Japan Cosmetic Regulatory Updates: January to July 2019

Japan made several amendments to its cosmetic’s regulatory framework in the first 7 months of 2019.

1. Japan expands the scope of UV Absorbers for cosmetics ^[1]

On March 20, Japan Ministry of Health, Labour and Welfare (MHLW) officially approved the amendments to the positive list of UV absorbers in the Standards for Cosmetics with the addition of a new UV absorber and its maximum limit.

Specifics of the new UV absorber are as follows:

Ingredient name	Maximum amount (g) of ingredient per 100g
Ingredient name	Cosmetics not used for mucosa and to be washed away	Cosmetics not used for mucosa and not to be washed away	Cosmetics that may be used for mucosa
2-methylphenyl 4-methoxycinnamate (４－メトキシケイ皮酸２－メチルフェニル)	10.0	10.0	Prohibited

2. Japan adopts a new alternative animal testing method for the safety assessment of cosmetics and quasi drugs ^[2]

On June 24, Japan MHLW issued technical guidance on the use of the Reconstructed human Cornea-like Epithelium (RhCE) test method (OECD Test Guideline 492) as a new alternative to the eye irritation test of quasi drugs and cosmetics.

The guidance specifies the experimental principle, preparation, procedure, determination results, etc. Since there are several models of the RhCE method, the explanations of eye irritation test method for each model are also included in it.

3. Japan updates quasi-drug manufacturing/marketing license application template ^[3]

On July 4, Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued a notice updating the template originally issued on Dec. 8, 2015.

The previous template consisted of 5 parts:

Chapter 1 Items except for manufacture methods and specifications
Chapter 2 Manufacture methods
Chapter 3 Specifications and test methods
Tables of the precedents
Additional documents

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