The Regulation ofCosmetics in Japan
Presented by Dr. Mike Hayashida, YDC Tokyo
Obtained doctorate degree in law school of Tokyo University.

An ex-lawyer and a member of the government advisory committee forfunctional food in Japan.
Currently, a principal of YDC Tokyo and its associated companies of his own.

1. Overview
1.1 The regulation by the Pharmaceutical Affairs Act[Fig. 1] Coverage of pharmaceutical Affairs Act

Pharmaceutical Affairs
ActDrugs

Quasi Drugs

Cosmetics

MHLW

MedicalDevices

1. Overview
1.1 The regulation by the Pharmaceutical Affairs Act[Fig. 2] Two types of Cosmetics

Cosmetics(General)Cosmetics

Medicated
Cosmetics

1. Overview
1.1 The regulation by the Pharmaceutical Affairs Act[Fig. 3] Composition of Quasi Drug category

Quasi Drugs

Medicated
Cosmetics

Hair growth products
Hair removal products,etc.

1. Overview
1.1 The regulation by the Pharmaceutical Affairs Act[Fig. 4] Regulation history

2001 ―

Abolition of approval system
Implementation of self-responsibility system

2005 ―

Implementation of primary distribution system
Introduction of GQP and GVP

1.2 Cosmetics and Medicated Cosmetics[Fig. 5] Definition of Cosmetics

Any item having mild effects on the humanbody that is rubbed, spread, or otherwise
applied in a similar manner for the purpose ofcleansing, beautifying, or enhancing theattractiveness of the human body, tochange physical appearance, or to maintainskin or hair in a healthy condition.

2. Cosmetics
2.1 What is Cosmetics?

[Fig. 6] Key 3 roles of cosmetic company

Primary

Responsible forMarketingDistributor

Manufacturer

Manufacture

Seller

Sell

GovernmentalApprovalPrimary Distributor
Manufacturer
Seller○○×2. Cosmetics
2.1 What is Cosmetics?

[Fig. 7] Role-playing patterns of cosmetic company

Primary Distributor Manufacturer

Seller

1Company A

Company A

Company A

2Company A

Company A

Company B

3Company A

Company B

Company C

2. Cosmetics
2.1 What is Cosmetics?

[Fig. 8] General requirements of Primary Distributor and Manufacturer

Requirements
Primary Distributor
Manufacturer

Personnel requirements(applicant and generalmanager of P)

Personnel requirements(applicant and headtechnical)

GQP/GVP conformity:
Physical requirements
Execution of operations for (buildings and facilities ofquality control and postmanufacturing plant)
manufacturing/sales safety
management, andappropriate managementof manuals and records.

2. Cosmetics
2.1 What is Cosmetics?

[Fig. 9] Must-dos for GQP/GVP

GQP

GVP

Sufficient staff having theSufficient staff having thecapability to appropriately and capability to appropriately andsmoothly execute operations
smoothly execute operations
Duties of general manager ofDuties of general manager ofmanufacturing and sales
manufacturing and sales
Assignment of quality assurance Assignment of safety
officermanagement officer
Duties of quality assurance
Duties of safety managementofficer
officer
Preparation of procedure
Implementation of duties formanuals for quality control
safety management
Implementation of duties for
Record keeping
quality control
Management of documents
and records

2.2 The requirements for product launch
1) Three types of key person
2) Registration to the government3) Product name[Fig. 10] Prohibited cases of product naming

1 The same name as that of Drugs or Quasi Drugs

2 A name which leads to misrepresentation
3 A name which suggests Drug-like efficacy
4 A name which includes ingredients name
A name which is composed of only by the5Roman alphabet...etc.

2.2 The requirements for product launch4) Ingredients[Fig. 11] Types of list for ingredients

Preservatives, UV absorbs,
Tar colors

Positive list

Others

Negative list

2.2 The requirements for product launch4) Ingredients[Fig. 12] A list of 30 prohibited ingredients
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1415
1617181920
2122232425
26
27
28
29
30

6-Acetoxy-2,4-dimethyl-m-dioxane
Antihistamines except those of aminoether type (such as diphenhydramine)
Hormones and those derivatives except estradiol, estrone and ethinylestradiol
Vinyl chloride monomer
Methylene chloride
Bismuth compounds other than bismuth oxychloride
Hydrogen peroxide
Cadmium compounds
Sodium perborate
Chloroform
Progrenolone acetate
Dichlorophene
Mercury and its compounds
Strontium compounds
Sulfamide and its derivatives
Selenium compounds
Nitrofuran type compounds
Hydroquinone monobenzylether
Halogenated salicylanilide
Vitamin L1 and Vitamin L2
Bithionol
Pilocalpin
Pyrogallol
Inorganic fluorine compounds
Pregnanediol
Local anesthetics such as procaine
Hexachlorophen
Boric acid
Formalin
Methyl alcohol

2.2 The requirements for product launch4) Ingredients[Fig. 13] Additional Prohibition

AdditionalProhibition#1 Medical drug
ingredients#2 Ingredients that do notmeet the standards
for Biological Materials

2.2 The requirements for product launch
4) Ingredients[Fig. 14] DHC, CoQ10’s case
CoQ10

Not among 30 negative ingredients

DHC: Launch cosmetic with CoQ10MHLW suspended
ingredient theory

dueto

medicaldrug

2.2 The requirements for product launch5) Time Required[Fig. 15] Time required for approval

The local government accepts theapplication usually within one week.

