Cosmetics

For cosmetics, we perform tests on regulated substances in accordance with various laws and regulations.

Laws & Regulations
Test
Other services

Laws & Regulations

In addition to Pharmaceuticals and Medical Devices Act (commonly known as the Pharmaceuticals Act) etc. laws and regulations, there are regulations such as self-standards set by JCIA (Japan Cosmetic Industry Association) for handling cosmetics manufacturing and sales.
Caution is required when it comes to advertisement, it is a must to comply with Pharmaceuticals and Medical devices, proper advertising standards for pharmaceuticals etc., unjustifiable premiums and illegal labeling prevention law (landscape law).

Definition of cosmetic

The definition in "Act on Securing Quality, Efficacy and Safety of Products Including
Pharmaceuticals and Medical Devices"

The term "cosmetic" as used in this Act refers to items which are intended to be used on the human body by rubbing, sprinkling or other similar means, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition, and which have mild effects on the human body.

Advertising and explanation

There are provisions for explanation range of the effect and efficacy of cosmetics advertisement guidelines for cosmetics 2017 ver.” of JCIA, Japan Cosmetic Industry Association.

Examples regarding explanation range of effects

・Normalize hair on the head and body
・Fix skin texture
・Prevent mouth smell being bad

Examples regarding prohibition of explanation about ensuring effects and (or) safety

・Explanation data such as clinical trial and experience is prohibited.
・Restriction on reviews and user experience
・Restriction on exaggerated explanations such as "Fabulous effects" and "Huge effects".

Prohibition of recommendation from pharmaceutical personnel

・Principle of restriction on recommendations from pharmaceutical personnel

Advertisement regarding effectiveness for pharmaceutical personnel, barber, beautician, cosmetician, hairdresser, hospital, clinic and other cosmetics specified, certified, recommended, instructed, selected etc. by public offices, schools or organizations is prohibited.
However, special cases that need advertisement for maintenance and promotion of public health and public office or something equivalent to this are an exception.

・Recommendation from pharmaceutical personnel

Even if it’s true, it is prohibited except in certain cases.

Regarding Patent

Prohibit any explanation on "patent" even if it’s true.
However, in case that the explanation is for special purpose such as patent infringement prevention, the advertisement must be clearly separated from any cosmetic advertisement.

Restriction on advertisement giving discomfort, uneasiness and inconvenience

・Prohibit cosmetic advertisement that gives a fear for feeling discomfort, uneasiness, and inconvenience.
・Advertisement by e-mail etc.

①Contact information such as an e-mail address for the manufacturer of the cosmetics must be labelled.
②In case of sending an e-mail unilaterally, the e-mail subject must say advertisement.
③In a case the consumer does not want to receive any advertisement, along with a method for displaying the intention to that effect advertisement offered by e-mails etc. must stop.

Regarding "Explanation range for cosmetic effects", detailed data can be downloaded from this link for those who wants to get.

Data download
page(Japanese)

※Available only in Japanese.

Cosmetic components regulations

For components inside cosmetics, there are prohibition of use against some substances such as preservative and ultraviolet absorbing agent and restrictions on the quantity.

Examples of prohibited substances	Examples of restrictions on formulation for all cosmetics	Components that have limited composition depending on the type of cosmetic
・Hydrogen peroxide ・Formalin ・Methyl alcohol	・Salicylic acid ・Phenoxyethanol ・4-tertbutyl-4′-methoxydibenzoylmethane	・Cresol ・Panthenyl Ethyl Ether Benzoate ・4-(2-beta gulcopyranosiloxy) propoxy- 2-hydroxybenzophenone

Regarding "Explanation range for cosmetic effects", detailed data can be downloaded from this link for those who wants to get.

Data download
page(Japanese)

※Available only in Japanese.

Restriction on tar dye

Tar dye for cosmetic can be used in accordance with "Ordinance for determining tar dyes that can be used in pharmaceuticals"

Examples of designated tar dye

・Red No.2 (aka "Amaranth")
・Yellow No.5 (aka “Sunset Yellow FCF)
・Blue No.1 (aka Brilliant Blue FCF)

Regarding “Explanation range for cosmetic effects”, detailed data can be downloaded from this link for those who wants to get.

Data download
page(Japanese)

※Available only in Japanese.

Standards related on bacteria

Limitation value against bacteria for cosmetic, medical cosmetic and quasi drug is set in JCIA self-standard.

Item		Products for toddler in less than 3 years old, for using around eye, for using onto membrana mucosa	Others
Product			Others
Bacteria quantity (Note 1)		1×10²CFU/g and less, or 1×10²CFU/mL (Note 2)	1×10³CFU/g and less, or 1×10³CFU/mL (Note3)
Designated bacteria	・Escherichia coli ・Pseudomonas aeruginosa ・Staphylococcus aureus ・Candida albicans	They are all negative/g, or negative/mL	They are all negative/g, or negative/mL

(Note 1) Total both bacteria and fungus (mold and yeast) in aerobic mesophile
(Note 2) In case that a test result is more than 200 CFU/g or 200 CFU/mL, the value is regarded as over its limit value considering dispersion in the bacteria test result. FYI, CFU is the abbreviation of “Colony Forming Unit”.
(Note 3) In case that a test result is more than 2000 CFU/g or 2000 CFU/mL, the value is regarded as over its limit value considering dispersion in the bacteria test result.

Test

Test menu

We have various test menu based on restricted substances or products.

Nissenken is a registered testing agency with the Ministry of Health, Labor and Welfare

*Enforcement regulations on laws for ensuring quality, effectiveness and safety of pharmaceuticals and medical devices. Ministry of Health and Welfare Ordinance No. 1 of 1961 Testing and inspection institutes specified in Article 12 clause 2

Registration No.: No. 184
Testing classification: Physical and Chemical test
Registration date: October 30, 2019

Corresponding range of testing & inspection
・Quantitative testing of pharmaceutical ingredients etc. contained in cosmetics
・Quantitative testing of active ingredients included in quasi-drugs for oral use (vitamins, motion sickness etc.) or control use (insect repellent etc.)
・Quantitative testing of active ingredients in pharmaceuticals

Use	Object substances and test name
Skincare (Cosmetics, cream, milky lotion, essence), makeup (rouge, foundation, eyebrow, lipstick), haircare	・Prohibited substances (Formaldehyde) ・Heavy metal ・Preservative ・Ultraviolet absorbing agent ・Antioxidant ・Dye ・General bacteria quantity
Non dye skincare (Cosmetics, cream, milky lotion, essence), sunscreen, haircare (hair jam, hair gel) Non-oil hair wax	・Prohibited substances (Formaldehyde) ・Heavy metal ・Preservative ・Ultraviolet absorbing agent ・Antioxidant ・General bacteria quantity
Nail set	・Prohibited substances (Formaldehyde) ・Heavy metal ・Preservative ・Ultraviolet absorbing agent ・Antioxidant ・Dye ・General bacteria quantity
Personal care (Shampoo, rinse, soap, facewash)	・Personal care (Shampoo, rinse, soap, facewash) ・Heavy metal ・Antioxidant ・Dye ・General bacteria quantity

Regarding “Explanation range for cosmetic effects”,detailed data can be downloaded from this link for those who wants to get.

Data download
page(Japanese)

※Available only in Japanese.

Other services

We provide you with cosmetic test, consultation about explanation of package and product based on client’s request and seminar regarding laws and rules.
Please feel free to contact us for details.