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Takehome:
Documentation requirements, validity and other related issues for cosmetics notification are specified in the draft regulation.
On Nov 1, 2018, TFDA released four draft regulations namely 1) Administrative Measures for Cosmetics Notification 2) Administrative Measures for Registration Exemption Application of Imported Special-use Cosmetics 3) Administrative Measures for Cosmetic Professional Technician Qualifications and Training 4) Limitation of Imported Special-use Cosmetics for Personal Use. Public consultation will last until Jan 2, 2019. Any suggestions can be submitted on Taiwan Public Policy Participation Platform.
Specific terms related to cosmetic enterprises are as follows:
- The draft of Taiwan Cosmetic Hygiene Safety Administration Act released on May 2, 2018 stipulated that all cosmetics are required to complete notification before entering market (not effective now). The table shows the documentation necessary for cosmetic notification.
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Product notification number |
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Product Chinese and English name (English name is not necessary for products manufactured in Taiwan) |
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Product category and usage |
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Product specification |
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Product model |
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Precautions for use |
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Manufacturer or importer’s name, address and phone number |
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Manufacturing site’s name, address, country and condition in line with cosmetics GMP |
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A list of all ingredients |
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Other related product descriptions |
- Under the following 3 conditions, cosmetic products can be notified as one category.
- Products with the same ingredients, formula and usage;
- Series products with the same specification and usage, only different in fragrances or colorants;
- Product collection with more than 2 kinds of cosmetics, but these cosmetics do not provide, sell, gift, display or offer for consumer trials separately.
- Handmade soap makers without factory registration do not require product notification
- Only products with ingredient changes need to re-notify to TFDA, other conditions can apply for notification information changes. The notification validity is 3 years, stakeholders shall extend the notification 3 months before the expiration date.
- Imported special-use cosmetics used as examination samples for registration or used for research and experiment are exempted from TFDA registration. But each product category shall not exceed 12 bottles.
- Cosmetic manufacturers shall hire pharmacists or cosmetic professional technicians to supervise product preparation and manufacture. Professional technicians are responsible for the supervision of cosmetics preparation and manufacture, manufactories facilities, equipment maintenance inspection and guidance, cosmetic manufactory GMP plan’s formulation and implementation.
- Special-use cosmetics accompanying passengers entering Taiwan for personal use, each category of which shall not exceed 12 bottles, totaling no more than 36 bottles, can be exempted from registration at TFDA. Cosmetics exceeding the limitation shall be destroyed or returned at the port.
The effective date of the four drafts is consistent with Taiwan Cosmetics Hygiene Safety Administration Act, which is expected to take effect in mid-2019. Stakeholders that have any other questions about cosmetics notification in Taiwan, please refer to CL news offering guidance on the most frequently asked questions.
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