China Taiwan Cosmetic Regulation
Jul 18, 2019
Ye Chen
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CONTENTS

On 1st July 2019, the overarching cosmetic regulation “Cosmetic Hygiene and Safety Act” in Taiwan entered into force, replacing the former one “Statue for Control of Cosmetic Hygiene”. The categories of cosmetics changes from general cosmetics and medicated cosmetics in the old regulation to general cosmetics and specific purpose cosmetics in the regulation.  

The newly enforced cosmetic hygiene and safety act establishes a completely new administrative system including a new notification system and requires the establishment of a PIF (product information files). Starting from the effective date (1st July, 2019), all general cosmetics can start their notification procedure through an online platform.

The actual implementation date for general cosmetic notification is 1st July, 2021. After that, cosmetic products without notification will be regarded as illegal. The notification functions as a record to help TFDA to assign liability in case of any safety problems. Specific purpose cosmetics are still subject to registration, but 5 years later (1st July, 2024), they will be subject to a notification and PIF system as well. TFDA has also strengthened provisions related to post-market surveillance. In addition, the registration of colorants has been abolished.

Part 1 Regulatory Framework and Competent Authority

1 Existing Key Cosmetic Regulations in China Taiwan

TypesRegulationsDate of ImplementationStatus
 Cosmetic Hygiene and Safety Act01-07-2019In force
 Enforcement Rules of Cosmetic Hygiene and Safety Act01-07-2019In force
LicenseRegulations Governing Notification of Cosmetic Products01-07-2019In force
Regulations for Cosmetic Product Information File Management01-07-2019In force
Regulations for Issuance of Permit License of Specific Purpose Cosmetics01-07-2019In force
ManufacturingCosmetic Good Manufacturing Practice Regulations01-07-2019In force
Specified Cosmetic Categories Shall Comply with Cosmetics Good Manufacturing Practice Regulations01-07-2019In force
IngredientsList of Ingredients Prohibited in Cosmetic Products01-07-2019In force
List of Preservatives in Cosmetic Products01-07-2019In force
List of Preservatives in Cosmetic Products (to be Enforced)01-07-2020To be enforced
List of Ingredients Restricted in Cosmetic Products01-01-2020In force
List of Micro-organisms Limits in Cosmetic Products01-01-2020In force
List of Colorants in Cosmetic Products01-01-2020In force
List of Specific Purpose Ingredients in Cosmetic Products01-01-2020To be enforced
LabelingRequirements for Cosmetic Labeling, Instruction and Packaging01-01-2008Still in force
Labeling Requirements for Cosmetic Packaging, Containers, Labels or Directions01-07-2021To be enforced

2 Cosmetic Competent Authorities

"Taiwan Food and Drug Administration", a sub department of the Ministry of Health and Welfare oversees comprehensive supervision on cosmetics, including formulating and releasing cosmetic regulations, governing the notification of cosmetic products, issuing specific purpose cosmetic licenses and etc.

Part 2 Cosmetic Products

1 Definition

The "Cosmetic Hygiene and Safety Act" stipulates that "Cosmetics" means 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. However, this is not applicable to those that are regarded as drugs in accordance with other laws or regulations.
The "Regulations for Issuance of Permit License of Specific Purpose Cosmetics" stipulates that  "Specific Purpose Cosmetics" means cosmetic products used for sunscreen, hair dyes, hair perms, deodorants, teeth whitening and other functions.

2 Classification

Taiwan regulates cosmetics based on functions. Cosmetic products are categorized into general cosmetics and specific purpose cosmetics. The old name "medicated cosmetics" has been abolished. Specific purpose cosmetics include:

  • Sunscreen

  • hair dyes

  • hair perms

  • deodorants

  • teeth whitening

  • cosmetics with other purposes

3 Obligations of Manufacturers and Importers

Obligations for Different Cosmetics

General cosmeticsSpecific purpose cosmetics
NotificationRegistration
Note: from 1st July, 2024, registration will be replaced by notification and PIF.
Build product information files (PIF)

Flow Chart

Documents Required

Notification Dossier
Product Notification Number
Product Chinese and English name (English name is not necessary for products manufactured in Taiwan.)
Product category and usage
Product specification (If the product belongs to a series of products, the type or color information is needed to be submitted.)
Product model
Precautions for use
Manufacturer or importer’s name, address and phone number
Manufacturing site’s name, address, country and condition in line with cosmetics GMP
A list of all ingredients
Other related product descriptions

