事務連絡
令和３年９月 30 日

各都道府県衛生主管部（局）薬務主管課 御中

厚生労働省医薬・生活衛生局医薬品審査管理課

パーマネント・ウェーブ用剤製造販売承認基準の英訳について

医薬部外品のうち、パーマネント・ウェーブ用剤の製造販売の承認基準については、「パーマネント・ウェーブ用剤製造販売承認基準について」(令和３年６月 28 日付け
薬生発 0628 第 10 号厚生労働省医薬・生活衛生局長通知)により示してきたところですが、別添のとおり、当該基準の英訳を作成しましたのでお知らせいたします。
なお、本事務連絡の発出に伴い、「パーマネント・ウェーブ用剤製造販売承認基準の英訳について」（平成 27 年 11 月 11 日付け厚生労働省医薬食品局審査管理課事務連絡）は廃止します。

Provisional Translationfrom Japanese Original
June 28, 2021
Notification PSEHB No.0628-10

The Standards for Marketing Approval of Permanent Wave Agents
1. Scope of the standards
The standards shall apply to external preparations for hair (except leg/arm hair andeyebrow/eyelash) intended to be used for “creating and preserving waves in the hair” or“straightening the frizzy, curly or wavy hairs, and preserving that condition”; these preparations
are hereinafter referred to as “permanent wave agents”, regardless of ingredients contained
therein.
2. Standards
The standards for marketing approval of permanent wave agents (hereinafter referred to as“standards for approval”) are as follows.
For permanent wave agents that do not meet the standards, documents regarding its efficacy,
safety, and ingredient formulation, purpose, etc. shall be submitted for review.
(1) Types of active ingredients
Active ingredients which are permitted to be used shall be those listed in the attached Table 2
and their corresponding usage classification shall be listed in the attached Table 1.
A. Dual-step Cold or Tepid Permanent Wave Agents containing thioglycolic acid and/or its salt as
active ingredients
The preparation shall contain at least one or more active ingredients listed in Column I of theattached Table 2 as the first agent and at least one or more active ingredients listed in either A or
B of Column III of the same Table as the second agent.
B. Dual-step Cold or Tepid Permanent Wave Agents containing cysteine, its salt and/or
acetylcysteine as active ingredients
The preparation shall contain at least one or more active ingredients listed in Column II of theattached Table 2 as the first agent and at least one or more active ingredients listed in either A or
B of Column III of the same Table as the second agent.
C. Single-step Cold Permanent Wave Agents containing thioglycolic acid and/or its salt as active
ingredients
The preparation shall contain at least one or more active ingredients listed in Column I of theattached Table 2.
D. 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)
The preparation shall contain at least one or more active ingredients listed in Column I of theattached Table 2 as the first agent (1), at least one or more active ingredients listed in A of Column
III of the same Table as the first agent (2) and at least one or more active ingredients listed ineither A or B of Column III of the same Table as the second agent.
E. Dual-step Cold or Dual-step Tepid Hair Straightening Agents or Dual-step Cold or Dual-step
Tepid (using a high temperature hair-iron) Hair Straightening Agents containing thioglycolicacid and/or its salt as active ingredients
The preparation shall contain at least one or more active ingredients listed in Column I of theattached Table 2 as the first agent and at least one or more active ingredients listed in either A or
B of Column III of the same Table as the second agent.
(2) Amounts of active ingredients
The range and the upper limit of the content of active ingredients and the oxidizing activity perdose per person shall be as shown in the attached Table 2.
(3) Standards of active ingredients
The standards of active ingredients shall be as shown in the attached Table 2.
(4) Types, standards and amounts of additives
A. Types, standards and amounts of additives shall be as specified by the Director of thePharmaceutical Evaluation Division in Pharmaceutical Safety and Environmental HealthBureau, the Ministry of Health, Labor and Welfare.
B. If the first agent of Dual-step Cold Permanent Wave Agents, Dual-step Cold Hair
Straightening Agents or Dual-step Cold (using a high temperature hair-iron) Hair Straightening
Agents contains the active ingredients listed in Column I of the attached Table 2 with a total
amount as thioglycolic acid exceeding 7.0%, it shall contain dithiodiglycolic acid and/or its saltwith an amount as dithiodiglycolic acid equal to or more than the excess of the active ingredientsas thioglycolic acid.
C. If cysteine, its salt and/or acetylcysteine are contained as additives in preparations with theactive ingredients in Column I of the attached Table 2, the total amount of the additives shall be
no more than 1.5% as cysteine. In this case, the total reducing power shall not exceed the upper
limit of that corresponding to “the reducing substance after boiling under acidic condition”.
D. If thioglycolic acid and/or its salt are contained as additives in preparations with the active
ingredients in Column II of the attached Table 2 as additives, the total amount of the additives
shall be no more than 1.0% as thioglycolic acid. In this case, the total reducing power shall not
exceed the upper limit of that corresponding to “cysteine”.
(5)

Each active ingredient listed in the attached Table 2 shall be specified with the standards of theJapanese Standards of Quasi-Drug Ingredients (indicated by “Q” in the Table), the Japan’sSpecifications and Standards for Food Additives (indicated by “F” in the Table), and the JapaneseIndustrial Standards (indicated by “J” in the Table), and the attachment of the aforementioned
standards may be omitted.

