EU Regulatory Update: The Individual Safety Assessment–a Practical Approach towards Regulation (EC) No 1223/2009

By: Annelie Struessmann, PhD, CONUSBAT

Posted: October 19, 2011

page 2 of 2

After the characterization of the product ingredients, the overall product safety assessment requires the risk assessment of the finished cosmetic product. This includes product stability testing and may also involve tests on humans that need to be based on distinct scientific and ethical requirements, as provided by the World Medical Association and through the EU's Good Clinical Practice Compliance. Specific aspects for human volunteer compatibility studies on finished cosmetic products are described in the guidance documents SCCNFP/0068/98 and SCCNFP/0245/99.

Another important aspect for the safety of the finished cosmetic product is the microbiological quality. In the Notes of Guidance, the necessity to perform a microbiological analysis for each batch of the finished product is requested and rationalized. The safety assessors' view is that attention should be paid to substances and mixtures that are susceptible to microbiological contamination, e.g. water-based mixtures, protein-rich materials and plant or animal raw materials. However, for products with a low microbiological risk—i.e. products with >20% alcohol content, products based on organic solvents or high/low pH products—neither a preservation challenge test nor a microbiological quality test in the finished product are considered necessary.  The parameters examined, the criteria and methods used, the results per batch and, if applicable, the reasoning for non-inclusion of microbiological data have to be included in the CPSR’s part B.