COSMESERVICE

MoCRA

Modernization of the Cosmetics Regulation Act

The 2022 Modernization of the Cosmetics Regulation Act (MoCRA) marks a pivotal shift in the FDA’s cosmetics regulatory approach, being its first major overhaul in 85 years. Established on Dec. 29, 2022, within the 2023 Consolidation Act, its core intent is to bolster product safety assurances from cosmetic manufacturers. This encompasses product integrity, manufacturing, and labeling.

By year’s end, (Dec. 29, 2023) all cosmetic industry stakeholders must align with facility norms, product listings, SAE provisions, and safety validations.

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MoCRA
MoCRA

Who falls under MoCRA regulations?

MoCRA predominantly affects cosmetic manufacturers, importers, packers, and distributors. While some small businesses, specifically those with U.S. cosmetic sales under $1M over the past three years, are exempt from certain aspects like GMP and registration, many larger entities must fully engage with MoCRA’s provisions.

Cosmetic products under MoCRA are defined as “formulations with a specific ingredient composition intended for finished product use.”

Notably, MoCRA doesn’t govern over-the-counter (OTC) drugs, such as sunscreens with cosmetic claims. These fall under OTC regulations, barring new provisions on fragrance allergen disclosure and professional use labeling.

Cosmeservice, established in EU and the UK,

is now expanding into the US market

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Timeline

December 29, 2022
1
December 29, 2022

Enactment of MoCRA

December 29, 2023
2
December 29, 2023

MoCRA comes into force

Facilities must be registered

Existing products must be listed

June24, 2024
3
June24, 2024

Proposition of a list of fragrance allergens

December 29, 2024
4
December 29, 2024

Labelling requirements enforced

Cosmetics GMP proposition

December 29, 2025
5
December 29, 2025

Cosmetic GMP Final Rule publication by FDA

US Agent

The recent Modernization of the Cosmetics Regulation Act (MoCRA) legislation for cosmetic products in the US mandates several prerequisites for manufacturers aiming to penetrate the US market. Specifically, it dictates that non-US facilities must appoint an in-country representative, known as a US Agent. 

This role, although not yet detailed by regulators, has parallels in other FDA-regulated sectors like food and pharmaceuticals, hinting at its potential responsibilities. Brands outside the USA should also maintain a domestic point of contact, potentially the US Agent. 

Cosmeservice anticipates that the FDA’s communication with the US Agent will align with existing practices in other industries. In essence, the US Agent acts as a conduit, adept at liaising with the FDA and upholding the legal duties of the Responsible Person within the US.

 

What can Cosmeservice do as your US Agent?

Dive into the realm of compliance with confidence, knowing Cosmeservice acting as your US Agent has got your back. We meticulously review your formulas, labels, and technical documents to ensure they’re up to par. Need advice on product safety substantiation? We’re here to guide you, holding onto all essential documentation for you. Our US Agent services will handle the registration of your facilities and products, ensuring they remain current and compliant.

But our support doesn’t end there. As your dedicated US Agent, we’ll keep you informed about the ever-shifting regulatory requirements, ensuring you’re always a step ahead. If adverse events arise, trust us to evaluate, record, and report them, especially the serious ones.

 Consider us as your US Agent  before the FDA, standing by your side during recalls, registration challenges, or inspections. And as the regulatory world evolves, we’ll keep you updated with the latest news and changes. With us, you’re always in safe and knowledgeable hands.

 

Choose Cosmeservice as your

US Agent
December 29, 2022
1
December 29, 2022

Enactment of MoCRA

December 29, 2023
2
December 29, 2023

MoCRA comes into force

Facilities must be registered

Existing products must be listed

June24, 2024
3
June24, 2024

Proposition of a list of fragrance allergens

December 29, 2024
4
December 29, 2024

Labelling requirements enforced

Cosmetics GMP proposition

December 29, 2025
5
December 29, 2025

Cosmetic GMP Final Rule publication by FDA

US Agent

The recent Modernization of the Cosmetics Regulation Act (MoCRA) legislation for cosmetic products in the US mandates several prerequisites for manufacturers aiming to penetrate the US market. Specifically, it dictates that non-US facilities must appoint an in-country representative, known as a US Agent. 

This role, although not yet detailed by regulators, has parallels in other FDA-regulated sectors like food and pharmaceuticals, hinting at its potential responsibilities. Brands outside the USA should also maintain a domestic point of contact, potentially the US Agent. 

