5th Report of Market Access Ombudsman Council (March 17, 1998)

2-(3) Give the regulations on the ingredients used in cosmetics the same form as those of the E.U.

1. Complainant: Tokyo Chamber of Commerce

2. Ministry concerned: Ministry of Health and Welfare

3. Complaint:

(1) Concerning regulations on the ingredients used in cosmetics, abolishing the system requiring approval for each type and switching to regulations based on a "negative list" would give direction to the deregulation. Along with giving the following content the same form as that of the E.U., the E.U.'s data should be accepted for conformance evaluation.

1) Negative list
2) A positive list for when the transition to the negative list is made
3) Handling of new combined ingredients
4) List of existing combined ingredients

(2) Items unique to Japan (concerning report format, data submission, etc.) should not be part of the approval procedure.

4. Corresponding Policy of the Ministries concerned:

Concerning Japan's cosmetic regulations, in December of 1996, an investigative committee on appropriate cosmetic regulations was established to investigate how to achieve deregulation; international harmonization is under investigation, giving maximum consideration to ensuring consumer safety. In March of 1997, the collected findings were presented in terms of future direction for cosmetic regulations and related subjects.

Concerning regulations on the ingredients used in cosmetics, it has been indicated that from the standpoint of corresponding promptly to diverse needs and ensuring safety, ingredients for which combination is prohibited or limited that are published on the negative list will be regulated, the same as in the EU and U.S.A., and along with abolishing the approval system, for a specified group of ingredients, such as preservative, ultraviolet-light absorbent, and tar pigment, the names of the ingredients that it is possible to combine will be collected, a positive list established, and regulation enforced in kind.

At present, concerning the actual topics pertaining to the adoption of such methods that are similar to those of the EU and U.S.A. have been examined by the working group of the investigative committee. Differences between the U.S. and Europe in the items published on the list and differences in the groups of ingredients on the positive list will be examined and the challenge of achieving international harmonization with the EU and U.S.A. taken on.

The working group was held in December of 1997 and January of 1998, and their report is scheduled for discussion by the investigative committee during fiscal year 1997.

The final report of the investigative committee is expected to be made public in May of 1998.

5. Remarks
The complainant's opinion is as follows:
"This policy is satisfactory."