Workshop on Mode of Action and Human Relevance Framework under CLH, BP and PPP Regulations
The workshop on Mode of Action and Human Relevance Framework in the context of Classification and Labelling (CLH) and Regulatory Assessment of Biocides and Plant Protection Products, took place on the 4th of November 2014 at ECHA. The workshop was organised by ECHA in collaboration with EFSA.
The aim of the workshop
- To present the current scientific activities on modes or mechanisms of action (MoA), human relevance framework (HRF) and adverse outcome pathways (AOPs)
- To present the regulatory status of human relevance analysis in Europe under CLP, PPP, and BP Regulations
- In the context of CLH, to review existing tools, analyses and frameworks which could help to translate scientific knowledge in support of regulatory decisions
- To address scientific challenges by promoting and developing the scientific and regulatory capacity of scientific committees and other actors.
The Workshop on MoA and HRF under CLH, BP and PPP Regulations brought together 55 participants from Member State Competent Authorities, RAC members, industry representatives, EFSA, ECHA, the European Commission Joint Research Centre, the European Commission and Academia. This workshop was also streamed live via a web conference which was followed by 84 people.
Workshop agenda and report
- Welcome & Background and objectives of the workshop – Jack de Bruijn, Fabrice Broeckaert, ECHA
- Scientific decision-making in a Committee context – Tim Bowmer, ECHA RAC Chairperson
- WHO/OECD work on Mode of Action: MoA/HRF & AOP: key definitions, concepts and current activities – George Fotakis, ECHA
- Background and Regulatory challenges of CLH for PPP/BPs - Bennard van Ravenzwaay, European Crop Protection
- Challenges of MoA/HRF under CLH – Marja Pronk, RAC
- Challenges of MoA/HRF under the PPP review - Danièle Court Marques, EFSA
- Similar and dissimilar mode of actions for PPPs - Susanne Hougaard Bennekou - Danish EPA – EFSA PPR Panel Vice Chair
- Practical application of the MOA/HRF framework in the assessment of PPPs - Alan R Boobis, Imperial College London
- Case studies with TK/TD aspects and species differences - Jos Bessems, Joint Research Centre
- MoA Carcinogenicity Case Study – Christian Strupp, Carole Langrand-Lerche, Claire Terry, European Crop Protection
- MoA Reproductive Toxicity Case Study - Ivana Fegert, Claire Terry, European Crop Protection