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Government Legislation

  • Partial amendment to the Enforcement Regulations on the Health Functional Foods Act
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2019-03-19
    • Opinion Submission Deadline : 2019-04-29

(1) Reasons for Proposal
With the amendment of the Health Functional Foods Act (Act No. 16295, promulgated on January 15, 2019, and enacted on July 16, 2019), if a business entity or relevant person, without any justifiable grounds, refuses, interferes with, or evades measures such as entry, inspection, collection and access of relevant public officials or seizure and disposal for managing the hygiene of the health functional foods and maintaining business order, it becomes possible to take administrative dispositions such as suspension of business; therefore, the amendment aims to newly insert related provisions, and also, to improve and complement a number of weaknesses that have emerged in the operation of the current system such as allowing the report on revised matters of manufacturing items if a part of the recognized functions of health functional foods are deleted and newly inserting a provision of administrative dispositions for the case of violation of the order to change cautions for consuming health functional foods.

(2) Major Provisions
A. Allow the report on revised matters of manufacturing items if a part of the recognized functions is deleted (Article 9 (2))
(1) If a function is changed due to the change in the content of functional main materials or ingredients, the current Act requires a new report on manufacturing items.
(2) Since difficulties are arising, such as expiry date setting test and re-registration of tracking management of records when newly reporting manufacturing items, the amendment intends to allow reporting on revisions to matters on reporting of manufacturing items if a part of the recognized functions is deleted.

 B. Newly insert administrative disposition standards (attached Table 9)
(1) The amendment allows to take administrative dispositions such as suspension of business for a person who, without any justifiable grounds, refuses, interferes with, or evades the seizure and disposal of the health functional foods manufactured with neither entry, inspection, and collection of relevant public officials nor permission for engaging in the business of managing the hygiene of the health functional foods and maintaining business order.
(2) The amendment allows the taking of an administrative disposition if a business entity violates the order to change the mark of cautions for consuming health functional foods, which is done to the business entity when there is a possibility that hygiene is or is likely to be compromised.


Regulatory effect assessment
  • 규제영향분석서_시행규칙_행정처분기준.hwp [download]
Legislative proposal (draft)
  • 「건강기능식품에 관한 법률 시행규칙」 일부개정령안 입법예고(규제심사대상여부검토).hwp [download]