Cosmetic product testing is the laboratory analysis required to verify that cosmetic products are safe, properly labeled, and free from harmful levels of contaminants before they reach consumers. Under the Modernization of Cosmetics Regulation Act (MoCRA) signed into law in December 2022, the FDA now requires cosmetic manufacturers to substantiate product safety through adequate testing, register facilities, list products, and report serious adverse events.

The MoCRA Revolution: What Changed for Cosmetic Manufacturers

For decades, the cosmetics industry operated under the original Federal Food, Drug, and Cosmetic Act of 1938, which gave the FDA remarkably limited authority over cosmetic products. Manufacturers were not required to register with the FDA, list their products, or submit safety data. That era ended on December 29, 2022, when President Biden signed the Consolidated Appropriations Act of 2023, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as Title III, Subtitle E.

MoCRA represents the most significant expansion of FDA authority over cosmetics in over 80 years. For manufacturers, contract laboratories, and brands operating in Arizona and across the United States, the implications are substantial and the compliance deadlines are real.

Key MoCRA Requirements

MoCRA introduces several new mandatory requirements for cosmetic manufacturers:

• Facility registration: All facilities that manufacture or process cosmetic products for distribution in the United States must register with the FDA. Initial registration was required by December 29, 2023, with renewals required every two years. The FDA estimates that approximately 10,000 to 15,000 facilities will need to register.
• Product listing: Manufacturers must submit a list of every cosmetic product marketed in the United States, including the product’s ingredients, to the FDA. Initial listings were due by December 29, 2023.
• Safety substantiation: Manufacturers must ensure and maintain records supporting that their products are safe. The FDA can take action against products that do not have adequate safety substantiation.
• Serious adverse event reporting: Manufacturers must report serious adverse events associated with their cosmetic products to the FDA within 15 business days of receiving a report.
• Good Manufacturing Practices (GMPs): The FDA is authorized to establish GMPs for cosmetic manufacturing. Proposed GMP regulations are expected to be finalized by 2025-2026.
• Mandatory recall authority: For the first time, the FDA has the authority to issue mandatory recalls of cosmetic products that are adulterated or misbranded and present a risk of serious adverse health consequences.
• Fragrance allergen labeling: MoCRA requires disclosure of specific fragrance allergens on product labels, with implementation expected through future rulemaking.

Who Is Affected

MoCRA applies to virtually all cosmetic products marketed in the United States, with limited exemptions for certain small businesses. The small business exemption applies to companies with average gross annual sales of less than $1 million in cosmetic products over the previous 3-year period, but this exemption does not apply to products that contain certain color additives or are otherwise subject to specific FDA regulations. Arizona has a growing beauty and personal care manufacturing sector, with an estimated 200 to 400 cosmetic product companies operating in the state, ranging from large contract manufacturers to small artisanal brands selling through farmers markets, online platforms, and local retailers.

Required Testing Types for Cosmetic Products

Safety substantiation under MoCRA requires manufacturers to demonstrate through testing and scientific evidence that their products are safe under labeled or customary conditions of use. The following types of testing form the foundation of a comprehensive cosmetic safety program.

Microbiological Testing

Microbiological testing is arguably the most critical safety test for cosmetic products. Contaminated cosmetics have been responsible for serious infections, including cases of antibiotic-resistant Pseudomonas aeruginosa infections from contaminated eye cosmetics, and Klebsiella and Enterobacter infections from contaminated lotions and creams.

Standard microbiological testing for cosmetics includes:

• Total aerobic microbial count (TAMC): Measures the total number of bacteria in the product. FDA guidelines and industry standards (ISO 17516) set limits at 100 CFU/g for eye-area and lip products and 1,000 CFU/g for other cosmetic products.
• Total combined yeast and mold count (TYMC): Measures fungal contamination. Limits are typically 10 CFU/g for eye-area products and 100 CFU/g for other products.
• Pathogen screening: Testing for the absence of specific pathogenic organisms including Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, and Escherichia coli. These organisms must be absent in specified quantities of the product.

Microbiological testing should be performed on raw materials, in-process samples, and finished products. The testing methods are standardized under USP chapters 61 and 62, and ISO 21149, ISO 21150, ISO 22717, ISO 22718, and ISO 18415. AATLS performs microbiological testing using these validated methods under our ISO 17025 accredited quality system. Visit our testing services page for details.

Heavy Metals Testing

Heavy metals in cosmetics pose serious health risks, particularly with repeated dermal exposure over time. Lead, arsenic, mercury, cadmium, and chromium have all been detected in cosmetic products, with some categories of products showing higher contamination rates than others.

