Since the beginning of the 21st century in Japan, cosmetics companies have opened up a large number of cosmetics stores for primary and middle school students by promoting and selling the anxiety of "getting away from toys and becoming mature", causing the beauty and hairdressing industry becomes more popular at younger age. According to an interview conducted by a Japanese folk magazine in 2004, the proportion of girls aged 10 to 15 who wear makeup is as high as 87%, this data continues to grow. At this stage, the awareness of "you can't go to school without makeup", "you shouldn't go out without makeup" has taken root in the mainstream Japanese culture, and the makeup frenzy has swept Japan, accelerating the market cycle of Japan's cosmetics industry, and the rapid development of production technology. The trend of economic globalization continues to expand overseas.

In Japan, cosmetics-related business licenses are divided into cosmetics manufacturing and sales licenses and cosmetics manufacturing licenses. In this guideline, Kaizen will summarize the application process and required materials for Japan's cosmetics manufacturing license in accordance with Japan's "Pharmaceuticals and Medical Devices Law" and related laws to provide Kaizen's existing customers and potential customers for reference. In addition, our firm can provide services to assist in the registration of various companies in Japan. If necessary, please contact our professional consultants.

1. Definition of cosmetics
   
   According to the Japan Pharmaceuticals and Medical Devices Law (Japanese for "Medical Products and Medical Devices Law", the full name of the law is "The Law on Ensuring Quality, Effectiveness and Safety of Medical Products, Medical Devices, etc.") Article 2, Paragraph 3, Cosmetics (“Cosmetics” in Japanese) refer to items that have a soothing effect on the human body by smearing, spraying or other similar methods on the body for the purpose of cleaning, smearing the human body, enhancing charm, changing appearance, maintaining skin and hair, etc., including Soaps, perfumes, hand sanitizers, etc., but excluding articles for the diagnosis, treatment or prevention of human or animal diseases and articles that affect the structural functions of the human or animal body.
   
   
2. Cosmetics manufacturing and sales license
   
   Amongst them, the manufacture and sale of cosmetics ("Cosmetics Manufacturing and Sales License" in Japanese) refers to the business of taking responsibility for the quality and safety of the cosmetics manufactured and imported by itself, and distributing the cosmetics in (Japan). However, it is worth noting that holding a cosmetic manufacturing and selling license does not mean that an enterprise can engage in the "manufacturing" and "selling" of cosmetics, and only the products of cosmetics can be listed. Specifically, companies that hold a license for the manufacture and sale of cosmetics can generally engage in the following businesses:
   
   (1) Selling cosmetic products made by cosmetic manufacturers of their own companies;
   (2) Import cosmetics from overseas and selling them in Japan;
   (3) Consign an OEM manufacturer (cosmetics factory) to manufacture cosmetics and selling them under the company's trademark.
    
   In conclusion, enterprises that hold a license for the manufacture and sale of cosmetics are not allowed to manufacture cosmetics, including manufacturing, trademark OEM, additional instructions, secondary processing, and repackaging. If you only purchase and sell cosmetics from domestic cosmetics manufacturers, distributors, etc., you do not need a cosmetics-related business license. If you want to achieve self-production and sales of cosmetics in Japan, you must hold both a cosmetics manufacturing and sales business license, cosmetics and manufacturing license.
   
   
3. Application Requirements for Cosmetics Manufacture and Sales License
   
   

   (1)

   Application Requirements for Operators According to Articles 12 and 5 of the Japanese Pharmaceuticals and Medical Devices Act, if the applicant (who is a legal person, the directors, supervisors, council members, accountants, and liquidators of the legal person) meet the following conditions, the Prefectures (first-level administrative region in Japan) government will not approve the application for a cosmetic manufacturing and sales license submitted by the applicant: (a) Persons who have not been within 3 years from the date of revocation of the previously held cosmetic manufacturing and sales license due to neglect of safety management or quality assurance, the operator's failure to meet legal requirements or the failure to set up relevant responsible personnel in accordance with legal requirements; (b) Persons who have obtained a cosmetic manufacturing and sales license due to providing false materials or using improper means, resulting in the cancellation of the cosmetic manufacturing and sales license for less than 3 years; (c) Persons who have been sentenced to imprisonment for more than three years from the end of the sentence; (d) Persons who have violated the Act on Drugs, Medical Devices, etc., the Act on the Suppression of Narcotics and Psychotropic Substances, and the Act on the Suppression of Poisons and Highly Toxic Substances within 2 years; (e) People who are addicted to narcotics, marijuana, opium or stimulants; (f) Those who are unable to properly operate the cosmetics manufacturing and selling business due to mental or physical disabilities; (g) Persons who are still wards after they reach adulthood.

   (2)

   Other request (a) Each office has at least one person in charge of overall manufacturing and sales; (b) Each office has at least one person in charge of quality assurance; (c) Each office has at least one person in charge of safety management; (d) Must meet the standards of the Ministry of Quality Assurance (GQP) and the Ministry of Safety Management (GVP).