2.3 Marketing Regulation1) Scope of effectiveness[Fig.16] Scope of recognized cosmetic effects
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Cleansing hair and scalp
Using fragrance to reduce unpleasant hair and scalp odors
Keep hair and scalp healthy
Give moisture and sheen to hair
Moisturize hair and scalp
Keep hair and scalp moist
Make hair supple
Make hair easier to brush
Keep hair lustrous
Give luster to hair
Stop dandruff and itching
Control dandruff and itching
Supplement and maintain hair moisture and oil content
Prevent hair breakage and frizzingImprove and maintain hair pattern
Prevent hair static electricity
Cleanse dry skin (that has become dry as aresult of cleansing)

Govt. approval is
not required

29303132333435363738
3940
41424344

Soften skinGive gloss to skinGive luster to skin
Make skin smooth
Make beards easier to shave
Condition skin after shaving
Prevent rashes
Prevent sunburn
Prevent skin splotches and freckles resulting from sunburnImpart fragrance
Protect nails
Keep nails healthy
Moisten nails
Prevent chapped lips
Fill in lip creases
Moisten lips

45

Keep lips healthy46Protect lips, prevent dryness

4748495051525354

Prevent lip roughness caused by dryness
Make lips smoothPrevent cavities (brushing teeth with toothpaste)
Whiten teeth (brushing teeth with toothpaste)
Remove plaque (brushing teeth with toothpaste)
Cleanse the mouth (toothpaste)
Prevent bad breath (toothpaste)
Remove tooth film (brushing teeth with toothpaste)

1920
21
22
23
24
25
26

Prevent blemishes and rashes (by cleansing)(facial wash)
Condition skin
Combat skin wrinkles
Keep dry skin supple
Prevent skin chapping
Tighten skin
Moisten skin
Supplement and preserve skin moisture and oil content
Keep skin soft

27

Protect the skin55

Prevent plaque deposits (brushing teeth with toothpaste)

28

Protect skin dryness

56

Making fine wrinkles due to dryness less noticeable

18

Note 1: Parenthesized text refers to aspects of physical form during usage, not to the effect itself.
Note 2: #56 should be based on the Guidelines for the Method of Evaluating the Functions of Cosmetic Products (2011, Japanese Cosmetic Science Society)2.3 Marketing Regulation
2) Advertising regulation[Fig.17] Scope of recognized cosmetic effectsMHLW

The Act

Mainly EfficacyAppropriate advertising standard
for Drugs, Quasi Drugs, Cosmetics
and Medical Devices

Other methods
besides efficacy

2.3 Marketing Regulation
2) Advertising regulation[Fig. 18] Prohibition in cosmetic advertising

1 Testimonials should not be used besides feeling of use

2 Before-After comparison should not be used
3 Clinical trial data should not be showed
Recommendation of medical experts such as a4
medical doctor is prohibited...etc.

3. Medicated Cosmetics
3.1 What is Medicated Cosmetics?

[Fig. 19] Important effectiveness for Medicated Cosmetics
Practically important effectiveness as Medicated Cosmetics

1Skin-whitening or to prevent sun spots and freckles

2To prevent acne3

Sterilization by soap

4Wrinkle improvement3.2 The Requirements for product launch
1) Tree types of key person ～ 4) Ingredients[Fig. 20] Approved ingredients for Medical Cosmetics
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Ascorbic acid/derivatives
Placental Extracts
Kojic Acid (Obtained by Sansho Seiyaku Co., Ltd. in 1988)
Arbutin (Obtained by Shiseido Co., Ltd. in 1989)
Ellagic Acid (Obtained by the Lion Corporation in 1996)
Chamomilla Extract (Obtained by the Kao Corporation in 1998)
4-n-Butylresorcinol (Rucinol®) (Obtained by POLA in 1998)
Linoleic Acid (Obtained by Sunstar Inc. in 2001)
Tranexamic Acid (Obtained by Shiseido Co., Ltd. in 2002)
4-Methoxy Potassium Salicylate (4MSK) (Obtained by Shiseido Co., Ltd.
in 2003)
Adenosine Monophosphate Disodium Salt (Obtained by Otsuka
Pharmaceutical Co., Ltd. in 2004)
5,5′-Dipropyl-biphenyl-2,2′-diol (Magnolignan®) (Obtained by Kanebo
Cosmetics Inc. in 2005)
4-(4-Hydroxyphenyl)-2-butanol (4-HPB) (Obtained by Kanebo Cosmetics
Inc. in 2007)
Tranexamic Acid Cetyl Ester Hydrochloride (Obtained by CHANEL .KK in2009)...etc.

3.2 The Requirements for product launch
5) Scope of effectiveness6) Time required[Fig. 21] Matrix chart: Active ingredients vs Effectiveness
Active Ingredients
NewB

A

Alreadyknown

Effectiveness
NewC

D
Alreadyknown

Type A

extraordinary difficult

Type Bvery difficult

Type C

very difficult

Type Deasy

3.3 Marketing regulation
1) Scope of claim[Fig. 22] Scope of claim

Drugs ＞ Medicated Cosmetics ＞ Cosmetics

3.3 Marketing regulation
1) Scope of claim[Fig. 23] Scope of claim for acne

Drugs

cure acne

Medicated Cosmetics prevent acne
Cosmetics

prevent acne by facial wash(soap)

4. Quick look of the regulatory requirements for exporting cosmetics to Japan[Fig. 24] Business flow of exporting cosmetics to Japan

Primary Distributor in Japan
Cooperatio
nForeign
Manufacturer

Responsible

ImportProcedure inJapan

Monitoring

Manufacturerin Japan
StorageLabelling

Market inJapan