The Cosmetic Regulatory Modernization Act of 2022, also known as “MoCRA”, is the new regulation that the FDA, the Food and Drug Administration Agency of the United States Government, will implement starting this year for all cosmetics manufacturers, especially those wishing to export to that market. According to the AGEXPORT Market Intelligence Unit, this regulation had not changed since 1938.
In more than 80 years there had been no changes in the regulations governing cosmetic manufacturers whose market is the United States. However, as of this year, the new Cosmetic Regulation Modernization Act of 2022, also known as “MoCRA”, enters into force, which specifies new responsibilities and around 7 specific guidelines that interested parties must be applying from December of this year.
Cosmetics, according to the US FDA, do not need pre-market approval, it is the companies that guarantee that their products and ingredients are safe, have correct labeling and comply with all regulatory aspects and in terms of Good Practices, it was at the discretion of registering in the Voluntary Cosmetic Registration Program, there was no specific policy that forced companies to comply with it. However, this changed after the MoCRA Act. Assured the specialist in standards and regulations of AGEXPORT, Inés Valle Balsells.
According to Valle Balsells, the FDA defines a cosmetic product as any article that is rubbed on, poured on, sprayed on, or otherwise applied to the body to cleanse, beautify, enhance attractiveness, or modify appearance. These types of products will be subject to the regulations of the 2022 Cosmetic Regulation Modernization Act, also known as “MoCRA”, which will put into effect around 7 new guidelines, focused on:
- The registration of facilities for manufacturers of cosmetics for personal and institutional consumption, as well as repackaging companies, distributors, and marketers of cosmetics for industrial or professional use. The exception is found for those who package, store, or distribute cosmetics.
- List of products.
- Labeling of cosmetics and disclosure of fragrance allergens.
- Record keeping.
- Notification of adverse effects from cosmetics.
- Good manufacturing practices.
- Product recall.
3 DATES THAT COSMETICS PRODUCERS AND MANUFACTURERS SHOULD CONSIDER
As in any Law, there is a period of flexibility to recognize the new parameters and thus begin to apply them. Therefore, the key dates to be considered by producers and manufacturers of cosmetic products who wish to export to the US are the following:
- By December 29, 2023, of the current year, MoCRA will enter into force and with it,
- all cosmetic facilities must be registered.
- By December 29, 2024, the new requirements will enter into force.
- labeling and the proposal for Good Manufacturing Practices—BPM.
- By December 29, 2025, FDA will publish the final GMP standard.
It is self-evident to recognize that MoCRA allows the United States to adopt more precise regulations regarding the safety of cosmetics. It is necessary to remember that since 1938, the regulations for cosmetics did not present changes. It has been until the current MoCRA Act. On the part of Guatemalan exporters, it will be vital to be informed about the changes and apply them as soon as the law allows it according to the different compliance dates of the official FDA calendar, concluded the AGEXPORT Specialist, Inés Valle.
