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After 17 years of long waiting, Taiwan new overarching cosmetic regulation, Cosmetic Hygiene and Safety Act was finally implemented on July 1, 2019. Several supplementary regulations also came into force together. The newly implemented cosmetic regulation divides cosmetics into two categories: general cosmetics and specific purpose cosmetics and differs the requirements for the two categories and for manufacturers and importers. There is no doubt that the new cosmetic scheme will significantly affected enterprises looking to enter Taiwan cosmetic market…[more]

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  • Taiwan to Implement 6 Administrative Measures Mainly about GMP, Border Inspection, Labelling
      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.
  • 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...
  • 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
  • Taiwan to Implement a Series of Supplementary Measures for Cosmetic Hygiene Safety Administration Act
    On 22nd and 28th May, 2019, Taiwan FDA released the final version of 10 cosmetic administrative measures which will enter into force on 1stJuly, 2019. The measures will aid implementation of Cosmetic Hygiene Safety Administration Act which is likely to enter into force on 1st July, 2019...
  • Taiwan Consults on Cosmetic Good Manufacturing Practice Regulations
    On Mar. 19, 2019, Taiwan released the draft Cosmetic Good Manufacturing Practice Regulations, detailing the requirements for cosmetic manufacturing sites’ personnel management, factory facilities and equipment, ingredients used, packaging materials, production process, products storage, quality control, etc...

Video Introduction

Main Regulations

Type
Regulation
Implementation Date
Note
 
Overarching
Cosmetic Hygiene and Safety Act
July 1 2019
The overriding regulation for cosmetics in Taiwan
Enforcement Rules of Cosmetic Hygiene and Safety Act
July 1 2019
 
Manufacture/import requirements
Cosmetic Good Manufacturing Practice Regulations
Draft
Implementation date:
1.     For specific purpose cosmetics: July 1 2024
2.     For baby, lip and eye products and unmedical toothpaste and mouth wash: July 1 2025
3.     Other general cosmetics: July 1 2026
Key Points on the Implementation of Voluntary Cosmetics Good Manufacturing Practices
June 9 2014
Still in force
Regulations Governing the Qualifications and Trainings of Cosmetics Professional Technicians
July 1 2019
Professional technicians are required for manufacturer
Border Inspection Methods for Imported Cosmetics
July 1 2019
Importer shall apply for examination within 15 days prior to import
Product Approval
Scope and Categories of Cosmetics
July 1 2019
Add unmedical oral products and teeth whitening products
Regulations Governing Notification of Cosmetic Products
July 1 2019
Requirements for general cosmetics
Regulations for Cosmetic Product Information File Management
July 1 2019
Requirements for general cosmetics
Regulations for Issuance of Permit License of Specific Purpose Cosmetics
July 1 2019
Requirements for specific purpose cosmetics
Regulation for Authorizing the Applications of Import of Non-licensed Specific Purpose Cosmetics
July 1 2019
Requirements for specific purpose cosmetics
Particulars of Specific Purpose Cosmetics that May Be Voluntarily Modified
July 1 2019
Requirements for specific purpose cosmetics
Documents Required for the Change of Registration Information and License Information of Specific Purpose Cosmetics
July 1 2019
Requirements for specific purpose cosmetics
Regulations Governing the Issuance and Management of Cosmetic Certificates
July 1 2019
Apply for GMP compliance certificate
Regulations Governing the Application of Animal Testing for the Safety Assessment of Cosmetics or Cosmetic Ingredients
Nov. 9 2019
 
Labeling/claim
Labeling Requirements for Cosmetic Packaging, Containers, Labels or Directions
July 1 2021
General labelling requirements for cosmetics which is to be enforced
Requirements for Cosmetic Labeling, Instruction and Packaging
Jan. 1 2008
Still in force
Regulations Governing of Criteria for the Label, Promotion and Advertisement of Cosmetic Products Identify False, Exaggerated or Having Medical Efficacy
July 1 2019
 
Notes that should be marked on the label, leaflet and package of hair dye products
Draft
 
Notes that should be marked on the label, leaflet and package of perm agent products
Draft
 
Notes that should be marked on the label, leaflet and package of decolorizing agent products
Draft
 
Ingredient List
List of Ingredients Prohibited in Cosmetic Products
July 1 2019
 
List of Preservatives in Cosmetic Products
July 1 2019
 
List of Specific Purpose Ingredients in Cosmetic Products
Jan 1 2020
To be enforced
Maximum Levels of Medical, Poisonous or Potent Drugs in Cosmetics
 
