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On August 19th, 2019, South Korean MFDS released an announcement amending Enforcement Rule of Cosmetics Act [1]. Public consultation will last until September 30th, 2019 [2]. Any suggestions can be submitted to Comprehensive Lawmaking System or mail [email protected].
The main amendments are:
1. Clarification of requirements and procedures of customized cosmetics sales registration and the details of qualification examination of customized cosmetics prescription manager.
South Korea Cosmetics Act [3] classified cosmetics business into 3 types, cosmetic manufacturing business, cosmetic responsible sale business and customized cosmetic sale business. Anyone who intends to sell customized cosmetics shall register with MFDS. Any enterprises engaged in the sale of customized cosmetics shall arrange a customized cosmetics prescription manager to carry out the dispensing and mixing of customized cosmetics. A MFDS qualification examination must be passed before dispensing activities can commence.
Customized cosmetics refers to cosmetics falling under any of the following:
Cosmetics blended the contents of cosmetics manufactured or imported with the contents of other cosmetics or ingredients prescribed by MFDS;
Cosmetics repackaged the contents of cosmetics manufactured or imported in small quantities.
2. Clarification of scope of product safety data that infant and children cosmetics shall establish and keep.
South Korea Cosmetics Act requires infant and children cosmetics to establish and keep product safety data to strengthen safety management.
3. Clarification of classification of cosmetics hazard rating.
4. Extension of the grace period for business registration information changes due to administrative zone restructuring.
5. Reduction of functional cosmetics registration review time.
| Amendments | Contents |
| Requirements and procedures of customized cosmetics sales registration | 1) Requirements for customized cosmetics sales registration: Hire a customized cosmetics prescription manager 2) Registration procedures: application to the local office --> review of registration materials --> issuance of registration certificate |
| Details of qualification examination of customized cosmetics prescription manager | 1) Time: expected to be in March 2020 2) Subject: understanding of the Cosmetics Act, manufacture and quality control of cosmetics, management on cosmetics circulation and understanding of customized cosmetics 3) Method: written test *Examination will be organized by organizations designated by the Head of MFDS |
| Scope of product safety data that infant and children cosmetics shall establish and keep | 1) Product description and manufacture method:
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| Classification of cosmetics hazard rating, recalling period and media of publishing hazardous cosmetics | 1) Classification of cosmetics hazard rating: divided into 1 to 3 levels according to the degree of harm to human body 2) Recalling period:
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| Extension of the grace period for business registration information changes due to administrative zone restructuring | From the current 30 days to 90 days |
| Reduction of functional cosmetics registration review period | 1) Applicable targets: functional cosmetics containing ingredients announced by MFDS and its concentration are consistent with MFDS requirements 2) Time period: from the current 60 days to 30 days |
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