It is of great significance to stay abreast of cosmetic regulations and updates before entering markets in different countries. ZMUni has sorted out important regulations from major markets. This article is Japan Standards for Cosmetics.
In accordance with the provisions of Article 42, Paragraph 2 of the Pharmaceutical Affairs
Law (Law No.145 of 1960), the Standards for Cosmetics are hereby established as follows
and shall be applied from April 1, 2001, and the Quality Standards for Cosmetics (Ministry of
Health and Welfare Notification No.321 of August 1967) and the Japanese Standards for
Cosmetic Ingredients (Ministry of Health and Welfare Notification No.322 of August 1967)
shall be abolished on March 31, 2001; provided, however, that any medical drug ingredients
which are also cosmetic ingredients that have actually been approved pursuant to Article 14,
Paragraph 1 of the said law at the time of application of this notification or which are also
cosmetic ingredients listed in the Appendix of the Ministry of Health and Welfare Notification
No.15 of February 1961 (Re: Designation of Cosmetic Ingredients that must be Approved for
Each Item in Accordance with the Provisions of Article 14, Paragraph 1 of the Pharmaceutical
Affairs Law) may, regardless of the provisions of section 2 below, be used as cosmetic
ingredients only if used in the amount for which the cosmetic ingredient was approved or the
amount of the cosmetic ingredient as listed in the said Appendix, as the case may be; and
provided further, that any cosmetics manufactured or imported on or before March 31, 2001,
shall be treated as though this notification were not established.
Standards for Cosmetics
1. General provisions
Ingredients of cosmetics, including any impurities contained therein, shall not contain
anything that may cause infection or that otherwise makes the use of the cosmetics a
potential health hazard.
2. Prohibition of inclusion of ingredients other than preservatives, UV absorbers and tar
colors
Cosmetics shall not contain any medical drug ingredients (excluding those used only as
additives and those listed in Appendix 2-1 through 4), or any ingredients that do not
meet the Standards for Biological Materials (Ministry of Health, Labour and Welfare
Notification No.210 of 2003), Class I Specified Chemical Substances provided in the
Law Concerning the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. Article 2, Paragraph 2 (Law No.117 of 1973), or Class II Specified
Substances provided in the same law Article 2, paragraph 3 or the materials that are
determined by the Minister of Health, Labour and Welfare and have property similar to
these substances, or any of the materials listed in Appendix 1.
3. Limitation on inclusion of ingredients other than preservatives, UV absorbers and tar
colors
If any of the materials listed in the section of ingredient names of Appendix 2 is
1incorporated in a cosmetic, the amount of such ingredient contained shall be under the
values in the column of maximum amount of ingredient per 100 g of the said Appendix.
4. Limitation on inclusion of preservatives, UV absorbers and tar colors
Any and all preservatives (meaning materials incorporated in cosmetics for the purpose
of inhibiting growth of microorganisms in such cosmetics) incorporated in cosmetics
shall be among those listed in Appendix 3.
Any and all UV absorbers (meaning materials that specifically absorb ultraviolet rays
and that are incorporated in cosmetics for the purpose of protecting skin or hair from
adverse effects of ultraviolet rays) incorporated in cosmetics shall be among those listed
in Appendix 4.
The provisions of Article 3 of the Ministerial Ordinance for the Designation of Tar
Colors That May Be Used in Medical Drugs, Etc. (Ministry of Health and Welfare
Ordinance No.30 of 1966) shall be applied mutatis mutandis to tar colors incorporated
in cosmetics; provided, however, that Red No.219 and Yellow No.204 may be
incorporated only in cosmetics applied to hair and nails.
Click here to read Appendix 1, 2, 3, and 4: https://www.zmuni.com/archives/8323
For more cosmetic information or regulations, please contact info@zmuni.com.
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