Cosmetics Under MoCRA

What is MoCRA?

On December 29, 2022, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as part of the 2023 omnibus spending bill. This legislation is the first major update to the U.S. Food and Drug Administration’s (FDA) authority over cosmetic products since 1938.

Regulatory framework

MoCRA imposes several new requirements for cosmetic manufacturers and brands, including the following:

• Product and facilities registration
• The introduction of good manufacturing practices (GMP) for facilities
• Safety substantiation and serious adverse event documentation
• Labeling changes for allergens, contact information and professional use
• Additional regulations for products containing talc
• Further investigation into the safety of per and polyfluoroalkyl substances (PFAS) in cosmetics

The key deadlines set up are as follow:

Why choose Eurofins?

Cosmetic companies and manufacturers need to align with the latest disposition from U.S. FDA.

To this aim, Eurofins Cosmetics and Personal Care regulatory department and ISO certified and accredited 17025 laboratories are expert in providing one-stop-shop comprehensive solutions accessing global network of capabilities for all your needs with local service and support.

We can be your trusted partner to help in meeting MoCRA requirements offering you:

• Consulting, regulatory and toxicological services:
  • Stay up to date with the latest FDA dispositions;
  • Toxicological risk assessment;
  • Label review;
  • Facility registration, Product and ingredient listing.
• Audit services and/or assistance to ensure compliance to the new Cosmetic GMP requirements.
• Standard Operating Procedures (SOP) that will provide support for:
  • Records;
  • Adverse Event reporting and record keeping;
  • Mandatory recall.
• Testing
  • Analytical testing on finished products and raw materials: Allergens; Heavy Metals; Microbiological testing according to relevant ISO, USP and EP norms (microbiological count, preservation efficacy test); Pesticides; Residual Solvents; Formaldehyde; Sulfates; Phthalates…;
  • Stability study: Evaluation of appearance, color, odor, pH, density, viscosity, weight loss;
  • Period after opening test;
  • In vitro studies for safety and efficacy on finished products and raw materials: Skin/Eye irritation; Skin Sensitization; Biodegradability…;
  • Clinical studies for safety: Patch test under clinical control; In use test under clinical control; Non-comodogenicity clinical test…;
  • Clinical studies for efficacy supporting cosmetics claims: Soothing; Microbiome analysis; Moisturization; Anti-inflammatory…;
  • Test on cosmetic packaging: Compatibility, Package Integrity, Packaging purity…