Taiwan to Implement 6 Administrative Measures Mainly about GMP, Border Inspection, Labelling

Taiwan is to implement 6 new/updated administrative measures including：

• Implementation Rules for Cosmetic Hygiene Safety Administration Act, 
  

• Border Inspection Methods for Imported Cosmetics, 

• Cosmetics Product Categories that Require GMP 

• Cosmetics Manufacturers that Are Exempted from Factory Registration,

• Labeling requirements for “Medicated” Cosmetics

• Documents Required for the Change of Registration Information and License Information of Specific Purpose Cosmetics.

Implementation Rules for Cosmetic Hygiene Safety Administration Act (2019.7.1)^[1]
Main changes:

1. Name changed fromImplementation Rules for Statue for Control of Cosmetic Hygiene to Implementation Rules for Cosmetic Hygiene Safety Administration Act.

2. Add the definition of the person who should be responsible for product notification and building product information file.

3. Add the definition of place of origin for cosmetics.

4. Add the definition of manufacturing sites.

5. Exceptional situations when pharmacists or professional technicians should be hired to supervise the manufacturing of cosmetics.

6. Add the explanation of sealing procedure and practitioners’ reservation obligations.

7. Redefines the situations in which cosmetics advertisements violate regulations.

Border Inspection Methods for Imported Cosmetics(2019.7.1)^[2]
Main content:

1. Documents required: Application form, the photocopy of imported product declaration, other documents required by other inspection administrations.

2. Inspection Methods: On-site inspection; sampling; inspection batch by batch

3. Different approaches to products with different results of inspection

4. Fee charging

Cosmetics Product Category that Should Comply with Good Manufacturing Practice(2019.7.1)^[3]

Note: Hand-made soaps manufacturers exempted from factory registration do not need to comply with GMP.

Cosmetics Manufacturers that Are Exempted from Factory Registration(2019.7.1)^[4]

1. Hand-made soaps manufacturing sites whose kitchen area or power capacity and scale of thermal energy of its production equipment do not reach the standards in Factory Management Guidance.

2. Manufacturing sites that only package cosmetics.

3. The above manufacturing sites still need to follow Standards for Cosmetics Manufacturing Factory.

The Sentence that Should Be Labelled on the Package if Imported Cosmetics Have the term “Medicate” or Similar Words on the Package(2021.7.1)^[5]
If imported cosmetics have “Medicate” or similar words on the package and are regulated in the places (countries) of origin or countries of sale as OTC drug or quasi drug, a sentence should be labelled on the package, which is “ This product is a cosmetic and not a medicine.”

Documents Required for the Change of Registration Information and License Information of Specific Purpose Cosmetics(2019.7.1)^[6]

If you have needs to translate these regulations, you are welcome to contact us by cosmetic@chemlinked.com.