FDA recommended limits and relevant guidelines include:

• Lead: FDA recommends a maximum of 10 ppm in cosmetic lip products and externally applied cosmetics. California Proposition 65 lists lead as a reproductive toxicant and carcinogen with an NSRL (No Significant Risk Level) of 0.5 micrograms per day for cancer and a MADL (Maximum Allowable Dose Level) of 0.5 micrograms per day for reproductive toxicity.
• Arsenic: No specific FDA limit for cosmetics, but Health Canada limits arsenic to 3 ppm. Industry best practices target less than 3 ppm.
• Mercury: FDA limits mercury to 1 ppm in cosmetics (21 CFR 700.13), with an exception for mercury-containing preservatives in eye-area cosmetics at concentrations not exceeding 65 ppm (rarely used in modern formulations).
• Cadmium: No specific FDA limit, but Health Canada limits cadmium to 3 ppm. Industry best practices target less than 5 ppm.
• Chromium: Hexavalent chromium (Cr VI) is a known carcinogen. No specific FDA limit for total chromium in cosmetics, but testing helps ensure absence of hexavalent forms.

Heavy metals testing is typically performed using ICP-MS (inductively coupled plasma mass spectrometry), which can detect metals at parts-per-billion concentrations. This level of sensitivity is essential for meeting the stringent limits required by FDA guidance and international regulations.

Preservative Efficacy Testing (Challenge Testing)

Preservative efficacy testing, also known as challenge testing or antimicrobial effectiveness testing, determines whether a cosmetic product’s preservation system is adequate to prevent microbial growth during the product’s shelf life. This testing is critical because cosmetic products are repeatedly exposed to potential contamination during consumer use, particularly multi-use products like creams, lotions, and liquid foundations.

The standard methodology is described in USP chapter 51 (Antimicrobial Effectiveness Testing) and ISO 11930:

• The product is inoculated with standardized concentrations of challenge organisms (typically Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Aspergillus brasiliensis, and Candida albicans).
• Microbial counts are measured at defined intervals over 28 days.
• The preservative system must demonstrate adequate reduction in microbial counts according to the acceptance criteria of the chosen standard.

Products that fail challenge testing are at risk of microbial contamination during consumer use, which can result in product recalls, adverse event reports, and regulatory action under MoCRA. Products marketed as “preservative-free” or using natural preservation systems require particular attention, as these formulations may be more susceptible to microbial growth.

Stability Testing

Stability testing evaluates how a cosmetic product performs over time under various storage conditions. It is essential for establishing expiration dates, validating packaging compatibility, and ensuring that the product remains safe and effective throughout its intended shelf life.

Key stability testing protocols include:

• Accelerated stability: Products are stored at elevated temperatures (typically 40 degrees Celsius and 75 percent relative humidity) and evaluated at intervals over 3 to 6 months. This predicts long-term stability in a compressed timeframe.
• Long-term stability: Products are stored at controlled room temperature (25 degrees Celsius, 60 percent relative humidity) and evaluated at intervals over 12 to 36 months.
• Freeze-thaw cycling: Products are subjected to alternating freezing and thawing cycles to evaluate physical stability under temperature extremes. This is particularly relevant for products shipped to or sold in Arizona, where summer temperatures can exceed 115 degrees Fahrenheit and products may be exposed to extreme heat during transport and storage.

Stability testing evaluations typically include physical appearance, color, odor, pH, viscosity, microbial quality, and active ingredient concentration (where applicable).

Chemical Analysis and Ingredient Verification

Beyond safety testing, cosmetic manufacturers must verify that their products contain the ingredients listed on the label in the correct concentrations. This includes:

• Active ingredient quantification: For products making specific claims (e.g., SPF sunscreen actives, anti-acne ingredients, anti-dandruff actives), the active ingredients must be present within label claim specifications.
• Prohibited and restricted substance screening: FDA maintains a list of prohibited and restricted ingredients for cosmetics (21 CFR Part 700). International markets have additional restrictions. Testing ensures compliance with these requirements.
• Contaminant screening: Testing for unintended contaminants such as 1,4-dioxane (a byproduct of ethoxylation found in many surfactants), nitrosamines, and formaldehyde releasers.

Arizona-Specific Considerations for Cosmetic Manufacturers

Arizona’s climate, regulatory environment, and growing manufacturing sector create unique considerations for cosmetic product testing.

Heat and Stability Challenges

Arizona’s extreme heat presents genuine challenges for cosmetic product stability. Products manufactured, stored, or sold in Arizona may be exposed to temperatures exceeding 120 degrees Fahrenheit during summer months, particularly during transit and in non-climate-controlled storage or delivery vehicles. The National Weather Service reports that Tucson averages 56 days per year above 100 degrees Fahrenheit, while Phoenix averages 110 days.

This makes stability testing under elevated temperature conditions especially important for Arizona manufacturers. Products that pass standard stability protocols may fail under the real-world conditions of an Arizona summer. Consider including high-temperature stability testing at 50 or 60 degrees Celsius in addition to standard protocols to simulate worst-case Arizona storage and transport conditions.

Water Quality for Manufacturing

Water is the primary ingredient in many cosmetic formulations. Arizona’s water quality characteristics, including high mineral content, elevated TDS, and the potential for trace contaminant presence, can affect both product quality and microbial stability. Manufacturers using local water sources should test their water supply regularly and may need purification systems (deionization, reverse osmosis) to meet USP Purified Water or equivalent specifications for cosmetic manufacturing. AATLS can test manufacturing water supplies to verify they meet your formulation requirements. Explore our water testing capabilities.