(6) Product forms
The first agent shall be in liquid, paste, cream or aerosol form etc. The second agent shall be inpowder, tablet, liquid, paste, cream or aerosol form etc. They shall not be misidentified to be a
medicinal product.

(7) Dosage and administration
Product labels shall clearly indicate the correct dosage and administration, leaving no room formisuse.
(8) Indications
Product indication shall be selected from “for creating and preserving waves in the hair” or“straightening the frizzy, curly or wavy hairs, and preserving that condition” depending on theintended uses.
(9) Standards and testing methods
Preparations shall meet the attached Quality Standards for Permanent Wave Agents.

[Attached Table 1]

Classification of active ingredients of Permanent Wave Agents
Column III

Column II

Column I

Product forms

Application type

Indications

Classification

Attached Table 2

A B

Hair straightening

Permanent wave

Dual-step Cold or Tepid Permanent Wave Agents
containing thioglycolic acid and/or its salt as active
ingredients

Dual-step Cold or Tepid Permanent Wave Agents
containing cysteine, its salt and/or acetylcysteine asactive ingredients

Single item
application
Separated
application※１
Single item
application

First agent
Second agent
First agent
First agent
Second agent

Separated
application※１

First agent

Single-step Cold Permanent Wave Agents containing
thioglycolic acid and/or its salt as active ingredients

Single item
application

First agent

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 atuse, generating exothermal reaction)

Single item
application

Dual-step Cold or Dual-step Tepid Hair Straightening
Agents or Dual-step Cold or Dual-step Tepid (using ahigh temperature hair-iron) Hair Straightening Agents
containing thioglycolic acid and/or its salt as active
ingredients

Oxidation Agents for Permanent Wave Agents※２

First agent-(1)First agent-(2)Second agent
Single item
application

First agent
Second agent

Separated
application※１

First agent

Separated
application※１

Second agent※１ For Professional Use Only
※２ Oxidation Agents for Permanent Wave Agents includes those used as Hair Straightening Second agents

Q
Q
Q
F
Q

Column III

F
A

J
Q

B

Q
Q
Q

Hydrogen peroxide
Hydrogen peroxide
solution
Sodium perborate
Potassium bromate
Sodium bromate

First agent(2) 2.7-3.0

Remarks

0.8-3.0

not less than
3.5

as thioglycolic
acid

2.5

as cysteine

Column IIQ

as hydrogen
peroxideQ

aspotassium
bromateQ

Oxidizing
activity perdose perpersonQ

Classification of active ingredients of Permanent Wave AgentsFirst agent
Second agent
Range of the content (%)
DualDual- SingleName of Components
Prepare
step
step
step
before use
Cold
Tepid
Cold
Thioglycolic acid
AmmoniumFirst agent
thioglycolate solution
2.0-11.0 1.0-5.0 3.0-3.3(1)
8.0-19.0
Monoethanolamine
thioglycolate solution
L-Cysteinehydrochloride
DL-Cysteinehydrochloride
L-Cysteine
3.0-7.5
1.5-5.5
DL-Cysteine
L-Cysteine
Monohydrochloride
N-acetyl-L-cysteine
Upper limitof thecontent (%)

Column I

Standard[Attached Table 2]

Attachment

Quality Standards for Permanent Wave Agents
1. Dual-step Cold Permanent Wave Agents containing thioglycolic acid and/or its salt as active
ingredients
These agents are used at room temperature. They consist of the first agent containing thioglycolicacid and/or its salt and the second agent containing an oxidizing agent. The quality standards forthe first and the second agents are as follows.
(1) First agent
The first agent is a liquid containing thioglycolic acid and/or its salt as active ingredient with a
total amount of nonvolatile inorganic alkali not exceeding the equivalent amount of thioglycolic
acid. It should meet the following requirements (a) to (f). A suitable alkaline substance, penetrant,
moisturizing agent, coloring agent, emulsifying agent, perfume and other substances may be
added to this agent in order to maintain quality and to enhance usefulness.
(a) pH
Measure the pH of this agent at 25°C using a glass electrode pH meter: it is between 4.5 and
9.6.
(b) Alkali
Take exactly 10 mL of a sample in a 100 mL volumetric flask, add purified water (hereinafterreferred to as “water”) conforming to the Japanese Standards of Quasi-Drug Ingredients (PSEHB
Notification No. 0325-1, March 25, 2021; hereinafter referred to as JSQI) to make 100 mL, anduse this solution as the sample solution.
Measure exactly 20 mL of the sample solution, and titrate with 0.1 mol/L hydrochloric acid VS.
The amount of the volumetric solution consumed is not more than 7 mL per mL of the sample(Indicator：2 drops of methyl red TS).
(c)

