MFDS Revises Health Functional Food Code

Newly approved functions of already approved active ingredients will not be listed in South Korea’s positive list of active ingredients and associated approved functional claims until after 3 years. This means companies that invest in R&D to substantiate the functional efficacy of an active ingredient can avail of 3 years protection for their IP. After this three years, any company can use the active ingredient within the scope specified in the government approval. The permitted and banned food additives are specified for Children’s functional foods. The principle of using more than two active ingredients is revised.

As revealed by Notice No. 2019-110 released on Nov. 25th, 2019, MFDS partially revised the Health Functional Food Code. Here’re the main revisions.

Main Revisions

Newly approved functions of already approved active ingredients will not be listed in South Korea’s positive list of active ingredients and associated approved functional claims until after three years. This means companies that invest in R&D to substantiate the functional efficacy of an active ingredient can avail of three years protection for their IP. After this three years, any company can use the active ingredient within the scope specified by the government approval.

Explanation:
For example, if company A gets a new function approved for an already approved active ingredient (i.e already listed in the Health Functional Food Code), then after three years, this new function will be added into the positive list of approved active ingredient functions specified within the Functional Food Code. After this three years other companies can begin to use that active ingredient within the scope specified within the approval without having to submit an application for approval to government.

But of course, during the three years, before the new function is finally added into the Code, company B can also apply for the approval of the same new function. If approved, company B can start production immediately.

*Supplement: It takes 6 years to add a function of a novel active ingredient into the Health Functional Food Code. Besides, the applicants must produce 50 products during the 6 years. In this way, the government can ensure the safety of the new raw material and add it into the Code.

Newly added the permitted and forbidden food additives for Children’s health functional foods.

e.g. Prohibited food additives for Children’s health functional food

Food coloring	Copper chlorophyll, iron sesquioxide, etc.
Color fixative	Sodium nitrite, sodium nitrate, etc.
Preservative	Natamycin, nisin, etc.
Food bleaching agent	sodium metabisulfite, potassium metabisulfite, etc
Antioxidant	BHT, propyl gallate, etc.
Aluminium-containing food additives	Sodium aluminium phosphate, sodium silicoaluminate, etc.
…	…

Principle of using more than two active ingredients

When using 2 or more active ingredients, once there are some overlaps in production requirements or specifications (eg. requirements of heavy metal amount, etc.), manufacturers can choose to follow the appropriate specification requirements based on the usage ratio of active ingredients.

For more translation services, please email contact@chemlinked.com.