Page 88 - 2019食藥署年報(英文版)

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Taiwan had established management regulations for the control of heavy metals
in cosmetics, as the heavy metal is harmful to the health of human body. However, the
international management regulations of cosmetics had been amended and there had reports
regarding Barium poison, and thus we amended the domestic "Regulations on the Residue Limit
for Impurity Heavy Metal Cadmium Contained in Cosmetics" and stipulated the "Regulations
on the Management of Barium in Cosmetics" for the nation. TFDA also amended the hair dye

ingredients and the precautions for the use of hair dye stipulated in the "Standard for Cosmetics
Containing Medical or Poisonous Drugs," to ensure the safety of consumers in the rapidly
developing cosmetics industry.

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TFDA referred to the management regulations in Korea, China and ASEAN, and enacted
the "Regulations on the Residue Limit for Impurity Heavy Metal Cadmium Contained in

Cosmetics" on March 28, 2018. TFDA referred to the management regulations in European
Union, ASEAN and China, and enacted the "Regulations on the Management of Barium in
Cosmetics" on March 28, 2018. In addition, we referred to the management regulations of hair
dyes in the EU, China and Japan, and announced the revise of the hair dye ingredients and the
precautions for the use of hair dye stipulated in the "Standard for Cosmetics Containing Medical
or Poisonous Drugs" on April 3, 2018.

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In the "Regulations on the Residue Limit for Impurity Heavy Metal Cadmium Contained
in Cosmetics" announced and amended by TFDA, the residue amount of heavy metal cadmium
contained in the final product was amended from 20 ppm to 5 ppm for the reason that the
cosmetics may contain natural residue in trace amount of heavy metal cadmium due to the
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announced the "Regulations on the Management of Barium in Cosmetics" to regulate the

ingredient Barium salts (except for barium sulfate, barium sulfide and pigment insoluble
barium salts, lakes and pigments), which are harmful to human health and must not be added to
cosmetics. In addition, we announced the revise of the hair dye ingredients and the precautions
for the use of hair dye stipulated in the "Standard for Cosmetics Containing Medical or
Poisonous Drugs", to ensure the health and safety of consumers.

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