7th Report of Market Access Ombudsman Council (March 18, 2002)

2-(2) Easing regulations on displaying ingredients of cosmetics

1. Complainant: Tokyo Chamber of Commerce and Industry

2. Ministry concerned: Ministry of Health, Labour and Welfare

3. Complaint:

With regard to labeling cosmetics, Article 61 of the Pharmaceutical Affairs Law As a result of deregulation of cosmetics in and after April 2001, the Enforcement Regulations of the Pharmaceutical Affairs Law was partially revised, increasing the number of ingredients that can be used in cosmetics and allowing the importation of previously prohibited ingredients of preservatives, such as "1,3-dimethylol-5, 5-imethyl hydantoin," "N, N"-methylenebis," and "N'-(3-hydroxymethyl-2, 5-dioxo-4-imidazoline) urea," although the amount of their use is restricted. However, the revised law stipulates that products that contain above ingredients shall be labeled with instruction to the effect of "Please refrain using the product to persons sensitive to allergy and infants."
Labeling the instruction on products may make consumers uneasy about the safety of the products and injure the reputation of the sellers. In the United States and other foreign countries, these ingredients have long been used without such an instruction.
Therefore, we want the requirement of labeling the instruction to be deleted from the regulations.

4. Corresponding Policy of the Ministries concerned:

We have approved the use of formalin-type preservatives as an ingredient of cosmetics on condition that an instruction, "Persons sensitive to formaldehyde and infants are advised to refrain from using," is labeled on the product. Our step is designed to isolate the skin-reactive, allergy-causing formaldehyde (a prohibited ingredient) and is based on the result of deliberation of scientific data by the Central Pharmaceutical Affairs Council.
If new scientific knowledge becomes available, we will carefully study whether to revise the labeling regulation in question, in consultation with the Pharmaceutical Affairs and Food Sanitation Council.

5. Remarks
The complainant accepted this policy.