Assessment and authorization of cosmetics

In the EU, cosmetic ingredients as well as cosmetic products are regulated by the European Cosmetics Directive 1223/2009/EC. Manufacturers are obligated to generate data on their cosmetic ingredients or products before placing them on the market.

A broad range of different ingredients are used in cos­metic products: UV filters, dyes and preservatives are only some of them. The use of these different classes is limited and strictly regulated in 1223/2009/EC. But also other substance classes such as fragrances, which are not regulated in the Cosmetics Directive, need to be evaluated for safety be­fore they can be sold to cosmetic product manufacturers.

According to 1223/2009/EC, manufacturers of cosmetic products need to provide a product information file (PIF) for their cosmetic products, before they can place them on the market. This file contains product and safety information as well as a product safety report.

Over the past 20 years, we have prepared substance assessments and safety evaluations at national and international levels for different regulatory purposes. At Fraunhofer ITEM, we support our clients in all scientific and regulatory issues. This includes the evaluation of all data available, identification and assessment of critical hazards, and preparation of PIFs. We furthermore support our clients with safety evaluations of fragrances and aromas, taking into account relevant safety standards of the International Fragrance Association (IFRA standards).