Cosmetic Product Safety Report (CPSR) on skin cream for a major UK healthcare products manufacturer

Client

A major UK health care products manufacturer.

Background

Under European Regulation (EC) 1223/2009, cosmetic manufacturers, importers or distributers must ensure that a cosmetic Product Safety Report (CPSR) has been compiled as part of the Product Information File (PIF) on their cosmetic product. The CPSR includes toxicological profiles on each cosmetic ingredient, as well as information on the product’s stability and microbiological quality. An assessment of overall safety should be carried out by a suitably qualified individual, and bibra scientists are more than qualified.

Project Goals

Compile a CPSR on a multi-component skin cream.

Approach

Bibra searched and reviewed the available literature to create toxicological profiles on the eight ingredients used in the skin cream, focussing on endpoints relevant to reasonably anticipated exposures. The possibility of component interactions was also considered. These profiles were compiled into a final peer-reviewed CPSR, together with the required non-toxicological information. By assessing the available data, a principal (and EUROTOX registered) bibra toxicologist provided a conclusion on the likely overall safety of the skin cream product.

Project Outcome

Bibra successfully provided the client with the completed CPSR, enabling them to continue to market the product in the EU in compliance with the new Cosmetics Regulation.

Project Leaders

Pete Watts
Beth O’Connell

Cosmetic Product Safety Reports

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