1. Reasons for Enactment

These Regulations prescribe detailed matters necessary for risk grades and criteria required for recalls, recall plan reports, post-report measures, recalls and disposal, reports on recall results, etc. in accordance with Article 16 of the Cleansing and Hygiene Products Control Act and Article 22 and Article 22-2 of the Enforcement Rule of the same Act.

2. Major Provisions

 A. Define recall terms (Article 2)

  1) Define recall, disposal, recall operator, recall order-issuing institution, planned recall volume, recall efficiency evaluation, and other terms used in the recall procedure

 B. Prescribe an urgent non-compliance notification procedure (Article 3)

  1) Prescribe an urgent non-compliance notification procedure for testing/examination agencies and supervision/inspection agencies

 C. Prescribe risk grade criteria and grounds for determination (Article 4)

  1) Distinguish between risk grades 1, 2, and 3 according to the type of risk factor, degree of risk to health and hygiene, severity of the violation, etc.

  2) Prescribe that the recall order-issuing institution shall determine the recall grade based on the risk grade criteria

 D. Prescribe step-by-step operating procedures for administrative agencies and recall operators (Articles 5 through 10)

  1) Boost work efficiency by prescribing step-by-step operating procedures for recall orders, recall announcements, recall plan reporting and monitoring, closing reports and efficiency evaluations, corrective and preventive action, and disposal and other follow-up measures

  2) Prepare a quick and consistent recall procedure by specifying deadlines for recall orders, recall plan reporting, and closing reports and recall efficiency evaluations according to the recall grade