Japan Updated the Positive List of Additives in Hair Dyes and Permanent Wave Products for the First Time in Five Years

"Collections of Quasi-drugs Additives Standards” is no longer used as a specification reference for additives of hair dyes and permanent wave products. A new hair dye additive has been added to the Positive List of Hair Dye Additives. Up to now, a total of 1,849 additives are included in the list.

On Sept. 30, 2021, Japan MHLW updated two positive lists, involving "The Positive List of Additives in Hair Dyes" and "The Positive List of Additives in Permanent Wave". This update not only revised the product specification requirements but also relaxed the additive change application requirements. At present, there are a total of 1,849 types of additives that can be used in hair dye products and 1,836 types of additives that can be used in permanent wave products.

The main revisions are as follows:

Revised Items	The Positive List of Additives in Hair Dyes	The Positive List of Additives in Permanent Wave Products	Remarks
Specification requirements	Specification References: Japanese Pharmacopeia Japanese Standards of Food Additives Japanese Standards of Quasi-drug Ingredients 2021 Japanese Industrial Standards Specification for tar pigments that can be used in pharmaceutical products (Attached Table 1, 2, 3)		Delete the "Collections of Quasi-drugs Additives Standards" from the specification references.
Specification requirements	[Column 12: Old Ingredient Name in Appendix 3 of Notification No. 533] is deleted in the new list for the Appendix 3* has already invalid.	[Column 12: Old Ingredient Name in Appendix 3 of Notification No. 111] is deleted in the new list for the Appendix 3* has already invalid.	/
Additives	"No.0047: Aminoethylaminopropylmethylsiloxane• Dimethylsiloxane Copolymer" is newly added to the list and in accordance with the "Japanese Standards of Quasi-drug Ingredients 2021".	No changes	Up to now, 1,849 additives are allowed to be used in hair dye products and 1,836 additives are allowed to be in permanent wave products.
Change approval application	It is not necessary to apply a partial amendment or minor change if only to revise the name or ingredient code of the additive. It is permissible to make changes simultaneously when there is an opportunity to submit a partial change approval application or a minor change notification pursuant to other reasons.		Relax the additive change application requirements. At present, if only the ingredient code is modified, there is also no need to apply for a partial modification or minor modification.
* In the original "Standards for Manufacturing and Marketing Approval of Hair Coloring Agents" and "Standards for Manufacturing and Marketing Approval of Permanent Wave Agents", active ingredients are listed in Appendix 3 are subject to specific standards. However, since 2015, Appendix 3 has been deleted.

On the same day, MHLW also released the template for the separated application of permanent wave products with immediate effect. Traditionally, permanent wave products' "first agent" and "second agent" are manufactured and sold as a bundle. Since 2014, for professional use only, the "first agent" and "second agent" are required to submit application separately.

According to the template, the active ingredients in Attached Table 1 of "The Standards for Marketing Approval of Permanent Wave Agents" shall be subject to separated application, excluding the following two ingredients.

Single-step Cold Permanent Wave Agents containing thioglycolic acid and/or its salt as active ingredients
Dual-step Permanent Wave Agents with the first agent containing thioglycolic acid and/or its salt as active ingredients (consisting of components to be mixed at use, generating exothermal reaction)