Report of Market Access Ombudsman Council (May 13, 1994)

1-(7) Relaxing Restrictions on Imports of Cosmetics and Perfumes

1. Complainant: French Embassy

2. Ministry concerned: Ministry of Health and Welfare

3. Complaint:

Under the provisions of Japan's Pharmaceutical Affairs Law, when cosmetics are imported a permit (in the case of cosmetics containing hormones, approval and permission) from the Minister of Health and Welfare is needed for each type of cosmetics product imported. The Law also states that the Minister of Health and Welfare may establish the necessary standards for cosmetics.

The complainant has raised the following issues regarding this system.

(1) It takes from 3-6 months to gain approval for import of cosmetics and perfumes, and this period of time should be shortened.

(2) Even ingredients already tested in European or American testing facilities must be retested in Japan, but foreign testing data should be accepted.

(3) Three types of ingredients made from formaldehyde (Germal 115, Dowicil 200, Glydant XL 1000), which are not allowed in Japan, are approved in Europe and the U.S., and their use should be permitted in Japan as well.

4. Results of deliberation:

(1) Regulations to ensure the quality and safety of cosmetics are necessary to improve public health and sanitation, but the question of whether the current system is fulfilling its purpose adequately should continue to be studied and regulation kept to a minimum.

(2) Regarding shortening the time needed for import approval, the fact that the ministry concerned will introduce an application and examination system using floppy disks for import approval procedures in FY1995 is a positive development. Active measures such as improving the examination system will be taken to speed up procedures and to improve the examination system.

The ministry concerned should continue to take steps to accept scientifically reliable foreign testing data and should clearly specify the testing data needed for import approval procedures and keep the required amount of data to a minimum.

The Central Pharmaceutical Affairs Council is already examining whether to accept the use of ingredients made from formaldehyde, and the concerned ministry should conduct this examination at as rapid a pace as possible.

Government decision (June 24, 1994)

1-(7) Simplifying and speeding up import approval procedures for cosmetics

(1) An application and examination system using floppy disks for import approval procedures will be introduced in FY1995, and the processing period for Import approval is expected to be shortened in FY1996.

(2) The Central Pharmaceutical Affairs Council is already whether to accept the use of ingredients made from formaldehyde, and this examination will be conducted as rapid a pace as possible.

Follow-up (June 5, 1995)

1-(7) Relaxing Restrictions on Imports of Cosmetics and Perfumes

(1) Regarding approval and permission for pharmaceuticals, quasi-pharmaceuticals and cosmetics, the rules on the application of the Pharmaceutical Affairs Law were amended in February 1995 to permit applications to be made by floppy disk, in addition to the existing method of submitting applications on paper.

Information regarding this new application and examination system is being spread to local governments through meetings of section chiefs in charge of this matter. The businesses concerned are being notified, and information on the system is also being spread through meetings to explain procedures for application by floppy disk. To ensure smooth application of the system, local governments are being sent operating manuals and training sessions on operation of the system are being held.

(2) Regarding whether to accept the use of ingredients made from formaldehyde, the Central Pharmaceutical Affairs Council is examining the safety of the ingredients in question. The applicant is currently preparing for replies to Council questions concerning data on the safety and effectiveness of the ingredients and collecting information on safety, and Council deliberations will proceed once this is received.