Responsible engineer

Updated: July 2025, 6

Cosmetics manufacturers are required to appoint a responsible engineer to be responsible for cosmetics manufacturing operations.
The role of the Chief Engineer is to manage the manufacturing process based on the manufacturing control procedures and the quality and product standards for each cosmetic product, and to determine whether or not the product can be shipped from the manufacturing facility.

　Article 17, paragraph 10 of the Pharmaceuticals and Medical Devices Act stipulates the following:

(Appointment of General Pharmaceutical Manufacturers and Distributors and Matters to be Complied with)
Article 16-2 Manufacturers of quasi-drugs or cosmetics must, pursuant to an Ordinance of the Ministry of Health, Labour and Welfare, appoint a technical supervisor at each manufacturing facility to supervise the on-site manufacture of quasi-drugs or cosmetics.

The important thing here is"By manufacturing plant"That's the point.
If a manufacturing company has multiple factories or other production locations, it must assign a production engineer to each production location.
On the other hand, unlike a cosmetics manufacturing and sales license, a cosmetics manufacturing license does not require multiple responsible persons such as the "three pharmaceutical officials."

　Requirements (qualifications) for a Chief Engineer

The responsible engineer can be appointed by a person who meets the following requirements based on Article 17, Paragraph 5 of the Pharmaceutical and Medical Device Act.

①Pharmacist

Applies to those who hold pharmacist qualifications.
Since full-time employment at a licensed cosmetics manufacturing company is required, a person who works at another pharmacy cannot be appointed as a responsible technician.

② Those who have completed a specialized course related to pharmacy or chemistry at a junior high school or high school under the old system, or a school of equivalent or higher level.

Those who have earned a certain number of credits in pharmacy or chemistry at a high school, vocational school, university, etc. fall under this requirement.
Although the number of credits etc. differs depending on the local government, in general, students are required to have completed 10 to 20 credits of courses related to pharmacy or chemistry as specialized courses at university.

③ A person who has completed specialized subjects related to pharmacy or chemistry at a junior high school or high school under the old system, or a school of equivalent or higher level, and has been engaged in work related to the manufacturing of pharmaceuticals, quasi-drugs, or cosmetics for three years or more.

Those who have earned a certain number of credits in pharmacy or chemistry at a high school, vocational school, university, etc., and who have worked in cosmetics manufacturing for three years or more at a licensed manufacturer of pharmaceuticals, quasi-drugs, and cosmetics. This requirement applies to those who have work experience.
Experience at a licensed manufacturer of pharmaceuticals, quasi-drugs, and cosmetics is required; experience at a manufacturing/distributing company or a manufacturer other than pharmaceuticals, quasi-drugs, and cosmetics does not meet this requirement.
The number of credits etc. differs depending on the local government, but generally speaking, if you have taken chemistry as a regular high school subject, you can be selected as long as you meet the qualifications for work experience.

　Concurrently serves as general manufacturing and sales manager of cosmetics manufacturing and sales industry

The general manufacturing and sales manager of a cosmetics manufacturer and the responsible technical officer of the manufacturing industry work at the same location, and it is possible for them to hold concurrent positions to the extent that it is reasonable, such as not interfering with each other's work..

　For consultation regarding cosmetics-related permits, 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 can be said to be one of the fields in which there are few administrative scriveners who can handle them.

Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.