Reducing substance after boiling under acidic condition
Measure exactly 20 mL of the sample solution obtained in (b), add 50 mL of water and 5 mL of
30 % sulfuric acid, and boil for 5 minutes by gentle heating. After cooling, titrate with 0.05 mol/Liodine VS, and designate the amount of 0.05 mol/L iodine VS consumed as A mL (indicator: 3 mLof starch TS).
The content (as thioglycolic acid, %) of the reducing substance after boiling under acidic
conditions calculated by the following equation shall be between 2.0 % and 11.0 %.
Content (%)(as thioglycolic acid) of the reducing substance after boiling under acidic
condition=0.4606×A
However, when the content of the reducing substance after boiling under acidic conditions ismore than 7.0 %, dithiodiglycolic acid or its salt shall be contained as additives in an amount of
dithiodiglycolic acid equal to or more than the excess of the reducing substance after boiling underacidic conditions.

(d) Reducing substance other than the reducing substance after boiling under acidic condition
To 50 mL of water and 5 mL of 30 % sulfuric acid in a 200 mL glass-stoppered flask add exactly
25 mL of 0.05 mol/L iodine VS. To this solution add exactly 20 mL of the sample solution obtainedin (b), stopper the flask tightly, shake, allow to stand at room temperature for 15 minutes, titratewith 0.1 mol/L sodium thiosulfate VS, and designate the amount of the volumetric solution
consumed as B mL (indicator: 3 mL of starch TS). Separately, take 70 mL of water and 5 mL of
30 % sulfuric acid in a 200 mL glass-stoppered flask, proceed in a similar manner and designate
the amount of the volumetric solution consumed as C mL.
The amount per mL of the sample of 0.05 mol/L iodine VS consumed for the reducing substanceother than the reducing substance after boiling under acidic condition, which is calculated by thefollowing equation, is not more than 0.6 mL.
Amount (mL) per mL of the sample of 0.05 mol/L iodine VS consumed for the reducing
substance other than the reducing substance after boiling under acidic condition= [(C-B)-A]/2(e) Reducing substance after reduction
Measure exactly 20 mL of the sample solution obtained in (b), add 30 mL of 1 mol/L hydrochloric
acid and 1.5 g of zinc powder (85), stir by a stirrer for 2 minutes with careful attention not to mix
air bubbles, and filter the solution under vacuum through a filter paper (4A). Wash the residue
with a small amount of water three times, add washing to the filtrate and boil for 5 minutes by
gentle heating. After cooling, titrate with 0.05 mol/L iodine VS, and designate the amount of 0.05
mol/L iodine VS consumed as D mL (indicator: 3 mL of starch TS).
Or, measure accurately 10 g of the sample, add 50 mL of sodium lauryl sulfate solution (1 in 10)
and 20 mL of water and heat to approximately 80°C on a water bath. After cooling, make 100 mL
in total, use this solution as the sample solution and proceed in a similar manner.
The content (%) of the reducing substance after reduction calculated by the following equation is
not more than 4.0 %.
Content (%) of the reducing substance after reduction = [4.556× (D-A)]/W
W: Amount of the sample (mL or g)
(f)

Iron
To 20 mL of the sample in a 300 mL decomposition flask add 20 mL of nitric acid, and heat
carefully until the reaction subsides. After cooling, add 5 mL of sulfuric acid, and heat again. To
this solution add carefully 2 mL portions of nitric acid, and heat until the solution is clear andcolorless or light yellow. After cooling, add 1 mL of perchloric acid (70), heat until the white fumesof sulfuric acid evolve, and allow to cool. Add 20 mL of a saturated solution of ammonium oxalate,and heat until white fumes evolve. After cooling, add water to make 100 mL, and use this solution
as the sample solution.
Separately, prepare a solution with 20 mL of water in the same manner as the sample solution.
To 50 mL of this solution add exactly 2.0 mL of Standard Iron Solution, adjust to a pH between 9.5
and 10.0 by adding carefully ammonia water (28) under cooling, and use this solution as thestandard matching fluid. Transfer the two solutions to separate Nessler tubes, to each add exactly
1.0 mL of mercaptoacetic acid, and add water to make 100 mL.
Compare the colors of the two solutions: the sample solution has no more color than thestandard matching fluid (not more than 2 ppm as iron).

(2) Second agent
The second agent should meet the following requirements (a) or (b).
(a) Potassium bromide, sodium bromide, sodium perborate or the mixture of these substances towhich a suitable osmotic agent, stabilizing agent, moisturizing agent, coloring agent, emulsifying
agent, perfume and other substances may be added for maintaining quality or enhancing

