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Taiwan Amends Requirement for Titanium Dioxide in Cosmetics

  •   20 Apr 2017
  •    Jo Zhou
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    Taiwan FDA amended the provision of controlling titanium dioxide in cosmetics last week.

    Cosmetics which contain titanium dioxide (concentration within 25%, exclude Nano sprayers) are designated as general cosmetics, and don't require registration. In this circumstance, already registered cosmetics don't have to renew their certificate after expiration. When cosmetics contain both titanium dioxide and Nano titanium dioxide, the total concentration cannot surpass 25%.

    Cosmetics which contain titanium dioxide (concentration exceeding 25%) or sprayers contain Nano titanium dioxide are still regarded as medicated cosmetics and registration is required. For registration, a new chemical compound ingredient technical specification should be provided.

    When a cosmetic with titanium dioxide is designated as a sunscreen, and the manufacturer has claimed or labeled its SPF, an SPF test report should be prepared by the manufacturing plant or retailers for reference by TFDA.

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    I'd like to seek more clarification on the use of TiO2 as colorant. I understand that TiO2 is allowed to be used as colorant by TFDA as it was approved by EU cosmetics regulation, although TiO2 is not on TW's colorant positive list. And there is no maximum concentration stipulated by EU regulation. My question is that, whether or not 25% will be the new maximum concentration to TiO2 when used as colorant functionality?
    Tuesday, 16 May 2017
    Thank you for your comments. regarding to your question, for Taiwan district, 25% is not a maximum limit for TiO2 usage in cosmetics. Currently, cosmetics in Taiwan containing TiO2 exceeding 25% are designated as medicated cosmetics, and a registration will be needed in case of import or sale.
    Tuesday, 16 May 2017
    Thanks for comments. TiO2 has functionality as both UV filter and colorant. when a color cosmetics product contains TiO2 > 25% as colorant function, should it be classified as medicated cosmetics? Based on my understanding, color cosmetics can contain TiO2 more than 25%, and classified as usual cosmetics. Nevertheless according to the new regulation, it seems any cosmetics containing TiO2 >25% is medicated cosmetics. This needs clarification.
    Tuesday, 16 May 2017
    Dear, YI LU, we look up to the latest list of allowed colorants for cosmetics of Taiwan, TiO2 is not on the list, but there is a note states that "if one ingredient is allowed to use as colorant in EU, US or Japan but not on the list, it can be used in Taiwan in compliance with requirements of these countries. This colorant requires a registration with documentation evidence to prove it is allowed to use by any of above country." That means, as a colorant, TiO2 is not regulated by rules specified in this news because TiO2 is not officially listed, but it can be used referring to EU's concentration limit. Hope this answer will help you.
    Wednesday, 17 May 2017