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Safety Assessment of Cosmetics in the EU

Safety of cosmetics is an important issue in the EU. From July 2013 onwards, the cosmetic Regulation EC 1223/2009 is instantly and directly enforced across the EU. Main drivers for this new legislation are codification, streamlining and simplifying to obtain a better harmonization between the 28 Member States.

The basic principles remain the same as before. Namely a cosmetic product on the EU market must be safe, and one must be in the position to demonstrate this safety by so-called 'Product Information File' (PIF), containing the safety assessment of the cosmetic product under consideration and its ingredients. It is compiled by a safety assessor, a qualified professional in the possession of a diploma or other evidence of formal qualifications, including completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State.

The 'Safety Assessment of Cosmetics in the EU' course is realized in close collaboration with the cosmetic industry and enables its participants to acquire the necessary qualifications. Particular emphasis is given to the toxicological requirements imposed at the Commission level with respect to cosmetic ingredients testing, application of alternative methods and the interpretation of the results. Practical exercises, with focus on the preparation of a PIF for a finished cosmetic product according to Annex I of Regulation EC 1223/2009, are included.

Key questions to be tackled by the course:

  • What are the major practical and legislative changes between the previous Directive 76/768/EEC and Regulation EC 1223/2009?
  • What are current challenges in safety assessment of cosmetics in the EU?
  • Are there special requirements for products that can be inhaled?
  • Which role does risk perception play in our society and how does it affect the cosmetic industry?
  • What is the impact of other legislations on the cosmetic industry?
  • What are 'validated' and 'valid' alternative methods? What is their actual use and how to perform these tests?
  • Which role does systemic toxicity testing play in the safety assessment of cosmetics?
  • How to make a Product Information File for a finished cosmetic product according to the actual EU Regulation?
  • How to make a Product Information File for a cosmetic ingredient to be taken up in one of the positive lists present in the actual Regulation?
  • Are there special requirements for nanoparticles-containing cosmetics?
  • What are the packaging requirements under Annex I?
  • Can the process of risk assessment be improved by new methodologies?

For detailed course programme, registration and other practical information, please visit the official course website:


Mrs. Manon Vivier or Mrs. Fabienne Van Bamis
+32 (0)2 4774507