Growing Arizona Beauty Industry

Arizona’s cosmetic and personal care manufacturing sector has grown significantly in recent years. The state’s favorable business climate, including no inventory tax, proximity to West Coast distribution networks, and a growing population of skilled workers, has attracted both established manufacturers and startups. The Tucson and Phoenix metropolitan areas are home to a diverse range of cosmetic companies, from large contract manufacturers producing for national brands to small businesses creating artisanal skincare, haircare, and color cosmetics.

Many of these companies, particularly smaller operations, are navigating MoCRA compliance requirements for the first time. Having an accredited local laboratory partner reduces shipping times for samples, enables faster turnaround on testing, and provides access to scientists who understand both the regulatory requirements and the local manufacturing environment.

Cross-Border Considerations

Arizona’s proximity to the Mexican border creates opportunities for manufacturers selling into or sourcing from Mexico. Cosmetic products sold in Mexico must comply with Mexican NOM standards, which have their own testing requirements. Products imported from Mexico for sale in the United States must meet all FDA and MoCRA requirements. Manufacturers with cross-border operations should ensure their testing program addresses both FDA and NOM requirements.

Building a Cosmetic Testing Program: Step by Step

For manufacturers developing or upgrading their testing program to meet MoCRA requirements, the following framework provides a structured approach.

Step 1: Raw Material Testing

Every ingredient entering your facility should be tested or verified against a certificate of analysis (CoA) from the supplier. Key tests for raw materials include:

• Identity confirmation (FTIR, HPLC, or other appropriate method)
• Microbial quality (TAMC, TYMC, pathogen screening)
• Heavy metals screening
• Purity and assay testing for active ingredients

Even when relying on supplier CoAs, periodic verification testing of incoming raw materials is a GMP best practice and may become a regulatory requirement under forthcoming MoCRA GMP rules.

Step 2: In-Process Testing

Testing during the manufacturing process helps identify problems before they affect a full production batch. In-process testing may include:

• pH monitoring
• Viscosity checks
• Temperature verification at critical process steps
• Microbial checks during water-phase preparation
• Homogeneity testing for emulsions and suspensions

Step 3: Finished Product Testing

Every finished product batch should undergo a defined testing protocol before release. At a minimum, this includes:

• Physical evaluation (appearance, color, odor, texture)
• pH measurement
• Microbial testing (TAMC, TYMC, pathogen screening)
• Heavy metals testing (lead, arsenic, mercury, cadmium at minimum)
• Weight or volume verification
• Label review and compliance check

Step 4: Ongoing Testing and Monitoring

MoCRA requires ongoing safety substantiation, not just point-in-time testing. Your testing program should include:

• Stability testing for new formulations and significant formula changes
• Preservative efficacy testing for new products and reformulations
• Annual or semi-annual heavy metals testing on finished products
• Environmental monitoring of manufacturing areas
• Water quality testing of manufacturing water
• Trend analysis of testing data to identify emerging issues

Choosing the Right Laboratory Partner

Selecting a laboratory for cosmetic product testing is a decision that affects your regulatory compliance, product safety, and brand reputation. Key factors to consider include:

Accreditation

ISO/IEC 17025 accreditation is the international standard for laboratory competence. An accredited laboratory has been independently evaluated and found to be technically competent for the specific tests listed on its scope of accreditation. For cosmetic testing, ensure the lab is accredited for the specific methods you need, including microbiological, chemical, and physical testing methods. Check our accreditations page for details on AATLS qualifications.

Method Capability

Verify that the laboratory uses the specific test methods required by FDA, USP, and ISO standards for cosmetic testing. Key methods include USP 51/61/62 for microbial testing, ICP-MS for heavy metals, and ISO 11930 for preservative efficacy. A laboratory that uses non-standard or internally developed methods may produce results that are not accepted by regulators or auditors.

Turnaround Time and Capacity

Cosmetic product releases are often time-sensitive. A laboratory that cannot deliver results within your production timeline becomes a bottleneck. Ask about standard turnaround times, rush options, and the lab’s current capacity utilization. AATLS offers standard turnaround of 3 to 5 business days for most analyses, with rush options available.

Technical Support

Regulatory requirements for cosmetics are evolving rapidly under MoCRA. A laboratory that can provide technical guidance on testing requirements, method selection, and regulatory interpretation is significantly more valuable than one that simply runs the tests and delivers a report. Look for a laboratory with scientists who understand both the analytical chemistry and the regulatory context.

How AATLS Supports Cosmetic Manufacturers

AATLS provides the accredited testing services, technical expertise, and responsive service that Arizona cosmetic manufacturers need to meet MoCRA requirements and ensure product safety.

• ISO 17025 accredited for microbiological, chemical, and physical testing methods relevant to cosmetic products.
• Comprehensive test menu including microbial limits testing, heavy metals analysis, preservative efficacy testing, and stability studies.
• Arizona-based with fast sample receipt and local pickup options for Tucson-area manufacturers.
• Expert guidance on MoCRA compliance, testing program design, and regulatory requirements.
• Fast turnaround to keep your production schedule on track.
• Veteran-owned and committed to supporting Arizona businesses. Learn more about us.