Page 87 - 2018食藥署年報(英文版)

rights of general consumers. Meanwhile, in light of the relatively extensive scope involved
in the current amendment, cosmetics businesses are given adequate and reasonable buffer
and preparation periods in order to reduce the impacts on the industry. The Administration
will also embark on the stipulation of sub-regulations and package measures according to
the post-amended Cosmetic Hygiene and Safety Act so that the cosmetic hygiene and safety
management system in our country is even sounder and complete.

Section 6 New System for the Management of Cosmetics

Origin of Policy

The use safety of cosmetics is closely related to the general public. Related management
laws and regulations shall be constantly updated with time. On November 9, 2016, it was
announced through Presidential Order that some articles of the Statute for Control of Cosmetic
Hygiene were revised: cosmetic businesses shall not subject animals to testing when conducting
safety evaluation of cosmetics or cosmetic ingredients in our country. If the ingredient is
widely used and its function cannot be replaced by other ingredients or there are evaluation

data demonstrating the potential for harming human health, cosmetic businesses must apply
for approval with the central competent authority prior to conducting animal tests and the new
requirement would take effect on November 9, 2019.
In order to protect the health of consumers, to ensure that natural botanical ingredients
in cosmetics came from safe sources, and to promote comparable management systems in our
country to international ones, on the other hand, current requirements are revised to prohibit the
use of 15 ingredients such as Safrole in cosmetics.

As for commercial nail cosmetics, although it is used on the surface of the nail and contact
with skin or inhalation should not occur when used correctly, in light of the fact that it mostly
contains organic solvents and that there have been prior events of skin or nail lesions, as a result,
improper use and that there is the concern of inhalation of excessive organic solvents during
storage and use, in order to protect the safety of users of such products, additional information
requirement on such products is included with reference to the requirement for nail cosmetics in
the United States and the European Union.

Implementation Measures

1. To go with the amended Statute for Control of Cosmetic Hygiene announced on November 9,
2016, the Administration stipulated the Information on Applying for Animal Studies of Cosmetics

or Cosmetic Ingredients (Draft). The draft was discussed in the meeting on December 26, 2016,
and pre-announced on February 2, 2017. The “Regulations Governing the Application of Animals

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