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Takehome:
According to the new Cosmetic Hygiene Safety Administration Act, cosmetic manufacturers and importers shall complete product notification and submit product information files prior to supply, sale, promotional giveaways, public displays or consumer product trials. Here Chemlinked offers an exclusive Q&A and will offer guidance on the most frequently asked questions.
On Product Notification System
Q: Which kind of cosmetics require product notification?
A: Cosmetic categories announced by TFDA and products from enterprises of a certain scale shall be notified on the cosmetics notification system before entering the market.
Q: Both general and medicated cosmetics require a notification to be made on the online system and prepare product information files. When the product is cleared at customs, will the PIF on the notification system be provided to the customs as the basis for clearance (replace the existing medicated cosmetics license)?
A: Both cosmetic categories announced by TFDA and products from cosmetic enterprises of a certain scale are required to notify on the cosmetics notification system before entering the market, but not before customs clearance. Therefore, the product PIF on the notification system is not relevant to the clearance.
Q: After cosmetic enterprises complete product notification, will the competent authority conduct on-sited inspections?
A: Yes. In order to confirm whether the content of the notification is true, the competent authority will inspect the cosmetic enterprise's workplace or business place and relevant supporting documents. The cosmetics enterprises shall not evade, obstruct or refuse when requested by the competent authority.
Q: After completing product notification, if the product name changes, but the ingredients remain unchanged, do I need to re-notify it as a new product? And what if the ingredients changed?
A: If there is any change in the current product information files, update the product PIF. As for the identification criteria of the new case notification and old case renewal, it will be announced separately in accordance with the revised regulations and enforcement rules of Cosmetic Hygiene Safety Administration Act.
Q: Is there any certification document required after completing product notification?
A: No. The purpose of establishing cosmetics notification system is to simplify product pre-market approval procedures and facilitate cosmetics management, so currently there is no plan to issue additional certification document requirements.
Q: How long is the validity period of product notification?
A: The validity period of product notification will be announced separately in accordance with the revised regulations and enforcement rules of Cosmetic Hygiene Safety Administration Act.
On Product Basic Information
Q: Can a product with the same ingredients but different product names be notified with the same product number?
A: If the product has the same ingredients, belongs to the same enterprise, and sells on the market with several product names, it can be notified with the same product number, but you need to notify every different product name separately.
Q: In a series of products, products which are different from fragrances and colorants can they be regarded as the same product? If they only differ in terms of their extracted ingredients can they be regarded as the same product?
A: "Series of product" means cosmetics in the same series, they share the same formula, same form and functions, and only differ in colorants or fragrance. If cosmetic enterprise regards the extracted ingredients as fragrances or colorants, then the products can be notified as the same product. However, if the enterprise regards the extracted ingredients as the functional ingredients or other ingredients, it shall be notified separately.
Q: If the hair dye contains No. 1 and No. 2 agents, it shall be notified as a series of product, or shall be notified separately for No. 1 and No. 2 agents?
A: It can be notified as a series of product. But if the No. 1 and No. 2 agents of hair dyes are sold separately, separate notification is required.
Q: Can a travel package be notified as one product on the system? Or is it necessary to conduct multiple notifications of each individual product (such as shampoo, shower gel, face wash, etc.)?
A: If the products in the travel package are not sold separately on the market, you can regard the travel package as one product. If the products are sold separately on the market, it shall be split into individual products each of which requires individual notification.
Q: Which product type do baby wet wipes belong to?
A: Choose "Lotion / Oil / Cream--Others”.
On Product Manufacturers
Q: If my product has more than one authorized manufacturer, are all manufacturers required to complete product notification?
A: Yes, all manufacturing plants are required to complete product notification.
On “All Ingredients”
Q: For imported cosmetics, if the definition of the ingredient function in the original country is different from that of Taiwan. How to fill in the blank of “function”?
A: It is recommended to choose the function set for this ingredient of the original manufacturer's design for this product.
Q: In the process of product notification, if I found that the foreign INCI database includes this ingredient data, but the notification system does not, how to deal with it?
A: Safety data of the ingredient which is not included in the system database, but included in INCI dictionary and EU COSING can be provided to the new ingredient database of TFDA.
Q: When the ingredient is a mixture of three components, should I notify the three components separately?
A: When completing product notification, the mixture’s components need to be labeled separately.
On Product Cancellation
Q: If the products that have been notified are discontinued, should I cancel the product information on the system?
A: If you want to cancel it, you can enter the system, find “Product Cancellation”, choose the product and click “cancel”.
General Problems
Q: If foreign manufacturer sells products to several importers, who should complete the product notification?
A: Importers of cosmetics, regardless of whether the products are the same, shall notify TFDA. Those who sell products without notification are considered to sell illegal products.
Q: Will all the information about product on the system be disclosed to consumers or the public?
A: Currently, product information on the system is not disclosed to the public and is only used for reference by TFDA. Enterprises should fill out information honestly, because the information will be disclosed partially (e.g. product name, responsible person) to the public in the future without revealing confidential business information.
Q: If overseas enterprises want to import cosmetics to Taiwan, can they apply for an account?
A: Currently, this system is only applicable to manufacturers and importers in Taiwan. Overseas enterprises cannot complete product notification by themselves.
Q: Do distributors require product notification?
A: No. Currently, the notification system is only applicable to manufacturers and importers in Taiwan. Distributors don’t need to complete product notification.
Q: The amendments to Statute for Control of Cosmetic Hygiene were finally approved, are the products previously notified still valid?
A: Yes, products previously notified are still valid.
Q: Do handmade soap manufacturers and importers require product notification?
A: According to the new Cosmetic Hygiene Safety Administration Act, cosmetics manufacturers of certain types announced by the central competent authority and importers of a certain scale shall complete product notification. Currently, handmade soap makers without factory registration do not require product notification.
Q: Do toothpastes require a notification?
A: According to the new Cosmetic Hygiene Safety Administration Act, non-medicated toothpastes and mouthwashes are classified as cosmetics, so toothpastes require notification.
Q: After finishing the notification, should enterprises periodically check if their products have been approved?
A: After finishing the notification, the system will inform the registered contact person listed in the product information files by e-mail or enterprise can check how the case is processed by clicking "inquiry" in the system.
These tips may help you operate the notification system and sell cosmetics in Taiwan' s market. Currently the cosmetic online notification system is free, however after the related enforcement rules of notification system are formulated and released, a fee shall be charged. It is recommended to complete product notification now if you want to circulate products in the Taiwanese market.
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