Taiwan to Implement Administrative Measures on Cosmetics Notification, Packaging, Ingredients and Advertising

Taiwan FDA recently released the final versions of several cosmetic administrative measures, mainly covering 3 aspects:

Restricted, prohibited and permitted cosmetic ingredients, microorganism and preservatives in cosmetics
Cosmetics notification and product information files
Cosmetics packaging, containers, leaflet, labels and advertisements

The following tables show the main contents of these measures:

Table 1: Restricted, prohibited and permitted cosmetic ingredients, microorganism and preservatives in cosmetics

Name	Effective Date	Note	Detailed content
List of Ingredients Restricted used in Cosmetics	1^st Jan, 2020	/	Details
List of Ingredients Prohibited in Cosmetics	1^st Jul, 2019	/	Details
List of Permitted Colorants Used in Cosmetics	1^st Jan, 2020	The same as the current list	Refer to CL News^[1]
Limitation Standards for Microorganism in Cosmetics	1^st Jan, 2020	The same as the current list
List of Name and Usage Limitation of Preservatives in Cosmetics	1^st Jul, 2019	Only the regulation’s name is changed. The content is the same as Standard for Usage and Limitation Requirements of Preservatives in Cosmetics. The original list will be replaced on 1^st Jul, 2019.
Standard for Usage and Limitation Requirements of Ingredients used in Specific Purpose Cosmetics	1^st Jan, 2020	/

Table 2: Notification and Product Information File (PIF)

Name	Summary	Effective Date	Detailed Content
Administrative Measures for Cosmetics Notification	Information about cosmetics notification, including materials needed, cancellation, period of validity and etc.	July 1^st, 2019	Refer to CL News^[2]
Cosmetic Product Category that Should Complete Product Notification and the Implementation Date	Implementation date for different cosmetics products notification	General cosmetics (Except handmade soaps without factory registration): July 1^st 2021 Specific purpose cosmetics: July 1^st 2024	/
Administrative Measures for Cosmetics Product Information Files	Information about how to build product information file(PIF), including qualifications of the manufacturer and importer who can establish the PIF, documents required for PIF, the time PIF should be kept, the qualifications for product safety data signers, etc.	July 1^st, 2019 Final version: the competent authority will notify the enterprise 7 days) before checking PIF	Refer to CL News^[3]
Cosmetic Product Category that Should Establish Product Information Files and the Implementation Date	Implementation Date for different cosmetics products to build product information files	Specific purpose cosmetics: July 1^st 2024 Non-medical toothpaste, mouthwash, general cosmetics for children, lips and eyes: July 1^st 2025 The rest except handmade soaps without registration :July 1^st 2026	/

Table 3: Cosmetic packaging, container, leaflet and label

Name	Summary	Effective Date	Detailed Content
Labeling Requirements for Cosmetic Packaging, Containers, Labels or Directions	The format, method and other compliance matters of cosmetic packaging, containers, labels and instructions.	Jul 1^st, 2021 Final version: For cosmetics with an outer package area less than 40 square centimeters, at least 4 items (product name, usages, manufacturer/importer name, date of manufacture and validity period) are required to be labeled on the instruction, label or tag.	Refer to CL News^[4]
1. Regulations of Labeling Cosmetics Label, Leaflet and Packaging 2. Name of All Ingredients Contained in the Product Should Be Indicated on the Outer Packaging	/	These two measures will be replaced on July 1^st 2021.	/
Cosmetics Imported by Sub-packagers, the Outer Packaging or Container shall Indicate the Designation “Sub-packaged in Taiwan”	TFDA announced that for cosmetics imported by re-packagers or sub-packagers, the outer packaging or container shall indicate the designation “Re-packaged in Taiwan”, “Sub-packaged in Taiwan”, “臺灣分裝”.	Jul 1^st, 2021	/
1. Notes that should be marked on the label, leaflet and package of hair dye products 2. Notes that should be marked on the label, leaflet and package of perm agent products 3. Notes that should be marked on the label, leaflet and package of decolorizing agent products	Detailed content which should be marked on the label, leaflet or package of hair dye products, perm agent products and decolorizing agent products, including precautions of using, storing and preparation.	These three measures are draft version.	/
1. Notes that should be marked on the label, leaflet and packaging of domestic or imported perm agent products. 2. Notes that should be marked on the label, leaflet and packaging of decolorizing agent products.	/	These two measures will be replaced on July 1^st 2021.	/
Regulations Governing of Criteria for the Label, Promotion and Advertisement of Cosmetic Products Identify False, Exaggerated or Medical Efficacy	The draft clarifies the scope of false, exaggerated or medical efficacy claims, as well as acceptable claims/labels/advertisements.	1^st July, 2019	Refer to CL News^[5]