(1) Reasons for Proposal
The amendment aims to strengthen the safety management of cosmetics by adding “Pigment Red No. 5,” one of the materials of beauty soaps, which are currently classified as an industrial product, to the list of color additives for cosmetics to continue to use it even after the conversion of beauty soaps to cosmetics on December 31, 2019, and by prohibiting the six types of color additives including “Orange No. 201 (Dibromofluorescein)” from being used around the eyes in consideration of the results of the ocular mucosal stimulation test performed by the National Institute of Food and Drug Safety Evaluation and the regulatory trends in foreign countries.
(2) Major Provisions
A. Add color additives available to use in preparation for the conversion of beauty soaps to cosmetics (attached Table 1)
Newly add "Pigment Red No. 5,” which is currently used in the production of beauty soaps, to the list of color additives for cosmetics and allow restrictively using the color additive in beauty soaps so that there will be no disruption in the conversion of beauty soaps (from Dec. 31, 2019), which are managed as industrial products, to cosmetics.
B. Restrict the use of six color additives that may stimulate the mucous membranes of the eye (attached Table 1)
Restrict the use of the six types of color additives including “Orange No. 201”, which may stimulate the mucous membrane of the eye, to prohibit using them around the eyes, referring to the results of the ocular mucous membrane stimulation test conducted by the National Institute of Food and Drug Safety Evaluation and the U.S. regulatory trends.
C. Expand the range of color additives that cannot be used in cosmetics for children (attached Table 1)
Aim to strengthen the safety management of cosmetics for children by prohibiting two types of color additives including “Red No. 102”, which are prohibited to use in products for infants and babies due to safety concerns, from being used even in products for children.