MoCRA’s ongoing implementation has intensified beauty industry stakeholder focus on documented safety substantiation and good manufacturing practices (GMPs) across the US market.
In response to what the organization characterizes as a longstanding gap in defined safety benchmarks for finished products, NSF is introducing NSF/ANSI 527, a nationally adopted standard that provides an independent framework for evaluating cosmetic products.
CosmeticsDesign spoke with Sarah Krol, VP Food and Nutrition at NSF, to discuss the drivers behind the new certification, its scientific foundation and its potential effects for brands, contract manufacturers and retailers.
CDU: What specific market gaps or consumer concerns prompted NSF to develop the new NSF/ANSI 527 certification, and why is now the right time for it?
SK: For many years, cosmetics in the United States have been expected to be safe, but there has not been a clearly defined framework outlining how finished product safety should be demonstrated.
MoCRA, which is already in effect and binding on companies, requires adequate safety substantiation and manufacturing under GMPs. However, it does not define in detail what constitutes adequate safety substantiation, and formal cosmetic GMP regulations are still forthcoming.
In the absence of detailed FDA guidance in these areas, companies are looking for a clear and objective benchmark.
NSF/ANSI 527 was developed as a nationally adopted standard to help address that gap, providing a structured framework for evaluating finished cosmetic products against defined safety and quality criteria.
At the same time, recall data continue to highlight risk in the marketplace. Combined FDA and EU RAPEX data from 2005 to 2025 show more than 400 cosmetic recalls due to bacteria, and microbial contamination remains the leading cause. We also know that recall events can carry significant financial and reputational impact.
With MoCRA implementation underway and regulatory expectations increasing, now is the appropriate time for a standard that supports documented safety substantiation and independent evaluation rather than assumption.
CDU: How does NSF/ANSI 527 differ from existing clean beauty standards or self-reported claims, especially in terms of testing finished products?
SK: Many clean beauty claims rely on ingredient positioning or self-reported standards, and clean beauty itself is not legally defined.
NSF/ANSI 527 evaluates the finished product. That includes microbiological testing, preservative challenge testing, heavy metal screening and ingredient review against international standards. It also includes claims and label review, GMP verification and annual retesting.
Certification indicates that safety has been evaluated according to established criteria and that results have been reviewed independently. It moves the conversation from marketing language to documented assessment.
CDU: Can you walk us through the scientific and analytical testing behind the certification? What exactly is evaluated to verify safety, label accuracy and product quality?
SK: The standard is built around finished product evaluation.
During certification, finished products in final packaging undergo microbiological testing, including challenge testing for preservative systems. We screen for microorganisms relevant to industry, as well as those specifically identified in the recent FDA draft guidance.
Heavy metals are evaluated, with lower limits for products intended for babies and young children. An additional allergenic metal panel is available where appropriate.
We also conduct ingredient review against international expectations, assess label and content claim substantiation, verify GMP compliance and require annual retesting.
Safety is evaluated according to established criteria. Brands receive detailed laboratory documentation outlining testing and results. The focus is on substantiated review, not assumptions.
CDU: How might this new certification influence brands, contract manufacturers and retailers? Who stands to be impacted first and most significantly?
SK: Brands will likely feel the impact first, especially those making safety, sensitive skin, hypoallergenic or clean beauty claims. Under MoCRA and FDA guidance, companies are expected to maintain safety substantiation and finished product testing data.
Contract manufacturers may see increased expectations around documentation and testing coordination. Retailers and practitioners are also asking more direct questions about finished product testing and independent verification.
Certification provides documented evaluation that can support brand protection, regulatory preparedness and retailer confidence.
CDU: With growing regulatory pressure under MoCRA, how does NSF/ANSI 527 support brands’ compliance efforts or go beyond basic requirements?
SK: MoCRA expanded FDA authority and clarified that companies must adequately substantiate safety and maintain records, including analytical data and adverse event documentation.
NSF/ANSI 527 incorporates MoCRA requirements and aligns with FDA draft guidance. It evaluates finished product safety utilizing screens for microbial and heavy metal risks, relevant adulterants, formulation review, substantiation documentation for specific claims, and assesses labeling practices.
Additionally, for topical OTC, which are also encompassed in this standard, the product is reviewed against the specific monograph and any required evaluations, such as SPF testing, are verified.
While FDA regulations continue to evolve, a nationally adopted standard provides a structured pathway for demonstrating compliance with defined benchmarks. It helps brands prepare rather than react.
CDU: From a consumer perspective, what will this trust signal look like on products, and how do you expect it to reshape purchasing behavior across categories?
SK: For consumers, the trust signal is the NSF certification mark, which indicates that the finished product has been evaluated according to established safety and quality criteria.
It is important to clarify that no product is entirely risk-free. Certification indicates that safety has been assessed in line with defined standards and that results have been verified by qualified reviewers.
As consumers increasingly look for evidence behind claims, independent evaluation is a strong differentiator across categories such as skin care, hair care, fragrance and oral care.
In an era defined by a lack of trust, NSF is shaping a healthier and safer world for everyone. We are the go-to partner for the food, nutrition and wellness industries – ensuring the highest level of product safety, quality, integrity and sustainability.