usefulness of the product.
(i) Clarity and color of solution
For preparations in powder or in tablet form, dissolve an amount of the sample per dose perperson in 200 mL of cold or lukewarm water, take in a colorless flat bottomed colorimetric tube,
and observe vertically against white paper: no distinct insoluble foreign matters are observable.
(ii) pH
Perform the test as directed in 1-(1)-(a) with the second agent prepared before use inaccordance with Dose and Administration: the pH of this solution is between 4.0 and 10.5.
(iii) Oxidizing activity
Measure accurately about a tenth of an amount of the second agent prepared before use
according to the Dose and Administration in a 200 mL volumetric flask and add water to make200 mL. Transfer 20 mL of the solution to a glass-stoppered flask, add 10 mL of dilute sulfuric
acid, stopper tightly at once, and shake once or twice gently. To this solution, add 10 mL ofpotassium iodide TS carefully, stopper tightly, allow to stand in a dark place for 5 minutes,
titrate with 0.1 mol/L sodium thiosulfate VS, and designate the amount of the volumetricsolution consumed as E mL (indicator: 3 mL of starch TS).
The oxidizing activity per dose per person, calculated by the following equation, is not lessthan 3.5.
Oxidizing activity per dose per person=0.2783×E(b) Hydrogen peroxide or hydrogen peroxide to which a suitable osmotic agent, stabilizing agent,moisturizing agent, coloring agent, emulsifying agent, perfume and other substances may be
added for maintaining quality or enhancing usefulness of the product.
(i) pH
Perform the test as directed in 1-(2)-(a)-(ii): the pH of the solution obtained is between 2.5 and
4.5.
(ii) Oxidizing activity
Measure exactly 1 mL of the sample in a 200 mL glass-stoppered flask, add 10 mL of waterand 5 mL of 30% sulfuric acid, stopper tightly at once, and shake once or twice gently. To thissolution, add 5 mL of potassium iodide TS carefully, stopper tightly, allow to stand in a darkplace for 30 minutes, titrate with 0.1 mol/L sodium thiosulfate VS, and designate the amount of
the volumetric solution consumed as F mL (indicator: 3 mL of starch TS).
The oxidizing activity per dose per person, calculated by the following equation, is between 0.8
and 3.0.
Oxidizing activity per dose per person = 0.001701×F×amount (mL) per dose per person
The content (%) of hydrogen peroxide, calculated by the following equation, is not more than
2.5%.
Content (%) of hydrogen peroxide = 0.1701×F
2. Dual-step Cold Permanent Wave Agents containing cysteine, its salt and/or acetylcysteine asactive ingredients
These agents are used at room temperature. They consist of the first agent containing cysteine,its salt and/or acetylcysteine as an active ingredient and the second agent containing an oxidizing
agent. The quality standards for the first and the second agents are as follows.
(1) First agent
The first agent is a liquid containing cysteine, its salt and/or acetylcysteine as an active
ingredient and not containing nonvolatile inorganic alkali. It should meet the following
requirements (a) to (e). A suitable alkaline substance, penetrant, moisturizing agent, coloringagent, emulsifying agent, perfume and other substances may be added to this agent in order tomaintain quality and to enhance usefulness.
(a) pH
Perform the test as directed in 1-(1)-(a): the pH of the solution obtained is between 8.0 and 9.5.
(b) Alkali
Perform the test as directed in 1-(1)-(b): the amount of 0.1 mol/L hydrochloric acid VS consumed
is not more than 12 mL per mL of the sample.
(c) Cysteine(i) Preparation of the sample stock solution
Measure 10 mL of the sample in a suitable reflux apparatus, add 40 mL of water and 20 mL of
5 mol/L hydrochloric acid TS and heat under reflux for 2 hours. After cooling, transfer thesolution into a 100 mL volumetric flask, add water to make 100 mL and use this solution as theundiluted sample stock solution.
For the sample which is known to contain no acetylcysteine, take exactly 10 mL of the sample
in a 100 mL volumetric flask, add water to make 100 mL and use this solution as the undiluted
sample stock solution.
(ii) Preparation of the sample solution
Pass 25 mL of the sample undiluted stock solution through a layer of a column 8 to 15 mm ininside diameter packed with 30 mL of strongly acidic ion-exchange resin (H type) at the flow rateof 2 mL/min. Wash the resin layer with water and discard the eluate and washing. Pass 60 mL of
3 mol/L ammonia water through the resin layer at the flow rate of 2 mL/min, transfer the eluate
to a 100 mL volumetric flask, wash the resin layer with water, and to the combined washing andeluate add water to make 100 mL and use this solution as the sample solution.
(iii) Assay of cysteine
Measure exactly 20 mL of the sample solution, neutralized with dilute hydrochloric acid asneeded (indicator: methyl orange TS), add 4 g of potassium iodide and 5 mL of dilutehydrochloric acid and dissolve with shaking. To this solution, add exactly 10 mL of 0.05 mol/Liodine solution, stopper tightly, allow to stand in ice water in a dark place for 20 minutes, titratewith 0.1 mol/L sodium thiosulfate VS, and designate the amount of the volumetric solution
consumed as G mL (indicator: 3 mL of starch TS).
Perform a blank test in a similar manner and designate the amount of the volumetric solution
consumed as H mL.
The content (%) of cysteine calculated by the following equation is between 3.0 % and 7.5 %.
Content (%) of cysteine=1.212×2× (H-G)
For “Total reducing power” described in 2-(4)-(d) of the approval standards, “20 mL of thesample solution” in this test method shall be deemed to be replaced with “5 mL of the undiluted
sample stock solution”.
(d) Reducing substance after reduction
Measure exactly 10 mL of the sample solution obtained in 2-(1)-(b), add 30 mL of 1 mol/Lhydrochloric acid TS and 1.5 g of zinc powder (85), stir by a stirrer for 2 minutes with carefulattention not to mix air bubbles, and filter the solution under vacuum through a filter paper (4A).
Wash the residue with a small amount of water three times and combine washings and filtrate.
Add 4 g of potassium iodide and dissolve with shaking. To this solution, add exactly 10 mL of 0.05
mol/L iodine solution, stopper tightly, allow to stand in ice water in a dark place for 20 minutes,
titrate with 0.1 mol/L sodium thiosulfate VS, and designate the amount of the volumetric solution

