Taiwan to Revise Hair Dye Ingredient Requirements

  •   17 Oct 2017
  •    Jo Zhou

    Takehome:

    • TFDA will revise hair dye ingredient requirements in list of “Maximum levels of Medical, Poisonous or Potent Drugs in Cosmetics”;
    • Limitations and requirements for certain ingredients have changed and 33 new hair dye ingredients are added to the list

    The new standard will be effective on Jan 1st 2019. In the new list, the hair dye ingredients part will add columns including INCI name, CAS Number and Restriction/Precaution, and refine the column “limitation” to “limitation standard (oxidative/non-oxidative)”. Some hair dye ingredients have been deleted, while 33 new ingredients are added to make a total of 104 hair dye ingredients. Besides, limitation and requirements of some ingredients are adjusted. For example, the maximum limits of Toluene 2,5-diamine was 4% in the past (Toluene 2,5-diamine), but in the new list, it stipulates a maximum limit of 2% (free base) and 3.6% as a sulfate salt.

    Hair dye products should obtain a medicated cosmetic certificate. Some conditions/prerequisites of the certificate need to be adjusted to ensure compliance with the new requirements:

    1. If the product is manufactured before Dec.31st 2018, it can be sold until its expiration date
    2. If the usage of ingredients which were once approved but now don’t comply with new requirements, the applicant should update the certificate registration or repeal the certificate before Jan. 1st 2019
    3. If the original ingredient used in the product is not on the new list, but complies with the published standard of any country of EU, US or Japan, the applicant can be exempted from certificate update.

    Please visit: “Taiwan New Requirements of Hair Dye Ingredients (Contrast with Old Version)” to compare the new and current list.

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    Comments

    Hi Jo, thanks for information. Could you please verify or correct my take away from this news? 1. The maximum percentages in oxidative hair dyes refer to "after mixing with peroxide/developer", same logic as EU regulation, correct? 2. "3.If the original ingredient used in the product is not on the new list, but complies with the published standard of any country of EU, US or Japan, the applicant can be exempted from certificate update." Does it mean TW FDA accepts the new products containing a dye which is not on TW's positive list but published in EU/US/JP regulation?
    Hi Roy, 1. correct; 2. as long as the ingredient is published in EU/US/JP and not listed on prohibited list of TW, then it can be accepted in new product if not on the positive list as well.