1. Reason for the Amendment
1) In accordance with the amendment to the "Sanitary Products Management Act" (Law No. 19474, June 13, 2023), oral care products such as toothbrushes and dental floss, which are manufactured for the purpose of promoting and maintaining oral health, have been added to the types of sanitary products. This amendment aims to establish individual standards, specifications, and testing methods for oral care products.
2) In addition, tattoo dyes, which are substances used for creating patterns on human skin (skin pigmentation materials), have been added to the types of sanitary products. This amendment aims to establish individual standards, specifications, and testing methods for tattoo dyes.
3) To improve the efficiency of testing, the amendment allows the use of ready-made standard products, which are manufactured for easy use with standard solutions, making the testing process more efficient.
2. Key Provisions
1) New and Strengthened (Regulated):
Based on safety standards and industrial standards (KS standards) for children's (general use) toothbrushes, etc., implemented under the "Children's Product Safety Act" and the "Industrial Standardization Act," the amendment specifies the "Manufacturing Standards and Specifications" for toothbrushes (including interdental toothbrushes), dental floss, and tongue scrapers in the individual standards, specifications, and testing methods for oral care products (Article 3, 20).
2) Abolition and Relaxation (Unregulated):
a. In accordance with the previous Ministry of Environment’s safety standards notice, the individual standards, specifications, and testing methods for tattoo dyes will be specifically defined (Article 3, 21, 5, 42, 43, 44, 45, and 46).
Additional instructions on testing procedures to check compliance with standards for substances like content-limited materials in tattoo dyes.
b. The individual standards, specifications, and testing methods for oral care products will be specifically defined (Article 3, 20, 5, 34, 35, 36, 37, 38, 40, and 41).
Additional instructions on testing procedures to check compliance with individual specifications, in line with the previous children's product safety standards.
c. General principles for the use of ready-made standard products for heavy metals and other substances [Article 1, 3, 27].
Improved use of ready-made standard products designed for easy use with standard solutions to enhance the efficiency of testing for heavy metals.