   
   
4. Cosmetics manufacturing and sales license application materials
   
   The application materials stipulated by the prefectural governments in Japan are slightly different. Kaizen has organized the application materials as follows according to the official information of the Tokyo Metropolitan Government, and provides them for customers' reference:
   
   (1) An application for a license for the manufacture and sale of cosmetics (records the name and address of the firm, the type of license applied for, and the information of the person in charge of technology, etc.);
   (2) If the applicant is a legal person, the certificate of legal person registration issued within 6 months before the date of application shall be provided;
   (3) Business distribution table;
   (4) Medical certificate of business-related personnel (to confirm whether the relevant personnel are addicted to drugs such as marijuana);
   (5) If the applicant is a legal person, the organizational chart of the legal person shall be provided;
   (6) Coordinate the labour contract of the person in charge of manufacturing and sales or materials that can prove the employment relationship or usage relationship;
   (7) Coordinate the relevant qualification certificates of the person in charge of manufacturing and sales;
   (8) Quality assurance department system related materials (GQP system chart);
   (9) Related materials of the safety management department system (GVP system chart);
   (10) Configuration diagram (clearly marked with the specific location of the office inside the building, land, etc. where the office is located);
   (11) The floor plan of the office;
   (12) Storage of equipment related drawings;
   (13) The guide map of the office (clearly marked with the route from the nearby station to the office).
   
   
5. Person in charge
   
   Operators engaged in the manufacturing and sales of cosmetics must appoint responsible persons in accordance with the Pharmaceuticals and Medical Devices Act. Specifically, each office must appoint at least one full-time person in charge of overall manufacturing and sales, one person in charge of quality assurance, and one person in charge of safety management. When certain conditions are met, the same person can concurrently serve as the person in charge of overall manufacturing and sales, the person in charge of quality assurance, and the person in charge of safety management.
   
   

   (1)	Coordinate manufacturing and salesperson in charge The person in charge of manufacturing and sales (Japanese for "manufacturing and sales responsible person") is mainly responsible for supervising the work of the person in charge of quality assurance and the person in charge of safety management, listening to and respecting the opinions of the person in charge of quality assurance and safety management, and coordinating the responsibility for quality assurance. The work between people and the head of safety management. The person in charge of manufacturing and sales shall meet any of the following: (a) Pharmacists; (b) Those who have completed professional courses in pharmacy or chemistry in high school or above; (c) Those who have completed pharmacy or chemistry-related courses in high school or above, and have been engaged in the quality management or safety management of cosmetics for 3 years; (d) Other persons who are deemed by the Minister of Health, Labour and Welfare to have the same level of knowledge as the above-mentioned persons.
   (2)	Person in charge of quality assurance The person in charge of quality assurance (“person in charge of quality assurance” in Japanese) is mainly responsible for the management of cosmetic product launch, manufacturing, management and assurance of quality management implementation, quality management information, handling of defective problems, and recycling in accordance with the Ministry of Quality Assurance Order (GQP), document and record management. The requirements for the quality assurance person in charge are as follows: (a) Must be a full-time regular employee. Part-time employees and dispatched employees cannot serve as the person in charge of quality assurance; (b) Have the ability to properly handle the cosmetic quality assurance business; (c) Have more than 3 years of relevant experience in quality assurance; (d) Must be the person in charge of the quality assurance coordinating department of the enterprise; (e) Employees of departments involved in the sales of cosmetics shall not serve as the person in charge of quality assurance.
   (3)	Safety management officer The person in charge of safety management (“person in charge of safety management” in Japanese) is mainly responsible for collecting and processing safety management information, establishing safety assurance measures based on safety management information, and implementing safety assurance measures in accordance with the Ministry of Safety Management (GVP). The requirements for the role of the person in charge of safety management are as follows: (a) Must be a full-time regular employee. Part-time employees and dispatched employees are not allowed to serve as the person in charge of safety management; (b) Have the ability to properly handle the cosmetic safety management business; (c) Have more than 3 years of relevant experience in safety management; (d) Must be the person in charge of the safety management and coordination department of the enterprise; (e) Employees of departments involved in the sales of cosmetics cannot serve as the person in charge of safety management.

   
   
6. The application process for the license of cosmetic manufacturing and sales
   
   Briefly, the process of applying for a cosmetic manufacturing and selling business license is as follows:
   
   (1) Confirm whether the cosmetics to be manufactured, imported or sold comply with relevant Japanese laws and regulations, such as whether there are ingredients in cosmetics additives that are strictly prohibited by the Japanese government;
   (2) Leasing or purchasing an office;
   (3) Hire or appoint personnel to be the person in charge of overall manufacturing and sales, the person in charge of quality assurance, and the person in charge of safety management, and signing labour contracts or prepare letters of appointment;
   (4) Prepare relevant materials for the quality assurance department system and safety management department system according to the company system and scale;
   (5) Prepare application materials according to the requirements of the prefectural government. After all the materials have been prepared, submit an application for a license to manufacture and sell cosmetics to the prefectural government where you are located, and pay the handling fee;
   (6) Within about 1 to 3 weeks after submitting the application, the staff of the business department of the prefectural government will conduct a field survey of the office used for the application. Before the field survey, the prefectural government will notify the applicant, and the applicant must ensure that the relevant responsible persons are present during the on-site investigation;
   (7) If the on-site investigation fails, the staff will conduct a second on-site investigation after the applicant completes the rectification within the specified time;
   (8) If the on-site investigation is passed, the applicant will receive a cosmetic manufacturing and sales business license issued by the prefectural government within 45~60 days after the on-site investigation; or the prefectural government will issue a permit postcard, and the applicant holds the postcard can go to the government department to obtain a cosmetic manufacturing and selling business license;
   (9) For all cosmetics to be manufactured, imported and sold, relevant declaration forms should be submitted to the prefectural government;
   (10) Commence the operation of business.
   

KAIZEN Group is equipped with experienced and highly qualified professional consultants and is therefore well positioned to provide professional advices and services in respect of the formation and registration of company, application for various business licences and permits, company compliance, tax planning, audit and accounting in China. Please call and talk to our professional consultants for details.