MoCRA

The MoCRA act, or Modernization of Cosmetics Regulation Act, signifies a fundamental shift in FDA regulation for cosmetics, aiming to enhance safety assurances for industry-manufactured products.

Starting in 2024, all stakeholders in the cosmetics industry must comply with facility regulations, product listings, SAE provisions, and safety validations.

Latest MoCRA updates: Delay in enforcing cosmetic facility and product registration requirements.

On November 8, the FDA announced a six-month postponement of obligations related to cosmetic facility registration and product listing requirements under the MoCRA. This allows the industry additional time to submit facility registration and product listing information.

The FDA has confirmed non-enforcement of these Mocra requirements for an additional six months beyond December 29, 2023, until July 1, 2024, while maintaining safety and adverse event reporting mandates.

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.

FDA Mocra: What are the MoCRA requirements?

modernization of cosmetics regulation act of 2022

Cosmetic product listing

The Responsible Person must annually update cosmetic products with the FDA, focusing on rigorous labeling and setting deadlines for both existing and new products.

mocra regitration portal

Facility registration

Cosmetic facilities in the U.S. must register on the FDA platform according to MoCRA and Sec. 607(a), with established deadlines for existing and new facilities. Registration must be renewed every two years.

Safety substantiation

MoCRA requires the Responsible Person for a cosmetic product to maintain records justifying the safety of the product. This justification may include tests, studies, research and other evidence that experts deem sufficient to ensure the safety of the product.

Labelling requirements

Article 609 of MoCRA regulation introduces new labeling requirements for cosmetics, including contact information for reporting adverse effects and the identification of fragrance allergens.

mocra labelling requirements

Adverse events reporting

Companies reporting adverse events for their cosmetics in the U.S. must keep records for six years (three for small businesses). In the case of serious events, the Responsible Person must notify the FDA and update medical data for one year after the initial report.

mocra responsible person

Good Manufacturing Practices

MoCRA registration underscores the significance of Good Manufacturing Practices (GMP) for the safety of cosmetic products. The FDA must propose GMP regulations by December 29, 2024, aligning with international standards such as ISO 22716.

MoCRA 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

MOCRA COMPLIANCE: Discover how Cosmeservice supports you

To comply with the FDA, having the FEI number, facility registration, and product listing is crucial. We will verify/obtain your FEI (FDA Establishment Identifier) and handle the facility registration and product listing on your behalf.

We ensure that your cosmetic products comply with FDA standards and MoCRA requirements. We review formulas, labels, and claims justifications. For sales in California, we ensure compliance with Proposition 65 to warn about potential chemical risks.

The US Responsible Person (US RP) is the entity whose name appears on the label of a cosmetic product, taking legal responsibility to ensure its safety, regulatory compliance, and proper labeling. Foreign companies acting as US RP must designate a US Agent in the United States to communicate with the FDA. Cosmeservice can serve as a US Agent, offering support and keeping you informed about regulatory updates.

Your cosmetic products fully comply with FDA standards. As your representative in the U.S., we will oversee your products and provide regulatory updates.

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

It is 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.

 

Your trusted US Agent

Consider us your US Agent at the FDA, providing support during market withdrawals, registration challeges and inspections. We will keep you informed about regulatory changes and assess and report adverse effects. We ensure regulatory compliance of your products by meticulously reviewing formulas, labels, and technical documents, offering products safety advice, and managing records.

FAQS

The 2022 Modernization of the Cosmetics Regulation Act (MoCRA) is the FDA’s first major cosmetics regulatory update in 85 years, focusing on product safety and manufacturing standards. Non-US cosmetic facilities need a US Agent for representation. Cosmeservice offers US Agent services, ensuring compliance and liaising with the FDA.

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.

  • 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. 

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.

Are you ready?

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