On May 20, 2026, the Pharmaceuticals and Cosmetics Safety Division of Japan's Ministry of Health, Labour and Welfare (MHLW) issued a notification, instructing prefectural and municipal health authorities to disseminate existing safety requirements for hair cosmetics containing henna and henna-derived substances.
The notification was prompted by a report released the same day by the National Consumer Affairs Center of Japan (NCAC), which documented cases of anaphylaxis linked to henna products containing oxidation dyes, with some products found to have inadequate allergy risk warnings on their packaging. CIRS Group has summarized the core content of the notification and compliance recommendations below.
Background
Henna (Lawsonia inermis) is a dicotyledonous plant of the Lythraceae family, whose leaves contain the dye component lawsone. In cosmetics, henna has long been widely used in hair coloring products.
On September 6, 2006, MHLW issued Notification Yakushoku-an-hatsu No. 0906001, requiring hair and shampoo cosmetics containing henna and henna-derived substances to display allergy warning information on their containers or outer packaging and to provide detailed instructions for conducting skin allergy tests (patch tests) in package inserts.
On May 20, 2026, the NCAC released an investigation report titled "Anaphylaxis Caused by Henna Products Containing Oxidation Dyes," which found that among the products tested, some hair products had insufficient labeling regarding usage precautions, failing to adequately warn consumers of allergy risks.
In response, MHLW issued two notifications on May 20, 2026, requesting renewed dissemination of the 2006 notification requirements with an updated regulatory cross-reference.
Precautionary Labeling Requirements
Hair cosmetics and shampoo products containing henna or henna-derived substances must display the following warnings on their containers or outer packaging:
1. Container or outer packaging warnings:
- Discontinue use if the product causes skin irritation. Individuals who have previously experienced allergic reactions to hair dyes should exercise particular caution.
- Always perform a skin (patch) test before use.
2. Package insert requirements:
- Detailed instructions for conducting the patch test must be provided in package inserts or other accompanying materials.
Transition Arrangements
The notification provides the following implementation timeline:
- Newly manufactured products: Must follow the required precautionary labeling on containers or outer packaging.
- Existing products: Labeling should be revised as soon as possible, and no later than one year from the date of the notification.
- Interim measures: Until labeling revisions are completed, supplementary leaflets, stickers, or other explanatory materials bearing the required precautions may be affixed to products as a temporary alternative.
CIRS Reminder
This notification strengthens the allergy warning requirements for henna-containing hair cosmetics. Cosmetics enterprises exporting to Japan should pay attention to the following:
1. Review product formulations. Companies should check whether their hair cosmetic products exported to Japan contain henna or henna-derived substances (such as henna leaf extract). If so, product labels must comply with the notification requirements.
2. Update product labeling. Ensure that containers or outer packaging display: (i) a warning to discontinue use if skin irritation occurs, with particular caution for individuals with a history of hair dye allergies; and (ii) a requirement to perform a patch test before use. Detailed patch test instructions must also be provided in package inserts.
3. Note the transition period. Products already manufactured but not yet relabeled may use supplementary leaflets or stickers as an interim measure, but formal labeling revisions must be completed within one year at the latest.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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