美国

• 美国(FDA)医疗机械
• 美国(FDA) 化妆品
• 美国(FDA) OTC

What is VCRP (Voluntary Cosmetic Registration Program) as defined by the US (FDA)?

The VCRP is a voluntary system for reporting to the FDA by manufacturers, packers, and foreign manufacturers for export of cosmetic products for commercial distribution in the United States.

• Advantages of VCRP

In order to register VCRP, cosmetics must consist of individual ingredients that have been proven safe by the FDA, and only products that have proven safety through cosmetic ingredient review (CIR) by the CIR expert panel can be registered. It can be seen that this has been proven.

• VCRP registration process

RCPE (Registration of Cosmetic Product Establishment)
VCRP manufacturing facility registration _ FDA2511 form confirmation

CPIS (Cosmetic Product Ingredients Statement)
Registration of cosmetic product ingredients and composition _ FDA2512

Peer review with FDA reviewers

What is RCPE (Registration of Cosmetic Product Establishment) as defined by the United States (FDA)?

Any cosmetic manufacturer intended for sale in the United States may register its establishment, either before or after commercial distribution of its products. If there is more than one production plant, the plant that handles the final production process must be registered. Information required for factory registration: company name, address, country of origin, position of the person in charge of FDA manufacturing factory registration, email address, and phone number After the registration application, FDA will assign a registration number to the applicant, and after registration is completed, the company list is published and managed on the FDA website. In the event of an accident that causes harm to human health or the death of an employee in the manufacturing plant, registration will be suspended, and if you do not report this to FDA within 10 days, your registration will be completely revoked.

•RCPE (VCRP facility registration)

Cosmetics manufacturer (Manufacturer)

Packer

Foreign manufacturer

• RCPE Checklist

Unable to register as a distributor

Submission of form for registration of facilities

In case of minor changes such as change of manufacturer's name, address, and product name after facility registration, submit a revised facility registration plan

What is CPIS (Product Ingredient and Composition Registration) as defined by the United States (FDA)?

Because VCRP is intended to enable purchasers in the United States to purchase its products, any cosmetic manufacturer that intends to sell in the United States must have a way to make their products available for purchase to consumers in the United States and then register the ingredients and composition of their products. (This applies to cosmetics currently sold in the United States.)

Information necessary for product ingredient and composition registration: brand name and cosmetic name, type of cosmetic, cosmetic ingredient, position in charge, email address, and phone number

After entering the cosmetic composition through VCRP, the CPIS registration number is granted by the FDA and activated
(*In case of including ingredients classified as drugs, registration and management are required in accordance with the Drug regulation)
When reporting, you must use the latest updated words from the International Cosmetic Ingredient Dictionary.

• Subject to CPIS (Product Ingredient and Composition Registration)

Cosmetics manufacturer (Manufacturer)

Packer

Distributor

Foreign manufacturer

• CPIS Checklist

Submission of form for product ingredient and composition registration

If the composition of the product is changed after registration of product ingredients and composition, submit amendments
(The FDA reassigns a CPIS number to each composition registered in the VCRP)