What is the Pharmaceutical Affairs Law?

Japan's Pharmaceutical Affairs Law was established with the principal aim of ensuring the safety and efficacy of drugs, quasi-drugs, cosmetics, and medical equipment. Products that are affected by the law and that do not meet the relevant rules and regulations are held to be in violation of the law.
In addition to providing a facility for a drug approval and licensing system, the Pharmaceutical Affairs Law also provides a legal description of sales names, manufacturer name, lot numbers, and complete ingredient labelling for such products. This is in addition to establishing the necessary rules and regulations for ensuring the safety and efficacy of the relevant products, and regulating advertising standards to prevent any misleading or false advertising.
In the case of OEM cosmetics, rest assured that Cosmetec Japan's staff have an in-depth knowledge and experience of the Pharmaceutical Affairs Law to ensure that we can handle any facet of the law.

What are "Manufacturer-sellers" and the "seller"?

As stipulated in the Pharmaceutical Affairs Law, Manufacturer-sellers refers to companies involved in moving manufactured or imported products onto the market.
Companies that have not acquired the relevant license to act as manufacturer-sellers as prescribed in the Pharmaceutical Affairs Law, cannot carry out the manufacture or sale of cosmetics or quasi-drugs. In the event of a company contracting the services of an OEM company, however, this does not mean that any client company has to have applied for permission to operate as a manufacturer or sales company.
As you would expect from one of the industry's leading companies, Cosmetec Japan has obtained the relevant license to act as a manufacturer-seller of cosmetics and quasi-drugs in line with the Pharmaceutical Affairs Law, although this means that as a manufacturer-seller of these products the company has a responsibility to ensure safety management and quality control in manufacturing the relevant product and delivering it to its client companies. This ensures that the client company can mark its company name as the "Seller" on these products.

Complete list of ingredients for cosmetics

The Pharmaceutical Affairs Law underwent revision in 2001, which led to a requirement for cosmetic products to display all of the ingredients that were included in the product.
Such displays of all ingredients that go into a particular cosmetic product were intended to display information and promote a relaxation of regulations, although from the company’s point of view, this was seen as a demand for companies to improve their levels of product safety. Such lists of components are expected to list ingredients in descending order from the most commonly used substance, although ingredients that are included in quantities of 1% or less of the product can be included in no particular order.

What are quasi-drugs?

Quasi-drugs provide for milder treatment than regular drugs, but also include active ingredients that have been approved by the Minister of Health, Labour and Welfare, and are defined as such by the Pharmaceutical Affairs Law.
More specifically, quasi-drugs include external preparations for bad breath and body odors; powders and bath powders that prevent prickly heat and inflammation; and an external preparation for hair regrowth; this is in addition to medicated cosmetics such as hair removal cream; soap for preventing outbreaks of acne or with antibacterial properties; and effective essences that contain whitening components.
In the case of quasi-drugs, having an active ingredient approved by the Minister of Health, Labour and Welfare allows the product to display its effectiveness for a result that has yet to be recognized. This allows companies to indicate that the product is "Medicated." Prior to any manufacture and sale of these quasi-drugs, an application for pharmaceutical status needs to be made, which entails an approximately six month period-following data analysis and initial submission of an application-for the Ministry of Health, Labour and Welfare to carry out the appropriate examination.
Due to the strict regulation and management by the Ministry of Health, Labour and Welfare of the product's ingredients' effectiveness, stability, and safety, in addition to a number of components that cannot be used in the manufacture of quasi-drugs, in the event of using a ingredient with no precedents in products examined by the Ministry of Health, Labour and Welfare, then this may result in a longer time period than normal being required for the processing and examination process.
Cosmetec Japan can carry out all necessary application procedures for OEM cosmetics.

Configuration and materials used for containers

The configuration of cosmetic containers used for Cosmetec Japan's products can be mainly divided into the categories outlined below, based on usability and content.
Bottle container (lotions/essences); jar containers (creams/gels)
Pump-type containers (shampoo/cleansers); tube containers (soaps/creams)
Pouch containers (samples); aerosol containers (hairstyling products)
Compact containers (foundation); pencil containers (eyeliner)
Push-up containers (lipstick); applicator containers (mascara)
The materials used in these containers are selected based on their compatibility with the product contents and ability to preserve the product. They include resins such as polyethylene (PE), polypropylene (PP), and polyethylene terephthalate (PET); glass material such as soda lime glass and boron trioxide glass; and metal containers such as aerosol cans.
Cosmetec Japan will ensure that the most appropriate container is used for OEM cosmetics that are sent out to our customers.

Role of preservatives

Preservatives are mixed in with cosmetics to prevent any changes in quality, odor, and onset of mold, from the manufacturing process to shipment to the customer until they have been ultimately finished through the use of micro organisms.
The paraben group of chemicals is the most commonly used preservative in cosmetic products. These consist of members such as methylparaben, ethylparaben, and buytlparaben. Based on the intended purpose of preservation, and whether the subject product is water-soluble material or oil-soluble material, we select the appropriate paraben and base material (such as lotion or cream, etc.) to blend in with the product. The paraben group of chemicals has been used as a cosmetic preservative to great success for over 40 years now.
Recent years have seen the development of cosmetics that are paraben-free. Products that do not contain any paraben are developed and manufactured in special clean rooms where there is a lower risk of bacterial contamination. Such products also make use of an alternative stabilizer that provides an anti-bacterial capability, thereby ensuring the safety and stability of the cosmetic product.
For OEM cosmetics, Cosmetec Japan carries out all relevant production and development activities to ensure that your products are provided in a safe and secure way.

What are natural cosmetics?

Natural cosmetics generally refer to cosmetic products that do not contain any former display specification ingredients. Display specification ingredients are components defined as such by the Ministry of Health, Labour, and Welfare based on regulations predating the 2001 revisions to the Pharmaceutical Affairs Law. These include 102 types of ingredients that were suspected of causing allergic reaction in users. These 102 ingredients were found to have an effect on peoples' skin and were subsequently required to be listed on any products that they were used in. Following the 2001 revisions to the Pharmaceutical Affairs Law, however, these requirements for display ingredients were extended to all ingredients used in cosmetics. This means that the designation "Display Specification Ingredients" is no longer used and is now referred to as the "Former Display Specification Ingredients."

Mandatory information to be displayed on containers and gift boxes

The display on these cosmetic and quasi-drug products is intended to provide consumers with an understanding of what the actual product contains, and purpose, and to avoid any confusion. This should provide realistic information without any exaggeration, which requires this to be stated on a label that is attached directly to the container or box in which the container is held. Displaying such labels is mandatory as stipulated in the relevant Japanese laws and regulations.
These instructions and ingredients must be displayed directly on the cosmetic or quasi-drug container. In the event of not being able to clearly see such instructions, such as through a clear display, for containers for retail use that are enclosed by separate packaging, then these should be directly attached to the outside of the packaging as outlined above.
The content of the display for cosmetics as stipulated by the Pharmaceutical Affairs Law are as follows:
1. Name and address of manufacturer-seller
2. Sales name
3. Manufacturers' serial number or manufacturing code
4. Display of all ingredients
5. Weight, capacity, or quantity of product
6. Expiry date (not applicable to cosmetics which have remained stable for over three years)
7. Category name (in the event of sales name being ambiguous)
8. Warning regarding use and handling
9. Description of container
The required display for quasi-drugs is essentially the same as for cosmetics, although the method of display for quasi-drug ingredients and requirement for indicating that the products are quasi-drugs are different.
Cosmetec Japan can provide you with the most comprehensive and appropriate support when using OEM cosmetics.