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Japan PMDA, Regulatory revision on the special labeling of specific ingredients in cosmetics

JNM Global 제이엔엠글로벌 2025. 4. 10. 10:34

On March 10, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) announced a regulatory revision regarding the special labeling of specific ingredients in cosmetics. Through this notification, the long-standing regulation in place since 1985 has been repealed, and the rules concerning the labeling and advertising of specific cosmetic ingredients have been revised.

 

The key points of the revision are as follows:

Special labeling of specific ingredients refers to the indication of particular ingredients among those contained in a product. As such labeling may cause consumers to mistakenly believe that the ingredient is an active or medicinal component, it should, in principle, be avoided. However, it is permitted only in cases where the special labeling is based on the conditions outlined below.

 

1. Precautions

- When a specific ingredient is specially labeled, its purpose of inclusion must also be clearly stated. Furthermore, the stated purpose must be based on the cosmetic products functions, effects, or formulation technology, and must be objectively substantiated.

- Even when a specific ingredient is represented through images or design elements (including English terms), the ingredient name must still be indicated together with its purpose, using a format such as: [OO (ingredient name), △△ (purpose of inclusion)].

 

2. Cases where special labeling is not permitted

- When the name of a specific ingredient includes the character “medicine or drug ()”. Ex) Crude drug extract (エキス), medicinal herb extract (草抽出物), extract of medicinal plants (用植物のエキス)

- When the labeling may give the impression that the product is a pharmaceutical. Ex) Kampo ingredient extract (漢方成分抽出物)

 

Please refer to the attached document below.

20250310_1 (PMDA_Cos).pdf
0.17MB


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