Korea | Partial Revision of the Health Functional Food Code (No. 2020-42)
The Ministry of Food and Drug Safety, Korea (MFDS) announced partial revisions for the "Standards and specifications of health functional food" (hereafter referred to as the "Health Functional Food Code") under notification no. 2020-42 on May 28, 2020.
Reasons for revision
The content range of the functional ingredient (or indicator ingredient) among the manufacturing standards of the functional ingredients is set to reflect the advanced manufacturing technology so that it can be manufactured with a suitable ingredients if it is at least the minimum content and remove the provisions for the product form of propolis extract related to the functional content of oral antibacterials; the phrasing of the precautionary statement of saw palmetto fruit extract when ingested with pharmaceuticals shall be changed to include only those for which potential causual risks have been reported; the functional content and daily intake of chito-oligosaccharides recognized as individually recognized ingredients shall be added to the specifications and standards of the relevant notification type ingredient to expand the scope of approval, and the general rules and standards for health functional foods are changed in accordance with the relevant notices. Additionally, improvements shall be made in areas where the raw materials used in the manufacture of functional raw materials are unclear or the prescribed phrases are difficult to understand. The MFDS also seeks to complement and improve operational inadequacies, such as clarifying the application of the standards and specifications of health functional foods by revising the health functional foods test methods through the reconciliation of the notice contents and terminology related to other regulations.
Main Revisions
1) Clarification of "Health Functional Food Code'' provisions (Article 1., 1. 1), 2. 3), 3. 1), 4.)
a) Necessity to revise the contents in accordance with the relevant notices as the Health Functional Food Code is described in the General standards and specifications of Health Functional Food Act.
b) Revision of the terms of the Health Functional Food Code to the relevant notification name and align it with the scope covered by the 「Health Functional Food Act」.
c) Clarification of the general provisions of the notification.
2) Delete the content range of functional ingredients (or indicator ingredients) (Articles 3. 2. 2-1∼2, 2-7, 2-10∼15, 2-23∼24, 2-27∼28, 2-58∼59, 2-64∼68)
a) If the content range of the functional ingredient (or indicator ingredient) is set, the raw material cannot be used even if the manufacturing technology develops and the raw material beyond the content range can be manufactured.
b) Amend the content of functional ingredients (or indicator ingredients) to a minimum amount.
c) Expand the scope of ingredients that can be used as functional ingredients.
3) Amendment to the final product requirements for propolis extracts (Article 3. 2. 2-8)
a) Propolis extracts related to antibacterial action in the oral cavity can be manufactured only in the form of sprays, tinctures, and chewable soft capsules.
b) If it is in a form that can be directly in contact with the oral cavity, it may exhibit oral antibacterial activity.
c) Vitalization of product production as it can be manufactured in various product forms.
4) Amendment of precautionary statement when taking saw palmetto fruit extract (Article 3. 2. 2-28)
a) There is a concern that among the precautionary statement when ingesting saw palmetto fruit, it is described as pharmaceuticals other than anticoagulants, it could be interpreted in an expanded manner to include all pharmaceuticals.
b) Revision of wordings for the combined use of pharmaceutical by indicating 'etc.' along with the pharmaceuticals for which potential causual risks have been reported.
c) Communication of precautions required by consumers when ingesting concomitant medications.
5) Addition of approval of chito-oligosaccharides (Article 3. 2. 2-49)
a) If the functional content, etc., are additionally recognized as a notification type ingredient, it shall be registered as the specifications and standards of the notification type ingredient.
b) Revision of specifications and standards to reflect the approval details of chito-oligosaccharides recognized as individually recognized ingredients in the relevant notification type ingredients.
6) Clarification of contents of "Health Functional Food Code'' (Article 3. 2. 2-9, 2-19, 2-21, 2-32, 2-51, Article 4. 3. 3-1-2, Article 5.)
a) Necessity to improve as the sunset deadline is not set in the relevant notice; and the raw materials used in the manufacture of functional raw materials are unclear or the prescribed phrases are difficult to understand.
b) Amendment to specify only the ingredients used for the production of functional ingredients, simplify of difficult phrases, unify the relevant contents in the relevant regulations and establishment of the sunset deadline.
c) Increased understanding of consumers and business operators by clarifying the Health Functional Food Code.
7) Sychronization of other regulations related terms and terms (Articles 3. 1. 1-2, 1-4, 1-14, 2., 2-4-5, 2-9-16, 2-24-30, 2- 49, 2-54 ~ 67, [Table 4], Article 4. 1. 1-2, 3., 3-12, 3-14, 3-34)
a) Necessity to improve among the health functional foods as there are parts that apply the same or differently expresses the terminology used in ``Korean Food Code '' and `` Korean Food Additives Code''.
b) Reflection of the notices and terms used in other regulations, uniformly.
c) Systematic provision of regulations by standardzing the content and terms of related regulations.
8) Revision of test methods (Articles 4. 3. 3-29, 3-34 ~ 35, 3-45, 3-51, 3-54, 3-56, 3-64, 3-66, 3-71)
a) Necessity to revise test methods such as the improvement of sample collection amount, pre-treatment method and analysis condition etc.
b) Improvement of test methods for 10 kinds of chitosan, phosphatidylcholine content in phospholipids, cholesterol, astaxanthin, total monocholine K, ginsenoside, total peoporbide, PGG, theanine, anthocyanide.
c) Efficient and accurate analysis through revision of test methods.
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