Peter Fisk Associates and University of Surrey hold Collaborative Conference on Natural Products
January 19th, 2015
The conference ‘Natural Products Research to Regulation’ was held on November 19th at Surrey University. This was the first of a series of events focusing on natural product chemistry and the associated regulatory challenges.
In addition to addressing some of the challenges of the regulation specific to natural products, case studies of bringing such substances to the market were presented.
Dr Rüdiger Hauschild – (head of biopesticides, GAB Consulting), gave a comprehensive summary of the regulatory aspects of natural products in the area of plant protection and biocidal products. Dr Hauschild emphasised that generally there are no specific distinctions in place for natural products in the relevant regulations, although European Commission (DG SANCO) guidance is available on botanical active substances for use in plant protection products.
Dr Lucius Tamm (FiBL Switzerland) addressed the challenges and opportunities of developing botanical based plant protection products, with some details from product case studies.
Dr David Potter and Dr Peter Gibson from GW Pharmaceuticals presented their work on development of cannabinoid pharmaceutical products. This included aspects of bringing the products to the market, with focus on demonstrating product consistency and efficacy.
Dr Anton Hutter of patent attorneys Venner Shipley addressed the importance and intricacies of patenting plant isolates. Dr Hutter shared some valuable insights into the patenting process at national and international level.
PFA’s presentations focussed on sharing learning points gained from the risk assessment of natural products and very complex substances (such as substances of Unknown or Variable composition, Complex reaction products or Biological materials – ‘UVCB’) for registrations under REACH. This included the application of ‘blocking methods’ – grouping of similar constituents in complex mixtures based on similar properties – to simplify the risk assessment of such substances. The importance of identifying substances with high hazard potential (substances of very high concern – ‘SVHC’) was also highlighted, since the identification of a substance as an SVHC due to the hazard profile of one or more of its constituents can mean that its uses can be limited or banned.
PFA will be following up the event with a free webinar on the risk assessment of UVCBs. This topic was highlighted as one of the key areas of uncertainty regarding how to fulfil regulatory requirements for natural products, and to-date regulatory guidance on the matter is limited.