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On April 30th, 2019, MFDS released 3 notices officially opening the public consultation period on draft regulations related to health functional food. Here are the details.
1. Standard and Specification of Health Functional Food (MFDS Notice No. 2019-229 [1])
Main content:
International units were newly added to describe the daily intake of vitamin A, D and E. Eg: “3∼10 ㎍” was revised as “3∼10㎍(120～400 IU)”.
The daily intake of glucosamine was changed from “1.5~2g” into “1.5g”.
Residual solvent testing of evening primrose seed extract was revised.
Rancidity management of oil and fat was newly added.
Functional terminology permitted to be used on “garcinia cambogia” products was changed to “could” help to lose body fat.
Revision of the testing methods of glucosamine, catechin, etc. The testing items of the content of 10-HAD, testing method of alpha-amylase, etc were deleted.
Contact info:
Any feedback shall be submitted to MFDS prior to July 1, 2019.
Tel: +82- 043-719-2443
Fax: 043-719-2400
2. Food Circulation Period: Food Additive, Livestock Products and Health Functional Food (MFDS Notice No. 2019-227 [2])
Main content:
Complying with subparagraph 4 of Article 12, health functional foods can be exempted from tests and can enjoy the same circulation period of similar products whose circulation period have been approved already.
The scope of comparative objects (similar products whose circulation period were approved) was expanded from “new products” to “current products”.
Contact info:
Any feedback shall be submitted to MFDS prior to May 20, 2019.
Tel: +82- 043-719-2448
Fax: 043-719-2400
3. Regulations on Recognition of Raw Materials, Criteria and Standards for Health Functional Foods (MFDS Notice No. 2019-224 [3])
Main content:
The scope of intake assessment materials was expanded to the circulation and sales materials of food products sold domestically or abroad. Circulation and sales material of food products sold abroad shall be submitted to the authority along with the authentication materials offered by foreign countries.
Provided that the health functional food products are confirmed as being substantially different from pharmaceutical drugs as substantiated by submitting relevant certificates, etc., it is not necessary to submit materials related on the active functional ingredients.
Materials, requirements and assessment items of children’s functional food were specified.
Food products which contain unapproved functional ingredients as the raw material can not apply for certification.
Contact info:
Any feedback shall be submitted to MFDS prior to June 30, 2019.
Tel: +82-043-719-2439
Fax: 043-719-2400
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