◆Self-introduction
◆What do you feel about the differences between Japan and other countries?
Regarding quality, safety, effectiveness (side effects)
◆Act on ensuring the quality, effectiveness, and safety of pharmaceuticals, medical devices, etc.
It is generally called the Pharmaceutical Machinery Act.
https://www.mhlw.go.jp/web/t_doc?dataId=81004000&dataType=0
There is a principle of precaution.
This principle is to ensure quality, safety, and effectiveness (side effects).
Article 1-2 In order to achieve the purpose of this law, the state shall ensure the quality, effectiveness, and safety of pharmaceuticals, etc., prevent the occurrence and spread of health and hygiene hazards due to their use, and take other necessary measures. must be formulated and implemented.
The Food Sanitation Act only states safety. On the other hand, cosmetics, which are controlled under the Pharmaceutical and Medical Devices Act, are even more strictly controlled.
◆Permission to manufacture cosmetics
◆How are companies that make cosmetics managed around the world?
① Japan:
A manufacturing permit (permission to manufacture the product. It cannot be shipped or placed on the market. Manufacture can be done on contract, etc.) and a manufacturing and sales license (permission to sell, lend, or give the product to the market) are required.
(Refer to Chapter 2 of Cosmetics/Quasi-drug Manufacturing and Sales Guidebook 2022)
https://yakuji-shop.jp/SHOP/9784840815697.html
Companies with the above manufacturing and sales license must ensure that their quality control methods and post-marketing safety control methods comply with the standards specified by the Ordinance of the Ministry of Health, Labor and Welfare.
It is audited by the prefecture once a year.
Import: Regarding the import of cosmetics from overseas
・Foreign manufacturer: The importer (overseas) manufacturer must be certified by the Minister of Health, Labor and Welfare.
*Special exceptions apply.
・Domestic importer: In order to import cosmetics manufactured in a foreign country and manufacture and sell them domestically, the name of the person who will manufacture, sell or manufacture the cosmetics in the foreign country must be notified to the Minister of Health, Labor and Welfare.
Article 13-3 of the Act on Ensuring the Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, etc.
https://elaws.e-gov.go.jp/document?lawid=335AC0000000145
② America:
Manufacturing:
https://www.fda.gov/cosmetics/resources-industry-cosmetics/small-businesses-homemade-cosmetics-fact-sheet
14. Do I need to get a license from FDA to manufacture or market cosmetics?
FDA does not license cosmetics firms. However, state or local authorities may require licensing or have other requirements you need to know about. You will need to contact your state or local authorities directly. Again, the Small Business Administration may be able to help.
No manufacturing license is required (there seem to be exceptions in state and local governments).
However, it is managed by the FDA as follows.
FDA regulates cosmetics under the Federal Food, Drug and Cosmetic Act (FD&C Act). Under MoCRA, which expanded FDA’s authority under the FD&C Act law, cosmetics must not be adulterated or misbranded. For example, they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled. Any color additives they contain must be approved for the intended use, and some must be from batches certified in FDA’s own labs. Packaging and labeling must not be deceptive. If you manufacture or market cosmetics, you have a legal responsibility for the safety and labeling of your products.
◆other countory
You generally don’t need a licence to make and sell skincare from your home in the USA, UK, most countries in the EU, Canada, Australia and many other countries. You may of course need a licence to run your business, but that requirement will then apply to every business owner in your country and is separate to the question of whether you need a licence to sell skincare.
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