Japan Revises the Approval Requirements for Quasi-drugs

The drafts of marketing approval standards of medicated oral-care products, hair dyes and permanent wave agents were approved and became effective on July 1, 2021; Enterprises can apply for the manufacture and sale permission of liquid toothpaste to the prefectural government; MHLW revised the list of permitted additives in quasi-drugs.

At the end of 2020, Japan MHLW unveiled three amendments for public consultation, proposing to amend the manufacturing and marketing approval standards of medicated oral-care products, hair dyes, and permanent wave agents. On June 28, 2021, MHLW released several announcements, which officially approved these three amendments and made some adjustments to the approval requirements for medicated oral-care products. In addition, the MHLW modified the List of Permitted Additives in Quasi-drugs. These amendments came into force on July 1, 2021.

The details of these announcements are as follows:

1. The application for liquid toothpaste can be submitted to the prefectural government

With liquid toothpaste (used for brushing teeth after spitting it out) becoming a new class in medicated oral-care product, MHLW brought corresponding changes in its approval requirements. According to the newly issued “To Revise Prefectural-government-approved Quasi-drugs”on June 28, 2021, the application for manufacture and sale permission for liquid toothpaste with the following active ingredients and efficacy claims can be submitted to the prefectural government for approval.

		Active ingredients	Concentration（%）
Ⅰ	A	Dipotassium glycyrrhizate	0.015~0.24
Ⅰ	B	β-glycyrrhetinic acid	0.03~0.2
Ⅱ	A	Cetylpyridinium chloride (CPC)	0.05
Ⅲ	A	DL-α-Tocopherol Acetate Dl-α-Tocopheryl Nicotinate	0.05~1.0 0.2

Table 1 Active Ingredients in Liquid Toothpaste

Efficacy	Active Ingredient	Notes
Prevention of periodontitis (alveolar pyorrhea)	Ⅰ, Ⅲ in table1	When the efficacy claim "Prevention of periodontitis (alveolar pyorrhea)" is approved, the product is allowed to label only "Prevention of Periodontitis" or only "Prevention of Alveolar Pyorrhea".
Prevention of gingivitis	Ⅰ, Ⅱ,Ⅲ in table 1	/
Prevention of tooth decay and its progress	Ⅱ in table 1	/
Prevention of halitosis	Ⅰ, Ⅱ,Ⅲ in table 1	/

Table 2 Efficacy Claims for Liquid Toothpaste

Besides, MHLW also revised the efficacy of solid, liquid (it can be put in mouth and brush teeth directly), powder, or paste type of toothpaste. As revealed by the revised version, "preventing tartar deposition" was modified to "preventing tartar formation and deposition", and "prevention of halitosis" was amended to "prevention of halitosis or its occurrence".

2. Regulations on heavy metals and arsenic are deleted in the Quality Specification of Permanent Wave Agents

In the newly effective "Quality Specification for Permanent Wave Agents" heavy metals and arsenic regulations have been deleted. If a permanent wave agent complies with the quality specifications for other quasi-drugs instead of the one for permanent wave agents, a partial change application needs to be submitted.

3. The List of Permitted Additives in Quasi-drugs is revised

Due to the incomplete content of No. 1002 ingredient in the List of Permitted Additives in Quasi-drugs⁵, MHLW announced to make the following modifications.

	NO.	Additives Name	English Name	Ingredient Name in the Japanese Standards of Quasi-drug Ingredients 2021
Before	1002	シクロヘキサンジカルボン酸ビスエトキシジグリコール	Bis(Ethoxydiglycol) Cyclohexane-1,4- Dicarboxylate	/
After	1002	シクロヘキサンジカルボン酸ビスエトキシジグリコール	Bis(Ethoxydiglycol) Cyclohexane-1,4- Dicarboxylate	シクロヘキサンジカルボン酸ビスエトキシジグリコール