Pharmaceutical and Medical Device Act: The Law Regulating Cosmetics
In Japan, the Pharmaceutical and Medical Device Act serves as the primary regulatory framework for the manufacture and sale of cosmetics. This section provides an overview of the law, recent regulatory reforms, and the relationship between cosmetics manufacturing, relevant permits, and cosmetic ingredients.
Cosmetics are industrial products made by blending natural and synthetic substances. What sets cosmetics apart from other industrial products is that they are:
“Industrial products intended to act directly on the human body.”
This may sound complex, but examples include:
“Applying foundation directly to the skin to smooth complexion.”
“Applying eye shadow around the eyes to enhance their appearance.”
“Applying lipstick directly to the lips to colour them vividly.”
“Spraying perfume directly onto the body to carry a pleasant scent.”
In the case of gel nail products, this would be:
“Applying gel directly to natural nails to decorate and colour them beautifully.”
The key point here is that cosmetics act **directly on the human body**, including gel nails. Because of this significant characteristic, cosmetic manufacturers are not given complete freedom to choose ingredients. Certain regulations are enforced—and these regulations are governed by the **Pharmaceutical and Medical Device Act**.
The full name of the law is:
**”Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics.”**
This law regulates the manufacture and sale of pharmaceuticals, medical devices, and cosmetics in Japan.
Under this law, cosmetics are defined as:
“Articles intended to be applied to the human body by rubbing, sprinkling or similar methods for the purpose of cleansing, beautifying, enhancing attractiveness, altering appearance, or keeping the skin or hair in good condition, with mild effects on the human body.”
Thus, cosmetics are explicitly defined as products used directly on the body.
The purpose of this regulation is:
“To ensure that products used directly on the human body, such as cosmetics and pharmaceuticals, are manufactured only within the regulated scope, particularly with regard to their ingredients.”
This prevents companies from formulating products with harmful substances that could cause health issues for consumers.
Violations of the law can result in public disclosure of the incident, mandatory product recalls, loss of consumer trust, high costs of compensation or replacement, and even lawsuits—potentially endangering the future of the business.
Since gel nail products are applied directly to the natural nail, they clearly fall under the legal category of “cosmetics.” Failure to comply with the law could result in severe damage. More importantly, it is the manufacturer’s duty to ensure legal compliance in product manufacturing and distribution.
The law sets out **Cosmetic Standards** to ensure minimum product quality. Among the five established standards, two main regulatory aspects are explained below.
1. Prohibited Ingredients
The Cosmetic Standards prohibit the use of certain ingredients, such as formaldehyde, and impose quantity limits on others. This system is based on a **“negative list”** approach.
A “negative list” means that only listed substances are restricted—any unlisted substances are, in principle, freely usable.
Manufacturers can freely choose ingredients and amounts **unless the substance is explicitly prohibited or restricted**. However, they are fully responsible for ensuring ingredient safety. Therefore, deep technical knowledge and a strong ethical stance are required when formulating cosmetics.
2. Permitted Tar Colorants (Legal Colorants)
Conversely, for petroleum-derived tar colorants, only specific approved ones may be used. These are regulated by the **Ministry of Health Order No. 30 (1966)** and are referred to as **legal colorants**.
Legal colorants are managed under a **“positive list”** system. This means that only listed substances may be used—everything else is prohibited.
In gel nail color products, formulators must create all colors using only the limited range of legal colorants, which is technically challenging but demonstrates the skill of experienced color mixers.
The term **“non-legal colorant”** refers to tar colorants not included in the positive list. Their use in cosmetics violates the law.
Legal colorants are selected primarily for safety (e.g., non-staining), but often fall short in vibrancy or fade resistance—especially in red tones. In some cases, prioritizing colour performance over compliance has led to legal violations involving non-legal colorants.
Compliance with the Pharmaceutical and Medical Device Act ensures only **minimum product safety**, and aside from prohibited ingredients, quantity-limited substances, and legal colorants, ingredient choices are generally unrestricted.
Therefore, the law **does not guarantee that all ingredients used in cosmetics are completely safe**, and consumers should not assume that a cosmetic is entirely harmless just because it’s legally classified as one.
The current Pharmaceutical and Medical Device Act governs cosmetic regulations, but previous frameworks are sometimes confused with the current one. Below is an overview of recent changes in Japanese pharmaceutical and cosmetic regulations.
