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MoCRA - FDA 2024

Modernization of the Cosmetics Regulation Law

MoCRA is the most significant expansion of the FDA's authority to regulate cosmetics to ensure the safety of the cosmetic products we consume every day.

Complying with MoCRA regulations is more complex than it seems, if you want us to do it for you in an easy and professional way, do not hesitate to contact us.

MoCRA: Modernization of the Cosmetics Regulation Act

What is MoCRA?

Last December 2022, the US Senate approved the MoCRA regulations (Modernization of the Cosmetic Regulatory Act), introducing significant changes to the requirements that cosmetics and the companies that manufacture them must meet in order to sell in the United States.

The main new features established by MoCRA are:

  • Strengthening the role of the FDA in market control, supervision of products and manufacturers.

  • The mandatory registration of products and companies.

  • The need to have a physical address in the US on the label.

  • Strengthening market surveillance through the US Responsible Person.

  • The obligation to prepare a product evaluation (CPSR).

  • Reinforcing the role of GMP.

  • Tightening claims control, transparency and veracity of the information shown to the consumer.

Requirements that affect cosmetic products

Responsible Person - US Market Surveillance Contact

Each cosmetic product must have a designated Responsible Person. The name and address of the responsible person must be clearly stated on the product label. This contact agent located in US territory will be in charge of market surveillance.

List of products

All cosmetic products must be compulsorily registered on the new MoCRA registration portal by the Responsible Person. At the time of registration, products whose manufacturer is not registered with the FDA cannot be registered. 

CPSR Mandatory

The Cosmetic Product Safety Report (CPSR) prepared following the guidelines of the European Cosmetics Regulation EC No 1223/2009 is considered appropriate to convincingly and technically demonstrate the safety of a cosmetic product in the United States. However, those cosmetic products that are not marketed in the European Union or the United Kingdom will require a toxicological risk assessment that meets the same objective as the CPSR.

MOCRA

Requirements for manufacturers

Facility registration

Manufacturers and processors must register their facilities with the FDA through a US agent.

 

The FDA will have the authority to suspend the registration of a facility if it determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable probability of causing serious adverse consequences, prohibiting the entry or sale of its products in the United States. USA.

Registration with the FDA and obtaining the FEI number

At the end of the registration process, the facilities will obtain an FEI number, with which cosmetic products can be registered.

US agent as primary contact with FDA authorities

The US Agent is the contact agent between the FDA and cosmetic product manufacturers. The role of the US agent is to ensure:

  • Compliance of facilities in accordance with Good Manufacturing Practices (GMP)

  • Act as a channel between the manufacturer and the authority.

  • Renew the authorization every two years.

  • Coordinate action measures dictated by the FDA with the manufacturer.

Adverse Event Reporting and Record Keeping for MoCRA

Regarding the reporting of adverse events, according to the guidelines established by MoCRA, companies are required to maintain a comprehensive record of any health-related adverse events related to the use of cosmetic products marketed in the United States, during a period of six years. In the case of small businesses, they are required to keep these records for three years. In situations where a Serious Adverse Incident occurs, the responsible person must submit a report to the Food and Drug Administration (FDA) and be constantly updated with said agency regarding any new medical information. for one year after submitting the initial report.

FDA News in 2024: Regulatory Advances and Crucial Decisions

In the exciting world of regulation and approval of medical and pharmaceutical products, the year 2024 has brought with it a number of significant developments by the United States Food and Drug Administration.

FDA NEWS

1. Cosmetics Direct: A new electronic filing portal

FDA introduces "Cosmetics Direct," an electronic portal designed to expedite the submission of registration and listing applications. This platform promises efficiency and ease of use, ensuring that interested parties can seamlessly navigate the submission process.

2. Essential Registration Numbers: FDA Establishment Identifier (FEI)

A notable aspect of the guidance is the introduction of the FDA Establishment Identifier (FEI) as a mandatory facility registration number. Interested parties must obtain an FEI number before submitting their installation registration.

3. Detailed presentation criteria

The guidelines provide a structured breakdown of the information that must be included in submissions, submission deadlines and exemptions. For example, while small businesses may have exemptions, certain cosmetic products, such as those intended for internal use or injectables, remain under strict scrutiny.

4. Draft guidelines and feedback mechanisms

FDA invites industry professionals and interested parties to submit comments on the new draft guidance section, Appendix B. This section addresses frequently asked questions, providing clarity on various aspects of facility registration and listing. of products.

Understanding the magnitude of these regulatory changes, the FDA has shown flexibility by delaying the implementation of certain requirements.

With the original application date set for December 29, 2023, the FDA has extended this deadline until July 1, 2024.
 

The objective of this extension is to give the industry more time to adapt and comply with the updated regulations.


Additionally, facilities that began operating after December 29, 2022 will also benefit from this grace period.

 

They will not be subject to registration and listing requirements until the stipulated deadline of July 1, 2024.

 

It is imperative to familiarize yourself with the new guidelines, utilize available resources, and proactively engage with the FDA.
 

We will be happy to help you, do not hesitate to contact us.

  • EU Responsible Person and UK Responsible Person
    Another important aspect of regulation is that of the responsible person. In Europe, the responsible person is someone who has legal responsibility for ensuring that a product meets legal requirements. The same goes for the UK responsible person in the UK. Experts in cosmetics and healthcare product regulation can help companies understand the roles and responsibilities involved in this process.
  • CPNP and SCPN and PIF registration
    CPNP Registration (Cosmetic Product Notification Portal) is a legal requirement for cosmetic products in Europe. SCPN is the UK equivalent. In order to register on these portals, detailed information about the product is required, including ingredients and formulations. Experts in cosmetics and healthcare product regulation can help companies complete these registrations and ensure they are complying with legal requirements.
  • Technical dossier for product authorization in Europe
    A technical dossier is a document that describes the technical and safety aspects of a product. ​ It is a legal requirement for most cosmetic and health products in Europe. Experts in cosmetics and medical device regulation can help companies complete a technical dossier for product authorization in Europe.
  • Who is responsible for the regulation of cosmetic products in Europe?
    In Europe, the regulation of cosmetic products is the responsibility of the European Commission, which establishes regulations and requirements to guarantee the safety and quality of the products that are marketed
  • What are the requirements that a cosmetic product must meet in order to be marketed in Europe?
    A cosmetic product must comply with a series of requirements established in European Regulation 1223/2009. These requirements include aspects related to safety, labeling, permitted ingredients, animal testing and prior notification before marketing.
  • What products are not considered cosmetics according to European Regulation 1223/2009?
    According to European Regulation 1223/2009, products that have a medical purpose, such as medicines, medical devices or health products, are not considered cosmetics. These products are regulated by other specific regulations.

MoCRA timeline

Dec, 29 2022

  • MoCRA goes into effect

  • Product Listing

  • Facility registration

Jun, 29 2024

  • compliance with labeling requirements

  • GMP proposal in cosmetics

Dec, 29 2025

  • Promulgation  by MoCRA

Dec, 29 2023

  • proposal for a list of aromatic allergens

Dec, 29 2024

  • cosmetic GMP final rule publication by FDA

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