Under the Modernization of Cosmetics Regulation Act (MoCRA), companies placing cosmetic products on the U.S. market must ensure that there is adequate substantiation of the safety of their cosmetic products.

Our MoCRA Cosmetic Safety Substantiation service provides a professional safety assessment of your cosmetic formulation and supporting documentation to help demonstrate that your product has adequate safety substantiation for the U.S. market.

What is Cosmetic Safety Substantiation?

Cosmetic Safety Substantiation is the documentation and scientific evidence used to support the conclusion that a cosmetic product is safe under its intended and reasonably foreseeable conditions of use.

MoCRA does not require a European-style Cosmetic Product Safety Report (CPSR). Instead, the responsible person must ensure and maintain records supporting adequate substantiation of safety for each cosmetic product.

Our service brings the available safety information together into a structured safety assessment for your finished cosmetic product.

What do we assess?

Our safety experts evaluate the product formulation and the available safety information, including:

• Complete qualitative and quantitative formulation
• Ingredient concentrations and functions
• Toxicological information on the ingredients
• Intended use of the cosmetic product
• Area and frequency of application
• Expected consumer exposure
• Relevant ingredient restrictions and safety considerations
• Fragrance and allergen information, where applicable
• Available product and raw-material documentation
• Other relevant scientific safety information

Based on the available information, we assess whether there is sufficient evidence to substantiate the safety of the finished cosme

Variations

Do you have one cosmetic formula that you want to offer in multiple fragrances or colors? Our MoCRA Cosmetic Safety Substantiation Bundle combines a complete safety substantiation for your base formula with the assessment of eligible product variations.

This is ideal for product ranges such as soaps, body lotions, shower products, lip products, or other cosmetics where the base formulation remains the same, but different versions are created using different fragrances or colors.

What is included?

The bundle includes:

• 1 complete MoCRA Cosmetic Safety Substantiation for your base formula
• Safety assessment of the selected number of variations
• Review of the documentation for the different fragrances or colors
• Safety substantiation documentation for the assessed product range

What counts as a variation?

A variation is based on the same base formula, with one type of change:

• Different fragrance – the base formula remains the same, but a different fragrance is used; or
• Different color – the base formula remains the same, but a different color or colorant combination is used.

When is it a new recipe?

If a product has both a different fragrance and a different color, it is considered a new recipe and cannot be included as a variation under this bundle.

Changes to the base ingredients, ingredient concentrations, or other aspects of the formulation may also result in the product being considered a new recipe.

Why choose the Bundle?

When you already know that your product will be available in several fragrances or colors, the Bundle provides a convenient way to arrange the base Safety Substantiation and its variations together.

Instead of ordering the base assessment first and adding variations separately, you can submit the complete product range for assessment at once.

What do we need from you?

Please provide:

• The complete formula for the base product
• The complete formulas for all variations
• Ingredient documentation
• Fragrance documentation, where applicable
• Colorant documentation, where applicable
• Any additional information requested by our safety assessors

Our safety experts will review the base formula and each submitted variation to determine whether the available safety information adequately substantiates the safety of the cosmetic products under their intended conditions of use.