4. Labeling Requirements

Cosmetics
Japan

This section provides information on labeling requirements and the label approval process.

4.1 Mandatory Labeling Parameters

There are 2 types of packaging:

1. Secondary packaging
2. Primary packaging 

Mandatory Labeling Parameters for Secondary Packaging [1]

1. Name and address of the seller: no information on the place of manufacture is required.
2. Notified Japanese marketing name: ingredient names cannot be used in marketing names.
3. Lot Number
4. List of ingredients
   1. Full ingredient labeling in Japanese is mandatory on the outer package of cosmetics but can be omitted from the primary package. Both outer and primary packages must have the same information except full ingredient labeling.
   2. All non-color ingredients are listed in descending order of predominance followed by all colors and non-color ingredients of which content is 1% or less in random order.
   3. The Japan Cosmetic Industry Association (JCIA) has compiled a Japanese version of the "List of Cosmetic Ingredient Label Names" to be used in conjunction with the Pharmaceutical and Medical Devices Law (PMDL)'s requirements to list all ingredients' names on the labeling. Companies can refer to the document to standardize the Japanese name of ingredients [2].
5. Product category [3]
6. Content quantity - Indication in ml or g [3].
7. Country of origin [3]
8. Inquiries - Display phone number [3]
9. Directions for use
10. Precautions for use and storage

Mandatory Labeling Parameters for Primary Packaging [1]

1. Name and address of the seller: no information on the place of manufacture is required.
2. Notified Japanese marketing name: ingredient names cannot be used in marketing names.
3. Lot Number
4. List of ingredients (OPTIONAL)
   1. Full ingredient labeling in Japanese is mandatory on the outer package of cosmetics but can be omitted from the primary package. Both outer and primary packages must have the same information except full ingredient labeling.
   2. All non-color ingredients are listed in descending order of predominance followed by all colors and non-color ingredients of which content is 1% or less in random order.
   3. The Japan Cosmetic Industry Association (JCIA) has compiled a Japanese version of the "List of Cosmetic Ingredient Label Names" to be used in conjunction with the Pharmaceutical and Medical Devices Law (PMDL)'s requirements to list all ingredients' names on the labeling. Companies can refer to the document to standardize the Japanese name of ingredients [2].
5. Product category [3]
6. Content quantity - Indication in ml or g [3].
7. Country of origin [3]
8. Inquiries - Display phone number [3]

Directions for use, precautions for use, and storage are not required to be added to primary packaging.

4.2 Languages

Japanese

4.3 Alternative Supports to Display Information

The mandatory information can be presented on an undetachable label.  

The mandatory information cannot be presented on an enclosed or attached leaflet, label, tape, tag, or card or online only.

4.4 B2B Ingredient-specific Labeling Statements

Labeling requirements for active and functional ingredients supplied to a B2B manufacturer [4] include:

1. Ingredients
2. Warnings
3. Effects on the human body, stability, and reactivity
4. Storage and handling precautions
5. Hazardous pictogram
6. Name, address, and telephone number of the person who is to display the label

4.5 References

1. Act on securing quality, efficacy and safety of products including pharmaceuticals and medical devices

https://www.japaneselawtranslation.go.jp/ja/laws/view/3213

2. List of Cosmetic Ingredient Label Names (JCIA)

https://www.jcia.org/user/business/ingredients/namelist

3. Fair Competition Code Concerning Cosmetics Labeling

https://www.cftc.jp/kiyaku/kiyaku01.html

4. Overview of Chemical Substance Labeling and Document Delivery System

https://www.mhlw.go.jp/topics/bukyoku/roudou/ghs/dl/aramashi.pdf