Still in force
List of Micro-organisms Limits in Cosmetic Products
Jan 1 2020
To be enforced
Standard for Usage of Antimicrobial Ingredients in Cosmetics
 
Still in force
List of Ingredients Restricted in Cosmetic Products
Jan 1 2020
To be enforced
Ingredients Restricted in Cosmetics
 
Still in force
List of Colorants in Cosmetic Products
Jan 1 2020
To be enforced
Legal Colorants in Cosmetics
 
Still in force
Post-market surveillance
Administrative Measures for Cosmetics Supply Source and Supply Chain flow information
July 1 2019
 
Regulations for Reporting Cosmetics Posing Serious Adverse Effects and Hazards to Hygiene and Safety
July 1 2019
 
Regulations for Cosmetic Recall
July 1 2019
 
Regulations on Cosmetic Hygiene and Safety Violation Report and Reward
July 1 2019
 
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Before-and-after Comparison

 

Before Revision

After Revision

Cosmetic Definition

The substance(s) for external use on human body in order to freshen the hair or skin, to stimulate the sense of smell, to cover body odor, or to improve facial appearance.

Products applied externally to the human body, teeth, or oral cavity mucous membranes, and used to moisturize hair and skin, stimulate the sense of smell, improve body odors, change appearance, or cleanse the body.

Cosmetic Classification

  • General cosmetics
  • Medicated cosmetics

(Cosmetics contain the ingredient in Standard List of Maximum Levels of Medical, Poisonous or Potent Drugs in Cosmetics)

  • General cosmetics (includes unmedical toothpaste and mouth wash)
  • Specific purpose cosmetics
    1. 1. Sunscreens
    2. 2. Hair dyes
    3. 3. Hair perms
    4. 4. Deodorants
    5. 5. Teeth whitening
    6. 6. Cosmetics with other purposes

Pre-market Requirements

  • General cosmetics: No requirements for pre-market approval

     

    Medicated cosmetics: Register with TFDA

  • Voluntary GMP
  • Pre-market advertisement approval
  • Colorant registration
  • General cosmetics: Complete product notification (implemented on July 1st 2021)

     

    Specific purpose cosmetics: Register with TFDA before July 1st, 2024 and complete notification after July 1st, 2024

  • Establish PIF
  • Mandatory GMP

    [Implementation date of GMP and PIF:

    for specific purpose cosmetics, July 1st, 2024;

    for baby, lip and eye products and unmedical toothpaste and mouthwash, July 1st, 2025;

    for other general cosmetics (solid handmade soap excluded), July 1st, 2026]

Dossiers required for notification

/

  • Notification No.
  • Product Chinese and English name
  • Product category and usage
  • Product type. If it is kind of series products, type the model and color
  • Product dosage form
  • Product use warning
  • Name, address and tel number of manufacturer and importer
  • Name, address and country of factory and its compliance situation with GMP
  • Full ingredient list
  • Other related explanations

Enterprises’ obligations

  • Bear corresponding criminal responsibility of illegal cosmetic operation activities
  • Establish and maintain data on direct supply sources and destinations of products (products directly sold to consumers excluded)
  • Report the serious adverse effects initiatively
  • Notify sellers and recall violating products from the market initiatively
  • Criminal liability of illegal cosmetic operation activities is abolished while fines are increased

Animal testing

Allowed

Banned

unless one of the following conditions applies and has been approved by the central competent authority:

1. The ingredient is widely used, and its function cannot be replaced by other ingredients;

2. Those that require animal testing to be conducted, having evaluation data that demonstrate the potential for harming human health.

Others

/

  • Border control of cosmetics is tightened
  • Individuals reporting illegal activities will be rewarded

Company Obligation

process

Clarification & Interpretation

Clarification & Interpretation
  1. The manufacturing and sale license regulated in the Regulations Governing the Issuance and Management of Cosmetic Certificates only applies to cosmetics in Taiwan exported to other regions.
  2. Border Inspection Methods for Imported Cosmetics is not a mandatory regulation. Companies need to comply with it only after the competent authority released related announcements.
  3. For PIF, international safety assessment report is acceptable.
  4. For notification, international GMP certificate or similar certificate is acceptable.
  5. Company can now notify or register with TFDA according to the new cosmetic ingredient regulations even if they will be effective since Jan 1 2020.
  6. For GMP, the authority may inspect the overseas factory depending on circumstances and related expense shall be borne by the company.

Consultation

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