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)
- Name changed fromImplementation Rules for Statue for Control of Cosmetic Hygiene to Implementation Rules for Cosmetic Hygiene Safety Administration Act.
- Add the definition of the person who should be responsible for product notification and building product information file.
- Add the definition of place of origin for cosmetics.
- Add the definition of manufacturing sites.
- Exceptional situations when pharmacists or professional technicians should be hired to supervise the manufacturing of cosmetics.
- Add the explanation of sealing procedure and practitioners’ reservation obligations.
- Redefines the situations in which cosmetics advertisements violate regulations.
Border Inspection Methods for Imported Cosmetics(2019.7.1)
- Documents required: Application form, the photocopy of imported product declaration, other documents required by other inspection administrations.
- Inspection Methods: On-site inspection; sampling; inspection batch by batch
- Different approaches to products with different results of inspection
- Fee charging
Cosmetics Product Category that Should Comply with Good Manufacturing Practice(2019.7.1)
|Cosmetic category||Implementation date|
|Specific purpose cosmetics||Jul. 1, 2024|
|General cosmetics used for infants, used around the eyes or mouth||Jul. 1, 2025|
|General cosmetics (except for cosmetics used for infants, used around the eyes or mouth)||Jul. 1, 2026|
Cosmetics Manufacturers that Are Exempted from Factory Registration(2019.7.1)
- 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.
- Manufacturing sites that only package cosmetics.
- 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)
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)
|Application form for Registration Information change||Original license||Original verification certificate for leaflet, label and package||New leaflet, label and package draft (Two)||Testing Report||Ingredient list (Domestic products Exempted)||Approved License for manufacturing and sale issued by the producing country||Notification letter sent to the original manufacturer (Domestic productsexempted)||The photocopy of pharmacist license or degree certificate of technical personnel, employment certificate of this person(Imported products exempted)||Other materials|
|Chinese or English product name change||⚪||⚪||⚪||⚪||X||X||X||⚪ (Products only changing Chinese name exempted)||X|
|New product models or product color change||⚪||⚪||⚪||⚪||⚪||⚪||X||X||X|
|New Product items||⚪||⚪||X||⚪||⚪||⚪||⚪||X||X|
|Main ingredients or formulations Change||⚪||⚪||⚪||⚪||⚪||⚪||⚪||X||X|
|leaflet, label and package Change||⚪||⚪||⚪||⚪||X||X||X||⚪||X|
|Cosmetic purpose change||⚪||⚪||⚪||⚪||X||X||X||X||X|
|Company’s name change||⚪||⚪||X||X||X||X||X||X||X||Photocopy of company registration or business registration certificate|
|Manufacturer’s name, address Change||⚪||⚪||⚪||⚪||X||X||⚪||X||⚪||1.Factory registration certificate (Imported products exempted)|
2.If there is a commissioned manufacturer, commission information on the manufacturing process should be submitted
|Add specific names for exported products (only for Domestic products)||⚪||⚪||⚪||⚪||X||X||X||X||X|
|License transfer registration||⚪||⚪||X||X||X||X||X||X||⚪||1.The transfer form signed by both sides|
3.A photocopy of the transferee’s company registration or business registration certificate
4.Factory registration certificate after transfer (Imported products exempted)
5.The original document of the foreign manufacturer's transfer of the import agency right plus verification (Domestic products exempted)
If you have needs to translate these regulations, you are welcome to contact us by firstname.lastname@example.org.
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