consumed as I mL (indicator: 3 mL of starch TS). Perform a blank test in a similar manner anddesignate the amount of the volumetric solution consumed as J mL.
Separately, measure exactly 10 mL of the sample solution, neutralized with dilute hydrochloric
acid as needed (indicator: methyl orange TS), add 4 g of potassium iodide and 5 mL of dilutehydrochloric acid and dissolve with shaking. To this solution, add exactly 10 mL of 0.05 mol/Liodine solution, stopper tightly, allow to stand in ice water in a dark place for 20 minutes, titratewith 0.1 mol/L sodium thiosulfate VS, and designate the amount of the volumetric solution
consumed as K mL (indicator: 3 mL of starch TS). Perform a blank test in a similar manner anddesignate the amount of the volumetric solution consumed as L mL.
The content (%) of the reducing substance (as cystine) after reduction, calculated by thefollowing equation, is not more than 0.65 %.
Content (%) of the reducing substance (as cystine) after reduction=1.202× {(J-I)-(L-K)}(e) Iron
Proceed as directed in 1-(1)-(f).
(2) Second agent
Proceed as directed in 1-(2).
3. Dual-step Tepid Permanent Wave Agents containing thioglycolic acid and/or its salt as active
ingredients
These agents are warmed to a temperature lower than about 60°C before use. They consist of thefirst agent containing thioglycolic acid and/or its salt as active ingredient and the second agent
containing an oxidizing agent. The quality standards for the first and the second agents are as
follows.
(1) First agent
The first agent is a liquid containing thioglycolic acid and/or its salt as active ingredient, with a
total amount of nonvolatile inorganic alkali not exceeding the equivalent amount of thioglycolicacid.
It should meet the following requirements (a) to (f). A suitable alkaline substance, penetrant,
moisturizing agent, coloring agent, emulsifying agent, perfume and other substances may be
added to this agent in order to maintain quality and to enhance usefulness.
(a) pH
Perform the test as directed in 1-(1)-(a): the pH of the solution obtained is between 4.5 and 9.3.
(b) Alkali
Perform the test as directed in 1-(1)-(b): the amount of 0.1 mol/L hydrochloric acid VS consumed
is not more than 5 mL per mL of the sample.
(c)Reducing substance after boiling under acidic condition
Perform the test as directed in 1-(1)-(c): the content (as thioglycolic acid, %) of the reducing
substance after boiling under acidic conditions is between 1.0 % and 5.0 %.

(d) Reducing substance other than the reducing substance after boiling under acidic condition
Proceed as directed in 1-(1)-(d).
(e) Reducing substance after reductionProceed as directed in 1-(1)-(e).
(f)

Iron
Proceed as directed in 1-(1)-(f).

(2) Second agent
Proceed as directed in 1-(2).
4. Dual-step Tepid Permanent Wave Agents containing cysteine, its salt and/or acetylcysteine asactive ingredients
These agents are warmed to a temperature lower than about 60°C before use. They consist of thefirst agent containing cysteine, its salt and/or acetylcysteine as an active ingredient and the second
agent containing an oxidizing agent. The quality standards for the first and the second agents are
as follows.
(1) First agent
The first agent is a liquid containing cysteine, its salt and/or acetylcysteine as an active
ingredient and not containing nonvolatile inorganic alkali. It should meet the following
requirements (a) to (e).
A suitable alkaline substance, penetrant, moisturizing agent, coloring agent, emulsifying agent,perfume and other substances may be added to this agent in order to maintain quality and toenhance usefulness.
(a) pH
Perform the test as directed in 1-(1)-(a): the pH of the solution obtained is between 4.0 and 9.5.
(b) Alkali
Perform the test as directed in 1-(1)-(b): the amount of 0.1 mol/L hydrochloric acid VS consumed
is not more than 9 mL per mL of the sample.
(c)

Cysteine
Perform the test as directed in 2-(1)-(c): the content (%) of cysteine is between 1.5 and 5.5 %.

