Japan Revises the Standards for Marketing Approval of Some Quasi-drugs

The medicated oral-care products are re-classified from two to three classes, and the new regulations regarding the types, specifications and dosages of active ingredients in the new class are stipulated. The specifications of active ingredients in hair coloring agents and permanent wave agents are modified.

On Dec. 8, 2020, Japan MHLW released three amendments for public consultation, which proposes the modification of the standards for marketing approval of three kinds of quasi-drugs, namely medicated oral-care products, hair coloring agents and permanent wave agents. Any comments shall be submitted before Jan. 6, 2021.

Standards for Marketing Approval of Medicated Oral-care Products

1. Amendments to the liquid toothpaste: new classification and new requirements

Japan has made different regulations on the relevant standards for the active ingredients in various medicated oral-care products.

According to the notice, the MHLW subdivided medicated oral-care products from the original two classes into three classes:

Existing standard	Standard after amendments
Toothpaste (Paste, liquid, powder, solid)	Toothpaste [solid, liquid (it can be put in mouth and brush teeth directly), powder, paste]
mouth wash	Liquid toothpaste (brush teeth after spitting it out)
/	mouth wash

Generally, there are two ways for the use of liquid toothpaste. The first one can be in the mouth and directly used with the brush; the second one shall be spit out first and then brush teeth. MHLW puts forward the active ingredient requirements for the second one. The enterprises may need to pay more attention to active ingredients in liquid toothpaste in the future.

The types, specifications and dosages of active ingredients for the new class are as follow:

The types, standards and dosages of the active ingredient

Column	Item	Specification	Ingredient	Concentration（%）
Ⅰ	A	Q	Dipotassium glycyrrhizate	0.015～0.24
		G	Dipotassium glycyrrhizinate
	B	Q	β-glycyrrhetinic acid	0.03～0.2
		G	Glycyrrhetinic acid
Ⅱ	A	Q	Cetylpyridinium chloride	0.05
		G	Cetylpyridinium chloride hydrate
Ⅲ	A	Q	DL-α-Tocopherol Acetate	0.05～1.0
		P	Tocopherol Acetate
		Q	dl-α-Tocopheryl Nicotinate	0.2
		P	Tocopherol Nicotinate

If enterprises want to claim the efficacy listed in the following table, it must contain at least one active ingredient specified in the table's right column.

Efficacy	Active ingredient
Prevention of periodontitis	Above Table -Ⅰ, Ⅱ
prevention of gingivitis	Above Table 2-Ⅰ, Ⅱ, Ⅲ
Prevention of tooth decay and its progress	Above Table 2-Ⅱ
Prevent halitosis	Above Table 2-Ⅰ, Ⅱ, Ⅲ

2. Other amendments to the medicated oral-care products

1) It points out that the requirements for medicated oral-care products additives shall refer to the provisions of the List of Permitted Additives for Quasi-Drugs - medicated oral-care products.

2) Modifies the claims allowed

"Prevent tartar deposition" is amended to "Prevent tartar formation/deposition."
"Prevent bad breath" is amended to "Prevent bad breath (occurrence)."

Standards for Marketing Approval of Hair Coloring Agents

1. Expands the scope of active ingredients in two-dosage oxidative hair dyes;

2. Narrows the scope of the active components of oxidizing agent in oxidative hair dying agent and decoloring oxidants.

Standards for Marketing Approval of Permanent Wave Agents

1. The application method of active ingredients of permanent wave agent is further subdivided.

2. The regulations on heavy metals and arsenic in the quality specification of permanent wave agents are deleted.