SGS Launches Comprehensive Solution for MoCRA Compliance

SGS Launches Comprehensive Solution for MoCRA Compliance

(IN BRIEF) SGS has introduced a comprehensive solution to support organizations in complying with the Modernization of Cosmetics Regulation Act (MoCRA) in the United States. MoCRA, which expands the FDA’s authority over cosmetic products, imposes new requirements on manufacturers and processors, including registration with the FDA by July 1, 2024, or within 60 days of any changes. SGS’s solution covers various aspects of MoCRA compliance, such as facility registration, product listing, GMP preparation, adverse event reporting, safety substantiation, label compliance, and more. With extensive experience in the cosmetics industry and US regulations, SGS aims to provide a one-stop-shop for MoCRA compliance needs, helping organizations navigate the regulatory landscape effectively and ensure product safety and compliance.

(PRESS RELEASE) GENEVA, 4-Mar-2024 — /EuropaWire/ — Because the first step on the MoCRA journey is registering with the FDA by July 1, 2024, SGS has launched its one-stop solution to support you, from registration to peace of mind compliance.

The Modernization of Cosmetics Regulation Act (MoCRA) ensures the safety of cosmetic products distributed in the US, expanding the Food and Drug Administration’s (FDA) authority to regulate consumer cosmetic products.

It significantly impacts manufacturers and processors selling cosmetic products in the US, with new and redefined requirements for cosmetic brands, manufacturing facilities and distributors. Your organization’s first step is registering with the FDA by July 1, 2024, or within 60 days of any changes. We can support this first step.

The regulation also outlines responsibilities for the responsible person (RP) whose name appears on the product’s label. Key requirements include:

• Facility registration and product listing
• Good manufacturing practice (GMP)
• Mandatory reporting of adverse events
• Substantiating product safety
• Labeling fragrance allergens
• Testing methods for talc-containing cosmetics

An all-encompassing solution to suit your MoCRA mission

Combining decades of experience in the cosmetics industry and US regulations with regular engagement and knowledge sharing with US regulatory bodies, we have developed services for all your MoCRA compliance needs.

We can help:

• Find a US agent (if your facility is based outside the US)
• Register your facility with the FDA
• List your products on the FDA portal
• Prepare you for GMP compliance
• Strengthen your adverse event reporting
• Substantiate product safety, including toxicological risk assessment and testing
• Review your product label’s compliance

We also provide:

• Training and education
• Audits and certification
• Supply chain mapping and assessments

What are the benefits of SGS’s MoCRA compliance services?

We enable you to:

• Meet all your MoCRA needs in one convenient place
• Gain easy access to the latest MoCRA knowledge
• Pinpoint which requirements apply to your organization and products
• Ensure facility GMP readiness with our ANAB-accredited ISO 22716 (cosmetics GMP) certification
• Verify compliance with ever-evolving MoCRA requirements
• Ensure your contract manufacturers’ compliance
• Meet and exceed compliance requirements within regulatory deadlines

Complete our simple form for SGS MoCRA registration support. Already registered? Contact our expert team directly to enhance your MoCRA mission.

About SGS

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world.

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SOURCE: SGS