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Republic of Korea - : Proposed Amendments for "Regulations for Re-assessment of Functional Ingredients"

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Republic of Korea - : Proposed Amendments for "Regulations for Re-assessment of Functional Ingredients"

Ministry of Food and Drug Safety has issued regulation which is pursuant to Article 15(2) of the "Functional Health Foods Act" and Article 20(3) of the Enforcement Rules of the Act, to establish the requirements for the standards, methods, procedures, etc. of reviewing and assessing the safety and functionality of functional ingredients (including final products) that have been previously identified, as well as of health functional foods, to the latest scientific level.

·  To set forth conditions and methods of re-assessment of functional ingredients

·  To determine matters related to the publishing of re-assessment results

·  Related data of functionality contents, including the human study, cases collected through        distribution, literature information, etc.

·  Related data of safety, including adverse event, toxicological data, cases collected through        distribution, literature information, etc.

·  To determine the scope of data of functional ingredients needed to be submitted for their re-         assessment

To determine matters needed to be taken into account in examining draft proposals for re-assessment

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

Final date for comments: 60 days from notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures before 20 February 2016, so that these can be taken up suitably.

 


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