Public Announcement No. 2019-67 by the Ministry of Food and Drug Safety Regulations on Substantiation of Claims in Labeling or Advertising of Foods July 30, 2019 1. Reason of Establishment These Regulations aim to substantiate claims in labeling and advertising of foods, and protect consumers from unfair labeling and advertising by establishing details such as the requirements for substantiating information and methods, as delegated under the Act on Labeling and Advertising of Foods (Act No. 15483, March 13, 2018) and Article 9 of the Enforcement Rules of the same Act (Ordinance of the Prime Minister No. 1535, April 25, 2019). 2. Main Contents A. General Requirements for Substantiating Information (Article 3) 1) It is necessary to induce those who label or advertise foods to make appropriate labeling and advertising by presenting an association between the claims in the food labeling or advertising and the substantiating data. 2) When a person tries to substantiate his/her claims in the labeling or advertising, he/she shall provide information directly related to the claims in the labeling or advertising. 3) It is expected to increase the objectivity and efficiency of substantiating labeling and advertising of food, etc. and contribute to consumer protection. B. Requirements for Test Results (Article 4) 1) It is necessary to set basic requirements such as human and physical resources and test inspection methods, etc. when substantiating claims in food labeling or advertising with test data. 2) When substantiating claims in food labeling or advertising, a reliable testing agency shall conduct the substantiation objectively. 3) The objectivity and reliability of test data are expected to be secured by specifying the requirements for test data. C. Requirements for Investigation Results (Article 5) 1) It is necessary to define the requirements for data that can be recognized as a reasonable basis when substantiating claims in labeling or advertising with an investigation result. 2) An independent investigation body capable of conducting the investigation shall conduct the investigation, and the related procedures and methods shall be appropriate and fair. 3) The objectivity and reliability of substantiating data are expected to be secured by specifying the requirements for review results. D. Requirements for Experts’ Opinion (Article 6) 1) It is necessary to define requirements for data that can be recognized as a reasonable basis when substantiating claims in food labeling or advertising with an expert’s opinion. 2) The expert’s opinions shall be based on his/her field of expertise, and the related procedures shall be formal and objective. 3) The objectivity and reliability of substantiating data are expected to be secured by specifying the requirements for expert’s opinions.