USA
General
information
General information
The US is the world's largest beauty market, requiring all products to comply with a dual system: federal legislation (governed by the FDA) and diverse state-specific provisions.
Success requires simultaneous adherence to both these layers of law to ensure full legal access across the country.
The US is the world's largest beauty market, requiring all products to comply with a dual system: federal legislation (governed by the FDA) and diverse state-specific provisions.
Success requires simultaneous adherence to both these layers of law to ensure full legal access across the country.
The US is the world's largest beauty market, requiring all products to comply with a dual system: federal legislation (governed by the FDA) and diverse state-specific provisions.
Success requires simultaneous adherence to both these layers of law to ensure full legal access across the country.
Phases
Registration in USA
Q&A
What is MoCRA?
MoCRA is the regulation of Cosmetic Modernization of 2022 and was transformed into law on December 29, 2022. MoCRA is the largest reform of cosmetic regulations in the United States in 84 years and sets many new requirements, such as: - Registration of installations - List of products - Good manufacturing practice (BPF) - Safety grounds - New labelling requirements - Reporting of adverse events - Keeping records
How will MoCRA affect cosmetic manufacturers?
According to MoCRA, the major changes for cosmetic product manufacturers are the need to register facilities and comply with the BPF, which will be issued by the FDA at the end of 2025.
Who is considered responsible under the MoCRA?
The term "responsible person" means the manufacturer, packager or distributor of a cosmetic product whose name appears on the product label in accordance with section 609(a) of the FD&C Act or Section 4 of the Fair Packaging and Labeling Act. Under the MoCRA, it is mandatory to designate a Responsible Person for each cosmetic product placed on the US market, which is responsible for: - List of cosmetic products - Management of adverse effects - Grounds for the safety of cosmetic products - Labeling
Are there exemptions for the registration of premises and listing of products?
Yes, small businesses will have more flexible and simplified requirements and are exempt from the obligation to register and list products. FDA defines a small company as a company with average annual gross sales in the USA below $1,000,000 for the previous 3 year period, adjusted by inflation. However, regardless of their sales volume, companies involved in the manufacture or processing of the following cosmetic products shall not be exempted: - Cosmetic products that come into contact with the eyes - Cosmetic products that are injected - Cosmetic products intended for internal use - Cosmetic products which alter appearance for more than 24 hours under normal conditions of use and whose removal by the consumer is not part of those conditions.
When are plant records and product lists needed?
For existing installations, registration of installations and lists of products shall be made by 29 December 2023. New installations that manufacture or process cosmetic products for distribution in the USA should be registered within 60 days of the marketing of the product or 60 days after the deadline for existing installations, whichever is the latest.
What if I have several cosmetic products? Can I list them in a simplified way?
MoCRA allows flexible listings. In these cases, it is possible to present a single list for cosmetic products with identical formulations, or formulations that differ only with respect to colours, fragrances or aromas, or nominal content.
What is MoCRA?
MoCRA is the regulation of Cosmetic Modernization of 2022 and was transformed into law on December 29, 2022. MoCRA is the largest reform of cosmetic regulations in the United States in 84 years and sets many new requirements, such as: - Registration of installations - List of products - Good manufacturing practice (BPF) - Safety grounds - New labelling requirements - Reporting of adverse events - Keeping records
How will MoCRA affect cosmetic manufacturers?
According to MoCRA, the major changes for cosmetic product manufacturers are the need to register facilities and comply with the BPF, which will be issued by the FDA at the end of 2025.
Who is considered responsible under the MoCRA?
The term "responsible person" means the manufacturer, packager or distributor of a cosmetic product whose name appears on the product label in accordance with section 609(a) of the FD&C Act or Section 4 of the Fair Packaging and Labeling Act. Under the MoCRA, it is mandatory to designate a Responsible Person for each cosmetic product placed on the US market, which is responsible for: - List of cosmetic products - Management of adverse effects - Grounds for the safety of cosmetic products - Labeling
Are there exemptions for the registration of premises and listing of products?
Yes, small businesses will have more flexible and simplified requirements and are exempt from the obligation to register and list products. FDA defines a small company as a company with average annual gross sales in the USA below $1,000,000 for the previous 3 year period, adjusted by inflation. However, regardless of their sales volume, companies involved in the manufacture or processing of the following cosmetic products shall not be exempted: - Cosmetic products that come into contact with the eyes - Cosmetic products that are injected - Cosmetic products intended for internal use - Cosmetic products which alter appearance for more than 24 hours under normal conditions of use and whose removal by the consumer is not part of those conditions.
When are plant records and product lists needed?
For existing installations, registration of installations and lists of products shall be made by 29 December 2023. New installations that manufacture or process cosmetic products for distribution in the USA should be registered within 60 days of the marketing of the product or 60 days after the deadline for existing installations, whichever is the latest.
What if I have several cosmetic products? Can I list them in a simplified way?
MoCRA allows flexible listings. In these cases, it is possible to present a single list for cosmetic products with identical formulations, or formulations that differ only with respect to colours, fragrances or aromas, or nominal content.
Conquer the world
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Fill out the form today and experience expert services
Conquer the world
with your brand
Fill out the form today and experience expert services
Conquer the world
with your brand
Fill out the form today and experience expert services