Newsletter
RULES ON USE OF STANDARD CONTENT OF MEDICAL, POISON-OUS OR POTENT DRUGS CONTAINABLE IN COSMETIC PRODUCTS
On 29 July 2008, the Department of Health (DOH) announced the Provisions Regulating the Use of Standard Content of Medical, Poisonous or Potent Drugs Containable in Cosmetic Products. The main content is as follows:
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Hair dyes, hair perm preparations, sunscreens agents, anti-perspirants, and tooth whitening agents containing peroxides, that under current DOH regulations are categorized as cosmetics containing medical, poisonous or potent drugs ("medicated cosmetics"), are subject to regulation as cosmetics, and they may be imported, manufactured, or offered for sale only after being registered and licensed under Article 7 Paragraph 1 or Article 16 Paragraph 1 of the Act Governing Cosmetics Hygiene.
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Where standard ingredients are used in such medicated cosmetics, if the DOH has already announced standards for their use, then the provisions of such standards should be followed. If an ingredient is not covered by standards thus far announced by the DOH, but an official standard for its use is currently in force in the European Union, the USA, or Japan, the DOH may grant permission for the ingredient's use in accordance with the standards and usage allowance stated in the relevant foreign standard, and will not undertake procedures to prepare and announce an additional standard of its own. But when filing its application for registration, the manufacturer or importer must append documentary evidence of the relevant foreign usage standard. If no standards are in force in any of the above three jurisdictions, then the ingredient must be assessed as a new ingredient, and the applicant must submit basic technical information for review in accordance with the requirements announced by the DOH on 1 August 2006.