 

Product Information Files Dossier
Note: Both Chinese and English versions are accepted. If the original version is in neither Chinese nor English, a translation
in Chinese or English is required.
Product basic information (name, category, formulation, usage, name and address of manufacturer, importer’s information)
Documents that can prove products have completed notification
Full ingredients and concentration
Product label, instruction, outer packaging or container
GMP certificate
Manufacture method and process
Use method, application area, usage amount, frequency and target users
Adverse reaction data
Physical and chemical properties of products and ingredients
Ingredients’ toxicological data
Product stability test report
Microbiological test report
Anticorrosion efficacy test report
Functional assessment supporting data
Packaging materials information in contact with products
Product safety data
1) safety assessment conclusions and advices signed by safety data signer
2) certificate of safety data signers’ qualifications

 

Specific Purpose Cosmetics License Application Dossier
Products manufactured in TaiwanImported products
Copy of business registration certificateCopy of company/business registration certificate
Copy of pharmacist's practicing license/ resident cosmetic manufacturing supervisors’ certificate of qualifications and employmentSamples of product label, leaflet and packaging
 
Samples of product label, instruction and packagingAuthorization certificate in the recent 2 years (signed by foreign manufacturers that agree the applicant to import and sale products in Taiwan)
Testing report (including product characters, main ingredients, testing methods, quantitative methods, ingredients’ limitations, testing results, etc.)
Note: inspection report can be replaced by Cosmetic GMP certificate
Manufacture and sales certificate of country of origin in the recent 2 years
 
For entrusted manufacturers, copies of applicant’s company/business registration certificate and entrustment contractIngredient list from the recent 2 years:
  • Product name

  • Main ingredients, preservatives, colorants and other ingredients’ name and content

 Inspection report (including product characters, main ingredients, testing methods, quantitative methods, ingredients’ limitations, testing results, etc.)
 For entrusted manufacturers, documents to explain the relationship between the entrusting party and the entrustee.

Implementation Date

Notification
General cosmetics (Except handmade soap that is exempt from factory registration)1st July, 2021
Specific purpose cosmetics1st July, 2024


Establishment of Product Information Files (PIF)
Specific purpose cosmetics1st July, 2024
Baby cosmetics, lip care cosmetics, eye care Cosmetics, non-medical toothpaste and mouthwash1st July, 2025
General Cosmetics (Except baby cosmetics, lip care cosmetics, eye care Cosmetics, non-medical toothpaste, mouthwash and handmade soap that is exempt from factory registration)1st July, 2026

4 Manufacturing Requirements

On 1st July 2013 Taiwan released a regulation named Key Points on the Implementation of Voluntary Cosmetics Good Manufacturing Practices (GMP), which specifies advanced and severe requirements for manufacturers. However, this regulation only provided voluntary standards for manufacturers. And the new cosmetic regulation, which was implemented on 1st July 2019, regulates that GMP should to be mandatory for manufactures and importers. And on 13th August 2019, Taiwan released the final revised GMP standard. The implementation date for this new standard is 1st July 2019, which means it has entered into force since the day when it was released. In the meantime, another document (Specified Cosmetic Categories Shall Comply with Cosmetics Good Manufacturing Practice Regulations) tells us that the central competent authority sets different implementation date of mandatory GMP for different categories of cosmetics for a smooth transition (see below):

Cosmetic categoryImplementation date
Specific purpose cosmetics1st July, 2024
Baby cosmetics, lip care cosmetics, eye care Cosmetics, non-medical toothpaste and mouthwash1st July, 2025
General Cosmetics (Except baby cosmetics, lip care cosmetics, eye care Cosmetics, non-medical toothpaste, mouthwash and handmade soap that is exempt from factory registration)1st July, 2026
 

In addition, a manufacturer complying with this GMP can apply for a GMP compliance certificate and is exempt from requirements to submit testing reports for registration of specific purpose cosmetics (manufactured in Taiwan).

