Suchergebnisse

Background: Methods and approaches that can be used in toxicology and safety assessment are changing at a faster pace than ever. Members of the International Life Sciences Institute (ILSI) Europe have formed an expert group to review possibilities, opportunities and challenges for the potential use of non-animal testing strategies in food safety and nutrition research, which can ultimately be used in support of regulatory submissions for pre-market authorisation. Scope and approach: For the different areas of food improvement agents, genetically modified foods and novel foods, the acceptability of non-animal strategies is evaluated in comparison to legislative requirements in Europe. Current hazard and risk assessment tools that do not require additional animal testing are reviewed and emerging tools and methodologies considered, covering advanced in vitro methods, in silico and system biology approaches and high-throughput methods for mode-of-action assessment. Conclusions: The paper highlights the great potential for research strategies to be developed that reduce or avoid the use of animal tests, with the generation of more human-relevant data from multiple sources. It also shows the discordance in current legislation: on one hand saying non-animal strategies should be used, but on the other hand not providing sufficient guidance, leading in practice to lack of use of these non-animal testing strategies. This emphasizes the need for scientific developments and acceptability to be more reflected in legislation (e.g. guidance). What are we waiting for?

Background: Methods and approaches that can be used in toxicology and safety assessment are changing at a faster pace than ever. Members of the International Life Sciences Institute (ILSI) Europe have formed an expert group to review possibilities, opportunities and challenges for the potential use of non-animal testing strategies in food safety and nutrition research, which can ultimately be used in support of regulatory submissions for pre-market authorisation. Scope and approach: For the different areas of food improvement agents, genetically modified foods and novel foods, the acceptability of non-animal strategies is evaluated in comparison to legislative requirements in Europe. Current hazard and risk assessment tools that do not require additional animal testing are reviewed and emerging tools and methodologies considered, covering advanced in vitro methods, in silico and system biology approaches and high-throughput methods for mode-of-action assessment. Conclusions: The paper highlights the great potential for research strategies to be developed that reduce or avoid the use of animal tests, with the generation of more human-relevant data from multiple sources. It also shows the discordance in current legislation: on one hand saying non-animal strategies should be used, but on the other hand not providing sufficient guidance, leading in practice to lack of use of these non-animal testing strategies. This emphasizes the need for scientific developments and acceptability to be more reflected in legislation (e.g. guidance). What are we waiting for?