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General matters

The purposes of the PMD Act and related matters

1. The purposes of the PMD Act are broadly divided into the following two areas.
(1) To ensure the quality, efficacy, and safety of cosmetics and pharmaceuticals before they are put on the market.
(2) To prevent hazards to public health and hygiene caused by the use of the products after they are put on the market.

2. The most important parts of the PMD Act that are related to cosmetics are the paragraphs in Chapter IV that are concerned with marketing and manufacturing, the paragraphs in Chapter X that are concerned with advertisement, and the paragraphs in Chapter XI that are concerned with safety measures.

Standards for Cosmetics

The standards list cosmetics ingredients that cannot be contained (the “negative list”), cosmetics ingredients that may be contained (the “positive list”), and cosmetics ingredients in the specific ingredient group that may be contained. Summary is shown below. Please note that all cosmetics must comply with cosmetic standards.

・Ingredients in general
Ingredients for cosmetics, including impurities contained in the ingredients, must not contain substances that may be infective or must not be any other substances that may cause a potential health or hygiene hazard when used.

・Negative list
(1) Stipulates ingredients that cannot be blended.
(2) Stipulates restricted ingredients.

・Positive list
(1) Specifies the types of preservative that may be contained, and their maximum amounts allowed.
(2) Specifies the types of UV absorbers that may be contained, and their maximum compounding amounts allowed.

Labeling of all ingredients and preparation of labeling names

For cosmetics, “all ingredients” must be labeled as information to help consumers in choosing products. The notification by the MHLW clearly states that the names of ingredients used for the “full-ingredient labeling” shall be taken from the List of Japanese Labeling Names for Cosmetics prepared by Japan Cosmetic Industry Association, etc. For this reason, the JCIA determines labeling names when applications are received from those involved in the marketing of cosmetics.