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MoCRA Cosmetics

The Modernization of the Cosmetic Regulation Act

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: The Modernization of the Cosmetic 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.

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.

MoCRA timeline

Dec, 29 2022

  • MoCRA entra en vigor

  • Product Lisitng

  • Registro de instalaciones

Jun, 29 2024

  • cumplimiento de los requisitos de etiquetado

  • Propuesta de GMP en cosméticos

Dec, 29 2025

  • Promulgación  de MoCRA

Dec, 29 2023

  • propuesta de una lista de alérgenos aromáticos

Dic, 29 2024

  • cosmetic GMP final rule publication by FDA

  • 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.
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