(1) Reasons for Proposal

As the Health Functional Foods Act has been amended to ensure reporting to the Minister of Food and Drug Safety when a salesperson, etc., becomes aware of an abnormal case (Act No. 16715, promulgated on 12. 3. 2019, to be enforced on 6.4. 2020), the Enforcement Rule aims to determine the matters delegated under the Act such as the method of reporting abnormal cases and the measures needed to enforce it, and to clearly define the training time for quality control managers appointed to the manufacturers of functional foods for health from the current 6 hours or less to 16 hours for new training and 6 hours for refresher training, thereby remedying some of the inadequacies revealed in the operation of the current system. 

(2) Major Provisions

A. Report within 15 days after the end of each quarter by filling in the Form 27-2, if a person who sells functional foods for health, etc., becomes aware of abnormal cases arising from having such functional foods for health; provided, however, that such case be reported within 15 days from the date he/she becomes aware of severely abnormal cases such as causing death or threatening life (Article 12-2)

B. Prescribe 16 hours for new training, and 6 hours for refresher training to strengthen practical training in quality control for newly appointed quality control managers, though the current Act provides that quality control managers appointed to the manufacturers of functional foods for health should receive less than 6 hours of new and refresher training (Article 19)

C. Deregulate to ensure that the outer packaging process for the product which completed the inner packaging of the functional foods for health is contracted out to food manufacturing and processing businesses in step with the release of various types of products and trend changes (attached Table 1, Facility Standard by Business Category, attached Table 4. Terms of Compliance by Salesperson)