Do you already have a MoCRA Cosmetic Safety Substantiation for a cosmetic product and want to introduce a variation with a different fragrance or color? Our Variation Safety Substantiation allows eligible product variations to be assessed based on an existing base formula.

This service is intended for products where the base formulation remains the same and only one specific aspect is changed.

What is considered a variation?

A product may qualify as a variation when the existing base formula remains unchanged, except for:

• A different fragrance, while the rest of the formulation remains the same; or
• A different color or colorant combination, while the rest of the formulation remains the same.

For example, if you already have a substantiated body lotion and want to offer the same lotion in a different fragrance, this may be assessed as a variation. The same applies when the formulation remains identical but the product is offered in another color.

When is it a new recipe?

If both the fragrance and the color are changed, we consider the product to be a new recipe rather than a variation. In this case, a new full MoCRA Cosmetic Safety Substantiation is required.

Changes to other ingredients, ingredient concentrations, the base formulation, or other characteristics that may affect product safety may also mean that the product does not qualify for the variation service.

What we assess

For each variation, our safety experts review the changes compared with the previously assessed base formula. We evaluate the safety information relevant to the changed ingredient(s) and determine whether the available evidence supports the safety of the variation under its intended conditions of use.

The assessment is documented to support your company’s MoCRA safety substantiation records.

Requirements

To use this service, you must already have a MoCRA Cosmetic Safety Substantiation for the base formula. You will need to provide:

• The existing/base formula and its Safety Substantiation
• The complete formula of the variation
• Documentation for the new fragrance or colorant(s), where applicable
• Any additional documentation requested by our safety assessors

Important

One variation = one change type.

Different fragrance only → Variation
Different color only → Variation
Different fragrance + different color → New recipe / full Safety Substantiation

This approach helps keep the assessment process efficient while ensuring that each marketed cosmetic product is supported by appropriate safety documentation.