1. 

As the Act on Assessment of Hazard of Human-Applicable Products was established and disseminated  (Act No. 18365, July 27, 2021) for the comprehensive assessment and control of influences of harmful factors in various consumable consumer products such as foods and drugs on human health and physical bodies, it stipulates that hazard assessment and safety controls be performed systematically and efficiently by preparing the following matters: additional designation of consumable consumer products, detailed procedure to establish a master plan and yearly execution plan, forming  and operating the Hazard Assessment Policy Committee and Professional Committee, and conditions, methods, and procedures for requesting hazard assessment, pertaining to the Act and the matters needed to be addressed.

2.

A. Additional designation of consumable consumer products (Article 2 of draft)

1) Products which were chosen to be controlled under MFDS by the Product Safety Policy Council in accordance with Article 7-2 of Framework Act on Product Safety are included in consumable products.

B. Preparation of detailed procedure to establish a master plan and yearly execution plan thereof (Article 3 of draft)

1) Establishing and amending a master plan and execution plan shall be notified to the head of relative central government agency.

2) Execution plan shall be established until December 31 in the previous year of enforcement and the matters to be included in the execution plan are prescribed.

C. Regulation on the matters required for forming and operating the Hazard Assessment Policy Committee and Professional Committee (Article 4 through Article 10 of draft)

1) Ex-officio members in the members of the Hazard Assessment Policy Committee (hereinafter referred to as the Committee) are Grade 3 or higher level public officials of the Ministry of Agriculture, Food and Rural Affairs, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, the Ministry of Environment, the Ministry of Maritime Affairs and Fisheries, and MFDS designated by the respective heads.

2) The matters on tenure of the members of the Committee and Professional Committee and the matters on operation of the Committee and Professional Committee such as convocation, attendance, quorum, exclusion, avoidance, withdrawal of designation, and dismissal are hereby prescribed.

D. Preparation of the range, method, and procedure to disclose the results of hazard assessment (Article 11 of draft)

1) The methods to disclose hazard assessment results, the temporary prohibition and release thereof, and the safety standard for human exposure are determined.

2) The matters required for the disclosure procedure are decided by the head of MFDS.

E. Preparation of the condition, methods, procedure to request a hazard assessment (Article 12 of draft)

1) “Consumers not less than fixed number decided by Presidential Decree” to request a hazard assessment is determined as five (5) consumers.

2) Condition for consumer groups and consumers to request a hazard assessment, documents to be submitted, cases not selected as the subjects of a hazard assessment, and result notification method are prescribed herein.

F. Prescribing the matters on the construction and operation of computer systems (Article 13 of draft)

1) The head of the National Institute of Food and Drug Safety Evaluation may construct and operate the “Comprehensive control system for human hazard assessment” as an information processing computer system to collect, analyze, and use the information from a hazard assessment and may construct, operate, integrate, and manage statistical data on information on toxicity tests, toxicity, and a hazard assessment result.

G. Some authority of the head of MFDS is delegated to the heads of corresponding agencies (Article 14 of draft)

1) The head of MFDS delegates the authority for entry, investigation, and collection to the heads of district MFDS under Article 12 of the Act.

2) The head of MFDS delegates the authority for the performing a hazard assessment & toxicity tests, constructing and operating computer systems, conducting education and PR, cultivating staffers’ expertise, and pursuing international cooperation to the head of the National Institute of Food and Drug Safety Evaluation under Article 8.5, Article 10, Article 11, and Article 18 through Article 21.

H. Prescribing the matters needed for the heads of MFDS and the National Institute of Food and Drug Safety Evaluation to delegate whole or part of the work (Article 15 of draft).

1) The agencies and groups to which the heads of MFDS and the National Institute of Food and Drug Safety Evaluation delegate authority are prescribed.

2) The range of work to be delegated by the head of the National Institute of Food and Drug Safety Evaluation to agencies or groups based on the authority delegated by the head of MFDS is prescribed.

3) When the heads of MFDS and the National Institute of Food and Drug Safety Evaluation delegates authority, corresponding agencies/ groups and delegated responsibilities shall be publicly notified.

I. Prescribing the matters on processing of sensitive information and personal ID information for privacy protection (Article 16 of draft).

1) Unavoidable cases to process the data containing sensitive information and personal ID information during a hazard assessment are prescribed.