Taiwan to implement Cosmetic Good Manufacturing Practice Regulations

On 1st July 2013, Taiwan released a regulation named Key Points on the Implementation of Voluntary Cosmetic Good Manufacturing Practices (GMP), which specifies advanced requirements for manufacturers. On 15th March 2019, Taiwan released the draft of Cosmetic Good Manufacturing Practice Regulation. The implementation of the new overarching cosmetic regulation, Cosmetic Hygiene and Safety Act, on 1st July 2019, stipulates that GMP is not voluntary but mandatory for manufacturers and importers. However, Taiwan FDA didn’t confirm the final version of Cosmetic Good Manufacturing Practice Regulation until 13th August. According to the TFDA announcement, the implementation date for this new regulation is 1st July 2019, which means the new GMP requirement has actually been effective since this date.

In the meantime, the central competent authority sets different implementation date of mandatory GMP for different categories of cosmetics for a smooth transition (see below):

As for overseas companies, it is also worth noting that TFDA also accepts ISO 22716. In fact, the main content of the new standard is also based on ISO 22716: Cosmetics – Good manufacturing practices (GMP) – Guidelines on good manufacturing practices. And TFDA will also conduct on-site inspections to overseas manufacturing sites if necessary.

The main content of Cosmetic Good Manufacturing Practice Regulation

1. Define all the special terms in this regulation, such as Out-of-specification, consumable and etc

2. Specified Cosmetic Categories Shall Comply with Cosmetics Good Manufacturing Practice Regulations

3. The requirements and responsibilities for cosmetic managers and practitioners

4. Plant and facilities, including lighting, ventilation and etc

5. Requirements for using Ingredients and packaging

6. Requirements during manufacturing process

7. Requirements for dealing with finished products, such as storage requirements and transportation requirements

8. Requirements for quality control laboratory

9. The disposal of out-of-specification products

10. The disposal of waste

11. Requirements for entrusted manufacturers

12. Deviation processing

13. Complaints and recalling

14. Internal audit: manufacturers should conduct internal audit regularly or unregularly.

15. Build a documentation system and make sure the readability of all documentations.

16. Other rules

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