(d) Reducing substance after reduction
Proceed as directed in 2-(1)-(d).
(e) Iron
Proceed as directed in 1-(1)-(f).
(2) Second agent
Proceed as directed in 1-(2).
5. Single-step Cold Permanent Wave Agents containing thioglycolic acid and/or its salt as active
ingredients
These agents are used at room temperature. They contain thioglycolic acid and/or its salt as anactive ingredient with a total amount of nonvolatile inorganic alkali not exceeding the equivalentamount of thioglycolic acid. They should meet the following requirements (1) to (6).
A suitable alkaline substance, penetrant, moisturizing agent, coloring agent, emulsifying agent,perfume and other substances may be added to this agent in order to maintain quality and toenhance usefulness.
(1) pH
Perform the test as directed in 1-(1)-(a): the pH of the solution obtained is between 9.4 and 9.6.
(2) Alkali
Perform the test as directed in 1-(1)-(b): the amount of 0.1 mol/L hydrochloric acid VS consumed
is between 3.5 and 4.6 mL per mL of the sample.
(3) Reducing substance after boiling under acidic condition
Perform the test as directed in 1-(1)-(c): the content (as thioglycolic acid, %) of the reducing
substance after boiling under acidic condition is between 3.0 % and 3.3 %.
(4) Reducing substance other than the reducing substance after boiling under acidic condition
Proceed as directed in 1-(1)-(d).
(5) Reducing substance after reduction
Perform the test as directed in 1-(1)-(e): the content (%) of the reducing substance after reduction
is not more than 0.5 %.
(6) Iron
Proceed as directed in 1-(1)-(f).
6. 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)
These agents consist of the first agent-(1) containing thioglycolic acid and/or its salt as active
ingredient, the first agent-(2) containing an amount of hydrogen peroxide smaller than theequivalent amount of thioglycolic acid and/or its salt contained in the first agent-(1) and the second
agent containing oxidizing agent. The first agent-(1) and the first agent-(2) are mixed to raise its
temperature to about 40°C with an exothermic reaction before use. The quality standards for theseagents are as follows.
(1) First agent-(1)This agent is a liquid containing thioglycolic acid and/or its salt as active ingredient. It shouldmeet the following requirements (a) to (f).
A suitable alkaline substance, penetrant, moisturizing agent, coloring agent, emulsifying agent,perfume and other substances may be added to this agent in order to maintain quality and toenhance usefulness.
(a) pH
Perform the test as directed in 1-(1)-(a): the pH of the solution obtained is between 4.5 and 9.5.
(b) Alkali
Perform the test as directed in 1-(1)-(b): the amount of 0.1 mol/L hydrochloric acid VS consumed
is not more than 10 mL per mL of the sample.
(c)Reducing substance after boiling under acidic condition
Perform the test as directed in 1-(1)-(c): the content (as thioglycolic acid, %) of the reducing

substance after boiling under acidic condition is between 8.0 % and 19.0 %.
(d) Reducing substance other than the reducing substance after boiling under acidic condition
Perform the test as directed in 1-(1)-(d): the amount of 0.05 mol/L iodine VS consumed for the
reducing substance other than the reducing substance after boiling under acidic condition per mLof the sample is not more than 0.8 mL. In this test add 50 mL of 0.05 mol/L iodine VS.
(e) Reducing substance after reduction
Perform the test as directed in 1-(1)-(e): the content (%) of the reducing substance after
reduction is not more than 0.5 %.
(f)

Iron
Proceed as directed in 1-(1)-(f).

(2) First agent-(2)This agent is a liquid containing an amount of hydrogen peroxide smaller than the equivalentamount of thioglycolic acid and/or its salt contained in the first agent-(1). It should meet thefollowing requirements (a) to (b).
A suitable penetrant, pH adjusting agent, stabilizing agent, moisturizing agent, coloring agent,emulsifying agent, perfume and other substances may be added to this agent in order to maintainquality and to enhance usefulness.
(a) pH
Perform the test as directed in 1-(1)-(a): the pH of the solution obtained is between 2.5 and 4.5.
(b) Hydrogen peroxide
Take exactly 1 mL of the sample in a 200 mL glass-stoppered flask, add 10 mL of water and 5
mL of 30% sulfuric acid, stopper tightly at once, and shake once or twice gently. To this solution,
add 5 mL of potassium iodide TS carefully, stopper tightly, allow to stand in a dark place for 30
minutes, titrate with 0.1 mol/L sodium thiosulfate VS, and designate the amount of thevolumetric solution consumed as M mL (indicator: 3 mL of starch TS). The content (%) ofhydrogen peroxide calculated by the following equation is between 2.7 % and 3.0 %.
Content(%) of hydrogen peroxide=0.1701× M(3) Mixture of the First Agent-(1) and (2)This product is a 3:1 mixture (in volume) of the first agent-(1) and (2). It contains thioglycolicacid or its salt as active ingredient, with a total amount of nonvolatile inorganic alkali notexceeding the equivalent amount of thioglycolic acid. It should meet the following requirements (a)to (f). It generates heat on mixing and is warmed to about 40°C before using. In the test, mix one
dose per person of the first agent-(1) with one dose per person of the first agent-(2), allow to standat room temperature for 10 minutes, cool to room temperature and use the solution as the sample
solution.
(a) pH
Perform the test as directed in 1-(1)-(a): the pH of the solution obtained is between 4.5 and 9.4.
(b) Alkali
Perform the test as directed in 1-(1)-(b): the amount of 0.1 mol/L hydrochloric acid VS consumed
is not more than 7 mL per mL of the sample.

