Gel Nails and the Pharmaceutical Affairs Act.
Under Japan's Pharmaceutical Affairs Law, cosmetics are defined as 'articles intended to be used by rubbing, spraying or other similar methods on the body to cleanse, beautify, enhance the attractiveness, change the appearance, or maintain the health of the skin or hair, and which have a lessening effect on the human body.' This is defined as.
Internationally, nail polish and gel nail polish are classified as cosmetics in most countries, and in Japan, they are required by law to be manufactured and sold in accordance with the Pharmaceutical Affairs Law.
In Japan, however, there is a mixture of cosmetic gel nail polish products that have been registered for cosmetic sales and gel nail polish products that are classified as miscellaneous goods. What is the difference? As a cosmetics manufacturer, I would like to explain the difference between the two.
Advantages of selling gel nail polish as a cosmetic product.
Cosmetic gel nail polishes with a "cosmetics sales notification" are designed for use on the human body (nails). Therefore, it can be expressed in catalogs and advertisements that it is a product to be applied directly to the human body (nails) and that it is a product that makes nails look healthy and beautiful.
In doing so, it can explain and express the purpose and wording of the application of gel nail cosmetics to the human body (nails and nails), images of gel nail cosmetics being applied to the human body (nails and nails), and how the gel nail cosmetics are used on the human body (nails).
When selling gel nail polish, it is very important in terms of image strategy to be able to explain how the product is used and that it can be used on the human body (nails) at seminars and other events.
■ Gel nails must be manufactured in a factory with a cosmetics manufacturing licence, and a cosmetics manufacturing and sales licence is also required for distribution on the market. The fact that cosmetics are produced by cosmetic manufacturers operating under administrative audit is an important factor for consumers to use the products with peace of mind.
In addition to Base Gels, there are many other items that are applied directly to the nail, such as Non-wipe Colour Gels and Polish Gels, enabling a wide range of products to be developed.
■ Gel Nail Products whose entire composition consists of INCI Name cosmetic ingredients can be exported abroad as cosmetics. *The composition must conform to the regulations of the exporting country.
Points to keep in mind for commercialising gel nail polish as a cosmetic product.
■ Raw materials must be selected and blended within the scope of the regulations set out in the Pharmaceutical and Industrial Safety Law. In particular, the number of tar pigments used for colouring that can be used in cosmetics is decreasing year by year due to regulations. The same applies to glitters and holograms. There are limits to the expression of toning and colour tones under various regulations.
The Pharmaceutical Affairs Law strictly restricts the expression of efficacy of cosmetics. Therefore, sellers are required to comply with the Pharmaceutical Affairs Law in their sales promotion activities.
In addition, cosmetics manufacturers and distributors must strictly comply with the Pharmaceutical Affairs Law, including the obligation to conduct analytical inspections of regulated ingredients to check for the presence of regulated ingredients in their products, and to manage and report information on health and safety.
By practicing actions to ensure safety and security together with sellers and cosmetics manufacturers and distributors, customers can purchase and use cosmetics with peace of mind.
Advantages of commercialising sundry gel nail products.
■The available pigments, glitters and other materials are extremely rich, enabling the expression of vivid colours that cannot be expressed with cosmetic pigments. As colour tones and effect-type glitters that cannot be expressed with cosmetic raw materials can be freely blended, a wide range of colours can be developed. A wide range of pigments can be freely selected by the manufacturer's authority, which expands the range of options.
■ Since no administrative procedures such as cosmetics sales notifications are required and the products are not restricted by the Pharmaceutical and Industrial Safety Law, anyone can manufacture and sell the products anywhere.
Points to keep in mind when manufacturing miscellaneous Gel Nails
Sundry gel nails (paints) are 'restricted to use on the artificial nail surface'.
It must not be represented that it can be used on the human body (nails), or sold or described as being for the purpose of being applied to the human body (nails). In addition, because the paints are treated as paints that cannot be used directly on the human body (nails), no images, expressions, or descriptions of the direct application of the paints on the human body (nails) are allowed in catalogs, advertisements, or other such means.
Of course, it is also prohibited to verbally explain the act of applying gel nail polish directly to the human body (nails) at seminars, etc., or to make expressions or explanations that may mislead people into thinking that the product is to be applied directly to the human body (nails). It is important to note that any description or expression that misleads the public into believing that the product is a cosmetic may be punished as a violation of the Pharmaceutical Affairs Law.
However, if the product is clearly intended to be applied to the surface layer of artificial nails, and the product is labeled as a sundry or miscellaneous product so as not to mislead consumers, and information on usage, precautions, etc. are correctly and clearly indicated in accordance with the guidelines, and the difference between cosmetics and sundries is clearly distinguished and indicated, even miscellaneous gel-like paints can be Even miscellaneous gel paints can be sold as gel nail polish if they are clearly differentiated from cosmetics and miscellaneous goods.
For example, the government has clearly stated that the base gel, which is intended to be applied directly to the nail, must be cosmetic, but the color gel and top gel applied on top of the base layer do not necessarily need to be cosmetic, since the second and subsequent layers on top of the base layer are the artificial nail surface layer.
However, since the product liability law (PL Law) applies, it does not mean that anything can be blended without regard to safety. It is important to select materials and manufacturing methods that give the utmost consideration to the effects on the human body so that users can use the product safely.
■In most cases overseas, gel nails are defined as a cosmetic product as a system product applied to a single nail, regardless of the layer applied to the nail, regardless of the item for each process (base, color, and top).
Since the pharmaceutical affairs law is a law that applies only to Japan, if you are considering exporting gel nail polish to overseas, exporting is difficult unless the product is manufactured using cosmetic raw materials composed of all ingredients under the INCI Names.
The theory that the artificial nail surface layer after the base is applied is not a nail and therefore does not need to be cosmetic is a limited interpretation in Japan, and is completely unacceptable under many foreign cosmetics regulations.
It is necessary to fully understand the differences between cosmetic and sundry categories before proceeding with the branding of gel nails.
The overwhelming majority of customers who contact us say that they want to manufacture their products as cosmetics, not as sundries. Only for colors that are difficult to achieve with cosmetic raw materials, we use non-statutory pigments and glitters, and sell them as general merchandise gel nail polish.
While cosmetic ingredients that comply with cosmetic standards can be safely blended into cosmetics, non-statutory pigments and industrial glitters and holograms may contain toxic substances that are harmful to the human body. Therefore, we conduct tests for heavy metals such as mercury, arsenic, and lead, as well as formaldehyde, to determine their safety before blending them into sundry gel nails.
We want to help our customers develop their business by providing them with oem manufacturing of high-quality gel nail products, something that no other company can do, something that only nippi can achieve, unparalleled technology and a wealth of ideas.
We have obtained the licences and permits for the manufacture and sale of cosmetics and cosmetic products under the pharmaceutical and industrial safety law, so there is no need for customers to obtain these licences individually. As the manufacturer, we also guarantee product liability (PL), so customers are not held liable in any way.
The following link provides detailed information on the rules regarding the labeling of cosmetic ingredients under the Pharmaceutical Affairs Law of the Ministry of Health, Labour and Welfare.
The INCI name is decided at the INCI meeting (INCI Nomenclature Committee) held at the PCPC.
INCI Names named by the US PCPC are included in the list of cosmetic labeling names published by the japan cosmetic industry association. Cosmetics distributed in Japan must be labeled with cosmetic ingredients based on this list.