1. Current Law: Pharmaceutical and Medical Device Act
The official name is “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics.”
It was renamed under the 2013 amendment to the Pharmaceutical Affairs Act (Act No. 84 of 2013).
The law was revised to accommodate advances in IT and the emergence of medical software and programs. This revision and renaming came into effect in 2014.
While the law changed from “Pharmaceutical Affairs Act” to “Pharmaceutical and Medical Device Act,” regulations concerning cosmetics remained largely unchanged.
2. Pharmaceutical Affairs Act
Originally enacted in 1960 (Act No. 145 of 1960)
The legal history of pharmaceutical regulations in Japan dates back to 1871 with the “Patent Medicine Control Regulation.” The Pharmaceutical Affairs Act of 1960 served as the precursor to the current law.
Within the two decades before its revision, two significant changes were made to cosmetic regulations under this law. Below is a timeline.
● Before March 2001
Cosmetic products required approval by the Ministry of Health and Welfare (now the Ministry of Health, Labour and Welfare), covering all ingredients, formulation ratios, and manufacturing methods.
Widely used ingredients like glycerin were subject to repeated reviews, resulting in inefficiencies. To address this, a standardized approval framework known as the **“Cosmetic Category Approval Standards”** was introduced.
Products using only the ingredients listed in the standard underwent simplified review, while products using other ingredients required full review.
● From April 2001 to March 2005
In response to global deregulation trends, Japan implemented significant reforms in April 2001.
Ingredient regulation shifted to the current system based on a **negative list of prohibited substances** and a **positive list of permitted colorants**, while the approval system for cosmetics remained in place.
● From April 2005 to Present
The 2005 revision of the Pharmaceutical Affairs Act abolished the approval system for cosmetics and replaced it with a **notification system**.
Manufacturers are now only required to notify the relevant prefectural government of the cosmetics they produce. This deregulation remained in place after the law was renamed to the **Pharmaceutical and Medical Device Act**.
Although the **“Cosmetic Category Approval Standards”** have been abolished and are no longer legally valid, some manufacturers still refer to the 1999 edition as a guideline for formulation development.
Some misunderstandings persist—such as claims that gel nail products using ingredients not listed in the old standards cannot legally be sold as cosmetics. However, since the standards have been abolished and ingredient usage has been liberalized, **as long as the current Cosmetic Standards are followed, any compliant formulation is legally acceptable.**
Thanks to deregulation, cosmetics no longer require individual product approval. However, this does not mean anyone can make cosmetics just by filing a notification.
To manufacture or sell cosmetics, businesses must obtain specific licenses from the governor of the prefecture where their facility is located:
1. Cosmetic Manufacturing License
This license grants permission to manufacture cosmetics. Without it, manufacturing is not legally permitted.
2. Cosmetic Manufacturing and Sales License
While similar to the above, this license covers the “sales” aspect—meaning it is required to distribute cosmetics to the market.
If a business only manufactures cosmetics, they need the **Cosmetic Manufacturing License**. If they also plan to market and sell them, they must obtain the **Cosmetic Manufacturing and Sales License** as well.
For gel nail production, the process of filling gel into containers requires a **Cosmetic Manufacturing License**, while assessing the final product and shipping it to market requires a **Cosmetic Manufacturing and Sales License**.
Therefore, businesses making gel nail products must obtain the **manufacturing license**, and those selling them must obtain the **manufacturing and sales license**.
(Some companies hold both licenses.)
A common misconception regarding cosmetics is:
**“If a product complies with the Pharmaceutical and Medical Device Act and is legally sold as a cosmetic, then it must be safe in terms of allergies too.”**
In reality, this assumption is incorrect. The correct understanding is:
“Compliance with the Pharmaceutical and Medical Device Act has little to do with whether the ingredients are allergenic.”
Yes, the law restricts the use of harmful substances through the **prohibited ingredients** and **maximum quantity limits**.
However, the basic principle is:
**“Cosmetic manufacturers are responsible for assessing the safety of the ingredients they use.”**
This means manufacturers are free to use ingredients that are not restricted, regardless of whether they have allergenic potential or not.
**Allergenicity is not covered by the law.**
Therefore, even if a product is legally classified as a cosmetic, its safety regarding allergies is **not** guaranteed under the Pharmaceutical and Medical Device Act.
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