(c)Reducing substance after boiling under acidic condition
Perform the test as directed in 1-(1)-(c): the content (as thioglycolic acid, %) of the reducing
substance after boiling under acidic condition is between 2.0 % and 11.0 %.

(d) Reducing substance other than the reducing substance after boiling under acidic condition
Proceed as directed in 1-(1)-(d).
(e) Reducing substance after reduction
Perform the test as directed in 1-(1)-(e): the content (%) of the reducing substance after
reduction is between 3.2 % and 4.0 %.
(f)Temperature rise
Place one dose per person of the first agent-(1) and one dose per person of the first agent-(2) in athermostat maintained at 25°C, and allow to stand until the temperature of the agents rises to
25°C. Transfer the first agent-(1) to a 100 mL beaker and record temperature (T0) of the solution.
To this add the first agent-(2), measure temperature immediately with shaking, and record thehighest temperature (T1).
Calculate the temperature rise by deducting T0 from T1: it is between 14°C and 20°C.

(4) Second agent
Proceed as directed in 1-(2).
7. Dual-step Cold Hair Straightening Agents containing thioglycolic acid and/or its salt as active
ingredients
These agents are used at room temperature. They consist of the first agent containing thioglycolicacid and/or its salt as active ingredient and the second agent containing an oxidizing agent. The
quality standards for the first and the second agents are as follows.
(1) First agent
The first agent contains thioglycolic acid and/or its salt as active ingredients, with a total
amount of nonvolatile inorganic alkali not exceeding the equivalent amount of thioglycolic acid. It
should meet the following requirements (a) to (g).
A suitable alkaline substance, penetrant, moisturizing agent, coloring agent, emulsifying agent,viscous agent, perfume and other substances may be added to this agent in order to maintainquality and to enhance usefulness.
(a) pH
Proceed as directed in 1-(1)-(a).
(b) Alkali
Proceed as directed in 1-(1)-(b).
(c)

Reducing substance after boiling under acidic condition
Proceed as directed in 1-(1)-(c).

(d) Reducing substance other than the reducing substance after boiling under acidic condition
Proceed as directed in 1-(1)-(d).

(e) Reducing substance after reduction
Proceed as directed in 1-(1)-(e).
(f)

Viscosity
Perform the test according to Method 2 under the Viscosity of the JSQI General Tests; the limit
is not more than 40,000 mPa s.

(g) Iron
Proceed as directed in 1-(1)-(f).
(2) Second agent
Proceed as directed in 1-(2).
8. Dual-step Tepid Hair Straightening Agents containing thioglycolic acid and/or its salt as active
ingredients
These agents are warmed to a temperature lower than about 60°C before use. They consist of thefirst agent containing thioglycolic acid and/or its salt as active ingredient and the second agent
containing an oxidizing agent. The quality standards for the first and the second agents are as
follows.
(1) First agent
The first agent contains thioglycolic acid and/or its salt as active ingredient, with a total amountof nonvolatile inorganic alkali not exceeding the equivalent amount of thioglycolic acid. It shouldmeet the following requirements (a) to (g).
A suitable alkaline substance, penetrant, moisturizing agent, coloring agent, emulsifying agent,viscous agent, perfume and other substances may be added to this agent in order to maintainquality and to enhance usefulness.
(a) pH
Proceed as directed in 3-(1)-(a).
(b) Alkali
Proceed as directed in 3-(1)-(b).
(c)

Reducing substance after boiling under acidic condition
Proceed as directed in 3-(1)-(c).

(d) Reducing substance other than the reducing substance after boiling under acidic condition
Proceed as directed in 1-(1)-(d).
(e) Reducing substance after reduction
Proceed as directed in 1-(1)-(e).
(f)

Viscosity
Proceed as directed in 7-(1)-(f).

(g) Iron
Proceed as directed in 1-(1)-(f).

(2) Second agent
Proceed as directed in 1-(2).
9. Dual-step Cold, Hair Straightening Agents containing thioglycolic acid and/or its salt as active
ingredients using a high temperature hair-iron
For these agents, after treatment with the first agent at room temperature, the first agent iswashed with water sufficiently and the moisture is wiped off. The procedure includes the use of ahigh temperature hair-iron (not more than 180°C). They consist of the first agent containing
thioglycolic acid and/or its salt as active ingredient, and the second agent containing an oxidizing
agent. The quality standards for the first and the second agents are as follows.
(1) First agent
The first agent contains thioglycolic acid and/or its salt as active ingredient, with a total amountof nonvolatile inorganic alkali not exceeding the equivalent amount of thioglycolic acid. It shouldmeet the following requirements (a) to (g).
A suitable alkaline substance, penetrant, moisturizing agent, coloring agent, emulsifying agent,viscous agent, perfume and other substances may be added to this agent in order to maintainquality and to enhance usefulness.
(a) pH
Proceed as directed in 1-(1)-(a).
(b) Alkali
Proceed as directed in 1-(1)-(b).
(c)

Reducing substance after boiling under acidic condition
Proceed as directed in 1-(1)-(c).

