The Japanese Government sets objectives to relax or abolish many of the current regulatory items in various industries. As a part of these plans, cosmetic deregulation has been progressing based on the government's policy to review current licensing systems and ingredient labeling controls . A committee, which was organized on the basis of a plan drafted by the government, was commissioned in order to figure out how to bring about a deregulated domestic market and a harmonized international market . On March 31, 1997 the future direction and issues to be addressed in connection with cosmetic regulations were set out by the committee in the form of an interim report . The following is an outline that indicates the shift of the regulatory system to one based on the manufacturers' self-responsibility, basically similar to that of the European Union and the United States [4,10].
1. Ingredient substance controls: Recompilation of the Negative List, the Positive List, and the Existing List of Ingredient Substances in order to abolish the current premarketing licensing systems.
2. Licensing systems for companies manufacturing and importing cosmetics: Maintenance of current systems in principle, while establishing new quality-control systems and simplifying requirements for license approval.
3. Ingredients labeling control: Creation of regulations that force cosmetic manufactures and importing companies to include all ingredients on the label in order to give consumers sufficient information to help them evaluate and select the cosmetics.
4. Promotion of the appropriate uses of cosmetics, and collecting and releasing to the public information on the safety of cosmetics.
After investigation by the working group on the specific issues indicated by the interim report, the committee has issued a final report. The report is entitled ''How cosmetic regulations should be in the future'' and consists of three parts [4,5]; 1) background of discussions on cosmetic regulation, 2) desired future regulations and specific handling procedure, and 3) issues remaining to be addressed.
The main points of the second part (desired future regulations and specific handling procedure) are as follows:
(1) Ingredient Control. It is appropriate to control the use of the ingredients through a list of prohibited and restricted ingredients (Negative List), and by doing so to abolish the approval system by category, as well as to control specific ingre-
Development of a new ingredient or introduction of a product containing a new ingredient
Verification [collection and examination of information! by the company manufacturing (or importing) the product (or raw material) •Verification of its applicability to the Positive List •Verification of Its applicability to the Negative List or Restricted List -Application for name to be used in labeling (naming review committee of the industry association) ^
Specification of the ingredient and decision on the name to be used for labeling, followed by placement on the existing ingredient list
(Positive List ingredients)
(Nonpositive List ingredients)
Request to have the Product can be marketed ingredient listed on the -Label indicating all
Positive List the ingredierts
•Attach safety data documents
Acquisition of new information pertaining to safety of the ingredient used (companies and administration)
^(Ingredients requiring review on whether to place on Negative List or Restricted List)
Submission of safety data documents, etc.
Implementation of safety évaluation (MHW)
Entry in Positive List
Marketing of product enabled
Evaluation and review of safety, etc. (MHW)
Entry in Negative List ar Restricted List
Figure 1 Flow chart of the procedure for treating new ingredients for cosmetics. (From Refs. 4 and 5.)
dient groups (preservatives, UV absorbents, coal tar colors) that require cautious handling under appropriate safety evaluation, by drawing up a list of ingredients that may be used in formulations (Positive List). As for the new ingredients, the procedure for introducing them shall be as indicated on the flow chart shown in Figure 1 [4,5].
(2) Licensing System. A manufacturing or importing licensing system should be maintained.
(3) Regulations on Ingredient Labeling. As it is important to provide adequate information to consumers to facilitate their selection and verification of a product, in principle an ''all-ingredient labeling system'' shall be adopted for ingredients used in formulations.
(4) Cosmetic information, etc.
The MHW is now studying the possibility of amending the law and regulations in order to implement the new system by fiscal year 2000 according to the final report.
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