. /.WORLD TRADE
ORGANIZATIONG/TBT/N/KOR/44
6 December 2002
(02-6765)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   REPUBLIC OF KOREA
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Korea Food and Drug Administration
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:           
3. Notified under Article 2.9.2 [     ], 2.10.1 [    ], 5.6.2 [ X], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Cosmetics
5. Title, number of pages and language(s) of the notified document:   The public
Notification of Draft Amendment of “The regulation of evaluation on functional cosmetics,
etc.”(Available in Korean, 16 pages)
6. Description of content:   This amendment specifies the regulation of evaluation on
functional cosmetics, etc., in less restrictive manner.
- Additional tests for products with changed additives, such as colorings and fragrance,
that do not affect safety, effectiveness, criteria and testing methods among the already
evaluated items will be exempted.
- One of the requirements for the paperwork submitted to establish the functions, such as
the efficacy and effectiveness when it applies to humans, is changed to include not only
a specialist but also a person with five or more years of testing experience at research
institutes or hospitals.
- Data demonstrating the effectiveness or function of cosmetics are exempt from
submitting efficacy data only when data establishing human-tested efficacy and
effectiveness are submitted.
- The items required to submit safety test data are adjusted to the items containing five
ingredients, including tocopherol, which allows businesses to autonomously supervisethe safety tests.
- The cosmetic ingredients registered in the International Cosmetic Ingredient Dictionary
(ICID) used freely in general cosmetics are exempted from specification evaluationsexcept for those on functional ingredients and ingredients with designated mixture
limit.
- The method of SPF marking on sunscreen products was improved to allow markings in
positive numbers within the 20% range from the average test value.G/TBT/N/KOR/44
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7. Objective and rationale, including the na ture of urgent problems where applicable:
Human Health
8. Relevant documents:   KFDA Notification 2002-86, Official Gazette (2002.09.28).
9. Proposed date of adoption:
Proposed date of entry into force: }To be determined
10. Final date for comments:           
11. Texts available from:  National enquiry point [ X] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:
Pharmaceutical Safety Division,
Bureau of Pharmaceutical Safety
Korea Food and Drug Administration#5, Nokbun-dong, Eunpyung-ku Seoul,
Republic of Korea. 122-704.
Tel: +822-380.18.24
Fax: +822-359.69.65