Introduction
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was enacted on December 29, 2022. It represents the most extensive update to the Federal Food, Drug, and Cosmetic Act (FD&C Act) was passed in 1938.
MoCRA establishes new and comprehensive compliance requirements for cosmetics in the American market, including facility registration, product listing, requirements for adverse events, Good Manufacturing Practices (GMPs), adequate safety substantiation, and fragrance allergen disclosure.
Safety Substantiation under MoCRA
MoCRA mandates that cosmetic products marketed in the U.S. must have adequate safety evidence.
“A responsible person is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products.”
MoCRA defines adequate safety substantiation as “tests, studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a product is safe”.
The cores of safety substantiation include:
Toxicological Risk Assessments (TRA)
Product safety testing, such as clinical studies, microbiological analysis, and contaminant control.
What is TRA (Toxicological Risk Assessment)?
A Toxicological Risk Assessment (TRA) is a safety evaluation of a product based on its composition, ingredients and the intended uses. This detailed, scientific assessment report consists of all the available information and data regarding a specific ingredient within the context of the nature of the product, including its dosage or concentration, and the specific exposure scenario to cause acute and chronic effects.
TRA is commonly required for several product categories in the US, including art materials and other consumer products subject to CPSC/FHSA. Although the FDA has not provided detailed safety assessment requirements for cosmetics, a TRA report that aligns with the Cosmetic, Toiletry, and Fragrance Association (CTFA) Safety Evaluation Guidelines in the United States can be provided.
TRA reports must be signed by internationally certified toxicologists, such as those credentialed by:
DABT - Diplomate of the American Board of Toxicology
ERT - EUROTOX Registered Toxicologist
REACH24H's Comprehensive MoCRA Safety Compliance Solutions Service
REACH24H offers comprehensive solutions to help you meet MoCRA safety substantiation requirements:
Toxicological Risk Assessment (TRA) reports
Product testing, including: Heavy metal testing, Microbiological testing, Irritation and sensitization testing, and clinical trials
Cosmetic products’ formulation review and compliance based on MoCRA and relevant U.S. federal regulations
Why REACH24H?
Expert Safety Assessment Team: trained professionals with extensive experience in cosmetic safety evaluation and toxicological analysis.
Real-time U.S. Regulatory Updates: continuous communication with U.S. cosmetic associations ensures timely updates on cosmetic laws and regulations.
TRA Reports: Our TRA reports are signed by DABT-certified toxicologists, recognized by the American Board of Toxicology (ABT), which is the largest professional toxicology credentialing organization in the world, and strive to identify, maintain, and evolve a standard for professional competency in the field of toxicology. TRA signed by DABT-certified toxicologists is globally trusted and highly credible.
Global Regulatory Network: In-depth understanding of cosmetic compliance requirements across major international markets, including the U.S., EU, UK, and Asia-Pacific regions etc.
Integrated Laboratory Network: partnerships with top domestic and international laboratories enable us to design efficient, customized testing programs tailored to each product’s unique characteristics.
For more information and inquiries, please feel free to contact us at customer@reach24h.com.
