Cosmetics manufacturing and sales business, manufacturing business license, manufacturing and sales notification
What are cosmetics? Explanation of the definition under the Pharmaceutical Affairs Law and the difference between cosmetics and medicines and quasi-drugs
Updated: July 2025, 6
Cosmetics are, needless to say, one of the most widely used products in our daily lives.
So how is a "cosmetic" defined under the law?
Intended for use by rubbing, spraying, or similar methods on the human body to cleanse, beautify, increase attractiveness, change appearance, or maintain healthy skin or hair. A substance that has a mild effect on the human body. (Excluding pharmaceuticals and quasi-drugs.)
Items that are ``applied to the body for the purpose of cleansing the body or making it look beautiful'' include many everyday items such as lotions, milky lotions, moisturizing creams, foundations, lipsticks, soaps, and nail polish. It falls under "cosmetics".
As defined in the Pharmaceutical Affairs Law, "cosmetics" are defined as "Items with mild effects on the human body” is limited to.
When dealing with cosmetics according to this definition, the Pharmaceuticals and Medical Devices Act imposes strict restrictions on the ingredients that can be mixed into the product and the effects and efficacy that can be advertised.
However, items defined as "pharmaceuticals" or "quasi-drugs" do not fall into this category.
Check it out in the video!
[Cosmetics Permit] Think about what cosmetics are in the first place.
The Pharmaceuticals and Medical Devices Act defines "drugs" and "quasi-drugs" separately from "cosmetics."
① "Medicinal products" whose purpose is treatment, etc.
Example) Oral liquids such as cold medicines sold at pharmacies, ointments, eye drops, etc.
② "Quasi-drugs" for preventive purposes (sterilization, disinfection, etc.)
Example) Medicinal cosmetics, whitening cream, toothpaste powder for periodontal disease prevention, etc.
Although cosmetics, quasi-drugs, and pharmaceuticals all have different purposes of use, the strength of their effects on the human body increases in the following order: cosmetics < quasi-drugs < pharmaceuticals.
Depending on whether a product falls under the category of cosmetics, quasi-drugs, or pharmaceuticals, the ingredients that can be included in the product, their amounts, and the desired effects and efficacy will vary.
When considering handling cosmetics from overseas, special care must be taken as pharmaceutical regulations vary by country.
For example, there are many cases where ingredients that are allowed in cosmetics overseas are prohibited in Japan, or where claims of effects and efficacy that are accepted overseas are not accepted in Japan.
56 cosmetic efficacy categories
The scope of efficacy of cosmetics is regulated under the following 56 items.
Cleanses the scalp and hair.
The fragrance reduces unpleasant odors from hair and scalp.
Keeps the scalp and hair healthy.
Gives hair elasticity and body.
Moisturizes the scalp and hair.
Maintains moisture in the scalp and hair.
Makes hair supple.
Makes combing easier.
Maintains hair shine.
Gives hair shine.
Eliminates dandruff and itchiness.
Reduces dandruff and itching.
Replenishes and maintains hair's moisture and oil content.
Prevents hair breakage, split ends and breakage.
Style and hold your hairstyle.
Prevents hair from becoming statically charged.
To cleanse the skin (by removing dirt).
Prevents acne and heat rash (by cleansing) (face wash).
Tones the skin.
Refines skin texture.
Keeps skin healthy.
Prevents skin irritation.
Tightens the skin.
Moisturizes the skin.
Replenishes and maintains skin moisture and oil.
Maintains skin flexibility.
Protect your skin.
Prevents dry skin.
Softens the skin.
Gives skin firmness.
Gives skin a radiant glow.
Smoothes skin.
Makes shaving easier.
Tone the skin after shaving.
Prevent heat rash (dusting powder).
Prevents sunburn.
Prevents sun spots and freckles.
Gives fragrance.
Protects nails.
Keep your nails healthy.
Moisturizes nails.
Prevents chapped lips.
Refine the texture of your lips.
Provides moisture to the lips.
Keeps your lips healthy.
Protects the lips. Prevents the lips from drying out.
Prevents dry, chapped lips.
Smoothes the lips.
Prevents tooth decay (toothpastes that require brushing when used).
Whitens teeth (toothpastes that require brushing when used).
Remove plaque (toothpastes that require brushing when used).
Cleanse your mouth (toothpaste, etc.).
Prevent bad breath (toothpaste, etc.).
Removes plaque from teeth (toothpastes that require brushing when used).
Prevents the buildup of tartar (toothpastes that require brushing when used).
Reduces the appearance of fine lines caused by dryness.
Note 1) For example, "supplement and maintain" can also have the effect of "supplement" or "maintain." Note 2) It is acceptable to use "skin" and "hada" interchangeably. Note 3) ( ) indicates that the indication is not included in the efficacy, but is a limitation based on the mode of use. Source: https://www.mhlw.go.jp/web/t_doc?dataId=00tb7518&dataType=1&pageNo=
Cosmetic ingredient standards
Cosmetics are subject to strict standards regarding the ingredients they contain. The main points are as follows:
1. Negative List
This is a list of ingredients that are prohibited or restricted from being used in cosmetics. Contains preservatives, UV absorbers, tar dyes, etc.