GMP application dossier
Applicant’s copy of company/business registration certificate
Copy of factory registration certificate

5 Labeling & Claims & Advertisements

Present Labeling Policy

Taiwan stipulates that all cosmetics must contain the following information on the labels and packages:

Label itemCarton, package or container (that is inner or outer packages)
Product nameV
Name and address of manufacturer (domestic)
Name and address of importer (imported)
Net weight or capacity of content
Applications
Usages
Batch number or date of production
Full ingredients
Storage method and storage life
No. of license

Note 1: for item with “V” sign, it shall be prominently labeled on both carton package and container.
2. for item with “▲” sign, if the product has both carton package and container, it shall be labeled on carton package, and if the product doesn’t have carton package, it shall be labeled on the container.
3. Medicated cosmetics (specific purpose cosmetics) must bear the name, content and warnings specifying product composition.
The above items must be labeled in Chinese. If the item cannot be labeled in Chinese appropriately, it must be labeled in international general words or symbols. The trade name and overseas manufacturer name and address can be marked in foreign language.

Future Labeling Policy

According to Cosmetic Hygiene and Safety Act, the outer packaging or containers of cosmetics shall conspicuously label the following information:
1. Product name;
2. Function;
3. Usage and storage instructions;
4. Net weight, volume, or amount;
5. Full ingredient names. For specific purpose cosmetics, the content of specific purpose ingredients contained therein shall be labeled separately;
6. Precautions for use;
7. Name, address, and telephone number of manufacturer or importer; country of origin of imported product;
8. Manufacturing date and shelf life, or manufacturing date and expiration date, or shelf life and expiration date;
9. Lot number;
10. Other information required to be labeled as per public announcement of the central competent authority.
The information to be labeled as specified in the preceding paragraph shall be provided in Chinese or internationally common symbols. However, the information of Subparagraph 5 may be labeled in English. For the information of each subparagraph in Paragraph 1, if it cannot be labeled due to surface area limitations of outer packaging or container being too small or other special circumstances, said information shall be stated on the label, in the leaflet, or by other means.
More details about packaging, containers, labels and directions are in Labeling Requirements for Cosmetic Packaging, Containers, Labels or Directions which was released on 30th May, 2019. This regulation is going to enter into force on 1st July, 2021.

Advertisement

Taiwan's existing pre-market approval of advertisements has been invalidated according to explanation No. 744 of Grand Justice. And according to Regulations Governing of Criteria for the Label, Promotion and Advertisement of Cosmetic Products Identify False, Exaggerated or Having Medical Efficacy, cosmetics advertisements, labels or claims shall not be exaggerated, fake or related to medical efficacy. If a product advertisement violates related regulations, the manufacturer will be subject to fines. Severe violations of the regulations are subject to product recall and rectification of all future advertisements.

6 Post-market Surveillance

Compared to the previous cosmetic regulation system in Taiwan, the new system focuses more on post-market surveillance.

Establish and Maintain Data on Direct Supply Sources and Destinations of Products

After notification and building product information files (PIF) or registration, cosmetics businesses shall establish and maintain data on direct supply sources and destinations of products.
According to Regulations for Cosmetics Supply Source and Supply Chain Flow Information, supply source and flow information shall be recorded by cosmetic manufacturers, importers and distributors. Cosmetic enterprises shall keep product supply source and supply chain information in the form of a written or electronic document for at least 5 years.

For cosmetic manufacturers and importers:
1. Manufacture or import information and credentials
Product name, notification number or license number, packing specifications and net content or capacity, batch number, product total number, import date and customs declaration number
2. Supply chain information and credentials
Supplier's name, address, contact person and phone number, product name, notification number or license number, packing specification and net content or capacity, batch number, product total number, and delivery date.

For cosmetic distributors:
1. Supply source information and credentials
Supplier's name, address, contact person, and phone number, product name, notification number or license number, packing specification and net content or capacity, batch number, product total number, and receipt date
2. Supply chain information and credentials
Supplier's name, address, contact person, and phone number, product name, notification number or license number, packing specification and net content or capacity, batch number, product total number, and delivery date.

Action Shall Be Taken When Cosmetics Have Serious Adverse Effects and/or Are Shown to Be A Safety Hazard

Cosmetics businesses shall report the serious adverse effects generated by cosmetics under conditions of normal or reasonable use, or any findings showing that the product is a hazard to hygiene and safety. These situations will be handled in accordance with the provisions of Article 10 of the Consumer Protection Act.
Serious adverse effects mentioned in the preceding paragraph refers to one of the following conditions:

1. Death;
2. Life-threatening;
3. Temporary or permanent disability/incapacity;
4. Congenital anomaly/birth defect of fetus/infant;
5. Resulting in hospitalization of users for treatment.

