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FDA MoCRA Responsible Person vs EU Cosmetics Responsible Person

mocra responsible person

The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 marks a watershed moment for the U.S. cosmetics industry. This legislation significantly expands the Food and Drug Administration's (FDA) authority over how cosmetics are manufactured, distributed, and marketed. A critical new element of MoCRA is the establishment of the "cosmetics responsible person" (RP).

Beyond Regulation: A More Robust Framework

MoCRA doesn't just introduce stricter regulations; it creates a more comprehensive oversight system. Companies must now comply with Facility Registration, Product Listings, Good Manufacturing Practices (GMPs), Safety Substantiation, revamped labeling requirements, and mandatory Adverse Event Reporting.

Pinpointing Accountability: The Facility and Responsible Person

MoCRA assigns clear lines of accountability. The designated "facility" and the "responsible person" are jointly responsible for ensuring compliance with the new regulations.

The Evolving Role of the Cosmetics Responsible Person

For companies solely focused on the U.S. market, the concept of a "responsible person" may be new. However, it's a familiar term for those already navigating the European Union (EU) cosmetics market.

Understanding the "Responsible Person": A Bifurcated Approach

While both the U.S. and EU have a "responsible person" role, key distinctions exist:

  • EU: Defined under EU Regulation (EC) No 1223/2009, the RP must be a legal entity or individual residing within the EU. They're responsible for ensuring compliance with all relevant regulations for each marketed cosmetic product.

  • U.S.: MoCRA defines the RP as "the manufacturer, packer, or distributor whose name appears on the cosmetic product label." This definition has particular significance for Adverse Event Reporting, requiring the RP's contact information to be readily available on the label.

Responsibilities: A Comparative Analysis

Under MoCRA, the U.S. RP is responsible for:

  • Product Listings

  • Product Labeling Compliance

  • Safety Substantiation

  • Disclosing Fragrance Allergens

  • Recalls

  • Adverse Event Reporting

The RP can be located anywhere globally and can appoint an authorized agent to handle specific tasks like managing adverse events. However, the RP cannot be just anyone. Companies outside the U.S. may consider designating a qualified U.S. agent to ensure MoCRA compliance.

EU vs. U.S. RP: A Breakdown

In contrast, the EU RP is tasked with:

  • Maintaining the Product Information File (PIF) with relevant documentation.

  • Alerting authorities of potential risks and collaborating with market surveillance activities.

  • Ensuring that the brand owner takes appropriate corrective measures for any non-compliant products.

Crucially, the EU RP must be located within the EU. Companies outside the region must appoint an EU-based RP to handle cosmetic registrations. This RP can be a third-party service provider.

Navigating the Global Landscape: Understanding International RP Regulations

For companies operating internationally, grasping the intricacies of both the U.S. and EU responsible person roles is crucial for ensuring compliance.

Contact Provision Consulting Group Today!

MoCRA presents a new regulatory landscape for the U.S. cosmetics industry. We can help you navigate these changes. Our team of FDA compliance specialists can assist you with understanding your obligations under MoCRA, appointing a qualified U.S. RP if needed, and ensuring smooth compliance with the new regulations.

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