Assessment and authorization of cosmetics

Regulatory research beyond standard toxicology

Registration and risk assessment of cosmetics
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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.

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).

Our services

We support you with regulatory affairs in the authorization of your cosmetics.

Our services

 
  • Scientific and regulatory advice
  • Consulting on the registration strategy and the implementation of regulatory requirements

Services for fragrances

  • Evaluation of existing data
  • Safety assessment
  • Preparation of IFRA standards

Services for cosmetic products

  • Evaluation of existing data
  • Study monitoring (e.g. stability of cosmetic products)
  • Exposure assessment
  • Safety evaluation
  • Preparation of a product information file

Further services

  • Training courses
  • Assistance with strategic decisions and production development
  • In-house exposure measurements and analytics (focus on release estimation of spray products)

Our expertise

Our team of experienced human and environmental toxicologists offers:

  • Long-term experience in dossier preparation for chemicals and biocides and other legislation
  • Exposure assessment and risk assessment for human health and the environment
  • Consulting and support in related regulatory areas including biocides, human and veterinary medicinal products, and food additives
  • Qualification through DGK seminars (safety assessor DGK)
  • Evaluation and development of concepts and methods for chemical risk assessment including development of (Q)SAR/read-across, exposure models, and risk mitigation measures

Your contact for the assessment and authorization of cosmetics

Contact Press / Media

Dr. Stefanie Scheffler

Researcher

Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM
Nikolai-Fuchs-Str. 1
30625 Hannover

Phone +49 511 5350-366

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