②Positive List
This is a list of ingredients that are permitted in the product under certain conditions.
3) Prohibition of use of pharmaceutical ingredients
Cosmetics must not contain any pharmaceutical ingredients, except for ingredients used solely as additives.
However, even if a pharmaceutical ingredient is a cosmetic ingredient that was already approved by March 13, 3, or an ingredient that was listed in the cosmetic type permission standards, it may be permitted to be used only in the amount of the approved ingredient or the amount listed in the permission standards.
Manufacturing cosmetics and ensuring safety
Cosmetic standards are established based on the policy of "ensuring the provision of necessary information to consumers, while allowing them more choices to meet diversifying consumer demands." Cosmetic standards are intended to make it easier for consumers to choose products that are right for them, and they include regulations on cosmetic ingredients and safety management procedures during the manufacturing process.
The following measures are required for ingredients contained in cosmetics:
1. Safety check
Cosmetic manufacturers and distributors are responsible for thoroughly verifying the safety of the ingredients they use and determining their suitability. For this reason, manufacturers must evaluate the safety of ingredients based on scientific data and clinical trial results, and decide whether or not to use them based on those results. Safety verification is an essential step to ensure product quality.
②Collection and storage of materials
Documentation regarding ingredients and product safety must be collected, created and stored. This includes information about the ingredients' origins, manufacturing methods, and usage history. In addition, the collected documents are necessary to prove the safety of the product, and manufacturers are required to properly manage these documents and keep them ready to submit when necessary. Proper management of documents ensures product traceability and makes it easier to respond quickly in the unlikely event of a problem occurring.
For consultation regarding cosmetics licenses, please contact Support Administrative Scrivener Corporation
At the Support Administrative Scrivener Corporation, we provide procedural support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the cosmetics industry to existing marketing agents, manufacturers, and distributors. Applications for cosmetics are highly specialized, and are one of the areas that few administrative scriveners can handle. Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.
What is the difference between cosmetics and quasi-drugs?
Cosmetics are products that are used to cleanse, beautify, or increase the attractiveness of the human body, change appearance, or keep the skin or hair healthy, and have a mild effect on the human body. On the other hand, quasi-drugs are products that contain effective ingredients at certain concentrations with effects and efficacy approved by the Ministry of Health, Labor and Welfare and are made primarily for the purpose of prevention and hygiene. For example, there are lotions to prevent dandruff and itching, products to maintain oral hygiene, etc. Under the Pharmaceuticals and Medical Devices Act, rules are set out for labeling the efficacy and effects of cosmetics based on these classifications.
What are the principles for expressing the names of cosmetics, etc.?
The name of a cosmetic product must not mislead people into thinking that it is the same as another product. Therefore, you must not use a name other than the brand name for which you have submitted the manufacturing and sales notification.
What points should I be careful about when using an abbreviation or nickname for a brand name?
When using an abbreviation or nickname for a brand name, please note the following points.
The abbreviation or nickname of the sales name of cosmetics, etc. must not be likely to cause confusion as to their identity when viewed comprehensively in the context of the advertisement.
Regarding the abbreviation or nickname of the sales name of cosmetics, etc., if it cannot be used as the sales name, it should not be used as the nickname either.
The name must be clearly expressed and must not be expressed in small words or phrases that make it difficult to distinguish the name.
As long as there is no risk of misunderstanding the identity, there is no problem in adding furigana to kanji or writing alphabets together.
What types of names cannot be used as abbreviations or nicknames for sales names?
The following restrictions apply to the expression of abbreviations and nicknames for cosmetics, etc.
Do not use names that are the same as those of existing drugs or quasi-drugs.
Do not use false, exaggerated or misleading names.
The names of specific ingredients contained in the product must not be used in the product name.
Do not use names in Roman characters only.
Use as few letters, numbers, symbols, etc. as possible.
Do not use a name that differs from the dosage form.
Do not use names that are clearly trademarked by other companies.
Do not use anything that conflicts with the fair competition code regarding cosmetic labeling.
Do not use names that may be confused with drugs or quasi-drugs. (For example, ____ medicine, medicinal ____, herbal medicine ____, medical ____, ____ drug, atopic ____, acne ____, allergy ____, pack "____ hap", etc.)
Are there any rules to follow when advertising cosmetics?
The Pharmaceuticals and Medical Devices Act prohibits cosmetic advertisements from exaggerating their actual effects or using expressions that could be mistaken for medicines. For example, expressions such as "treat" or "completely cure" should be avoided, and expressions should be within the range of efficacy and effects approved for cosmetics. In addition, in accordance with the rules set by the Ministry of Health, Labor and Welfare, even when indicating that a product such as lotion is suitable for a specific use, it is important to be mindful of using wording that will not mislead general consumers.
What types of oral cosmetics are available?
Oral cosmetics mainly include mouthwashes to prevent bad breath and products that are expected to have a teeth whitening effect. These products are also subject to the Pharmaceuticals and Medical Devices Act, and the indication of efficacy and effectiveness and advertising expressions must follow the rules set out by the Ministry of Health, Labour and Welfare. In particular, it is required that the product be appropriately described as a general cosmetic product so that it is not mistaken for a medicine.