Cosmeservice anticipates that the FDA’s communication with the US Agent will align with existing practices in other industries. In essence, the US Agent acts as a conduit, adept at liaising with the FDA and upholding the legal duties of the Responsible Person within the US.

What can Cosmeservice do as your US Agent?

Dive into the realm of compliance with confidence, knowing Cosmeservice acting as your US Agent has got your back. We meticulously review your formulas, labels, and technical documents to ensure they’re up to par. Need advice on product safety substantiation? We’re here to guide you, holding onto all essential documentation for you. Our US Agent services will handle the registration of your facilities and products, ensuring they remain current and compliant.

But our support doesn’t end there. As your dedicated US Agent, we’ll keep you informed about the ever-shifting regulatory requirements, ensuring you’re always a step ahead. If adverse events arise, trust us to evaluate, record, and report them, especially the serious ones.

 Consider us as your US Agent  before the FDA, standing by your side during recalls, registration challenges, or inspections. And as the regulatory world evolves, we’ll keep you updated with the latest news and changes. With us, you’re always in safe and knowledgeable hands.

Choose Cosmeservice as your

US Agent

You don't need to be located in the USA to be the Responsible Person! If you're from abroad, just appoint us as your US Agent within the US to represent you. We make it seamless for you!

Responsible Person & US Agent

The roles of the Responsible Person and the US Agent might initially seem intricate, but let’s break it down for clarity:

  • The Responsible Person: This is the entity that introduces the products onto the market. It’s vital to understand that the Responsible Person doesn’t necessarily have to be physically located in the United States. Their primary task is to ensure that the products being introduced to the market adhere to all relevant safety regulations and standards.

  • The US Agent: This role is specifically mentioned in the establishment registration. Unlike the Responsible Person, the US Agent must be situated within the US territory. Their role is pivotal as they must be available 24/7 for Adverse Events reporting, answering queries, addressing health emergencies, and cooperating in controls and inspections. They act as a bridge between the FDA and the entity introducing the product, ensuring smooth and efficient communication.

In light of the new MoCRA guidelines, Cosmeservice is thrilled to extend its expertise as a US Agent for brands outside the US. Additionally, we stand ready to serve as trusted advisors for US Responsible Persons. Let us guide and assist you through every step, ensuring compliance and success.

Responsible Person & US Agent

The roles of the Responsible Person and the US Agent might initially seem intricate, but let’s break it down for clarity:

  • The Responsible Person: This is the entity that introduces the products onto the market. It’s vital to understand that the Responsible Person doesn’t necessarily have to be physically located in the United States. Their primary task is to ensure that the products being introduced to the market adhere to all relevant safety regulations and standards.

  • The US Agent: This role is specifically mentioned in the establishment registration. Unlike the Responsible Person, the US Agent must be situated within the US territory. Their role is pivotal as they must be available 24/7 for Adverse Events reporting, answering queries, addressing health emergencies, and cooperating in controls and inspections. They act as a bridge between the FDA and the entity introducing the product, ensuring smooth and efficient communication.

In light of the new MoCRA guidelines, Cosmeservice is thrilled to extend its expertise as a US Agent for brands outside the US. Additionally, we stand ready to serve as trusted advisors for US Responsible Persons. Let us guide and assist you through every step, ensuring compliance and success.

Stay tuned! Subscribe to our newsletter to stay up to date about MoCRA changes!

Who is exempt from MoCRA?

Small businesses with gross annual sales in the U.S. from cosmetic products totaling less than $1M over the past three years are exempt from:

  • Good Manufacturing practices
  • Facility Registration
  • Product Listing

However, certain exemptions for small businesses do not extend to companies producing:

  • Cosmetics that come into contact with the eye or eyeball
  • Injectable products
  • Products designed for internal consumption
  • Products that modify appearance for over 24 hours.

What are the MoCRA requirements?

Cosmetic product listing​

The responsible person is required to annually update and list their cosmetic products with the FDA, detailing product name, type, and ingredients. MoCRA emphasizes stringent product and ingredient labeling, mandating manufacturers and distributors to provide comprehensive ingredient and manufacturing data. Products available before MoCRA’s inception must be listed by December 29th, 2023, while those introduced afterward have a 120-day listing window. All listings will be facilitated through a forthcoming FDA IT platform, with the VCRP database being archived and not migrated. Importantly, a single product listing can encompass multiple products with identical or slightly varied formulations, considering differences like colors or fragrances.

crema

Facility registration

Facilities involved in the manufacturing, processing, or distribution of cosmetics in the USA are mandated to register on the FDA’s dedicated IT platform, as per MoCRA and Sec. 607 (a). Existing facilities have until December 29th, 2023, to register, while new ones must do so within 60 days of commencing their operations or after the initial transition period ending on the same date. This registration isn’t a one-off requirement; it must be renewed every two years, ensuring that both US and foreign facilities producing cosmetics for US distribution remain compliant.

