Taiwan Adopts 4 Regulations Related to the Licensing and Approval of Specific Purpose Cosmetics

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June 18, 2019 - Xiaolu Wang

Taiwan's Ministry of Health and Welfare finalized four regulations related to the licensing and approval requirements for specific purpose cosmetics on 28 May 2019.

Verisk 3E Review

On 28 May 2019 the Ministry of Health and Welfare of Taiwan (MoHW) issued four regulations concerning specific purpose cosmetic products that are manufactured in or imported into Taiwan, as follows:

  • Regulations for Issuance of Permit License of Specific Purpose Cosmetics (特定用途化粧品許可證核發辦法)
  • Regulation for Authorizing the Applications of Import of Non-licensed Specific Purpose Cosmetics (特定用途化粧品申請專案核准輸入辦法)
  • Particulars of Specific Purpose Cosmetics that May Be Voluntarily Modified (特定用途化粧品得自行變更之查驗登記事項)
  • Limited Numbers on Registration of Exemptions from the Inspection of Imported Specific Purpose Cosmetics for Personal Use (輸入特定用途化粧品供個人自用免申請查驗登記之限量)

These four regulations were issued to further implement the licensing requirement prescribed under the Cosmetic Hygiene and Safety Act (化粧品衛生安全管理法), which mandates that no specific purpose cosmetics may be manufactured or imported into Taiwan without a license.

However, cosmetics may be exempted from this licensing requirement if one of the following scenarios applies:

  • The product is manufactured or imported for personal use in a quantity below the threshold volume prescribed by the MOHW or
  • The product is manufactured or imported for the purpose of obtaining a license for a special purpose cosmetic. However, this exemption requires approval from the MoHW, as per the application procedures outlined in Article 5 of the act.

The MoHW issued the four new implementing regulations to provide more detailed instructions on the licensing process and associated exemptions.

Specific purpose cosmetics are defined as cosmetic products that are designated by the MoHW and that fall under one of the following product categories: sunscreens, hair dyes, permanent hair waving products, antiperspirants, deodorants, teeth whitening products and others.

Regulations for Issuance of Permit License of Specific Purpose Cosmetics

The Regulations for Issuance of Permit License of Specific Purpose Cosmetics provide requirements for the application, issuance, alteration, revocation, extension and renewal of the license to produce or import specific purpose cosmetics, including the required application documents and application procedures. The regulations will become effective on 1 July 2019.

Regulation for Authorizing the Applications of Import of Non-licensed Specific Purpose Cosmetics

The Regulation for Authorizing the Applications of Import of Non-licensed Specific Purpose Cosmetics regulates the approval process for the manufacture and import of specific purpose cosmetics that are exempt from the licensing requirements under the Cosmetic Hygiene and Safety Act:

  • Application scope: The following activities are subject to the approval requirements as provided under the regulation:
    • Import of non-licensed specific purpose cosmetics for the purpose of obtaining a license for these cosmetics; and
    • Import of specific purpose cosmetics for research purposes.
  • Required application documents: For activities that fall under the scope mentioned above, various supporting documents must be provided to obtain approval:
    • Business registration and the license of the applicant;
    • Information on containers and packaging materials used and
    • Volume of concerned cosmetics to be imported.

The regulation will become effective on 1 July 2019.

Particulars of Specific Purpose Cosmetics that May Be Voluntarily Modified

The Particulars of Specific Purpose Cosmetics that May Be Voluntarily Modified makes modifications of certain information on the product labels, user manuals or outer packaging of specific purpose cosmetics exempt from the approval requirements under the Cosmetic Hygiene and Safety Act.

Examples of exempted modifications of labeling information for specific purpose cosmetics include the following:

  • Change of the material, shape or color of product labels, user manuals or outer packaging;
  • Change of font used in the product labels, user manuals or outer packaging;
  • Addition of barcodes;
  • Addition of safety instructions for users and
  • Deletion of the wording "cosmetics containing a medical or poisonous drug.”

The particulars will become effective on 1 July 2019, with the exception of article 2.10, which will become effective on 1 July 2021.

Limited Numbers on Registration of Exemptions from the Inspection of Imported Specific Purpose Cosmetics for Personal Use

The Limited Numbers on Registration of Exemptions from the Inspection of Imported Specific Purpose Cosmetics for Personal Use makes the import of specific purpose cosmetic products exempt from the licensing requirements under the Cosmetic Hygiene and Safety Act, provided that the volume of import does not exceed 12 individual containers (e.g. bottles, boxes or bags) per product type and 36 individual containers in total. The exempted specific purpose cosmetics must be for personal use only. This regulation will become effective on 1 July 2019.

Verisk 3E Analysis          

Companies that manufacture specific purpose cosmetics or import these products into Taiwan should note that the Taiwanese authorities have finalized new implementing measures under the Cosmetic Hygiene and Safety Act. The majority of these regulations will become effective on 1 July 2019, with the exception of article 2.10, of the Particulars of Specific Purpose Cosmetics that May Be Voluntarily Modified, which will become effective on 1 July 2021.

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