(d) Reducing substance other than the reducing substance after boiling under acidic condition
Proceed as directed in 1-(1)-(d).
(e) Reducing substance after reduction
Proceed as directed in 1-(1)-(e).
(f)

Viscosity
Proceed as directed in 7-(1)-(f).

(g) Iron
Proceed as directed in 1-(1)-(f).
(2) Second agent
Proceed as directed in 1-(2).
10. Dual-step Tepid, Hair Straightening Agents containing thioglycolic acid and/or its salt as active
ingredients using a high temperature hair-iron
These agents are warmed to a temperature lower than about 60°C before use and after treatment
with the first agent, the first agent is washed with water sufficiently and the moisture is wiped off.
The procedure includes the use of a high temperature hair-iron (not more than 180°C). They consistof the first agent containing thioglycolic acid and/or its salt as active ingredient, and the second

agent containing an oxidizing agent. The quality standards for the first and the second agents are
as follows.
(1) First agent
The first agent contains thioglycolic acid and/or its salt as active ingredient, with a total amountof nonvolatile inorganic alkali not exceeding the equivalent amount of thioglycolic acid. It shouldmeet the following requirements (a) to (g).
A suitable alkaline substance, penetrant, moisturizing agent, coloring agent, emulsifying agent,viscous agent, perfume and other substances may be added to this agent in order to maintainquality and to enhance usefulness.
(a) pH
Proceed as directed in 3-(1)-(a).
(b) Alkali
Proceed as directed in 3-(1)-(b).
(c)

Reducing substance after boiling under acidic condition
Proceed as directed in 3-(1)-(c).

(d) Reducing substance other than the reducing substance after boiling under acidic condition
Proceed as directed in 1-(1)-(d).
(e) Reducing substance after reduction
Proceed as directed in 1-(1)-(e).
(f)

Viscosity
Proceed as directed in 7-(1)-(f).

(g) Iron
Proceed as directed in 1-(1)-(f).
(2) Second agent
Proceed as directed in 1-(2).
11. Reagents, Test Solutions and Standard Solutions
The reagents, test solutions and standard solutions used in the tests in 1, 2, 3, 4, 5, 6, 7, 8, 9 and
10 above are shown as follows unless otherwise specified.
(1) Reagents and Test solutions(a) Zinc powder (85), ammonia solution (28), 1 mol/L hydrochloric acid TS, 5 mol/L hydrochloric
acid TS, dilute hydrochloric acid, perchloric acid (70), ammonium oxalate, nitric acid, starch TS,
methyl orange TS, methyl red TS, mercaptoacetic acid, potassium iodide, potassium iodide TS,
sodium lauryl sulfate, sulfuric acid and dilute sulfuric acidAs specified in the Reagents and Test Solutions of the JSQI General Tests.
(b) 3 mol/L ammonia solution
To 61 mL of strong ammonia solution (JSQI reagent) add water to make 300 mL.

(c)30 % Sulfuric acid
Cautiously add 17.1 mL of sulfuric acid (JSQI reagent) to 30 mL of water, cool and dilute withwater to make 100 mL.

(2) Standard solution(a) 0.1 mol/L hydrochloric acid, 0.1 mol/L sodium thiosulfate and 0.05 mol/L iodine solution
As specified in the Standard Solutions for Volumetric Analysis of the JSQI General Tests.
(b) Standard Iron solution
Dissolve 0.7021 g of ammonium iron (II) sulfate hexahydrate (JSQI reagent), accurately
weighed, in 50 mL of water, add 20 mL of sulfuric acid, then add dropwise 0.6% potassium
permanganate solution (prepared by dissolving 0.6 g of potassium permanganate (JSQI reagent)in water to make 100 mL) with warming until the pale red color of the solutions persists, cool andadd water to make exactly 1000 mL. Take 10 mL of this solution in a 100 mL volumetric flask andadd water to make 100 mL.
12. Remarks(1) Quality standards for the Separated application should adapt with the (1) First agent of eachclassification for the first agent and the (2) Second agent of the classification 1 for the second
agent.
(2)“%” and “ppm” used in the standards are defined as follows. In the case of a liquid preparation,“%” and “ppm” denote percent weight in volume and parts per million weight in volume. In thecase of a powder or tablet preparation, “%” and “ppm” denote percent weight in weight and parts
per million weight in weight. In the case of viscous sample which cannot be measured exactly in a
directed volume, it may be measured in equivalent weight. In such case, 1 g is deemed equivalent
to 1 mL.

(3)

An alternative method for the test method specified in the standards, of which the correctness
and accuracy are equal to or greater than that specified, may be used. However, when aquestionable result is obtained, the specified method shall be used for the final determination.