Highlights MoCRA safety requirements, EU CPSR compliance, heavy metal limits, and choosing an ISO 17025-accredited lab.
IRVINE, CA, UNITED STATES, March 25, 2026 /EINPresswire.com/ — Qalitex Laboratories, an ISO 17025-accredited third-party testing laboratory with a dedicated cosmetic testing practice serving beauty and personal care brands across North America, today announced the release of a comprehensive guide to cosmetic ingredient safety testing. The resource outlines key regulatory requirements under the Modernization of Cosmetics Regulation Act (MoCRA) and EU Regulation 1223/2009, along with best practices for safety substantiation, heavy metal testing, and laboratory selection.
The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, introduced new safety substantiation requirements that took effect in 2024. Under MoCRA, cosmetic brands must maintain adequate evidence demonstrating the safety of their products and ingredients. The U.S. Food and Drug Administration (FDA) has indicated that safety substantiation should be supported by reliable scientific data, including microbiological testing, stability studies, and ingredient safety assessments.
In parallel, EU Regulation 1223/2009 requires a Cosmetic Product Safety Report (CPSR) for all cosmetic products marketed in the European Union. The CPSR includes Part A (Cosmetic Product Safety Information), which documents formulation data, microbiological quality, impurities, and packaging compatibility, and Part B (Cosmetic Product Safety Assessment), which provides a formal safety conclusion prepared by a qualified assessor.
“The safety testing frameworks under MoCRA and EU Regulation 1223/2009 are more aligned than many brands realize,” said Nour Abochama, Vice President of Operations at Qalitex Laboratories. “Both require microbiological quality data, stability evidence, and ingredient safety documentation. In many cases, testing programs designed to meet EU requirements can also support MoCRA compliance, helping brands streamline their regulatory strategy across markets.”
Core cosmetic safety testing typically includes microbiological analysis per USP and for total microbial counts and absence of specified pathogens; preservative efficacy testing per USP and ISO 11930 to verify antimicrobial protection during product use; stability testing to confirm shelf life under labeled storage conditions; and heavy metal screening using ICP-MS for elements such as lead, arsenic, cadmium, and mercury.
Regulatory agencies have also established guidance on acceptable heavy metal levels. The FDA recommends that lead in cosmetic lip products and externally applied cosmetics not exceed 10 ppm, while arsenic guidance is set at 3 ppm. In the European Union, Regulation 1223/2009 prohibits the intentional addition of heavy metals, with enforcement supported through market surveillance and product testing.
For brands selecting a testing partner, ISO 17025 accreditation remains the foundational benchmark. However, Qalitex emphasizes that accreditation must specifically cover the relevant cosmetic testing methods. Laboratories accredited for unrelated scopes, such as environmental testing, may not meet the requirements expected by regulators, retailers, or e-commerce platforms.
“When evaluating testing needs, it’s critical to align the program with both current distribution channels and future market expansion,” Abochama added. “A brand selling on Amazon in the U.S. while preparing for EU entry will require a different testing strategy than a brand operating in a single market. A well-designed testing program should support both compliance and scalability.”
RESOURCES
Full article: https://qalitex.com/blog/how-to-test-cosmetic-ingredients-for-safety/
ABOUT QALITEX LABORATORIES
Qalitex Laboratories is an ISO 17025-accredited third-party analytical testing laboratory with facilities in Irvine and San Diego, California. The laboratory provides certificate of analysis (COA) testing, heavy metal analysis by ICP-MS, microbiological testing per USP and , preservative efficacy testing, stability studies under ICH guidelines, and regulatory compliance support for dietary supplement, cosmetic, and consumer product manufacturers. Testing programs are designed to meet FDA, EU, Amazon, and international regulatory requirements, with turnaround times starting at 48 hours for standard panels.
Nour Abochama
Qalitex Laboratories
+ +1 (949) 881-6661
nour@qalitex.com
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