(1) Reasons for Proposal
The Amendment reflects hazard assessment results and international regulatory trends to newly designate ingredients that shall not be used in cosmetics and strengthen usage restrictions for preservatives. It also prohibits the use in cosmetics of any prohibited substance pursuant to the Act on Registration, Evaluation, etc. of Chemicals, thereby aiming to ensure the safety of cosmetics and protect national health. The Amendment also improves the methanol test and microbial limit test method for the safety control of distributed cosmetics, and modifies or corrects a number of terms.
(2) Major Provisions
A. Add to the list of prohibited ingredients for cosmetics “nitromethane,” for which in-house hazard assessment results have not established a safety margin; three fragrance materials for which in-house hazard assessment results have not established a safety margin and the use of which has been prohibited in Europe; and “prohibited substances” designated under Article 2, subparagraph 9 and Article 27 of the Act on Registration, Evaluation, etc. of Chemicals (attached Tables 1 and 2)
1) Delete from the list of restricted ingredients (attached Table 2) “nitromethane,” currently a restricted ingredient (limit of 0.3%) but for which in-house hazard assessment results have not established a safety margin, and add to the list of prohibited ingredients (attached Table 1)
2) Prohibit the use of “atranol,” “chloroatranol,” and “hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC),” for which in-house hazard assessment results have not established a safety margin and the use of which has been prohibited in Europe (to be enforced in August 2019)
3) Prohibit the use of “methylene glycol” based on in-house safety assessment results
4) Add to the list of prohibited ingredients “prohibited substances,” the manufacture, import, sale, storage, transportation, or use of which is prohibited under Article 2, subparagraph 9 and Article 27 of the Act on Registration, Evaluation, etc. of Chemicals
B. Strengthen usage restrictions on cosmetics preservatives to ensure a sufficient safety margin based on in-house hazard assessment results (attached Table 2)
1) Modify usage limits for cosmetics preservatives from 0.1% to 0.05% for “4,4-dimethyl-1,3-oxazolidine (dimethyloxazolidine),” from 0.2% to 0.04% for “p-chloro-m-cresol,” from 0.2% to 0.05% for “chlorophene (2-benzyl-4-chlorophenol),” and from 2% to 0.9% for “propionic acid and its salts”
2) Prohibit the use of the cosmetics ingredient (sterilization preservative) “sodium lauroyl sarcosinate” in “products containing amines or amides”
C. Improve test methods for the safety control of distributed cosmetics (attached Table 4)
1) Improve pre-treatment in the test method for methanol, a prohibited substance that may be unintentionally derived, and add mass spectrometry as a verification test upon detection
2) Improve sample pre-treatment in the microbial limit test method to account for the characteristics of formulations, and improve the culture medium performance and test method suitability test methods
D. Modify terms (Article 4, attached Table 2)
Modify terms to reflect the amendment of the term “sterilization preservative” to “preservative” in Article 8 of the Cosmetics Act (amended on March 13, 2018; to be enforced on March 14, 2019)
