Our Policy: Always Providing Safe and Reliable Products
“Premium Gel” is developed using only safe ingredients that comply with Japan’s Pharmaceutical and Medical Device Act. We go beyond legal requirements by applying our own stringent safety standards to carefully select raw materials, ensuring customers can always enjoy high-quality gel nail products with peace of mind.
The Pharmaceutical and Medical Device Act is a Japanese law that regulates the ingredients and quality of products like pharmaceuticals, medical devices, and cosmetics that are applied to or used directly on the human body.
Although cosmetics are regulated differently from pharmaceuticals in terms of ingredients, quality standards, and testing requirements, the same law applies due to their direct contact with the human body. It aims to protect users by legally regulating the ingredients used.
Under this law, there are specific “prohibited ingredients” and “approved tar colorants” that may be used in cosmetics.
Therefore, any product containing prohibited ingredients or using unauthorized tar colorants cannot be sold as a cosmetic.
These restricted substances are often harmful, potentially carcinogenic, or known to cause pigment deposits. Thus, their inclusion in gel nail products makes them unsuitable for human use and restricts them to classification as “miscellaneous goods.”
“Premium Gel” is officially registered as a cosmetic (nail cosmetic) and formulated in full compliance with Japan’s Pharmaceutical and Medical Device Act.
Although the law allows only a limited number of approved colorants, creating a wide range of gel nail colours using only these approved pigments is said to be extremely challenging.
This is particularly true for red shades, which have few options that are both vivid and resistant to fading.
At “Premium Gel”, our expertise in colour formulation allows us to combine pigments in creative ways to produce vibrant, fade-resistant, and stable colour recipes. This know-how enables the development of a wide range of high-quality gel colours.
By adhering strictly to the law while meeting customer demands, we continue to craft colours that are both legally compliant and aligned with customer ideals.
Is every gel nail product compliant with the Pharmaceutical and Medical Device Act safe? The answer is “no.”
The law provides only the **minimum safety standard** and operates on a “negative list” system — only specifying which ingredients cannot be used. This means any substance not on the prohibited list can technically be used in cosmetics.
However, this does **not** mean that all non-prohibited ingredients are safe for human use.
In other words, “legal compliance” does not equal “safety.”
At our company, we believe that assessing the **safety of non-regulated ingredients** is crucial when selecting raw materials for gel nail products.
Gel nails are complex mixtures of chemicals, and understanding chemistry is essential to ensure safety. At “Premium Gel”, our specialists scientifically evaluate the potential impact of each ingredient on the human body before incorporating it into the formula.
Even if a raw material performs well in gel products, we will **never use** it if it is highly irritating or likely to cause allergic reactions.
Of course, it is impossible to prevent allergic reactions in every single user. However, by prioritizing ingredients less likely to cause harm, we strive to minimise the risk and ensure safer products.
At “Premium Gel”, we focus on the following four aspects of quality:
1. Product quality – ensuring high and consistent performance
2. Manufacturing quality – eliminating production inconsistencies
3. Safety quality – verifying and ensuring product safety
4. Raw material quality – using ingredients that strictly meet specifications
To meet these high standards, we are fully committed to domestic production in Japan.
We also rigorously inspect the entire production process, including:
● Ensuring raw materials are delivered according to specification
● Confirming that received ingredients meet all criteria
● Verifying that raw materials are used exactly as specified
● Ensuring every manufacturing step is properly executed
● Checking that the final products meet expected performance levels
● Confirming products are completed within approved tolerances
● Verifying that raw materials, manufacturing, and final inspections all align to ensure the product is safe for shipment
By producing “Premium Gel” exclusively in our own factory in Japan, we maintain world-class quality that upholds the global reputation of **”Made in Japan.”**
Feel free to reach out for OEM services, nail product consultations, or launching your own nail brand.