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MFDS to Reduce Regulatory Compliance Burden on Functional Food Sector

New regulations will make it easier for food manufacturers to access Korea’s functional food markets.

On May 16, 2019, MFDS submitted 13 new regulations schemes designed to reduce the regulatory burden on emerging industries. This included 4 schemes for health functional food and 1 for online food [1]. Here are the details:

1. Help excellent food manufacturers gain GMP Certification

In order to help food manufacturers who earned HACCP certification to apply for manufacturing license and GMP certification of health functional food, MFDS will revise Good Manufacturing Practice for Health Functional Food by December 2019. The amendments will focus on reducing unnecessary red tape, and cut down on the unnecessary submission of duplicate information, all of which should significantly decrease application review time and approval times.

According to data released by MFDS, up to September 2018, only 260 enterprises have got GMP certification for health functional food due to the high cost and long review time, while 10,659 enterprises have earned HACCP certification.

2. Pharmaceutical ingredients can be used in the manufacture of health functional food

Once the safety and function of pharmaceutical ingredients have been substantiated, they can also be used in the production of health functional food in South Korea. On April 30th, 2019, MFDS has consulted on Standard and Specification of Health Functional Food [2] already and it will be officially released before September 2019.

3. Circulation and sales material of food products sold abroad are recognized in South Korea

MFDS will revise Regulations on Recognition of Raw Materials, Criteria and Standards for Health Functional Food by September 2019. And circulation and sales material of food products sold abroad within the last five years can be used as intake assessment materials in South Korea in future. Read more about its draft for soliciting opinions [3] in ChemLinked.

4. The foods sold online as packs do not require labels on the outer package

Currently, the labeling info of each individual product shall be printed on the outer package when they are sold as a whole pack. In future, it is not necessary anymore for consumers can see the labeling info on webpage clearly. MFDS will release an administrative measure this year.

5. Compliance procedure for the alteration of previously registered functional food simplified

Previously alteration of a functional food formula, for example changing an ingredient required submission of a new registration application. MFDS plans to revise relevant implementation rules of health functional food to simplify this compliance procedure.

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