The List of Additives for Quasi -drugs was partially revised by Japan Ministry of Health, Labor and Welfare on Dec.23 2022. The Additives list (hereinafter referred to as “additives list”) is attached, please see below.
Please keep this in mind and inform the related companies under your jurisdiction.
Japan Partial Revision of the List of Additives for Quasi-drugs
Record
1 In the additive list, serial number 1172 “Stearyldimethylamine”, serial number 2323 “Methylrosa “ Nirin chloride” was deleted.
2. Serial No. 798 “Synthetic Zeolite”, Serial No. 1341 “Sodium Thiosulfate (Anhydrous)”, Serial No. 1488 “Trichlorohydroxydiphenyl Ether” and Serial No. 1541 “Monohydrogen Dicarbonate’s “Additive name”, “ingredient code”, “English name” and “ingredient name in JIS 2021” of “trisodium” are revised accordingly to serial number 63, serial number 2342, serial number 2342, No. 1251, Serial No. 2279, Serial No. 1485, and Serial No. 1259
3. The “English name” of “Bron Maleic Anhydride Copolymer” should be corrected to the “English name” of serial number 590 and serial number 2323 in the list respectively.
4. The items deleted this time can be considered to be included in the additive list until December 31, 2022.
5. Regarding the handling of approval application forms associated with this revision, etc., please refer to PFSB Notification No. 0630004 dated June 30, 2009, “Quasi-drugs Manufacturing PFSB/ELD Notification No. 0329 No. 4 dated March 29, 2013, “Approval for manufacturing and marketing of Handling of applications, etc.”
 is attached, please see below. Please keep this in mind and inform the related companies under your jurisdiction.){kind=link}