The Modernization of the Cosmetics Regulation Act 2022 (MoCRA)
On December 29th, 2022, the most significant to cosmetic requirements (21 U.S.C., Sec. 321-392) since 1938 was enacted. This new piece of legislation introduces new obligations for the cosmetics industry, and we anticipate a substantial impact for cosmetic brands distributing in the USA. Beyond new regulatory provisions, MoCRA is considered as a paradigm shift in the way cosmetic products are regulated in this region. More surveillance, inspection and injunction powers are allocated to the FDA to protect public health. Among other mandates, the FDA is allowed under MoCRA to suspend the registration of a facility and order product recalls. In that sense, the way to regulate cosmetic products in the USA tends to align with the European law philosophy.
Responsible Person / US Agent
Every cosmetic product must have a designated Responsible Person, as defined by Sec. 604 (4), who can be the manufacturer, the packager, or the distributor. Responsible Person’s name and address shall be clearly stated on the product label.
As clarified in June 2023 by the FDA, the Responsible Person is not required to be located within the US territory. However, foreign Responsible Persons must designate an Agent located in the USA. To learn more about the obligations associated with the roles of Responsible Person and US Agent, please, visit our specific page on this topic.
EU and UK Responsible Person for many years, Biorius is now ready to extend its support as US Agent with the introduction of MoCRA.
Registration of facilities and cosmetic product listing
As laid down by Sec. 607, MoCRA also comes with registration obligations, namely the registration of facilities and the cosmetic product listing. These two operations will be conducted via the same system and may be conducted at the same time :
Facility registrations
Any facility involved in the manufacturing, processing, or distribution of cosmetic products in the USA must register on the dedicated IT platform of the FDA and maintain this registration up-to-date (Sec. 607 (a)). Registrations of existing facilities are due by December 29th, 2023
These facility registrations shall be renewed every 2 years and new facilities must be registered within 60 days after the first engaging in their activity (or 60 days after the initial transition period ending on December 29th, 2023).
Cosmetic product listing
The responsible person must maintain an up-to-date annual listing of their marketed cosmetic products with the FDA. The listing will have to include details such as the product name, type, and ingredients. Cosmetic product listing is due by December 29th, 2023 and new cosmetic products shall be listed within 120 days following their marketing in interstate commerce.
Like the facility registration, the cosmetic product listing will be made possible by an IT platform (still to be) provided by the FDA. This platform may be developed based on the former platform dedicated to the Voluntary Cosmetic Registration Program (VCRP), which got inactivated on March 27th, 2023. Though, we know that this VCRP database will not be migrated to the new system but archived by the FDA.
A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.
Safety substantiation
MoCRA provides in Sec. 608 that the responsible person for a cosmetic product must ensure and maintain records that support the adequate substantiation of safety for the product.
While the Amendment is non-prescriptive about the method to adequately substantiate the safety of cosmetic products, it clarifies that “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe”.
On this basis and further discussions with relevant trade associations, Biorius confirms that a Cosmetic Product Safety Report (CPSR) established in accordance with the European Cosmetics Regulation EC No 1223/2009 is deemed sufficient to adequately substantiate the safety of a cosmetic product in the USA. Cosmetic products not marketed in the EU or the UK will require a Toxicological Risk Assessment, serving the same purpose as the CPSR.
Finally, Sec. 614 (a) lays down that no State may establish or continue in effect any law or regulations concerning safety substantiation of cosmetic products that would be “different from or in addition to, or otherwise not identical with” any requirement applicable under the MoCRA.
Mandatory elements to label
Sec. 609 of MoCRA creates new labeling requirements. Their enforcement comes with no prejudice to the usual labeling requirements such as foreseen in 21 U.S.C., Sec. 321-392 (FD&C Act, implemented via 21 C.F.R., Sec. 700-740) and 15 U.S.C., Sec. 1451-1460 (Fair Packaging and Labeling Act, implemented via 16 C.F.R., Sec. 500-503).
- These new labeling requirements include A domestic address, telephone number, or electronic contact information through which the Responsible Person (or its US Agent) can receive Adverse Event Reports. The transition period to comply with this labeling requirement is 2 years, meaning that the packaging of cosmetic products placed on the US market must be adapted by December 29th, 2024.
- Disclosure of fragrance allergens to be identified by the FDA. The FDA shall identify these fragrance allergens to disclose by May 29th, 2024, and issue a final rulemaking not later than 180 days after the date on which the public comment period on the proposed rulemaking closes.
- Clear and prominent labeling for products intended for use only by professionals, indicating that they should be administered or used by licensed professionals and confirming compliance with the FDA requirements established in this regard. This labeling requirement will start to apply from December 29th, 2023.
As reported in Sec. 614 (b), the MoCRA does not prevent any State from continuing in effect a requirement of any State that is in effect at the time of its enactment for the reporting to the State of an ingredient in a cosmetic product. In other words, initiatives like Prop. 65 in California remain fully applicable.
Ingredients
Talc (Sec. 3504)
Standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products shall be drafted by the FDA within one year after the enactment of the MoCRA (December 29th, 2023). A final regulation reporting the standardized methods will be adopted not later than 180 days after the date on which the public comment period on the proposed regulation closes.
PFAS [Perfluoroalkyl and Polyfloroalkyl substances] (Sec. 3506)
The FDA is required to evaluate the use and safety of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products, including any associated risks. A report summarizing the evaluation results must be published on the FDA website no later than 3 years after the enactment of the Act.
No limitation
Sec. 614 (b) lays down that the MoCRA does not prevent any state from prohibiting the use of limiting the amount of an ingredient in a cosmetic product. Therefore, States provisions remain fully applicable.
Adverse Events
Sec. 605 lays down important obligations for the Responsible Person regarding the reporting and management of Adverse Events.
Serious Adverse Event (defined as an Adverse Event resulting in death, life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, a significant disfigurement other than as intended under reasonably foreseeable use conditions or requiring a medical intervention to prevent such an outcome) must be reported to the FDA within 15 days.
Adverse Events have to be recorded by the Responsible Person and kept for a period of minimum 3 years and maximum 6 years, depending on the size of business. The FDA, among other new mandates, has the right to inspect these records.
Good Manufacturing Practices
Via Sec. 606, MoCRA also introduces the obligation to comply with Good Manufacturing Practices (GMPs)
to ensure that cosmetic products are not adulterated. A draft for these specific GMP requirements shall be published by the FDA within 2 years following the date of enactment of MoCRA (December 29th, 2022) in view to have them finalize no later than 3 years after such date of enactment. At this stage, we only know that such GMP requirements will have to be aligned with national and international standards to the extent practicable.
The FDA will have the authority to inspect the records of facilities engaged in the manufacture of cosmetic products and verify their compliance with these GMP. Though, the Regulators required the FDA to adapt its requirements to the specific constraints of smaller businesses.
Timeline
As these changes will not all occur simultaneously, here is a summary of the next steps and compliance :
- Facility registration and product listing requirements.
- Mandatory elements labeling required for professional-use products.
- Obligation to track, record, and report adverse events.The safety of all products must be adequately substantiated.
- Talc-testing standardized methods proposed by the FDA.
- Allergen labeling Rulemaking proposed by the FDA
- Talc-testing standardized methods finalized
- GMPs rulemaking proposed
- Mandatory elements labeling required for all products
- Allergen labeling regulation finalized
- Publication of the PFAS report on the FDA website
- GMP regulation finalized
*Estimated based on a 60-day comment period and a directive to finalize no later than 180 days after the close of the public comment period.
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