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Government Legislation

  • Partial amendment to the Standards and Specifications for Health Functional Foods (Regulations)
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2019-04-29
    • Opinion Submission Deadline : 2019-06-30

(1) Reasons for Proposal
The amendment aims to supply safe and functionally verified health functional foods to the public by strengthening and establishing new precautions for consuming of vitamin D, EPA and DHA-containing oils and fats, saw palmetto fruit extract, glucosamine, and fructooligosaccharide, by adding anisidine value and total oxidation value specifications of EPA and DHA-containing oils and fats and related tests, by providing the specifications for arsenic of glucosamine, and by changing the functional content of fructooligosaccharide, according to the results of reevaluation of health functional foods in 2018.


(2) Major Provisions
A. Strengthen and establish new precautions for consuming (Article 3. 1. 1-3, Article 2. 2-16, Article 2-28, Article 2-30, and Article 2-50)
(1) The results of 2018’s reevaluation of health functional foods suggested providing precautions for the consumption of vitamin D, EPA and DHA-containing oils and fats, saw palmetto fruit extract, glucosamine, and fructooligosaccharide.
(2) Add and newly insert precautions for consumption of these products.
(3) Provide consumers with accurate safety information when purchasing and consuming products.

B. Additionally establish the rancidity management standards for EPA and DHA-containing oils and fats (Article 3. 2. 2-16)
(1) It is necessary to manage rancidity for products of EPA and DHA-containing oils and fats.
(2) Additionally insert specifications for anisidine value and total oxidation value.
(3) Improve confidence in health functional foods by supplying rancidity-managed products to consumers.
C. Revise the specifications for the heavy metal of glucosamine (Article 3. 2. 2-30)
(1) The results of 2018’s reevaluation of health functional foods suggested providing the specifications for total arsenic of glucosamine
(2) Additionally add specifications for the heavy metal of glucosamine.
(3) Supply safer health functional foods by strengthening the heavy metal standard management.

D. Revise the functional content of fructooligosaccharide (Article 4. 2. 2-50)
(1) The results of 2018’s reevaluation of health functional foods suggested changing the functional content of fructooligosaccharide.
(2) Delete functionality of “can prevent harmful bacteria and help to absorb calcium” in functional contents, which were not verified.
(3) Improve consumer confidence by supplying health functional foods by confirming accurate functional contents.

E. Newly insert a test method (Article 4. 2. 2-6, 2-6-1)
(1) Since a specification is newly inserted to manage the rancidity of EPA and DHA-containing oils and fats, it is necessary to establish a test method.
(2) Newly establish a test method for EPA and DHA-containing oils and fats.
(3) Perform to manage the specification set for anisidine value due to establishing a test method.


Regulatory effect assessment
  • 20180418_규제영향분석서(규제).hwp [download]
Legislative proposal (draft)
  • 20190415_「건강기능식품의 기준 및 규격」 일부개정고시안(규제).hwp [download]