Safety substantiation

The Modernization of the Cosmetics Regulation Act (MoCRA), as detailed in Sec. 608, mandates that the responsible person for a cosmetic product maintain records substantiating the product’s safety. This substantiation can include tests, studies, research, and other evidence deemed sufficient by experts to ensure a product’s safety. While the method for this substantiation isn’t strictly defined, Cosmeservice has confirmed that a Cosmetic Product Safety Report (CPSR) in line with the European Cosmetics Regulation EC No 1223/2009 meets the criteria for the USA. Products not marketed in the EU or UK will need a Toxicological Risk Assessment, similar to the CPSR. MoCRA also emphasizes that records should be accessible to FDA personnel, especially if concerns arise about product safety. This poses challenges for smaller cosmetic companies, Cosmeservice, as regulatory expert, can guide you through the safety substantiation. 

Formula review

Labelling requirements

MoCRA’s Sec. 609 introduces new labeling requirements for cosmetics. In addition to existing standards, these stipulate the inclusion of contact details for the Responsible Person (or its US Agent) to receive Adverse Event Reports, with a compliance deadline by December 29th, 2024. By May 29th, 2024, the FDA will identify fragrance allergens for disclosure, with a rule set to be finalized after a 180-day comment period, potentially aligning with international standards like the European Union’s. Furthermore, by December 29th, 2023, products intended solely for professionals must be clearly labeled, indicating their exclusive use by licensed professionals. It’s worth noting that state-specific requirements, such as California’s Prop. 65, remain unaffected by MoCRA.

Adverse events reporting

Regarding Adverse Event Reporting, MoCRA asks companies to maintain records of any Health-related Adverse Event associated with the use of the cosmetic products sold in the USA for six years. Small business, only need to maintain it for three years. In the case of any Serious Adverse Event, the Responsible Person should present to the FDA a report and they must update the Agency regarding any new medical information during one year after the initial report.

Furthermore, MoCRA asks the FDA to propose a Cosmetic Good Manufacturing Practices (GMP) rule before December 2024. It also asks the FDA to issue a regulation for detection of asbestos in talc-containing cosmetics. Concerning animal welfare, the law is trying to reduce or to banish animal testing for safety of cosmetics.

Foto pop up

Good Manufacturing Practices

MoCRA, through Sec. 606, emphasizes the importance of Good Manufacturing Practices (GMPs) to ensure the consistent quality and safety of cosmetic products. The FDA is tasked with proposing specific GMP regulations for cosmetics by December 29th, 2024, and finalizing them by December 29th, 2025. These regulations are expected to align with both current FDA guidelines and international standards, such as ISO 22716. The FDA will have the authority to inspect facilities manufacturing cosmetic products to ensure GMP compliance, with considerations for the unique challenges faced by smaller businesses. As MoCRA’s definition of facilities encompasses establishments manufacturing or processing cosmetics for US distribution, companies should review and align with existing requirements, while noting certain exclusions like beauty shops and certain relabeling entities.

Cosmeservice is ready to answer your questions about MoCRA

FAQS

While there’s no guarantee, given the vast number of companies needing to register, it’s advisable to prepare your data early to avoid potential business interruptions. manufacturing facility with the FDA and the Responsible Person to list (register) each cosmetic product sold in the American market.

It’s recommended to start early. The FDA has outlined many requirements, and starting now ensures you stay ahead and prevent business disruptions due to non-compliance.

All products and facilities must be registered by December 29, 2023.

Every company responsible for a cosmetic product sold in the US must comply. Share your manufacturer’s contact details with experts like us to ensure they’re educated and compliant.

While the FDA hasn’t provided explicit guidelines, MoCRA suggests aligning with international standards. A Cosmetic Product Safety Report (CPSR) used in the European Union is a recognized standard that can be adapted for the US.

Labels must include contact details for Adverse Event Reports and disclose identified fragrance allergens. Products for professionals should be clearly labeled as such by December 29, 2023.

Facility registrations under Modernization of the Cosmetics Regulation Act (MoCRA) must be renewed every two years.

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