MoCRA and the Safety Review Process for Children’s Cosmetics

Consumer safety is more critical than ever, particularly regarding children's products. These products deserve special attention due to their significant impact on vulnerable populations. Regulatory frameworks, such as the US Modernization of Cosmetics Regulation Act of 2022 (MoCRA), place a strong emphasis on the need for rigorous safety evaluations to protect vulnerable populations.

MoCRA represents a landmark advancement in US cosmetics regulations, establishing enhanced safety and transparency requirements for cosmetic and personal care products. These regulations are applied with even greater stringency to products designed for vulnerable populations, such as children, where the stakes of safety and compliance are at their highest.

The cornerstone of any comprehensive product evaluation is the safety review. It sets the stage for subsequent testing, ensuring all aspects of a product are scrutinized for potential risks. When it comes to children's products, this process takes on an added significance due to the vulnerability of the target population and the strict regulatory requirements outlined by MoCRA.

Every safety review begins with a thorough analysis of the product's ingredients. This process includes evaluating the toxicological profile, use levels and the compatibility of components within the formulation:

1. Toxicology profiles: ingredients are assessed for their capacity to cause harm, covering acute and chronic testing, sensitization and irritation potential. Reliable data is gathered from databanks like the Cosmetic Ingredient Review (CIR) and published toxicological studies from the European Chemicals Agency (ECHA)
2. Concentration/use levels: while some ingredients are safe in small amounts, their toxicity may increase at higher concentrations. To address this, formulations must remain within acceptable limits, especially in children's products
3. Component compatibility: certain combinations of ingredients can amplify or reduce potential risks. For example, interactions between fragrances and preservatives in product mixtures can heighten sensitization risks

For children's products, the focus extends to ensuring that no banned or restricted substances, such as formaldehyde donors, are present in the formulation.

Along with the ingredient assessment, regulatory compliance checks are also conducted. Under MoCRA, manufacturers are required to:

• Provide documented evidence demonstrating that a product is safe for its intended use
• Comply with ingredient restrictions specific to children's products, such as adhering to lower thresholds for potential allergens or irritants
• Prepare for post-market surveillance by maintaining records of adverse event reporting and corrective actions

This ensures that products can be marketed confidently across different jurisdictions while avoiding costly recalls and regulatory fines.

The safety review also identifies high-risk scenarios where a product could be misused. For example, if children accidentally ingest creams or lip balms, the ingredients must be non-toxic and safe for consumption. Prolonged exposure must also be considered, requiring an evaluation of cumulative exposure risks. Furthermore, ingredients known to trigger allergic reactions, such as fragrances and colorants, are subject to higher scrutiny.

All findings gathered during the review process are compiled into a toxicological risk assessment (TRA) or cosmetic safety report (CSR). These detail:

• Hazard identification and characterization
• Dose-response assessments
• Exposure assessments (with particular focus on children's usage patterns)
• An overall risk characterization that balances the potential hazards against exposure levels

In some cases, limited information or data gaps on ingredients necessitate further investigation. In such instances, in-vitro, in-vivo and patch testing are recommended early in the development process to prevent potential issues once the product reaches shelves worldwide.