Objectives of the online training course

Safety of cosmetics is a key issue in the EU. 

Cosmetics in the EU are regulated by Regulation (EC) N° 1223/2009, requiring that cosmetic products are shown to be safe before reaching the market. This must be done through safety assessment and for that purpose a unique dossier (Product Information File, PIF) need to be composed by a qualified safety assessor for each individual cosmetic coming on the European market. Safety assessment of cosmetic products in Europe is based on the safety assessment of the composing ingredients and is exposure-driven. This scientific exercise is usual performed based on data obtained through animal experimentation. Since 11 March 2013, the testing and marketing bans that were introduced via the 7th Amendment of the former Cosmetic Directive 76/768/EC, fully apply. This means that oral No-observable-Adverse-Effect-Levels (NOAELs), obtained through sub-chronic toxicity studies or developmental toxicity studies, are no longer available. New ways to guarantee the safety of cosmetic products must be explored. Therefore, the topic of New Generation Risk Assessment (NGRA) of cosmetics has been added to this training course.

Key questions to be tackled by the course

  • What are the key points of Regulation EC 1223/2009?
  • What rules apply for borderline products?
  • What are the current challenges in safety assessment of cosmetics in the EU?
  • Which role does risk perception play in our society and how does it affect the cosmetic industry?
  • What are animal-free alternative methods? What are NAMs?
  • What validated replacement tests do we actually have? How to interpret the results?
  • How to integrate in chemico, in silico and in vitro data with historical in vivo data into a PIF?
  • What in silico methodology is available that is useful in safety assessment of cosmetics and their ingredients?  
  • Which role does local toxicity testing play in the safety assessment of cosmetics?
  • Which role does systemic toxicity testing play in the safety assessment of cosmetics? 
  • What is NGRA? How to apply this new methodology for the assessment of long-term toxicity of cosmetic ingredients? 
  • How to apply NGRA for the assessment of skin sensitization of a cosmetic ingredient? 
  • How to deal with nanoparticles in cosmetic products?
  • How to make a PIF for a finished cosmetic product according to the actual EU Regulation?
  • How to make a complete dossier for a cosmetic ingredient to be taken up in the Annexes of the Regulation?
  • What are the packaging requirements under Annex I?
  • How to practically use the Notes of Guidance of the Scientific Committee on Consumer Safety (SCCS)?