1. Reason for Revision

With the amendment of the Hygienic Products Control Act (Act No. 19474, promulgated on June 13, 2023, effective June 14, 2025), which adds tattoo dyes and oral hygiene products such as toothbrushes and dental floss, which come into direct contact with the human body, to the types of hygienic products managed as safety-confirmed household chemical products, there is a need to establish detailed safety management measures for newly added items, such as inspection methods for imported hygienic products and the amount of free collection.
Additionally, the revision aims to improve and supplement some shortcomings in the current system, such as adjusting the self-quality inspection cycle to maintain the effectiveness of the safety management system while reducing the burden on businesses, and eliminating the deadline for hygiene education completion to reasonably ease regulations.

2. Main Content

a. Clarification of Business Change Report Period (Amendment of Article 4)
The period for reporting changes in business registration details is explicitly set to within 30 days from the date of change.
b. Expansion of Pre-Import Clearance Scope for Imported Hygienic Products (Amendment of Article 13, Appendices 2 and 7)
For imported hygienic products that include specific inspection items requiring extended time for testing, conditional pre-import clearance is allowed. However, if products are distributed before completing the inspection, stricter penalties will be applied, thus alleviating the burden on businesses while ensuring compliance.
c. Relaxation of Hygiene Education Completion Period Requirements (Amendment of Article 16)
If a hygienic products business operator has already received hygiene education, they will not be required to undergo the same training again if they wish to engage in additional hygienic product business activities, thus relaxing regulations.
d. Relaxation of Self-Quality Inspection Cycle for Hygienic Products (Amendment of Article 18, Appendix 5)
Considering the minimal quality changes in hygienic products due to manufacturing environments, the self-quality inspection cycle is relaxed: for items subject to manufacturing reports, inspections will be required every 6 months, and for other hygienic products, inspections will be required every 12 months, thereby reducing the burden on businesses.
e. Import Inspection Requirements and Free Collection Amounts for Tattoo Dyes and Oral Hygiene Products (Appendices 3 and 6)
For newly included items, regulations on business compliance will be established based on the same operational requirements for imported hygienic products. The number of precise inspections will be adjusted, and the minimum free collection amounts will be defined according to inspection items and methods.