. Severe violations of the regulations are subject to product recall and rectification of all future advertisements.

Detailed comparison with the previous cosmetic overarching regulation, Statute for Control of Cosmetic Hygiene can be found in CL News ^[4].

Supplementary Regulations that Take Effect Together

Contact [email protected] if translations are needed. ChemLinked will hold a webinar analyzing key amendments and detailing implementation rules of Cosmetic Hygiene and Safety Act on July 18^th. Please stay tuned if you are interested.