Japan Amends Quasi-drug Ingredients Standard 2006

On September 11^th, Japan Ministry of Health, Labour and Welfare (MHLW) issued a notice to amend the specifications of 48 ingredients in the Japanese Standards of Quasi-drug Ingredients 2006 (JSQI, please refer to Cosme-List for all the lists). The revisions were promulgated on September 11, 2019. A 1.5-year grace period which will end on March 31, 2021 was granted for stakeholders to prepare for enforcement of the new requirements.

Revisions to the JSQI

The 48 amended ingredients are:

1. Dicocoyl Dimethyl Ammonium Chloride

2. N-[2-Hydroxy-3-(cocoalkyldimethylammonio)propyl] Hydrolyzed Keratin Chloride

3. N-[2-Hydroxy-3-(cocoalkyldimethylammonio)propyl] Hydrolyzed Wheat Protein Chloride Solution

4. N-[2-Hydroxy-3-(cocoyldimethylammonio)propyl] Hydrolyzed Collagen Chloride

5. N-[2-Hydroxy-3-(cocoalkyldimethylammonio)propyl] Hydrolyzed Silk Chloride Solution

6. N-[2-Hydroxy-3-(cocoalkyldimethylammonio)propyl] Hydrolyzed Soybean Protein Chloride Solution

7. Glyceryl Caprylate/Caprate/Cocoate

8. Sodium Hydrogenated Glyceryl Cocoate Sulfate

9. Higher Fatty Acid Pentaerythritol Citrate・Beeswax・Nonion Emulsifying Mixture

10. Polyethylene Glycol･Epichlorohydrine･Cocoalkyl Amine･Dipropylene Triamine Condensate Solution

11. Polyoxyethylene Glyceryl Monococoate

12. Polyoxyethylene Cocoalkyl Amine

13. Polyoxyethylene Cocoalkyl Dimethyl Amine Oxide Solution

14. Polyoxyethylene Coconut Fatty Acid Amide (5E.O.)

15. Disodium Polyoxyethylene Coconut Fatty Acid Isopropanolamide Sulfosuccinate Solution

16. Polyoxyethylene Glyceryl Monococoate

17. Polyoxyethylene Coconut Fatty Acid Monoethanolamide Sodium Sulfate Solution

18. Polyoxypropylene Coconut Fatty Acid Monoisopropanolamide (1P.O.)

19. Condensate of Methylsilanol and Polyoxyethylene Glyceryl Monococoate

20. Cocoalkyl Dimethyl Amine Oxide Solution

21. Cocoalkyl Dimethyl Glycine Solution

22. Magnesium･Triethanolamine Coco Sulfate Solution

23. Potassium Cocoyl Soap Solution

24. Coconut Fatty Acid

25. DL-Pyrrolidonecarboxylic Acid Salt of N-Cocoyl-L-Arginine Ethyl Ester

26. Potassium N-Cocoyl-Hydrolyzed Yeast

27. Sodium N-Cocoyl-N′-Carboxyethyl-N′-Hydroxyethyl Ethylenediamine

28. Disodium N-Cocoyl- N′-Carboxyethoxyethyl-N′-Carboxyethyl Ethylenediamine Solution

29. Disodium N-Cocoacyl-N-carboxymethoxyethyl-N-carboxy methylethylenediamine Polyoxyethylene Tridecyl Sulfate Solution

30. Disodium N-Cocoyl-N-carboxymethoxyethyl-N-carboxymethylethylenediamine

31. Disodium N-Cocoyl-N′-Carboxymethoxyethyl- N′-Carboxymethyl Ethylenediamine Lauryl Sulfate

32. N-Cocoyl-L-Glutamic Acid

33. Potassium N-Cocoyl-L-Glutamate

34. Triethanolamine N-Cocoyl-L-Glutamate Solution

35. Sodium N-Cocoyl-L-Glutamate

36. Coconut Fatty Acid Amide

37. Cocoyl Amide Propyldimethyl Glycine

38. Cocoyl Amide Propyldimethyl Glycine Solution

39. Sodium Cocoyl Ethyl Ester Sulfonate

40. Hydrolyzed Collagen Cocoate Solution

41. Coconut Fatty Acid Diethanolamide

42. Sodium Cocoyl Taurate

43. N-Cocoyl-N-methyl-β-alanine

44. Sodium Cocoyl N-Methyl β-Alaninate Solution

45. Coconut Fatty Acid N-Methylethanolamide

46. Potassium N-Cocoyl-N-Methyl Taurate Solution

47. Sodium N-Cocoyl-N-Methyl Taurate

48. Magnesium Cocoyl Methyl Taurate Solution

Revisions to the approval of quasi-drugs

Along with the revisions to the specifications of quasi-drug ingredients, the relevant application for quasi-drugs manufacturing and marketing licenses has been modified accordingly.

• As per the Notice, for quasi drugs containing one of the 48 ingredients and which are newly manufactured in line with the amended specifications, stakeholders shall comply with new rules and apply for manufacturing and marketing licenses. This requires applicants to select “Japanese Standards of Quasi-drug Ingredients (‘外原規’ in Japanese)” in the “Ingredient and Content” column of the application form, instead of filling the specific specification of ingredients as per previous requirements.

• In cases where stakeholders have products which contain any of the 48 ingredients and have already applied for or obtained a manufacturing or marketing license under the old specifications, the application or license will be valid until the end of the grace period.

• Stakeholders shall apply for slight modification to prepare for the new specifications. An application form of slight modification shall be submitted before March 31, 2021. In the remark’s column it should be indicated that “The application is made on the basis of the No.1 Notice issued by Japan MHLW on the partial revisions to the Japanese Standards of Quasi-drug Ingredients 2006”.Besides, an additional paper shall be attached indicating the specification and experimental methods of the ingredient in the Japanese Standards of Quasi-drug Ingredients 2006.