For more details, please refer to Regulations for Reporting Cosmetics Posing Serious Adverse Effects and Hazards to Hygiene and Safety.

Random Sampling Check

Competent authorities may dispatch personnel to enter the premises of cosmetics businesses to conduct sampling checks of their facilities, product information files, data on product supply sources and destinations, relevant records and documents, or sampling tests of cosmetics or raw materials. Cosmetics businesses shall give their cooperation, and shall not evade, obstruct, or refuse inspection.

Border Inspection

In order to enhance border control of cosmetics imports, the central competent authority may make public announcement about certain cosmetics categories or items that could possibly pose a hazard to hygiene and safety and may only be imported after sampling checks and sampling tests show compliance.
For more details, please refer to Border Inspection Methods for Imported Cosmetics.

Other Relevant Regulations

RegulationsStatus
Regulations for Cosmetic RecallIn force
Regulations on Cosmetic Hygiene and Safety Violation Report and RewardIn force

Part 3 Ingredients

Cosmetic ingredients must comply with the following list:

ListsDetailed requirements Implementation DateStatus
List of Ingredients Prohibited in Cosmetic ProductsIngredients prohibited in cosmetic products1st July, 2019In force
List of Preservatives in Cosmetic ProductsPreservatives allowed in cosmetic products with its INCI name, CAS No., scope of use, limited dosage, limitation and precautions needed to be labelled.1st July, 2019In force
List of Preservatives in Cosmetic Products(new)A new version of preservative list, different from the old version, to be enforced.1st July, 2020In force
List of Ingredients Restricted in Cosmetic ProductsIngredients allowed in cosmetic products with its INCI name, CAS No., scope of use, limited dosage, limitation and precautions needed to be labelled.1st Jan, 2020In force
List of Specific Purpose Ingredients in Cosmetic ProductsIngredients allowed in specific purpose cosmetic products with its INCI name, CAS No., scope of use, limited dosage, limitation and precautions needed to be labelled.1st Jan, 2020In force
Legal Colorants in CosmeticsLegal Colorants1st Jan, 2020In force
List of Micro-organisms Limits in Cosmetic ProductsLimitation Standards for Microorganism of different kinds of cosmetics1st Jan, 2020In force

Part 4 Conclusion

The implementation of Cosmetic Hygiene and Safety Act in Taiwan has a significant influence on domestic and international cosmetic companies. For a smooth transition, TFDA sets different implementation dates for this Act.

ArticlesEffective date
Paragraph 4, 5 and 6 of Article 6,
Subparagraph 6 of Paragraph 1 of Article 23,
Article 23-2,
Paragraph 2 and 3 of Article 27.
9th Nov, 2019
Article 7,
Subparagraph 5 of Paragraph 1 of Article 16,
Subparagraph 4 of Paragraph 1 of Article 17,
Subparagraph 4 of Paragraph 1 of Article 18,
Subparagraph 7 of Paragraph 1 of Article 23
1st July, 2021
Other Articles1st July, 2019

In conclusion, there are 8 main amendments in this update:

1. Modify cosmetic definitions

  • The scope of cosmetics is extended to oral products. From Jul. 1st, 2021, non-medicated toothpastes and mouthwashes will be regulated as cosmetics.

2. Reclassify cosmetic products

  • Cosmetic products are categorized into general cosmetics and specific purpose cosmetics. Use of the old name “medicated cosmetics” has been abolished.

3. Establish a product notification system and a product information file (PIF) system for general cosmetics.

4. Specific purpose cosmetics still require registration before 1st July 202 However, after that, specific purpose cosmetics will be subject to the notification and PIF system.

5. Implement mandatory GMP for the production of cosmetics

6. Specify cosmetic enterprises' obligations including:

  • Disclosure of product safety information

  • Manufacturers are required to adopt appropriate measures to deal with severe adverse events or when products cause hygiene and safety problems.

  • Strengthen supervision on cosmetic production and take steps to tighten border control.

  • Manufacturer violating the regulations is required to recall or destroy unqualified products within stipulated time.

7. Ban use of advertisements prior to market approval

8. Abolish the registration of colorants